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Comparing pulmonary embolism mortality risk scores
Background: Though most PEs do not have significant complications, 15% may be associated with risk of death or hemodynamic compromise. Retrospectively derived risk scores are used to risk-stratify patients and guide acute treatment strategies. It is unclear how well existing risk scores estimate mortality outcomes in patients with acute PE.
Study design: Multicenter cohort study.
Setting: Eight hospitals participating in Pulmonary Embolism Response Team (PERT) consortium registry.
Synopsis: The study included 416 patients with radiographically confirmed acute PE, baseline data for risk calculations, and PERT consultation to consider advanced therapies. Four risk scores (PESI, simplified PESI, BOVA, and European Society of Cardiology) were calculated for each patient independently of clinical care. Patients were assigned into lower- and higher-risk groups. All-cause mortality was assessed on days 7 and 30. The discrimination of each risk score was measured using area under the curve (AUC). Seven-day mortality ranged 1.3%-3.1% in the lower-risk group, and 7%-16.3% in the high-risk group. Thirty-day mortality in the low-risk group ranged 2.6%-10.2% and 14.4%-26.3% in the high-risk group. PE risk scores have only moderate discrimination for mortality at 7 days (AUC range, 0.616-0.666) and less discrimination at 30 days (AUC range, 0.550-0.694) with little association among the risk scores. Limitations include failure to capture all presenting PEs and inability to differentiate between all-cause and specific PE-related mortality.
Bottom line: While helpful in predicting shorter-term mortality, acute PE risk scores are not highly accurate at predicting longer-term mortality and should be integrated with broad clinical information when making management decisions.
Citation: Barnes GD et al. Comparison of 4 acute pulmonary embolism mortality risk scores in patients evaluated by pulmonary embolism response teams. JAMA Netw Open. 2020 Aug 3;3(8):e2010779. doi:
Dr. Korovaichuk is a hospitalist at Northwestern Memorial Hospital and assistant professor of medicine, Feinberg School of Medicine, both in Chicago.
Background: Though most PEs do not have significant complications, 15% may be associated with risk of death or hemodynamic compromise. Retrospectively derived risk scores are used to risk-stratify patients and guide acute treatment strategies. It is unclear how well existing risk scores estimate mortality outcomes in patients with acute PE.
Study design: Multicenter cohort study.
Setting: Eight hospitals participating in Pulmonary Embolism Response Team (PERT) consortium registry.
Synopsis: The study included 416 patients with radiographically confirmed acute PE, baseline data for risk calculations, and PERT consultation to consider advanced therapies. Four risk scores (PESI, simplified PESI, BOVA, and European Society of Cardiology) were calculated for each patient independently of clinical care. Patients were assigned into lower- and higher-risk groups. All-cause mortality was assessed on days 7 and 30. The discrimination of each risk score was measured using area under the curve (AUC). Seven-day mortality ranged 1.3%-3.1% in the lower-risk group, and 7%-16.3% in the high-risk group. Thirty-day mortality in the low-risk group ranged 2.6%-10.2% and 14.4%-26.3% in the high-risk group. PE risk scores have only moderate discrimination for mortality at 7 days (AUC range, 0.616-0.666) and less discrimination at 30 days (AUC range, 0.550-0.694) with little association among the risk scores. Limitations include failure to capture all presenting PEs and inability to differentiate between all-cause and specific PE-related mortality.
Bottom line: While helpful in predicting shorter-term mortality, acute PE risk scores are not highly accurate at predicting longer-term mortality and should be integrated with broad clinical information when making management decisions.
Citation: Barnes GD et al. Comparison of 4 acute pulmonary embolism mortality risk scores in patients evaluated by pulmonary embolism response teams. JAMA Netw Open. 2020 Aug 3;3(8):e2010779. doi:
Dr. Korovaichuk is a hospitalist at Northwestern Memorial Hospital and assistant professor of medicine, Feinberg School of Medicine, both in Chicago.
Background: Though most PEs do not have significant complications, 15% may be associated with risk of death or hemodynamic compromise. Retrospectively derived risk scores are used to risk-stratify patients and guide acute treatment strategies. It is unclear how well existing risk scores estimate mortality outcomes in patients with acute PE.
Study design: Multicenter cohort study.
Setting: Eight hospitals participating in Pulmonary Embolism Response Team (PERT) consortium registry.
Synopsis: The study included 416 patients with radiographically confirmed acute PE, baseline data for risk calculations, and PERT consultation to consider advanced therapies. Four risk scores (PESI, simplified PESI, BOVA, and European Society of Cardiology) were calculated for each patient independently of clinical care. Patients were assigned into lower- and higher-risk groups. All-cause mortality was assessed on days 7 and 30. The discrimination of each risk score was measured using area under the curve (AUC). Seven-day mortality ranged 1.3%-3.1% in the lower-risk group, and 7%-16.3% in the high-risk group. Thirty-day mortality in the low-risk group ranged 2.6%-10.2% and 14.4%-26.3% in the high-risk group. PE risk scores have only moderate discrimination for mortality at 7 days (AUC range, 0.616-0.666) and less discrimination at 30 days (AUC range, 0.550-0.694) with little association among the risk scores. Limitations include failure to capture all presenting PEs and inability to differentiate between all-cause and specific PE-related mortality.
Bottom line: While helpful in predicting shorter-term mortality, acute PE risk scores are not highly accurate at predicting longer-term mortality and should be integrated with broad clinical information when making management decisions.
Citation: Barnes GD et al. Comparison of 4 acute pulmonary embolism mortality risk scores in patients evaluated by pulmonary embolism response teams. JAMA Netw Open. 2020 Aug 3;3(8):e2010779. doi:
Dr. Korovaichuk is a hospitalist at Northwestern Memorial Hospital and assistant professor of medicine, Feinberg School of Medicine, both in Chicago.
Sea buckthorn: What is it and what is it good for?
To avoid jumping on the bandwagon of another ingredient trend, we sought to examine the scientific background and properties of sea buckthorn oil and it’s utility for the skin.
Sea buckthorn (Hippophae rhamnoides) – also known as a Siberian pineapple tree, and as sandthorn, sallowthorn, or seaberry – is a thorny, dioecious shrub (or tree) in the oleaster family. It can grow up to 23 feet high and is found in coastal sea cliff areas and on mountain slopes of Western Europe, and in dry sandy areas of Asia Minor and Central Asia, Siberia, China, and Tibet. Common sea buckthorn flowers in late April and early May, producing a large number of small, green and brown flowers, turning into edible, usually yellow or orange round berries. The berries have a bitter, sour taste and have a mild aroma, resembling that of a pineapple. The fruit contains a small stone that covers an oily seed.
The berries are a source of antioxidant vitamins, flavonoids, and organic acids, and when pressed, produce a juice that separates into three layers: a thick cream (upper layer), a combination of saturated and unsaturated fatty acids (middle layer), and juice that is a source of fat (lower layer). The berries contain mainly vitamin C, but also vitamin A (alpha- and beta-carotene) and a mixture of other carotenoids, as well as varying concentrations of tocopherols (vitamin E), folic acid, and vitamin B complex–group vitamins.
In addition to flavonoids, the berries contain catechins and procyanidins, cyclitols, phospholipids, tannins, sugars (galactose, fructose, xylose), organic acids (maleic acid, oxalic acid, malic acid, tartaric acid), phenolic acids (such as ferulic acid), and fatty oil. The amount of vitamin C content varies with the variety of the plant and where it is found. The oil of sea buckthorn may be extracted from two parts of the plant, with mechanical cold pressing of seeds (up to 12.5% weight as oil content) and fruit pulp (8%-12% oil content).
Among vegetable oils, sea buckthorn fruit oil has the highest content of palmitoleic acid (omega-7).
Fruit and seed oils contain tocotrienols and plant sterols. Pulp sea buckthorn oil has a high carotenoid content, as opposed to seed oil, and in Mongolia, Russia, and China, is used as a topical therapy for skin burns.
Other significant fatty acids found in sea buckthorn oil are saturated fatty acids (palmitic acid and stearic acid) and polyunsaturated fatty acids, which include alpha-linolenic acid (omega-3), gamma-linolenic acid (omega-6), linolic acid (omega-6), oleic acid (omega-9), and eicosanoic acid (omega-9). Gamma-linoleic acid in particular is reduced in dry skin conditions, such as aging and atopic dermatitis. The human body can produce some gamma-linolenic acid, oleic acid, and palmitoleic acid, but not linolic acid and alpha-linolenic acid. The addition of these substances to diet or skin care has been found to be beneficial in improving dryness and the skin barrier.
In addition, linolic acid, a natural component of human sebum, has been noted to be decreased in the sebum of people with acne-prone skin. Preliminary evidence indicates that dietary supplements containing fatty acids such as docosahexaenoic acid, sea buckthorn oil, and hemp seed oil may decrease the severity of atopic dermatitis.
Besides use in topical skin care and cosmetic preparations, sea buckthorn has also been used successfully in the treatment of chronic gastric ulcer disease, inflammation of the vagina and cervix, and cervical erosion. The bark and leaves of sea buckthorn used to be applied to treat diarrhea and dermatologic conditions, while berry oil has been applied topically or taken orally to soften the skin.
In traditional Indian, Chinese, and Tibetan medicines, sea buckthorn berries are used for medicinal purposes, as their ingredients were thought to have a beneficial effect on the function of the alimentary, respiratory, and circulatory systems. Current studies and uses are now confirming their utility experienced over hundreds of years.
Harvesting sea buckthorn fruit is difficult because of dense thorn arrangement among the berries. Therefore, sometimes the only way to obtain fruit is to remove the entire branch of the shrub, which reduces future crops. For this reason berries can only be harvested once every 2 years.
Sea buckthorn has interesting properties and could be of benefit in topical skin care, as long as it is not overharvested or harvested in a way that has a detrimental impact on the environment.
Dr. Wesley and Lily Talakoub, MD, are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.
References
United States Department of Agriculture. PLANTS Profile for Hippophae rhamnoides (seaberry). 2007.
Zielińska A and Nowak I. Lipids Health Dis. 2017 May 19;16(1):95.
Reynolds KA et al. Int J Dermatol. 2019 Dec;58(12):1371-6.
To avoid jumping on the bandwagon of another ingredient trend, we sought to examine the scientific background and properties of sea buckthorn oil and it’s utility for the skin.
Sea buckthorn (Hippophae rhamnoides) – also known as a Siberian pineapple tree, and as sandthorn, sallowthorn, or seaberry – is a thorny, dioecious shrub (or tree) in the oleaster family. It can grow up to 23 feet high and is found in coastal sea cliff areas and on mountain slopes of Western Europe, and in dry sandy areas of Asia Minor and Central Asia, Siberia, China, and Tibet. Common sea buckthorn flowers in late April and early May, producing a large number of small, green and brown flowers, turning into edible, usually yellow or orange round berries. The berries have a bitter, sour taste and have a mild aroma, resembling that of a pineapple. The fruit contains a small stone that covers an oily seed.
The berries are a source of antioxidant vitamins, flavonoids, and organic acids, and when pressed, produce a juice that separates into three layers: a thick cream (upper layer), a combination of saturated and unsaturated fatty acids (middle layer), and juice that is a source of fat (lower layer). The berries contain mainly vitamin C, but also vitamin A (alpha- and beta-carotene) and a mixture of other carotenoids, as well as varying concentrations of tocopherols (vitamin E), folic acid, and vitamin B complex–group vitamins.
In addition to flavonoids, the berries contain catechins and procyanidins, cyclitols, phospholipids, tannins, sugars (galactose, fructose, xylose), organic acids (maleic acid, oxalic acid, malic acid, tartaric acid), phenolic acids (such as ferulic acid), and fatty oil. The amount of vitamin C content varies with the variety of the plant and where it is found. The oil of sea buckthorn may be extracted from two parts of the plant, with mechanical cold pressing of seeds (up to 12.5% weight as oil content) and fruit pulp (8%-12% oil content).
Among vegetable oils, sea buckthorn fruit oil has the highest content of palmitoleic acid (omega-7).
Fruit and seed oils contain tocotrienols and plant sterols. Pulp sea buckthorn oil has a high carotenoid content, as opposed to seed oil, and in Mongolia, Russia, and China, is used as a topical therapy for skin burns.
Other significant fatty acids found in sea buckthorn oil are saturated fatty acids (palmitic acid and stearic acid) and polyunsaturated fatty acids, which include alpha-linolenic acid (omega-3), gamma-linolenic acid (omega-6), linolic acid (omega-6), oleic acid (omega-9), and eicosanoic acid (omega-9). Gamma-linoleic acid in particular is reduced in dry skin conditions, such as aging and atopic dermatitis. The human body can produce some gamma-linolenic acid, oleic acid, and palmitoleic acid, but not linolic acid and alpha-linolenic acid. The addition of these substances to diet or skin care has been found to be beneficial in improving dryness and the skin barrier.
In addition, linolic acid, a natural component of human sebum, has been noted to be decreased in the sebum of people with acne-prone skin. Preliminary evidence indicates that dietary supplements containing fatty acids such as docosahexaenoic acid, sea buckthorn oil, and hemp seed oil may decrease the severity of atopic dermatitis.
Besides use in topical skin care and cosmetic preparations, sea buckthorn has also been used successfully in the treatment of chronic gastric ulcer disease, inflammation of the vagina and cervix, and cervical erosion. The bark and leaves of sea buckthorn used to be applied to treat diarrhea and dermatologic conditions, while berry oil has been applied topically or taken orally to soften the skin.
In traditional Indian, Chinese, and Tibetan medicines, sea buckthorn berries are used for medicinal purposes, as their ingredients were thought to have a beneficial effect on the function of the alimentary, respiratory, and circulatory systems. Current studies and uses are now confirming their utility experienced over hundreds of years.
Harvesting sea buckthorn fruit is difficult because of dense thorn arrangement among the berries. Therefore, sometimes the only way to obtain fruit is to remove the entire branch of the shrub, which reduces future crops. For this reason berries can only be harvested once every 2 years.
Sea buckthorn has interesting properties and could be of benefit in topical skin care, as long as it is not overharvested or harvested in a way that has a detrimental impact on the environment.
Dr. Wesley and Lily Talakoub, MD, are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.
References
United States Department of Agriculture. PLANTS Profile for Hippophae rhamnoides (seaberry). 2007.
Zielińska A and Nowak I. Lipids Health Dis. 2017 May 19;16(1):95.
Reynolds KA et al. Int J Dermatol. 2019 Dec;58(12):1371-6.
To avoid jumping on the bandwagon of another ingredient trend, we sought to examine the scientific background and properties of sea buckthorn oil and it’s utility for the skin.
Sea buckthorn (Hippophae rhamnoides) – also known as a Siberian pineapple tree, and as sandthorn, sallowthorn, or seaberry – is a thorny, dioecious shrub (or tree) in the oleaster family. It can grow up to 23 feet high and is found in coastal sea cliff areas and on mountain slopes of Western Europe, and in dry sandy areas of Asia Minor and Central Asia, Siberia, China, and Tibet. Common sea buckthorn flowers in late April and early May, producing a large number of small, green and brown flowers, turning into edible, usually yellow or orange round berries. The berries have a bitter, sour taste and have a mild aroma, resembling that of a pineapple. The fruit contains a small stone that covers an oily seed.
The berries are a source of antioxidant vitamins, flavonoids, and organic acids, and when pressed, produce a juice that separates into three layers: a thick cream (upper layer), a combination of saturated and unsaturated fatty acids (middle layer), and juice that is a source of fat (lower layer). The berries contain mainly vitamin C, but also vitamin A (alpha- and beta-carotene) and a mixture of other carotenoids, as well as varying concentrations of tocopherols (vitamin E), folic acid, and vitamin B complex–group vitamins.
In addition to flavonoids, the berries contain catechins and procyanidins, cyclitols, phospholipids, tannins, sugars (galactose, fructose, xylose), organic acids (maleic acid, oxalic acid, malic acid, tartaric acid), phenolic acids (such as ferulic acid), and fatty oil. The amount of vitamin C content varies with the variety of the plant and where it is found. The oil of sea buckthorn may be extracted from two parts of the plant, with mechanical cold pressing of seeds (up to 12.5% weight as oil content) and fruit pulp (8%-12% oil content).
Among vegetable oils, sea buckthorn fruit oil has the highest content of palmitoleic acid (omega-7).
Fruit and seed oils contain tocotrienols and plant sterols. Pulp sea buckthorn oil has a high carotenoid content, as opposed to seed oil, and in Mongolia, Russia, and China, is used as a topical therapy for skin burns.
Other significant fatty acids found in sea buckthorn oil are saturated fatty acids (palmitic acid and stearic acid) and polyunsaturated fatty acids, which include alpha-linolenic acid (omega-3), gamma-linolenic acid (omega-6), linolic acid (omega-6), oleic acid (omega-9), and eicosanoic acid (omega-9). Gamma-linoleic acid in particular is reduced in dry skin conditions, such as aging and atopic dermatitis. The human body can produce some gamma-linolenic acid, oleic acid, and palmitoleic acid, but not linolic acid and alpha-linolenic acid. The addition of these substances to diet or skin care has been found to be beneficial in improving dryness and the skin barrier.
In addition, linolic acid, a natural component of human sebum, has been noted to be decreased in the sebum of people with acne-prone skin. Preliminary evidence indicates that dietary supplements containing fatty acids such as docosahexaenoic acid, sea buckthorn oil, and hemp seed oil may decrease the severity of atopic dermatitis.
Besides use in topical skin care and cosmetic preparations, sea buckthorn has also been used successfully in the treatment of chronic gastric ulcer disease, inflammation of the vagina and cervix, and cervical erosion. The bark and leaves of sea buckthorn used to be applied to treat diarrhea and dermatologic conditions, while berry oil has been applied topically or taken orally to soften the skin.
In traditional Indian, Chinese, and Tibetan medicines, sea buckthorn berries are used for medicinal purposes, as their ingredients were thought to have a beneficial effect on the function of the alimentary, respiratory, and circulatory systems. Current studies and uses are now confirming their utility experienced over hundreds of years.
Harvesting sea buckthorn fruit is difficult because of dense thorn arrangement among the berries. Therefore, sometimes the only way to obtain fruit is to remove the entire branch of the shrub, which reduces future crops. For this reason berries can only be harvested once every 2 years.
Sea buckthorn has interesting properties and could be of benefit in topical skin care, as long as it is not overharvested or harvested in a way that has a detrimental impact on the environment.
Dr. Wesley and Lily Talakoub, MD, are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.
References
United States Department of Agriculture. PLANTS Profile for Hippophae rhamnoides (seaberry). 2007.
Zielińska A and Nowak I. Lipids Health Dis. 2017 May 19;16(1):95.
Reynolds KA et al. Int J Dermatol. 2019 Dec;58(12):1371-6.
Surgery offers best chance in cancer but needs more ‘support’
warns a European expert.
In addition, there are many obstacles to the delivery of optimal cancer surgery, says Domenico M. D’Ugo, MD, professor of surgery at the Catholic University of Rome – A. Gemelli Medical School, Rome, Italy.
Dr. D’Ugo, who is president of the European Society of Surgical Oncology (ESSO), calls for a range of measures to improve the quality of cancer surgery and patient access in Europe.
These measures include recognition of surgical oncology as a specialist discipline, greater support for surgical research and innovation, and a greater role for surgery in multidisciplinary care.
The demands were made in open letter that was published by ESSO on Nov. 9 to coincide with the society’s annual meeting, held in Lisbon, Portugal.
The theme of this year’s meeting was the future of cancer surgery in Europe – a future that “holds many promises to make surgical oncology safer, more efficient and minimally invasive,” writes Dr. D’Ugo.
However, ESSO needs the support of European leaders to bring the recommendations to life and, ultimately, to help provide high-quality cancer treatment, he adds. This is particularly important given the upcoming implementation of Europe’s Beating Cancer Plan.
The open letter is addressed to Stella Kyriakides, European commissioner for health and food safety, and Bartosz Arłukowicz, chair of the European Parliament Special Committee on Beating Cancer, among others.
Best chance of cure
“High-quality surgery remains the best chance to cure solid cancer when diagnosed early,” Dr. D’Ugo notes in his letter. It is also the most cost-effective treatment for the majority of nonmetastasized tumors, he writes.
In addition, surgery is “fundamental” to the prevention of cancer in patients with inherited susceptibility and to the diagnosis and staging of cancer, as well as to the treatment of metastatic disease, the preservation of quality of life, and the alleviation of cancer symptoms, he writes.
There is thus a substantial and steadily growing demand for surgical oncology.
It is estimated that approximately 80% of cancer patients will require surgical intervention at some point during the course of their disease, and 45 million surgical procedures will be needed worldwide by 2030.
Dr. D’Ugo says that at present, fewer than a quarter of cancer patients receive safe, affordable, or timely surgery.
It is time to give surgical oncology the political and financial attention it deserves, he argues. He outlines a four-point plan to achieve this.
The first point is to enhance recognition of surgical oncology as a specialist discipline through, for example, the global curriculum proposed by ESSO and the Society of Surgical Oncology in 2016.
At present, only eight countries in Europe recognize surgical oncology as a specialty, and the lack of harmonization is “causing disparities in training, qualifications and practices,” as well as in patient access, Dr. D’Ugo says.
Next is a call to support research and innovation. Despite recent advances, research in cancer surgery “remains highly underfunded in Europe when compared with pharmaceutical research,” he says.
Improved screening and early detection of cancer are the next key area, because when the disease is diagnosed at an early stage, curative surgery has “a greater chance to be successful.”
At present, screening programs in Europe address only colorectal, breast, and cervical cancers, and the uptake remains “low,” he writes.
Lastly, he emphasizes that surgery is “integral” to multidisciplinary care and that outcomes for patients are better in comprehensive cancer centers that support patients throughout the disease pathway.
Dr. D’Ugo suggests that surgical oncologists take on a “bigger role” in multidisciplinary care, and he calls for the certification and accreditation of cancer units to increase and unify standards of care across the region.
D’Ugo has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
warns a European expert.
In addition, there are many obstacles to the delivery of optimal cancer surgery, says Domenico M. D’Ugo, MD, professor of surgery at the Catholic University of Rome – A. Gemelli Medical School, Rome, Italy.
Dr. D’Ugo, who is president of the European Society of Surgical Oncology (ESSO), calls for a range of measures to improve the quality of cancer surgery and patient access in Europe.
These measures include recognition of surgical oncology as a specialist discipline, greater support for surgical research and innovation, and a greater role for surgery in multidisciplinary care.
The demands were made in open letter that was published by ESSO on Nov. 9 to coincide with the society’s annual meeting, held in Lisbon, Portugal.
The theme of this year’s meeting was the future of cancer surgery in Europe – a future that “holds many promises to make surgical oncology safer, more efficient and minimally invasive,” writes Dr. D’Ugo.
However, ESSO needs the support of European leaders to bring the recommendations to life and, ultimately, to help provide high-quality cancer treatment, he adds. This is particularly important given the upcoming implementation of Europe’s Beating Cancer Plan.
The open letter is addressed to Stella Kyriakides, European commissioner for health and food safety, and Bartosz Arłukowicz, chair of the European Parliament Special Committee on Beating Cancer, among others.
Best chance of cure
“High-quality surgery remains the best chance to cure solid cancer when diagnosed early,” Dr. D’Ugo notes in his letter. It is also the most cost-effective treatment for the majority of nonmetastasized tumors, he writes.
In addition, surgery is “fundamental” to the prevention of cancer in patients with inherited susceptibility and to the diagnosis and staging of cancer, as well as to the treatment of metastatic disease, the preservation of quality of life, and the alleviation of cancer symptoms, he writes.
There is thus a substantial and steadily growing demand for surgical oncology.
It is estimated that approximately 80% of cancer patients will require surgical intervention at some point during the course of their disease, and 45 million surgical procedures will be needed worldwide by 2030.
Dr. D’Ugo says that at present, fewer than a quarter of cancer patients receive safe, affordable, or timely surgery.
It is time to give surgical oncology the political and financial attention it deserves, he argues. He outlines a four-point plan to achieve this.
The first point is to enhance recognition of surgical oncology as a specialist discipline through, for example, the global curriculum proposed by ESSO and the Society of Surgical Oncology in 2016.
At present, only eight countries in Europe recognize surgical oncology as a specialty, and the lack of harmonization is “causing disparities in training, qualifications and practices,” as well as in patient access, Dr. D’Ugo says.
Next is a call to support research and innovation. Despite recent advances, research in cancer surgery “remains highly underfunded in Europe when compared with pharmaceutical research,” he says.
Improved screening and early detection of cancer are the next key area, because when the disease is diagnosed at an early stage, curative surgery has “a greater chance to be successful.”
At present, screening programs in Europe address only colorectal, breast, and cervical cancers, and the uptake remains “low,” he writes.
Lastly, he emphasizes that surgery is “integral” to multidisciplinary care and that outcomes for patients are better in comprehensive cancer centers that support patients throughout the disease pathway.
Dr. D’Ugo suggests that surgical oncologists take on a “bigger role” in multidisciplinary care, and he calls for the certification and accreditation of cancer units to increase and unify standards of care across the region.
D’Ugo has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
warns a European expert.
In addition, there are many obstacles to the delivery of optimal cancer surgery, says Domenico M. D’Ugo, MD, professor of surgery at the Catholic University of Rome – A. Gemelli Medical School, Rome, Italy.
Dr. D’Ugo, who is president of the European Society of Surgical Oncology (ESSO), calls for a range of measures to improve the quality of cancer surgery and patient access in Europe.
These measures include recognition of surgical oncology as a specialist discipline, greater support for surgical research and innovation, and a greater role for surgery in multidisciplinary care.
The demands were made in open letter that was published by ESSO on Nov. 9 to coincide with the society’s annual meeting, held in Lisbon, Portugal.
The theme of this year’s meeting was the future of cancer surgery in Europe – a future that “holds many promises to make surgical oncology safer, more efficient and minimally invasive,” writes Dr. D’Ugo.
However, ESSO needs the support of European leaders to bring the recommendations to life and, ultimately, to help provide high-quality cancer treatment, he adds. This is particularly important given the upcoming implementation of Europe’s Beating Cancer Plan.
The open letter is addressed to Stella Kyriakides, European commissioner for health and food safety, and Bartosz Arłukowicz, chair of the European Parliament Special Committee on Beating Cancer, among others.
Best chance of cure
“High-quality surgery remains the best chance to cure solid cancer when diagnosed early,” Dr. D’Ugo notes in his letter. It is also the most cost-effective treatment for the majority of nonmetastasized tumors, he writes.
In addition, surgery is “fundamental” to the prevention of cancer in patients with inherited susceptibility and to the diagnosis and staging of cancer, as well as to the treatment of metastatic disease, the preservation of quality of life, and the alleviation of cancer symptoms, he writes.
There is thus a substantial and steadily growing demand for surgical oncology.
It is estimated that approximately 80% of cancer patients will require surgical intervention at some point during the course of their disease, and 45 million surgical procedures will be needed worldwide by 2030.
Dr. D’Ugo says that at present, fewer than a quarter of cancer patients receive safe, affordable, or timely surgery.
It is time to give surgical oncology the political and financial attention it deserves, he argues. He outlines a four-point plan to achieve this.
The first point is to enhance recognition of surgical oncology as a specialist discipline through, for example, the global curriculum proposed by ESSO and the Society of Surgical Oncology in 2016.
At present, only eight countries in Europe recognize surgical oncology as a specialty, and the lack of harmonization is “causing disparities in training, qualifications and practices,” as well as in patient access, Dr. D’Ugo says.
Next is a call to support research and innovation. Despite recent advances, research in cancer surgery “remains highly underfunded in Europe when compared with pharmaceutical research,” he says.
Improved screening and early detection of cancer are the next key area, because when the disease is diagnosed at an early stage, curative surgery has “a greater chance to be successful.”
At present, screening programs in Europe address only colorectal, breast, and cervical cancers, and the uptake remains “low,” he writes.
Lastly, he emphasizes that surgery is “integral” to multidisciplinary care and that outcomes for patients are better in comprehensive cancer centers that support patients throughout the disease pathway.
Dr. D’Ugo suggests that surgical oncologists take on a “bigger role” in multidisciplinary care, and he calls for the certification and accreditation of cancer units to increase and unify standards of care across the region.
D’Ugo has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
EU panel endorses first-of-its-kind lung cancer drug
At its November meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) endorsed the novel oral therapy sotorasib (Lumykras). The indication is use in the treatment of adults with advanced NSCLC with a KRAS G12C mutation who have progressed after at least one prior line of systemic therapy.
Sotorasib is an inhibitor of KRAS G12C, an oncogenic driver of tumorigenesis. The drug blocks tumor cell signaling and survival, inhibits cell growth, and selectively promotes apoptosis in tumors harboring KRAS G12C, according to the CHMP.
KRAS mutations are the most common mutations in NSCLC tumors, but for a long time appeared to be resistant to drug therapy.
The KRAS G12C mutation occurs in about 13% of NSCLC mutations.
When clinical data on sotorasib were presented at the 2020 World Conference on Lung Cancer, lung cancer experts greeted the results enthusiastically.
“This is a historic milestone in lung cancer therapy. After four decades of scientific efforts in targeting KRAS, sotorasib has potential to be the first targeted treatment option for this patient population with a high unmet need,” Bob Li, MD, PhD, MPH, of Memorial Sloan Kettering Cancer Center in New York City, said at the time.
The drug was approved by the U.S. Food and Drug Administration in May based on a study of 124 patients with locally advanced or metastatic KRAS G12C-mutated NSCLC with disease progression after receiving an immune checkpoint inhibitor and/or platinum-based chemotherapy.
The FDA approval was based on an overall response rate of 36%, the study’s primary outcome. Of the patients who responded, 58% had a duration of response of 6 months or longer.
The EMA says its recommendation for approval is based on objective response rate and response duration data.
The most common side effects of sotorasib are diarrhea, nausea, fatigue, increased aspartate aminotransferase, and arthralgia said the CHMP.
A version of this article first appeared on Medscape.com.
At its November meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) endorsed the novel oral therapy sotorasib (Lumykras). The indication is use in the treatment of adults with advanced NSCLC with a KRAS G12C mutation who have progressed after at least one prior line of systemic therapy.
Sotorasib is an inhibitor of KRAS G12C, an oncogenic driver of tumorigenesis. The drug blocks tumor cell signaling and survival, inhibits cell growth, and selectively promotes apoptosis in tumors harboring KRAS G12C, according to the CHMP.
KRAS mutations are the most common mutations in NSCLC tumors, but for a long time appeared to be resistant to drug therapy.
The KRAS G12C mutation occurs in about 13% of NSCLC mutations.
When clinical data on sotorasib were presented at the 2020 World Conference on Lung Cancer, lung cancer experts greeted the results enthusiastically.
“This is a historic milestone in lung cancer therapy. After four decades of scientific efforts in targeting KRAS, sotorasib has potential to be the first targeted treatment option for this patient population with a high unmet need,” Bob Li, MD, PhD, MPH, of Memorial Sloan Kettering Cancer Center in New York City, said at the time.
The drug was approved by the U.S. Food and Drug Administration in May based on a study of 124 patients with locally advanced or metastatic KRAS G12C-mutated NSCLC with disease progression after receiving an immune checkpoint inhibitor and/or platinum-based chemotherapy.
The FDA approval was based on an overall response rate of 36%, the study’s primary outcome. Of the patients who responded, 58% had a duration of response of 6 months or longer.
The EMA says its recommendation for approval is based on objective response rate and response duration data.
The most common side effects of sotorasib are diarrhea, nausea, fatigue, increased aspartate aminotransferase, and arthralgia said the CHMP.
A version of this article first appeared on Medscape.com.
At its November meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) endorsed the novel oral therapy sotorasib (Lumykras). The indication is use in the treatment of adults with advanced NSCLC with a KRAS G12C mutation who have progressed after at least one prior line of systemic therapy.
Sotorasib is an inhibitor of KRAS G12C, an oncogenic driver of tumorigenesis. The drug blocks tumor cell signaling and survival, inhibits cell growth, and selectively promotes apoptosis in tumors harboring KRAS G12C, according to the CHMP.
KRAS mutations are the most common mutations in NSCLC tumors, but for a long time appeared to be resistant to drug therapy.
The KRAS G12C mutation occurs in about 13% of NSCLC mutations.
When clinical data on sotorasib were presented at the 2020 World Conference on Lung Cancer, lung cancer experts greeted the results enthusiastically.
“This is a historic milestone in lung cancer therapy. After four decades of scientific efforts in targeting KRAS, sotorasib has potential to be the first targeted treatment option for this patient population with a high unmet need,” Bob Li, MD, PhD, MPH, of Memorial Sloan Kettering Cancer Center in New York City, said at the time.
The drug was approved by the U.S. Food and Drug Administration in May based on a study of 124 patients with locally advanced or metastatic KRAS G12C-mutated NSCLC with disease progression after receiving an immune checkpoint inhibitor and/or platinum-based chemotherapy.
The FDA approval was based on an overall response rate of 36%, the study’s primary outcome. Of the patients who responded, 58% had a duration of response of 6 months or longer.
The EMA says its recommendation for approval is based on objective response rate and response duration data.
The most common side effects of sotorasib are diarrhea, nausea, fatigue, increased aspartate aminotransferase, and arthralgia said the CHMP.
A version of this article first appeared on Medscape.com.
DREAM-HF: Negative stem cell trial in heart failure may still offer promise
A large, multicenter, sham-controlled trial in heart failure showed no benefit at all from stem cell delivery on the primary outcome of recurrent nonfatal decompensated HF events, but the results were still promising, according to the DREAM-HF study’s principal investigator.
When added to guideline-directed medical therapy in patients with HF, a single dose of mesenchymal progenitor cells (MPC) significantly reduced major adverse cardiovascular events (MACE) – a composite of cardiac death, nonfatal MI, and nonfatal stroke – and all-cause death in New York Heart Association (NYHA) class II (but not class III patients), reported Emerson C. Perin, MD, PhD, at the American Heart Association scientific sessions.
The problem is that none of these outcomes were included in the primary endpoint, which was recurrent events because of nonfatal decompensated heart failure. On this endpoint, the hazard ratio for events by the end of follow-up was nonsignificantly but slightly increased among those randomized to MPCs rather than sham control (HR, 1.2; P = .406).
“We learned a lot in this trial,” said Dr. Perin, who is medical director of the Texas Heart Institute in Houston, acknowledging that the expectation of benefit on the primary endpoint now appears to have been misplaced, but the positive result on other outcomes opens a new research direction.
With a negative result on the primary endpoint, a benefit on secondary endpoints is considered hypothesis generating. But Dr. Perin defended his sense of overall optimism about the results, because all of the endpoints on which benefit was demonstrated were prespecified. The positive findings “are not from a post hoc analyses,” he emphasized.
DREAM-HF
In the trial, 537 patients with chronic ischemic or nonischemic heart failure with NYHA class II or III symptoms and a left ventricular ejection fraction of 40% or lower were randomized at 51 sites in the United States and Canada. Patients were required to have elevated N-terminal of the prohormone brain natriuretic peptide levels, at least one prior hospitalization for heart failure, and have been on positive inotropic therapy for more than 1 month (but less than 9 months).
The intracardiac administration of MPCs, which are derived from adult human bone marrow, were delivered by injection guided with the NOGA left ventricular electromechanical mapping system. Multiple transendocardial injections were delivered, all in a single session.
There were no differences in baseline characteristics between those receiving MPCs and those who underwent a sham procedure. In both groups, more than half of patients had a previous MI and a coronary revascularization. Nearly 85% had an implanted defibrillator. Roughly two-thirds were in NYHA class III HF and the remaining were in class II.
Over the follow-up, the lines on a graph documenting nonfatal decompensated heart failure events were largely superimposed for the MPC-treated and sham-treated patients, with no significant differences seen over time.
However, the differences on the secondary events were sizable. For the composite outcome of nonfatal MI and nonfatal stroke over a mean follow-up of about 30 months, the rate of events was less than half as great in those randomized to MPCs (4.6% vs. 13.0%). This translated into about 65% reduction in risk (HR, 0.346; P = .001) overall, and the reduction was about the same in class II or III patients.
For a composite endpoint of MACE, events in the group treated with MPCs were about one-third lower than in the sham procedure group (20.3% vs. 30.1%), a difference that also reached significance (HR, 0.667; P = .021).
For this MACE endpoint, response was evaluated by systemic inflammation. For those with a high-sensitivity C-reactive protein (hsCRP) level of less than 2 mg/L, the risk reduction was small and not significant (HR, 0.843; P = .519). Conversely, there was a large risk reduction in those with hsCRP of at least 2 mg/L that did reach statistical significance (HR, 0.551; P = .012).
Inflammation was also found to be a discriminator for time to cardiac death among the patients with NYHA class II HF. Again, there was no benefit among those with hsCRP below 2 mg/L (HR, 1.355; P = .672), but an 80% risk reduction for those with hsCRP of at least 2 mg/L (HR, 0.204; P = .005).
In class II patients with hsCRP at least 2 mg/L, there was also a 60% reduction in all-cause death (HR, 0.401; P = .027). Neither the reduction in cardiac death nor all-cause death was observed in class III HF patients whether or not they had elevated hsCRP.
These signals of benefit provide a direction for a new set of studies, but Dr. Perin said that safety analyses from the DREAM-HF trial are reassuring for further clinical development.
In addition to the fact that “treatment-emergent adverse events and serious adverse events were similar in the MPC-treated and control patients,” Dr. Perin said that MPC administration was not associated with any clinically meaningful immune responses.
MPCs were first injected into a human 15 years ago, according to Dr. Perin. While a phase 2 trial published several years ago did show an association of MPC administration with a reduction in HF-associated events as well as a reduction in adverse ventricular remodeling, the ischemic benefits observed in this trial, particularly in those with elevated hsCRP, provide a new direction for future trials.
“This turns the page in heart failure research. We now have a new mechanism to consider,” Dr. Perin said.
Not so fast, expert says
This might be a reasonable conclusion, but the AHA-invited discussant, Larry Allen, MD, believes there is essentially no clinical message from this trial. He reiterated multiple times that this trial was neutral with no trend for benefit on the primary outcome.
“There was benefit on the secondary outcomes of nonfatal MI or stroke, but these are not the outcomes we follow in heart failure patients,” he said, noting that benefit from regenerative therapy on ischemic events has not been a major focus of the trials that preceded DREAM-HF.
Despite these intriguing results, “patients should understand that stem cells remain experimental,” he said. For the patient, it is “more important to double down on the importance of guideline directed medical therapy,” which is still being administered at levels that are suboptimal, according to Dr. Allen, medical director of advanced heart failure at the University of Colorado at Denver, Aurora.
“Keep up the investment” in the promise of stem cell therapy, he said, but he cautioned that some of the secondary benefits observed in DREAM-HF, such as the greater response in patients with elevated hsCRP, appear to be new observations that will require a great deal more study to validate.
Dr. Perin has a financial relationship with Mesoblast, which provided funding for the DREAM-HF trial. Dr. Allen reported no relevant conflicts of interest.
A large, multicenter, sham-controlled trial in heart failure showed no benefit at all from stem cell delivery on the primary outcome of recurrent nonfatal decompensated HF events, but the results were still promising, according to the DREAM-HF study’s principal investigator.
When added to guideline-directed medical therapy in patients with HF, a single dose of mesenchymal progenitor cells (MPC) significantly reduced major adverse cardiovascular events (MACE) – a composite of cardiac death, nonfatal MI, and nonfatal stroke – and all-cause death in New York Heart Association (NYHA) class II (but not class III patients), reported Emerson C. Perin, MD, PhD, at the American Heart Association scientific sessions.
The problem is that none of these outcomes were included in the primary endpoint, which was recurrent events because of nonfatal decompensated heart failure. On this endpoint, the hazard ratio for events by the end of follow-up was nonsignificantly but slightly increased among those randomized to MPCs rather than sham control (HR, 1.2; P = .406).
“We learned a lot in this trial,” said Dr. Perin, who is medical director of the Texas Heart Institute in Houston, acknowledging that the expectation of benefit on the primary endpoint now appears to have been misplaced, but the positive result on other outcomes opens a new research direction.
With a negative result on the primary endpoint, a benefit on secondary endpoints is considered hypothesis generating. But Dr. Perin defended his sense of overall optimism about the results, because all of the endpoints on which benefit was demonstrated were prespecified. The positive findings “are not from a post hoc analyses,” he emphasized.
DREAM-HF
In the trial, 537 patients with chronic ischemic or nonischemic heart failure with NYHA class II or III symptoms and a left ventricular ejection fraction of 40% or lower were randomized at 51 sites in the United States and Canada. Patients were required to have elevated N-terminal of the prohormone brain natriuretic peptide levels, at least one prior hospitalization for heart failure, and have been on positive inotropic therapy for more than 1 month (but less than 9 months).
The intracardiac administration of MPCs, which are derived from adult human bone marrow, were delivered by injection guided with the NOGA left ventricular electromechanical mapping system. Multiple transendocardial injections were delivered, all in a single session.
There were no differences in baseline characteristics between those receiving MPCs and those who underwent a sham procedure. In both groups, more than half of patients had a previous MI and a coronary revascularization. Nearly 85% had an implanted defibrillator. Roughly two-thirds were in NYHA class III HF and the remaining were in class II.
Over the follow-up, the lines on a graph documenting nonfatal decompensated heart failure events were largely superimposed for the MPC-treated and sham-treated patients, with no significant differences seen over time.
However, the differences on the secondary events were sizable. For the composite outcome of nonfatal MI and nonfatal stroke over a mean follow-up of about 30 months, the rate of events was less than half as great in those randomized to MPCs (4.6% vs. 13.0%). This translated into about 65% reduction in risk (HR, 0.346; P = .001) overall, and the reduction was about the same in class II or III patients.
For a composite endpoint of MACE, events in the group treated with MPCs were about one-third lower than in the sham procedure group (20.3% vs. 30.1%), a difference that also reached significance (HR, 0.667; P = .021).
For this MACE endpoint, response was evaluated by systemic inflammation. For those with a high-sensitivity C-reactive protein (hsCRP) level of less than 2 mg/L, the risk reduction was small and not significant (HR, 0.843; P = .519). Conversely, there was a large risk reduction in those with hsCRP of at least 2 mg/L that did reach statistical significance (HR, 0.551; P = .012).
Inflammation was also found to be a discriminator for time to cardiac death among the patients with NYHA class II HF. Again, there was no benefit among those with hsCRP below 2 mg/L (HR, 1.355; P = .672), but an 80% risk reduction for those with hsCRP of at least 2 mg/L (HR, 0.204; P = .005).
In class II patients with hsCRP at least 2 mg/L, there was also a 60% reduction in all-cause death (HR, 0.401; P = .027). Neither the reduction in cardiac death nor all-cause death was observed in class III HF patients whether or not they had elevated hsCRP.
These signals of benefit provide a direction for a new set of studies, but Dr. Perin said that safety analyses from the DREAM-HF trial are reassuring for further clinical development.
In addition to the fact that “treatment-emergent adverse events and serious adverse events were similar in the MPC-treated and control patients,” Dr. Perin said that MPC administration was not associated with any clinically meaningful immune responses.
MPCs were first injected into a human 15 years ago, according to Dr. Perin. While a phase 2 trial published several years ago did show an association of MPC administration with a reduction in HF-associated events as well as a reduction in adverse ventricular remodeling, the ischemic benefits observed in this trial, particularly in those with elevated hsCRP, provide a new direction for future trials.
“This turns the page in heart failure research. We now have a new mechanism to consider,” Dr. Perin said.
Not so fast, expert says
This might be a reasonable conclusion, but the AHA-invited discussant, Larry Allen, MD, believes there is essentially no clinical message from this trial. He reiterated multiple times that this trial was neutral with no trend for benefit on the primary outcome.
“There was benefit on the secondary outcomes of nonfatal MI or stroke, but these are not the outcomes we follow in heart failure patients,” he said, noting that benefit from regenerative therapy on ischemic events has not been a major focus of the trials that preceded DREAM-HF.
Despite these intriguing results, “patients should understand that stem cells remain experimental,” he said. For the patient, it is “more important to double down on the importance of guideline directed medical therapy,” which is still being administered at levels that are suboptimal, according to Dr. Allen, medical director of advanced heart failure at the University of Colorado at Denver, Aurora.
“Keep up the investment” in the promise of stem cell therapy, he said, but he cautioned that some of the secondary benefits observed in DREAM-HF, such as the greater response in patients with elevated hsCRP, appear to be new observations that will require a great deal more study to validate.
Dr. Perin has a financial relationship with Mesoblast, which provided funding for the DREAM-HF trial. Dr. Allen reported no relevant conflicts of interest.
A large, multicenter, sham-controlled trial in heart failure showed no benefit at all from stem cell delivery on the primary outcome of recurrent nonfatal decompensated HF events, but the results were still promising, according to the DREAM-HF study’s principal investigator.
When added to guideline-directed medical therapy in patients with HF, a single dose of mesenchymal progenitor cells (MPC) significantly reduced major adverse cardiovascular events (MACE) – a composite of cardiac death, nonfatal MI, and nonfatal stroke – and all-cause death in New York Heart Association (NYHA) class II (but not class III patients), reported Emerson C. Perin, MD, PhD, at the American Heart Association scientific sessions.
The problem is that none of these outcomes were included in the primary endpoint, which was recurrent events because of nonfatal decompensated heart failure. On this endpoint, the hazard ratio for events by the end of follow-up was nonsignificantly but slightly increased among those randomized to MPCs rather than sham control (HR, 1.2; P = .406).
“We learned a lot in this trial,” said Dr. Perin, who is medical director of the Texas Heart Institute in Houston, acknowledging that the expectation of benefit on the primary endpoint now appears to have been misplaced, but the positive result on other outcomes opens a new research direction.
With a negative result on the primary endpoint, a benefit on secondary endpoints is considered hypothesis generating. But Dr. Perin defended his sense of overall optimism about the results, because all of the endpoints on which benefit was demonstrated were prespecified. The positive findings “are not from a post hoc analyses,” he emphasized.
DREAM-HF
In the trial, 537 patients with chronic ischemic or nonischemic heart failure with NYHA class II or III symptoms and a left ventricular ejection fraction of 40% or lower were randomized at 51 sites in the United States and Canada. Patients were required to have elevated N-terminal of the prohormone brain natriuretic peptide levels, at least one prior hospitalization for heart failure, and have been on positive inotropic therapy for more than 1 month (but less than 9 months).
The intracardiac administration of MPCs, which are derived from adult human bone marrow, were delivered by injection guided with the NOGA left ventricular electromechanical mapping system. Multiple transendocardial injections were delivered, all in a single session.
There were no differences in baseline characteristics between those receiving MPCs and those who underwent a sham procedure. In both groups, more than half of patients had a previous MI and a coronary revascularization. Nearly 85% had an implanted defibrillator. Roughly two-thirds were in NYHA class III HF and the remaining were in class II.
Over the follow-up, the lines on a graph documenting nonfatal decompensated heart failure events were largely superimposed for the MPC-treated and sham-treated patients, with no significant differences seen over time.
However, the differences on the secondary events were sizable. For the composite outcome of nonfatal MI and nonfatal stroke over a mean follow-up of about 30 months, the rate of events was less than half as great in those randomized to MPCs (4.6% vs. 13.0%). This translated into about 65% reduction in risk (HR, 0.346; P = .001) overall, and the reduction was about the same in class II or III patients.
For a composite endpoint of MACE, events in the group treated with MPCs were about one-third lower than in the sham procedure group (20.3% vs. 30.1%), a difference that also reached significance (HR, 0.667; P = .021).
For this MACE endpoint, response was evaluated by systemic inflammation. For those with a high-sensitivity C-reactive protein (hsCRP) level of less than 2 mg/L, the risk reduction was small and not significant (HR, 0.843; P = .519). Conversely, there was a large risk reduction in those with hsCRP of at least 2 mg/L that did reach statistical significance (HR, 0.551; P = .012).
Inflammation was also found to be a discriminator for time to cardiac death among the patients with NYHA class II HF. Again, there was no benefit among those with hsCRP below 2 mg/L (HR, 1.355; P = .672), but an 80% risk reduction for those with hsCRP of at least 2 mg/L (HR, 0.204; P = .005).
In class II patients with hsCRP at least 2 mg/L, there was also a 60% reduction in all-cause death (HR, 0.401; P = .027). Neither the reduction in cardiac death nor all-cause death was observed in class III HF patients whether or not they had elevated hsCRP.
These signals of benefit provide a direction for a new set of studies, but Dr. Perin said that safety analyses from the DREAM-HF trial are reassuring for further clinical development.
In addition to the fact that “treatment-emergent adverse events and serious adverse events were similar in the MPC-treated and control patients,” Dr. Perin said that MPC administration was not associated with any clinically meaningful immune responses.
MPCs were first injected into a human 15 years ago, according to Dr. Perin. While a phase 2 trial published several years ago did show an association of MPC administration with a reduction in HF-associated events as well as a reduction in adverse ventricular remodeling, the ischemic benefits observed in this trial, particularly in those with elevated hsCRP, provide a new direction for future trials.
“This turns the page in heart failure research. We now have a new mechanism to consider,” Dr. Perin said.
Not so fast, expert says
This might be a reasonable conclusion, but the AHA-invited discussant, Larry Allen, MD, believes there is essentially no clinical message from this trial. He reiterated multiple times that this trial was neutral with no trend for benefit on the primary outcome.
“There was benefit on the secondary outcomes of nonfatal MI or stroke, but these are not the outcomes we follow in heart failure patients,” he said, noting that benefit from regenerative therapy on ischemic events has not been a major focus of the trials that preceded DREAM-HF.
Despite these intriguing results, “patients should understand that stem cells remain experimental,” he said. For the patient, it is “more important to double down on the importance of guideline directed medical therapy,” which is still being administered at levels that are suboptimal, according to Dr. Allen, medical director of advanced heart failure at the University of Colorado at Denver, Aurora.
“Keep up the investment” in the promise of stem cell therapy, he said, but he cautioned that some of the secondary benefits observed in DREAM-HF, such as the greater response in patients with elevated hsCRP, appear to be new observations that will require a great deal more study to validate.
Dr. Perin has a financial relationship with Mesoblast, which provided funding for the DREAM-HF trial. Dr. Allen reported no relevant conflicts of interest.
FROM AHA 2021
Transcervical fibroid radiofrequency ablation: A look inside
Uterine leiomyomas affect 70% to 80% of reproductive-age women. Interventions for symptomatic patients include myomectomy, hysterectomy, uterine artery embolization (UAE), and radiofrequency ablation (RFA). Several RFA devices exist on the market. One such device is the sonography-guided transcervical ablation of uterine fibroids (Sonata), which is unique in its transcervical approach that allows for incisionless treatment.1 It can be used to treat fibroids classified as FIGO 1-6 with a radius up to 5 cm.1 Postablative therapy outcomes at 1 and 2 years have been promising for total volume reduction (mean maximal volume reduction, 63.8%) and improvement in symptoms, including quality-of-life measures and amount of bleeding (95% reported reduction).2,3
In our practice, we find this tool most helpful for medium-sized (3–5 cm) intramural fibroids and large type 2 fibroids.
In the accompanying video, we illustrate the steps for use of transcervical ultrasonographic RFA with Sonata treatment and demonstrate its impact on the uterus during simultaneous laparoscopy. We present a patient who underwent Sonata treatment for a 4-cm intramural fibroid and simultaneous laparoscopic myomectomy for a 4-cm pedunculated fibroid. This allowed for the unique ability to view the external effect on the uterus during Sonata use. We review the key surgical steps with this approach, including:
- cervical dilation
- introduction of the Sonata system
- sonographic identification of the target fibroid
- adjust size and shape of Smart Guide overlays
- deploy the introducer
- safety rotation check
- deploy the needle electrodes
- initiate RFA
- withdraw needle electrodes and introducer.
RFA with Sonata treatment is a simple, minimally invasive therapeutic option for fibroids.
We hope that you find this video useful to your clinical practice.
>>DR. ARNOLD P. ADVINCULA AND COLLEAGUES
- Toub DB. A new paradigm for uterine fibroid treatment: transcervical, intrauterine sonography-guided radiofrequency ablation of uterine fibroids with the Sonata system. Curr Obstet Gynecol Rep. 2017;6:67-73.
- Hudgens J, Johns DA, Lukes AS, et al. 12-month outcomes of the US patient cohort in the Sonata pivotal IDE trial of transcervical ablation of uterine fibroids. Int J Womens Health. 2019;11:387-394.
- Miller CE, Osman KM. Transcervical radiofrequency ablation of symptomatic uterine fibroids: 2-year results of the Sonata pivotal trial. J Gynecol Surg. 2019;35:345-349.
Uterine leiomyomas affect 70% to 80% of reproductive-age women. Interventions for symptomatic patients include myomectomy, hysterectomy, uterine artery embolization (UAE), and radiofrequency ablation (RFA). Several RFA devices exist on the market. One such device is the sonography-guided transcervical ablation of uterine fibroids (Sonata), which is unique in its transcervical approach that allows for incisionless treatment.1 It can be used to treat fibroids classified as FIGO 1-6 with a radius up to 5 cm.1 Postablative therapy outcomes at 1 and 2 years have been promising for total volume reduction (mean maximal volume reduction, 63.8%) and improvement in symptoms, including quality-of-life measures and amount of bleeding (95% reported reduction).2,3
In our practice, we find this tool most helpful for medium-sized (3–5 cm) intramural fibroids and large type 2 fibroids.
In the accompanying video, we illustrate the steps for use of transcervical ultrasonographic RFA with Sonata treatment and demonstrate its impact on the uterus during simultaneous laparoscopy. We present a patient who underwent Sonata treatment for a 4-cm intramural fibroid and simultaneous laparoscopic myomectomy for a 4-cm pedunculated fibroid. This allowed for the unique ability to view the external effect on the uterus during Sonata use. We review the key surgical steps with this approach, including:
- cervical dilation
- introduction of the Sonata system
- sonographic identification of the target fibroid
- adjust size and shape of Smart Guide overlays
- deploy the introducer
- safety rotation check
- deploy the needle electrodes
- initiate RFA
- withdraw needle electrodes and introducer.
RFA with Sonata treatment is a simple, minimally invasive therapeutic option for fibroids.
We hope that you find this video useful to your clinical practice.
>>DR. ARNOLD P. ADVINCULA AND COLLEAGUES
Uterine leiomyomas affect 70% to 80% of reproductive-age women. Interventions for symptomatic patients include myomectomy, hysterectomy, uterine artery embolization (UAE), and radiofrequency ablation (RFA). Several RFA devices exist on the market. One such device is the sonography-guided transcervical ablation of uterine fibroids (Sonata), which is unique in its transcervical approach that allows for incisionless treatment.1 It can be used to treat fibroids classified as FIGO 1-6 with a radius up to 5 cm.1 Postablative therapy outcomes at 1 and 2 years have been promising for total volume reduction (mean maximal volume reduction, 63.8%) and improvement in symptoms, including quality-of-life measures and amount of bleeding (95% reported reduction).2,3
In our practice, we find this tool most helpful for medium-sized (3–5 cm) intramural fibroids and large type 2 fibroids.
In the accompanying video, we illustrate the steps for use of transcervical ultrasonographic RFA with Sonata treatment and demonstrate its impact on the uterus during simultaneous laparoscopy. We present a patient who underwent Sonata treatment for a 4-cm intramural fibroid and simultaneous laparoscopic myomectomy for a 4-cm pedunculated fibroid. This allowed for the unique ability to view the external effect on the uterus during Sonata use. We review the key surgical steps with this approach, including:
- cervical dilation
- introduction of the Sonata system
- sonographic identification of the target fibroid
- adjust size and shape of Smart Guide overlays
- deploy the introducer
- safety rotation check
- deploy the needle electrodes
- initiate RFA
- withdraw needle electrodes and introducer.
RFA with Sonata treatment is a simple, minimally invasive therapeutic option for fibroids.
We hope that you find this video useful to your clinical practice.
>>DR. ARNOLD P. ADVINCULA AND COLLEAGUES
- Toub DB. A new paradigm for uterine fibroid treatment: transcervical, intrauterine sonography-guided radiofrequency ablation of uterine fibroids with the Sonata system. Curr Obstet Gynecol Rep. 2017;6:67-73.
- Hudgens J, Johns DA, Lukes AS, et al. 12-month outcomes of the US patient cohort in the Sonata pivotal IDE trial of transcervical ablation of uterine fibroids. Int J Womens Health. 2019;11:387-394.
- Miller CE, Osman KM. Transcervical radiofrequency ablation of symptomatic uterine fibroids: 2-year results of the Sonata pivotal trial. J Gynecol Surg. 2019;35:345-349.
- Toub DB. A new paradigm for uterine fibroid treatment: transcervical, intrauterine sonography-guided radiofrequency ablation of uterine fibroids with the Sonata system. Curr Obstet Gynecol Rep. 2017;6:67-73.
- Hudgens J, Johns DA, Lukes AS, et al. 12-month outcomes of the US patient cohort in the Sonata pivotal IDE trial of transcervical ablation of uterine fibroids. Int J Womens Health. 2019;11:387-394.
- Miller CE, Osman KM. Transcervical radiofrequency ablation of symptomatic uterine fibroids: 2-year results of the Sonata pivotal trial. J Gynecol Surg. 2019;35:345-349.
People of color missing in inflammatory bowel disease trials
LAS VEGAS – Clinical trials of treatments for inflammatory bowel disease (IBD) have disproportionately enrolled White people, researchers say.
These skewed demographics could result in researchers overlooking differences in how the disease and its treatments might affect other racial and ethnic groups, said Jellyana Peraza, MD, a chief resident at Albert Einstein College of Medicine, New York.
“The only way we can determine that therapies work differently in different populations is by including those populations in these clinical trials,” she said in an interview. “We think that diversity should be present, and that will answer some questions about the pathogenesis of the disease in general.”
Dr. Peraza presented the findings at the annual meeting of the American College of Gastroenterology.
Previous studies have found that, in trials of other conditions, such as cancer and cardiovascular disease, White people have been disproportionately represented. However, little research has been conducted regarding race and ethnicity in IBD trials.
To fill that gap, Dr. Peraza and colleagues analyzed data from completed trials through the U.S. National Library of Medicine’s registry, ClinicalTrials.gov, for the period from 2000 to 2020.
They found 22 trials conducted exclusively in the United States and 56 conducted in other countries that reported the race or ethnicity of participants; 54 trials did not include this information.
With regard to the prevalence of IBD in White people and Asian people, these populations were overrepresented in U.S. clinical trials. All other groups were underrepresented.
The researchers calculated the odds ratio of being included in an IBD clinical trial for each group. Compared with White people, all the other groups were less likely to be included except for Asian people, who were 85% more likely to be included. These ORs were all statistically significant (P < .03) except for Hispanic people (OR, 0.81; 95% confidence interval, 0.65-1.01; P = .06).
It’s not clear why Asian people are overrepresented, Dr. Peraza said. “Honestly, that was kind of surprising for us. We initially thought that could be related to where these studies were conducted, for example, if some of them were conducted on the West Coast, where maybe more Asian communities are located. However, we didn’t find any specific association between location and Asian representation.”
IBD is more prevalent among White people, although its prevalence is increasing among other groups, Dr. Peraza said. However, that is not reflected in the trials. In an analysis of data in 5-year increments, the researchers found that the participation of White and Hispanic people in IBD trials had not changed much, whereas the participation of Black people had declined, and the participation of Asian and Native American people had increased.
On the basis of work of other researchers, Dr. Peraza said that people of color are as willing to participate in trials as White people. “There is not so much a mistrust as a lack of education and a lack of access to the tertiary centers or the centers where these studies are conducted,” she said.
Clinical trial investigators should recruit more participants from community centers, and health care practitioners should talk about the trials with people in underrepresented groups, she said. “They should have the conversation with their patients about how these clinical trials can benefit the evolution of their diseases.”
One research center that is working hard to diversify its IBD trials is the Ohio State University IBD Center, Columbus, said Anita Afzali, MD, its medical director.
“We have a great team that works actively on the recruitment of all patients,” she said in an interview. “Oftentimes, it just takes a little bit of education and spending time with the patient on discussing what the options are for them.”
Some research indicates that Black people with IBD are more likely to have fistulizing disease, Dr. Afzali said. “However, it doesn’t come so much of their differences in phenotype that we’re seeing but more so the differences in access to care and getting the appropriate therapy in a timely way.”
Dr. Peraza and Dr. Afzali disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
LAS VEGAS – Clinical trials of treatments for inflammatory bowel disease (IBD) have disproportionately enrolled White people, researchers say.
These skewed demographics could result in researchers overlooking differences in how the disease and its treatments might affect other racial and ethnic groups, said Jellyana Peraza, MD, a chief resident at Albert Einstein College of Medicine, New York.
“The only way we can determine that therapies work differently in different populations is by including those populations in these clinical trials,” she said in an interview. “We think that diversity should be present, and that will answer some questions about the pathogenesis of the disease in general.”
Dr. Peraza presented the findings at the annual meeting of the American College of Gastroenterology.
Previous studies have found that, in trials of other conditions, such as cancer and cardiovascular disease, White people have been disproportionately represented. However, little research has been conducted regarding race and ethnicity in IBD trials.
To fill that gap, Dr. Peraza and colleagues analyzed data from completed trials through the U.S. National Library of Medicine’s registry, ClinicalTrials.gov, for the period from 2000 to 2020.
They found 22 trials conducted exclusively in the United States and 56 conducted in other countries that reported the race or ethnicity of participants; 54 trials did not include this information.
With regard to the prevalence of IBD in White people and Asian people, these populations were overrepresented in U.S. clinical trials. All other groups were underrepresented.
The researchers calculated the odds ratio of being included in an IBD clinical trial for each group. Compared with White people, all the other groups were less likely to be included except for Asian people, who were 85% more likely to be included. These ORs were all statistically significant (P < .03) except for Hispanic people (OR, 0.81; 95% confidence interval, 0.65-1.01; P = .06).
It’s not clear why Asian people are overrepresented, Dr. Peraza said. “Honestly, that was kind of surprising for us. We initially thought that could be related to where these studies were conducted, for example, if some of them were conducted on the West Coast, where maybe more Asian communities are located. However, we didn’t find any specific association between location and Asian representation.”
IBD is more prevalent among White people, although its prevalence is increasing among other groups, Dr. Peraza said. However, that is not reflected in the trials. In an analysis of data in 5-year increments, the researchers found that the participation of White and Hispanic people in IBD trials had not changed much, whereas the participation of Black people had declined, and the participation of Asian and Native American people had increased.
On the basis of work of other researchers, Dr. Peraza said that people of color are as willing to participate in trials as White people. “There is not so much a mistrust as a lack of education and a lack of access to the tertiary centers or the centers where these studies are conducted,” she said.
Clinical trial investigators should recruit more participants from community centers, and health care practitioners should talk about the trials with people in underrepresented groups, she said. “They should have the conversation with their patients about how these clinical trials can benefit the evolution of their diseases.”
One research center that is working hard to diversify its IBD trials is the Ohio State University IBD Center, Columbus, said Anita Afzali, MD, its medical director.
“We have a great team that works actively on the recruitment of all patients,” she said in an interview. “Oftentimes, it just takes a little bit of education and spending time with the patient on discussing what the options are for them.”
Some research indicates that Black people with IBD are more likely to have fistulizing disease, Dr. Afzali said. “However, it doesn’t come so much of their differences in phenotype that we’re seeing but more so the differences in access to care and getting the appropriate therapy in a timely way.”
Dr. Peraza and Dr. Afzali disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
LAS VEGAS – Clinical trials of treatments for inflammatory bowel disease (IBD) have disproportionately enrolled White people, researchers say.
These skewed demographics could result in researchers overlooking differences in how the disease and its treatments might affect other racial and ethnic groups, said Jellyana Peraza, MD, a chief resident at Albert Einstein College of Medicine, New York.
“The only way we can determine that therapies work differently in different populations is by including those populations in these clinical trials,” she said in an interview. “We think that diversity should be present, and that will answer some questions about the pathogenesis of the disease in general.”
Dr. Peraza presented the findings at the annual meeting of the American College of Gastroenterology.
Previous studies have found that, in trials of other conditions, such as cancer and cardiovascular disease, White people have been disproportionately represented. However, little research has been conducted regarding race and ethnicity in IBD trials.
To fill that gap, Dr. Peraza and colleagues analyzed data from completed trials through the U.S. National Library of Medicine’s registry, ClinicalTrials.gov, for the period from 2000 to 2020.
They found 22 trials conducted exclusively in the United States and 56 conducted in other countries that reported the race or ethnicity of participants; 54 trials did not include this information.
With regard to the prevalence of IBD in White people and Asian people, these populations were overrepresented in U.S. clinical trials. All other groups were underrepresented.
The researchers calculated the odds ratio of being included in an IBD clinical trial for each group. Compared with White people, all the other groups were less likely to be included except for Asian people, who were 85% more likely to be included. These ORs were all statistically significant (P < .03) except for Hispanic people (OR, 0.81; 95% confidence interval, 0.65-1.01; P = .06).
It’s not clear why Asian people are overrepresented, Dr. Peraza said. “Honestly, that was kind of surprising for us. We initially thought that could be related to where these studies were conducted, for example, if some of them were conducted on the West Coast, where maybe more Asian communities are located. However, we didn’t find any specific association between location and Asian representation.”
IBD is more prevalent among White people, although its prevalence is increasing among other groups, Dr. Peraza said. However, that is not reflected in the trials. In an analysis of data in 5-year increments, the researchers found that the participation of White and Hispanic people in IBD trials had not changed much, whereas the participation of Black people had declined, and the participation of Asian and Native American people had increased.
On the basis of work of other researchers, Dr. Peraza said that people of color are as willing to participate in trials as White people. “There is not so much a mistrust as a lack of education and a lack of access to the tertiary centers or the centers where these studies are conducted,” she said.
Clinical trial investigators should recruit more participants from community centers, and health care practitioners should talk about the trials with people in underrepresented groups, she said. “They should have the conversation with their patients about how these clinical trials can benefit the evolution of their diseases.”
One research center that is working hard to diversify its IBD trials is the Ohio State University IBD Center, Columbus, said Anita Afzali, MD, its medical director.
“We have a great team that works actively on the recruitment of all patients,” she said in an interview. “Oftentimes, it just takes a little bit of education and spending time with the patient on discussing what the options are for them.”
Some research indicates that Black people with IBD are more likely to have fistulizing disease, Dr. Afzali said. “However, it doesn’t come so much of their differences in phenotype that we’re seeing but more so the differences in access to care and getting the appropriate therapy in a timely way.”
Dr. Peraza and Dr. Afzali disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ACG 2021
Adding Insult to Injury
ANSWER
The correct answer is inclusion cyst (choice “c”).
DISCUSSION
Inclusion cysts are also called traumatic inclusion cysts or implantation cysts and are quite distinct from “sebaceous,” epidermal, or epidermoid cysts. An inclusion cyst results from traumatic implantation of surface adnexal structures (eg, sebaceous glands) that continue to function, eventuating in the formation of an organized sac whose wall is composed of stratified squamous epithelium with a granular layer, no significant atypia, and surrounding pasty lamellated acellular keratin.
Hands are the most commonly affected area, although the precipitating puncture wound doesn’t have to be as impressive as this patient’s was. Nails and sewing needles can produce the same result.
The patient’s lesion was removed, at which point its pasty contents (a diagnostic clue) were revealed, and the wound closed. Although the absence of redness or tenderness helped to rule out some items in the differential (eg, felon, abscess), and the lesion demonstrated clear cystic features, the specimen was sent for pathologic examination for confirmation, since cancer would also belong in the differential for such a lesion.
ANSWER
The correct answer is inclusion cyst (choice “c”).
DISCUSSION
Inclusion cysts are also called traumatic inclusion cysts or implantation cysts and are quite distinct from “sebaceous,” epidermal, or epidermoid cysts. An inclusion cyst results from traumatic implantation of surface adnexal structures (eg, sebaceous glands) that continue to function, eventuating in the formation of an organized sac whose wall is composed of stratified squamous epithelium with a granular layer, no significant atypia, and surrounding pasty lamellated acellular keratin.
Hands are the most commonly affected area, although the precipitating puncture wound doesn’t have to be as impressive as this patient’s was. Nails and sewing needles can produce the same result.
The patient’s lesion was removed, at which point its pasty contents (a diagnostic clue) were revealed, and the wound closed. Although the absence of redness or tenderness helped to rule out some items in the differential (eg, felon, abscess), and the lesion demonstrated clear cystic features, the specimen was sent for pathologic examination for confirmation, since cancer would also belong in the differential for such a lesion.
ANSWER
The correct answer is inclusion cyst (choice “c”).
DISCUSSION
Inclusion cysts are also called traumatic inclusion cysts or implantation cysts and are quite distinct from “sebaceous,” epidermal, or epidermoid cysts. An inclusion cyst results from traumatic implantation of surface adnexal structures (eg, sebaceous glands) that continue to function, eventuating in the formation of an organized sac whose wall is composed of stratified squamous epithelium with a granular layer, no significant atypia, and surrounding pasty lamellated acellular keratin.
Hands are the most commonly affected area, although the precipitating puncture wound doesn’t have to be as impressive as this patient’s was. Nails and sewing needles can produce the same result.
The patient’s lesion was removed, at which point its pasty contents (a diagnostic clue) were revealed, and the wound closed. Although the absence of redness or tenderness helped to rule out some items in the differential (eg, felon, abscess), and the lesion demonstrated clear cystic features, the specimen was sent for pathologic examination for confirmation, since cancer would also belong in the differential for such a lesion.
A 38-year-old man sustained an on-the-job injury to his finger, which was punctured by a tiny drill bit. He was promptly seen by a clinician, who administered a tetanus injection and prescribed a 2-week course of an antibiotic. However, within a few weeks, the patient noticed a lesion on the affected finger. It caused little to no pain but grew steadily, until it interfered with his functioning and prompted a return to the clinic.
The patient was in good health, despite being a long-term smoker. X-rays of the finger showed no bony changes or evidence of a foreign body. A referral to dermatology was provided.
Examination revealed a firm, painless, 2-cm subcutaneous mass in the pad of his left index finger. The surface felt quite tense, but there was no disruption nor any redness. Palpation of relevant nodal locations failed to reveal any palpable masses.
In the military, Latino and Black MSM receive more PrEP prescriptions than White counterparts
Among active-duty men who have sex with men (MSM), , according to new survey results.
“In the civilian population, we see a lot of challenges and barriers to [accessing PrEP] in our high-risk populations – populations in the MSM sphere that are people of color,” study author Colten Staten, RN, a first lieutenant in the army at Walter Reed National Military Medical Center in Bethesda, Md., told this news organization. Because all active-duty service members have free medical care and prescriptions through the Military Health System, the findings demonstrate “what happens when access becomes less of an issue in regard to receiving PrEP prescriptions,” he noted.
The survey, which was presented at the Association of Nurses in AIDS Care 2021 conference, was available for 5 days in 2020. All participants were at least 18 years old, identified as MSM, and were active-duty members of the United States military.
Of the 354 men included in the study, 37.6% were White, 25.4% were Black, 20.3% were identified as Latino, 6.5% were Asian/Pacific Islanders, and 5.6% were Native Americans. In addition, 69.5% identified as gay, 23.4% identified as bisexual, and 7% said they were straight. And 17.2% had a partner who disclosed he was HIV positive, but 19.2% did not know the status of their partner.
Black participants were three times more likely to have been prescribed PrEP than White service members (P < .001). Similarly, Latino respondents were 3.6 times more likely to be prescribed PrEP than their White counterparts (P = .003). Participants whose partner disclosed an HIV-positive status were 7.1 times more likely to receive a PrEP prescription than someone who did not know the status of their partner (P = .013), and bisexual respondents were 2.1 times less likely to have received a PrEP prescription than respondents who identified as gay (P = .04).
While the study demonstrates that at-risk populations are receiving PrEP in the military, research suggests that PrEP is still underprescribed in this population, Mr. Staten said. A 2018 study published in Morbidity and Mortality Weekly Report found that 20.9% of U.S. service members reported a high risk of HIV infection, and an estimated 12,000 individuals in the military qualify for a PrEP prescription. Yet, from Feb. 1, 2014, to June 10, 2016, only 759 service members were prescribed Truvada. The 2018 report found that approximately 350 active-duty service members are diagnosed with HIV every year, with a disproportionate number of new infections occurring in Black individuals.
While the study suggests prescriptions are reaching target populations, “the most concerning finding is that it is not happening in the robust nature that we need,” said Justin Alves, RN, ACRN, CARN, a nurse at Boston Medical Center in Massachusetts who was not involved with the study, in an interview. “This is the start of a lot of research that needs to happen, because not only does the study shed light on people who are serving in the military, but it also sheds light on unique vulnerable populations that we have a hard time capturing and helping in general healthcare settings,” Mr. Alves said.
Mr. Staten agreed that more research is needed to identify additional barriers to care in the military. Additionally, including more information on sexual history in the yearly physical all active-duty service members complete could also help identify more individuals who would benefit from a PrEP prescription.
“There is no screening for sexual health, as far as the MSM experience,” Mr. Staten said. And he suggested that more questions around sexuality should be included in the screening process. That could help spur more open conversations between patients and providers to bridge gaps in access and care.
Mr. Staten is an active-duty service member. Mr. Alves has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Among active-duty men who have sex with men (MSM), , according to new survey results.
“In the civilian population, we see a lot of challenges and barriers to [accessing PrEP] in our high-risk populations – populations in the MSM sphere that are people of color,” study author Colten Staten, RN, a first lieutenant in the army at Walter Reed National Military Medical Center in Bethesda, Md., told this news organization. Because all active-duty service members have free medical care and prescriptions through the Military Health System, the findings demonstrate “what happens when access becomes less of an issue in regard to receiving PrEP prescriptions,” he noted.
The survey, which was presented at the Association of Nurses in AIDS Care 2021 conference, was available for 5 days in 2020. All participants were at least 18 years old, identified as MSM, and were active-duty members of the United States military.
Of the 354 men included in the study, 37.6% were White, 25.4% were Black, 20.3% were identified as Latino, 6.5% were Asian/Pacific Islanders, and 5.6% were Native Americans. In addition, 69.5% identified as gay, 23.4% identified as bisexual, and 7% said they were straight. And 17.2% had a partner who disclosed he was HIV positive, but 19.2% did not know the status of their partner.
Black participants were three times more likely to have been prescribed PrEP than White service members (P < .001). Similarly, Latino respondents were 3.6 times more likely to be prescribed PrEP than their White counterparts (P = .003). Participants whose partner disclosed an HIV-positive status were 7.1 times more likely to receive a PrEP prescription than someone who did not know the status of their partner (P = .013), and bisexual respondents were 2.1 times less likely to have received a PrEP prescription than respondents who identified as gay (P = .04).
While the study demonstrates that at-risk populations are receiving PrEP in the military, research suggests that PrEP is still underprescribed in this population, Mr. Staten said. A 2018 study published in Morbidity and Mortality Weekly Report found that 20.9% of U.S. service members reported a high risk of HIV infection, and an estimated 12,000 individuals in the military qualify for a PrEP prescription. Yet, from Feb. 1, 2014, to June 10, 2016, only 759 service members were prescribed Truvada. The 2018 report found that approximately 350 active-duty service members are diagnosed with HIV every year, with a disproportionate number of new infections occurring in Black individuals.
While the study suggests prescriptions are reaching target populations, “the most concerning finding is that it is not happening in the robust nature that we need,” said Justin Alves, RN, ACRN, CARN, a nurse at Boston Medical Center in Massachusetts who was not involved with the study, in an interview. “This is the start of a lot of research that needs to happen, because not only does the study shed light on people who are serving in the military, but it also sheds light on unique vulnerable populations that we have a hard time capturing and helping in general healthcare settings,” Mr. Alves said.
Mr. Staten agreed that more research is needed to identify additional barriers to care in the military. Additionally, including more information on sexual history in the yearly physical all active-duty service members complete could also help identify more individuals who would benefit from a PrEP prescription.
“There is no screening for sexual health, as far as the MSM experience,” Mr. Staten said. And he suggested that more questions around sexuality should be included in the screening process. That could help spur more open conversations between patients and providers to bridge gaps in access and care.
Mr. Staten is an active-duty service member. Mr. Alves has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Among active-duty men who have sex with men (MSM), , according to new survey results.
“In the civilian population, we see a lot of challenges and barriers to [accessing PrEP] in our high-risk populations – populations in the MSM sphere that are people of color,” study author Colten Staten, RN, a first lieutenant in the army at Walter Reed National Military Medical Center in Bethesda, Md., told this news organization. Because all active-duty service members have free medical care and prescriptions through the Military Health System, the findings demonstrate “what happens when access becomes less of an issue in regard to receiving PrEP prescriptions,” he noted.
The survey, which was presented at the Association of Nurses in AIDS Care 2021 conference, was available for 5 days in 2020. All participants were at least 18 years old, identified as MSM, and were active-duty members of the United States military.
Of the 354 men included in the study, 37.6% were White, 25.4% were Black, 20.3% were identified as Latino, 6.5% were Asian/Pacific Islanders, and 5.6% were Native Americans. In addition, 69.5% identified as gay, 23.4% identified as bisexual, and 7% said they were straight. And 17.2% had a partner who disclosed he was HIV positive, but 19.2% did not know the status of their partner.
Black participants were three times more likely to have been prescribed PrEP than White service members (P < .001). Similarly, Latino respondents were 3.6 times more likely to be prescribed PrEP than their White counterparts (P = .003). Participants whose partner disclosed an HIV-positive status were 7.1 times more likely to receive a PrEP prescription than someone who did not know the status of their partner (P = .013), and bisexual respondents were 2.1 times less likely to have received a PrEP prescription than respondents who identified as gay (P = .04).
While the study demonstrates that at-risk populations are receiving PrEP in the military, research suggests that PrEP is still underprescribed in this population, Mr. Staten said. A 2018 study published in Morbidity and Mortality Weekly Report found that 20.9% of U.S. service members reported a high risk of HIV infection, and an estimated 12,000 individuals in the military qualify for a PrEP prescription. Yet, from Feb. 1, 2014, to June 10, 2016, only 759 service members were prescribed Truvada. The 2018 report found that approximately 350 active-duty service members are diagnosed with HIV every year, with a disproportionate number of new infections occurring in Black individuals.
While the study suggests prescriptions are reaching target populations, “the most concerning finding is that it is not happening in the robust nature that we need,” said Justin Alves, RN, ACRN, CARN, a nurse at Boston Medical Center in Massachusetts who was not involved with the study, in an interview. “This is the start of a lot of research that needs to happen, because not only does the study shed light on people who are serving in the military, but it also sheds light on unique vulnerable populations that we have a hard time capturing and helping in general healthcare settings,” Mr. Alves said.
Mr. Staten agreed that more research is needed to identify additional barriers to care in the military. Additionally, including more information on sexual history in the yearly physical all active-duty service members complete could also help identify more individuals who would benefit from a PrEP prescription.
“There is no screening for sexual health, as far as the MSM experience,” Mr. Staten said. And he suggested that more questions around sexuality should be included in the screening process. That could help spur more open conversations between patients and providers to bridge gaps in access and care.
Mr. Staten is an active-duty service member. Mr. Alves has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
To boost HIV screening, ED nurses need institutional support
, according to a national survey of ED nurses. Nearly 43% of respondents said they had received “little” or “very little” HIV education as part of their professional development and practice.
This lack of continuing HIV education “often translated into attitudes that did not support the policy” of routine HIV screening in EDs, lead author Candace Elam, DNP, a family nurse practitioner at the Institute of Family Health in the Bronx, New York City, told this news organization. “But more than individual attitudes, what came out most clearly in the research was that organizational support for HIV screening in EDs was the one factor that could make or break whether an emergency nurse performs HIV screening,” she said. This includes working routine HIV screening into ED workflows and providing resources to streamline screening and testing efforts.
In 2006, the Centers for Disease Control and Prevention released guidance recommending routine HIV screening in all healthcare settings, including urgent care and EDs. Elam, who conducted the research as a student at Rutgers University School of Nursing in New Brunswick, N.J., noticed during her time as an ED nurse that, while her department had a policy supporting routine HIV screening, the practice was not consistent across all nursing staff. To find out how HIV screening varied nationally, Elam ran a national survey from Oct. through Dec. 2020, recruiting participants both by email outreach and Facebook.
In the 30- to 45-minute survey, respondents reported:
- Demographic information
- Knowledge of the CDC HIV screening recommendations
- Workplace HIV screening policy
- Self-reported performance of HIV screening
- Beliefs and attitudes pertaining to HIV screening
Overall, 371 individuals from 43 states filled out at least some part of the survey, and 171 individuals completed it. Of the 251 individuals who answered whether their EDs routinely conducted HIV screening, 76.9% responded affirmatively. Overall, 28.5% of respondents thought HIV screening was “not important” or “not at all important.” Nearly half – 47.6% – reported never offering HIV testing to all eligible patients regardless of risk factors, and only 14.3% reported offering testing all of the time. Only 25% of participants said they received “adequate” or “a lot” of HIV-related nursing education, and 42.9% reported “little” or “very little” education.
“For the most part, those of us working in hospitals, all the education that we get about HIV took place in school,” Elam said. “So, if you went to school in the early 2000s or in the 1990s, you don’t know much else.” Elam noted that she keeps informed on HIV research issues because it is an area of interest, but the hospital she had worked at did not contribute much to her knowledge.
Elam also found that in practice there were several barriers to performing screening, such as lack of availability of a dedicated HIV educator, tester, or counselors; not knowing where to refer patients who had a positive HIV test result; and insufficient time to address positive HIV test results in ED practice.
“A lot of these things are outside an individual nurse’s control,” said Elam, and can result in missing patients who would benefit from care. Lisa Leimer, RN, a nurse at Primary Health Care in Des Moines, works with patients after they have been diagnosed with HIV, but noted that many of her patients could have been identified earlier. “Once we get someone, you look back at medical records and you see that they have been in and out of the hospital,” she said. “There’s been multiple encounters,” she said.
Prioritizing HIV screening in all healthcare settings and including HIV education for all medical professionals – not just nurses – could help in the continuing battle against HIV. “So much has changed in the world of HIV,” she said. “We’re trying to end the epidemic, and it could happen if we identified, diagnosed, and treated the people that are living with it.”
Elam and Leimer have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to a national survey of ED nurses. Nearly 43% of respondents said they had received “little” or “very little” HIV education as part of their professional development and practice.
This lack of continuing HIV education “often translated into attitudes that did not support the policy” of routine HIV screening in EDs, lead author Candace Elam, DNP, a family nurse practitioner at the Institute of Family Health in the Bronx, New York City, told this news organization. “But more than individual attitudes, what came out most clearly in the research was that organizational support for HIV screening in EDs was the one factor that could make or break whether an emergency nurse performs HIV screening,” she said. This includes working routine HIV screening into ED workflows and providing resources to streamline screening and testing efforts.
In 2006, the Centers for Disease Control and Prevention released guidance recommending routine HIV screening in all healthcare settings, including urgent care and EDs. Elam, who conducted the research as a student at Rutgers University School of Nursing in New Brunswick, N.J., noticed during her time as an ED nurse that, while her department had a policy supporting routine HIV screening, the practice was not consistent across all nursing staff. To find out how HIV screening varied nationally, Elam ran a national survey from Oct. through Dec. 2020, recruiting participants both by email outreach and Facebook.
In the 30- to 45-minute survey, respondents reported:
- Demographic information
- Knowledge of the CDC HIV screening recommendations
- Workplace HIV screening policy
- Self-reported performance of HIV screening
- Beliefs and attitudes pertaining to HIV screening
Overall, 371 individuals from 43 states filled out at least some part of the survey, and 171 individuals completed it. Of the 251 individuals who answered whether their EDs routinely conducted HIV screening, 76.9% responded affirmatively. Overall, 28.5% of respondents thought HIV screening was “not important” or “not at all important.” Nearly half – 47.6% – reported never offering HIV testing to all eligible patients regardless of risk factors, and only 14.3% reported offering testing all of the time. Only 25% of participants said they received “adequate” or “a lot” of HIV-related nursing education, and 42.9% reported “little” or “very little” education.
“For the most part, those of us working in hospitals, all the education that we get about HIV took place in school,” Elam said. “So, if you went to school in the early 2000s or in the 1990s, you don’t know much else.” Elam noted that she keeps informed on HIV research issues because it is an area of interest, but the hospital she had worked at did not contribute much to her knowledge.
Elam also found that in practice there were several barriers to performing screening, such as lack of availability of a dedicated HIV educator, tester, or counselors; not knowing where to refer patients who had a positive HIV test result; and insufficient time to address positive HIV test results in ED practice.
“A lot of these things are outside an individual nurse’s control,” said Elam, and can result in missing patients who would benefit from care. Lisa Leimer, RN, a nurse at Primary Health Care in Des Moines, works with patients after they have been diagnosed with HIV, but noted that many of her patients could have been identified earlier. “Once we get someone, you look back at medical records and you see that they have been in and out of the hospital,” she said. “There’s been multiple encounters,” she said.
Prioritizing HIV screening in all healthcare settings and including HIV education for all medical professionals – not just nurses – could help in the continuing battle against HIV. “So much has changed in the world of HIV,” she said. “We’re trying to end the epidemic, and it could happen if we identified, diagnosed, and treated the people that are living with it.”
Elam and Leimer have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to a national survey of ED nurses. Nearly 43% of respondents said they had received “little” or “very little” HIV education as part of their professional development and practice.
This lack of continuing HIV education “often translated into attitudes that did not support the policy” of routine HIV screening in EDs, lead author Candace Elam, DNP, a family nurse practitioner at the Institute of Family Health in the Bronx, New York City, told this news organization. “But more than individual attitudes, what came out most clearly in the research was that organizational support for HIV screening in EDs was the one factor that could make or break whether an emergency nurse performs HIV screening,” she said. This includes working routine HIV screening into ED workflows and providing resources to streamline screening and testing efforts.
In 2006, the Centers for Disease Control and Prevention released guidance recommending routine HIV screening in all healthcare settings, including urgent care and EDs. Elam, who conducted the research as a student at Rutgers University School of Nursing in New Brunswick, N.J., noticed during her time as an ED nurse that, while her department had a policy supporting routine HIV screening, the practice was not consistent across all nursing staff. To find out how HIV screening varied nationally, Elam ran a national survey from Oct. through Dec. 2020, recruiting participants both by email outreach and Facebook.
In the 30- to 45-minute survey, respondents reported:
- Demographic information
- Knowledge of the CDC HIV screening recommendations
- Workplace HIV screening policy
- Self-reported performance of HIV screening
- Beliefs and attitudes pertaining to HIV screening
Overall, 371 individuals from 43 states filled out at least some part of the survey, and 171 individuals completed it. Of the 251 individuals who answered whether their EDs routinely conducted HIV screening, 76.9% responded affirmatively. Overall, 28.5% of respondents thought HIV screening was “not important” or “not at all important.” Nearly half – 47.6% – reported never offering HIV testing to all eligible patients regardless of risk factors, and only 14.3% reported offering testing all of the time. Only 25% of participants said they received “adequate” or “a lot” of HIV-related nursing education, and 42.9% reported “little” or “very little” education.
“For the most part, those of us working in hospitals, all the education that we get about HIV took place in school,” Elam said. “So, if you went to school in the early 2000s or in the 1990s, you don’t know much else.” Elam noted that she keeps informed on HIV research issues because it is an area of interest, but the hospital she had worked at did not contribute much to her knowledge.
Elam also found that in practice there were several barriers to performing screening, such as lack of availability of a dedicated HIV educator, tester, or counselors; not knowing where to refer patients who had a positive HIV test result; and insufficient time to address positive HIV test results in ED practice.
“A lot of these things are outside an individual nurse’s control,” said Elam, and can result in missing patients who would benefit from care. Lisa Leimer, RN, a nurse at Primary Health Care in Des Moines, works with patients after they have been diagnosed with HIV, but noted that many of her patients could have been identified earlier. “Once we get someone, you look back at medical records and you see that they have been in and out of the hospital,” she said. “There’s been multiple encounters,” she said.
Prioritizing HIV screening in all healthcare settings and including HIV education for all medical professionals – not just nurses – could help in the continuing battle against HIV. “So much has changed in the world of HIV,” she said. “We’re trying to end the epidemic, and it could happen if we identified, diagnosed, and treated the people that are living with it.”
Elam and Leimer have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.