MDedge Pediatrics

Six medical societies from across the globe are emphasizing the importance of individuals obtaining the daily recommended dose of vitamin D, especially given the impact of the COVID-19 pandemic on outdoor time.

The statement, “Joint Guidance on Vitamin D in the Era of COVID-19,” is supported by the American Society for Bone and Mineral Research, the Endocrine Society, and the American Association of Clinical Endocrinologists, among others.

They felt the need to clarify the recommendations for clinicians. Central to the guidance is the recommendation to directly expose the skin to sunlight for 15-30 minutes per day, while taking care to avoid sunburn.

The statement noted that “vitamin D is very safe when taken at reasonable dosages and is important for musculoskeletal health. Levels are likely to decline as individuals reduce outside activity (sun exposure) during the pandemic.”

It added that “most older and younger adults can safely take 400-1000 IU daily to keep vitamin D levels within the optimal range as recommended by [the US] Institute of Medicine guidelines.”

The statement also noted that the scientific evidence clearly supports the benefits that vitamin D (in combination with calcium intake) plays in building a strong skeleton and preventing bone loss.

Other societies supporting the statement are the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

What role for vitamin D in COVID-19?

Over recent months, the role of vitamin D in relation to prevention of COVID-19 has been the subject of intense debate. Now, these societies have joined forces and endorsed evidence-based guidance to clarify the issue around obtaining the daily recommended dosage of vitamin D.

During the pandemic, orders to stay at home meant individuals were likely to spend less time outdoors and have less opportunity to draw their vitamin D directly from sunlight, which is its main source, other than a limited number of foods or as a dietary supplement, the societies explained.

However, they acknowledged that the role of vitamin D in COVID-19 remains unclear.

“The current data do not provide any evidence that vitamin D supplementation will help prevent or treat COVID-19 infection; however, our guidance does not preclude further study of the potential effects of vitamin D on COVID-19,” the joint statement said.

Research to date suggests that vitamin D may play a role in enhancing the immune response, and given prior work demonstrating a role for the activated form of vitamin D – 1,25(OH)2D – in immune responses, “further research into vitamin D supplementation in COVID-19 disease is warranted,” it added. “Trials to date have been observational and there have been no randomized, controlled trials from which firm conclusions about causal relationships can be drawn. Observational studies suggest associations between low vitamin D concentrations and higher rates of COVID-19 infection.”

Medscape Medical News previously reported on the existing observational data regarding vitamin D in COVID-19. A recent rapid evidence review by the National Institute for Health and Care Excellence failed to find any evidence that vitamin D supplementation reduces the risk or severity of COVID-19.

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

Six medical societies from across the globe are emphasizing the importance of individuals obtaining the daily recommended dose of vitamin D, especially given the impact of the COVID-19 pandemic on outdoor time.

The statement, “Joint Guidance on Vitamin D in the Era of COVID-19,” is supported by the American Society for Bone and Mineral Research, the Endocrine Society, and the American Association of Clinical Endocrinologists, among others.

They felt the need to clarify the recommendations for clinicians. Central to the guidance is the recommendation to directly expose the skin to sunlight for 15-30 minutes per day, while taking care to avoid sunburn.

The statement noted that “vitamin D is very safe when taken at reasonable dosages and is important for musculoskeletal health. Levels are likely to decline as individuals reduce outside activity (sun exposure) during the pandemic.”

It added that “most older and younger adults can safely take 400-1000 IU daily to keep vitamin D levels within the optimal range as recommended by [the US] Institute of Medicine guidelines.”

The statement also noted that the scientific evidence clearly supports the benefits that vitamin D (in combination with calcium intake) plays in building a strong skeleton and preventing bone loss.

Other societies supporting the statement are the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

What role for vitamin D in COVID-19?

Over recent months, the role of vitamin D in relation to prevention of COVID-19 has been the subject of intense debate. Now, these societies have joined forces and endorsed evidence-based guidance to clarify the issue around obtaining the daily recommended dosage of vitamin D.

During the pandemic, orders to stay at home meant individuals were likely to spend less time outdoors and have less opportunity to draw their vitamin D directly from sunlight, which is its main source, other than a limited number of foods or as a dietary supplement, the societies explained.

However, they acknowledged that the role of vitamin D in COVID-19 remains unclear.

“The current data do not provide any evidence that vitamin D supplementation will help prevent or treat COVID-19 infection; however, our guidance does not preclude further study of the potential effects of vitamin D on COVID-19,” the joint statement said.

Research to date suggests that vitamin D may play a role in enhancing the immune response, and given prior work demonstrating a role for the activated form of vitamin D – 1,25(OH)2D – in immune responses, “further research into vitamin D supplementation in COVID-19 disease is warranted,” it added. “Trials to date have been observational and there have been no randomized, controlled trials from which firm conclusions about causal relationships can be drawn. Observational studies suggest associations between low vitamin D concentrations and higher rates of COVID-19 infection.”

Medscape Medical News previously reported on the existing observational data regarding vitamin D in COVID-19. A recent rapid evidence review by the National Institute for Health and Care Excellence failed to find any evidence that vitamin D supplementation reduces the risk or severity of COVID-19.

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

Six medical societies from across the globe are emphasizing the importance of individuals obtaining the daily recommended dose of vitamin D, especially given the impact of the COVID-19 pandemic on outdoor time.

The statement, “Joint Guidance on Vitamin D in the Era of COVID-19,” is supported by the American Society for Bone and Mineral Research, the Endocrine Society, and the American Association of Clinical Endocrinologists, among others.

They felt the need to clarify the recommendations for clinicians. Central to the guidance is the recommendation to directly expose the skin to sunlight for 15-30 minutes per day, while taking care to avoid sunburn.

The statement noted that “vitamin D is very safe when taken at reasonable dosages and is important for musculoskeletal health. Levels are likely to decline as individuals reduce outside activity (sun exposure) during the pandemic.”

It added that “most older and younger adults can safely take 400-1000 IU daily to keep vitamin D levels within the optimal range as recommended by [the US] Institute of Medicine guidelines.”

The statement also noted that the scientific evidence clearly supports the benefits that vitamin D (in combination with calcium intake) plays in building a strong skeleton and preventing bone loss.

Other societies supporting the statement are the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

What role for vitamin D in COVID-19?

Over recent months, the role of vitamin D in relation to prevention of COVID-19 has been the subject of intense debate. Now, these societies have joined forces and endorsed evidence-based guidance to clarify the issue around obtaining the daily recommended dosage of vitamin D.

During the pandemic, orders to stay at home meant individuals were likely to spend less time outdoors and have less opportunity to draw their vitamin D directly from sunlight, which is its main source, other than a limited number of foods or as a dietary supplement, the societies explained.

However, they acknowledged that the role of vitamin D in COVID-19 remains unclear.

“The current data do not provide any evidence that vitamin D supplementation will help prevent or treat COVID-19 infection; however, our guidance does not preclude further study of the potential effects of vitamin D on COVID-19,” the joint statement said.

Research to date suggests that vitamin D may play a role in enhancing the immune response, and given prior work demonstrating a role for the activated form of vitamin D – 1,25(OH)2D – in immune responses, “further research into vitamin D supplementation in COVID-19 disease is warranted,” it added. “Trials to date have been observational and there have been no randomized, controlled trials from which firm conclusions about causal relationships can be drawn. Observational studies suggest associations between low vitamin D concentrations and higher rates of COVID-19 infection.”

Medscape Medical News previously reported on the existing observational data regarding vitamin D in COVID-19. A recent rapid evidence review by the National Institute for Health and Care Excellence failed to find any evidence that vitamin D supplementation reduces the risk or severity of COVID-19.

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

Nearly half of hospitalized COVID-19 patients without a prior diabetes diagnosis have hyperglycemia, and the latter is an independent predictor of mortality at 28 days, new research indicates.

The findings, from a retrospective analysis of 605 patients with COVID-19 seen at two hospitals in Wuhan, China, were published online July 10 in Diabetologia by Sufei Wang, of the department of respiratory and critical care medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and colleagues.

Several previous studies have demonstrated a link between hyperglycemia and worse outcomes in COVID-19, and at least one diabetes diagnosis, but this is the first to focus specifically on that group of patients.

Wang and colleagues found that a fasting blood glucose of 7.0 mmol/L (126 mg/dL) or greater on admission – present in 45.6% of those without a prior diabetes diagnosis – was an independent predictor of 28-day mortality.

Although A1c data weren’t analyzed, the population is believed to include both individuals with preexisting but undiagnosed diabetes and those without diabetes who have acute stress hyperglycemia.

“Glycemic testing and control should be recommended for all COVID-19 patients even if they do not have preexisting diabetes, as most COVID-19 patients are prone to glucose metabolic disorders,” they emphasized.

“Addressing elevated fasting blood glucose at an early stage can help clinicians better manage the condition and lower the mortality risk of COVID-19 patients,” Wang and colleagues noted.
 

Hyperglycemia predicts COVID-19 death, complications

The study involved consecutive patients with COVID-19 and definitive 28-day outcome and fasting blood glucose measurement on admission to two Wuhan-area hospitals between Jan. 24 to Feb. 10, 2020. A total of 605 patients did not have a previous diabetes diagnosis. They were a median age of 59 years and 53.2% were men.

Just over half, 54.4%, had a fasting blood glucose below 6.1 mmol/L (110.0 mg/dL). The rest had dysglycemia: 16.5% had a fasting blood glucose of 6.1-6.9 mmol/L (110-125 mg/dL), considered the prediabetes range, and 29.1% had a fasting blood glucose of 7 mmol/L (126 mg/dL) or above, the cutoff for diabetes.

“These results indicate that our study included both undiagnosed diabetic patients and nondiabetic patients with hyperglycemia caused by an acute blood glucose disorder,” the authors noted.

Over 28 days of hospitalization, 18.8% (114) of the patients died and 39.2% developed one or more in-hospital complications. 

The authors used the CRB-65 score, which assigns 1 point for each of four indicators – confusion, respiratory rate >30 breaths/min, systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤60 mm Hg, and age ≥65 years – to assess pneumonia severity.

Just over half, 55.2%, had a CRB-65 score of 0, 43.1% had a score of 1-2, and 1.7% had a score of 3-4.

In multivariable analysis, significant independent predictors of 28-day mortality were age (hazard ratio, 1.02), male sex (HR, 1.75), CRB-65 score 1-2 (HR, 2.68), CRB-65 score 3-4 (HR, 5.25), and fasting blood glucose ≥7.0 mmol/L (HR, 2.30).

Compared with patients with normal glucose (<6.1 mmol/L), 28-day mortality was twice as high (HR, 2.06) for those with a fasting blood glucose of 6.1-6.9 mmol/L and more than threefold higher for ≥7.0 mmol/L (HR, 3.54).

Pneumonia severity also predicted 28-day mortality, with hazard ratios of 4.35 and 13.80 for patients with CRB-65 scores of 1-2 and 3-4, respectively, compared with 0.

Inhospital complications, including acute respiratory distress syndrome or acute cardiac, kidney, or liver injury or cerebrovascular accident, occurred in 14.2%, 7.9%, and 17.0% of those in the lowest to highest fasting blood glucose groups.

Complications were more than twice as common in patients with a fasting blood glucose of 6.1-6.9 mmol/L (HR, 2.61) and four times more common (HR, 3.99) among those with a fasting blood glucose ≥7.0 mmol/L, compared with those with normoglycemia.

The study was supported by the National Natural Science Foundation of China and Major Projects of the National Science and Technology. The authors have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Nearly half of hospitalized COVID-19 patients without a prior diabetes diagnosis have hyperglycemia, and the latter is an independent predictor of mortality at 28 days, new research indicates.

The findings, from a retrospective analysis of 605 patients with COVID-19 seen at two hospitals in Wuhan, China, were published online July 10 in Diabetologia by Sufei Wang, of the department of respiratory and critical care medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and colleagues.

Several previous studies have demonstrated a link between hyperglycemia and worse outcomes in COVID-19, and at least one diabetes diagnosis, but this is the first to focus specifically on that group of patients.

Wang and colleagues found that a fasting blood glucose of 7.0 mmol/L (126 mg/dL) or greater on admission – present in 45.6% of those without a prior diabetes diagnosis – was an independent predictor of 28-day mortality.

Although A1c data weren’t analyzed, the population is believed to include both individuals with preexisting but undiagnosed diabetes and those without diabetes who have acute stress hyperglycemia.

“Glycemic testing and control should be recommended for all COVID-19 patients even if they do not have preexisting diabetes, as most COVID-19 patients are prone to glucose metabolic disorders,” they emphasized.

“Addressing elevated fasting blood glucose at an early stage can help clinicians better manage the condition and lower the mortality risk of COVID-19 patients,” Wang and colleagues noted.
 

Hyperglycemia predicts COVID-19 death, complications

The study involved consecutive patients with COVID-19 and definitive 28-day outcome and fasting blood glucose measurement on admission to two Wuhan-area hospitals between Jan. 24 to Feb. 10, 2020. A total of 605 patients did not have a previous diabetes diagnosis. They were a median age of 59 years and 53.2% were men.

Just over half, 54.4%, had a fasting blood glucose below 6.1 mmol/L (110.0 mg/dL). The rest had dysglycemia: 16.5% had a fasting blood glucose of 6.1-6.9 mmol/L (110-125 mg/dL), considered the prediabetes range, and 29.1% had a fasting blood glucose of 7 mmol/L (126 mg/dL) or above, the cutoff for diabetes.

“These results indicate that our study included both undiagnosed diabetic patients and nondiabetic patients with hyperglycemia caused by an acute blood glucose disorder,” the authors noted.

Over 28 days of hospitalization, 18.8% (114) of the patients died and 39.2% developed one or more in-hospital complications. 

The authors used the CRB-65 score, which assigns 1 point for each of four indicators – confusion, respiratory rate >30 breaths/min, systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤60 mm Hg, and age ≥65 years – to assess pneumonia severity.

Just over half, 55.2%, had a CRB-65 score of 0, 43.1% had a score of 1-2, and 1.7% had a score of 3-4.

In multivariable analysis, significant independent predictors of 28-day mortality were age (hazard ratio, 1.02), male sex (HR, 1.75), CRB-65 score 1-2 (HR, 2.68), CRB-65 score 3-4 (HR, 5.25), and fasting blood glucose ≥7.0 mmol/L (HR, 2.30).

Compared with patients with normal glucose (<6.1 mmol/L), 28-day mortality was twice as high (HR, 2.06) for those with a fasting blood glucose of 6.1-6.9 mmol/L and more than threefold higher for ≥7.0 mmol/L (HR, 3.54).

Pneumonia severity also predicted 28-day mortality, with hazard ratios of 4.35 and 13.80 for patients with CRB-65 scores of 1-2 and 3-4, respectively, compared with 0.

Inhospital complications, including acute respiratory distress syndrome or acute cardiac, kidney, or liver injury or cerebrovascular accident, occurred in 14.2%, 7.9%, and 17.0% of those in the lowest to highest fasting blood glucose groups.

Complications were more than twice as common in patients with a fasting blood glucose of 6.1-6.9 mmol/L (HR, 2.61) and four times more common (HR, 3.99) among those with a fasting blood glucose ≥7.0 mmol/L, compared with those with normoglycemia.

The study was supported by the National Natural Science Foundation of China and Major Projects of the National Science and Technology. The authors have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Nearly half of hospitalized COVID-19 patients without a prior diabetes diagnosis have hyperglycemia, and the latter is an independent predictor of mortality at 28 days, new research indicates.

The findings, from a retrospective analysis of 605 patients with COVID-19 seen at two hospitals in Wuhan, China, were published online July 10 in Diabetologia by Sufei Wang, of the department of respiratory and critical care medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and colleagues.

Several previous studies have demonstrated a link between hyperglycemia and worse outcomes in COVID-19, and at least one diabetes diagnosis, but this is the first to focus specifically on that group of patients.

Wang and colleagues found that a fasting blood glucose of 7.0 mmol/L (126 mg/dL) or greater on admission – present in 45.6% of those without a prior diabetes diagnosis – was an independent predictor of 28-day mortality.

Although A1c data weren’t analyzed, the population is believed to include both individuals with preexisting but undiagnosed diabetes and those without diabetes who have acute stress hyperglycemia.

“Glycemic testing and control should be recommended for all COVID-19 patients even if they do not have preexisting diabetes, as most COVID-19 patients are prone to glucose metabolic disorders,” they emphasized.

“Addressing elevated fasting blood glucose at an early stage can help clinicians better manage the condition and lower the mortality risk of COVID-19 patients,” Wang and colleagues noted.
 

Hyperglycemia predicts COVID-19 death, complications

The study involved consecutive patients with COVID-19 and definitive 28-day outcome and fasting blood glucose measurement on admission to two Wuhan-area hospitals between Jan. 24 to Feb. 10, 2020. A total of 605 patients did not have a previous diabetes diagnosis. They were a median age of 59 years and 53.2% were men.

Just over half, 54.4%, had a fasting blood glucose below 6.1 mmol/L (110.0 mg/dL). The rest had dysglycemia: 16.5% had a fasting blood glucose of 6.1-6.9 mmol/L (110-125 mg/dL), considered the prediabetes range, and 29.1% had a fasting blood glucose of 7 mmol/L (126 mg/dL) or above, the cutoff for diabetes.

“These results indicate that our study included both undiagnosed diabetic patients and nondiabetic patients with hyperglycemia caused by an acute blood glucose disorder,” the authors noted.

Over 28 days of hospitalization, 18.8% (114) of the patients died and 39.2% developed one or more in-hospital complications. 

The authors used the CRB-65 score, which assigns 1 point for each of four indicators – confusion, respiratory rate >30 breaths/min, systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤60 mm Hg, and age ≥65 years – to assess pneumonia severity.

Just over half, 55.2%, had a CRB-65 score of 0, 43.1% had a score of 1-2, and 1.7% had a score of 3-4.

In multivariable analysis, significant independent predictors of 28-day mortality were age (hazard ratio, 1.02), male sex (HR, 1.75), CRB-65 score 1-2 (HR, 2.68), CRB-65 score 3-4 (HR, 5.25), and fasting blood glucose ≥7.0 mmol/L (HR, 2.30).

Compared with patients with normal glucose (<6.1 mmol/L), 28-day mortality was twice as high (HR, 2.06) for those with a fasting blood glucose of 6.1-6.9 mmol/L and more than threefold higher for ≥7.0 mmol/L (HR, 3.54).

Pneumonia severity also predicted 28-day mortality, with hazard ratios of 4.35 and 13.80 for patients with CRB-65 scores of 1-2 and 3-4, respectively, compared with 0.

Inhospital complications, including acute respiratory distress syndrome or acute cardiac, kidney, or liver injury or cerebrovascular accident, occurred in 14.2%, 7.9%, and 17.0% of those in the lowest to highest fasting blood glucose groups.

Complications were more than twice as common in patients with a fasting blood glucose of 6.1-6.9 mmol/L (HR, 2.61) and four times more common (HR, 3.99) among those with a fasting blood glucose ≥7.0 mmol/L, compared with those with normoglycemia.

The study was supported by the National Natural Science Foundation of China and Major Projects of the National Science and Technology. The authors have reported no relevant financial relationships.

This article first appeared on Medscape.com.

The Food and Drug Administration has approved expanded use of Dysport to treat upper- and lower-limb spasticity – including that caused by cerebral palsy – for patients as young as 2 years and older, according to manufacturer Ipsen Biopharmaceuticals.

When Dysport (abobotulinumtoxinA) initially was approved for treating pediatric lower limb spasticity by the FDA in 2016, Ipsen was granted Orphan Drug exclusivity for children whose lower-limb spasticity was caused by cerebral palsy. In 2019, Dysport was approved by the FDA for treating of upper-limb spasticity in children 2 years older. But if that spasticity was caused by cerebral palsy, Dysport could be used to treat it only through Orphan Drug exclusivity granted to another manufacturer, according to an Ipsen press release.

“The proactive step to resolve the uncertainty created by the previous CP [cerebral palsy] carve out enables us as physicians to prescribe consistent therapy for pediatric patients experiencing both upper- and lower-limb spasticity,” Sarah Helen Evans, MD, division chief of rehabilitation medicine in the department of pediatrics at the Children’s Hospital of Philadelphia, said in the press release.

The most common adverse effects among children with lower-limb spasticity treated with Dysport were nasopharyngitis, cough, and pyrexia. Among children with upper-limb spasticity, the most common effects associated with Dysport treatment were upper respiratory tract infection and pharyngitis.

The press release also included a warning of the distant spread of the botulinum toxin from the area of injection hours to weeks afterward, causing symptoms including blurred vision, generalized muscle weakness, and swallowing and breathing difficulties that can be life threatening; there have been reports of death.

Suspected adverse effects can be reported to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The Food and Drug Administration has approved expanded use of Dysport to treat upper- and lower-limb spasticity – including that caused by cerebral palsy – for patients as young as 2 years and older, according to manufacturer Ipsen Biopharmaceuticals.

When Dysport (abobotulinumtoxinA) initially was approved for treating pediatric lower limb spasticity by the FDA in 2016, Ipsen was granted Orphan Drug exclusivity for children whose lower-limb spasticity was caused by cerebral palsy. In 2019, Dysport was approved by the FDA for treating of upper-limb spasticity in children 2 years older. But if that spasticity was caused by cerebral palsy, Dysport could be used to treat it only through Orphan Drug exclusivity granted to another manufacturer, according to an Ipsen press release.

“The proactive step to resolve the uncertainty created by the previous CP [cerebral palsy] carve out enables us as physicians to prescribe consistent therapy for pediatric patients experiencing both upper- and lower-limb spasticity,” Sarah Helen Evans, MD, division chief of rehabilitation medicine in the department of pediatrics at the Children’s Hospital of Philadelphia, said in the press release.

The most common adverse effects among children with lower-limb spasticity treated with Dysport were nasopharyngitis, cough, and pyrexia. Among children with upper-limb spasticity, the most common effects associated with Dysport treatment were upper respiratory tract infection and pharyngitis.

The press release also included a warning of the distant spread of the botulinum toxin from the area of injection hours to weeks afterward, causing symptoms including blurred vision, generalized muscle weakness, and swallowing and breathing difficulties that can be life threatening; there have been reports of death.

Suspected adverse effects can be reported to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The Food and Drug Administration has approved expanded use of Dysport to treat upper- and lower-limb spasticity – including that caused by cerebral palsy – for patients as young as 2 years and older, according to manufacturer Ipsen Biopharmaceuticals.

When Dysport (abobotulinumtoxinA) initially was approved for treating pediatric lower limb spasticity by the FDA in 2016, Ipsen was granted Orphan Drug exclusivity for children whose lower-limb spasticity was caused by cerebral palsy. In 2019, Dysport was approved by the FDA for treating of upper-limb spasticity in children 2 years older. But if that spasticity was caused by cerebral palsy, Dysport could be used to treat it only through Orphan Drug exclusivity granted to another manufacturer, according to an Ipsen press release.

“The proactive step to resolve the uncertainty created by the previous CP [cerebral palsy] carve out enables us as physicians to prescribe consistent therapy for pediatric patients experiencing both upper- and lower-limb spasticity,” Sarah Helen Evans, MD, division chief of rehabilitation medicine in the department of pediatrics at the Children’s Hospital of Philadelphia, said in the press release.

The most common adverse effects among children with lower-limb spasticity treated with Dysport were nasopharyngitis, cough, and pyrexia. Among children with upper-limb spasticity, the most common effects associated with Dysport treatment were upper respiratory tract infection and pharyngitis.

The press release also included a warning of the distant spread of the botulinum toxin from the area of injection hours to weeks afterward, causing symptoms including blurred vision, generalized muscle weakness, and swallowing and breathing difficulties that can be life threatening; there have been reports of death.

Suspected adverse effects can be reported to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Adding subcutaneous nemolizumab to topical treatments for atopic dermatitis patients significantly improved their itching, compared with a placebo, in a phase 3 study of 215 patients in Japan.

Controlling the pruritus associated with atopic dermatitis (AD) can have a significant impact on patients’ quality of life, wrote Kenji Kabashima, MD, PhD, of the department of dermatology at Kyoto University, and coauthors. Frequent scratching can cause not only mechanical skin damage, but also may enhance inflammatory reactions and contribute to sleep problems.

In earlier phase studies, nemolizumab, a humanized monoclonal antibody against interleukin-31 receptor A, showed efficacy in reducing pruritus in patients with AD, but has not been well studied in patients who are also using topical agents, they wrote.

In the study published in the New England Journal of Medicine, the researchers randomized 143 patients with AD and moderate to severe pruritus to 60 mg of subcutaneous nemolizumab and 72 patients to a placebo every 4 weeks for 16 weeks. All patients were aged 13 years and older with a confirmed AD diagnosis and a history of inadequate response to or inability to use treatments, including topical glucocorticoids and oral antihistamines. Their average age was 40 years, approximately two-thirds were male, and the average disease duration was approximately 30 years. Topical treatments included a medium potency glucocorticoid in 97% of patients in both groups, and a topical calcineurin inhibitor in 41% of those on nemolizumab, and 40% of those on placebo; almost 90% of the patients in both groups were on oral antihistamines.

At 16 weeks, scores on the visual analog scale for pruritus (the primary outcome) significantly improved from baseline in the nemolizumab group, compared with the placebo group (a mean change of –42.8% and –21.4%, respectively, P < .001).

In addition, more patients in the nemolizumab group, compared with the placebo group (40% vs. 22%) achieved a score of 4 or less on the Dermatology Life Quality Index, with lower scores reflecting less impact of disease on daily life. In addition, more patients in the nemolizumab group, compared with the placebo group (55% vs. 21%) achieved a score of 7 or less on the Insomnia Severity Index.

During the study, 71% of the patients in each group reported adverse events, most were mild or moderate. The most common adverse event was worsening AD, reported by 24% of the nemolizumab patients and 21% of the placebo patients. Reactions related to the injection occurred in 8% of nemolizumab patients and 3% of placebo patients. Cytokine abnormalities, which included an increased level of thymus and activation regulated chemokine, were reported in 10 (7%) of the patients on nemolizumab, none of which occurred in those on placebo. “Most were not accompanied by a worsening of signs of or the extent of atopic dermatitis,” the authors wrote.

Severe adverse events were reported in three patients (2%) in the nemolizumab group, which were Meniere’s disease, acute pancreatitis, and AD in one patient each. No severe adverse events were reported in the placebo group. In addition, three patients in the nemolizumab group experienced four treatment-related adverse events that led them to discontinue treatment: AD, Meniere’s disease, alopecia, and peripheral edema.

The study findings were limited by several factors including the relatively short treatment period, inclusion only of Japanese patients, inclusion of patients aged as young as 13 years, and the inability to draw conclusions from the secondary endpoints such as quality of life and sleep issues, the researchers noted.

However, the results suggest that “nemolizumab plus topical agents may ameliorate both pruritus and signs of eczema and may lessen the severity of atopic dermatitis by disrupting the itch-scratch cycle,” they added.

“Novel therapies [for AD] are needed, as there are still patients who need better disease control despite current therapies, and AD is a heterogeneous disease that may need different treatment approaches,” Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, said in an interview.

Dr. Simpson, who was not an investigator in this study, said that he was somewhat surprised that the itch reduction was lower in the current study, compared with previous studies by the same group. Also surprising was the increase in cytokine abnormalities in the nemolizumab group, which “needs further study.”

Overall, the data “provide support that blockade of the IL-31 receptor improves itch in AD and appears to have some effect on inflammation,” Dr. Simpson said.

One challenge to the clinical use of nemolizumab will be identifying “where this type of drug fits into the treatment paradigm,” and determining whether specific patients whose disease is driven more by this neuroimmune pathway could benefit more than with the traditional IL-4 or IL-13 blockade, he said.

The study was supported by Maruho. Dr. Kabashima disclosed consulting fees from Maruho and two coauthors were Maruho employees. Dr. Simpson had no financial conflicts relevant to this study, but he reported receiving research grants and other financial relationships with manufacturers of AD therapies.

SOURCE: Kabashima K et al. N Engl J Med. 2020 Jul 9. doi: 10.1056/NEJMoa1917006.

Adding subcutaneous nemolizumab to topical treatments for atopic dermatitis patients significantly improved their itching, compared with a placebo, in a phase 3 study of 215 patients in Japan.

Controlling the pruritus associated with atopic dermatitis (AD) can have a significant impact on patients’ quality of life, wrote Kenji Kabashima, MD, PhD, of the department of dermatology at Kyoto University, and coauthors. Frequent scratching can cause not only mechanical skin damage, but also may enhance inflammatory reactions and contribute to sleep problems.

In earlier phase studies, nemolizumab, a humanized monoclonal antibody against interleukin-31 receptor A, showed efficacy in reducing pruritus in patients with AD, but has not been well studied in patients who are also using topical agents, they wrote.

In the study published in the New England Journal of Medicine, the researchers randomized 143 patients with AD and moderate to severe pruritus to 60 mg of subcutaneous nemolizumab and 72 patients to a placebo every 4 weeks for 16 weeks. All patients were aged 13 years and older with a confirmed AD diagnosis and a history of inadequate response to or inability to use treatments, including topical glucocorticoids and oral antihistamines. Their average age was 40 years, approximately two-thirds were male, and the average disease duration was approximately 30 years. Topical treatments included a medium potency glucocorticoid in 97% of patients in both groups, and a topical calcineurin inhibitor in 41% of those on nemolizumab, and 40% of those on placebo; almost 90% of the patients in both groups were on oral antihistamines.

At 16 weeks, scores on the visual analog scale for pruritus (the primary outcome) significantly improved from baseline in the nemolizumab group, compared with the placebo group (a mean change of –42.8% and –21.4%, respectively, P < .001).

In addition, more patients in the nemolizumab group, compared with the placebo group (40% vs. 22%) achieved a score of 4 or less on the Dermatology Life Quality Index, with lower scores reflecting less impact of disease on daily life. In addition, more patients in the nemolizumab group, compared with the placebo group (55% vs. 21%) achieved a score of 7 or less on the Insomnia Severity Index.

During the study, 71% of the patients in each group reported adverse events, most were mild or moderate. The most common adverse event was worsening AD, reported by 24% of the nemolizumab patients and 21% of the placebo patients. Reactions related to the injection occurred in 8% of nemolizumab patients and 3% of placebo patients. Cytokine abnormalities, which included an increased level of thymus and activation regulated chemokine, were reported in 10 (7%) of the patients on nemolizumab, none of which occurred in those on placebo. “Most were not accompanied by a worsening of signs of or the extent of atopic dermatitis,” the authors wrote.

Severe adverse events were reported in three patients (2%) in the nemolizumab group, which were Meniere’s disease, acute pancreatitis, and AD in one patient each. No severe adverse events were reported in the placebo group. In addition, three patients in the nemolizumab group experienced four treatment-related adverse events that led them to discontinue treatment: AD, Meniere’s disease, alopecia, and peripheral edema.

The study findings were limited by several factors including the relatively short treatment period, inclusion only of Japanese patients, inclusion of patients aged as young as 13 years, and the inability to draw conclusions from the secondary endpoints such as quality of life and sleep issues, the researchers noted.

However, the results suggest that “nemolizumab plus topical agents may ameliorate both pruritus and signs of eczema and may lessen the severity of atopic dermatitis by disrupting the itch-scratch cycle,” they added.

“Novel therapies [for AD] are needed, as there are still patients who need better disease control despite current therapies, and AD is a heterogeneous disease that may need different treatment approaches,” Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, said in an interview.

Dr. Simpson, who was not an investigator in this study, said that he was somewhat surprised that the itch reduction was lower in the current study, compared with previous studies by the same group. Also surprising was the increase in cytokine abnormalities in the nemolizumab group, which “needs further study.”

Overall, the data “provide support that blockade of the IL-31 receptor improves itch in AD and appears to have some effect on inflammation,” Dr. Simpson said.

One challenge to the clinical use of nemolizumab will be identifying “where this type of drug fits into the treatment paradigm,” and determining whether specific patients whose disease is driven more by this neuroimmune pathway could benefit more than with the traditional IL-4 or IL-13 blockade, he said.

The study was supported by Maruho. Dr. Kabashima disclosed consulting fees from Maruho and two coauthors were Maruho employees. Dr. Simpson had no financial conflicts relevant to this study, but he reported receiving research grants and other financial relationships with manufacturers of AD therapies.

SOURCE: Kabashima K et al. N Engl J Med. 2020 Jul 9. doi: 10.1056/NEJMoa1917006.

Adding subcutaneous nemolizumab to topical treatments for atopic dermatitis patients significantly improved their itching, compared with a placebo, in a phase 3 study of 215 patients in Japan.

Controlling the pruritus associated with atopic dermatitis (AD) can have a significant impact on patients’ quality of life, wrote Kenji Kabashima, MD, PhD, of the department of dermatology at Kyoto University, and coauthors. Frequent scratching can cause not only mechanical skin damage, but also may enhance inflammatory reactions and contribute to sleep problems.

In earlier phase studies, nemolizumab, a humanized monoclonal antibody against interleukin-31 receptor A, showed efficacy in reducing pruritus in patients with AD, but has not been well studied in patients who are also using topical agents, they wrote.

In the study published in the New England Journal of Medicine, the researchers randomized 143 patients with AD and moderate to severe pruritus to 60 mg of subcutaneous nemolizumab and 72 patients to a placebo every 4 weeks for 16 weeks. All patients were aged 13 years and older with a confirmed AD diagnosis and a history of inadequate response to or inability to use treatments, including topical glucocorticoids and oral antihistamines. Their average age was 40 years, approximately two-thirds were male, and the average disease duration was approximately 30 years. Topical treatments included a medium potency glucocorticoid in 97% of patients in both groups, and a topical calcineurin inhibitor in 41% of those on nemolizumab, and 40% of those on placebo; almost 90% of the patients in both groups were on oral antihistamines.

At 16 weeks, scores on the visual analog scale for pruritus (the primary outcome) significantly improved from baseline in the nemolizumab group, compared with the placebo group (a mean change of –42.8% and –21.4%, respectively, P < .001).

In addition, more patients in the nemolizumab group, compared with the placebo group (40% vs. 22%) achieved a score of 4 or less on the Dermatology Life Quality Index, with lower scores reflecting less impact of disease on daily life. In addition, more patients in the nemolizumab group, compared with the placebo group (55% vs. 21%) achieved a score of 7 or less on the Insomnia Severity Index.

During the study, 71% of the patients in each group reported adverse events, most were mild or moderate. The most common adverse event was worsening AD, reported by 24% of the nemolizumab patients and 21% of the placebo patients. Reactions related to the injection occurred in 8% of nemolizumab patients and 3% of placebo patients. Cytokine abnormalities, which included an increased level of thymus and activation regulated chemokine, were reported in 10 (7%) of the patients on nemolizumab, none of which occurred in those on placebo. “Most were not accompanied by a worsening of signs of or the extent of atopic dermatitis,” the authors wrote.

Severe adverse events were reported in three patients (2%) in the nemolizumab group, which were Meniere’s disease, acute pancreatitis, and AD in one patient each. No severe adverse events were reported in the placebo group. In addition, three patients in the nemolizumab group experienced four treatment-related adverse events that led them to discontinue treatment: AD, Meniere’s disease, alopecia, and peripheral edema.

The study findings were limited by several factors including the relatively short treatment period, inclusion only of Japanese patients, inclusion of patients aged as young as 13 years, and the inability to draw conclusions from the secondary endpoints such as quality of life and sleep issues, the researchers noted.

However, the results suggest that “nemolizumab plus topical agents may ameliorate both pruritus and signs of eczema and may lessen the severity of atopic dermatitis by disrupting the itch-scratch cycle,” they added.

“Novel therapies [for AD] are needed, as there are still patients who need better disease control despite current therapies, and AD is a heterogeneous disease that may need different treatment approaches,” Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, said in an interview.

Dr. Simpson, who was not an investigator in this study, said that he was somewhat surprised that the itch reduction was lower in the current study, compared with previous studies by the same group. Also surprising was the increase in cytokine abnormalities in the nemolizumab group, which “needs further study.”

Overall, the data “provide support that blockade of the IL-31 receptor improves itch in AD and appears to have some effect on inflammation,” Dr. Simpson said.

One challenge to the clinical use of nemolizumab will be identifying “where this type of drug fits into the treatment paradigm,” and determining whether specific patients whose disease is driven more by this neuroimmune pathway could benefit more than with the traditional IL-4 or IL-13 blockade, he said.

The study was supported by Maruho. Dr. Kabashima disclosed consulting fees from Maruho and two coauthors were Maruho employees. Dr. Simpson had no financial conflicts relevant to this study, but he reported receiving research grants and other financial relationships with manufacturers of AD therapies.

SOURCE: Kabashima K et al. N Engl J Med. 2020 Jul 9. doi: 10.1056/NEJMoa1917006.

While guidelines for bronchiolitis aim to reduce gratuitous tests and treatments, one-third of infants presenting at EDs with bronchiolitis receive an unnecessary intervention, according to a new global study.

For infants with symptoms of bronchiolitis, viral testing, blood tests, and chest x-rays are discouraged in most cases. Antibiotics are not recommended as treatment.

In a study published in Pediatrics, Amy Zipursky, MD, of the Hospital for Sick Children and the University of Toronto, and colleagues, reviewed records for 2,359 infants aged 2-11 months diagnosed with bronchiolitis during the year 2013. The data came from a network of 38 EDs in the Australia, Canada, Ireland, New Zealand, Portugal, Spain, the United Kingdom, and the United States.

Dr. Zipursky and colleagues found that, while 8% of infants in the cohort had been treated with antibiotics, 33% had received at least one nonrecommended test, with rates ranging widely across regions. In the United Kingdom and Ireland, for example, only 15% received such a test, compared with 50% in Spain and Portugal.

Of the children given antibiotics, two-thirds had suspected bacterial infections, the researchers found. Antibiotic use was highest in the United States, at 11% of infants seen for bronchiolitis, and lowest in the United Kingdom and Ireland at 4%. Administration of chest x-rays – which occurred in nearly a quarter of the cohort – increased the likelihood of antibiotics being administered (odds ratio, 2.29; 95% confidence interval, 1.62-3.24) independent of fever or severe symptoms.

The most common nonrecommended tests performed in the study were:

• Nasopharyngeal viral testing without admission to hospital (n = 591).
• Chest x-ray without ICU admission (n = 507).
• Complete blood counts (n = 222).
• Blood cultures (n = 129).
• Urinalysis in the absence of fever (n = 86).
• Febrile infants 3 months of age or less had blood cultures (n = 49).

In some treatment centers the rate of nonrecommended tests performed was 6%, while others saw rates of 74%.

“Despite the evidence that laboratory testing rarely impacts bronchiolitis management and that bacterial infections in bronchiolitis are uncommon, our study reveals that these tests continue to be performed frequently in many parts of the world,” Dr. Zipursky and colleagues wrote in their analysis.

“Plausible reasons may include ‘automatic’ blood draws with intravenous placement, uncertainty about institutional policies, perceived need for reassurance about the diagnosis, perception of ‘doing something,’ and parental desire for a viral label,” the authors surmised. “Because parental pressure to provide interventions may be a driver of care in infants with bronchiolitis in some countries, ED clinicians need to have higher confidence in the evidence-based bronchiolitis care and convey this trust to families.”

The researchers listed among the weaknesses of their study its retrospective design, and that results from x-rays and lab tests performed were not available.

In an editorial comment accompanying the study, Joseph J. Zorc, MD, of Children’s Hospital of Philadelphia and the University of Pennsylvania in Philadelphia, noted that some of the regional differences seen in the study may be attributable to different clinical criteria used to diagnose bronchiolitis. In the United Kingdom, for example, national guidelines include the presence of crackles, while in North America guidelines focus on wheeze. “Perhaps clinicians in the United Kingdom accept the presence of crackles as an expected finding in infant with bronchiolitis and are less likely to order imaging,” Dr. Zorc said (Pediatrics. 2020 Jul 13;146[2]:e20193684).

He also pointed out that the coronavirus pandemic caused by SARS-CoV-2 (COVID- 19) could have an impact on global testing and treatment practices for bronchiolitis, as coronaviruses are a known cause of bronchiolitis. The Pediatric Emergency Research Network, comprising the 38 EDs from which Dr. Zipursky and colleagues drew their data, is conducting a prospective study looking at pediatric disease caused by SARS-CoV-2.

The “collaboration of international networks of pediatric emergency providers is an encouraging sign of potential opportunities to come ... [providing] an opportunity to evaluate variation that can lead to innovation,” Dr. Zorc concluded.

Dr. Zipursky and colleagues reported no external funding or relevant financial disclosures. Dr. Zorc reported no relevant conflicts of interest.

SOURCE: Zipursky A et al. Pediatrics. 2020 Jul 13;146(2):e2020002311.

While guidelines for bronchiolitis aim to reduce gratuitous tests and treatments, one-third of infants presenting at EDs with bronchiolitis receive an unnecessary intervention, according to a new global study.

For infants with symptoms of bronchiolitis, viral testing, blood tests, and chest x-rays are discouraged in most cases. Antibiotics are not recommended as treatment.

In a study published in Pediatrics, Amy Zipursky, MD, of the Hospital for Sick Children and the University of Toronto, and colleagues, reviewed records for 2,359 infants aged 2-11 months diagnosed with bronchiolitis during the year 2013. The data came from a network of 38 EDs in the Australia, Canada, Ireland, New Zealand, Portugal, Spain, the United Kingdom, and the United States.

Dr. Zipursky and colleagues found that, while 8% of infants in the cohort had been treated with antibiotics, 33% had received at least one nonrecommended test, with rates ranging widely across regions. In the United Kingdom and Ireland, for example, only 15% received such a test, compared with 50% in Spain and Portugal.

Of the children given antibiotics, two-thirds had suspected bacterial infections, the researchers found. Antibiotic use was highest in the United States, at 11% of infants seen for bronchiolitis, and lowest in the United Kingdom and Ireland at 4%. Administration of chest x-rays – which occurred in nearly a quarter of the cohort – increased the likelihood of antibiotics being administered (odds ratio, 2.29; 95% confidence interval, 1.62-3.24) independent of fever or severe symptoms.

The most common nonrecommended tests performed in the study were:

• Nasopharyngeal viral testing without admission to hospital (n = 591).
• Chest x-ray without ICU admission (n = 507).
• Complete blood counts (n = 222).
• Blood cultures (n = 129).
• Urinalysis in the absence of fever (n = 86).
• Febrile infants 3 months of age or less had blood cultures (n = 49).

In some treatment centers the rate of nonrecommended tests performed was 6%, while others saw rates of 74%.

“Despite the evidence that laboratory testing rarely impacts bronchiolitis management and that bacterial infections in bronchiolitis are uncommon, our study reveals that these tests continue to be performed frequently in many parts of the world,” Dr. Zipursky and colleagues wrote in their analysis.

“Plausible reasons may include ‘automatic’ blood draws with intravenous placement, uncertainty about institutional policies, perceived need for reassurance about the diagnosis, perception of ‘doing something,’ and parental desire for a viral label,” the authors surmised. “Because parental pressure to provide interventions may be a driver of care in infants with bronchiolitis in some countries, ED clinicians need to have higher confidence in the evidence-based bronchiolitis care and convey this trust to families.”

The researchers listed among the weaknesses of their study its retrospective design, and that results from x-rays and lab tests performed were not available.

In an editorial comment accompanying the study, Joseph J. Zorc, MD, of Children’s Hospital of Philadelphia and the University of Pennsylvania in Philadelphia, noted that some of the regional differences seen in the study may be attributable to different clinical criteria used to diagnose bronchiolitis. In the United Kingdom, for example, national guidelines include the presence of crackles, while in North America guidelines focus on wheeze. “Perhaps clinicians in the United Kingdom accept the presence of crackles as an expected finding in infant with bronchiolitis and are less likely to order imaging,” Dr. Zorc said (Pediatrics. 2020 Jul 13;146[2]:e20193684).

He also pointed out that the coronavirus pandemic caused by SARS-CoV-2 (COVID- 19) could have an impact on global testing and treatment practices for bronchiolitis, as coronaviruses are a known cause of bronchiolitis. The Pediatric Emergency Research Network, comprising the 38 EDs from which Dr. Zipursky and colleagues drew their data, is conducting a prospective study looking at pediatric disease caused by SARS-CoV-2.

The “collaboration of international networks of pediatric emergency providers is an encouraging sign of potential opportunities to come ... [providing] an opportunity to evaluate variation that can lead to innovation,” Dr. Zorc concluded.

Dr. Zipursky and colleagues reported no external funding or relevant financial disclosures. Dr. Zorc reported no relevant conflicts of interest.

SOURCE: Zipursky A et al. Pediatrics. 2020 Jul 13;146(2):e2020002311.

While guidelines for bronchiolitis aim to reduce gratuitous tests and treatments, one-third of infants presenting at EDs with bronchiolitis receive an unnecessary intervention, according to a new global study.

For infants with symptoms of bronchiolitis, viral testing, blood tests, and chest x-rays are discouraged in most cases. Antibiotics are not recommended as treatment.

In a study published in Pediatrics, Amy Zipursky, MD, of the Hospital for Sick Children and the University of Toronto, and colleagues, reviewed records for 2,359 infants aged 2-11 months diagnosed with bronchiolitis during the year 2013. The data came from a network of 38 EDs in the Australia, Canada, Ireland, New Zealand, Portugal, Spain, the United Kingdom, and the United States.

Dr. Zipursky and colleagues found that, while 8% of infants in the cohort had been treated with antibiotics, 33% had received at least one nonrecommended test, with rates ranging widely across regions. In the United Kingdom and Ireland, for example, only 15% received such a test, compared with 50% in Spain and Portugal.

Of the children given antibiotics, two-thirds had suspected bacterial infections, the researchers found. Antibiotic use was highest in the United States, at 11% of infants seen for bronchiolitis, and lowest in the United Kingdom and Ireland at 4%. Administration of chest x-rays – which occurred in nearly a quarter of the cohort – increased the likelihood of antibiotics being administered (odds ratio, 2.29; 95% confidence interval, 1.62-3.24) independent of fever or severe symptoms.

The most common nonrecommended tests performed in the study were:

• Nasopharyngeal viral testing without admission to hospital (n = 591).
• Chest x-ray without ICU admission (n = 507).
• Complete blood counts (n = 222).
• Blood cultures (n = 129).
• Urinalysis in the absence of fever (n = 86).
• Febrile infants 3 months of age or less had blood cultures (n = 49).

In some treatment centers the rate of nonrecommended tests performed was 6%, while others saw rates of 74%.

“Despite the evidence that laboratory testing rarely impacts bronchiolitis management and that bacterial infections in bronchiolitis are uncommon, our study reveals that these tests continue to be performed frequently in many parts of the world,” Dr. Zipursky and colleagues wrote in their analysis.

“Plausible reasons may include ‘automatic’ blood draws with intravenous placement, uncertainty about institutional policies, perceived need for reassurance about the diagnosis, perception of ‘doing something,’ and parental desire for a viral label,” the authors surmised. “Because parental pressure to provide interventions may be a driver of care in infants with bronchiolitis in some countries, ED clinicians need to have higher confidence in the evidence-based bronchiolitis care and convey this trust to families.”

The researchers listed among the weaknesses of their study its retrospective design, and that results from x-rays and lab tests performed were not available.

In an editorial comment accompanying the study, Joseph J. Zorc, MD, of Children’s Hospital of Philadelphia and the University of Pennsylvania in Philadelphia, noted that some of the regional differences seen in the study may be attributable to different clinical criteria used to diagnose bronchiolitis. In the United Kingdom, for example, national guidelines include the presence of crackles, while in North America guidelines focus on wheeze. “Perhaps clinicians in the United Kingdom accept the presence of crackles as an expected finding in infant with bronchiolitis and are less likely to order imaging,” Dr. Zorc said (Pediatrics. 2020 Jul 13;146[2]:e20193684).

He also pointed out that the coronavirus pandemic caused by SARS-CoV-2 (COVID- 19) could have an impact on global testing and treatment practices for bronchiolitis, as coronaviruses are a known cause of bronchiolitis. The Pediatric Emergency Research Network, comprising the 38 EDs from which Dr. Zipursky and colleagues drew their data, is conducting a prospective study looking at pediatric disease caused by SARS-CoV-2.

The “collaboration of international networks of pediatric emergency providers is an encouraging sign of potential opportunities to come ... [providing] an opportunity to evaluate variation that can lead to innovation,” Dr. Zorc concluded.

Dr. Zipursky and colleagues reported no external funding or relevant financial disclosures. Dr. Zorc reported no relevant conflicts of interest.

SOURCE: Zipursky A et al. Pediatrics. 2020 Jul 13;146(2):e2020002311.

The way James R. Treat, MD, sees it, if there ever were a truism in the field of dermatology, it’s that everyone hates molluscum contagiosum.

“It tortures all of us,” Dr. Treat, a pediatric dermatologist at Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “It’s very distressing to parents, but often more distressing to parents than to kids.”

A viral disorder of the skin and mucous membranes characterized by discrete single or multiple, flesh-colored papules, molluscum contagiosum (MC) lesions often appear on the face, neck, armpits, arms, and tops of the hands in children. The abdomen and inner thighs can also be affected. “When you look at inflamed molluscum it can be very difficult to recognize because it looks like a more complicated infection,” said Dr. Treat, who is also associate professor of clinical pediatrics and dermatology, at the University of Pennsylvania, Philadelphia.

An epidemiologic review of 302 MC cases found that 80% of patients were aged younger than 8 years, 63% had more than 15 lesions, and 24% had concomitant atopic dermatitis (J Am Acad Dermatol. 2006; 2006;54[1]:47-54). “Children with atopic dermatitis often have their molluscum last longer,” he said. “The average time course for molluscum is 18 months, but it can certainly be longer than that. So if you say, ‘it’s probably going to go away in a few months,’ that’s probably not going to happen.”

The telltale MC lesion is glossy and contains a white core in the center that can be revealed by shining an otoscope sideways on the lesion. “Umbilication doesn’t always occur, but if the center part looks white, that will help with diagnosis,” Dr. Treat said. “If they’re inflamed and they’re red and you’re worried that there’s a bacterial infection, do a culture, pop the lesion open, and get some of the pus out. If you’re concerned, start them on antibiotics. It’s always worse to miss an infection than to overtreat molluscum. But once you’ve done it a few times and you realize that the cultures are coming back negative, then you’ll probably have your threshold a little higher.”

The most useful clinical sign of MC is the so-called “BOTE” (beginning of the end) sign, which is characterized by erythema and swelling of MC skin lesions. “When the parents come to us in pediatric dermatology, often it’s because their kids have had molluscum for a while,” he said. “It spreads and becomes inflamed and the parents ask, ‘Is it infected?’ The answer is, yes, it’s an infection, but it’s not infected with what you think it is [which is Staphylococcus or Streptococcus], it’s the virus being recognized by the body. When the virus is recognized by the body, it creates a huge inflammatory reaction. That’s usually the time at which the body has had enough of the virus, and it eradicates the rest of it. It means the inflammatory response is finding the molluscum and it’s going to take care of it.”

MC brings its own eczematous response, which can complicate efforts to confirm the diagnosis. Dr. Treat spoke of a young patient he recently saw who had an eczematous reaction on the inner parts of the arms and the upper flank – with no such clinical history. “It kind of came out of the blue,” he said. “You think about contact allergies and other types of dermatitis, but molluscum brings its own eczema. Often what the parents recognize is the eczematous eruption and not the little dots of molluscum. So if you see someone with a new eruption in typical molluscum areas – the flank and your thighs and the back of the legs – and they’ve never had eczema in the past, or they’ve only had mild eczema, think about eczema as a response to molluscum.”

MC can also result in a Gianotti-Crosti syndrome-like reactions (Arch Dermatol. 2012;148[11]:1257-64). “These are angry, inflamed red papules on the knees and on the elbows and on the buttocks and on the cheeks,” Dr. Treat said. “It typically spares the trunk, and they look like molluscum.”

He went on to note that MC can present as cysts, and that MC in the gluteal cleft is a mimicker of condyloma. MC can also cause conjunctivitis, which is increased in HIV patients and in those with atopic dermatitis. “These are patients who should probably see an ophthalmologist” to make no damage has occurred, Dr. Treat said.

He closed his remarks by noting that rarely, MC can be the presenting sign of an immunodeficiency. “The immune system dysregulation that shows up this way is called a DOCK8 mutation, which have eczema and widespread viral disease including warts and molluscum,” Dr. Treat said.

He reported having no financial disclosures.

[email protected]

The way James R. Treat, MD, sees it, if there ever were a truism in the field of dermatology, it’s that everyone hates molluscum contagiosum.

“It tortures all of us,” Dr. Treat, a pediatric dermatologist at Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “It’s very distressing to parents, but often more distressing to parents than to kids.”

A viral disorder of the skin and mucous membranes characterized by discrete single or multiple, flesh-colored papules, molluscum contagiosum (MC) lesions often appear on the face, neck, armpits, arms, and tops of the hands in children. The abdomen and inner thighs can also be affected. “When you look at inflamed molluscum it can be very difficult to recognize because it looks like a more complicated infection,” said Dr. Treat, who is also associate professor of clinical pediatrics and dermatology, at the University of Pennsylvania, Philadelphia.

An epidemiologic review of 302 MC cases found that 80% of patients were aged younger than 8 years, 63% had more than 15 lesions, and 24% had concomitant atopic dermatitis (J Am Acad Dermatol. 2006; 2006;54[1]:47-54). “Children with atopic dermatitis often have their molluscum last longer,” he said. “The average time course for molluscum is 18 months, but it can certainly be longer than that. So if you say, ‘it’s probably going to go away in a few months,’ that’s probably not going to happen.”

The telltale MC lesion is glossy and contains a white core in the center that can be revealed by shining an otoscope sideways on the lesion. “Umbilication doesn’t always occur, but if the center part looks white, that will help with diagnosis,” Dr. Treat said. “If they’re inflamed and they’re red and you’re worried that there’s a bacterial infection, do a culture, pop the lesion open, and get some of the pus out. If you’re concerned, start them on antibiotics. It’s always worse to miss an infection than to overtreat molluscum. But once you’ve done it a few times and you realize that the cultures are coming back negative, then you’ll probably have your threshold a little higher.”

The most useful clinical sign of MC is the so-called “BOTE” (beginning of the end) sign, which is characterized by erythema and swelling of MC skin lesions. “When the parents come to us in pediatric dermatology, often it’s because their kids have had molluscum for a while,” he said. “It spreads and becomes inflamed and the parents ask, ‘Is it infected?’ The answer is, yes, it’s an infection, but it’s not infected with what you think it is [which is Staphylococcus or Streptococcus], it’s the virus being recognized by the body. When the virus is recognized by the body, it creates a huge inflammatory reaction. That’s usually the time at which the body has had enough of the virus, and it eradicates the rest of it. It means the inflammatory response is finding the molluscum and it’s going to take care of it.”

MC brings its own eczematous response, which can complicate efforts to confirm the diagnosis. Dr. Treat spoke of a young patient he recently saw who had an eczematous reaction on the inner parts of the arms and the upper flank – with no such clinical history. “It kind of came out of the blue,” he said. “You think about contact allergies and other types of dermatitis, but molluscum brings its own eczema. Often what the parents recognize is the eczematous eruption and not the little dots of molluscum. So if you see someone with a new eruption in typical molluscum areas – the flank and your thighs and the back of the legs – and they’ve never had eczema in the past, or they’ve only had mild eczema, think about eczema as a response to molluscum.”

MC can also result in a Gianotti-Crosti syndrome-like reactions (Arch Dermatol. 2012;148[11]:1257-64). “These are angry, inflamed red papules on the knees and on the elbows and on the buttocks and on the cheeks,” Dr. Treat said. “It typically spares the trunk, and they look like molluscum.”

He went on to note that MC can present as cysts, and that MC in the gluteal cleft is a mimicker of condyloma. MC can also cause conjunctivitis, which is increased in HIV patients and in those with atopic dermatitis. “These are patients who should probably see an ophthalmologist” to make no damage has occurred, Dr. Treat said.

He closed his remarks by noting that rarely, MC can be the presenting sign of an immunodeficiency. “The immune system dysregulation that shows up this way is called a DOCK8 mutation, which have eczema and widespread viral disease including warts and molluscum,” Dr. Treat said.

He reported having no financial disclosures.

[email protected]

The way James R. Treat, MD, sees it, if there ever were a truism in the field of dermatology, it’s that everyone hates molluscum contagiosum.

“It tortures all of us,” Dr. Treat, a pediatric dermatologist at Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “It’s very distressing to parents, but often more distressing to parents than to kids.”

A viral disorder of the skin and mucous membranes characterized by discrete single or multiple, flesh-colored papules, molluscum contagiosum (MC) lesions often appear on the face, neck, armpits, arms, and tops of the hands in children. The abdomen and inner thighs can also be affected. “When you look at inflamed molluscum it can be very difficult to recognize because it looks like a more complicated infection,” said Dr. Treat, who is also associate professor of clinical pediatrics and dermatology, at the University of Pennsylvania, Philadelphia.

An epidemiologic review of 302 MC cases found that 80% of patients were aged younger than 8 years, 63% had more than 15 lesions, and 24% had concomitant atopic dermatitis (J Am Acad Dermatol. 2006; 2006;54[1]:47-54). “Children with atopic dermatitis often have their molluscum last longer,” he said. “The average time course for molluscum is 18 months, but it can certainly be longer than that. So if you say, ‘it’s probably going to go away in a few months,’ that’s probably not going to happen.”

The telltale MC lesion is glossy and contains a white core in the center that can be revealed by shining an otoscope sideways on the lesion. “Umbilication doesn’t always occur, but if the center part looks white, that will help with diagnosis,” Dr. Treat said. “If they’re inflamed and they’re red and you’re worried that there’s a bacterial infection, do a culture, pop the lesion open, and get some of the pus out. If you’re concerned, start them on antibiotics. It’s always worse to miss an infection than to overtreat molluscum. But once you’ve done it a few times and you realize that the cultures are coming back negative, then you’ll probably have your threshold a little higher.”

The most useful clinical sign of MC is the so-called “BOTE” (beginning of the end) sign, which is characterized by erythema and swelling of MC skin lesions. “When the parents come to us in pediatric dermatology, often it’s because their kids have had molluscum for a while,” he said. “It spreads and becomes inflamed and the parents ask, ‘Is it infected?’ The answer is, yes, it’s an infection, but it’s not infected with what you think it is [which is Staphylococcus or Streptococcus], it’s the virus being recognized by the body. When the virus is recognized by the body, it creates a huge inflammatory reaction. That’s usually the time at which the body has had enough of the virus, and it eradicates the rest of it. It means the inflammatory response is finding the molluscum and it’s going to take care of it.”

MC brings its own eczematous response, which can complicate efforts to confirm the diagnosis. Dr. Treat spoke of a young patient he recently saw who had an eczematous reaction on the inner parts of the arms and the upper flank – with no such clinical history. “It kind of came out of the blue,” he said. “You think about contact allergies and other types of dermatitis, but molluscum brings its own eczema. Often what the parents recognize is the eczematous eruption and not the little dots of molluscum. So if you see someone with a new eruption in typical molluscum areas – the flank and your thighs and the back of the legs – and they’ve never had eczema in the past, or they’ve only had mild eczema, think about eczema as a response to molluscum.”

MC can also result in a Gianotti-Crosti syndrome-like reactions (Arch Dermatol. 2012;148[11]:1257-64). “These are angry, inflamed red papules on the knees and on the elbows and on the buttocks and on the cheeks,” Dr. Treat said. “It typically spares the trunk, and they look like molluscum.”

He went on to note that MC can present as cysts, and that MC in the gluteal cleft is a mimicker of condyloma. MC can also cause conjunctivitis, which is increased in HIV patients and in those with atopic dermatitis. “These are patients who should probably see an ophthalmologist” to make no damage has occurred, Dr. Treat said.

He closed his remarks by noting that rarely, MC can be the presenting sign of an immunodeficiency. “The immune system dysregulation that shows up this way is called a DOCK8 mutation, which have eczema and widespread viral disease including warts and molluscum,” Dr. Treat said.

He reported having no financial disclosures.

[email protected]

The role of probiotics in the management of gastrointestinal disorders remains largely unclear, according to a clinical practice guideline published by the American Gastroenterological Association (AGA).

Out of eight disorders reviewed by the guideline panel, four had enough relevant data to support conditional recommendations, while the other four were associated with knowledge gaps that precluded guidance, reported lead author Grace L. Su, MD, AGAF, of the University of Michigan, Ann Arbor, and colleagues.

“It is estimated that 3.9 million American adults used some form of probiotics or prebiotics ... in 2015, an amount which is four times that in 2007,” the guideline panelists wrote. Their report is in Gastroenterology. “Given widespread use and often biased sources of information, it is essential that clinicians have objective guidance for their patients about the appropriate use of and indications for probiotics.”

The creation of such guidance, however, proved a challenging task for the panel, who faced an “extremely varied” evidence base.

Dr. Su and colleagues, who were selected by the AGA Governing Board and Clinical Guidelines Committee, encountered “differences in the strain of microbe(s) used, dose, and route of administration.”

They noted that such differences can significantly affect clinical outcomes.

“Within species, different strains can have widely different activities and biologic effects,” they wrote. “Many immunologic, neurologic, and biochemical effects of gut microbiota are likely not only to be strain specific, but also dose specific. Furthermore, combinations of different microbial strains may also have widely different activity as some microbial activities are dependent on interactions between different strains.”

Beyond differences in treatments, the investigators also reported wide variability in endpoints and outcomes, as well as relatively small study populations compared with pharmacological trials.

Still, data were sufficient to provide some conditional recommendations.

The guideline supports probiotics for patients with pouchitis, those receiving antibiotic therapy, and preterm/low-birthweight infants. In contrast, the panel recommended against probiotics for children with acute infectious gastroenteritis, noting that this recommendation differs from those made by other medical organizations.

“While other society guidelines have previously recommended the use of probiotics in [children with acute infectious gastroenteritis], these guidelines were developed without utilizing GRADE methodology and also relied on data outside of North America which became available after the recommendations were made,” wrote Dr. Su and colleagues. They described a moderate quality of evidence relevant to this indication.

In comparison, the quality of evidence was very low for patients with pouchitis, low for those receiving antibiotics, and moderate/high for preterm/low-birthweight infants.

For Clostridioides difficile infection, Crohn’s disease, ulcerative colitis, and irritable bowel syndrome, the panel recommended probiotics only in the context of a clinical trial, citing knowledge gaps in these areas.

They also noted that probiotics may not be suitable for those at high risk of infection.

“[F]or patients who place a high value on avoidance of potential harms, particularly those with severe illnesses or immunosuppression, it would be reasonable to select not to use probiotics,” the panelists wrote.

Concluding their discussion, Dr. Su and colleagues called for more high-quality research.

“We identified that significant knowledge gaps exist in this very promising and important area of research due to the significant heterogeneity between studies and variability in the probiotic strains studied,” they wrote. “The lack of consistent harms reporting makes it difficult to assess true harms. The lack of product manufacturing details prohibits true comparisons and decreases the feasibility of obtaining certain products by patients. Future high-quality studies are urgently needed which address these pitfalls.”

According to the panelists, the probiotic guideline will be updated in 3-5 years, or possibly earlier if practice-altering findings are published.

The investigators disclosed relationships with Nestex, AbbVie, Takeda, and others.

The role of probiotics in the management of gastrointestinal disorders remains largely unclear, according to a clinical practice guideline published by the American Gastroenterological Association (AGA).

Out of eight disorders reviewed by the guideline panel, four had enough relevant data to support conditional recommendations, while the other four were associated with knowledge gaps that precluded guidance, reported lead author Grace L. Su, MD, AGAF, of the University of Michigan, Ann Arbor, and colleagues.

“It is estimated that 3.9 million American adults used some form of probiotics or prebiotics ... in 2015, an amount which is four times that in 2007,” the guideline panelists wrote. Their report is in Gastroenterology. “Given widespread use and often biased sources of information, it is essential that clinicians have objective guidance for their patients about the appropriate use of and indications for probiotics.”

The creation of such guidance, however, proved a challenging task for the panel, who faced an “extremely varied” evidence base.

Dr. Su and colleagues, who were selected by the AGA Governing Board and Clinical Guidelines Committee, encountered “differences in the strain of microbe(s) used, dose, and route of administration.”

They noted that such differences can significantly affect clinical outcomes.

“Within species, different strains can have widely different activities and biologic effects,” they wrote. “Many immunologic, neurologic, and biochemical effects of gut microbiota are likely not only to be strain specific, but also dose specific. Furthermore, combinations of different microbial strains may also have widely different activity as some microbial activities are dependent on interactions between different strains.”

Beyond differences in treatments, the investigators also reported wide variability in endpoints and outcomes, as well as relatively small study populations compared with pharmacological trials.

Still, data were sufficient to provide some conditional recommendations.

The guideline supports probiotics for patients with pouchitis, those receiving antibiotic therapy, and preterm/low-birthweight infants. In contrast, the panel recommended against probiotics for children with acute infectious gastroenteritis, noting that this recommendation differs from those made by other medical organizations.

“While other society guidelines have previously recommended the use of probiotics in [children with acute infectious gastroenteritis], these guidelines were developed without utilizing GRADE methodology and also relied on data outside of North America which became available after the recommendations were made,” wrote Dr. Su and colleagues. They described a moderate quality of evidence relevant to this indication.

In comparison, the quality of evidence was very low for patients with pouchitis, low for those receiving antibiotics, and moderate/high for preterm/low-birthweight infants.

For Clostridioides difficile infection, Crohn’s disease, ulcerative colitis, and irritable bowel syndrome, the panel recommended probiotics only in the context of a clinical trial, citing knowledge gaps in these areas.

They also noted that probiotics may not be suitable for those at high risk of infection.

“[F]or patients who place a high value on avoidance of potential harms, particularly those with severe illnesses or immunosuppression, it would be reasonable to select not to use probiotics,” the panelists wrote.

Concluding their discussion, Dr. Su and colleagues called for more high-quality research.

“We identified that significant knowledge gaps exist in this very promising and important area of research due to the significant heterogeneity between studies and variability in the probiotic strains studied,” they wrote. “The lack of consistent harms reporting makes it difficult to assess true harms. The lack of product manufacturing details prohibits true comparisons and decreases the feasibility of obtaining certain products by patients. Future high-quality studies are urgently needed which address these pitfalls.”

According to the panelists, the probiotic guideline will be updated in 3-5 years, or possibly earlier if practice-altering findings are published.

The investigators disclosed relationships with Nestex, AbbVie, Takeda, and others.

The role of probiotics in the management of gastrointestinal disorders remains largely unclear, according to a clinical practice guideline published by the American Gastroenterological Association (AGA).

Out of eight disorders reviewed by the guideline panel, four had enough relevant data to support conditional recommendations, while the other four were associated with knowledge gaps that precluded guidance, reported lead author Grace L. Su, MD, AGAF, of the University of Michigan, Ann Arbor, and colleagues.

“It is estimated that 3.9 million American adults used some form of probiotics or prebiotics ... in 2015, an amount which is four times that in 2007,” the guideline panelists wrote. Their report is in Gastroenterology. “Given widespread use and often biased sources of information, it is essential that clinicians have objective guidance for their patients about the appropriate use of and indications for probiotics.”

The creation of such guidance, however, proved a challenging task for the panel, who faced an “extremely varied” evidence base.

Dr. Su and colleagues, who were selected by the AGA Governing Board and Clinical Guidelines Committee, encountered “differences in the strain of microbe(s) used, dose, and route of administration.”

They noted that such differences can significantly affect clinical outcomes.

“Within species, different strains can have widely different activities and biologic effects,” they wrote. “Many immunologic, neurologic, and biochemical effects of gut microbiota are likely not only to be strain specific, but also dose specific. Furthermore, combinations of different microbial strains may also have widely different activity as some microbial activities are dependent on interactions between different strains.”

Beyond differences in treatments, the investigators also reported wide variability in endpoints and outcomes, as well as relatively small study populations compared with pharmacological trials.

Still, data were sufficient to provide some conditional recommendations.

The guideline supports probiotics for patients with pouchitis, those receiving antibiotic therapy, and preterm/low-birthweight infants. In contrast, the panel recommended against probiotics for children with acute infectious gastroenteritis, noting that this recommendation differs from those made by other medical organizations.

“While other society guidelines have previously recommended the use of probiotics in [children with acute infectious gastroenteritis], these guidelines were developed without utilizing GRADE methodology and also relied on data outside of North America which became available after the recommendations were made,” wrote Dr. Su and colleagues. They described a moderate quality of evidence relevant to this indication.

In comparison, the quality of evidence was very low for patients with pouchitis, low for those receiving antibiotics, and moderate/high for preterm/low-birthweight infants.

For Clostridioides difficile infection, Crohn’s disease, ulcerative colitis, and irritable bowel syndrome, the panel recommended probiotics only in the context of a clinical trial, citing knowledge gaps in these areas.

They also noted that probiotics may not be suitable for those at high risk of infection.

“[F]or patients who place a high value on avoidance of potential harms, particularly those with severe illnesses or immunosuppression, it would be reasonable to select not to use probiotics,” the panelists wrote.

Concluding their discussion, Dr. Su and colleagues called for more high-quality research.

“We identified that significant knowledge gaps exist in this very promising and important area of research due to the significant heterogeneity between studies and variability in the probiotic strains studied,” they wrote. “The lack of consistent harms reporting makes it difficult to assess true harms. The lack of product manufacturing details prohibits true comparisons and decreases the feasibility of obtaining certain products by patients. Future high-quality studies are urgently needed which address these pitfalls.”

According to the panelists, the probiotic guideline will be updated in 3-5 years, or possibly earlier if practice-altering findings are published.

The investigators disclosed relationships with Nestex, AbbVie, Takeda, and others.

What do you do now?

Your waiting room is filled with mask-wearing individuals, except for one person. Your staff offers a mask to this person, citing your office policy of requiring masks for all persons in order to prevent asymptomatic COVID-19 spread, and the patient refuses to put it on.

What can you/should you/must you do? Are you required to see a patient who refuses to wear a mask? If you ask the patient to leave without being seen, can you be accused of patient abandonment? If you allow the patient to stay, could you be liable for negligence for exposing others to a deadly illness?

The rules on mask-wearing, while initially downright confusing, have inexorably come to a rough consensus. By governors’ orders, masks are now mandatory in most states, though when and where they are required varies. For example, effective July 7, the governor of Washington has ordered that a business not allow a customer to enter without a face covering.

So far, there are no cases or court decisions to guide us about whether it is negligence to allow an unmasked patient to commingle in a medical practice. Nor do we have case law to help us determine whether patient abandonment would apply if a patient is sent home without being seen.

We can apply the legal principles and cases from other situations to this one, however, to tell us what constitutes negligence or patient abandonment. The practical questions, legally, are who might sue and on what basis?

Who might sue?

Someone who is injured in a public place may sue the owner for negligence if the owner knew or should have known of a danger and didn’t do anything about it. For example, individuals have sued grocery stores successfully after they slipped on a banana peel and fell. If, say, the banana peel was black, that indicates that it had been there for a while, and judges have found that the store management should have known about it and removed it.

Compare the banana peel scenario with the scenario where most news outlets and health departments are telling people, every day, to wear masks while in indoor public spaces, yet owners of a medical practice or facility allow individuals who are not wearing masks to sit in their waiting room. If an individual who was also in the waiting room with the unmasked individual develops COVID-19 2 days later, the ill individual may sue the medical practice for negligence for not removing the unmasked individual.

What about the individual’s responsibility to move away from the person not wearing a mask? That is the aspect of this scenario that attorneys and experts could argue about, for days, in a court case. But to go back to the banana peel case, one could argue that a customer in a grocery store should be looking out for banana peels on the floor and avoid them, yet courts have assigned liability to grocery stores when customers slip and fall.

Let’s review the four elements of negligence which a plaintiff would need to prove:

• Duty: Obligation of one person to another
• Breach: Improper act or omission, in the context of proper behavior to avoid imposing undue risks of harm to other persons and their property
• Damage
• Causation: That the act or omission caused the harm

Those who run medical offices and facilities have a duty to provide reasonably safe public spaces. Unmasked individuals are a risk to others nearby, so the “breach” element is satisfied if a practice fails to impose safety measures. Causation could be proven, or at least inferred, if contact tracing of an individual with COVID-19 showed that the only contact likely to have exposed the ill individual to the virus was an unmasked individual in a medical practice’s waiting room, especially if the unmasked individual was COVID-19 positive before, during, or shortly after the visit to the practice.

What about patient abandonment?

“Patient abandonment” is the legal term for terminating the physician-patient relationship in such a manner that the patient is denied necessary medical care. It is a form of negligence.

Refusing to see a patient unless the patient wears a mask is not denying care, in this attorney’s view, but rather establishing reasonable conditions for getting care. The patient simply needs to put on a mask.

What about the patient who refuses to wear a mask for medical reasons? There are exceptions in most of the governors’ orders for individuals with medical conditions that preclude covering nose and mouth with a mask. A medical office is the perfect place to test an individual’s ability or inability to breathe well while wearing a mask. “Put the mask on and we’ll see how you do” is a reasonable response. Monitor the patient visually and apply a pulse oximeter with mask off and mask on.

One physician recently wrote about measuring her own oxygen levels while wearing four different masks for 5 minutes each, with no change in breathing.

Editor’s note: Read more about mask exemptions in a Medscape interview with pulmonologist Albert Rizzo, MD, chief medical officer of the American Lung Association.

What are some practical tips?

Assuming that a patient is not in acute distress, options in this scenario include:

• Send the patient home and offer a return visit if masked or when the pandemic is over.
• Offer a telehealth visit, with the patient at home.

What if the unmasked person is not a patient but the companion of a patient? What if the individual refusing to wear a mask is an employee? In neither of these two hypotheticals is there a basis for legal action against a practice whose policy requires that everyone wear masks on the premises.

A companion who arrives without a mask should leave the office. An employee who refuses to mask up could be sent home. If the employee has a disability covered by the Americans with Disabilities Act, then the practice may need to make reasonable accommodations so that the employee works in a room alone if unable to work from home.

Those who manage medical practices should check the websites of the state health department and medical societies at least weekly, to see whether the agencies have issued guidance. For example, the Texas Medical Association has issued limited guidance.

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

What do you do now?

Your waiting room is filled with mask-wearing individuals, except for one person. Your staff offers a mask to this person, citing your office policy of requiring masks for all persons in order to prevent asymptomatic COVID-19 spread, and the patient refuses to put it on.

What can you/should you/must you do? Are you required to see a patient who refuses to wear a mask? If you ask the patient to leave without being seen, can you be accused of patient abandonment? If you allow the patient to stay, could you be liable for negligence for exposing others to a deadly illness?

The rules on mask-wearing, while initially downright confusing, have inexorably come to a rough consensus. By governors’ orders, masks are now mandatory in most states, though when and where they are required varies. For example, effective July 7, the governor of Washington has ordered that a business not allow a customer to enter without a face covering.

So far, there are no cases or court decisions to guide us about whether it is negligence to allow an unmasked patient to commingle in a medical practice. Nor do we have case law to help us determine whether patient abandonment would apply if a patient is sent home without being seen.

We can apply the legal principles and cases from other situations to this one, however, to tell us what constitutes negligence or patient abandonment. The practical questions, legally, are who might sue and on what basis?

Who might sue?

Someone who is injured in a public place may sue the owner for negligence if the owner knew or should have known of a danger and didn’t do anything about it. For example, individuals have sued grocery stores successfully after they slipped on a banana peel and fell. If, say, the banana peel was black, that indicates that it had been there for a while, and judges have found that the store management should have known about it and removed it.

Compare the banana peel scenario with the scenario where most news outlets and health departments are telling people, every day, to wear masks while in indoor public spaces, yet owners of a medical practice or facility allow individuals who are not wearing masks to sit in their waiting room. If an individual who was also in the waiting room with the unmasked individual develops COVID-19 2 days later, the ill individual may sue the medical practice for negligence for not removing the unmasked individual.

What about the individual’s responsibility to move away from the person not wearing a mask? That is the aspect of this scenario that attorneys and experts could argue about, for days, in a court case. But to go back to the banana peel case, one could argue that a customer in a grocery store should be looking out for banana peels on the floor and avoid them, yet courts have assigned liability to grocery stores when customers slip and fall.

Let’s review the four elements of negligence which a plaintiff would need to prove:

• Duty: Obligation of one person to another
• Breach: Improper act or omission, in the context of proper behavior to avoid imposing undue risks of harm to other persons and their property
• Damage
• Causation: That the act or omission caused the harm

Those who run medical offices and facilities have a duty to provide reasonably safe public spaces. Unmasked individuals are a risk to others nearby, so the “breach” element is satisfied if a practice fails to impose safety measures. Causation could be proven, or at least inferred, if contact tracing of an individual with COVID-19 showed that the only contact likely to have exposed the ill individual to the virus was an unmasked individual in a medical practice’s waiting room, especially if the unmasked individual was COVID-19 positive before, during, or shortly after the visit to the practice.

What about patient abandonment?

“Patient abandonment” is the legal term for terminating the physician-patient relationship in such a manner that the patient is denied necessary medical care. It is a form of negligence.

Refusing to see a patient unless the patient wears a mask is not denying care, in this attorney’s view, but rather establishing reasonable conditions for getting care. The patient simply needs to put on a mask.

What about the patient who refuses to wear a mask for medical reasons? There are exceptions in most of the governors’ orders for individuals with medical conditions that preclude covering nose and mouth with a mask. A medical office is the perfect place to test an individual’s ability or inability to breathe well while wearing a mask. “Put the mask on and we’ll see how you do” is a reasonable response. Monitor the patient visually and apply a pulse oximeter with mask off and mask on.

One physician recently wrote about measuring her own oxygen levels while wearing four different masks for 5 minutes each, with no change in breathing.

Editor’s note: Read more about mask exemptions in a Medscape interview with pulmonologist Albert Rizzo, MD, chief medical officer of the American Lung Association.

What are some practical tips?

Assuming that a patient is not in acute distress, options in this scenario include:

• Send the patient home and offer a return visit if masked or when the pandemic is over.
• Offer a telehealth visit, with the patient at home.

What if the unmasked person is not a patient but the companion of a patient? What if the individual refusing to wear a mask is an employee? In neither of these two hypotheticals is there a basis for legal action against a practice whose policy requires that everyone wear masks on the premises.

A companion who arrives without a mask should leave the office. An employee who refuses to mask up could be sent home. If the employee has a disability covered by the Americans with Disabilities Act, then the practice may need to make reasonable accommodations so that the employee works in a room alone if unable to work from home.

Those who manage medical practices should check the websites of the state health department and medical societies at least weekly, to see whether the agencies have issued guidance. For example, the Texas Medical Association has issued limited guidance.

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

What do you do now?

Your waiting room is filled with mask-wearing individuals, except for one person. Your staff offers a mask to this person, citing your office policy of requiring masks for all persons in order to prevent asymptomatic COVID-19 spread, and the patient refuses to put it on.

What can you/should you/must you do? Are you required to see a patient who refuses to wear a mask? If you ask the patient to leave without being seen, can you be accused of patient abandonment? If you allow the patient to stay, could you be liable for negligence for exposing others to a deadly illness?

The rules on mask-wearing, while initially downright confusing, have inexorably come to a rough consensus. By governors’ orders, masks are now mandatory in most states, though when and where they are required varies. For example, effective July 7, the governor of Washington has ordered that a business not allow a customer to enter without a face covering.

So far, there are no cases or court decisions to guide us about whether it is negligence to allow an unmasked patient to commingle in a medical practice. Nor do we have case law to help us determine whether patient abandonment would apply if a patient is sent home without being seen.

We can apply the legal principles and cases from other situations to this one, however, to tell us what constitutes negligence or patient abandonment. The practical questions, legally, are who might sue and on what basis?

Who might sue?

Someone who is injured in a public place may sue the owner for negligence if the owner knew or should have known of a danger and didn’t do anything about it. For example, individuals have sued grocery stores successfully after they slipped on a banana peel and fell. If, say, the banana peel was black, that indicates that it had been there for a while, and judges have found that the store management should have known about it and removed it.

Compare the banana peel scenario with the scenario where most news outlets and health departments are telling people, every day, to wear masks while in indoor public spaces, yet owners of a medical practice or facility allow individuals who are not wearing masks to sit in their waiting room. If an individual who was also in the waiting room with the unmasked individual develops COVID-19 2 days later, the ill individual may sue the medical practice for negligence for not removing the unmasked individual.

What about the individual’s responsibility to move away from the person not wearing a mask? That is the aspect of this scenario that attorneys and experts could argue about, for days, in a court case. But to go back to the banana peel case, one could argue that a customer in a grocery store should be looking out for banana peels on the floor and avoid them, yet courts have assigned liability to grocery stores when customers slip and fall.

Let’s review the four elements of negligence which a plaintiff would need to prove:

• Duty: Obligation of one person to another
• Breach: Improper act or omission, in the context of proper behavior to avoid imposing undue risks of harm to other persons and their property
• Damage
• Causation: That the act or omission caused the harm

Those who run medical offices and facilities have a duty to provide reasonably safe public spaces. Unmasked individuals are a risk to others nearby, so the “breach” element is satisfied if a practice fails to impose safety measures. Causation could be proven, or at least inferred, if contact tracing of an individual with COVID-19 showed that the only contact likely to have exposed the ill individual to the virus was an unmasked individual in a medical practice’s waiting room, especially if the unmasked individual was COVID-19 positive before, during, or shortly after the visit to the practice.

What about patient abandonment?

“Patient abandonment” is the legal term for terminating the physician-patient relationship in such a manner that the patient is denied necessary medical care. It is a form of negligence.

Refusing to see a patient unless the patient wears a mask is not denying care, in this attorney’s view, but rather establishing reasonable conditions for getting care. The patient simply needs to put on a mask.

What about the patient who refuses to wear a mask for medical reasons? There are exceptions in most of the governors’ orders for individuals with medical conditions that preclude covering nose and mouth with a mask. A medical office is the perfect place to test an individual’s ability or inability to breathe well while wearing a mask. “Put the mask on and we’ll see how you do” is a reasonable response. Monitor the patient visually and apply a pulse oximeter with mask off and mask on.

One physician recently wrote about measuring her own oxygen levels while wearing four different masks for 5 minutes each, with no change in breathing.

Editor’s note: Read more about mask exemptions in a Medscape interview with pulmonologist Albert Rizzo, MD, chief medical officer of the American Lung Association.

What are some practical tips?

Assuming that a patient is not in acute distress, options in this scenario include:

• Send the patient home and offer a return visit if masked or when the pandemic is over.
• Offer a telehealth visit, with the patient at home.

What if the unmasked person is not a patient but the companion of a patient? What if the individual refusing to wear a mask is an employee? In neither of these two hypotheticals is there a basis for legal action against a practice whose policy requires that everyone wear masks on the premises.

A companion who arrives without a mask should leave the office. An employee who refuses to mask up could be sent home. If the employee has a disability covered by the Americans with Disabilities Act, then the practice may need to make reasonable accommodations so that the employee works in a room alone if unable to work from home.

Those who manage medical practices should check the websites of the state health department and medical societies at least weekly, to see whether the agencies have issued guidance. For example, the Texas Medical Association has issued limited guidance.

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

Children who were overweight or obese at ages 2-3 years and at 6-7 years were significantly more likely than were healthy-weight children to show cardiometabolic risk factors at 11-12 years in a population-based study of more than 5,000 children.

SolStock/iStock

Previous studies of the impact of childhood body mass index on cardiovascular disease have used a single BMI measurement, wrote Kate Lycett, PhD, of Deakin University, Victoria, Australia, and colleagues. “This overlooks the considerable physiologic changes in BMI throughout childhood as part of typical growth.”

In a study published in Pediatrics, the researchers examined overweight and obesity at five time points in a cohort of 5,107 infants by measuring BMI every 2 years between the ages of 2-3 years and 10-11 years.

Overall, children with consistently high BMI trajectories from age 3 years had the highest risk of metabolic syndrome. At age 6-7 years, overweight and obese children had, respectively, higher metabolic syndrome risk scores by 0.23 and 0.76 mean standard deviation (SD) units, compared with healthy-weight children; these associations approximately doubled by age 11-12 years.

In addition, obese children had higher pulse wave velocity (PWV) from age 6-7 years (0.64-0.73 standard deviation units) and slightly higher carotid artery intima-media thickness (cIMT) at all measured ages, compared with healthy-weight children (0.20-0.30 SD units).

The findings were limited by several factors, including the inability to evaluate the effects of BMI on actual cardiovascular disease because of the young age of the study population, the researchers noted.

However, the “results are in keeping with previous studies but provide additional important insights that suggest BMI from as early as 2 to 3 years of age is predictive of preclinical cardiometabolic phenotypes by ages 11 to 12 years,” Dr. Lycett and associates said. The results have implications for public health by highlighting the subclinical effects of obesity in childhood and the importance of early intervention, they concluded.

“This important and comprehensive study has two important implications: first, high BMI by age 2 to 3 tends to stay high, and second, normal BMI occasionally increases to high BMI, but the reverse is rarely true,” Sarah Armstrong, MD, Jennifer S. Li, MD, and Asheley C. Skinner, PhD, wrote in an accompanying editorial (Pediatrics. 2020 Jul 6. doi: 10.1542/peds.2020-1353).

The finding that children who were obese at age 3 years showed significant markers of silent atherosclerotic disease by age 11 years was “striking,” noted the editorialists, who are affiliated with Duke University, Durham, N.C.

“An important caveat is that although the relationships were significant, the amount of variance attributable directly to child BMI was small,” which highlights the complex relationship between obesity and health, they noted.

“Early-onset obesity is unlikely to change and, if it persists, will lead to detectable precursors of atherosclerosis by the time a child enters middle school,” and parents and primary care providers have an opportunity to “flatten the curve” by addressing BMI increases early in life to delay or prevent obesity, the editorialists concluded.

The study was supported by Australia’s National Health and Medical Research Council, The Royal Children’s Hospital Foundation, Murdoch Children’s Research Institute, The University of Melbourne, National Heart Foundation of Australia, Financial Markets Foundation for Children, and Victorian Deaf Education Institute. A number of the researchers were supported by grants from these and other universities and organizations. The researchers had no relevant financial disclosures. The editorialists had no financial conflicts to disclose.

SOURCE: Lycett K et al. Pediatrics. 2020 Jul 6. doi: 10.1542/peds.2019-3666.

Children who were overweight or obese at ages 2-3 years and at 6-7 years were significantly more likely than were healthy-weight children to show cardiometabolic risk factors at 11-12 years in a population-based study of more than 5,000 children.

SolStock/iStock

Previous studies of the impact of childhood body mass index on cardiovascular disease have used a single BMI measurement, wrote Kate Lycett, PhD, of Deakin University, Victoria, Australia, and colleagues. “This overlooks the considerable physiologic changes in BMI throughout childhood as part of typical growth.”

In a study published in Pediatrics, the researchers examined overweight and obesity at five time points in a cohort of 5,107 infants by measuring BMI every 2 years between the ages of 2-3 years and 10-11 years.

Overall, children with consistently high BMI trajectories from age 3 years had the highest risk of metabolic syndrome. At age 6-7 years, overweight and obese children had, respectively, higher metabolic syndrome risk scores by 0.23 and 0.76 mean standard deviation (SD) units, compared with healthy-weight children; these associations approximately doubled by age 11-12 years.

In addition, obese children had higher pulse wave velocity (PWV) from age 6-7 years (0.64-0.73 standard deviation units) and slightly higher carotid artery intima-media thickness (cIMT) at all measured ages, compared with healthy-weight children (0.20-0.30 SD units).

The findings were limited by several factors, including the inability to evaluate the effects of BMI on actual cardiovascular disease because of the young age of the study population, the researchers noted.

However, the “results are in keeping with previous studies but provide additional important insights that suggest BMI from as early as 2 to 3 years of age is predictive of preclinical cardiometabolic phenotypes by ages 11 to 12 years,” Dr. Lycett and associates said. The results have implications for public health by highlighting the subclinical effects of obesity in childhood and the importance of early intervention, they concluded.

“This important and comprehensive study has two important implications: first, high BMI by age 2 to 3 tends to stay high, and second, normal BMI occasionally increases to high BMI, but the reverse is rarely true,” Sarah Armstrong, MD, Jennifer S. Li, MD, and Asheley C. Skinner, PhD, wrote in an accompanying editorial (Pediatrics. 2020 Jul 6. doi: 10.1542/peds.2020-1353).

The finding that children who were obese at age 3 years showed significant markers of silent atherosclerotic disease by age 11 years was “striking,” noted the editorialists, who are affiliated with Duke University, Durham, N.C.

“An important caveat is that although the relationships were significant, the amount of variance attributable directly to child BMI was small,” which highlights the complex relationship between obesity and health, they noted.

“Early-onset obesity is unlikely to change and, if it persists, will lead to detectable precursors of atherosclerosis by the time a child enters middle school,” and parents and primary care providers have an opportunity to “flatten the curve” by addressing BMI increases early in life to delay or prevent obesity, the editorialists concluded.

The study was supported by Australia’s National Health and Medical Research Council, The Royal Children’s Hospital Foundation, Murdoch Children’s Research Institute, The University of Melbourne, National Heart Foundation of Australia, Financial Markets Foundation for Children, and Victorian Deaf Education Institute. A number of the researchers were supported by grants from these and other universities and organizations. The researchers had no relevant financial disclosures. The editorialists had no financial conflicts to disclose.

SOURCE: Lycett K et al. Pediatrics. 2020 Jul 6. doi: 10.1542/peds.2019-3666.

Children who were overweight or obese at ages 2-3 years and at 6-7 years were significantly more likely than were healthy-weight children to show cardiometabolic risk factors at 11-12 years in a population-based study of more than 5,000 children.

SolStock/iStock

Previous studies of the impact of childhood body mass index on cardiovascular disease have used a single BMI measurement, wrote Kate Lycett, PhD, of Deakin University, Victoria, Australia, and colleagues. “This overlooks the considerable physiologic changes in BMI throughout childhood as part of typical growth.”

In a study published in Pediatrics, the researchers examined overweight and obesity at five time points in a cohort of 5,107 infants by measuring BMI every 2 years between the ages of 2-3 years and 10-11 years.

Overall, children with consistently high BMI trajectories from age 3 years had the highest risk of metabolic syndrome. At age 6-7 years, overweight and obese children had, respectively, higher metabolic syndrome risk scores by 0.23 and 0.76 mean standard deviation (SD) units, compared with healthy-weight children; these associations approximately doubled by age 11-12 years.

In addition, obese children had higher pulse wave velocity (PWV) from age 6-7 years (0.64-0.73 standard deviation units) and slightly higher carotid artery intima-media thickness (cIMT) at all measured ages, compared with healthy-weight children (0.20-0.30 SD units).

The findings were limited by several factors, including the inability to evaluate the effects of BMI on actual cardiovascular disease because of the young age of the study population, the researchers noted.

However, the “results are in keeping with previous studies but provide additional important insights that suggest BMI from as early as 2 to 3 years of age is predictive of preclinical cardiometabolic phenotypes by ages 11 to 12 years,” Dr. Lycett and associates said. The results have implications for public health by highlighting the subclinical effects of obesity in childhood and the importance of early intervention, they concluded.

“This important and comprehensive study has two important implications: first, high BMI by age 2 to 3 tends to stay high, and second, normal BMI occasionally increases to high BMI, but the reverse is rarely true,” Sarah Armstrong, MD, Jennifer S. Li, MD, and Asheley C. Skinner, PhD, wrote in an accompanying editorial (Pediatrics. 2020 Jul 6. doi: 10.1542/peds.2020-1353).

The finding that children who were obese at age 3 years showed significant markers of silent atherosclerotic disease by age 11 years was “striking,” noted the editorialists, who are affiliated with Duke University, Durham, N.C.

“An important caveat is that although the relationships were significant, the amount of variance attributable directly to child BMI was small,” which highlights the complex relationship between obesity and health, they noted.

“Early-onset obesity is unlikely to change and, if it persists, will lead to detectable precursors of atherosclerosis by the time a child enters middle school,” and parents and primary care providers have an opportunity to “flatten the curve” by addressing BMI increases early in life to delay or prevent obesity, the editorialists concluded.

The study was supported by Australia’s National Health and Medical Research Council, The Royal Children’s Hospital Foundation, Murdoch Children’s Research Institute, The University of Melbourne, National Heart Foundation of Australia, Financial Markets Foundation for Children, and Victorian Deaf Education Institute. A number of the researchers were supported by grants from these and other universities and organizations. The researchers had no relevant financial disclosures. The editorialists had no financial conflicts to disclose.

SOURCE: Lycett K et al. Pediatrics. 2020 Jul 6. doi: 10.1542/peds.2019-3666.

Physician consensus and a broadly effective treatment for heavy menstrual bleeding was not found among young patients with inherited platelet function disorders, according to the results of a retrospective chart review reported in the Journal of Pediatric and Adolescent Gynecology.

Heavy menstrual bleeding (HMB) in girls with inherited platelet function disorders (IPFD) can be difficult to control despite ongoing follow-up and treatment changes, reported Christine M. Pennesi, MD, of the University of Michigan, Ann Arbor, and colleagues.

They assessed 34 young women and girls (ages 9-25 years) diagnosed with IPFDs referred to gynecology and/or hematology at a tertiary care hospital between 2006 and 2018.

Billing codes were used to determine hormonal or nonhormonal treatments, and outcomes over a 1- to 2-year period were collected. The initial treatment was defined as the first treatment prescribed after referral. The primary outcome was treatment failure, defined as a change in treatment method because of continued bleeding.

The majority (56%) of patients failed initial treatment (n = 19); among all 34 individuals followed in the study, an average of 2.7 total treatments were required.

Six patients (18%) remained uncontrolled despite numerous treatment changes (mean treatment changes, four; range, two to seven), and two patients (6%) remained uncontrolled because of noncompliance with treatment.

Overall, the researchers identified a 18% failure rate of successfully treatment of HMB in young women and girls with IPFDs over a 2-year follow-up period.

Of the 26 women who achieved control of HMB within 2-year follow-up, 54% (n = 14) were on hormonal treatments, 27% (n = 7) on nonhormonal treatments, 12% (n = 3) on combined treatments, and 8% (n = 2) on no treatment at time of control, the authors stated.

“The heterogeneity in treatments that were described in this study, clearly demonstrate that, in selecting treatment methods for HMB in young women, other considerations are often in play. This includes patient preference and need for contraception. Some patients or parents may have personal or religious objections to hormonal methods or worry about hormones in this young age group,” the researchers speculated.

“Appropriate counseling in these patients should include that it would not be unexpected for a patient to need more than one treatment before control of bleeding is achieved. This may help to alleviate the fear of teenagers when continued bleeding occurs after starting their initial treatment,” Dr. Pennesi and colleagues concluded.

One of the authors participated in funded trials and received funding from several pharmaceutical companies. The others reported having no disclosures.

[email protected]

SOURCE: Pennesi CM et al. J Pediatr Adolesc Gynecol. 2020 Jun 22. doi: 10.1016/j.jpag.2020.06.019.

Physician consensus and a broadly effective treatment for heavy menstrual bleeding was not found among young patients with inherited platelet function disorders, according to the results of a retrospective chart review reported in the Journal of Pediatric and Adolescent Gynecology.

Heavy menstrual bleeding (HMB) in girls with inherited platelet function disorders (IPFD) can be difficult to control despite ongoing follow-up and treatment changes, reported Christine M. Pennesi, MD, of the University of Michigan, Ann Arbor, and colleagues.

They assessed 34 young women and girls (ages 9-25 years) diagnosed with IPFDs referred to gynecology and/or hematology at a tertiary care hospital between 2006 and 2018.

Billing codes were used to determine hormonal or nonhormonal treatments, and outcomes over a 1- to 2-year period were collected. The initial treatment was defined as the first treatment prescribed after referral. The primary outcome was treatment failure, defined as a change in treatment method because of continued bleeding.

The majority (56%) of patients failed initial treatment (n = 19); among all 34 individuals followed in the study, an average of 2.7 total treatments were required.

Six patients (18%) remained uncontrolled despite numerous treatment changes (mean treatment changes, four; range, two to seven), and two patients (6%) remained uncontrolled because of noncompliance with treatment.

Overall, the researchers identified a 18% failure rate of successfully treatment of HMB in young women and girls with IPFDs over a 2-year follow-up period.

Of the 26 women who achieved control of HMB within 2-year follow-up, 54% (n = 14) were on hormonal treatments, 27% (n = 7) on nonhormonal treatments, 12% (n = 3) on combined treatments, and 8% (n = 2) on no treatment at time of control, the authors stated.

“The heterogeneity in treatments that were described in this study, clearly demonstrate that, in selecting treatment methods for HMB in young women, other considerations are often in play. This includes patient preference and need for contraception. Some patients or parents may have personal or religious objections to hormonal methods or worry about hormones in this young age group,” the researchers speculated.

“Appropriate counseling in these patients should include that it would not be unexpected for a patient to need more than one treatment before control of bleeding is achieved. This may help to alleviate the fear of teenagers when continued bleeding occurs after starting their initial treatment,” Dr. Pennesi and colleagues concluded.

One of the authors participated in funded trials and received funding from several pharmaceutical companies. The others reported having no disclosures.

[email protected]

SOURCE: Pennesi CM et al. J Pediatr Adolesc Gynecol. 2020 Jun 22. doi: 10.1016/j.jpag.2020.06.019.

Physician consensus and a broadly effective treatment for heavy menstrual bleeding was not found among young patients with inherited platelet function disorders, according to the results of a retrospective chart review reported in the Journal of Pediatric and Adolescent Gynecology.

Heavy menstrual bleeding (HMB) in girls with inherited platelet function disorders (IPFD) can be difficult to control despite ongoing follow-up and treatment changes, reported Christine M. Pennesi, MD, of the University of Michigan, Ann Arbor, and colleagues.

They assessed 34 young women and girls (ages 9-25 years) diagnosed with IPFDs referred to gynecology and/or hematology at a tertiary care hospital between 2006 and 2018.

Billing codes were used to determine hormonal or nonhormonal treatments, and outcomes over a 1- to 2-year period were collected. The initial treatment was defined as the first treatment prescribed after referral. The primary outcome was treatment failure, defined as a change in treatment method because of continued bleeding.

The majority (56%) of patients failed initial treatment (n = 19); among all 34 individuals followed in the study, an average of 2.7 total treatments were required.

Six patients (18%) remained uncontrolled despite numerous treatment changes (mean treatment changes, four; range, two to seven), and two patients (6%) remained uncontrolled because of noncompliance with treatment.

Overall, the researchers identified a 18% failure rate of successfully treatment of HMB in young women and girls with IPFDs over a 2-year follow-up period.

Of the 26 women who achieved control of HMB within 2-year follow-up, 54% (n = 14) were on hormonal treatments, 27% (n = 7) on nonhormonal treatments, 12% (n = 3) on combined treatments, and 8% (n = 2) on no treatment at time of control, the authors stated.

“The heterogeneity in treatments that were described in this study, clearly demonstrate that, in selecting treatment methods for HMB in young women, other considerations are often in play. This includes patient preference and need for contraception. Some patients or parents may have personal or religious objections to hormonal methods or worry about hormones in this young age group,” the researchers speculated.

“Appropriate counseling in these patients should include that it would not be unexpected for a patient to need more than one treatment before control of bleeding is achieved. This may help to alleviate the fear of teenagers when continued bleeding occurs after starting their initial treatment,” Dr. Pennesi and colleagues concluded.

One of the authors participated in funded trials and received funding from several pharmaceutical companies. The others reported having no disclosures.

[email protected]

SOURCE: Pennesi CM et al. J Pediatr Adolesc Gynecol. 2020 Jun 22. doi: 10.1016/j.jpag.2020.06.019.