Dermatology News

A diagnosis of atopic dermatitis in individuals ages 15 years or older, compared with controls without atopic dermatitis, was nearly twice as likely to be associated with autoimmune disease, in a case control study derived from Swedish national health care registry data.

Atopic dermatitis (AD) is known to be associated with other atopic conditions, and there is increasing evidence it is associated with some nonatopic conditions, including some cancers, cardiovascular disease, and neuropsychiatric disorders, according to Lina U. Ivert, MD, of the dermatology and venereology unit at the Karolinska Institutet, Stockholm, and coauthors. There are also some data indicating that autoimmune diseases, particularly those involving the skin and gastrointestinal tract, are more common in people with AD.

The aim of their study, published in the British Journal of Dermatology, was to investigate a wide spectrum of autoimmune diseases for associations with AD in a large-scale, population-based study using Swedish registers. Findings could lead to better monitoring of comorbidities and deeper understanding of disease burden and AD pathophysiology, they noted.
 

Large-scale study

With data from the Swedish Board of Health and Welfare’s National Patient Register on inpatient diagnoses since 1964 and specialist outpatient visits since 2001, the investigators included all patients aged 15 years and older with AD diagnoses (104,832) and matched them with controls from the general population (1,022,435). The authors noted that the large number of people included in the analysis allowed for robust estimates, and underscored that 80% of the AD patients included had received their diagnosis in a dermatology department, which reduces the risk of misclassification.

Association with autoimmune disease

The investigators found an association between AD and autoimmune disease, with an adjusted odds ratio) of 1.97 (95% confidence interval, 1.93-2.01). The association was present with several organ systems, particularly the skin and gastrointestinal tract, and with connective tissue diseases. The strongest associations with autoimmune skin diseases were found for dermatitis herpetiformis (aOR, 9.76; 95% CI, 8.10-11.8), alopecia areata (aOR, 5.11; 95% CI, 4.75-5.49), and chronic urticaria (aOR, 4.82; 95% CI, 4.48-5.19).

AD was associated with gastrointestinal diseases, including celiac disease (aOR, 1.96; 95% CI, 1.84-2.09), Crohn disease (aOR 1.83; CI, 1.71-1.96), and ulcerative colitis (aOR 1.58; 95% CI, 1.49-1.68).

Connective tissue diseases significantly associated with AD included systemic lupus erythematosus (aOR, 1.65; 95% CI, 1.42-1.90), ankylosing spondylitis (aOR, 1.46; 95% CI, 1.29-1.66), and RA (aOR, 1.44; 95% CI,1.34-1.54]). Hematologic or hepatic autoimmune disease associations with AD were not observed.
 

Stronger association with multiple diseases

The association between AD and two or more autoimmune diseases was significantly stronger than the association between AD and having one autoimmune disease. For example, the OR for AD among people with three to five autoimmune diseases was 3.33 (95% CI, 2.86-3.87), and was stronger in men (OR, 3.96; 95% CI, 2.92-5.37) than in women (OR, 3.14; 95% CI, 2.63-3.74).
 

Sex differences

In the study overall, the association with AD and autoimmune diseases was stronger in men (aOR, 2.18; 95% CI, 2.10-2.25), compared with women (aOR, 1.89; 95% CI, 1.85-1.93), but this “sex difference was only statistically significant between AD and RA and between AD and Celiac disease,” they noted.

Associations between AD and dermatomyositis, systemic scleroderma, systemic lupus erythematosus, Hashimoto’s disease, Graves disease, multiple sclerosis, and polymyalgia rheumatica were found only in women. Dr. Ivert and coauthors observed that “women are in general more likely to develop autoimmune diseases, and 80% of patients with autoimmune diseases are women.”
 

Provocative questions

Commenting on the findings, Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology, George Washington University, Washington, said, “At a high level, it is important for clinicians to recognize that atopic dermatitis is a systemic immune-mediated disease. AD is associated with higher rates of comorbid autoimmune disease, similar to psoriasis and other chronic inflammatory skin diseases.”

“At this point, there is nothing immediately actionable about these results,” noted Dr. Silverberg, who was not an author of this study. “That said, in my mind, they raise some provocative questions: What is the difference between AD in adults who do versus those who do not get comorbid autoimmune disease? Does AD then present differently? Does it respond to the same therapies? These will have to be the subject of future research.”

The study was funded by the Swedish Asthma and Allergy Association Research Foundation, Hudfonden (the Welander-Finsen Foundation), and the Swedish Society for Dermatology and Venereology. The authors disclosed no conflicts of interest.

SOURCE: Ivert LU et al. Br J Dermatol. 2020 Oct 22. doi: 10.1111/bjd.19624.

A diagnosis of atopic dermatitis in individuals ages 15 years or older, compared with controls without atopic dermatitis, was nearly twice as likely to be associated with autoimmune disease, in a case control study derived from Swedish national health care registry data.

Atopic dermatitis (AD) is known to be associated with other atopic conditions, and there is increasing evidence it is associated with some nonatopic conditions, including some cancers, cardiovascular disease, and neuropsychiatric disorders, according to Lina U. Ivert, MD, of the dermatology and venereology unit at the Karolinska Institutet, Stockholm, and coauthors. There are also some data indicating that autoimmune diseases, particularly those involving the skin and gastrointestinal tract, are more common in people with AD.

The aim of their study, published in the British Journal of Dermatology, was to investigate a wide spectrum of autoimmune diseases for associations with AD in a large-scale, population-based study using Swedish registers. Findings could lead to better monitoring of comorbidities and deeper understanding of disease burden and AD pathophysiology, they noted.
 

Large-scale study

With data from the Swedish Board of Health and Welfare’s National Patient Register on inpatient diagnoses since 1964 and specialist outpatient visits since 2001, the investigators included all patients aged 15 years and older with AD diagnoses (104,832) and matched them with controls from the general population (1,022,435). The authors noted that the large number of people included in the analysis allowed for robust estimates, and underscored that 80% of the AD patients included had received their diagnosis in a dermatology department, which reduces the risk of misclassification.

Association with autoimmune disease

The investigators found an association between AD and autoimmune disease, with an adjusted odds ratio) of 1.97 (95% confidence interval, 1.93-2.01). The association was present with several organ systems, particularly the skin and gastrointestinal tract, and with connective tissue diseases. The strongest associations with autoimmune skin diseases were found for dermatitis herpetiformis (aOR, 9.76; 95% CI, 8.10-11.8), alopecia areata (aOR, 5.11; 95% CI, 4.75-5.49), and chronic urticaria (aOR, 4.82; 95% CI, 4.48-5.19).

AD was associated with gastrointestinal diseases, including celiac disease (aOR, 1.96; 95% CI, 1.84-2.09), Crohn disease (aOR 1.83; CI, 1.71-1.96), and ulcerative colitis (aOR 1.58; 95% CI, 1.49-1.68).

Connective tissue diseases significantly associated with AD included systemic lupus erythematosus (aOR, 1.65; 95% CI, 1.42-1.90), ankylosing spondylitis (aOR, 1.46; 95% CI, 1.29-1.66), and RA (aOR, 1.44; 95% CI,1.34-1.54]). Hematologic or hepatic autoimmune disease associations with AD were not observed.
 

Stronger association with multiple diseases

The association between AD and two or more autoimmune diseases was significantly stronger than the association between AD and having one autoimmune disease. For example, the OR for AD among people with three to five autoimmune diseases was 3.33 (95% CI, 2.86-3.87), and was stronger in men (OR, 3.96; 95% CI, 2.92-5.37) than in women (OR, 3.14; 95% CI, 2.63-3.74).
 

Sex differences

In the study overall, the association with AD and autoimmune diseases was stronger in men (aOR, 2.18; 95% CI, 2.10-2.25), compared with women (aOR, 1.89; 95% CI, 1.85-1.93), but this “sex difference was only statistically significant between AD and RA and between AD and Celiac disease,” they noted.

Associations between AD and dermatomyositis, systemic scleroderma, systemic lupus erythematosus, Hashimoto’s disease, Graves disease, multiple sclerosis, and polymyalgia rheumatica were found only in women. Dr. Ivert and coauthors observed that “women are in general more likely to develop autoimmune diseases, and 80% of patients with autoimmune diseases are women.”
 

Provocative questions

Commenting on the findings, Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology, George Washington University, Washington, said, “At a high level, it is important for clinicians to recognize that atopic dermatitis is a systemic immune-mediated disease. AD is associated with higher rates of comorbid autoimmune disease, similar to psoriasis and other chronic inflammatory skin diseases.”

“At this point, there is nothing immediately actionable about these results,” noted Dr. Silverberg, who was not an author of this study. “That said, in my mind, they raise some provocative questions: What is the difference between AD in adults who do versus those who do not get comorbid autoimmune disease? Does AD then present differently? Does it respond to the same therapies? These will have to be the subject of future research.”

The study was funded by the Swedish Asthma and Allergy Association Research Foundation, Hudfonden (the Welander-Finsen Foundation), and the Swedish Society for Dermatology and Venereology. The authors disclosed no conflicts of interest.

SOURCE: Ivert LU et al. Br J Dermatol. 2020 Oct 22. doi: 10.1111/bjd.19624.

A diagnosis of atopic dermatitis in individuals ages 15 years or older, compared with controls without atopic dermatitis, was nearly twice as likely to be associated with autoimmune disease, in a case control study derived from Swedish national health care registry data.

Atopic dermatitis (AD) is known to be associated with other atopic conditions, and there is increasing evidence it is associated with some nonatopic conditions, including some cancers, cardiovascular disease, and neuropsychiatric disorders, according to Lina U. Ivert, MD, of the dermatology and venereology unit at the Karolinska Institutet, Stockholm, and coauthors. There are also some data indicating that autoimmune diseases, particularly those involving the skin and gastrointestinal tract, are more common in people with AD.

The aim of their study, published in the British Journal of Dermatology, was to investigate a wide spectrum of autoimmune diseases for associations with AD in a large-scale, population-based study using Swedish registers. Findings could lead to better monitoring of comorbidities and deeper understanding of disease burden and AD pathophysiology, they noted.
 

Large-scale study

With data from the Swedish Board of Health and Welfare’s National Patient Register on inpatient diagnoses since 1964 and specialist outpatient visits since 2001, the investigators included all patients aged 15 years and older with AD diagnoses (104,832) and matched them with controls from the general population (1,022,435). The authors noted that the large number of people included in the analysis allowed for robust estimates, and underscored that 80% of the AD patients included had received their diagnosis in a dermatology department, which reduces the risk of misclassification.

Association with autoimmune disease

The investigators found an association between AD and autoimmune disease, with an adjusted odds ratio) of 1.97 (95% confidence interval, 1.93-2.01). The association was present with several organ systems, particularly the skin and gastrointestinal tract, and with connective tissue diseases. The strongest associations with autoimmune skin diseases were found for dermatitis herpetiformis (aOR, 9.76; 95% CI, 8.10-11.8), alopecia areata (aOR, 5.11; 95% CI, 4.75-5.49), and chronic urticaria (aOR, 4.82; 95% CI, 4.48-5.19).

AD was associated with gastrointestinal diseases, including celiac disease (aOR, 1.96; 95% CI, 1.84-2.09), Crohn disease (aOR 1.83; CI, 1.71-1.96), and ulcerative colitis (aOR 1.58; 95% CI, 1.49-1.68).

Connective tissue diseases significantly associated with AD included systemic lupus erythematosus (aOR, 1.65; 95% CI, 1.42-1.90), ankylosing spondylitis (aOR, 1.46; 95% CI, 1.29-1.66), and RA (aOR, 1.44; 95% CI,1.34-1.54]). Hematologic or hepatic autoimmune disease associations with AD were not observed.
 

Stronger association with multiple diseases

The association between AD and two or more autoimmune diseases was significantly stronger than the association between AD and having one autoimmune disease. For example, the OR for AD among people with three to five autoimmune diseases was 3.33 (95% CI, 2.86-3.87), and was stronger in men (OR, 3.96; 95% CI, 2.92-5.37) than in women (OR, 3.14; 95% CI, 2.63-3.74).
 

Sex differences

In the study overall, the association with AD and autoimmune diseases was stronger in men (aOR, 2.18; 95% CI, 2.10-2.25), compared with women (aOR, 1.89; 95% CI, 1.85-1.93), but this “sex difference was only statistically significant between AD and RA and between AD and Celiac disease,” they noted.

Associations between AD and dermatomyositis, systemic scleroderma, systemic lupus erythematosus, Hashimoto’s disease, Graves disease, multiple sclerosis, and polymyalgia rheumatica were found only in women. Dr. Ivert and coauthors observed that “women are in general more likely to develop autoimmune diseases, and 80% of patients with autoimmune diseases are women.”
 

Provocative questions

Commenting on the findings, Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology, George Washington University, Washington, said, “At a high level, it is important for clinicians to recognize that atopic dermatitis is a systemic immune-mediated disease. AD is associated with higher rates of comorbid autoimmune disease, similar to psoriasis and other chronic inflammatory skin diseases.”

“At this point, there is nothing immediately actionable about these results,” noted Dr. Silverberg, who was not an author of this study. “That said, in my mind, they raise some provocative questions: What is the difference between AD in adults who do versus those who do not get comorbid autoimmune disease? Does AD then present differently? Does it respond to the same therapies? These will have to be the subject of future research.”

The study was funded by the Swedish Asthma and Allergy Association Research Foundation, Hudfonden (the Welander-Finsen Foundation), and the Swedish Society for Dermatology and Venereology. The authors disclosed no conflicts of interest.

SOURCE: Ivert LU et al. Br J Dermatol. 2020 Oct 22. doi: 10.1111/bjd.19624.

Wound cultures from patients with the rare disease epidermolysis bullosa (EB) were most frequently positive for Staphylococcus aureus (SA), Pseudomonas aeruginosa (PA), and Streptococcus pyogenes (GAS) – and antibiotic resistance was common – in a retrospective analysis of over 700 wound cultures from 158 patients across the United States and Canada.

The findings from the EB Clinical Characterization and Outcomes Database speak to the value of surveillance cultures with routine testing for microbial resistance – including mupirocin resistance – and to the importance of antibiotic stewardship not only for oral antibiotics but for topicals as well, according to Laura E. Levin, MD, and Kimberly D. Morel, MD, of the departments of dermatology and pediatrics, Columbia University Irving Medical Center, New York, the lead and senior authors, respectively, of the paper recently published in Pediatric Dermatology.

Almost all of the 158 patients with at least one wound culture recorded in the database from the period of 2001-2018 had one or more positive culture results. Of 152 patients with positive cultures, 131 (86%) were positive for SA and 56 (37%) and 34 (22%) were positive for PA and GAS, respectively. Other bacteria isolated included Corynebacterium spp and Proteus spp. Nearly half (47%) of patients with SA-positive cultures had methicillin-resistant SA, and 68% had methicillin-susceptible SA. (Some patients grew both MSSA and MRSA at different points in time.)

Mupirocin-susceptibility testing was performed at only some of the 13 participating centers. Of 15 patients whose cultures had recorded SA mupirocin-susceptibility testing, 11 had cultures positive for mupirocin-susceptible SA and 6 (40%) had mupirocin-resistant SA isolates (2 patients grew both). Of these six patients, half had isolates that were also methicillin-resistant.

Mupirocin, a topical antibiotic, has been a cornerstone of decolonization regimens for MSSA and MRSA, but resistance has been demonstrated in other research as well and is not specific to EB, wrote Dr. Levin, Dr. Morel, and coauthors.

“Pediatric dermatologists often rely on topical antimicrobials in the treatment of patients’ open wounds to both prevent and treat infection, depending on the clinical scenario,” and surveillance cultures with routine testing for mupirocin resistance can help guide antibiotic choice and management strategies, Dr. Levin said in an interview.

More broadly, she added, “it’s helpful to know what bacteria are routinely colonizing wounds, not causing infection, versus those that are more likely to be associated with infection, chronic wounds, or the risk of developing skin cancer ... [to know] which wounds need to be treated more aggressively.”

A subset of patients with EB have been known to be at risk for squamous cell carcinoma, and research is implicating certain bacteria “as contributing to wound inflammation,” Dr. Morel said in an interview.

SCC was reported in 23 out of 717 patients in the database – but fewer than half of the patients with SCC had recorded wound cultures. The small numbers precluded the identification of microbes that may confer significant risk.

Correlating particular microbes with clinical features also will take more research. About half (57%) of the patients with recorded wound cultures had wounds with purulent exudate or other features of clinical infection. However, the presence or absence of clinical signs of infection was not temporally correlated with culture results in the database.

The 158 patients with recorded wound cultures had a mean age of 12.8 years and represented a range of EB subtypes.

PA was present in the wounds of patients as young as 1 month old, the authors noted. Investigators are “looking to further study PA and characterize clinical features ... to understand more about this microbe and its impact on patients with EB,” Dr. Morel said.

In the meantime, the analysis reaffirms the importance of antibiotic stewardship. Mupirocin is labeled to be used three times a day for a short period of time, but “tends to be prescribed and used less judiciously than intended,” Dr. Morel said. “It’s important [not to overuse it]. We have seen that patients’ culture results become sensitive to mupirocin again in the future when they avoid it for a period of time.”

The work was supported by the EB Research Partnership and EB Medical Research Foundation, as well as an NIH/NCATS grant. No investigator disclosures were listed.

SOURCE: Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14444.

Wound cultures from patients with the rare disease epidermolysis bullosa (EB) were most frequently positive for Staphylococcus aureus (SA), Pseudomonas aeruginosa (PA), and Streptococcus pyogenes (GAS) – and antibiotic resistance was common – in a retrospective analysis of over 700 wound cultures from 158 patients across the United States and Canada.

The findings from the EB Clinical Characterization and Outcomes Database speak to the value of surveillance cultures with routine testing for microbial resistance – including mupirocin resistance – and to the importance of antibiotic stewardship not only for oral antibiotics but for topicals as well, according to Laura E. Levin, MD, and Kimberly D. Morel, MD, of the departments of dermatology and pediatrics, Columbia University Irving Medical Center, New York, the lead and senior authors, respectively, of the paper recently published in Pediatric Dermatology.

Almost all of the 158 patients with at least one wound culture recorded in the database from the period of 2001-2018 had one or more positive culture results. Of 152 patients with positive cultures, 131 (86%) were positive for SA and 56 (37%) and 34 (22%) were positive for PA and GAS, respectively. Other bacteria isolated included Corynebacterium spp and Proteus spp. Nearly half (47%) of patients with SA-positive cultures had methicillin-resistant SA, and 68% had methicillin-susceptible SA. (Some patients grew both MSSA and MRSA at different points in time.)

Mupirocin-susceptibility testing was performed at only some of the 13 participating centers. Of 15 patients whose cultures had recorded SA mupirocin-susceptibility testing, 11 had cultures positive for mupirocin-susceptible SA and 6 (40%) had mupirocin-resistant SA isolates (2 patients grew both). Of these six patients, half had isolates that were also methicillin-resistant.

Mupirocin, a topical antibiotic, has been a cornerstone of decolonization regimens for MSSA and MRSA, but resistance has been demonstrated in other research as well and is not specific to EB, wrote Dr. Levin, Dr. Morel, and coauthors.

“Pediatric dermatologists often rely on topical antimicrobials in the treatment of patients’ open wounds to both prevent and treat infection, depending on the clinical scenario,” and surveillance cultures with routine testing for mupirocin resistance can help guide antibiotic choice and management strategies, Dr. Levin said in an interview.

More broadly, she added, “it’s helpful to know what bacteria are routinely colonizing wounds, not causing infection, versus those that are more likely to be associated with infection, chronic wounds, or the risk of developing skin cancer ... [to know] which wounds need to be treated more aggressively.”

A subset of patients with EB have been known to be at risk for squamous cell carcinoma, and research is implicating certain bacteria “as contributing to wound inflammation,” Dr. Morel said in an interview.

SCC was reported in 23 out of 717 patients in the database – but fewer than half of the patients with SCC had recorded wound cultures. The small numbers precluded the identification of microbes that may confer significant risk.

Correlating particular microbes with clinical features also will take more research. About half (57%) of the patients with recorded wound cultures had wounds with purulent exudate or other features of clinical infection. However, the presence or absence of clinical signs of infection was not temporally correlated with culture results in the database.

The 158 patients with recorded wound cultures had a mean age of 12.8 years and represented a range of EB subtypes.

PA was present in the wounds of patients as young as 1 month old, the authors noted. Investigators are “looking to further study PA and characterize clinical features ... to understand more about this microbe and its impact on patients with EB,” Dr. Morel said.

In the meantime, the analysis reaffirms the importance of antibiotic stewardship. Mupirocin is labeled to be used three times a day for a short period of time, but “tends to be prescribed and used less judiciously than intended,” Dr. Morel said. “It’s important [not to overuse it]. We have seen that patients’ culture results become sensitive to mupirocin again in the future when they avoid it for a period of time.”

The work was supported by the EB Research Partnership and EB Medical Research Foundation, as well as an NIH/NCATS grant. No investigator disclosures were listed.

SOURCE: Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14444.

Wound cultures from patients with the rare disease epidermolysis bullosa (EB) were most frequently positive for Staphylococcus aureus (SA), Pseudomonas aeruginosa (PA), and Streptococcus pyogenes (GAS) – and antibiotic resistance was common – in a retrospective analysis of over 700 wound cultures from 158 patients across the United States and Canada.

The findings from the EB Clinical Characterization and Outcomes Database speak to the value of surveillance cultures with routine testing for microbial resistance – including mupirocin resistance – and to the importance of antibiotic stewardship not only for oral antibiotics but for topicals as well, according to Laura E. Levin, MD, and Kimberly D. Morel, MD, of the departments of dermatology and pediatrics, Columbia University Irving Medical Center, New York, the lead and senior authors, respectively, of the paper recently published in Pediatric Dermatology.

Almost all of the 158 patients with at least one wound culture recorded in the database from the period of 2001-2018 had one or more positive culture results. Of 152 patients with positive cultures, 131 (86%) were positive for SA and 56 (37%) and 34 (22%) were positive for PA and GAS, respectively. Other bacteria isolated included Corynebacterium spp and Proteus spp. Nearly half (47%) of patients with SA-positive cultures had methicillin-resistant SA, and 68% had methicillin-susceptible SA. (Some patients grew both MSSA and MRSA at different points in time.)

Mupirocin-susceptibility testing was performed at only some of the 13 participating centers. Of 15 patients whose cultures had recorded SA mupirocin-susceptibility testing, 11 had cultures positive for mupirocin-susceptible SA and 6 (40%) had mupirocin-resistant SA isolates (2 patients grew both). Of these six patients, half had isolates that were also methicillin-resistant.

Mupirocin, a topical antibiotic, has been a cornerstone of decolonization regimens for MSSA and MRSA, but resistance has been demonstrated in other research as well and is not specific to EB, wrote Dr. Levin, Dr. Morel, and coauthors.

“Pediatric dermatologists often rely on topical antimicrobials in the treatment of patients’ open wounds to both prevent and treat infection, depending on the clinical scenario,” and surveillance cultures with routine testing for mupirocin resistance can help guide antibiotic choice and management strategies, Dr. Levin said in an interview.

More broadly, she added, “it’s helpful to know what bacteria are routinely colonizing wounds, not causing infection, versus those that are more likely to be associated with infection, chronic wounds, or the risk of developing skin cancer ... [to know] which wounds need to be treated more aggressively.”

A subset of patients with EB have been known to be at risk for squamous cell carcinoma, and research is implicating certain bacteria “as contributing to wound inflammation,” Dr. Morel said in an interview.

SCC was reported in 23 out of 717 patients in the database – but fewer than half of the patients with SCC had recorded wound cultures. The small numbers precluded the identification of microbes that may confer significant risk.

Correlating particular microbes with clinical features also will take more research. About half (57%) of the patients with recorded wound cultures had wounds with purulent exudate or other features of clinical infection. However, the presence or absence of clinical signs of infection was not temporally correlated with culture results in the database.

The 158 patients with recorded wound cultures had a mean age of 12.8 years and represented a range of EB subtypes.

PA was present in the wounds of patients as young as 1 month old, the authors noted. Investigators are “looking to further study PA and characterize clinical features ... to understand more about this microbe and its impact on patients with EB,” Dr. Morel said.

In the meantime, the analysis reaffirms the importance of antibiotic stewardship. Mupirocin is labeled to be used three times a day for a short period of time, but “tends to be prescribed and used less judiciously than intended,” Dr. Morel said. “It’s important [not to overuse it]. We have seen that patients’ culture results become sensitive to mupirocin again in the future when they avoid it for a period of time.”

The work was supported by the EB Research Partnership and EB Medical Research Foundation, as well as an NIH/NCATS grant. No investigator disclosures were listed.

SOURCE: Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14444.

Optical treatments for acne are emerging as promising alternatives to conventional treatments, a development that inspires clinician researchers such as Fernanda H. Sakamoto, MD, PhD.

“I love treating acne, because it can have a huge impact on our patients’ lives,” Dr. Sakamoto, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “Acne is the most common disease in dermatology, affecting about 80% of our patients. Eleven percent of these patients have difficult-to-treat acne, and it is also the No. 1 cause of depression and suicide among teenagers and young adults. And, even though there’s no strong evidence that optical treatments work better than conventional acne treatments, people still spend a lot on those treatments: more than 220 million in 2019.”

Early results from a pilot study suggest that use of a novel laser system known as Accure in patients with mild to moderate acne resulted in an 80% reduction in acne lesions at 12 weeks. The laser prototype, which uses a 1,726 nm wavelength and is being developed by researchers at the Wellman Center for Photomedicine, features a built-in thermal camera in the handpiece that allows the user to monitor the skin’s temperature during treatment.

In initial pilot studies of the device, Dr. Sakamoto and colleagues observed consistent damage of the sebaceous glands, with no damage to the epidermis, surrounding dermis, or other follicular structures. “But because the contrast of absorption of lipids and water is not very high, we needed to create a laser with features that we have never seen before,” she said. “One of them is a robust cooling system. The second prototype features a built-in thermal camera within the handpiece that allows us to see the temperature while we’re treating the patient. It also has built-in software that would shut down the laser if the temperature is too high. “This is the first laser with some safety features that will give the user direct feedback while treating the patient,” she said, noting that its “unique cooling system and real-time monitoring ... makes it different from any of the lasers we see on the market right now.”

Dr. Sakamoto and colleagues (Emil Tanghetti, MD, in San Diego, Roy Geronemus, MD, in New York, and Joel L. Cohen, MD, in Colorado) are conducting a clinical trial of the device, to evaluate whether Accure can selectively target sebaceous glands. As of Oct. 23, 2020, the study enrolled more than 50 patients, who are followed at 4, 8, 12, and 24 weeks post treatment, she said.

To date, 16 patients have completed the study, and the researchers have observed an average lesion reduction of 80% at 12 weeks post treatment, after four treatment sessions. This amounted to more than 12,000 trigger pulls of the device, with no unexpected adverse events. Average visual analogue scale pain scores immediately after treatment have been 1.09 out of 10.

Histologic assessment of skin samples collected from the study participants have revealed selective damage of the sebaceous glands with a normal epidermis and surrounding dermis. “Because this laser is near infrared, it is not absorbed by melanin, making it possible for a safe treatment in darker skin tones,” Dr. Sakamoto said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine.

“We have shown that it is possible to create a selective laser for acne treatment at 1,726 nm. We have proven it mathematically as well as with histological samples,” she said. “Now we are moving on to a larger clinical trial for the FDA clearance.”

Another strategy being developed for acne treatment is to make nonselective lasers selective by adding gold microparticles into the hair follicle and sebaceous glands, to allow the lasers to be absorbed. In a study that used a free electron laser, Dr. Sakamoto and colleagues demonstrated that these microparticles can stay within the sebaceous glands for selective damage of the sebaceous glands. In a subsequent pilot clinical trial they showed that the addition of the gold microparticles followed by a diode laser treatment made it possible to reduce both inflammatory and noninflammatory lesions.

More recently, an open-label European study of acne treatment with light absorbing gold microparticles and optical pulses demonstrated that the treatment led to an 80%-90% reduction of inflammatory lesions at 12 weeks, with a reduction of Investigator’s Global Assessment scale from 2 to 4.

The Food and Drug Administration cleared the treatment, Sebacia Microparticles, for the treatment of mild to moderate acne in September of 2018, but according to Dr. Sakamoto, “the company has struggled, as they were only commercializing the device in California and Washington, DC.”

Photodynamic therapy (PDT) is also being studied as an acne treatment. “PDT uses a photosensitizer that needs to be activated by a light source,” she noted. “The combination of red light and aminolevulinic acid (ALA) or methyl ester ALA has been shown to damage the sebaceous glands”.

In a recent randomized controlled trial that compared PDT to adapalene gel plus oral doxycycline, PDT showed superiority. “Because PDT induces apoptosis of the sebaceous glands, it causes a lot of pain and side effects after treatment,” Dr. Sakamoto said. “However, it can clear 80%-90% of acne in 80%-90% of patients. But because of the side effects, PDT should be limited to those patients who cannot take conventional treatments.”

Dr. Sakamoto reported having received research funding and/or consulting fees from numerous device and pharmaceutical companies.

[email protected]

Optical treatments for acne are emerging as promising alternatives to conventional treatments, a development that inspires clinician researchers such as Fernanda H. Sakamoto, MD, PhD.

“I love treating acne, because it can have a huge impact on our patients’ lives,” Dr. Sakamoto, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “Acne is the most common disease in dermatology, affecting about 80% of our patients. Eleven percent of these patients have difficult-to-treat acne, and it is also the No. 1 cause of depression and suicide among teenagers and young adults. And, even though there’s no strong evidence that optical treatments work better than conventional acne treatments, people still spend a lot on those treatments: more than 220 million in 2019.”

Early results from a pilot study suggest that use of a novel laser system known as Accure in patients with mild to moderate acne resulted in an 80% reduction in acne lesions at 12 weeks. The laser prototype, which uses a 1,726 nm wavelength and is being developed by researchers at the Wellman Center for Photomedicine, features a built-in thermal camera in the handpiece that allows the user to monitor the skin’s temperature during treatment.

In initial pilot studies of the device, Dr. Sakamoto and colleagues observed consistent damage of the sebaceous glands, with no damage to the epidermis, surrounding dermis, or other follicular structures. “But because the contrast of absorption of lipids and water is not very high, we needed to create a laser with features that we have never seen before,” she said. “One of them is a robust cooling system. The second prototype features a built-in thermal camera within the handpiece that allows us to see the temperature while we’re treating the patient. It also has built-in software that would shut down the laser if the temperature is too high. “This is the first laser with some safety features that will give the user direct feedback while treating the patient,” she said, noting that its “unique cooling system and real-time monitoring ... makes it different from any of the lasers we see on the market right now.”

Dr. Sakamoto and colleagues (Emil Tanghetti, MD, in San Diego, Roy Geronemus, MD, in New York, and Joel L. Cohen, MD, in Colorado) are conducting a clinical trial of the device, to evaluate whether Accure can selectively target sebaceous glands. As of Oct. 23, 2020, the study enrolled more than 50 patients, who are followed at 4, 8, 12, and 24 weeks post treatment, she said.

To date, 16 patients have completed the study, and the researchers have observed an average lesion reduction of 80% at 12 weeks post treatment, after four treatment sessions. This amounted to more than 12,000 trigger pulls of the device, with no unexpected adverse events. Average visual analogue scale pain scores immediately after treatment have been 1.09 out of 10.

Histologic assessment of skin samples collected from the study participants have revealed selective damage of the sebaceous glands with a normal epidermis and surrounding dermis. “Because this laser is near infrared, it is not absorbed by melanin, making it possible for a safe treatment in darker skin tones,” Dr. Sakamoto said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine.

“We have shown that it is possible to create a selective laser for acne treatment at 1,726 nm. We have proven it mathematically as well as with histological samples,” she said. “Now we are moving on to a larger clinical trial for the FDA clearance.”

Another strategy being developed for acne treatment is to make nonselective lasers selective by adding gold microparticles into the hair follicle and sebaceous glands, to allow the lasers to be absorbed. In a study that used a free electron laser, Dr. Sakamoto and colleagues demonstrated that these microparticles can stay within the sebaceous glands for selective damage of the sebaceous glands. In a subsequent pilot clinical trial they showed that the addition of the gold microparticles followed by a diode laser treatment made it possible to reduce both inflammatory and noninflammatory lesions.

More recently, an open-label European study of acne treatment with light absorbing gold microparticles and optical pulses demonstrated that the treatment led to an 80%-90% reduction of inflammatory lesions at 12 weeks, with a reduction of Investigator’s Global Assessment scale from 2 to 4.

The Food and Drug Administration cleared the treatment, Sebacia Microparticles, for the treatment of mild to moderate acne in September of 2018, but according to Dr. Sakamoto, “the company has struggled, as they were only commercializing the device in California and Washington, DC.”

Photodynamic therapy (PDT) is also being studied as an acne treatment. “PDT uses a photosensitizer that needs to be activated by a light source,” she noted. “The combination of red light and aminolevulinic acid (ALA) or methyl ester ALA has been shown to damage the sebaceous glands”.

In a recent randomized controlled trial that compared PDT to adapalene gel plus oral doxycycline, PDT showed superiority. “Because PDT induces apoptosis of the sebaceous glands, it causes a lot of pain and side effects after treatment,” Dr. Sakamoto said. “However, it can clear 80%-90% of acne in 80%-90% of patients. But because of the side effects, PDT should be limited to those patients who cannot take conventional treatments.”

Dr. Sakamoto reported having received research funding and/or consulting fees from numerous device and pharmaceutical companies.

[email protected]

Optical treatments for acne are emerging as promising alternatives to conventional treatments, a development that inspires clinician researchers such as Fernanda H. Sakamoto, MD, PhD.

“I love treating acne, because it can have a huge impact on our patients’ lives,” Dr. Sakamoto, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “Acne is the most common disease in dermatology, affecting about 80% of our patients. Eleven percent of these patients have difficult-to-treat acne, and it is also the No. 1 cause of depression and suicide among teenagers and young adults. And, even though there’s no strong evidence that optical treatments work better than conventional acne treatments, people still spend a lot on those treatments: more than 220 million in 2019.”

Early results from a pilot study suggest that use of a novel laser system known as Accure in patients with mild to moderate acne resulted in an 80% reduction in acne lesions at 12 weeks. The laser prototype, which uses a 1,726 nm wavelength and is being developed by researchers at the Wellman Center for Photomedicine, features a built-in thermal camera in the handpiece that allows the user to monitor the skin’s temperature during treatment.

In initial pilot studies of the device, Dr. Sakamoto and colleagues observed consistent damage of the sebaceous glands, with no damage to the epidermis, surrounding dermis, or other follicular structures. “But because the contrast of absorption of lipids and water is not very high, we needed to create a laser with features that we have never seen before,” she said. “One of them is a robust cooling system. The second prototype features a built-in thermal camera within the handpiece that allows us to see the temperature while we’re treating the patient. It also has built-in software that would shut down the laser if the temperature is too high. “This is the first laser with some safety features that will give the user direct feedback while treating the patient,” she said, noting that its “unique cooling system and real-time monitoring ... makes it different from any of the lasers we see on the market right now.”

Dr. Sakamoto and colleagues (Emil Tanghetti, MD, in San Diego, Roy Geronemus, MD, in New York, and Joel L. Cohen, MD, in Colorado) are conducting a clinical trial of the device, to evaluate whether Accure can selectively target sebaceous glands. As of Oct. 23, 2020, the study enrolled more than 50 patients, who are followed at 4, 8, 12, and 24 weeks post treatment, she said.

To date, 16 patients have completed the study, and the researchers have observed an average lesion reduction of 80% at 12 weeks post treatment, after four treatment sessions. This amounted to more than 12,000 trigger pulls of the device, with no unexpected adverse events. Average visual analogue scale pain scores immediately after treatment have been 1.09 out of 10.

Histologic assessment of skin samples collected from the study participants have revealed selective damage of the sebaceous glands with a normal epidermis and surrounding dermis. “Because this laser is near infrared, it is not absorbed by melanin, making it possible for a safe treatment in darker skin tones,” Dr. Sakamoto said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine.

“We have shown that it is possible to create a selective laser for acne treatment at 1,726 nm. We have proven it mathematically as well as with histological samples,” she said. “Now we are moving on to a larger clinical trial for the FDA clearance.”

Another strategy being developed for acne treatment is to make nonselective lasers selective by adding gold microparticles into the hair follicle and sebaceous glands, to allow the lasers to be absorbed. In a study that used a free electron laser, Dr. Sakamoto and colleagues demonstrated that these microparticles can stay within the sebaceous glands for selective damage of the sebaceous glands. In a subsequent pilot clinical trial they showed that the addition of the gold microparticles followed by a diode laser treatment made it possible to reduce both inflammatory and noninflammatory lesions.

More recently, an open-label European study of acne treatment with light absorbing gold microparticles and optical pulses demonstrated that the treatment led to an 80%-90% reduction of inflammatory lesions at 12 weeks, with a reduction of Investigator’s Global Assessment scale from 2 to 4.

The Food and Drug Administration cleared the treatment, Sebacia Microparticles, for the treatment of mild to moderate acne in September of 2018, but according to Dr. Sakamoto, “the company has struggled, as they were only commercializing the device in California and Washington, DC.”

Photodynamic therapy (PDT) is also being studied as an acne treatment. “PDT uses a photosensitizer that needs to be activated by a light source,” she noted. “The combination of red light and aminolevulinic acid (ALA) or methyl ester ALA has been shown to damage the sebaceous glands”.

In a recent randomized controlled trial that compared PDT to adapalene gel plus oral doxycycline, PDT showed superiority. “Because PDT induces apoptosis of the sebaceous glands, it causes a lot of pain and side effects after treatment,” Dr. Sakamoto said. “However, it can clear 80%-90% of acne in 80%-90% of patients. But because of the side effects, PDT should be limited to those patients who cannot take conventional treatments.”

Dr. Sakamoto reported having received research funding and/or consulting fees from numerous device and pharmaceutical companies.

[email protected]

Poor sleep health and attention regulation problems are common in young children with atopic dermatitis (AD), and the burden intensifies with worse severity, results from a national survey demonstrated.

“We think it’s important for dermatologists and pediatricians to be monitoring children with AD for sleep and attention dysregulation,” Nina Y. Zhou said during a late-breaking research session at the Revolutionizing Atopic Dermatitis virtual symposium. “It’s also important to highlight sleep hygiene habits to improve sleep health overall.”

In an effort to determine the impact of AD severity on these symptoms in young children with AD and characterize sleep health and attention regulation behaviors, Ms. Zhou, a medical student at Northwestern University, Chicago, and colleagues drew from a national survey distributed via panel company OP4G and the National Eczema Association that was conducted with parents of 60 children with AD aged 1-5 years. Questionnaires included the Patient Reported Outcomes Measurement Information System (PROMIS) Early Childhood Sleep Health Measures to assess sleep health, the Peak Pruritus NRS to measure itch severity, and the Multidimensional Assessment Profile of Attention Regulation (MAPS-AR) to measure attention dysregulation related to inattention and hyperactivity. The researchers performed linear regression to determine the predictors of sleep health and attention dysregulation.

The mean age of 60 children was 3 years, 55% were male, 32% were black, 42% had severe disease, 42% had moderate disease, and 16% had mild disease. Children with more extensive AD were significantly more likely to report worse sleep disturbance. The proportion of children who reported sleep disturbance on at least 5 nights per week was 67% among those with severe AD, 24% among those with moderate AD, and 0% among those with mild AD.

In addition, 72% of parents of children with severe AD reported trouble paying attention at least 3 times per week “no matter what was going on,” compared with 24% of those with moderate AD and none of those with mild AD.

Parents of children with more severe AD reported more itch-related burden and significantly decreased quality of life for their children. For example, 76% of parents with children who had severe AD reported “because of itch, their child was frustrated,” compared to 44% of those with moderate AD and 10% with mild AD.

In fully adjusted linear regression analysis, the strongest predictors of sleep disturbance were AD severity (unstandardized beta value = 0.79, P less than .01) and being Black (unstandardized beta value = 3.89, P = .03). AD severity (unstandardized beta value = 1.22, P less than .01) and being Black (unstandardized beta value = 7.79, P less than .01) also predicted more attention dysregulation.

Household income appeared to differ significantly based on AD severity groups. “If you have mild AD, you are more likely to come from a higher income household,” Ms. Zhou said.

She concluded her presentation by calling for future studies with larger samples sizes to establish causality and directional effects between AD severity, itch, sleep, race, and attention.

The study was funded by the Agency for Healthcare Research and Quality. Ms. Zhou reported having no financial disclosures.

[email protected]

Poor sleep health and attention regulation problems are common in young children with atopic dermatitis (AD), and the burden intensifies with worse severity, results from a national survey demonstrated.

“We think it’s important for dermatologists and pediatricians to be monitoring children with AD for sleep and attention dysregulation,” Nina Y. Zhou said during a late-breaking research session at the Revolutionizing Atopic Dermatitis virtual symposium. “It’s also important to highlight sleep hygiene habits to improve sleep health overall.”

In an effort to determine the impact of AD severity on these symptoms in young children with AD and characterize sleep health and attention regulation behaviors, Ms. Zhou, a medical student at Northwestern University, Chicago, and colleagues drew from a national survey distributed via panel company OP4G and the National Eczema Association that was conducted with parents of 60 children with AD aged 1-5 years. Questionnaires included the Patient Reported Outcomes Measurement Information System (PROMIS) Early Childhood Sleep Health Measures to assess sleep health, the Peak Pruritus NRS to measure itch severity, and the Multidimensional Assessment Profile of Attention Regulation (MAPS-AR) to measure attention dysregulation related to inattention and hyperactivity. The researchers performed linear regression to determine the predictors of sleep health and attention dysregulation.

The mean age of 60 children was 3 years, 55% were male, 32% were black, 42% had severe disease, 42% had moderate disease, and 16% had mild disease. Children with more extensive AD were significantly more likely to report worse sleep disturbance. The proportion of children who reported sleep disturbance on at least 5 nights per week was 67% among those with severe AD, 24% among those with moderate AD, and 0% among those with mild AD.

In addition, 72% of parents of children with severe AD reported trouble paying attention at least 3 times per week “no matter what was going on,” compared with 24% of those with moderate AD and none of those with mild AD.

Parents of children with more severe AD reported more itch-related burden and significantly decreased quality of life for their children. For example, 76% of parents with children who had severe AD reported “because of itch, their child was frustrated,” compared to 44% of those with moderate AD and 10% with mild AD.

In fully adjusted linear regression analysis, the strongest predictors of sleep disturbance were AD severity (unstandardized beta value = 0.79, P less than .01) and being Black (unstandardized beta value = 3.89, P = .03). AD severity (unstandardized beta value = 1.22, P less than .01) and being Black (unstandardized beta value = 7.79, P less than .01) also predicted more attention dysregulation.

Household income appeared to differ significantly based on AD severity groups. “If you have mild AD, you are more likely to come from a higher income household,” Ms. Zhou said.

She concluded her presentation by calling for future studies with larger samples sizes to establish causality and directional effects between AD severity, itch, sleep, race, and attention.

The study was funded by the Agency for Healthcare Research and Quality. Ms. Zhou reported having no financial disclosures.

[email protected]

Poor sleep health and attention regulation problems are common in young children with atopic dermatitis (AD), and the burden intensifies with worse severity, results from a national survey demonstrated.

“We think it’s important for dermatologists and pediatricians to be monitoring children with AD for sleep and attention dysregulation,” Nina Y. Zhou said during a late-breaking research session at the Revolutionizing Atopic Dermatitis virtual symposium. “It’s also important to highlight sleep hygiene habits to improve sleep health overall.”

In an effort to determine the impact of AD severity on these symptoms in young children with AD and characterize sleep health and attention regulation behaviors, Ms. Zhou, a medical student at Northwestern University, Chicago, and colleagues drew from a national survey distributed via panel company OP4G and the National Eczema Association that was conducted with parents of 60 children with AD aged 1-5 years. Questionnaires included the Patient Reported Outcomes Measurement Information System (PROMIS) Early Childhood Sleep Health Measures to assess sleep health, the Peak Pruritus NRS to measure itch severity, and the Multidimensional Assessment Profile of Attention Regulation (MAPS-AR) to measure attention dysregulation related to inattention and hyperactivity. The researchers performed linear regression to determine the predictors of sleep health and attention dysregulation.

The mean age of 60 children was 3 years, 55% were male, 32% were black, 42% had severe disease, 42% had moderate disease, and 16% had mild disease. Children with more extensive AD were significantly more likely to report worse sleep disturbance. The proportion of children who reported sleep disturbance on at least 5 nights per week was 67% among those with severe AD, 24% among those with moderate AD, and 0% among those with mild AD.

In addition, 72% of parents of children with severe AD reported trouble paying attention at least 3 times per week “no matter what was going on,” compared with 24% of those with moderate AD and none of those with mild AD.

Parents of children with more severe AD reported more itch-related burden and significantly decreased quality of life for their children. For example, 76% of parents with children who had severe AD reported “because of itch, their child was frustrated,” compared to 44% of those with moderate AD and 10% with mild AD.

In fully adjusted linear regression analysis, the strongest predictors of sleep disturbance were AD severity (unstandardized beta value = 0.79, P less than .01) and being Black (unstandardized beta value = 3.89, P = .03). AD severity (unstandardized beta value = 1.22, P less than .01) and being Black (unstandardized beta value = 7.79, P less than .01) also predicted more attention dysregulation.

Household income appeared to differ significantly based on AD severity groups. “If you have mild AD, you are more likely to come from a higher income household,” Ms. Zhou said.

She concluded her presentation by calling for future studies with larger samples sizes to establish causality and directional effects between AD severity, itch, sleep, race, and attention.

The study was funded by the Agency for Healthcare Research and Quality. Ms. Zhou reported having no financial disclosures.

[email protected]

Mortality rates for inpatients with COVID-19 dropped significantly during the first 6 months of the pandemic, but outcomes depend on the hospital where patients receive care, new data show.

“[T]he characteristic that is most associated with poor or worsening hospital outcomes is high or increasing community case rates,” write David A. Asch, MD, MBA, executive director of the Center for Health Care Innovation at the University of Pennsylvania in Philadelphia, and colleagues.

The relationship between COVID-19 mortality rates and local disease prevalence suggests that “hospitals do worse when they are burdened with cases and is consistent with imperatives to flatten the curve,” the authors continue. “As case rates of COVID-19 increase across the nation, hospital mortality outcomes may worsen.”

The researchers published their study online December 22 in JAMA Internal Medicine.

The quick and substantial improvement in survival “is a tribute in part to new science — for example, the science that revealed the benefits of dexamethasone,” Asch told Medscape Medical News. “But it’s also a tribute to the doctors and nurses in the hospitals who developed experience. It’s a cliché to refer to them as heroes, but that is what they are. The science and the heroic experience continues on, and so I’m optimistic that we’ll see even more improvement over time.”

However, the data also indicate that “with lots of disease in the community, hospitals may have a harder time keeping patients alive,” Asch said.  “And of course the reason this is bad news is that community level case rates are rising all over, and in some cases at rapid rates. With that rise, we might be giving back some of our past gains in survival — just as the vaccine is beginning to be distributed.”
 

Examining mortality trends

The researchers analyzed administrative claims data from a large national health insurer. They included data from 38,517 adults who were admitted with COVID-19 to 955 US hospitals between January 1 and June 30 of this year. The investigators estimated hospitals’ risk-standardized rate of 30-day in-hospital mortality or referral to hospice, adjusted for patient-level characteristics.

Overall, 3179 patients (8.25%) died, and 1433 patients (3.7%) were referred to hospice. Risk-standardized mortality or hospice referral rates for individual hospitals ranged from 5.7% to 24.7%. The average rate was 9.1% in the best-performing quintile, compared with 15.7% in the worst-performing quintile.

In a subset of 398 hospitals that had at least 10 patients admitted for COVID-19 during early (January 1 through April 30) and later periods (between May 1 and June 30), rates in all but one hospital improved, and 94% improved by at least 25%. The average risk-standardized event rate declined from 16.6% to 9.3%.

“That rate of relative improvement is striking and encouraging, but perhaps not surprising,” Asch and coauthors write. “Early efforts at treating patients with COVID-19 were based on experience with previously known causes of severe respiratory illness. Later efforts could draw on experiences specific to SARS-CoV-2 infection.”

For instance, doctors tried different inpatient management approaches, such as early vs late assisted ventilation, differences in oxygen flow, prone or supine positioning, and anticoagulation. “Those efforts varied in how systematically they were evaluated, but our results suggest that valuable experience was gained,” the authors note.

In addition, variation between hospitals could reflect differences in quality or different admission thresholds, they continue.

The study provides “a reason for optimism that our healthcare system has improved in our ability to care for persons with COVID-19,” write Leon Boudourakis, MD, MHS, and Amit Uppal, MD, in a related commentary. Boudourakis and Uppal are both affiliated with NYC Health + Hospitals in New York City and with SUNY Downstate and New York University School of Medicine, respectively.

Similar improvements in mortality rates have been reported in the United Kingdom and in a New York City hospital system, the editorialists note. The lower mortality rates may represent clinical, healthcare system, and epidemiologic trends.

“Since the first wave of serious COVID-19 cases, physicians have learned a great deal about the best ways to treat this serious infection,” they say. “Steroids may decrease mortality in patients with respiratory failure. Remdesivir may shorten hospitalizations of patients with serious illness. Anticoagulation and prone positioning may help certain patients. Using noninvasive ventilation and high-flow oxygen therapy may spare subsets of patients from the harms of intubation, such as ventilator-induced lung injury.»
 

Overwhelmed hospitals

“Hospitals do not perform as well when they are overwhelmed,” which may be a reason for the correlation between community prevalence and mortality rates, Boudourakis and Uppal suggested. “In particular, patients with a precarious respiratory status require expert, meticulous therapy to avoid intubation; those who undergo intubation or have kidney failure require nuanced and timely expert care with ventilatory adjustments and kidney replacement therapy, which are difficult to perform optimally when hospital capacity is strained.”

Although the death rate has fallen to about 9% for hospitalized patients, “9% is still high,” Asch said.

“Our results show that hospitals can’t do it on their own,” Asch said. “They need all of us to keep the community spread of the disease down. The right answer now is the right answer since the beginning of the pandemic: Keep your distance, wash your hands, and wear a mask.”

Asch, Boudourakis, and Uppal have disclosed no relevant financial relationships. A study coauthor reported personal fees and grants from pharmaceutical companies outside the submitted work.

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

Mortality rates for inpatients with COVID-19 dropped significantly during the first 6 months of the pandemic, but outcomes depend on the hospital where patients receive care, new data show.

“[T]he characteristic that is most associated with poor or worsening hospital outcomes is high or increasing community case rates,” write David A. Asch, MD, MBA, executive director of the Center for Health Care Innovation at the University of Pennsylvania in Philadelphia, and colleagues.

The relationship between COVID-19 mortality rates and local disease prevalence suggests that “hospitals do worse when they are burdened with cases and is consistent with imperatives to flatten the curve,” the authors continue. “As case rates of COVID-19 increase across the nation, hospital mortality outcomes may worsen.”

The researchers published their study online December 22 in JAMA Internal Medicine.

The quick and substantial improvement in survival “is a tribute in part to new science — for example, the science that revealed the benefits of dexamethasone,” Asch told Medscape Medical News. “But it’s also a tribute to the doctors and nurses in the hospitals who developed experience. It’s a cliché to refer to them as heroes, but that is what they are. The science and the heroic experience continues on, and so I’m optimistic that we’ll see even more improvement over time.”

However, the data also indicate that “with lots of disease in the community, hospitals may have a harder time keeping patients alive,” Asch said.  “And of course the reason this is bad news is that community level case rates are rising all over, and in some cases at rapid rates. With that rise, we might be giving back some of our past gains in survival — just as the vaccine is beginning to be distributed.”
 

Examining mortality trends

The researchers analyzed administrative claims data from a large national health insurer. They included data from 38,517 adults who were admitted with COVID-19 to 955 US hospitals between January 1 and June 30 of this year. The investigators estimated hospitals’ risk-standardized rate of 30-day in-hospital mortality or referral to hospice, adjusted for patient-level characteristics.

Overall, 3179 patients (8.25%) died, and 1433 patients (3.7%) were referred to hospice. Risk-standardized mortality or hospice referral rates for individual hospitals ranged from 5.7% to 24.7%. The average rate was 9.1% in the best-performing quintile, compared with 15.7% in the worst-performing quintile.

In a subset of 398 hospitals that had at least 10 patients admitted for COVID-19 during early (January 1 through April 30) and later periods (between May 1 and June 30), rates in all but one hospital improved, and 94% improved by at least 25%. The average risk-standardized event rate declined from 16.6% to 9.3%.

“That rate of relative improvement is striking and encouraging, but perhaps not surprising,” Asch and coauthors write. “Early efforts at treating patients with COVID-19 were based on experience with previously known causes of severe respiratory illness. Later efforts could draw on experiences specific to SARS-CoV-2 infection.”

For instance, doctors tried different inpatient management approaches, such as early vs late assisted ventilation, differences in oxygen flow, prone or supine positioning, and anticoagulation. “Those efforts varied in how systematically they were evaluated, but our results suggest that valuable experience was gained,” the authors note.

In addition, variation between hospitals could reflect differences in quality or different admission thresholds, they continue.

The study provides “a reason for optimism that our healthcare system has improved in our ability to care for persons with COVID-19,” write Leon Boudourakis, MD, MHS, and Amit Uppal, MD, in a related commentary. Boudourakis and Uppal are both affiliated with NYC Health + Hospitals in New York City and with SUNY Downstate and New York University School of Medicine, respectively.

Similar improvements in mortality rates have been reported in the United Kingdom and in a New York City hospital system, the editorialists note. The lower mortality rates may represent clinical, healthcare system, and epidemiologic trends.

“Since the first wave of serious COVID-19 cases, physicians have learned a great deal about the best ways to treat this serious infection,” they say. “Steroids may decrease mortality in patients with respiratory failure. Remdesivir may shorten hospitalizations of patients with serious illness. Anticoagulation and prone positioning may help certain patients. Using noninvasive ventilation and high-flow oxygen therapy may spare subsets of patients from the harms of intubation, such as ventilator-induced lung injury.»
 

Overwhelmed hospitals

“Hospitals do not perform as well when they are overwhelmed,” which may be a reason for the correlation between community prevalence and mortality rates, Boudourakis and Uppal suggested. “In particular, patients with a precarious respiratory status require expert, meticulous therapy to avoid intubation; those who undergo intubation or have kidney failure require nuanced and timely expert care with ventilatory adjustments and kidney replacement therapy, which are difficult to perform optimally when hospital capacity is strained.”

Although the death rate has fallen to about 9% for hospitalized patients, “9% is still high,” Asch said.

“Our results show that hospitals can’t do it on their own,” Asch said. “They need all of us to keep the community spread of the disease down. The right answer now is the right answer since the beginning of the pandemic: Keep your distance, wash your hands, and wear a mask.”

Asch, Boudourakis, and Uppal have disclosed no relevant financial relationships. A study coauthor reported personal fees and grants from pharmaceutical companies outside the submitted work.

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

Mortality rates for inpatients with COVID-19 dropped significantly during the first 6 months of the pandemic, but outcomes depend on the hospital where patients receive care, new data show.

“[T]he characteristic that is most associated with poor or worsening hospital outcomes is high or increasing community case rates,” write David A. Asch, MD, MBA, executive director of the Center for Health Care Innovation at the University of Pennsylvania in Philadelphia, and colleagues.

The relationship between COVID-19 mortality rates and local disease prevalence suggests that “hospitals do worse when they are burdened with cases and is consistent with imperatives to flatten the curve,” the authors continue. “As case rates of COVID-19 increase across the nation, hospital mortality outcomes may worsen.”

The researchers published their study online December 22 in JAMA Internal Medicine.

The quick and substantial improvement in survival “is a tribute in part to new science — for example, the science that revealed the benefits of dexamethasone,” Asch told Medscape Medical News. “But it’s also a tribute to the doctors and nurses in the hospitals who developed experience. It’s a cliché to refer to them as heroes, but that is what they are. The science and the heroic experience continues on, and so I’m optimistic that we’ll see even more improvement over time.”

However, the data also indicate that “with lots of disease in the community, hospitals may have a harder time keeping patients alive,” Asch said.  “And of course the reason this is bad news is that community level case rates are rising all over, and in some cases at rapid rates. With that rise, we might be giving back some of our past gains in survival — just as the vaccine is beginning to be distributed.”
 

Examining mortality trends

The researchers analyzed administrative claims data from a large national health insurer. They included data from 38,517 adults who were admitted with COVID-19 to 955 US hospitals between January 1 and June 30 of this year. The investigators estimated hospitals’ risk-standardized rate of 30-day in-hospital mortality or referral to hospice, adjusted for patient-level characteristics.

Overall, 3179 patients (8.25%) died, and 1433 patients (3.7%) were referred to hospice. Risk-standardized mortality or hospice referral rates for individual hospitals ranged from 5.7% to 24.7%. The average rate was 9.1% in the best-performing quintile, compared with 15.7% in the worst-performing quintile.

In a subset of 398 hospitals that had at least 10 patients admitted for COVID-19 during early (January 1 through April 30) and later periods (between May 1 and June 30), rates in all but one hospital improved, and 94% improved by at least 25%. The average risk-standardized event rate declined from 16.6% to 9.3%.

“That rate of relative improvement is striking and encouraging, but perhaps not surprising,” Asch and coauthors write. “Early efforts at treating patients with COVID-19 were based on experience with previously known causes of severe respiratory illness. Later efforts could draw on experiences specific to SARS-CoV-2 infection.”

For instance, doctors tried different inpatient management approaches, such as early vs late assisted ventilation, differences in oxygen flow, prone or supine positioning, and anticoagulation. “Those efforts varied in how systematically they were evaluated, but our results suggest that valuable experience was gained,” the authors note.

In addition, variation between hospitals could reflect differences in quality or different admission thresholds, they continue.

The study provides “a reason for optimism that our healthcare system has improved in our ability to care for persons with COVID-19,” write Leon Boudourakis, MD, MHS, and Amit Uppal, MD, in a related commentary. Boudourakis and Uppal are both affiliated with NYC Health + Hospitals in New York City and with SUNY Downstate and New York University School of Medicine, respectively.

Similar improvements in mortality rates have been reported in the United Kingdom and in a New York City hospital system, the editorialists note. The lower mortality rates may represent clinical, healthcare system, and epidemiologic trends.

“Since the first wave of serious COVID-19 cases, physicians have learned a great deal about the best ways to treat this serious infection,” they say. “Steroids may decrease mortality in patients with respiratory failure. Remdesivir may shorten hospitalizations of patients with serious illness. Anticoagulation and prone positioning may help certain patients. Using noninvasive ventilation and high-flow oxygen therapy may spare subsets of patients from the harms of intubation, such as ventilator-induced lung injury.»
 

Overwhelmed hospitals

“Hospitals do not perform as well when they are overwhelmed,” which may be a reason for the correlation between community prevalence and mortality rates, Boudourakis and Uppal suggested. “In particular, patients with a precarious respiratory status require expert, meticulous therapy to avoid intubation; those who undergo intubation or have kidney failure require nuanced and timely expert care with ventilatory adjustments and kidney replacement therapy, which are difficult to perform optimally when hospital capacity is strained.”

Although the death rate has fallen to about 9% for hospitalized patients, “9% is still high,” Asch said.

“Our results show that hospitals can’t do it on their own,” Asch said. “They need all of us to keep the community spread of the disease down. The right answer now is the right answer since the beginning of the pandemic: Keep your distance, wash your hands, and wear a mask.”

Asch, Boudourakis, and Uppal have disclosed no relevant financial relationships. A study coauthor reported personal fees and grants from pharmaceutical companies outside the submitted work.

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

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) evaluated Moderna’s COVID-19 vaccine as highly effective with a favorable safety profile, based on interim data from an ongoing phase 3 trial.

The panel acknowledged that further studies will be required post issuance of an Emergency Use Authorization (EUA) to collect additional data on the safety and effectiveness of the vaccine. A briefing document released by the FDA on Dec. 17, 2020, summarized interim results and included recommendations from VRBPAC on use of Moderna’s mRNA-1273 COVID-19 vaccine.

“On November 30, 2020, ModernaTX (the Sponsor) submitted an EUA request to FDA for an investigational COVID-19 vaccine (mRNA-1273) intended to prevent COVID-19,” the committee wrote.
 

The mRNA-1273 vaccine trial

Among 30,351 individuals aged 18 years and older, the efficacy, safety, and immunogenicity of the mRNA-1273 vaccine candidate was evaluated in a randomized, stratified, observer-blind, placebo-controlled phase 3 study. Participants were randomly assigned (1:1) to receive two injections of either 100 mcg of mRNA-1273 (n = 15,181) or saline placebo (n = 15,170) administered intramuscularly on day 1 and day 29.

The primary efficacy endpoint was efficacy of mRNA-1273 against PCR-confirmed COVID-19 with onset at least 14 days following the second dose. The primary safety endpoint was to characterize the safety of the vaccine following one or two doses.
 

Efficacy

Among 27,817 subjects included in the first interim analysis (data cutoff: Nov. 7, 2020), 5 cases of COVID-19 with onset at least 14 days after the second dose occurred among vaccine recipients and 90 case occurred among placebo recipients, corresponding to 94.5% vaccine efficacy (95% confidence interval, 86.5%-97.8%).

“Subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across age groups, genders, racial and ethnic groups, and participants with medical comorbidities associated with high risk of severe COVID-19,” they reported.

Data from the final scheduled analysis of the primary efficacy endpoint (data cutoff: Nov. 21, 2020; median follow-up of >2 months after dose 2), demonstrated 94.1% vaccine efficacy (95% confidence interval, 89.3%-96.8%), corresponding to 11 cases of COVID-19 in the vaccine group and 185 cases in the placebo group.

When stratified by age, the vaccine efficacy was 95.6% (95% CI, 90.6%-97.9%) for individuals 18-64 years of age and 86.4% (95% CI, 61.4%-95.5%) for those 65 years of age or older.

In addition, results from secondary analyses indicated benefit for mRNA-1273 in preventing severe COVID-19 cases, COVID-19 in those with prior SARS-CoV-2 infection, and infection after the first dose, but these data were not conclusive.
 

Safety

Among 30,350 subjects included in the first interim analysis (data cutoff: Nov. 11, 2020; median follow-up of 7 weeks post second dose), no specific safety concerns were observed that would prevent issuance of an EUA.

Additional safety data (data cutoff: Nov. 25, 2020; median follow-up of 9 weeks post second dose) were provided on Dec. 7, 2020, but did not change the conclusions from the first interim analysis.

The most common vaccine-related adverse reactions were injection site pain (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44.8%), and chills (43.4%).

“The frequency of serious adverse events (SAEs) was low (1.0% in the mRNA-1273 arm and 1.0% in the placebo arm), without meaningful imbalances between study arms,” they reported.

Myocardial infarction (0.03%), nephrolithiasis (0.02%), and cholecystitis (0.02%) were the most common SAEs that were numerically greater in the vaccine arm than the placebo arm; however, the small number of cases does not infer a casual relationship.

“The 2-dose vaccination regimen was highly effective in preventing PCR-confirmed COVID-19 occurring at least 14 days after receipt of the second dose,” the committee wrote. “[However], it is critical to continue to gather data about the vaccine even after it is made available under EUA.”

The associated phase 3 study was sponsored by ModernaTX.

SOURCE: FDA Briefing Document: Moderna COVID-19 Vaccine. FDA Vaccines and Related Biological Products Advisory Committee. Published Dec. 17, 2020.

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) evaluated Moderna’s COVID-19 vaccine as highly effective with a favorable safety profile, based on interim data from an ongoing phase 3 trial.

The panel acknowledged that further studies will be required post issuance of an Emergency Use Authorization (EUA) to collect additional data on the safety and effectiveness of the vaccine. A briefing document released by the FDA on Dec. 17, 2020, summarized interim results and included recommendations from VRBPAC on use of Moderna’s mRNA-1273 COVID-19 vaccine.

“On November 30, 2020, ModernaTX (the Sponsor) submitted an EUA request to FDA for an investigational COVID-19 vaccine (mRNA-1273) intended to prevent COVID-19,” the committee wrote.
 

The mRNA-1273 vaccine trial

Among 30,351 individuals aged 18 years and older, the efficacy, safety, and immunogenicity of the mRNA-1273 vaccine candidate was evaluated in a randomized, stratified, observer-blind, placebo-controlled phase 3 study. Participants were randomly assigned (1:1) to receive two injections of either 100 mcg of mRNA-1273 (n = 15,181) or saline placebo (n = 15,170) administered intramuscularly on day 1 and day 29.

The primary efficacy endpoint was efficacy of mRNA-1273 against PCR-confirmed COVID-19 with onset at least 14 days following the second dose. The primary safety endpoint was to characterize the safety of the vaccine following one or two doses.
 

Efficacy

Among 27,817 subjects included in the first interim analysis (data cutoff: Nov. 7, 2020), 5 cases of COVID-19 with onset at least 14 days after the second dose occurred among vaccine recipients and 90 case occurred among placebo recipients, corresponding to 94.5% vaccine efficacy (95% confidence interval, 86.5%-97.8%).

“Subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across age groups, genders, racial and ethnic groups, and participants with medical comorbidities associated with high risk of severe COVID-19,” they reported.

Data from the final scheduled analysis of the primary efficacy endpoint (data cutoff: Nov. 21, 2020; median follow-up of >2 months after dose 2), demonstrated 94.1% vaccine efficacy (95% confidence interval, 89.3%-96.8%), corresponding to 11 cases of COVID-19 in the vaccine group and 185 cases in the placebo group.

When stratified by age, the vaccine efficacy was 95.6% (95% CI, 90.6%-97.9%) for individuals 18-64 years of age and 86.4% (95% CI, 61.4%-95.5%) for those 65 years of age or older.

In addition, results from secondary analyses indicated benefit for mRNA-1273 in preventing severe COVID-19 cases, COVID-19 in those with prior SARS-CoV-2 infection, and infection after the first dose, but these data were not conclusive.
 

Safety

Among 30,350 subjects included in the first interim analysis (data cutoff: Nov. 11, 2020; median follow-up of 7 weeks post second dose), no specific safety concerns were observed that would prevent issuance of an EUA.

Additional safety data (data cutoff: Nov. 25, 2020; median follow-up of 9 weeks post second dose) were provided on Dec. 7, 2020, but did not change the conclusions from the first interim analysis.

The most common vaccine-related adverse reactions were injection site pain (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44.8%), and chills (43.4%).

“The frequency of serious adverse events (SAEs) was low (1.0% in the mRNA-1273 arm and 1.0% in the placebo arm), without meaningful imbalances between study arms,” they reported.

Myocardial infarction (0.03%), nephrolithiasis (0.02%), and cholecystitis (0.02%) were the most common SAEs that were numerically greater in the vaccine arm than the placebo arm; however, the small number of cases does not infer a casual relationship.

“The 2-dose vaccination regimen was highly effective in preventing PCR-confirmed COVID-19 occurring at least 14 days after receipt of the second dose,” the committee wrote. “[However], it is critical to continue to gather data about the vaccine even after it is made available under EUA.”

The associated phase 3 study was sponsored by ModernaTX.

SOURCE: FDA Briefing Document: Moderna COVID-19 Vaccine. FDA Vaccines and Related Biological Products Advisory Committee. Published Dec. 17, 2020.

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) evaluated Moderna’s COVID-19 vaccine as highly effective with a favorable safety profile, based on interim data from an ongoing phase 3 trial.

The panel acknowledged that further studies will be required post issuance of an Emergency Use Authorization (EUA) to collect additional data on the safety and effectiveness of the vaccine. A briefing document released by the FDA on Dec. 17, 2020, summarized interim results and included recommendations from VRBPAC on use of Moderna’s mRNA-1273 COVID-19 vaccine.

“On November 30, 2020, ModernaTX (the Sponsor) submitted an EUA request to FDA for an investigational COVID-19 vaccine (mRNA-1273) intended to prevent COVID-19,” the committee wrote.
 

The mRNA-1273 vaccine trial

Among 30,351 individuals aged 18 years and older, the efficacy, safety, and immunogenicity of the mRNA-1273 vaccine candidate was evaluated in a randomized, stratified, observer-blind, placebo-controlled phase 3 study. Participants were randomly assigned (1:1) to receive two injections of either 100 mcg of mRNA-1273 (n = 15,181) or saline placebo (n = 15,170) administered intramuscularly on day 1 and day 29.

The primary efficacy endpoint was efficacy of mRNA-1273 against PCR-confirmed COVID-19 with onset at least 14 days following the second dose. The primary safety endpoint was to characterize the safety of the vaccine following one or two doses.
 

Efficacy

Among 27,817 subjects included in the first interim analysis (data cutoff: Nov. 7, 2020), 5 cases of COVID-19 with onset at least 14 days after the second dose occurred among vaccine recipients and 90 case occurred among placebo recipients, corresponding to 94.5% vaccine efficacy (95% confidence interval, 86.5%-97.8%).

“Subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across age groups, genders, racial and ethnic groups, and participants with medical comorbidities associated with high risk of severe COVID-19,” they reported.

Data from the final scheduled analysis of the primary efficacy endpoint (data cutoff: Nov. 21, 2020; median follow-up of >2 months after dose 2), demonstrated 94.1% vaccine efficacy (95% confidence interval, 89.3%-96.8%), corresponding to 11 cases of COVID-19 in the vaccine group and 185 cases in the placebo group.

When stratified by age, the vaccine efficacy was 95.6% (95% CI, 90.6%-97.9%) for individuals 18-64 years of age and 86.4% (95% CI, 61.4%-95.5%) for those 65 years of age or older.

In addition, results from secondary analyses indicated benefit for mRNA-1273 in preventing severe COVID-19 cases, COVID-19 in those with prior SARS-CoV-2 infection, and infection after the first dose, but these data were not conclusive.
 

Safety

Among 30,350 subjects included in the first interim analysis (data cutoff: Nov. 11, 2020; median follow-up of 7 weeks post second dose), no specific safety concerns were observed that would prevent issuance of an EUA.

Additional safety data (data cutoff: Nov. 25, 2020; median follow-up of 9 weeks post second dose) were provided on Dec. 7, 2020, but did not change the conclusions from the first interim analysis.

The most common vaccine-related adverse reactions were injection site pain (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44.8%), and chills (43.4%).

“The frequency of serious adverse events (SAEs) was low (1.0% in the mRNA-1273 arm and 1.0% in the placebo arm), without meaningful imbalances between study arms,” they reported.

Myocardial infarction (0.03%), nephrolithiasis (0.02%), and cholecystitis (0.02%) were the most common SAEs that were numerically greater in the vaccine arm than the placebo arm; however, the small number of cases does not infer a casual relationship.

“The 2-dose vaccination regimen was highly effective in preventing PCR-confirmed COVID-19 occurring at least 14 days after receipt of the second dose,” the committee wrote. “[However], it is critical to continue to gather data about the vaccine even after it is made available under EUA.”

The associated phase 3 study was sponsored by ModernaTX.

SOURCE: FDA Briefing Document: Moderna COVID-19 Vaccine. FDA Vaccines and Related Biological Products Advisory Committee. Published Dec. 17, 2020.

As the first American health care workers rolled up their sleeves for a COVID-19 vaccine, the images were instantly frozen in history, marking the triumph of scientific know-how and ingenuity. Cameras captured the first trucks pulling out of a warehouse in Portage, Mich., to the applause of workers and area residents. A day later, Boston Medical Center employees – some dressed in scrubs and wearing masks, face shields, and protective gowns – literally danced on the sidewalk when doses arrived. Some have photographed themselves getting the vaccine and posted it on social media, tagging it #MyCOVIDVax.

But the real story of the debut of COVID-19 vaccination is more methodical than monumental, a celebration of teamwork rather than of conquest. As hospitals waited for their first allotment, they reviewed their carefully drafted plans. They relied on each other, reaching across the usual divisions of competition and working collaboratively to share the limited supply. Their priority lists for the first vaccinations included environmental services workers who clean patient rooms and the critical care physicians who work to save lives.

“Health care workers have pulled together throughout this pandemic,” said Melanie Swift, MD, cochair of the COVID-19 Vaccine Allocation and Distribution Work Group at Mayo Clinic in Rochester, Minn. “We’ve gone through the darkest of years relying so heavily on each other,” she said. “Now we’re pulling together to get out of it.”

Still, a rollout of this magnitude has hitches. Stanford issued an apology Dec. 18 after its medical residents protested a vaccine distribution plan that left out nearly all of its residents and fellows, many of whom regularly treat patients with COVID-19.

There have already been more than 287,000 COVID-19 cases and 953 deaths among health care workers, according to the Centers for Disease Control and Prevention. In its guidance, the agency pointed out that the “continued protection of them at work, at home, and in the community remains a national priority.” That means vaccinating a workforce of about 21 million people, often the largest group of employees in a community.

“It collectively takes all of us to vaccinate our teams to maintain that stability in our health care infrastructure across the metro Atlanta area,” Christy Norman, PharmD, vice president of pharmacy services at Emory Healthcare, told reporters in a briefing as the health system awaited its first delivery.
 

Don’t waste a dose

One overriding imperative prevails: Hospitals don’t want to waste any doses. The storage requirements of the Pfizer vaccine make that tricky.

Once vials are removed from the pizza-box-shaped containers in ultracold storage and placed in a refrigerator, they must be used within 5 days. Thawed five-dose vials must be brought to room temperature before they are diluted, and they can remain at room temperature for no more than 2 hours. Once they are diluted with 1.8 mL of a 0.9% sodium chloride injection, the vials must be used within 6 hours.

COVID-19 precautions require employees to stay physically distant while they wait their turn for vaccination, which means the process can’t mirror typical large-scale flu immunization programs.

To prioritize groups, the vaccination planners at Mayo conducted a thorough risk stratification, considering each employee’s duties. Do they work in a dedicated COVID-19 unit? Do they handle lab tests or collect swabs? Do they work in the ICU or emergency department?

“We have applied some principles to make sure that as we roll it out, we prioritize people who are at greatest risk of ongoing exposure and who are really critical to maintaining the COVID response and other essential health services,” said Dr. Swift, associate medical director of Mayo’s occupational health service.

Mayo employees who are eligible for the first doses can sign up for appointments through the medical record system. If it seems likely that some doses will be left over at the end of the vaccination period – perhaps because of missed appointments – supervisors in high-risk areas can refer other health care workers. Mayo gave its first vaccines on Dec. 18, but the vaccination program began in earnest the following week. With the pleasant surprise that each five-dose vial actually provides six doses, 474 vials will allow for the vaccination of 2,844 employees in the top-priority group. “It’s going to expand each week or few days as we get more and more vaccine,” Dr. Swift said.
 

Sharing vials with small rural hospitals

Minnesota is using a hub-and-spoke system to give small rural hospitals access to the Pfizer vaccine, even though they lack ultracold storage and can’t use a minimum order of 975 doses. Large hospitals, acting as hubs, are sharing their orders. (The minimum order for Moderna is 100 doses.)

In south-central Minnesota, for example, two hub hospitals each have six spoke hospitals. Five of the 14 hospitals are independent, and the rest are part of large hospital systems, but affiliation doesn’t matter, said Eric Weller, regional health care preparedness coordinator for the South Central Healthcare Coalition. “We are all working together. It doesn’t matter what system you’re from,” he said. “We’re working for the good of the community.”

Each hospital designed a process to provide vaccine education, prioritize groups, allocate appointments, register people for vaccination, obtain signed consent forms, administer vaccines in a COVID-safe way, and provide follow-up appointments for the second dose. “We’re using some of the lessons we learned during H1N1,” said Mr. Weller, referring to immunization during the 2009 influenza pandemic. “The difference is that during H1N1, you could have lines of people.”

Coordinating the appointments will be more important than ever. “One of the vaccination strategies is to get people in groups of five, so you use one vial on those five people and don’t waste it,” he said.

Logistics are somewhat different for the Moderna vaccine, which will come in 10-dose vials that can be refrigerated for up to 30 days.

Both vaccines may produce mild flulike symptoms, such as fatigue, headache, or muscle pain, particularly after the second dose. That’s a sign that the immune system is reacting to the vaccine, but it’s also another consideration in the vaccination plans, because health care workers might take a day or two off work. “We’re not going to vaccinate a whole department at one time. It will be staggered,” said Kevin Smith, MD, medical director of the occupational medicine program at ProMedica, a health care system based in Toledo, Ohio.

Dr. Smith said he plans to encourage employees to use V-Safe, an app created by the CDC to track adverse effects in people who receive the vaccine. He pointed out that a day or two of achiness will be better than coping with the symptoms of COVID-19. Some employees who recovered from the infection still feel fatigued or haven’t regained their sense of taste and smell. “We are still monitoring quite a few employees to make sure they get back to 100%,” he said.
 

Hope for ending the pandemic

Public health officials have worried about vaccine hesitancy, even among health care workers, but so far, that concern seems overshadowed by enthusiasm. Dr. Smith said his department has been fielding calls from employees who want to know when they will be able to get the vaccine. “I think everyone feels relief,” he said. “We’re at the beginning of the end.”

At Mayo, Dr. Swift is surveying staff to gauge the willingness to get the vaccine, but she already senses excitement among employees. “No doubt there are still people who are hesitant, but I’m feeling a shift,” she said. “I’m feeling this momentum building of health care workers coming on board and wanting to take this vaccine, which is good, because they will set an example for their patients.”

For Colleen Kelley, MD, an infectious disease physician at Emory University in Atlanta who was principal investigator for an Emory-affiliated Moderna clinical trial site, it has been an emotional time. “Things were looking very bleak and dark for a time, and then we started to get these efficacy results that were greater than anyone imagined,” she said.

Dr. Kelley spends time talking to journalists and educating physician colleagues and hospital employees about how the vaccine was developed so quickly and how it works. “Everyone asks me, ‘Should I get it? Are you going to get it?’ My answer is ‘yes’ and ‘yes,’ “ she said. “I am 1,000% confident that the benefits of widespread vaccination outweigh the risks of continued COVID and a continued pandemic.”

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

As the first American health care workers rolled up their sleeves for a COVID-19 vaccine, the images were instantly frozen in history, marking the triumph of scientific know-how and ingenuity. Cameras captured the first trucks pulling out of a warehouse in Portage, Mich., to the applause of workers and area residents. A day later, Boston Medical Center employees – some dressed in scrubs and wearing masks, face shields, and protective gowns – literally danced on the sidewalk when doses arrived. Some have photographed themselves getting the vaccine and posted it on social media, tagging it #MyCOVIDVax.

But the real story of the debut of COVID-19 vaccination is more methodical than monumental, a celebration of teamwork rather than of conquest. As hospitals waited for their first allotment, they reviewed their carefully drafted plans. They relied on each other, reaching across the usual divisions of competition and working collaboratively to share the limited supply. Their priority lists for the first vaccinations included environmental services workers who clean patient rooms and the critical care physicians who work to save lives.

“Health care workers have pulled together throughout this pandemic,” said Melanie Swift, MD, cochair of the COVID-19 Vaccine Allocation and Distribution Work Group at Mayo Clinic in Rochester, Minn. “We’ve gone through the darkest of years relying so heavily on each other,” she said. “Now we’re pulling together to get out of it.”

Still, a rollout of this magnitude has hitches. Stanford issued an apology Dec. 18 after its medical residents protested a vaccine distribution plan that left out nearly all of its residents and fellows, many of whom regularly treat patients with COVID-19.

There have already been more than 287,000 COVID-19 cases and 953 deaths among health care workers, according to the Centers for Disease Control and Prevention. In its guidance, the agency pointed out that the “continued protection of them at work, at home, and in the community remains a national priority.” That means vaccinating a workforce of about 21 million people, often the largest group of employees in a community.

“It collectively takes all of us to vaccinate our teams to maintain that stability in our health care infrastructure across the metro Atlanta area,” Christy Norman, PharmD, vice president of pharmacy services at Emory Healthcare, told reporters in a briefing as the health system awaited its first delivery.
 

Don’t waste a dose

One overriding imperative prevails: Hospitals don’t want to waste any doses. The storage requirements of the Pfizer vaccine make that tricky.

Once vials are removed from the pizza-box-shaped containers in ultracold storage and placed in a refrigerator, they must be used within 5 days. Thawed five-dose vials must be brought to room temperature before they are diluted, and they can remain at room temperature for no more than 2 hours. Once they are diluted with 1.8 mL of a 0.9% sodium chloride injection, the vials must be used within 6 hours.

COVID-19 precautions require employees to stay physically distant while they wait their turn for vaccination, which means the process can’t mirror typical large-scale flu immunization programs.

To prioritize groups, the vaccination planners at Mayo conducted a thorough risk stratification, considering each employee’s duties. Do they work in a dedicated COVID-19 unit? Do they handle lab tests or collect swabs? Do they work in the ICU or emergency department?

“We have applied some principles to make sure that as we roll it out, we prioritize people who are at greatest risk of ongoing exposure and who are really critical to maintaining the COVID response and other essential health services,” said Dr. Swift, associate medical director of Mayo’s occupational health service.

Mayo employees who are eligible for the first doses can sign up for appointments through the medical record system. If it seems likely that some doses will be left over at the end of the vaccination period – perhaps because of missed appointments – supervisors in high-risk areas can refer other health care workers. Mayo gave its first vaccines on Dec. 18, but the vaccination program began in earnest the following week. With the pleasant surprise that each five-dose vial actually provides six doses, 474 vials will allow for the vaccination of 2,844 employees in the top-priority group. “It’s going to expand each week or few days as we get more and more vaccine,” Dr. Swift said.
 

Sharing vials with small rural hospitals

Minnesota is using a hub-and-spoke system to give small rural hospitals access to the Pfizer vaccine, even though they lack ultracold storage and can’t use a minimum order of 975 doses. Large hospitals, acting as hubs, are sharing their orders. (The minimum order for Moderna is 100 doses.)

In south-central Minnesota, for example, two hub hospitals each have six spoke hospitals. Five of the 14 hospitals are independent, and the rest are part of large hospital systems, but affiliation doesn’t matter, said Eric Weller, regional health care preparedness coordinator for the South Central Healthcare Coalition. “We are all working together. It doesn’t matter what system you’re from,” he said. “We’re working for the good of the community.”

Each hospital designed a process to provide vaccine education, prioritize groups, allocate appointments, register people for vaccination, obtain signed consent forms, administer vaccines in a COVID-safe way, and provide follow-up appointments for the second dose. “We’re using some of the lessons we learned during H1N1,” said Mr. Weller, referring to immunization during the 2009 influenza pandemic. “The difference is that during H1N1, you could have lines of people.”

Coordinating the appointments will be more important than ever. “One of the vaccination strategies is to get people in groups of five, so you use one vial on those five people and don’t waste it,” he said.

Logistics are somewhat different for the Moderna vaccine, which will come in 10-dose vials that can be refrigerated for up to 30 days.

Both vaccines may produce mild flulike symptoms, such as fatigue, headache, or muscle pain, particularly after the second dose. That’s a sign that the immune system is reacting to the vaccine, but it’s also another consideration in the vaccination plans, because health care workers might take a day or two off work. “We’re not going to vaccinate a whole department at one time. It will be staggered,” said Kevin Smith, MD, medical director of the occupational medicine program at ProMedica, a health care system based in Toledo, Ohio.

Dr. Smith said he plans to encourage employees to use V-Safe, an app created by the CDC to track adverse effects in people who receive the vaccine. He pointed out that a day or two of achiness will be better than coping with the symptoms of COVID-19. Some employees who recovered from the infection still feel fatigued or haven’t regained their sense of taste and smell. “We are still monitoring quite a few employees to make sure they get back to 100%,” he said.
 

Hope for ending the pandemic

Public health officials have worried about vaccine hesitancy, even among health care workers, but so far, that concern seems overshadowed by enthusiasm. Dr. Smith said his department has been fielding calls from employees who want to know when they will be able to get the vaccine. “I think everyone feels relief,” he said. “We’re at the beginning of the end.”

At Mayo, Dr. Swift is surveying staff to gauge the willingness to get the vaccine, but she already senses excitement among employees. “No doubt there are still people who are hesitant, but I’m feeling a shift,” she said. “I’m feeling this momentum building of health care workers coming on board and wanting to take this vaccine, which is good, because they will set an example for their patients.”

For Colleen Kelley, MD, an infectious disease physician at Emory University in Atlanta who was principal investigator for an Emory-affiliated Moderna clinical trial site, it has been an emotional time. “Things were looking very bleak and dark for a time, and then we started to get these efficacy results that were greater than anyone imagined,” she said.

Dr. Kelley spends time talking to journalists and educating physician colleagues and hospital employees about how the vaccine was developed so quickly and how it works. “Everyone asks me, ‘Should I get it? Are you going to get it?’ My answer is ‘yes’ and ‘yes,’ “ she said. “I am 1,000% confident that the benefits of widespread vaccination outweigh the risks of continued COVID and a continued pandemic.”

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

As the first American health care workers rolled up their sleeves for a COVID-19 vaccine, the images were instantly frozen in history, marking the triumph of scientific know-how and ingenuity. Cameras captured the first trucks pulling out of a warehouse in Portage, Mich., to the applause of workers and area residents. A day later, Boston Medical Center employees – some dressed in scrubs and wearing masks, face shields, and protective gowns – literally danced on the sidewalk when doses arrived. Some have photographed themselves getting the vaccine and posted it on social media, tagging it #MyCOVIDVax.

But the real story of the debut of COVID-19 vaccination is more methodical than monumental, a celebration of teamwork rather than of conquest. As hospitals waited for their first allotment, they reviewed their carefully drafted plans. They relied on each other, reaching across the usual divisions of competition and working collaboratively to share the limited supply. Their priority lists for the first vaccinations included environmental services workers who clean patient rooms and the critical care physicians who work to save lives.

“Health care workers have pulled together throughout this pandemic,” said Melanie Swift, MD, cochair of the COVID-19 Vaccine Allocation and Distribution Work Group at Mayo Clinic in Rochester, Minn. “We’ve gone through the darkest of years relying so heavily on each other,” she said. “Now we’re pulling together to get out of it.”

Still, a rollout of this magnitude has hitches. Stanford issued an apology Dec. 18 after its medical residents protested a vaccine distribution plan that left out nearly all of its residents and fellows, many of whom regularly treat patients with COVID-19.

There have already been more than 287,000 COVID-19 cases and 953 deaths among health care workers, according to the Centers for Disease Control and Prevention. In its guidance, the agency pointed out that the “continued protection of them at work, at home, and in the community remains a national priority.” That means vaccinating a workforce of about 21 million people, often the largest group of employees in a community.

“It collectively takes all of us to vaccinate our teams to maintain that stability in our health care infrastructure across the metro Atlanta area,” Christy Norman, PharmD, vice president of pharmacy services at Emory Healthcare, told reporters in a briefing as the health system awaited its first delivery.
 

Don’t waste a dose

One overriding imperative prevails: Hospitals don’t want to waste any doses. The storage requirements of the Pfizer vaccine make that tricky.

Once vials are removed from the pizza-box-shaped containers in ultracold storage and placed in a refrigerator, they must be used within 5 days. Thawed five-dose vials must be brought to room temperature before they are diluted, and they can remain at room temperature for no more than 2 hours. Once they are diluted with 1.8 mL of a 0.9% sodium chloride injection, the vials must be used within 6 hours.

COVID-19 precautions require employees to stay physically distant while they wait their turn for vaccination, which means the process can’t mirror typical large-scale flu immunization programs.

To prioritize groups, the vaccination planners at Mayo conducted a thorough risk stratification, considering each employee’s duties. Do they work in a dedicated COVID-19 unit? Do they handle lab tests or collect swabs? Do they work in the ICU or emergency department?

“We have applied some principles to make sure that as we roll it out, we prioritize people who are at greatest risk of ongoing exposure and who are really critical to maintaining the COVID response and other essential health services,” said Dr. Swift, associate medical director of Mayo’s occupational health service.

Mayo employees who are eligible for the first doses can sign up for appointments through the medical record system. If it seems likely that some doses will be left over at the end of the vaccination period – perhaps because of missed appointments – supervisors in high-risk areas can refer other health care workers. Mayo gave its first vaccines on Dec. 18, but the vaccination program began in earnest the following week. With the pleasant surprise that each five-dose vial actually provides six doses, 474 vials will allow for the vaccination of 2,844 employees in the top-priority group. “It’s going to expand each week or few days as we get more and more vaccine,” Dr. Swift said.
 

Sharing vials with small rural hospitals

Minnesota is using a hub-and-spoke system to give small rural hospitals access to the Pfizer vaccine, even though they lack ultracold storage and can’t use a minimum order of 975 doses. Large hospitals, acting as hubs, are sharing their orders. (The minimum order for Moderna is 100 doses.)

In south-central Minnesota, for example, two hub hospitals each have six spoke hospitals. Five of the 14 hospitals are independent, and the rest are part of large hospital systems, but affiliation doesn’t matter, said Eric Weller, regional health care preparedness coordinator for the South Central Healthcare Coalition. “We are all working together. It doesn’t matter what system you’re from,” he said. “We’re working for the good of the community.”

Each hospital designed a process to provide vaccine education, prioritize groups, allocate appointments, register people for vaccination, obtain signed consent forms, administer vaccines in a COVID-safe way, and provide follow-up appointments for the second dose. “We’re using some of the lessons we learned during H1N1,” said Mr. Weller, referring to immunization during the 2009 influenza pandemic. “The difference is that during H1N1, you could have lines of people.”

Coordinating the appointments will be more important than ever. “One of the vaccination strategies is to get people in groups of five, so you use one vial on those five people and don’t waste it,” he said.

Logistics are somewhat different for the Moderna vaccine, which will come in 10-dose vials that can be refrigerated for up to 30 days.

Both vaccines may produce mild flulike symptoms, such as fatigue, headache, or muscle pain, particularly after the second dose. That’s a sign that the immune system is reacting to the vaccine, but it’s also another consideration in the vaccination plans, because health care workers might take a day or two off work. “We’re not going to vaccinate a whole department at one time. It will be staggered,” said Kevin Smith, MD, medical director of the occupational medicine program at ProMedica, a health care system based in Toledo, Ohio.

Dr. Smith said he plans to encourage employees to use V-Safe, an app created by the CDC to track adverse effects in people who receive the vaccine. He pointed out that a day or two of achiness will be better than coping with the symptoms of COVID-19. Some employees who recovered from the infection still feel fatigued or haven’t regained their sense of taste and smell. “We are still monitoring quite a few employees to make sure they get back to 100%,” he said.
 

Hope for ending the pandemic

Public health officials have worried about vaccine hesitancy, even among health care workers, but so far, that concern seems overshadowed by enthusiasm. Dr. Smith said his department has been fielding calls from employees who want to know when they will be able to get the vaccine. “I think everyone feels relief,” he said. “We’re at the beginning of the end.”

At Mayo, Dr. Swift is surveying staff to gauge the willingness to get the vaccine, but she already senses excitement among employees. “No doubt there are still people who are hesitant, but I’m feeling a shift,” she said. “I’m feeling this momentum building of health care workers coming on board and wanting to take this vaccine, which is good, because they will set an example for their patients.”

For Colleen Kelley, MD, an infectious disease physician at Emory University in Atlanta who was principal investigator for an Emory-affiliated Moderna clinical trial site, it has been an emotional time. “Things were looking very bleak and dark for a time, and then we started to get these efficacy results that were greater than anyone imagined,” she said.

Dr. Kelley spends time talking to journalists and educating physician colleagues and hospital employees about how the vaccine was developed so quickly and how it works. “Everyone asks me, ‘Should I get it? Are you going to get it?’ My answer is ‘yes’ and ‘yes,’ “ she said. “I am 1,000% confident that the benefits of widespread vaccination outweigh the risks of continued COVID and a continued pandemic.”

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

Parts of three linked studies investigating increased levels of anticoagulation in hospitalized COVID-19 patients have been “paused” because of futility and safety concerns, a statement from the U.S. National Heart, Lung, and Blood Institute (NHLBI) confirms.

The trials involved are the REMAP-CAP, ACTIV-4, and ATTACC studies.

All three trials have paused enrollment of critically ill COVID-19 patients requiring intensive care unit support for whom therapeutic doses of anticoagulation drugs did not reduce the need for organ support, the NHLBI statement notes.

The statement also says that a potential for harm in this subgroup could not be excluded, noting that increased bleeding is a known complication of full-dose anticoagulation. The trials are working urgently to undertake additional analyses, which will be made available as soon as possible.   

The three clinical trial platforms are working together to test the effects of full therapeutic doses of anticoagulants vs. lower prophylactic doses in COVID-19 patients.

Informed by the deliberations of the data safety monitoring boards of these trials, all of the trial sites have paused enrollment of the most critically ill hospitalized patients with COVID-19. 

Enrollment continues in the trials for moderately ill hospitalized COVID-19 patients, the statement notes.  

“Whether the use of full-dose compared to low-dose anticoagulants leads to better outcomes in hospitalized patients with less COVID-19 severe disease remains a very important question,” the NHLBI statement says.

Patients who require full dose anticoagulants for another medical indication are not included in these trials.

The statement explains that COVID-19 is associated with significant inflammation and clinical and pathologic evidence of widespread blood clots. These trials were launched because clinicians have observed that many patients ill with COVID-19, including those who have died from the disease, formed blood clots throughout their bodies, even in their smallest blood vessels. This unusual clotting can cause multiple health complications, including lung failure, myocardial infarction, and stroke. 

The three trials are the result of a collaboration between major international partners. The trials include: the Randomized, Embedded, Multi-factorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) Therapeutic Anticoagulation; Accelerating COVID-19 Therapeutic Interventions and Vaccines-4 (ACTIV-4) Antithrombotics Inpatient; and Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC).

The trials, which span four continents, have the common goal of assessing the benefit of full doses of anticoagulants to treat moderately ill or critically ill adults hospitalized for COVID-19, compared with a lower dose often used to prevent blood clots in hospitalized patients.

In the United States, the ACTIV-4 trial is being led by a collaborative effort involving a number of universities, including the University of Pittsburgh and New York University.  

The trials are supported by multiple international funding organizations including the National Institutes of Health, Canadian Institutes of Health Research, the National Institute for Health Research (UK), the National Health and Medical Research Council (Australia), and the PREPARE and RECOVER consortia (European Union).

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

Parts of three linked studies investigating increased levels of anticoagulation in hospitalized COVID-19 patients have been “paused” because of futility and safety concerns, a statement from the U.S. National Heart, Lung, and Blood Institute (NHLBI) confirms.

The trials involved are the REMAP-CAP, ACTIV-4, and ATTACC studies.

All three trials have paused enrollment of critically ill COVID-19 patients requiring intensive care unit support for whom therapeutic doses of anticoagulation drugs did not reduce the need for organ support, the NHLBI statement notes.

The statement also says that a potential for harm in this subgroup could not be excluded, noting that increased bleeding is a known complication of full-dose anticoagulation. The trials are working urgently to undertake additional analyses, which will be made available as soon as possible.   

The three clinical trial platforms are working together to test the effects of full therapeutic doses of anticoagulants vs. lower prophylactic doses in COVID-19 patients.

Informed by the deliberations of the data safety monitoring boards of these trials, all of the trial sites have paused enrollment of the most critically ill hospitalized patients with COVID-19. 

Enrollment continues in the trials for moderately ill hospitalized COVID-19 patients, the statement notes.  

“Whether the use of full-dose compared to low-dose anticoagulants leads to better outcomes in hospitalized patients with less COVID-19 severe disease remains a very important question,” the NHLBI statement says.

Patients who require full dose anticoagulants for another medical indication are not included in these trials.

The statement explains that COVID-19 is associated with significant inflammation and clinical and pathologic evidence of widespread blood clots. These trials were launched because clinicians have observed that many patients ill with COVID-19, including those who have died from the disease, formed blood clots throughout their bodies, even in their smallest blood vessels. This unusual clotting can cause multiple health complications, including lung failure, myocardial infarction, and stroke. 

The three trials are the result of a collaboration between major international partners. The trials include: the Randomized, Embedded, Multi-factorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) Therapeutic Anticoagulation; Accelerating COVID-19 Therapeutic Interventions and Vaccines-4 (ACTIV-4) Antithrombotics Inpatient; and Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC).

The trials, which span four continents, have the common goal of assessing the benefit of full doses of anticoagulants to treat moderately ill or critically ill adults hospitalized for COVID-19, compared with a lower dose often used to prevent blood clots in hospitalized patients.

In the United States, the ACTIV-4 trial is being led by a collaborative effort involving a number of universities, including the University of Pittsburgh and New York University.  

The trials are supported by multiple international funding organizations including the National Institutes of Health, Canadian Institutes of Health Research, the National Institute for Health Research (UK), the National Health and Medical Research Council (Australia), and the PREPARE and RECOVER consortia (European Union).

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

Parts of three linked studies investigating increased levels of anticoagulation in hospitalized COVID-19 patients have been “paused” because of futility and safety concerns, a statement from the U.S. National Heart, Lung, and Blood Institute (NHLBI) confirms.

The trials involved are the REMAP-CAP, ACTIV-4, and ATTACC studies.

All three trials have paused enrollment of critically ill COVID-19 patients requiring intensive care unit support for whom therapeutic doses of anticoagulation drugs did not reduce the need for organ support, the NHLBI statement notes.

The statement also says that a potential for harm in this subgroup could not be excluded, noting that increased bleeding is a known complication of full-dose anticoagulation. The trials are working urgently to undertake additional analyses, which will be made available as soon as possible.   

The three clinical trial platforms are working together to test the effects of full therapeutic doses of anticoagulants vs. lower prophylactic doses in COVID-19 patients.

Informed by the deliberations of the data safety monitoring boards of these trials, all of the trial sites have paused enrollment of the most critically ill hospitalized patients with COVID-19. 

Enrollment continues in the trials for moderately ill hospitalized COVID-19 patients, the statement notes.  

“Whether the use of full-dose compared to low-dose anticoagulants leads to better outcomes in hospitalized patients with less COVID-19 severe disease remains a very important question,” the NHLBI statement says.

Patients who require full dose anticoagulants for another medical indication are not included in these trials.

The statement explains that COVID-19 is associated with significant inflammation and clinical and pathologic evidence of widespread blood clots. These trials were launched because clinicians have observed that many patients ill with COVID-19, including those who have died from the disease, formed blood clots throughout their bodies, even in their smallest blood vessels. This unusual clotting can cause multiple health complications, including lung failure, myocardial infarction, and stroke. 

The three trials are the result of a collaboration between major international partners. The trials include: the Randomized, Embedded, Multi-factorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) Therapeutic Anticoagulation; Accelerating COVID-19 Therapeutic Interventions and Vaccines-4 (ACTIV-4) Antithrombotics Inpatient; and Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC).

The trials, which span four continents, have the common goal of assessing the benefit of full doses of anticoagulants to treat moderately ill or critically ill adults hospitalized for COVID-19, compared with a lower dose often used to prevent blood clots in hospitalized patients.

In the United States, the ACTIV-4 trial is being led by a collaborative effort involving a number of universities, including the University of Pittsburgh and New York University.  

The trials are supported by multiple international funding organizations including the National Institutes of Health, Canadian Institutes of Health Research, the National Institute for Health Research (UK), the National Health and Medical Research Council (Australia), and the PREPARE and RECOVER consortia (European Union).

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

Widespread use of the MMR vaccine is not only crucial for protecting the community against infectious outbreaks, but also serves as the overall pacesetter for preventive services, said Sara M. Bode, MD and colleagues at Nationwide Children’s Hospital in Columbus.

CDC/Molly Kurnit, M.P.H.

As part of a bivariate logistic regression analysis, Dr. Bode and colleagues sought to evaluate changes in measles vaccination rates across 12 clinic sites of the Nationwide Children’s Hospital pediatric primary care network in Columbus among 23,534 children aged 16 months. The study period targeted the time between April and May 2020, when clinic access and appointment attendance declined following the start of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, until the June-to-August 2020 time period, when clinical care was allowed to return.

The need for the study was prompted by Centers for Disease Control and Prevention reporting on a state-specific precipitous decline in MMR vaccination rates shortly after the onset of COVID-19 in May 2020. Citing the results of one study, such reductions in vaccination have raised concerns over the possibility of a measles resurgence, noted Dr. Bode and associates.
 

MMR vaccination rates begin to drop with onset of COVID-19 pandemic.

From March 2017 to March 2020, the average rate of MMR vaccination in 16-month-olds was 72%. It subsequently decreased to 67% from April to May 2020, and then dropped further to 62% during the period June to August, 2020 (P = .001). Those without insurance were less likely to be vaccinated than were those carrying private insurance or Medicaid. Hispanic and Asian Americans were more likely than were White and Black patients (85% and 90% vs. 69% and 67%, respectively) to have been vaccinated.

Among patients who had not attended a preventive care visit after 12 months of age, the proportion who received vaccines declined during the same time periods, from 10% before the pandemic to 6% at the start of the pandemic and 3% during the summer months of 2020.

“Given the baseline low vaccination rates even before the pandemic and the subsequent decline, we face a critical need to improve timely vaccination and provide catch-up opportunities” in areas with the highest incidence of COVID-19, observed Dr. Bode and colleagues.

Innovative approaches are needed to encourage families to seek preventive care.

In response, the researchers announced the implementation of new community-based vaccination approaches in Ohio, including pop-up vaccine clinics, mobile clinics, and school-based clinics to provide families, who are reluctant to visit health care facilities over COVID-19 related concerns, with safe alternatives. “We believe that it is critical to develop innovative approaches to have families return for preventive care,” they added.

In a separate interview, Herschel Lessin, MD, a private practice pediatrician in Poughkeepsie, N.Y., noted: “This study confirms the anecdotal experience of pediatricians around the country, and our greatest fear that the pandemic will interfere with herd immunity of children for vaccine-preventable illness. Although the study was of urban offices with a primarily Medicaid population, I believe the results to be very worrisome should they prove to be generalizable to the country, as a whole. The significant reduction of well-child visits due to COVID-19 (and fear of COVID-19) seriously impaired the vaccination status of a standard required vaccine in a large population. What is even more worrisome is that the rates continued to fall even after the initial closure of many offices and well into their reopening, despite concerted efforts to try to catch up these missed visits and immunizations.”

Measles is an intensely contagious illness that has not been eradicated, as evidenced by the enormous measles outbreak stemming from Disneyland in 2014-2015, and again with the possible exposure of hundreds to an infected Disneyland visitor last fall, where coverage rates were even higher than in this study, added Dr. Lessin. “This phenomenon, unless forcefully remedied, could easily result in large outbreaks of other vaccine-preventable illness besides COVID-19,” he cautioned.

Dr. Bode and colleagues as well as Dr. Lessin had no conflicts of interest and no relevant financial disclosures.

SOURCE: Bode SM et al. Pediatrics. 2021. doi: 10.1542/peds.2020-035576.

Widespread use of the MMR vaccine is not only crucial for protecting the community against infectious outbreaks, but also serves as the overall pacesetter for preventive services, said Sara M. Bode, MD and colleagues at Nationwide Children’s Hospital in Columbus.

CDC/Molly Kurnit, M.P.H.

As part of a bivariate logistic regression analysis, Dr. Bode and colleagues sought to evaluate changes in measles vaccination rates across 12 clinic sites of the Nationwide Children’s Hospital pediatric primary care network in Columbus among 23,534 children aged 16 months. The study period targeted the time between April and May 2020, when clinic access and appointment attendance declined following the start of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, until the June-to-August 2020 time period, when clinical care was allowed to return.

The need for the study was prompted by Centers for Disease Control and Prevention reporting on a state-specific precipitous decline in MMR vaccination rates shortly after the onset of COVID-19 in May 2020. Citing the results of one study, such reductions in vaccination have raised concerns over the possibility of a measles resurgence, noted Dr. Bode and associates.
 

MMR vaccination rates begin to drop with onset of COVID-19 pandemic.

From March 2017 to March 2020, the average rate of MMR vaccination in 16-month-olds was 72%. It subsequently decreased to 67% from April to May 2020, and then dropped further to 62% during the period June to August, 2020 (P = .001). Those without insurance were less likely to be vaccinated than were those carrying private insurance or Medicaid. Hispanic and Asian Americans were more likely than were White and Black patients (85% and 90% vs. 69% and 67%, respectively) to have been vaccinated.

Among patients who had not attended a preventive care visit after 12 months of age, the proportion who received vaccines declined during the same time periods, from 10% before the pandemic to 6% at the start of the pandemic and 3% during the summer months of 2020.

“Given the baseline low vaccination rates even before the pandemic and the subsequent decline, we face a critical need to improve timely vaccination and provide catch-up opportunities” in areas with the highest incidence of COVID-19, observed Dr. Bode and colleagues.

Innovative approaches are needed to encourage families to seek preventive care.

In response, the researchers announced the implementation of new community-based vaccination approaches in Ohio, including pop-up vaccine clinics, mobile clinics, and school-based clinics to provide families, who are reluctant to visit health care facilities over COVID-19 related concerns, with safe alternatives. “We believe that it is critical to develop innovative approaches to have families return for preventive care,” they added.

In a separate interview, Herschel Lessin, MD, a private practice pediatrician in Poughkeepsie, N.Y., noted: “This study confirms the anecdotal experience of pediatricians around the country, and our greatest fear that the pandemic will interfere with herd immunity of children for vaccine-preventable illness. Although the study was of urban offices with a primarily Medicaid population, I believe the results to be very worrisome should they prove to be generalizable to the country, as a whole. The significant reduction of well-child visits due to COVID-19 (and fear of COVID-19) seriously impaired the vaccination status of a standard required vaccine in a large population. What is even more worrisome is that the rates continued to fall even after the initial closure of many offices and well into their reopening, despite concerted efforts to try to catch up these missed visits and immunizations.”

Measles is an intensely contagious illness that has not been eradicated, as evidenced by the enormous measles outbreak stemming from Disneyland in 2014-2015, and again with the possible exposure of hundreds to an infected Disneyland visitor last fall, where coverage rates were even higher than in this study, added Dr. Lessin. “This phenomenon, unless forcefully remedied, could easily result in large outbreaks of other vaccine-preventable illness besides COVID-19,” he cautioned.

Dr. Bode and colleagues as well as Dr. Lessin had no conflicts of interest and no relevant financial disclosures.

SOURCE: Bode SM et al. Pediatrics. 2021. doi: 10.1542/peds.2020-035576.

Widespread use of the MMR vaccine is not only crucial for protecting the community against infectious outbreaks, but also serves as the overall pacesetter for preventive services, said Sara M. Bode, MD and colleagues at Nationwide Children’s Hospital in Columbus.

CDC/Molly Kurnit, M.P.H.

As part of a bivariate logistic regression analysis, Dr. Bode and colleagues sought to evaluate changes in measles vaccination rates across 12 clinic sites of the Nationwide Children’s Hospital pediatric primary care network in Columbus among 23,534 children aged 16 months. The study period targeted the time between April and May 2020, when clinic access and appointment attendance declined following the start of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, until the June-to-August 2020 time period, when clinical care was allowed to return.

The need for the study was prompted by Centers for Disease Control and Prevention reporting on a state-specific precipitous decline in MMR vaccination rates shortly after the onset of COVID-19 in May 2020. Citing the results of one study, such reductions in vaccination have raised concerns over the possibility of a measles resurgence, noted Dr. Bode and associates.
 

MMR vaccination rates begin to drop with onset of COVID-19 pandemic.

From March 2017 to March 2020, the average rate of MMR vaccination in 16-month-olds was 72%. It subsequently decreased to 67% from April to May 2020, and then dropped further to 62% during the period June to August, 2020 (P = .001). Those without insurance were less likely to be vaccinated than were those carrying private insurance or Medicaid. Hispanic and Asian Americans were more likely than were White and Black patients (85% and 90% vs. 69% and 67%, respectively) to have been vaccinated.

Among patients who had not attended a preventive care visit after 12 months of age, the proportion who received vaccines declined during the same time periods, from 10% before the pandemic to 6% at the start of the pandemic and 3% during the summer months of 2020.

“Given the baseline low vaccination rates even before the pandemic and the subsequent decline, we face a critical need to improve timely vaccination and provide catch-up opportunities” in areas with the highest incidence of COVID-19, observed Dr. Bode and colleagues.

Innovative approaches are needed to encourage families to seek preventive care.

In response, the researchers announced the implementation of new community-based vaccination approaches in Ohio, including pop-up vaccine clinics, mobile clinics, and school-based clinics to provide families, who are reluctant to visit health care facilities over COVID-19 related concerns, with safe alternatives. “We believe that it is critical to develop innovative approaches to have families return for preventive care,” they added.

In a separate interview, Herschel Lessin, MD, a private practice pediatrician in Poughkeepsie, N.Y., noted: “This study confirms the anecdotal experience of pediatricians around the country, and our greatest fear that the pandemic will interfere with herd immunity of children for vaccine-preventable illness. Although the study was of urban offices with a primarily Medicaid population, I believe the results to be very worrisome should they prove to be generalizable to the country, as a whole. The significant reduction of well-child visits due to COVID-19 (and fear of COVID-19) seriously impaired the vaccination status of a standard required vaccine in a large population. What is even more worrisome is that the rates continued to fall even after the initial closure of many offices and well into their reopening, despite concerted efforts to try to catch up these missed visits and immunizations.”

Measles is an intensely contagious illness that has not been eradicated, as evidenced by the enormous measles outbreak stemming from Disneyland in 2014-2015, and again with the possible exposure of hundreds to an infected Disneyland visitor last fall, where coverage rates were even higher than in this study, added Dr. Lessin. “This phenomenon, unless forcefully remedied, could easily result in large outbreaks of other vaccine-preventable illness besides COVID-19,” he cautioned.

Dr. Bode and colleagues as well as Dr. Lessin had no conflicts of interest and no relevant financial disclosures.

SOURCE: Bode SM et al. Pediatrics. 2021. doi: 10.1542/peds.2020-035576.

The majority of video content related to acne on the mobile app TikTok was presented by nonphysicians and had serious shortcomings, according to an analysis of the top 100 videos using a consumer health validation tool.

The popularity of TikTok among adolescents in particular has implications for the dissemination of acne information, as some teens become “skinfluencers” and receive sponsorship from skin care brands in exchange for social media promotion, wrote David X. Zheng, BA, of the department of dermatology, Case Western Reserve University, Cleveland, and colleagues.

“However, the quality of dermatologic information found on TikTok is largely unknown,” they said.

In a brief report published in Pediatric Dermatology, the researchers identified the top 100 videos on TikTok on May 1, 2020, that were tagged with “#acne.” The information on each video included date of upload, type and gender of the individual uploading the video, physician specialty if applicable, and video category. These top 100 videos had 13,470,501 likes and 64,775 comments over a 7.6-month time period.

The researchers used the DISCERN criteria, a validated 1-5 scale designed to assess consumer health information, to evaluate the video content, with 1 (having “serious” or “extensive shortcomings”) and 5 (having “minimal shortcomings.”)

Overall, the average quality rating of the TikTok acne videos was 2.03. A total of 9 videos were produced by board-certified physicians in the United States, with an average DISCERN score of 2.41.

“Analysis of the DISCERN criteria dimensions suggested that major shortcomings common to both physician and nonphysician uploaders included failure to cite information sources, discuss treatment risks, and provide support for shared decision-making,” the researchers said.

Approximately one-third (34%) of the videos fell into the treatment-product advertisement category, while 26% were personal anecdotes, 20% presented information related to acne, 13% featured home remedy treatments, and 7% were classified as “other.” The researchers also identified the top 200 “#acne” videos on TikTok once a week from May 8, 2020 to June 5, 2020, to determine the evolution of acne content on the app and found a turnover rate of 10.9% per week.

Based on the high turnover and low quality based on DISCERN ratings, the authors suggested that patients seeking acne information should “view acne-related TikTok videos with caution and consult evidence-based resources whenever possible.”

The study findings were limited by several factors including the small sample size of physicians uploading videos, lack of information about the number of nonphysician medical professionals who uploaded videos, and lack of information about the number of video views and country of origin, the researchers noted. However, the results highlight the need for dermatologists to be aware that patients, especially teens, may be using TikTok for acne information that may be of poor quality, they said.

“Conversely, we understand that social media can be a powerful tool for advancing health literacy,” the researchers noted. “Therefore, we also recommend that health care professionals engaging on TikTok create thorough and perhaps standardized educational videos regarding acne, as well as correct any acne-related misinformation that may be present,” they concluded.

The other authors of the study were from the departments of dermatology at Case Western Reserve, University Hospitals Cleveland, and Johns Hopkins University, Baltimore.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Zheng DX et al. Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14471.

The majority of video content related to acne on the mobile app TikTok was presented by nonphysicians and had serious shortcomings, according to an analysis of the top 100 videos using a consumer health validation tool.

The popularity of TikTok among adolescents in particular has implications for the dissemination of acne information, as some teens become “skinfluencers” and receive sponsorship from skin care brands in exchange for social media promotion, wrote David X. Zheng, BA, of the department of dermatology, Case Western Reserve University, Cleveland, and colleagues.

“However, the quality of dermatologic information found on TikTok is largely unknown,” they said.

In a brief report published in Pediatric Dermatology, the researchers identified the top 100 videos on TikTok on May 1, 2020, that were tagged with “#acne.” The information on each video included date of upload, type and gender of the individual uploading the video, physician specialty if applicable, and video category. These top 100 videos had 13,470,501 likes and 64,775 comments over a 7.6-month time period.

The researchers used the DISCERN criteria, a validated 1-5 scale designed to assess consumer health information, to evaluate the video content, with 1 (having “serious” or “extensive shortcomings”) and 5 (having “minimal shortcomings.”)

Overall, the average quality rating of the TikTok acne videos was 2.03. A total of 9 videos were produced by board-certified physicians in the United States, with an average DISCERN score of 2.41.

“Analysis of the DISCERN criteria dimensions suggested that major shortcomings common to both physician and nonphysician uploaders included failure to cite information sources, discuss treatment risks, and provide support for shared decision-making,” the researchers said.

Approximately one-third (34%) of the videos fell into the treatment-product advertisement category, while 26% were personal anecdotes, 20% presented information related to acne, 13% featured home remedy treatments, and 7% were classified as “other.” The researchers also identified the top 200 “#acne” videos on TikTok once a week from May 8, 2020 to June 5, 2020, to determine the evolution of acne content on the app and found a turnover rate of 10.9% per week.

Based on the high turnover and low quality based on DISCERN ratings, the authors suggested that patients seeking acne information should “view acne-related TikTok videos with caution and consult evidence-based resources whenever possible.”

The study findings were limited by several factors including the small sample size of physicians uploading videos, lack of information about the number of nonphysician medical professionals who uploaded videos, and lack of information about the number of video views and country of origin, the researchers noted. However, the results highlight the need for dermatologists to be aware that patients, especially teens, may be using TikTok for acne information that may be of poor quality, they said.

“Conversely, we understand that social media can be a powerful tool for advancing health literacy,” the researchers noted. “Therefore, we also recommend that health care professionals engaging on TikTok create thorough and perhaps standardized educational videos regarding acne, as well as correct any acne-related misinformation that may be present,” they concluded.

The other authors of the study were from the departments of dermatology at Case Western Reserve, University Hospitals Cleveland, and Johns Hopkins University, Baltimore.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Zheng DX et al. Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14471.

The majority of video content related to acne on the mobile app TikTok was presented by nonphysicians and had serious shortcomings, according to an analysis of the top 100 videos using a consumer health validation tool.

The popularity of TikTok among adolescents in particular has implications for the dissemination of acne information, as some teens become “skinfluencers” and receive sponsorship from skin care brands in exchange for social media promotion, wrote David X. Zheng, BA, of the department of dermatology, Case Western Reserve University, Cleveland, and colleagues.

“However, the quality of dermatologic information found on TikTok is largely unknown,” they said.

In a brief report published in Pediatric Dermatology, the researchers identified the top 100 videos on TikTok on May 1, 2020, that were tagged with “#acne.” The information on each video included date of upload, type and gender of the individual uploading the video, physician specialty if applicable, and video category. These top 100 videos had 13,470,501 likes and 64,775 comments over a 7.6-month time period.

The researchers used the DISCERN criteria, a validated 1-5 scale designed to assess consumer health information, to evaluate the video content, with 1 (having “serious” or “extensive shortcomings”) and 5 (having “minimal shortcomings.”)

Overall, the average quality rating of the TikTok acne videos was 2.03. A total of 9 videos were produced by board-certified physicians in the United States, with an average DISCERN score of 2.41.

“Analysis of the DISCERN criteria dimensions suggested that major shortcomings common to both physician and nonphysician uploaders included failure to cite information sources, discuss treatment risks, and provide support for shared decision-making,” the researchers said.

Approximately one-third (34%) of the videos fell into the treatment-product advertisement category, while 26% were personal anecdotes, 20% presented information related to acne, 13% featured home remedy treatments, and 7% were classified as “other.” The researchers also identified the top 200 “#acne” videos on TikTok once a week from May 8, 2020 to June 5, 2020, to determine the evolution of acne content on the app and found a turnover rate of 10.9% per week.

Based on the high turnover and low quality based on DISCERN ratings, the authors suggested that patients seeking acne information should “view acne-related TikTok videos with caution and consult evidence-based resources whenever possible.”

The study findings were limited by several factors including the small sample size of physicians uploading videos, lack of information about the number of nonphysician medical professionals who uploaded videos, and lack of information about the number of video views and country of origin, the researchers noted. However, the results highlight the need for dermatologists to be aware that patients, especially teens, may be using TikTok for acne information that may be of poor quality, they said.

“Conversely, we understand that social media can be a powerful tool for advancing health literacy,” the researchers noted. “Therefore, we also recommend that health care professionals engaging on TikTok create thorough and perhaps standardized educational videos regarding acne, as well as correct any acne-related misinformation that may be present,” they concluded.

The other authors of the study were from the departments of dermatology at Case Western Reserve, University Hospitals Cleveland, and Johns Hopkins University, Baltimore.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Zheng DX et al. Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14471.