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Don’t choose hormones to protect postmenopausal women
Hormone therapy should not be used to prevent chronic conditions in postmenopausal women, according to updated recommendations from the U.S. Preventive Services Task Force. The recommendations were published online Dec. 12 in JAMA.
In the latest recommendation statement, the USPSTF issued D recommendations against using combination estrogen and progestin to prevent chronic conditions in postmenopausal women and against using estrogen only to prevent chronic conditions in postmenopausal women who have undergone hysterectomies (JAMA. 2017 Dec 12. doi: 10.1001/jama.2017.18261). A grade D recommendation is defined as “The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.”
In response to public comments, the USPSTF team made several changes including adjusting the language to clarify that the recommendations apply only to postmenopausal women, and adding tables showing estimates of increased or decreased risk of various outcomes for postmenopausal women receiving different hormone therapies.
Approximately 40,000 women aged 53-79 years were included in an evidence report from Gerald Gartlehner, MD, of the University of North Carolina, Chapel Hill, and his colleagues that accompanied the recommendations (JAMA. 2017 Dec 12. doi: 10.1001/jama.2017.16952).
The researchers found that women taking estrogen alone had significantly lower risk of breast cancer, diabetes, and osteoporotic fractures, but significantly higher risk of gallbladder disease, stroke, urinary incontinence, and venous thromboembolism, compared with women taking placebo. In addition, women using a combination of estrogen and progestin had significantly lower risk of colorectal cancer, diabetes, and osteoporotic fractures, but significantly higher risk of breast cancer, probable dementia, gallbladder disease, stroke, urinary incontinence, and venous thromboembolism, compared with women taking placebo.
“Hormone therapy for the primary prevention of chronic conditions in menopausal women is associated with some beneficial effects but also with a substantial increase of risks for harms,” and the current evidence for the risks and benefits of hormone therapy is inconclusive, the researchers said.
The final recommendation remains consistent with the USPSTF draft statement issued earlier in 2017 and with the final recommendation statements issued in 2012.
The researchers had no relevant financial conflicts to disclose.
Twenty-five years ago, the U.S. Preventive Services Task Force advised clinicians to consider hormone therapy for the prevention of disease in all women, particularly those at risk for coronary heart disease, Deborah Grady, MD, wrote in an editorial (JAMA Intern Med. 2017 Dec 12. doi: 10.1001/jamainternmed.2017.7861). Dr. Grady was one of the coauthors of a literature review supporting the American College of Physicians’ recommendation to counsel asymptomatic postmenopausal women about hormone therapy based on data from observational studies. “No randomized trials with clinical outcomes had been conducted,” Dr. Grady said. By 2002, data from three large randomized trials told a different story, and the Task Force recommended against using estrogen alone as a strategy to prevent chronic conditions in postmenopausal women, she noted.
“I believe that the fear of hormone therapy is overblown,” Dr. Grady wrote. “When adequately informed, women with moderate to severe symptoms and without contraindications should be able to take such small risks if hormone therapy improves symptoms and quality of life,” she said.
In fact, professional societies, including the North American Menopause Society, the American College of Obstetricians and Gynecologists, and the Endocrine Society support hormone therapy for symptomatic women who are recently menopausal, said Dr. Grady. However, a key lesson learned from the ongoing research on hormone therapy is the importance of conducting clinical trials that are large enough to identify serious adverse effects, she added.
Dr. Grady is affiliated with the University of California, San Francisco. She had no financial conflicts to disclose.
Twenty-five years ago, the U.S. Preventive Services Task Force advised clinicians to consider hormone therapy for the prevention of disease in all women, particularly those at risk for coronary heart disease, Deborah Grady, MD, wrote in an editorial (JAMA Intern Med. 2017 Dec 12. doi: 10.1001/jamainternmed.2017.7861). Dr. Grady was one of the coauthors of a literature review supporting the American College of Physicians’ recommendation to counsel asymptomatic postmenopausal women about hormone therapy based on data from observational studies. “No randomized trials with clinical outcomes had been conducted,” Dr. Grady said. By 2002, data from three large randomized trials told a different story, and the Task Force recommended against using estrogen alone as a strategy to prevent chronic conditions in postmenopausal women, she noted.
“I believe that the fear of hormone therapy is overblown,” Dr. Grady wrote. “When adequately informed, women with moderate to severe symptoms and without contraindications should be able to take such small risks if hormone therapy improves symptoms and quality of life,” she said.
In fact, professional societies, including the North American Menopause Society, the American College of Obstetricians and Gynecologists, and the Endocrine Society support hormone therapy for symptomatic women who are recently menopausal, said Dr. Grady. However, a key lesson learned from the ongoing research on hormone therapy is the importance of conducting clinical trials that are large enough to identify serious adverse effects, she added.
Dr. Grady is affiliated with the University of California, San Francisco. She had no financial conflicts to disclose.
Twenty-five years ago, the U.S. Preventive Services Task Force advised clinicians to consider hormone therapy for the prevention of disease in all women, particularly those at risk for coronary heart disease, Deborah Grady, MD, wrote in an editorial (JAMA Intern Med. 2017 Dec 12. doi: 10.1001/jamainternmed.2017.7861). Dr. Grady was one of the coauthors of a literature review supporting the American College of Physicians’ recommendation to counsel asymptomatic postmenopausal women about hormone therapy based on data from observational studies. “No randomized trials with clinical outcomes had been conducted,” Dr. Grady said. By 2002, data from three large randomized trials told a different story, and the Task Force recommended against using estrogen alone as a strategy to prevent chronic conditions in postmenopausal women, she noted.
“I believe that the fear of hormone therapy is overblown,” Dr. Grady wrote. “When adequately informed, women with moderate to severe symptoms and without contraindications should be able to take such small risks if hormone therapy improves symptoms and quality of life,” she said.
In fact, professional societies, including the North American Menopause Society, the American College of Obstetricians and Gynecologists, and the Endocrine Society support hormone therapy for symptomatic women who are recently menopausal, said Dr. Grady. However, a key lesson learned from the ongoing research on hormone therapy is the importance of conducting clinical trials that are large enough to identify serious adverse effects, she added.
Dr. Grady is affiliated with the University of California, San Francisco. She had no financial conflicts to disclose.
Hormone therapy should not be used to prevent chronic conditions in postmenopausal women, according to updated recommendations from the U.S. Preventive Services Task Force. The recommendations were published online Dec. 12 in JAMA.
In the latest recommendation statement, the USPSTF issued D recommendations against using combination estrogen and progestin to prevent chronic conditions in postmenopausal women and against using estrogen only to prevent chronic conditions in postmenopausal women who have undergone hysterectomies (JAMA. 2017 Dec 12. doi: 10.1001/jama.2017.18261). A grade D recommendation is defined as “The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.”
In response to public comments, the USPSTF team made several changes including adjusting the language to clarify that the recommendations apply only to postmenopausal women, and adding tables showing estimates of increased or decreased risk of various outcomes for postmenopausal women receiving different hormone therapies.
Approximately 40,000 women aged 53-79 years were included in an evidence report from Gerald Gartlehner, MD, of the University of North Carolina, Chapel Hill, and his colleagues that accompanied the recommendations (JAMA. 2017 Dec 12. doi: 10.1001/jama.2017.16952).
The researchers found that women taking estrogen alone had significantly lower risk of breast cancer, diabetes, and osteoporotic fractures, but significantly higher risk of gallbladder disease, stroke, urinary incontinence, and venous thromboembolism, compared with women taking placebo. In addition, women using a combination of estrogen and progestin had significantly lower risk of colorectal cancer, diabetes, and osteoporotic fractures, but significantly higher risk of breast cancer, probable dementia, gallbladder disease, stroke, urinary incontinence, and venous thromboembolism, compared with women taking placebo.
“Hormone therapy for the primary prevention of chronic conditions in menopausal women is associated with some beneficial effects but also with a substantial increase of risks for harms,” and the current evidence for the risks and benefits of hormone therapy is inconclusive, the researchers said.
The final recommendation remains consistent with the USPSTF draft statement issued earlier in 2017 and with the final recommendation statements issued in 2012.
The researchers had no relevant financial conflicts to disclose.
Hormone therapy should not be used to prevent chronic conditions in postmenopausal women, according to updated recommendations from the U.S. Preventive Services Task Force. The recommendations were published online Dec. 12 in JAMA.
In the latest recommendation statement, the USPSTF issued D recommendations against using combination estrogen and progestin to prevent chronic conditions in postmenopausal women and against using estrogen only to prevent chronic conditions in postmenopausal women who have undergone hysterectomies (JAMA. 2017 Dec 12. doi: 10.1001/jama.2017.18261). A grade D recommendation is defined as “The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.”
In response to public comments, the USPSTF team made several changes including adjusting the language to clarify that the recommendations apply only to postmenopausal women, and adding tables showing estimates of increased or decreased risk of various outcomes for postmenopausal women receiving different hormone therapies.
Approximately 40,000 women aged 53-79 years were included in an evidence report from Gerald Gartlehner, MD, of the University of North Carolina, Chapel Hill, and his colleagues that accompanied the recommendations (JAMA. 2017 Dec 12. doi: 10.1001/jama.2017.16952).
The researchers found that women taking estrogen alone had significantly lower risk of breast cancer, diabetes, and osteoporotic fractures, but significantly higher risk of gallbladder disease, stroke, urinary incontinence, and venous thromboembolism, compared with women taking placebo. In addition, women using a combination of estrogen and progestin had significantly lower risk of colorectal cancer, diabetes, and osteoporotic fractures, but significantly higher risk of breast cancer, probable dementia, gallbladder disease, stroke, urinary incontinence, and venous thromboembolism, compared with women taking placebo.
“Hormone therapy for the primary prevention of chronic conditions in menopausal women is associated with some beneficial effects but also with a substantial increase of risks for harms,” and the current evidence for the risks and benefits of hormone therapy is inconclusive, the researchers said.
The final recommendation remains consistent with the USPSTF draft statement issued earlier in 2017 and with the final recommendation statements issued in 2012.
The researchers had no relevant financial conflicts to disclose.
FROM JAMA
Early weight change has no special effect on mortality in RA
Weight loss at the time of rheumatoid arthritis diagnosis had the same impact on mortality in patients with and without RA, according to research trying to solve the so-called obesity paradox in RA, which has been related to prior observations of a protective effect of obesity on mortality in RA patients.
The finding indicates that clinicians can continue to encourage patients with rheumatoid arthritis to follow healthy weight-loss strategies, according to first author of the study, Jeffrey Sparks, MD, of Brigham and Women’s Hospital in Boston.
Dr. Sparks and his colleagues examined the impact of weight change and mortality in RA patients based on data from the Nurses’ Health Study.
“Our study is the first to focus on weight change around RA diagnosis and risk of death, rather than weight change in patients who had RA for many years,” Dr. Sparks noted.
By examining changes in weight near the time of RA diagnosis, Dr. Sparks and his colleagues said that they hoped to extract information about RA-specific processes rather than the underlying pathologies that might cause weight changes near the end of life.
In the study published in Arthritis & Rheumatology, the researchers compared women diagnosed with RA during follow-up to women without RA during the same index time period of 1976-2016. The study population included 121,701 women. Of these, 902 developed incident RA and were matched with 7,884 non-RA controls.
During an average of 18 years of follow-up, 41% of the RA cohort and 29% of the controls died. The risk of death was approximately twice as high (hazard ratio, 2.78; 95% confidence interval, 1.58-4.89) among those with weight loss greater than 30 pounds at the time of RA diagnosis, compared with those whose weight remained stable. However, the risk for mortality was similarly increased (HR, 2.16; 95% CI, 1.61-2.88) among the controls with weight loss greater than 30 pounds, compared with those with stable weight. No association with mortality was noted in either group among women who gained more than 30 pounds at the time of RA diagnosis.
Dr. Sparks said he was somewhat surprised by the findings.
“We expected severe, pathologic weight loss to be associated with increased risk of death among patients with RA and comparators. It was somewhat surprising that the risks in both groups were similar,” he said. “Conversely, prior studies suggested that weight gain might have been associated with increased risk of death. However, we found no association of weight gain with risk of death,” he noted.
In addition, “Our findings argue that there is not an RA-specific mortality risk based on either weight loss or gain,” he said. “While we found that weight loss was associated with increased mortality, this was most pronounced in the severe weight loss group, so was likely due to unintentional weight loss.”
Joshua F. Baker, MD, of the University of Pennsylvania, Philadelphia, and his colleagues identified an association between weight change and risk of death in RA patients in a study first published online in Arthritis & Rheumatology in 2015 (Arthritis Rheumatol. 2015 Jul;67[7]:1711-17). That study addressed the so-called obesity paradox in RA, and Dr. Baker and his colleagues noted that weight loss associated with the development of chronic illness is a significant confounder that may explain the observed protective effect of obesity on mortality.
“It is not clear how best to monitor changes in weight, when exactly to become concerned, and what to do when changes are observed,” Dr. Baker noted. “RA patients may lose weight for a number of reasons, not all related to their arthritis, and it is unlikely that there is a ‘one size fits all’ approach,” he said.
The study was limited in part by the women-only study population, so the results might not be generalizable to men, Dr. Sparks said. “The reason for weight change was unavailable,” he added. Directions for further research include investigation of how factors such as physical activity, diet, and weight loss may affect the risk of death among individuals with and without RA, he said.
Dr. Sparks had no financial conflicts to disclose. The study was supported in part by the National Institutes of Health and the Rheumatology Research Foundation’s Disease-Targeted Innovative Award and Scientist Development Awards.
SOURCE: Sparks J et al. Arthritis Rheumatol. 2017 Nov 30. doi: 10.1002/art.40346.
Weight loss at the time of rheumatoid arthritis diagnosis had the same impact on mortality in patients with and without RA, according to research trying to solve the so-called obesity paradox in RA, which has been related to prior observations of a protective effect of obesity on mortality in RA patients.
The finding indicates that clinicians can continue to encourage patients with rheumatoid arthritis to follow healthy weight-loss strategies, according to first author of the study, Jeffrey Sparks, MD, of Brigham and Women’s Hospital in Boston.
Dr. Sparks and his colleagues examined the impact of weight change and mortality in RA patients based on data from the Nurses’ Health Study.
“Our study is the first to focus on weight change around RA diagnosis and risk of death, rather than weight change in patients who had RA for many years,” Dr. Sparks noted.
By examining changes in weight near the time of RA diagnosis, Dr. Sparks and his colleagues said that they hoped to extract information about RA-specific processes rather than the underlying pathologies that might cause weight changes near the end of life.
In the study published in Arthritis & Rheumatology, the researchers compared women diagnosed with RA during follow-up to women without RA during the same index time period of 1976-2016. The study population included 121,701 women. Of these, 902 developed incident RA and were matched with 7,884 non-RA controls.
During an average of 18 years of follow-up, 41% of the RA cohort and 29% of the controls died. The risk of death was approximately twice as high (hazard ratio, 2.78; 95% confidence interval, 1.58-4.89) among those with weight loss greater than 30 pounds at the time of RA diagnosis, compared with those whose weight remained stable. However, the risk for mortality was similarly increased (HR, 2.16; 95% CI, 1.61-2.88) among the controls with weight loss greater than 30 pounds, compared with those with stable weight. No association with mortality was noted in either group among women who gained more than 30 pounds at the time of RA diagnosis.
Dr. Sparks said he was somewhat surprised by the findings.
“We expected severe, pathologic weight loss to be associated with increased risk of death among patients with RA and comparators. It was somewhat surprising that the risks in both groups were similar,” he said. “Conversely, prior studies suggested that weight gain might have been associated with increased risk of death. However, we found no association of weight gain with risk of death,” he noted.
In addition, “Our findings argue that there is not an RA-specific mortality risk based on either weight loss or gain,” he said. “While we found that weight loss was associated with increased mortality, this was most pronounced in the severe weight loss group, so was likely due to unintentional weight loss.”
Joshua F. Baker, MD, of the University of Pennsylvania, Philadelphia, and his colleagues identified an association between weight change and risk of death in RA patients in a study first published online in Arthritis & Rheumatology in 2015 (Arthritis Rheumatol. 2015 Jul;67[7]:1711-17). That study addressed the so-called obesity paradox in RA, and Dr. Baker and his colleagues noted that weight loss associated with the development of chronic illness is a significant confounder that may explain the observed protective effect of obesity on mortality.
“It is not clear how best to monitor changes in weight, when exactly to become concerned, and what to do when changes are observed,” Dr. Baker noted. “RA patients may lose weight for a number of reasons, not all related to their arthritis, and it is unlikely that there is a ‘one size fits all’ approach,” he said.
The study was limited in part by the women-only study population, so the results might not be generalizable to men, Dr. Sparks said. “The reason for weight change was unavailable,” he added. Directions for further research include investigation of how factors such as physical activity, diet, and weight loss may affect the risk of death among individuals with and without RA, he said.
Dr. Sparks had no financial conflicts to disclose. The study was supported in part by the National Institutes of Health and the Rheumatology Research Foundation’s Disease-Targeted Innovative Award and Scientist Development Awards.
SOURCE: Sparks J et al. Arthritis Rheumatol. 2017 Nov 30. doi: 10.1002/art.40346.
Weight loss at the time of rheumatoid arthritis diagnosis had the same impact on mortality in patients with and without RA, according to research trying to solve the so-called obesity paradox in RA, which has been related to prior observations of a protective effect of obesity on mortality in RA patients.
The finding indicates that clinicians can continue to encourage patients with rheumatoid arthritis to follow healthy weight-loss strategies, according to first author of the study, Jeffrey Sparks, MD, of Brigham and Women’s Hospital in Boston.
Dr. Sparks and his colleagues examined the impact of weight change and mortality in RA patients based on data from the Nurses’ Health Study.
“Our study is the first to focus on weight change around RA diagnosis and risk of death, rather than weight change in patients who had RA for many years,” Dr. Sparks noted.
By examining changes in weight near the time of RA diagnosis, Dr. Sparks and his colleagues said that they hoped to extract information about RA-specific processes rather than the underlying pathologies that might cause weight changes near the end of life.
In the study published in Arthritis & Rheumatology, the researchers compared women diagnosed with RA during follow-up to women without RA during the same index time period of 1976-2016. The study population included 121,701 women. Of these, 902 developed incident RA and were matched with 7,884 non-RA controls.
During an average of 18 years of follow-up, 41% of the RA cohort and 29% of the controls died. The risk of death was approximately twice as high (hazard ratio, 2.78; 95% confidence interval, 1.58-4.89) among those with weight loss greater than 30 pounds at the time of RA diagnosis, compared with those whose weight remained stable. However, the risk for mortality was similarly increased (HR, 2.16; 95% CI, 1.61-2.88) among the controls with weight loss greater than 30 pounds, compared with those with stable weight. No association with mortality was noted in either group among women who gained more than 30 pounds at the time of RA diagnosis.
Dr. Sparks said he was somewhat surprised by the findings.
“We expected severe, pathologic weight loss to be associated with increased risk of death among patients with RA and comparators. It was somewhat surprising that the risks in both groups were similar,” he said. “Conversely, prior studies suggested that weight gain might have been associated with increased risk of death. However, we found no association of weight gain with risk of death,” he noted.
In addition, “Our findings argue that there is not an RA-specific mortality risk based on either weight loss or gain,” he said. “While we found that weight loss was associated with increased mortality, this was most pronounced in the severe weight loss group, so was likely due to unintentional weight loss.”
Joshua F. Baker, MD, of the University of Pennsylvania, Philadelphia, and his colleagues identified an association between weight change and risk of death in RA patients in a study first published online in Arthritis & Rheumatology in 2015 (Arthritis Rheumatol. 2015 Jul;67[7]:1711-17). That study addressed the so-called obesity paradox in RA, and Dr. Baker and his colleagues noted that weight loss associated with the development of chronic illness is a significant confounder that may explain the observed protective effect of obesity on mortality.
“It is not clear how best to monitor changes in weight, when exactly to become concerned, and what to do when changes are observed,” Dr. Baker noted. “RA patients may lose weight for a number of reasons, not all related to their arthritis, and it is unlikely that there is a ‘one size fits all’ approach,” he said.
The study was limited in part by the women-only study population, so the results might not be generalizable to men, Dr. Sparks said. “The reason for weight change was unavailable,” he added. Directions for further research include investigation of how factors such as physical activity, diet, and weight loss may affect the risk of death among individuals with and without RA, he said.
Dr. Sparks had no financial conflicts to disclose. The study was supported in part by the National Institutes of Health and the Rheumatology Research Foundation’s Disease-Targeted Innovative Award and Scientist Development Awards.
SOURCE: Sparks J et al. Arthritis Rheumatol. 2017 Nov 30. doi: 10.1002/art.40346.
FROM ARTHRITIS & RHEUMATOLOGY
Key clinical point:
Major finding: The risk of death was approximately twice as high among women with weight loss greater than 30 pounds both for those diagnosed around the same time with RA (hazard ratio, 2.78) and for controls (HR, 2.16), compared with those whose weight remained stable.
Study details: A case-control study of 8,786 participants in the Nurses’ Health Study during 1976-2016.
Disclosures: Dr. Sparks had no financial conflicts to disclose. The study was supported in part by the National Institutes of Health and the Rheumatology Research Foundation’s Disease-Targeted Innovative Award and Scientist Development Awards.
Source: Sparks J et al. Arthritis Rheumatol. 2017 Nov 30. doi: 10.1002/art.40346.
Elevated antiphospholipid antibodies in celiac disease unrelated to gluten
Levels of antiphospholipid antibodies were significantly higher in adults with celiac disease compared with healthy controls, and gluten was not a factor, according to a study published in Digestive and Liver Disease (Dig Liver Dis. 2017. doi: 10.1016/j.dld.2017.11.018).
“In inflammatory bowel diseases active prophylaxis and treatment of thromboembolic complications is considered appropriate despite the increased risk of gastrointestinal bleeding,” wrote Outi Laine, MD, of Tampere University, Finland, and colleagues.
Results from previous studies suggest that thrombophilic autoantibodies are increased in celiac disease patients, but data are limited, the researchers wrote. In this study, the researchers measured antiphospholipid antibodies (cardiolipin IgG and M, prothrombin IgG, and aPS/PT IgG) in 179 adults with celiac disease (89 untreated, 90 on long-term gluten-free diets) and 91 nonceliac controls. Demographic characteristics were similar among the groups; the average age of the patients was 48 years in the untreated celiac disease group, 58 years in the treated group, and 45 years in the control group. In addition, the presentation of disease (gastrointestinal symptoms, malabsorption or anemia, and extraintestinal symptoms or screen-detected celiac disease) was similar among the groups.
Overall, the levels of antiphospholipid antibodies were significantly higher among celiac disease patients compared with controls 4.9 U/mL vs. 2.2 U/mL respectively, for anticardiolipin; 2.9 U/mL vs. 2.1 U/mL for antiprothrombin IgG, and 6.9 U/mL vs. 2.3 U/mL for antiphosphatidylserine-prothrombin. All three were higher among the untreated celiac disease patients compared with the treated patients.
“Treated patients with the highest levels of cardiolipin IgG and prothrombin IgG antibodies and aPS/PT were older than the newly diagnosed, untreated patients. This observation suggests that the formation of antibodies is not triggered by gluten but is related to the autoimmune-based celiac disease itself,” the researchers wrote.
The study was not designed to assess the impact of antiphospholipid antibodies on thrombosis, the researchers noted. However, “To guide therapeutic decisions, the optimal predictive biomarkers for thromboembolic episodes in patients with celiac disease should be determined,” and future areas of research should include identifying patients at high risk for thromboembolic episodes, they said.
The researchers had no financial conflicts to disclose. The study was funded in part by organizations including the Competitive State Research Financing of the Expert Responsibility Area of Tampere University Hospital, the Academy of Finland, and the Finnish Association of Hematology.
Levels of antiphospholipid antibodies were significantly higher in adults with celiac disease compared with healthy controls, and gluten was not a factor, according to a study published in Digestive and Liver Disease (Dig Liver Dis. 2017. doi: 10.1016/j.dld.2017.11.018).
“In inflammatory bowel diseases active prophylaxis and treatment of thromboembolic complications is considered appropriate despite the increased risk of gastrointestinal bleeding,” wrote Outi Laine, MD, of Tampere University, Finland, and colleagues.
Results from previous studies suggest that thrombophilic autoantibodies are increased in celiac disease patients, but data are limited, the researchers wrote. In this study, the researchers measured antiphospholipid antibodies (cardiolipin IgG and M, prothrombin IgG, and aPS/PT IgG) in 179 adults with celiac disease (89 untreated, 90 on long-term gluten-free diets) and 91 nonceliac controls. Demographic characteristics were similar among the groups; the average age of the patients was 48 years in the untreated celiac disease group, 58 years in the treated group, and 45 years in the control group. In addition, the presentation of disease (gastrointestinal symptoms, malabsorption or anemia, and extraintestinal symptoms or screen-detected celiac disease) was similar among the groups.
Overall, the levels of antiphospholipid antibodies were significantly higher among celiac disease patients compared with controls 4.9 U/mL vs. 2.2 U/mL respectively, for anticardiolipin; 2.9 U/mL vs. 2.1 U/mL for antiprothrombin IgG, and 6.9 U/mL vs. 2.3 U/mL for antiphosphatidylserine-prothrombin. All three were higher among the untreated celiac disease patients compared with the treated patients.
“Treated patients with the highest levels of cardiolipin IgG and prothrombin IgG antibodies and aPS/PT were older than the newly diagnosed, untreated patients. This observation suggests that the formation of antibodies is not triggered by gluten but is related to the autoimmune-based celiac disease itself,” the researchers wrote.
The study was not designed to assess the impact of antiphospholipid antibodies on thrombosis, the researchers noted. However, “To guide therapeutic decisions, the optimal predictive biomarkers for thromboembolic episodes in patients with celiac disease should be determined,” and future areas of research should include identifying patients at high risk for thromboembolic episodes, they said.
The researchers had no financial conflicts to disclose. The study was funded in part by organizations including the Competitive State Research Financing of the Expert Responsibility Area of Tampere University Hospital, the Academy of Finland, and the Finnish Association of Hematology.
Levels of antiphospholipid antibodies were significantly higher in adults with celiac disease compared with healthy controls, and gluten was not a factor, according to a study published in Digestive and Liver Disease (Dig Liver Dis. 2017. doi: 10.1016/j.dld.2017.11.018).
“In inflammatory bowel diseases active prophylaxis and treatment of thromboembolic complications is considered appropriate despite the increased risk of gastrointestinal bleeding,” wrote Outi Laine, MD, of Tampere University, Finland, and colleagues.
Results from previous studies suggest that thrombophilic autoantibodies are increased in celiac disease patients, but data are limited, the researchers wrote. In this study, the researchers measured antiphospholipid antibodies (cardiolipin IgG and M, prothrombin IgG, and aPS/PT IgG) in 179 adults with celiac disease (89 untreated, 90 on long-term gluten-free diets) and 91 nonceliac controls. Demographic characteristics were similar among the groups; the average age of the patients was 48 years in the untreated celiac disease group, 58 years in the treated group, and 45 years in the control group. In addition, the presentation of disease (gastrointestinal symptoms, malabsorption or anemia, and extraintestinal symptoms or screen-detected celiac disease) was similar among the groups.
Overall, the levels of antiphospholipid antibodies were significantly higher among celiac disease patients compared with controls 4.9 U/mL vs. 2.2 U/mL respectively, for anticardiolipin; 2.9 U/mL vs. 2.1 U/mL for antiprothrombin IgG, and 6.9 U/mL vs. 2.3 U/mL for antiphosphatidylserine-prothrombin. All three were higher among the untreated celiac disease patients compared with the treated patients.
“Treated patients with the highest levels of cardiolipin IgG and prothrombin IgG antibodies and aPS/PT were older than the newly diagnosed, untreated patients. This observation suggests that the formation of antibodies is not triggered by gluten but is related to the autoimmune-based celiac disease itself,” the researchers wrote.
The study was not designed to assess the impact of antiphospholipid antibodies on thrombosis, the researchers noted. However, “To guide therapeutic decisions, the optimal predictive biomarkers for thromboembolic episodes in patients with celiac disease should be determined,” and future areas of research should include identifying patients at high risk for thromboembolic episodes, they said.
The researchers had no financial conflicts to disclose. The study was funded in part by organizations including the Competitive State Research Financing of the Expert Responsibility Area of Tampere University Hospital, the Academy of Finland, and the Finnish Association of Hematology.
FROM DIGESTIVE AND LIVER DISEASE
Key clinical point: Antiphospholipid antibodies are elevated in celiac patients, and highest in those on a gluten-free diet.
Major finding: Levels among celiac patients vs. controls were 4.9 U/mL vs. 2.2 U/mL respectively, for anticardiolipin; 2.9 U/mL vs. 2.1 U/mL for antiprothrombin IgG, and 6.9 U/mL vs. 2.3 U/mL for antiphosphatidylserine-prothrombin.
Data source: Study of 179 adults with confirmed celiac disease and 91 controls.
Disclosures: The researchers had no financial conflicts to disclose. The study was funded in part by organizations including the Competitive State Research Financing of the Expert Responsibility Area of Tampere University Hospital, the Academy of Finland, and the Finnish Association of Hematology.
Pulmonary hypertension treatment gets under the skin
Pulmonary arterial hypertension (PAH) patients with moderate, stable disease can benefit from an implantable drug delivery system, based on data from a review of 60 adults with successful implantations. The findings were published in the December issue of CHEST.
“A fully implanted system offers patients the hope of returning to more normal activities such as bathing, swimming, and reduced risk of infections from externalized central venous catheter contamination or reduced subcutaneous pain from subcutaneous infusion,” wrote Aaron B. Waxman, MD, PhD, of Brigham and Women’s Hospital, Boston, and his colleagues (Chest. 2017 June 3. doi: 10.1016/j.chest.2017.04.188).
In the DelIVery Trial, clinicians at 10 locations in the United States placed a fully implantable delivery system in adults aged 18 years and older with stable PAH who were previously receiving treprostinil via an external pump at an average dose of 71 ng/kg per min.
All 60 patients were successfully implanted with a system consisting of a drug infusion pump placed in an abdominal pocket and an intravascular catheter linking the implanted pump to the superior vena cava.
“The location of the pump pocket was determined in partnership with the patient and was based on consideration of clothing styles, belt line and subcutaneous fat depth,” the researchers noted.
Procedure-related complications deemed clinically significant included one atrial fibrillation, two incidences of pneumothorax, two infections unrelated to catheter placement, and three catheter dislocations (two in the same patient). The most common patient complaints were expected implant site pain in 83% and bruising in 17%.
The findings were limited by the small number of patients, but the researchers identified several factors that contributed to the success of the procedure, including selecting patients who have shown response to treprostinil and are motivated to comply with pump refill visits, performing the procedure at centers with a high volume of PAH patients, keeping the procedure consistent for each patient, and using the same implant team in each case. “The implant procedure was successfully performed with a low complication rate by clinicians with a diverse range of specialty training,” the researchers added.
Patients reported satisfaction with the implant system at 6 weeks and 6 months, and said they spent an average of 75% less time managing their delivery system, according to previously published data on the patients’ perspective (CHEST 2016;150[1]:27-34).
Medtronic sponsored the study. The lead author, Dr. Waxman, had no financial conflicts to disclose; several coauthors reported relationships with companies including Medtronic, Actelion, Bayer, Gilead, Merck, and United Therapeutics.
The development of an implantable therapy for pulmonary hypertension could expand the use of treprostinil, a demonstrated effective treatment for PAH that has been limited in its use because of a range of side effects when given intravenously, orally, subcutaneously, or by inhalation, Joel A. Wirth, MD, FCCP, and Harold I. Palevsky, MD, FCCP, wrote in an editorial.
The use of an intravenous pump and catheter infusion system for stable PAH patients could help them return more quickly to normal activities and curb the risk of catheter-related infections, they said. “Having the potential to remove some of the burden and risk incumbent with an external delivery system may reduce several of the overall barriers to continuous intravenous prostanoid acceptance by both patients and providers,” they noted (Chest. 2017 Dec 6. doi: 10.1016/j.chest.2017.07.006).
Clinicians must be educated to perform the implant procedure itself, and care centers must be trained in identifying patient management issues and refilling the pump reservoir as needed, Dr. Wirth and Dr. Palevsky emphasized. Patients must be educated in what to expect, including how to monitor the pump and track the need for refills, they said. Although the pump is not appropriate for patients with severe PAH, “a planned staged approach of transitioning PAH patients from IV therapy to a less complex system could lend itself to employing prostanoid use earlier and for less severely affected PAH patients,” they said.
Dr. Wirth is affiliated with Tufts University, Boston. Dr. Palevsky is affiliated with the University of Pennsylvania, Philadelphia. Both Dr. Wirth and Dr. Palevsky disclosed serving as consultants and as principal investigators for United Therapeutics.
The development of an implantable therapy for pulmonary hypertension could expand the use of treprostinil, a demonstrated effective treatment for PAH that has been limited in its use because of a range of side effects when given intravenously, orally, subcutaneously, or by inhalation, Joel A. Wirth, MD, FCCP, and Harold I. Palevsky, MD, FCCP, wrote in an editorial.
The use of an intravenous pump and catheter infusion system for stable PAH patients could help them return more quickly to normal activities and curb the risk of catheter-related infections, they said. “Having the potential to remove some of the burden and risk incumbent with an external delivery system may reduce several of the overall barriers to continuous intravenous prostanoid acceptance by both patients and providers,” they noted (Chest. 2017 Dec 6. doi: 10.1016/j.chest.2017.07.006).
Clinicians must be educated to perform the implant procedure itself, and care centers must be trained in identifying patient management issues and refilling the pump reservoir as needed, Dr. Wirth and Dr. Palevsky emphasized. Patients must be educated in what to expect, including how to monitor the pump and track the need for refills, they said. Although the pump is not appropriate for patients with severe PAH, “a planned staged approach of transitioning PAH patients from IV therapy to a less complex system could lend itself to employing prostanoid use earlier and for less severely affected PAH patients,” they said.
Dr. Wirth is affiliated with Tufts University, Boston. Dr. Palevsky is affiliated with the University of Pennsylvania, Philadelphia. Both Dr. Wirth and Dr. Palevsky disclosed serving as consultants and as principal investigators for United Therapeutics.
The development of an implantable therapy for pulmonary hypertension could expand the use of treprostinil, a demonstrated effective treatment for PAH that has been limited in its use because of a range of side effects when given intravenously, orally, subcutaneously, or by inhalation, Joel A. Wirth, MD, FCCP, and Harold I. Palevsky, MD, FCCP, wrote in an editorial.
The use of an intravenous pump and catheter infusion system for stable PAH patients could help them return more quickly to normal activities and curb the risk of catheter-related infections, they said. “Having the potential to remove some of the burden and risk incumbent with an external delivery system may reduce several of the overall barriers to continuous intravenous prostanoid acceptance by both patients and providers,” they noted (Chest. 2017 Dec 6. doi: 10.1016/j.chest.2017.07.006).
Clinicians must be educated to perform the implant procedure itself, and care centers must be trained in identifying patient management issues and refilling the pump reservoir as needed, Dr. Wirth and Dr. Palevsky emphasized. Patients must be educated in what to expect, including how to monitor the pump and track the need for refills, they said. Although the pump is not appropriate for patients with severe PAH, “a planned staged approach of transitioning PAH patients from IV therapy to a less complex system could lend itself to employing prostanoid use earlier and for less severely affected PAH patients,” they said.
Dr. Wirth is affiliated with Tufts University, Boston. Dr. Palevsky is affiliated with the University of Pennsylvania, Philadelphia. Both Dr. Wirth and Dr. Palevsky disclosed serving as consultants and as principal investigators for United Therapeutics.
Pulmonary arterial hypertension (PAH) patients with moderate, stable disease can benefit from an implantable drug delivery system, based on data from a review of 60 adults with successful implantations. The findings were published in the December issue of CHEST.
“A fully implanted system offers patients the hope of returning to more normal activities such as bathing, swimming, and reduced risk of infections from externalized central venous catheter contamination or reduced subcutaneous pain from subcutaneous infusion,” wrote Aaron B. Waxman, MD, PhD, of Brigham and Women’s Hospital, Boston, and his colleagues (Chest. 2017 June 3. doi: 10.1016/j.chest.2017.04.188).
In the DelIVery Trial, clinicians at 10 locations in the United States placed a fully implantable delivery system in adults aged 18 years and older with stable PAH who were previously receiving treprostinil via an external pump at an average dose of 71 ng/kg per min.
All 60 patients were successfully implanted with a system consisting of a drug infusion pump placed in an abdominal pocket and an intravascular catheter linking the implanted pump to the superior vena cava.
“The location of the pump pocket was determined in partnership with the patient and was based on consideration of clothing styles, belt line and subcutaneous fat depth,” the researchers noted.
Procedure-related complications deemed clinically significant included one atrial fibrillation, two incidences of pneumothorax, two infections unrelated to catheter placement, and three catheter dislocations (two in the same patient). The most common patient complaints were expected implant site pain in 83% and bruising in 17%.
The findings were limited by the small number of patients, but the researchers identified several factors that contributed to the success of the procedure, including selecting patients who have shown response to treprostinil and are motivated to comply with pump refill visits, performing the procedure at centers with a high volume of PAH patients, keeping the procedure consistent for each patient, and using the same implant team in each case. “The implant procedure was successfully performed with a low complication rate by clinicians with a diverse range of specialty training,” the researchers added.
Patients reported satisfaction with the implant system at 6 weeks and 6 months, and said they spent an average of 75% less time managing their delivery system, according to previously published data on the patients’ perspective (CHEST 2016;150[1]:27-34).
Medtronic sponsored the study. The lead author, Dr. Waxman, had no financial conflicts to disclose; several coauthors reported relationships with companies including Medtronic, Actelion, Bayer, Gilead, Merck, and United Therapeutics.
Pulmonary arterial hypertension (PAH) patients with moderate, stable disease can benefit from an implantable drug delivery system, based on data from a review of 60 adults with successful implantations. The findings were published in the December issue of CHEST.
“A fully implanted system offers patients the hope of returning to more normal activities such as bathing, swimming, and reduced risk of infections from externalized central venous catheter contamination or reduced subcutaneous pain from subcutaneous infusion,” wrote Aaron B. Waxman, MD, PhD, of Brigham and Women’s Hospital, Boston, and his colleagues (Chest. 2017 June 3. doi: 10.1016/j.chest.2017.04.188).
In the DelIVery Trial, clinicians at 10 locations in the United States placed a fully implantable delivery system in adults aged 18 years and older with stable PAH who were previously receiving treprostinil via an external pump at an average dose of 71 ng/kg per min.
All 60 patients were successfully implanted with a system consisting of a drug infusion pump placed in an abdominal pocket and an intravascular catheter linking the implanted pump to the superior vena cava.
“The location of the pump pocket was determined in partnership with the patient and was based on consideration of clothing styles, belt line and subcutaneous fat depth,” the researchers noted.
Procedure-related complications deemed clinically significant included one atrial fibrillation, two incidences of pneumothorax, two infections unrelated to catheter placement, and three catheter dislocations (two in the same patient). The most common patient complaints were expected implant site pain in 83% and bruising in 17%.
The findings were limited by the small number of patients, but the researchers identified several factors that contributed to the success of the procedure, including selecting patients who have shown response to treprostinil and are motivated to comply with pump refill visits, performing the procedure at centers with a high volume of PAH patients, keeping the procedure consistent for each patient, and using the same implant team in each case. “The implant procedure was successfully performed with a low complication rate by clinicians with a diverse range of specialty training,” the researchers added.
Patients reported satisfaction with the implant system at 6 weeks and 6 months, and said they spent an average of 75% less time managing their delivery system, according to previously published data on the patients’ perspective (CHEST 2016;150[1]:27-34).
Medtronic sponsored the study. The lead author, Dr. Waxman, had no financial conflicts to disclose; several coauthors reported relationships with companies including Medtronic, Actelion, Bayer, Gilead, Merck, and United Therapeutics.
FROM CHEST
Key clinical point: An implantable drug delivery system was successfully placed in 100% of adult PAH patients with no serious complications.
Major finding: The most common complaints among patients who received an implant system to deliver treprostinil were implant site pain (83%) and bruising (17%).
Data source: A multicenter, prospective study of 60 adults with pulmonary arterial hypertension who received implantable pumps to deliver treprostinil.
Disclosures: Medtronic sponsored the study. The lead author, Dr. Waxman, had no financial conflicts to disclose; several coauthors reported relationships with companies including Medtronic, Actelion, Bayer, Gilead, Merck, and United Therapeutics.
Biosimilars and sources show mostly parallel safety profiles
Biosimilars are primarily as safe as their originators, based on data from a review of current European regulatory documents. The findings were published online in the British Journal of Clinical Pharmacology.
“Biosimilars are officially approved as similar products to a biopharmaceutical originator, which often share the same International Nonproprietary Name,” wrote L.R.A. Lepelaars, MD, of Utrecht University, the Netherlands, and colleagues. However, many clinicians remain cautious about using biosimilars, particularly those in the United States, they noted. The European Medicines Agency (EMA) has filed safety data on biosimilars, but comparative effectiveness studies often are lacking, they wrote.
In this study, the researchers compared data on 25 biologic medicinal products (19 biosimilars and 6 originators). The biosimilars were authorized by the EMA between Jan. 1, 2005 and Oct. 30, 2015 (Br. J. Clin. Pharmacol. 2017 Nov 22; doi: 10.1111/bcp.13454).
Overall, the researchers found 55 general safety concerns, including 22 that were deemed highly clinically relevant. Another 21 were defined as medium, while 12 had low levels of clinical relevance.
Infliximab was the only active substance with more than one difference in safety concerns between the biosimilar and originator; three more general safety concerns (all of medium clinical relevance) were noted for infliximab biosimilars compared with the originator (bowel obstruction, hematologic reactions, and lack of efficacy).
For all other active substances included in the study, one difference or no difference was found in the general safety concerns between the biosimilars and originators, and none of the differences was related to immunogenicity
The researchers assessed the safety of biosimilars by comparing them with European Risk Management Plan or Summary of Product Characteristics.
The findings support the value of biosimilars based on comparable safety profiles, the researchers noted. However, “a direct comparison between biosimilars and related originators through formal postmarketing studies (observational or clinical trials) is mandatory for specific safety and effectiveness issues emerging during the products’ life cycle,” they said.
The researchers had no financial conflicts to disclose.
Biosimilars are primarily as safe as their originators, based on data from a review of current European regulatory documents. The findings were published online in the British Journal of Clinical Pharmacology.
“Biosimilars are officially approved as similar products to a biopharmaceutical originator, which often share the same International Nonproprietary Name,” wrote L.R.A. Lepelaars, MD, of Utrecht University, the Netherlands, and colleagues. However, many clinicians remain cautious about using biosimilars, particularly those in the United States, they noted. The European Medicines Agency (EMA) has filed safety data on biosimilars, but comparative effectiveness studies often are lacking, they wrote.
In this study, the researchers compared data on 25 biologic medicinal products (19 biosimilars and 6 originators). The biosimilars were authorized by the EMA between Jan. 1, 2005 and Oct. 30, 2015 (Br. J. Clin. Pharmacol. 2017 Nov 22; doi: 10.1111/bcp.13454).
Overall, the researchers found 55 general safety concerns, including 22 that were deemed highly clinically relevant. Another 21 were defined as medium, while 12 had low levels of clinical relevance.
Infliximab was the only active substance with more than one difference in safety concerns between the biosimilar and originator; three more general safety concerns (all of medium clinical relevance) were noted for infliximab biosimilars compared with the originator (bowel obstruction, hematologic reactions, and lack of efficacy).
For all other active substances included in the study, one difference or no difference was found in the general safety concerns between the biosimilars and originators, and none of the differences was related to immunogenicity
The researchers assessed the safety of biosimilars by comparing them with European Risk Management Plan or Summary of Product Characteristics.
The findings support the value of biosimilars based on comparable safety profiles, the researchers noted. However, “a direct comparison between biosimilars and related originators through formal postmarketing studies (observational or clinical trials) is mandatory for specific safety and effectiveness issues emerging during the products’ life cycle,” they said.
The researchers had no financial conflicts to disclose.
Biosimilars are primarily as safe as their originators, based on data from a review of current European regulatory documents. The findings were published online in the British Journal of Clinical Pharmacology.
“Biosimilars are officially approved as similar products to a biopharmaceutical originator, which often share the same International Nonproprietary Name,” wrote L.R.A. Lepelaars, MD, of Utrecht University, the Netherlands, and colleagues. However, many clinicians remain cautious about using biosimilars, particularly those in the United States, they noted. The European Medicines Agency (EMA) has filed safety data on biosimilars, but comparative effectiveness studies often are lacking, they wrote.
In this study, the researchers compared data on 25 biologic medicinal products (19 biosimilars and 6 originators). The biosimilars were authorized by the EMA between Jan. 1, 2005 and Oct. 30, 2015 (Br. J. Clin. Pharmacol. 2017 Nov 22; doi: 10.1111/bcp.13454).
Overall, the researchers found 55 general safety concerns, including 22 that were deemed highly clinically relevant. Another 21 were defined as medium, while 12 had low levels of clinical relevance.
Infliximab was the only active substance with more than one difference in safety concerns between the biosimilar and originator; three more general safety concerns (all of medium clinical relevance) were noted for infliximab biosimilars compared with the originator (bowel obstruction, hematologic reactions, and lack of efficacy).
For all other active substances included in the study, one difference or no difference was found in the general safety concerns between the biosimilars and originators, and none of the differences was related to immunogenicity
The researchers assessed the safety of biosimilars by comparing them with European Risk Management Plan or Summary of Product Characteristics.
The findings support the value of biosimilars based on comparable safety profiles, the researchers noted. However, “a direct comparison between biosimilars and related originators through formal postmarketing studies (observational or clinical trials) is mandatory for specific safety and effectiveness issues emerging during the products’ life cycle,” they said.
The researchers had no financial conflicts to disclose.
FROM THE BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
Key clinical point: Most biosimilars show safety profiles comparable to their originators.
Major finding: Infliximab biosimilars demonstrated three more general safety concerns than the originator.
Data source: The data come from a cross-sectional analysis 19 biosimilars and 6 originators.
Disclosures: The researchers had no financial conflicts to disclose.
Emerging treatments tackling hair loss challenges include light therapies
according to Maria Hordinsky, MD.
“Although the precise mechanism remains unclear, it has been postulated that photobiomodulation acts through oxidative metabolism and transcription factor stimulation,” Dr. Hordinsky said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
She referred to one trial, which found that men with androgenetic alopecia who used the HairMax Lasercomb showed an increase in mean hair density at 26 weeks of daily use, compared with a group that used a sham device.
Photobiomodulation devices use either laser light or light-emitting diodes. Comparing the two types is a challenge, and the question of which is more effective remains unanswered, Dr. Hordinsky said.
Other issues to be addressed in future research include finding the optimal wavelength to use for different indications for light-based treatments, determining whether pulse or continuous wave is more effective, and evaluating the potential for systemic side effects of these therapies, she noted.
No treatment for alopecia areata is currently approved by the Food and Drug Administration, but factors to consider when choosing a treatment include the patient’s age, location and extent of hair loss, and the presence of other medical problems, as well as a scalp biopsy report with information on the hair cycle and inflammation. Patients and/or their parents should understand the risks and benefits associated with various treatments to make an informed decision, Dr. Hordinsky said.
Patients and their families “have heard the ‘buzz’ about potential new treatments for alopecia areata, and the discussion needs to include a conversation about ongoing and future clinical research opportunities, as well as off-label use of Janus kinase inhibitors,” particularly oral tofacitinib, she said.
Approximately two-thirds of patients in recent studies of oral tofacitinib have had clinically acceptable hair regrowth after 6 months, Dr. Hordinsky said. Ruxolitinib is also being studied. However, “until clinical research studies are completed, there will be ongoing debate regarding the risks and benefits, cost, and sustainability” of JAK inhibitors or other new treatments, she said.
Dr. Hordinsky disclosed that she is a consultant for companies including Procter & Gamble and Concert, and has received grant/research support from Incyte, Allergan, and the National Alopecia Areata Foundation.
SDEF and this news organization are owned by Frontline Medical Communications.
according to Maria Hordinsky, MD.
“Although the precise mechanism remains unclear, it has been postulated that photobiomodulation acts through oxidative metabolism and transcription factor stimulation,” Dr. Hordinsky said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
She referred to one trial, which found that men with androgenetic alopecia who used the HairMax Lasercomb showed an increase in mean hair density at 26 weeks of daily use, compared with a group that used a sham device.
Photobiomodulation devices use either laser light or light-emitting diodes. Comparing the two types is a challenge, and the question of which is more effective remains unanswered, Dr. Hordinsky said.
Other issues to be addressed in future research include finding the optimal wavelength to use for different indications for light-based treatments, determining whether pulse or continuous wave is more effective, and evaluating the potential for systemic side effects of these therapies, she noted.
No treatment for alopecia areata is currently approved by the Food and Drug Administration, but factors to consider when choosing a treatment include the patient’s age, location and extent of hair loss, and the presence of other medical problems, as well as a scalp biopsy report with information on the hair cycle and inflammation. Patients and/or their parents should understand the risks and benefits associated with various treatments to make an informed decision, Dr. Hordinsky said.
Patients and their families “have heard the ‘buzz’ about potential new treatments for alopecia areata, and the discussion needs to include a conversation about ongoing and future clinical research opportunities, as well as off-label use of Janus kinase inhibitors,” particularly oral tofacitinib, she said.
Approximately two-thirds of patients in recent studies of oral tofacitinib have had clinically acceptable hair regrowth after 6 months, Dr. Hordinsky said. Ruxolitinib is also being studied. However, “until clinical research studies are completed, there will be ongoing debate regarding the risks and benefits, cost, and sustainability” of JAK inhibitors or other new treatments, she said.
Dr. Hordinsky disclosed that she is a consultant for companies including Procter & Gamble and Concert, and has received grant/research support from Incyte, Allergan, and the National Alopecia Areata Foundation.
SDEF and this news organization are owned by Frontline Medical Communications.
according to Maria Hordinsky, MD.
“Although the precise mechanism remains unclear, it has been postulated that photobiomodulation acts through oxidative metabolism and transcription factor stimulation,” Dr. Hordinsky said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
She referred to one trial, which found that men with androgenetic alopecia who used the HairMax Lasercomb showed an increase in mean hair density at 26 weeks of daily use, compared with a group that used a sham device.
Photobiomodulation devices use either laser light or light-emitting diodes. Comparing the two types is a challenge, and the question of which is more effective remains unanswered, Dr. Hordinsky said.
Other issues to be addressed in future research include finding the optimal wavelength to use for different indications for light-based treatments, determining whether pulse or continuous wave is more effective, and evaluating the potential for systemic side effects of these therapies, she noted.
No treatment for alopecia areata is currently approved by the Food and Drug Administration, but factors to consider when choosing a treatment include the patient’s age, location and extent of hair loss, and the presence of other medical problems, as well as a scalp biopsy report with information on the hair cycle and inflammation. Patients and/or their parents should understand the risks and benefits associated with various treatments to make an informed decision, Dr. Hordinsky said.
Patients and their families “have heard the ‘buzz’ about potential new treatments for alopecia areata, and the discussion needs to include a conversation about ongoing and future clinical research opportunities, as well as off-label use of Janus kinase inhibitors,” particularly oral tofacitinib, she said.
Approximately two-thirds of patients in recent studies of oral tofacitinib have had clinically acceptable hair regrowth after 6 months, Dr. Hordinsky said. Ruxolitinib is also being studied. However, “until clinical research studies are completed, there will be ongoing debate regarding the risks and benefits, cost, and sustainability” of JAK inhibitors or other new treatments, she said.
Dr. Hordinsky disclosed that she is a consultant for companies including Procter & Gamble and Concert, and has received grant/research support from Incyte, Allergan, and the National Alopecia Areata Foundation.
SDEF and this news organization are owned by Frontline Medical Communications.
FROM SDEF WOMEN’S & PEDIATRIC DERMATOLOGY SEMINAR
How to decide which ‘birthmarks’ spell trouble
When evaluating lumps and bumps in infants, categorizing them can help determine whether they need immediate attention, said James R. Treat, MD, a pediatric dermatologist at Children’s Hospital of Philadelphia, Pennsylvania.
“Divide ‘birthmarks’ based on appearance, “then decide when to worry,” he said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
For example, Spitz nevi occur in patients younger than 20 years, most often on the face and lower extremities, but most are benign, Dr. Treat said. However, he recommends a biopsy if the patient is pubertal or older, or if the lesions are larger than 8 mm, amelanotic, or show asymmetry, ulceration, or excessive growth.
By contrast, neurocutaneous melanosis is a rare but serious skin condition that occurs in children and can be fatal if it progresses to melanoma, he pointed out. The condition involves the migration of melanocytes into the spinal canal and cerebrospinal fluid during development. Symptoms may include headache, seizures, and paralysis, and clinicians should keep them in mind when seeing children with melanocytic nevi, he noted. The highest risk for melanoma transformation is increased for individuals with more than 20 congenital moles, and “the second-highest risk is having a giant nevus lying overtop of the midline spine or scalp,” he said.
In some cases, yellow or tan lesions in children are benign and will resolve on their own, Dr. Treat said.
Juvenile xanthogranuloma (JXG), characterized by yellow-brown asymptomatic papules and nodules, develops most often within the first year of life, but the lesions usually resolve spontaneously by school age, he added.
Mastocytosis, localized collections of mast cells, presents as yellow/tan lesions that develop within the first 2 years of life. The condition can be systemic; patients may experience flushing and diarrhea because of localized release of histamines, and those with a history of weight loss, easy bruising or bleeding, hepatosplenomegaly, or lymphadenopathy may have systemic disease, Dr. Treat explained.
Subcutaneous fat necrosis can present within the first 2 weeks of life as firm, red-purple tender nodules that may be disturbing to parents. These lesions are most likely to appear on the cheeks, arms, back, and thighs, and are related to hypoxia or trauma, he added. The lesions usually resolve spontaneously within a period of weeks to months, although they may heal with some atrophy and scarring, he said. Subcutaneous fat necrosis is associated with hypercalcemia, so “it is important to check frequently, as hypercalcemia can occur weeks after the nodules resolve,” he commented.
Dr. Treat disclosed serving as a consultant to Procter & Gamble. SDEF and this news organization are owned by Frontline Medical Communications.
When evaluating lumps and bumps in infants, categorizing them can help determine whether they need immediate attention, said James R. Treat, MD, a pediatric dermatologist at Children’s Hospital of Philadelphia, Pennsylvania.
“Divide ‘birthmarks’ based on appearance, “then decide when to worry,” he said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
For example, Spitz nevi occur in patients younger than 20 years, most often on the face and lower extremities, but most are benign, Dr. Treat said. However, he recommends a biopsy if the patient is pubertal or older, or if the lesions are larger than 8 mm, amelanotic, or show asymmetry, ulceration, or excessive growth.
By contrast, neurocutaneous melanosis is a rare but serious skin condition that occurs in children and can be fatal if it progresses to melanoma, he pointed out. The condition involves the migration of melanocytes into the spinal canal and cerebrospinal fluid during development. Symptoms may include headache, seizures, and paralysis, and clinicians should keep them in mind when seeing children with melanocytic nevi, he noted. The highest risk for melanoma transformation is increased for individuals with more than 20 congenital moles, and “the second-highest risk is having a giant nevus lying overtop of the midline spine or scalp,” he said.
In some cases, yellow or tan lesions in children are benign and will resolve on their own, Dr. Treat said.
Juvenile xanthogranuloma (JXG), characterized by yellow-brown asymptomatic papules and nodules, develops most often within the first year of life, but the lesions usually resolve spontaneously by school age, he added.
Mastocytosis, localized collections of mast cells, presents as yellow/tan lesions that develop within the first 2 years of life. The condition can be systemic; patients may experience flushing and diarrhea because of localized release of histamines, and those with a history of weight loss, easy bruising or bleeding, hepatosplenomegaly, or lymphadenopathy may have systemic disease, Dr. Treat explained.
Subcutaneous fat necrosis can present within the first 2 weeks of life as firm, red-purple tender nodules that may be disturbing to parents. These lesions are most likely to appear on the cheeks, arms, back, and thighs, and are related to hypoxia or trauma, he added. The lesions usually resolve spontaneously within a period of weeks to months, although they may heal with some atrophy and scarring, he said. Subcutaneous fat necrosis is associated with hypercalcemia, so “it is important to check frequently, as hypercalcemia can occur weeks after the nodules resolve,” he commented.
Dr. Treat disclosed serving as a consultant to Procter & Gamble. SDEF and this news organization are owned by Frontline Medical Communications.
When evaluating lumps and bumps in infants, categorizing them can help determine whether they need immediate attention, said James R. Treat, MD, a pediatric dermatologist at Children’s Hospital of Philadelphia, Pennsylvania.
“Divide ‘birthmarks’ based on appearance, “then decide when to worry,” he said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
For example, Spitz nevi occur in patients younger than 20 years, most often on the face and lower extremities, but most are benign, Dr. Treat said. However, he recommends a biopsy if the patient is pubertal or older, or if the lesions are larger than 8 mm, amelanotic, or show asymmetry, ulceration, or excessive growth.
By contrast, neurocutaneous melanosis is a rare but serious skin condition that occurs in children and can be fatal if it progresses to melanoma, he pointed out. The condition involves the migration of melanocytes into the spinal canal and cerebrospinal fluid during development. Symptoms may include headache, seizures, and paralysis, and clinicians should keep them in mind when seeing children with melanocytic nevi, he noted. The highest risk for melanoma transformation is increased for individuals with more than 20 congenital moles, and “the second-highest risk is having a giant nevus lying overtop of the midline spine or scalp,” he said.
In some cases, yellow or tan lesions in children are benign and will resolve on their own, Dr. Treat said.
Juvenile xanthogranuloma (JXG), characterized by yellow-brown asymptomatic papules and nodules, develops most often within the first year of life, but the lesions usually resolve spontaneously by school age, he added.
Mastocytosis, localized collections of mast cells, presents as yellow/tan lesions that develop within the first 2 years of life. The condition can be systemic; patients may experience flushing and diarrhea because of localized release of histamines, and those with a history of weight loss, easy bruising or bleeding, hepatosplenomegaly, or lymphadenopathy may have systemic disease, Dr. Treat explained.
Subcutaneous fat necrosis can present within the first 2 weeks of life as firm, red-purple tender nodules that may be disturbing to parents. These lesions are most likely to appear on the cheeks, arms, back, and thighs, and are related to hypoxia or trauma, he added. The lesions usually resolve spontaneously within a period of weeks to months, although they may heal with some atrophy and scarring, he said. Subcutaneous fat necrosis is associated with hypercalcemia, so “it is important to check frequently, as hypercalcemia can occur weeks after the nodules resolve,” he commented.
Dr. Treat disclosed serving as a consultant to Procter & Gamble. SDEF and this news organization are owned by Frontline Medical Communications.
FROM SDEF WOMEN’S & PEDIATRIC DERMATOLOGY SEMINAR
Times change, but children still come first
After decades of pediatric practice, Thomas K. McInerny, MD, still accentuates the positive. “I decided to become a pediatrician in my third year of medical school after my pediatrics rotation. I loved working with the children and their families so full of joy and hope,” he said. “I still feel that pediatrics is the greatest profession despite some frustrations with rules, regulations, and computer work.”
Many childhood diseases, including birth defects and forms of cancer that were fatal 50 years ago, now can be treated successfully, he noted. “However, there are more children with emotional, behavioral, and school problems, which pediatricians are now treating as there is a great shortage of mental health professionals for children.”
Although the dedication of pediatricians to their specialty has remained strong over the past 50 years, their work environment has evolved in many ways.
David T. Tayloe Jr., MD, also a past president of the AAP, currently practices in Goldsboro, N.C. When he established a solo community practice in 1977, he was one of a few pediatricians in the area, and he was busy. “I was the only pediatrician who could take care of really sick newborns and hospital patients, so I basically was available 24-7 for those first 2 years; there were two older pediatricians in town, and they took routine night call with me, giving me some time with my family,” he said. “With 1,500 deliveries a year at our hospital, there were always sick babies who needed my services. My office hours were 9 a.m. until 5 p.m. but often, in the cooler months, we saw patients until 8 p.m.” These days, Dr. Tayloe said he works 3-4 days in the office, and “my practice is largely behavioral health, school problems, obesity, asthma, and well-baby/child care.”
“In the last 20 years, my typical work day has changed in many ways,” said Julia Richerson, MD, who practices at the Family Health Center Iroquois office in South Louisville, Ky.
“I use electronic resources to find patient education, to look up current treatments, and research complicated diagnosis,” she noted.
“I feel that having the computer in the room isn’t a barrier to communication with my patients and families. Using the EHR doesn’t take me more time to see a patient,” she said. “However, the review of consult and ER records is harder and takes longer to complete. Consult, ER, and other outside records are much larger with the key clinical data more disorganized and harder to find among the pages and pages of nonrelevant content. This makes the workday much longer.”
The conditions that take up most of a pediatric office visit have changed as well, and include more complex medical, behavioral, and social issues, Dr. Richerson observed. “Obesity, ADHD, autism, complications of prematurity, behavioral health issues, developmental delays, and asthma are commonly seen in practice now. One in five children nationally have a chronic illness or special health care need. And we strive to help ease the challenges for families struggling with economic insecurity, and children growing up experiencing significant adversities.”
The office and the EHR
EHRs are a fact of life in all specialties today, but should not get in the way of interacting with patients, Dr. McInerny said. Many pediatricians complete their medical records after hours at home because they don’t have time to complete them in the office.
“I would advise the younger pediatricians to be sure to look at and interact with their families as much as possible while working on the computer, and showing the families entries and graphs from the computer. We were able to interact with families much more easily when writing out notes with pen and paper,” he said.
In his early years of practice, Dr. Tayloe recalled, “I spent less time with each patient; my focus was infectious disease, and I treated many patients with what today are vaccine-preventable diseases. I could see patients much faster with paper charts, but my documentation left much to be desired,” he said. “With the electronic record, I spend more time with each patient, but I type really fast and finish my charts in the exam rooms with the patients.”
“EHRs have made daily practice easier and more complicated for pediatricians,” said Dr. Richerson. “In the moment-to-moment use of EHRs while seeing patients, we can fairly quickly document the information we need to for patient care.” However, she said, “It takes some additional time to document all the data points required for quality- and value-based reimbursement programs, and it takes a significant amount of additional time in most EHRs to retrieve relevant information because you cannot query the system for clinical content on a patient. Also, reviewing incoming records is difficult because the information is voluminous and poorly organized,” she noted. “There are so many opportunities for improvement, and hopefully 20 years from now we will have EHRs that significantly improve quality and safety of patient care.”
Money and malpractice
The Vaccines for Children program led to an increase in incomes for pediatricians in the United States after 1994, according to Dr. Tayloe. “We began to be paid by insurance companies for most of what we do during the mid-90s and that boosted revenues,” he said. However, “On the flip side, we are now at the mercy of private payers, and must participate in all their very burdensome quality improvement/assurance programs if we are to be paid fairly. Our incomes were pretty flat over the last 5-10 years, especially for practices that participate fully in Medicaid/CHIP.”
Over the past 50 years, malpractice claims against pediatricians have remained consistently among the lowest for any medical specialty, according to Paul Greve, JD, a registered professional liability underwriter and executive vice president and senior consultant at Willis Towers Watson Health Care Practice.
The impact of EHRs on pediatric practice from a legal standpoint depends on the format of the EHR itself, Mr. Greve said. “Many of the EHRs that are designed for physicians, particularly the ones used in acute care settings, don’t allow the doctor to really highlight their thinking as they work through the diagnostic process, and that is very important in the defense of a malpractice case against a pediatrician,” he said.
“The pediatrician doesn’t have to be correct all the time, but it is important for the lawyers defending the case to see what the pediatrician’s thought process was. If the EHR allows for capturing the doctor’s thought process, that’s a well-designed EHR, and that’s critical,” he emphasized.
Diagnostic error is one of the most entrenched problems in medical malpractice, said Mr. Greve. Failure to diagnose and delay in diagnosis remain the most common allegations against pediatricians, he noted. Also, being aware of the environment is important to risk management in the office.
“The American Academy of Pediatrics has excellent publications on safety and risk management that all pediatricians should be aware of,” he said.
Inspiration and intangibles
“I think the changes that we are starting to see will continue to evolve over the next 50 years,” said Dr. Richerson. “Increased medical and social complexity of patients, changes in health technology, EHRs, personal health data monitoring, and continued changes in value based payment methods will be key.
“I hope that we gain, as a health delivery system, an appreciation of the impact of child health on adult health. Long-term adult health outcomes depend on improved child health outcomes. Investing in diseases like childhood obesity, mental health, and developmental issues, to name a few, will have a bigger impact on adult disease than any adult interventions,” she said. And really dealing with the impact of childhood adversity in health care and in the community and nationally in general is critical. This requires grassroots interventions to support families as well as local, state, and national policy. It also requires payment for health care services for the needed interventions in the office and hospital. Providing comprehensive medical care and addressing the medical and social complexities of child health in an effective, compassionate, and family-centered way takes time. It’s not easy, but it’s not impossible. But it requires more resources than are currently given to child health care. Adult medicine is accustomed to paying for disease managers for diabetes or care coordinators for heart failure. This is not the current state of delivery for children’s care and it should be. These are some of the major issues confronting pediatricians.
What has remained the same in pediatrics is the love the doctors have for their work, and the reflections of veteran clinicians on the intangible rewards of the practice may inspire the next generation.
Dr. Tayloe said that he chose pediatrics because “I was really intrigued by the skills necessary to care for sick newborns, including premature babies. I wanted to practice in a remote location where I could use all the skills I developed during residency, and be of significant value to the community.” Two of his four adult children were similarly inspired and followed in his footsteps.
“For pediatricians, helping families raise healthy children is a real privilege and very satisfying,” Dr. McInerny said.
After decades of pediatric practice, Thomas K. McInerny, MD, still accentuates the positive. “I decided to become a pediatrician in my third year of medical school after my pediatrics rotation. I loved working with the children and their families so full of joy and hope,” he said. “I still feel that pediatrics is the greatest profession despite some frustrations with rules, regulations, and computer work.”
Many childhood diseases, including birth defects and forms of cancer that were fatal 50 years ago, now can be treated successfully, he noted. “However, there are more children with emotional, behavioral, and school problems, which pediatricians are now treating as there is a great shortage of mental health professionals for children.”
Although the dedication of pediatricians to their specialty has remained strong over the past 50 years, their work environment has evolved in many ways.
David T. Tayloe Jr., MD, also a past president of the AAP, currently practices in Goldsboro, N.C. When he established a solo community practice in 1977, he was one of a few pediatricians in the area, and he was busy. “I was the only pediatrician who could take care of really sick newborns and hospital patients, so I basically was available 24-7 for those first 2 years; there were two older pediatricians in town, and they took routine night call with me, giving me some time with my family,” he said. “With 1,500 deliveries a year at our hospital, there were always sick babies who needed my services. My office hours were 9 a.m. until 5 p.m. but often, in the cooler months, we saw patients until 8 p.m.” These days, Dr. Tayloe said he works 3-4 days in the office, and “my practice is largely behavioral health, school problems, obesity, asthma, and well-baby/child care.”
“In the last 20 years, my typical work day has changed in many ways,” said Julia Richerson, MD, who practices at the Family Health Center Iroquois office in South Louisville, Ky.
“I use electronic resources to find patient education, to look up current treatments, and research complicated diagnosis,” she noted.
“I feel that having the computer in the room isn’t a barrier to communication with my patients and families. Using the EHR doesn’t take me more time to see a patient,” she said. “However, the review of consult and ER records is harder and takes longer to complete. Consult, ER, and other outside records are much larger with the key clinical data more disorganized and harder to find among the pages and pages of nonrelevant content. This makes the workday much longer.”
The conditions that take up most of a pediatric office visit have changed as well, and include more complex medical, behavioral, and social issues, Dr. Richerson observed. “Obesity, ADHD, autism, complications of prematurity, behavioral health issues, developmental delays, and asthma are commonly seen in practice now. One in five children nationally have a chronic illness or special health care need. And we strive to help ease the challenges for families struggling with economic insecurity, and children growing up experiencing significant adversities.”
The office and the EHR
EHRs are a fact of life in all specialties today, but should not get in the way of interacting with patients, Dr. McInerny said. Many pediatricians complete their medical records after hours at home because they don’t have time to complete them in the office.
“I would advise the younger pediatricians to be sure to look at and interact with their families as much as possible while working on the computer, and showing the families entries and graphs from the computer. We were able to interact with families much more easily when writing out notes with pen and paper,” he said.
In his early years of practice, Dr. Tayloe recalled, “I spent less time with each patient; my focus was infectious disease, and I treated many patients with what today are vaccine-preventable diseases. I could see patients much faster with paper charts, but my documentation left much to be desired,” he said. “With the electronic record, I spend more time with each patient, but I type really fast and finish my charts in the exam rooms with the patients.”
“EHRs have made daily practice easier and more complicated for pediatricians,” said Dr. Richerson. “In the moment-to-moment use of EHRs while seeing patients, we can fairly quickly document the information we need to for patient care.” However, she said, “It takes some additional time to document all the data points required for quality- and value-based reimbursement programs, and it takes a significant amount of additional time in most EHRs to retrieve relevant information because you cannot query the system for clinical content on a patient. Also, reviewing incoming records is difficult because the information is voluminous and poorly organized,” she noted. “There are so many opportunities for improvement, and hopefully 20 years from now we will have EHRs that significantly improve quality and safety of patient care.”
Money and malpractice
The Vaccines for Children program led to an increase in incomes for pediatricians in the United States after 1994, according to Dr. Tayloe. “We began to be paid by insurance companies for most of what we do during the mid-90s and that boosted revenues,” he said. However, “On the flip side, we are now at the mercy of private payers, and must participate in all their very burdensome quality improvement/assurance programs if we are to be paid fairly. Our incomes were pretty flat over the last 5-10 years, especially for practices that participate fully in Medicaid/CHIP.”
Over the past 50 years, malpractice claims against pediatricians have remained consistently among the lowest for any medical specialty, according to Paul Greve, JD, a registered professional liability underwriter and executive vice president and senior consultant at Willis Towers Watson Health Care Practice.
The impact of EHRs on pediatric practice from a legal standpoint depends on the format of the EHR itself, Mr. Greve said. “Many of the EHRs that are designed for physicians, particularly the ones used in acute care settings, don’t allow the doctor to really highlight their thinking as they work through the diagnostic process, and that is very important in the defense of a malpractice case against a pediatrician,” he said.
“The pediatrician doesn’t have to be correct all the time, but it is important for the lawyers defending the case to see what the pediatrician’s thought process was. If the EHR allows for capturing the doctor’s thought process, that’s a well-designed EHR, and that’s critical,” he emphasized.
Diagnostic error is one of the most entrenched problems in medical malpractice, said Mr. Greve. Failure to diagnose and delay in diagnosis remain the most common allegations against pediatricians, he noted. Also, being aware of the environment is important to risk management in the office.
“The American Academy of Pediatrics has excellent publications on safety and risk management that all pediatricians should be aware of,” he said.
Inspiration and intangibles
“I think the changes that we are starting to see will continue to evolve over the next 50 years,” said Dr. Richerson. “Increased medical and social complexity of patients, changes in health technology, EHRs, personal health data monitoring, and continued changes in value based payment methods will be key.
“I hope that we gain, as a health delivery system, an appreciation of the impact of child health on adult health. Long-term adult health outcomes depend on improved child health outcomes. Investing in diseases like childhood obesity, mental health, and developmental issues, to name a few, will have a bigger impact on adult disease than any adult interventions,” she said. And really dealing with the impact of childhood adversity in health care and in the community and nationally in general is critical. This requires grassroots interventions to support families as well as local, state, and national policy. It also requires payment for health care services for the needed interventions in the office and hospital. Providing comprehensive medical care and addressing the medical and social complexities of child health in an effective, compassionate, and family-centered way takes time. It’s not easy, but it’s not impossible. But it requires more resources than are currently given to child health care. Adult medicine is accustomed to paying for disease managers for diabetes or care coordinators for heart failure. This is not the current state of delivery for children’s care and it should be. These are some of the major issues confronting pediatricians.
What has remained the same in pediatrics is the love the doctors have for their work, and the reflections of veteran clinicians on the intangible rewards of the practice may inspire the next generation.
Dr. Tayloe said that he chose pediatrics because “I was really intrigued by the skills necessary to care for sick newborns, including premature babies. I wanted to practice in a remote location where I could use all the skills I developed during residency, and be of significant value to the community.” Two of his four adult children were similarly inspired and followed in his footsteps.
“For pediatricians, helping families raise healthy children is a real privilege and very satisfying,” Dr. McInerny said.
After decades of pediatric practice, Thomas K. McInerny, MD, still accentuates the positive. “I decided to become a pediatrician in my third year of medical school after my pediatrics rotation. I loved working with the children and their families so full of joy and hope,” he said. “I still feel that pediatrics is the greatest profession despite some frustrations with rules, regulations, and computer work.”
Many childhood diseases, including birth defects and forms of cancer that were fatal 50 years ago, now can be treated successfully, he noted. “However, there are more children with emotional, behavioral, and school problems, which pediatricians are now treating as there is a great shortage of mental health professionals for children.”
Although the dedication of pediatricians to their specialty has remained strong over the past 50 years, their work environment has evolved in many ways.
David T. Tayloe Jr., MD, also a past president of the AAP, currently practices in Goldsboro, N.C. When he established a solo community practice in 1977, he was one of a few pediatricians in the area, and he was busy. “I was the only pediatrician who could take care of really sick newborns and hospital patients, so I basically was available 24-7 for those first 2 years; there were two older pediatricians in town, and they took routine night call with me, giving me some time with my family,” he said. “With 1,500 deliveries a year at our hospital, there were always sick babies who needed my services. My office hours were 9 a.m. until 5 p.m. but often, in the cooler months, we saw patients until 8 p.m.” These days, Dr. Tayloe said he works 3-4 days in the office, and “my practice is largely behavioral health, school problems, obesity, asthma, and well-baby/child care.”
“In the last 20 years, my typical work day has changed in many ways,” said Julia Richerson, MD, who practices at the Family Health Center Iroquois office in South Louisville, Ky.
“I use electronic resources to find patient education, to look up current treatments, and research complicated diagnosis,” she noted.
“I feel that having the computer in the room isn’t a barrier to communication with my patients and families. Using the EHR doesn’t take me more time to see a patient,” she said. “However, the review of consult and ER records is harder and takes longer to complete. Consult, ER, and other outside records are much larger with the key clinical data more disorganized and harder to find among the pages and pages of nonrelevant content. This makes the workday much longer.”
The conditions that take up most of a pediatric office visit have changed as well, and include more complex medical, behavioral, and social issues, Dr. Richerson observed. “Obesity, ADHD, autism, complications of prematurity, behavioral health issues, developmental delays, and asthma are commonly seen in practice now. One in five children nationally have a chronic illness or special health care need. And we strive to help ease the challenges for families struggling with economic insecurity, and children growing up experiencing significant adversities.”
The office and the EHR
EHRs are a fact of life in all specialties today, but should not get in the way of interacting with patients, Dr. McInerny said. Many pediatricians complete their medical records after hours at home because they don’t have time to complete them in the office.
“I would advise the younger pediatricians to be sure to look at and interact with their families as much as possible while working on the computer, and showing the families entries and graphs from the computer. We were able to interact with families much more easily when writing out notes with pen and paper,” he said.
In his early years of practice, Dr. Tayloe recalled, “I spent less time with each patient; my focus was infectious disease, and I treated many patients with what today are vaccine-preventable diseases. I could see patients much faster with paper charts, but my documentation left much to be desired,” he said. “With the electronic record, I spend more time with each patient, but I type really fast and finish my charts in the exam rooms with the patients.”
“EHRs have made daily practice easier and more complicated for pediatricians,” said Dr. Richerson. “In the moment-to-moment use of EHRs while seeing patients, we can fairly quickly document the information we need to for patient care.” However, she said, “It takes some additional time to document all the data points required for quality- and value-based reimbursement programs, and it takes a significant amount of additional time in most EHRs to retrieve relevant information because you cannot query the system for clinical content on a patient. Also, reviewing incoming records is difficult because the information is voluminous and poorly organized,” she noted. “There are so many opportunities for improvement, and hopefully 20 years from now we will have EHRs that significantly improve quality and safety of patient care.”
Money and malpractice
The Vaccines for Children program led to an increase in incomes for pediatricians in the United States after 1994, according to Dr. Tayloe. “We began to be paid by insurance companies for most of what we do during the mid-90s and that boosted revenues,” he said. However, “On the flip side, we are now at the mercy of private payers, and must participate in all their very burdensome quality improvement/assurance programs if we are to be paid fairly. Our incomes were pretty flat over the last 5-10 years, especially for practices that participate fully in Medicaid/CHIP.”
Over the past 50 years, malpractice claims against pediatricians have remained consistently among the lowest for any medical specialty, according to Paul Greve, JD, a registered professional liability underwriter and executive vice president and senior consultant at Willis Towers Watson Health Care Practice.
The impact of EHRs on pediatric practice from a legal standpoint depends on the format of the EHR itself, Mr. Greve said. “Many of the EHRs that are designed for physicians, particularly the ones used in acute care settings, don’t allow the doctor to really highlight their thinking as they work through the diagnostic process, and that is very important in the defense of a malpractice case against a pediatrician,” he said.
“The pediatrician doesn’t have to be correct all the time, but it is important for the lawyers defending the case to see what the pediatrician’s thought process was. If the EHR allows for capturing the doctor’s thought process, that’s a well-designed EHR, and that’s critical,” he emphasized.
Diagnostic error is one of the most entrenched problems in medical malpractice, said Mr. Greve. Failure to diagnose and delay in diagnosis remain the most common allegations against pediatricians, he noted. Also, being aware of the environment is important to risk management in the office.
“The American Academy of Pediatrics has excellent publications on safety and risk management that all pediatricians should be aware of,” he said.
Inspiration and intangibles
“I think the changes that we are starting to see will continue to evolve over the next 50 years,” said Dr. Richerson. “Increased medical and social complexity of patients, changes in health technology, EHRs, personal health data monitoring, and continued changes in value based payment methods will be key.
“I hope that we gain, as a health delivery system, an appreciation of the impact of child health on adult health. Long-term adult health outcomes depend on improved child health outcomes. Investing in diseases like childhood obesity, mental health, and developmental issues, to name a few, will have a bigger impact on adult disease than any adult interventions,” she said. And really dealing with the impact of childhood adversity in health care and in the community and nationally in general is critical. This requires grassroots interventions to support families as well as local, state, and national policy. It also requires payment for health care services for the needed interventions in the office and hospital. Providing comprehensive medical care and addressing the medical and social complexities of child health in an effective, compassionate, and family-centered way takes time. It’s not easy, but it’s not impossible. But it requires more resources than are currently given to child health care. Adult medicine is accustomed to paying for disease managers for diabetes or care coordinators for heart failure. This is not the current state of delivery for children’s care and it should be. These are some of the major issues confronting pediatricians.
What has remained the same in pediatrics is the love the doctors have for their work, and the reflections of veteran clinicians on the intangible rewards of the practice may inspire the next generation.
Dr. Tayloe said that he chose pediatrics because “I was really intrigued by the skills necessary to care for sick newborns, including premature babies. I wanted to practice in a remote location where I could use all the skills I developed during residency, and be of significant value to the community.” Two of his four adult children were similarly inspired and followed in his footsteps.
“For pediatricians, helping families raise healthy children is a real privilege and very satisfying,” Dr. McInerny said.
Consider different T. capitis presentations in children with hair loss
Categorizing hair loss in children depends on many factors, but it is important to rule out an infectious etiology as early as possible, according to Sheila Fallon Friedlander, MD.
“What can Tinea capitis look like? Anything,” she said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
Although T. capitis most often presents in children aged 3-7 years as a pattern of localized hair loss, often with scaling, sometimes with nodules, other possibilities include pustules, boggy masses, and diffuse hair loss, said Dr. Friedlander, professor of pediatrics and dermatology at the University of California, San Diego.
Sometimes the hair loss may be so subtle that families come in complaining of “dandruff” rather than hair loss, she noted. Evaluating the patient for the presence of cervical or occipital lymph nodes is crucial; big nodes are usually a tip-off that infection is present.
Clinicians treating T. capitis should ask about family pets, advised Dr. Friedlander, adding that city dwellers’ conditions may be more likely caused by Trichophyton tonsurans, T. violaceum, or Trichophyton soudanense. Also consider immigration status and family history when evaluating T. capitis, and use a Wood’s lamp for diagnosis if one is available, she advised. M. canis will fluoresce and T. tonsurans will not, she pointed out.
Other strategies to evaluate the condition include KOH, culture, polymerase chain reaction, and trichoscopy.
The optimal treatment plan for T. capitis depends on the source, Dr. Friedlander explained. If M. canis is the cause, “griseofulvin is the drug of choice,” along with a twice-weekly sporicidal shampoo, she said.
Other treatment options include terbinafine, itraconazole, and fluconazole, and each have their pros and cons, she said. Terbinafine – which persists for months in the skin, nails, and hair – is the least expensive, and is her first choice for infections caused by T. tonsurans.
Itraconazole is available as a liquid, but costs more, causes diarrhea, and comes with a boxed warning about the potential for cardiac complications; fluconazole is the most expensive, but may be used in infants, she added.
Other high-risk groups for T. capitis include female caretakers of high-risk individuals, such as “grandma”; wrestlers; and Buddhist monks, she said. “Short hair, sharing combs, and unclean barbers” contributed to a documented increased risk of T. capitis according to a recently published study of 60 Buddhist monks whose average age was 11.6 years, she added. (Pediatr Dermatol. 2017 May;34[3]:371-3).
Dr. Friedlander had no relevant financial conflicts to disclose.
SDEF and this news organization are owned by Frontline Medical Communications.
Categorizing hair loss in children depends on many factors, but it is important to rule out an infectious etiology as early as possible, according to Sheila Fallon Friedlander, MD.
“What can Tinea capitis look like? Anything,” she said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
Although T. capitis most often presents in children aged 3-7 years as a pattern of localized hair loss, often with scaling, sometimes with nodules, other possibilities include pustules, boggy masses, and diffuse hair loss, said Dr. Friedlander, professor of pediatrics and dermatology at the University of California, San Diego.
Sometimes the hair loss may be so subtle that families come in complaining of “dandruff” rather than hair loss, she noted. Evaluating the patient for the presence of cervical or occipital lymph nodes is crucial; big nodes are usually a tip-off that infection is present.
Clinicians treating T. capitis should ask about family pets, advised Dr. Friedlander, adding that city dwellers’ conditions may be more likely caused by Trichophyton tonsurans, T. violaceum, or Trichophyton soudanense. Also consider immigration status and family history when evaluating T. capitis, and use a Wood’s lamp for diagnosis if one is available, she advised. M. canis will fluoresce and T. tonsurans will not, she pointed out.
Other strategies to evaluate the condition include KOH, culture, polymerase chain reaction, and trichoscopy.
The optimal treatment plan for T. capitis depends on the source, Dr. Friedlander explained. If M. canis is the cause, “griseofulvin is the drug of choice,” along with a twice-weekly sporicidal shampoo, she said.
Other treatment options include terbinafine, itraconazole, and fluconazole, and each have their pros and cons, she said. Terbinafine – which persists for months in the skin, nails, and hair – is the least expensive, and is her first choice for infections caused by T. tonsurans.
Itraconazole is available as a liquid, but costs more, causes diarrhea, and comes with a boxed warning about the potential for cardiac complications; fluconazole is the most expensive, but may be used in infants, she added.
Other high-risk groups for T. capitis include female caretakers of high-risk individuals, such as “grandma”; wrestlers; and Buddhist monks, she said. “Short hair, sharing combs, and unclean barbers” contributed to a documented increased risk of T. capitis according to a recently published study of 60 Buddhist monks whose average age was 11.6 years, she added. (Pediatr Dermatol. 2017 May;34[3]:371-3).
Dr. Friedlander had no relevant financial conflicts to disclose.
SDEF and this news organization are owned by Frontline Medical Communications.
Categorizing hair loss in children depends on many factors, but it is important to rule out an infectious etiology as early as possible, according to Sheila Fallon Friedlander, MD.
“What can Tinea capitis look like? Anything,” she said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
Although T. capitis most often presents in children aged 3-7 years as a pattern of localized hair loss, often with scaling, sometimes with nodules, other possibilities include pustules, boggy masses, and diffuse hair loss, said Dr. Friedlander, professor of pediatrics and dermatology at the University of California, San Diego.
Sometimes the hair loss may be so subtle that families come in complaining of “dandruff” rather than hair loss, she noted. Evaluating the patient for the presence of cervical or occipital lymph nodes is crucial; big nodes are usually a tip-off that infection is present.
Clinicians treating T. capitis should ask about family pets, advised Dr. Friedlander, adding that city dwellers’ conditions may be more likely caused by Trichophyton tonsurans, T. violaceum, or Trichophyton soudanense. Also consider immigration status and family history when evaluating T. capitis, and use a Wood’s lamp for diagnosis if one is available, she advised. M. canis will fluoresce and T. tonsurans will not, she pointed out.
Other strategies to evaluate the condition include KOH, culture, polymerase chain reaction, and trichoscopy.
The optimal treatment plan for T. capitis depends on the source, Dr. Friedlander explained. If M. canis is the cause, “griseofulvin is the drug of choice,” along with a twice-weekly sporicidal shampoo, she said.
Other treatment options include terbinafine, itraconazole, and fluconazole, and each have their pros and cons, she said. Terbinafine – which persists for months in the skin, nails, and hair – is the least expensive, and is her first choice for infections caused by T. tonsurans.
Itraconazole is available as a liquid, but costs more, causes diarrhea, and comes with a boxed warning about the potential for cardiac complications; fluconazole is the most expensive, but may be used in infants, she added.
Other high-risk groups for T. capitis include female caretakers of high-risk individuals, such as “grandma”; wrestlers; and Buddhist monks, she said. “Short hair, sharing combs, and unclean barbers” contributed to a documented increased risk of T. capitis according to a recently published study of 60 Buddhist monks whose average age was 11.6 years, she added. (Pediatr Dermatol. 2017 May;34[3]:371-3).
Dr. Friedlander had no relevant financial conflicts to disclose.
SDEF and this news organization are owned by Frontline Medical Communications.
FROM SDEF WOMEN’S & PEDIATRIC DERMATOLOGY SEMINAR
Light therapy offers brighter future for scar patients
Current treatment with available light-based devices, notably ablative fractional resurfacing, can greatly improve quality of life for patients struggling with scars, according to Kristen Kelly, MD, of the University of California, Irvine.
Using multiple devices, and combining devices with other therapies, are among the strategies that can improve pain and function in these patients, she said in a presentation at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Dr. Kelly recommends “a CO2 laser or an Er:YAG [erbium-doped YAG],” as AFR options for scar treatment. The Er:YAG is less painful, but may cause bleeding, she noted.
Tips for a scar treatment protocol with AFR include low density and treating the entire scar plus a 1-2 mm rim, Dr. Kelly said. AFR treatment of scars can start in some cases soon after an injury, but it depends on the cause of the scar and treatment timing is controversial, especially for burn scars, she said. Dr. Kelly outlined a plan of treatment every 2-3 months, with the option of adding triamcinolone suspension immediately after the AFR treatment, she noted.
Other medications used after AFR to improve results include 5-fluorouracil, bimatoprost, and poly-L-lactic acid. However, “you should only consider this for medications that you would safely inject into the skin or bloodstream,” she emphasized.
Combining AFR with other devices can improve results, depending on the type of scar, said Dr. Kelly. Atrophic scars may be treated with AFR or NAFR, while red atrophic scars may improve with a combination AFR or NAFR and a pulsed dye laser, she said. For red hypertrophic scars, consider a combination of AFR plus a steroid combined with a pulsed dye laser, she added.
When embarking on a scar treatment plan, be sure to define goals and remind patients that scars can be “improved but not removed,” said Dr. Kelly. “Laser therapy is often not monotherapy,” she added. A surgical revision, such as a Z-plasty, and the use of physical and occupational therapy also can improve results and improve quality of life for patients, she said.
Dr. Kelly disclosed relationships with multiple companies including Allergan, MundiPharma, Syneron Candela, Light Sciences Oncology, Novartis, Sciton, and ThermiRF.
SDEF and this news organization are owned by the same parent company.
Current treatment with available light-based devices, notably ablative fractional resurfacing, can greatly improve quality of life for patients struggling with scars, according to Kristen Kelly, MD, of the University of California, Irvine.
Using multiple devices, and combining devices with other therapies, are among the strategies that can improve pain and function in these patients, she said in a presentation at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Dr. Kelly recommends “a CO2 laser or an Er:YAG [erbium-doped YAG],” as AFR options for scar treatment. The Er:YAG is less painful, but may cause bleeding, she noted.
Tips for a scar treatment protocol with AFR include low density and treating the entire scar plus a 1-2 mm rim, Dr. Kelly said. AFR treatment of scars can start in some cases soon after an injury, but it depends on the cause of the scar and treatment timing is controversial, especially for burn scars, she said. Dr. Kelly outlined a plan of treatment every 2-3 months, with the option of adding triamcinolone suspension immediately after the AFR treatment, she noted.
Other medications used after AFR to improve results include 5-fluorouracil, bimatoprost, and poly-L-lactic acid. However, “you should only consider this for medications that you would safely inject into the skin or bloodstream,” she emphasized.
Combining AFR with other devices can improve results, depending on the type of scar, said Dr. Kelly. Atrophic scars may be treated with AFR or NAFR, while red atrophic scars may improve with a combination AFR or NAFR and a pulsed dye laser, she said. For red hypertrophic scars, consider a combination of AFR plus a steroid combined with a pulsed dye laser, she added.
When embarking on a scar treatment plan, be sure to define goals and remind patients that scars can be “improved but not removed,” said Dr. Kelly. “Laser therapy is often not monotherapy,” she added. A surgical revision, such as a Z-plasty, and the use of physical and occupational therapy also can improve results and improve quality of life for patients, she said.
Dr. Kelly disclosed relationships with multiple companies including Allergan, MundiPharma, Syneron Candela, Light Sciences Oncology, Novartis, Sciton, and ThermiRF.
SDEF and this news organization are owned by the same parent company.
Current treatment with available light-based devices, notably ablative fractional resurfacing, can greatly improve quality of life for patients struggling with scars, according to Kristen Kelly, MD, of the University of California, Irvine.
Using multiple devices, and combining devices with other therapies, are among the strategies that can improve pain and function in these patients, she said in a presentation at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Dr. Kelly recommends “a CO2 laser or an Er:YAG [erbium-doped YAG],” as AFR options for scar treatment. The Er:YAG is less painful, but may cause bleeding, she noted.
Tips for a scar treatment protocol with AFR include low density and treating the entire scar plus a 1-2 mm rim, Dr. Kelly said. AFR treatment of scars can start in some cases soon after an injury, but it depends on the cause of the scar and treatment timing is controversial, especially for burn scars, she said. Dr. Kelly outlined a plan of treatment every 2-3 months, with the option of adding triamcinolone suspension immediately after the AFR treatment, she noted.
Other medications used after AFR to improve results include 5-fluorouracil, bimatoprost, and poly-L-lactic acid. However, “you should only consider this for medications that you would safely inject into the skin or bloodstream,” she emphasized.
Combining AFR with other devices can improve results, depending on the type of scar, said Dr. Kelly. Atrophic scars may be treated with AFR or NAFR, while red atrophic scars may improve with a combination AFR or NAFR and a pulsed dye laser, she said. For red hypertrophic scars, consider a combination of AFR plus a steroid combined with a pulsed dye laser, she added.
When embarking on a scar treatment plan, be sure to define goals and remind patients that scars can be “improved but not removed,” said Dr. Kelly. “Laser therapy is often not monotherapy,” she added. A surgical revision, such as a Z-plasty, and the use of physical and occupational therapy also can improve results and improve quality of life for patients, she said.
Dr. Kelly disclosed relationships with multiple companies including Allergan, MundiPharma, Syneron Candela, Light Sciences Oncology, Novartis, Sciton, and ThermiRF.
SDEF and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF LAS VEGAS DERMATOLOGY SEMINAR