Hemostasis-monitoring device

Photo courtesy of the Wyss

Institute at Harvard University

Scientists have developed a blood coagulation assay that, they say, is more reliable than existing assays and could one day be used to diagnose rare bleeding disorders and prevent toxic effects of anticoagulant and antiplatelet drugs.

The team created a microfluidic device with hollow channels through which blood is flowed and devised an algorithm for analyzing patient-specific data to predict when blood clots will form.

Together, these components make up the assay, which can monitor blood coagulation and platelet function.

Donald Ingber, MD, PhD, of the Wyss Institute for Biologically Inspired Engineering at Harvard University in Boston, Massachusetts, and his colleagues described the assay in Nature Communications.

The team developed a microfluidic device in which blood flows through a life-like network of small “vessels.” The blood is subjected to true-to-life shear stresses and force gradients of the human vascular network.

The device contains hollow channels that mimic the pathology of the narrowing of small blood vessels, which can often cause a shift in the fluid mechanics of blood flow that can lead to life-threatening blood clots or internal bleeds.

The device mimics rapid changes in blood flow dynamics associated with stenosis or narrowing of small blood vessels by pumping pressurized blood flow through the device’s microfluidic channels.

Using automated pressure sensors and a proprietary algorithm, data acquired from the device is analyzed in real-time, thereby predicting the time at which a certain blood sample will obstruct the blood vessel network.

“By combining our fabricated microfluidic device that mimics blood flow dynamics of small arterioles with our novel data analysis software, we can rapidly quantitate hemostasis in real-time and predict if blood clots will develop in an individual or blood sample,” Dr Ingber explained.

He and his colleagues found they could accurately monitor the effects of anticoagulant and antiplatelet drugs in blood samples from human subjects.

The team was able to monitor platelet function as well. In particular, they found they could detect abnormal platelet function in samples from patients with Hermansky–Pudlak syndrome, a rare bleeding disorder characterized by a deficiency of platelet-dense granules that cannot be easily identified using conventional assays.

The novel assay also proved successful in large animal experiments. The scientists integrated their device directly into a vascular access line that was inserted into the femoral vein of a living pig to measure clinical clotting parameters over time. They recorded precise predictions for clotting times that were more accurate and faster than currently used clinical assays.

The team noted that their device uses inexpensive in-line pressure sensors to measure clot formation. As a result, it does not require additional instrumentation, and it can be integrated directly into the blood lines of extracorporeal devices.

The scientists said the device’s ability to be configured for lab use or real-time patient monitoring opens the door for countless potential uses that could improve patient care.

Hemostasis-monitoring device

Photo courtesy of the Wyss

Institute at Harvard University

Scientists have developed a blood coagulation assay that, they say, is more reliable than existing assays and could one day be used to diagnose rare bleeding disorders and prevent toxic effects of anticoagulant and antiplatelet drugs.

The team created a microfluidic device with hollow channels through which blood is flowed and devised an algorithm for analyzing patient-specific data to predict when blood clots will form.

Together, these components make up the assay, which can monitor blood coagulation and platelet function.

Donald Ingber, MD, PhD, of the Wyss Institute for Biologically Inspired Engineering at Harvard University in Boston, Massachusetts, and his colleagues described the assay in Nature Communications.

The team developed a microfluidic device in which blood flows through a life-like network of small “vessels.” The blood is subjected to true-to-life shear stresses and force gradients of the human vascular network.

The device contains hollow channels that mimic the pathology of the narrowing of small blood vessels, which can often cause a shift in the fluid mechanics of blood flow that can lead to life-threatening blood clots or internal bleeds.

The device mimics rapid changes in blood flow dynamics associated with stenosis or narrowing of small blood vessels by pumping pressurized blood flow through the device’s microfluidic channels.

Using automated pressure sensors and a proprietary algorithm, data acquired from the device is analyzed in real-time, thereby predicting the time at which a certain blood sample will obstruct the blood vessel network.

“By combining our fabricated microfluidic device that mimics blood flow dynamics of small arterioles with our novel data analysis software, we can rapidly quantitate hemostasis in real-time and predict if blood clots will develop in an individual or blood sample,” Dr Ingber explained.

He and his colleagues found they could accurately monitor the effects of anticoagulant and antiplatelet drugs in blood samples from human subjects.

The team was able to monitor platelet function as well. In particular, they found they could detect abnormal platelet function in samples from patients with Hermansky–Pudlak syndrome, a rare bleeding disorder characterized by a deficiency of platelet-dense granules that cannot be easily identified using conventional assays.

The novel assay also proved successful in large animal experiments. The scientists integrated their device directly into a vascular access line that was inserted into the femoral vein of a living pig to measure clinical clotting parameters over time. They recorded precise predictions for clotting times that were more accurate and faster than currently used clinical assays.

The team noted that their device uses inexpensive in-line pressure sensors to measure clot formation. As a result, it does not require additional instrumentation, and it can be integrated directly into the blood lines of extracorporeal devices.

The scientists said the device’s ability to be configured for lab use or real-time patient monitoring opens the door for countless potential uses that could improve patient care.

Hemostasis-monitoring device

Photo courtesy of the Wyss

Institute at Harvard University

Scientists have developed a blood coagulation assay that, they say, is more reliable than existing assays and could one day be used to diagnose rare bleeding disorders and prevent toxic effects of anticoagulant and antiplatelet drugs.

The team created a microfluidic device with hollow channels through which blood is flowed and devised an algorithm for analyzing patient-specific data to predict when blood clots will form.

Together, these components make up the assay, which can monitor blood coagulation and platelet function.

Donald Ingber, MD, PhD, of the Wyss Institute for Biologically Inspired Engineering at Harvard University in Boston, Massachusetts, and his colleagues described the assay in Nature Communications.

The team developed a microfluidic device in which blood flows through a life-like network of small “vessels.” The blood is subjected to true-to-life shear stresses and force gradients of the human vascular network.

The device contains hollow channels that mimic the pathology of the narrowing of small blood vessels, which can often cause a shift in the fluid mechanics of blood flow that can lead to life-threatening blood clots or internal bleeds.

The device mimics rapid changes in blood flow dynamics associated with stenosis or narrowing of small blood vessels by pumping pressurized blood flow through the device’s microfluidic channels.

Using automated pressure sensors and a proprietary algorithm, data acquired from the device is analyzed in real-time, thereby predicting the time at which a certain blood sample will obstruct the blood vessel network.

“By combining our fabricated microfluidic device that mimics blood flow dynamics of small arterioles with our novel data analysis software, we can rapidly quantitate hemostasis in real-time and predict if blood clots will develop in an individual or blood sample,” Dr Ingber explained.

He and his colleagues found they could accurately monitor the effects of anticoagulant and antiplatelet drugs in blood samples from human subjects.

The team was able to monitor platelet function as well. In particular, they found they could detect abnormal platelet function in samples from patients with Hermansky–Pudlak syndrome, a rare bleeding disorder characterized by a deficiency of platelet-dense granules that cannot be easily identified using conventional assays.

The novel assay also proved successful in large animal experiments. The scientists integrated their device directly into a vascular access line that was inserted into the femoral vein of a living pig to measure clinical clotting parameters over time. They recorded precise predictions for clotting times that were more accurate and faster than currently used clinical assays.

The team noted that their device uses inexpensive in-line pressure sensors to measure clot formation. As a result, it does not require additional instrumentation, and it can be integrated directly into the blood lines of extracorporeal devices.

The scientists said the device’s ability to be configured for lab use or real-time patient monitoring opens the door for countless potential uses that could improve patient care.

Bottles of warfarin

Photo courtesy of NIGMS

The American College of Chest Physicians has released a new edition of guidelines for the treatment of patients with venous thromboembolism (VTE).

This 10th edition of the guidelines, published in CHEST, includes 54 recommendations. However, only 20 of these recommendations were deemed “strong,” and none were based on high-quality evidence.

“The guideline presents stronger recommendations and weaker suggestions for treatment based on the best available evidence and identifies gaps in our knowledge and areas for future research,” said lead author Clive Kearon, MD, PhD, of McMaster University in Hamilton, Ontario, Canada.

One of the key recommendations in the guidelines is a preference for novel oral anticoagulants (NOACs) over vitamin K antagonist (VKA) therapy for initial and long-term treatment of VTE in patients without cancer.

The guideline authors say that, since the publication of the 9th edition, studies have shown that NOACs are as effective as VKA therapy, and NOACs confer a reduced risk of bleeding and increased convenience for patients and healthcare providers.

As long-term anticoagulant therapy for patients without cancer, the guideline authors suggest dabigatran, rivaroxaban, apixaban, or edoxaban over VKA therapy. But they suggest VKA therapy over low-molecular-weight heparin.

For patients with VTE and cancer, the guideline authors suggest low-molecular-weight heparin over VKA, dabigatran, rivaroxaban, apixaban, or edoxaban.

The guidelines advise against an inferior vena cava filter for patients with VTE who are receiving anticoagulant treatment.

Another change to guideline recommendations from the 9th edition to the 10th edition concerns the routine use of compression stockings. Based on recent evidence, the 10th edition advises against routinely using compression stockings to prevent post-thrombotic syndrome in patients with acute deep vein thrombosis (DVT).

The 10th edition also suggests which patients diagnosed with isolated subsegmental pulmonary embolism (PE) should, and should not, receive anticoagulant therapy.

For subsegmental PE and no proximal DVT, the guidelines suggest clinical surveillance over anticoagulation if patients have a low risk of recurrent VTE and anticoagulation over clinical surveillance if patients have a high risk of recurrence.

The guidelines suggest thrombolytic therapy for patients with PE and hypotension and systemic therapy over catheter-directed thrombolysis.

To date, the updated guidelines have been endorsed by the American Association for Clinical Chemistry, American College of Clinical Pharmacy, International Society for Thrombosis and Haemostasis, and American Society of Health-System Pharmacists.

Bottles of warfarin

Photo courtesy of NIGMS

The American College of Chest Physicians has released a new edition of guidelines for the treatment of patients with venous thromboembolism (VTE).

This 10th edition of the guidelines, published in CHEST, includes 54 recommendations. However, only 20 of these recommendations were deemed “strong,” and none were based on high-quality evidence.

“The guideline presents stronger recommendations and weaker suggestions for treatment based on the best available evidence and identifies gaps in our knowledge and areas for future research,” said lead author Clive Kearon, MD, PhD, of McMaster University in Hamilton, Ontario, Canada.

One of the key recommendations in the guidelines is a preference for novel oral anticoagulants (NOACs) over vitamin K antagonist (VKA) therapy for initial and long-term treatment of VTE in patients without cancer.

The guideline authors say that, since the publication of the 9th edition, studies have shown that NOACs are as effective as VKA therapy, and NOACs confer a reduced risk of bleeding and increased convenience for patients and healthcare providers.

As long-term anticoagulant therapy for patients without cancer, the guideline authors suggest dabigatran, rivaroxaban, apixaban, or edoxaban over VKA therapy. But they suggest VKA therapy over low-molecular-weight heparin.

For patients with VTE and cancer, the guideline authors suggest low-molecular-weight heparin over VKA, dabigatran, rivaroxaban, apixaban, or edoxaban.

The guidelines advise against an inferior vena cava filter for patients with VTE who are receiving anticoagulant treatment.

Another change to guideline recommendations from the 9th edition to the 10th edition concerns the routine use of compression stockings. Based on recent evidence, the 10th edition advises against routinely using compression stockings to prevent post-thrombotic syndrome in patients with acute deep vein thrombosis (DVT).

The 10th edition also suggests which patients diagnosed with isolated subsegmental pulmonary embolism (PE) should, and should not, receive anticoagulant therapy.

For subsegmental PE and no proximal DVT, the guidelines suggest clinical surveillance over anticoagulation if patients have a low risk of recurrent VTE and anticoagulation over clinical surveillance if patients have a high risk of recurrence.

The guidelines suggest thrombolytic therapy for patients with PE and hypotension and systemic therapy over catheter-directed thrombolysis.

To date, the updated guidelines have been endorsed by the American Association for Clinical Chemistry, American College of Clinical Pharmacy, International Society for Thrombosis and Haemostasis, and American Society of Health-System Pharmacists.

Bottles of warfarin

Photo courtesy of NIGMS

The American College of Chest Physicians has released a new edition of guidelines for the treatment of patients with venous thromboembolism (VTE).

This 10th edition of the guidelines, published in CHEST, includes 54 recommendations. However, only 20 of these recommendations were deemed “strong,” and none were based on high-quality evidence.

“The guideline presents stronger recommendations and weaker suggestions for treatment based on the best available evidence and identifies gaps in our knowledge and areas for future research,” said lead author Clive Kearon, MD, PhD, of McMaster University in Hamilton, Ontario, Canada.

One of the key recommendations in the guidelines is a preference for novel oral anticoagulants (NOACs) over vitamin K antagonist (VKA) therapy for initial and long-term treatment of VTE in patients without cancer.

The guideline authors say that, since the publication of the 9th edition, studies have shown that NOACs are as effective as VKA therapy, and NOACs confer a reduced risk of bleeding and increased convenience for patients and healthcare providers.

As long-term anticoagulant therapy for patients without cancer, the guideline authors suggest dabigatran, rivaroxaban, apixaban, or edoxaban over VKA therapy. But they suggest VKA therapy over low-molecular-weight heparin.

For patients with VTE and cancer, the guideline authors suggest low-molecular-weight heparin over VKA, dabigatran, rivaroxaban, apixaban, or edoxaban.

The guidelines advise against an inferior vena cava filter for patients with VTE who are receiving anticoagulant treatment.

Another change to guideline recommendations from the 9th edition to the 10th edition concerns the routine use of compression stockings. Based on recent evidence, the 10th edition advises against routinely using compression stockings to prevent post-thrombotic syndrome in patients with acute deep vein thrombosis (DVT).

The 10th edition also suggests which patients diagnosed with isolated subsegmental pulmonary embolism (PE) should, and should not, receive anticoagulant therapy.

For subsegmental PE and no proximal DVT, the guidelines suggest clinical surveillance over anticoagulation if patients have a low risk of recurrent VTE and anticoagulation over clinical surveillance if patients have a high risk of recurrence.

The guidelines suggest thrombolytic therapy for patients with PE and hypotension and systemic therapy over catheter-directed thrombolysis.

To date, the updated guidelines have been endorsed by the American Association for Clinical Chemistry, American College of Clinical Pharmacy, International Society for Thrombosis and Haemostasis, and American Society of Health-System Pharmacists.

Doctor consults with a cancer

patient and her father

Photo by Rhoda Baer

The American Cancer Society’s 2016 report on cancer in the US suggests that, in recent years, overall trends in cancer incidence have remained stable for women and declined for men.

However, the rates of certain malignancies are on the rise. This includes some leukemia subtypes for men and women, as well as myeloma for men.

Leukemia is the leading cause of cancer death for men ages 20 to 39, but leukemia is no longer the leading cause of cancer death among children and adolescents (of both genders).

These and other data are included in the report, which is published in CA: A Cancer Journal for Clinicians.

The report estimates there will be 1,685,210 new cancer cases and 595,690 cancer deaths in the US in 2016. This includes 81,080 new lymphoma cases and 21,270 lymphoma deaths, 60,140 new leukemia cases and 24,400 leukemia deaths, and 30,330 new myeloma cases and 12,650 myeloma deaths.

Cancer incidence over time

The report suggests the overall cancer incidence for women has been stable from 1998 to 2012. But the incidence for men has declined by 3.1% per year from 2009 to 2012, with one-half of the drop in men due to recent rapid declines in prostate cancer diagnoses as prostate-specific antigen testing decreases.

Incidence rates increased from 2003 to 2012 among both men and women for some leukemia subtypes and for cancers of the tongue, tonsil, small intestine, liver, pancreas, kidney, renal pelvis, and thyroid.

Incidence rates increased in men for melanoma, myeloma, and cancers of the breast, testis, and oropharynx. Among women, incidence rates increased for cancers of the anus, vulva, and uterine corpus.

Cancer deaths

The rate of cancer deaths in the US has dropped 23% from its peak in 1991 to 2012. The incidence of cancer death was 215.1 per 100,000 in 1991 and 166.4 per 100,000 in 2012.

The decline is larger in men (28% since 1990) than in women (19% since 1991). Over the past decade of data, the rate dropped by 1.8% per year in men and 1.4% per year in women.

The decline in cancer death rates over the past 2 decades is driven by continued decreases in death rates for the 4 major cancer sites: lung, breast, prostate, and colon/rectum.

Breast cancer is the leading cause of cancer death in women ages 20 to 59, while lung cancer is the leading cause of cancer death in women 60 and older.

Among men, leukemia is the leading cause of cancer death for those ages 20 to 39, whereas lung cancer ranks first among men 40 and older.

Among children and adolescents (0-19), brain cancer has surpassed leukemia as the leading cause of cancer death, a result of more rapid therapeutic advances against leukemia.

The report also features an analysis of leading causes of death by state. It shows that, even as cancer remains the second leading cause of death nationwide, steep drops in deaths from heart disease have made cancer the leading cause of death in 21 states: Alaska, Arizona, Colorado, Delaware, Florida, Georgia, Idaho, Kansas, Maine, Massachusetts, Minnesota, Montana, Nebraska, New Hampshire, New Mexico, North Carolina, Oregon, South Carolina, Vermont, Virginia, and Washington.

In addition, cancer is the leading cause of death among adults ages 40 to 79 and among both Hispanics and Asian/Pacific Islanders, who together make up one-quarter of the US population.

Heart disease remains the top cause of death overall in the US. In 2012, there were 599,711 (24%) deaths from heart disease, compared to 582,623 (23%) deaths from cancer.

“We’re gratified to see cancer death rates continuing to drop,” said Otis W. Brawley, MD, chief medical officer of the American Cancer Society.

“But the fact that cancer is nonetheless becoming the top cause of death in many populations is a strong reminder that the fight is not over.”

Doctor consults with a cancer

patient and her father

Photo by Rhoda Baer

The American Cancer Society’s 2016 report on cancer in the US suggests that, in recent years, overall trends in cancer incidence have remained stable for women and declined for men.

However, the rates of certain malignancies are on the rise. This includes some leukemia subtypes for men and women, as well as myeloma for men.

Leukemia is the leading cause of cancer death for men ages 20 to 39, but leukemia is no longer the leading cause of cancer death among children and adolescents (of both genders).

These and other data are included in the report, which is published in CA: A Cancer Journal for Clinicians.

The report estimates there will be 1,685,210 new cancer cases and 595,690 cancer deaths in the US in 2016. This includes 81,080 new lymphoma cases and 21,270 lymphoma deaths, 60,140 new leukemia cases and 24,400 leukemia deaths, and 30,330 new myeloma cases and 12,650 myeloma deaths.

Cancer incidence over time

The report suggests the overall cancer incidence for women has been stable from 1998 to 2012. But the incidence for men has declined by 3.1% per year from 2009 to 2012, with one-half of the drop in men due to recent rapid declines in prostate cancer diagnoses as prostate-specific antigen testing decreases.

Incidence rates increased from 2003 to 2012 among both men and women for some leukemia subtypes and for cancers of the tongue, tonsil, small intestine, liver, pancreas, kidney, renal pelvis, and thyroid.

Incidence rates increased in men for melanoma, myeloma, and cancers of the breast, testis, and oropharynx. Among women, incidence rates increased for cancers of the anus, vulva, and uterine corpus.

Cancer deaths

The rate of cancer deaths in the US has dropped 23% from its peak in 1991 to 2012. The incidence of cancer death was 215.1 per 100,000 in 1991 and 166.4 per 100,000 in 2012.

The decline is larger in men (28% since 1990) than in women (19% since 1991). Over the past decade of data, the rate dropped by 1.8% per year in men and 1.4% per year in women.

The decline in cancer death rates over the past 2 decades is driven by continued decreases in death rates for the 4 major cancer sites: lung, breast, prostate, and colon/rectum.

Breast cancer is the leading cause of cancer death in women ages 20 to 59, while lung cancer is the leading cause of cancer death in women 60 and older.

Among men, leukemia is the leading cause of cancer death for those ages 20 to 39, whereas lung cancer ranks first among men 40 and older.

Among children and adolescents (0-19), brain cancer has surpassed leukemia as the leading cause of cancer death, a result of more rapid therapeutic advances against leukemia.

The report also features an analysis of leading causes of death by state. It shows that, even as cancer remains the second leading cause of death nationwide, steep drops in deaths from heart disease have made cancer the leading cause of death in 21 states: Alaska, Arizona, Colorado, Delaware, Florida, Georgia, Idaho, Kansas, Maine, Massachusetts, Minnesota, Montana, Nebraska, New Hampshire, New Mexico, North Carolina, Oregon, South Carolina, Vermont, Virginia, and Washington.

In addition, cancer is the leading cause of death among adults ages 40 to 79 and among both Hispanics and Asian/Pacific Islanders, who together make up one-quarter of the US population.

Heart disease remains the top cause of death overall in the US. In 2012, there were 599,711 (24%) deaths from heart disease, compared to 582,623 (23%) deaths from cancer.

“We’re gratified to see cancer death rates continuing to drop,” said Otis W. Brawley, MD, chief medical officer of the American Cancer Society.

“But the fact that cancer is nonetheless becoming the top cause of death in many populations is a strong reminder that the fight is not over.”

Doctor consults with a cancer

patient and her father

Photo by Rhoda Baer

The American Cancer Society’s 2016 report on cancer in the US suggests that, in recent years, overall trends in cancer incidence have remained stable for women and declined for men.

However, the rates of certain malignancies are on the rise. This includes some leukemia subtypes for men and women, as well as myeloma for men.

Leukemia is the leading cause of cancer death for men ages 20 to 39, but leukemia is no longer the leading cause of cancer death among children and adolescents (of both genders).

These and other data are included in the report, which is published in CA: A Cancer Journal for Clinicians.

The report estimates there will be 1,685,210 new cancer cases and 595,690 cancer deaths in the US in 2016. This includes 81,080 new lymphoma cases and 21,270 lymphoma deaths, 60,140 new leukemia cases and 24,400 leukemia deaths, and 30,330 new myeloma cases and 12,650 myeloma deaths.

Cancer incidence over time

The report suggests the overall cancer incidence for women has been stable from 1998 to 2012. But the incidence for men has declined by 3.1% per year from 2009 to 2012, with one-half of the drop in men due to recent rapid declines in prostate cancer diagnoses as prostate-specific antigen testing decreases.

Incidence rates increased from 2003 to 2012 among both men and women for some leukemia subtypes and for cancers of the tongue, tonsil, small intestine, liver, pancreas, kidney, renal pelvis, and thyroid.

Incidence rates increased in men for melanoma, myeloma, and cancers of the breast, testis, and oropharynx. Among women, incidence rates increased for cancers of the anus, vulva, and uterine corpus.

Cancer deaths

The rate of cancer deaths in the US has dropped 23% from its peak in 1991 to 2012. The incidence of cancer death was 215.1 per 100,000 in 1991 and 166.4 per 100,000 in 2012.

The decline is larger in men (28% since 1990) than in women (19% since 1991). Over the past decade of data, the rate dropped by 1.8% per year in men and 1.4% per year in women.

The decline in cancer death rates over the past 2 decades is driven by continued decreases in death rates for the 4 major cancer sites: lung, breast, prostate, and colon/rectum.

Breast cancer is the leading cause of cancer death in women ages 20 to 59, while lung cancer is the leading cause of cancer death in women 60 and older.

Among men, leukemia is the leading cause of cancer death for those ages 20 to 39, whereas lung cancer ranks first among men 40 and older.

Among children and adolescents (0-19), brain cancer has surpassed leukemia as the leading cause of cancer death, a result of more rapid therapeutic advances against leukemia.

The report also features an analysis of leading causes of death by state. It shows that, even as cancer remains the second leading cause of death nationwide, steep drops in deaths from heart disease have made cancer the leading cause of death in 21 states: Alaska, Arizona, Colorado, Delaware, Florida, Georgia, Idaho, Kansas, Maine, Massachusetts, Minnesota, Montana, Nebraska, New Hampshire, New Mexico, North Carolina, Oregon, South Carolina, Vermont, Virginia, and Washington.

In addition, cancer is the leading cause of death among adults ages 40 to 79 and among both Hispanics and Asian/Pacific Islanders, who together make up one-quarter of the US population.

Heart disease remains the top cause of death overall in the US. In 2012, there were 599,711 (24%) deaths from heart disease, compared to 582,623 (23%) deaths from cancer.

“We’re gratified to see cancer death rates continuing to drop,” said Otis W. Brawley, MD, chief medical officer of the American Cancer Society.

“But the fact that cancer is nonetheless becoming the top cause of death in many populations is a strong reminder that the fight is not over.”

As Ob.Gyn. News celebrates 50 years of publication, we’re taking a look back at our first year – 1966.

Not surprisingly, medicine looked a lot different in the mid-1960s, largely driven by the culture and technology of the time. A review of the 1966 issues of Obstetrics and Gynecology (the Green Journal), offers a snapshot of the state of the science.

With scientists still struggling to develop a rapid test to detect pregnancy, researchers from the Brookdale Hospital Center in Brooklyn, N.Y., detailed the possibility of using elevated breast temperature to get faster results. They compared 50 pregnant and 50 nonpregnant women and found a consistent rise in breast temperature in all pregnant women as early as 1 week after the first missed period. In the March issue, they concluded that the use of temperature difference between the breast and a baseline area on the anterior chest wall could be a rapid, simple, and accurate pregnancy test (Obstet Gynecol. 1966 Mar;27[3]:378-80).

In August, researchers from Australia published promising data on the use of ultrasonic echoscopic examination of the uterus in late pregnancy. They found that the technology was useful in determining fetal position and possible abnormalities and could be repeated as often as necessary to observe changes and growth. The big advantage, they noted, would be the opportunity to avoid excessive fetal exposure to x-rays (Obstet Gynecol. 1966 Aug;28[2]:164-9).

Advertising directed at physicians – in both the Green Journal and in Ob.Gyn. News – provided a glimpse into the practice of medicine at the time. Ob.gyns. saw ads for products such as Eskatrol – a capsule that contained dextroamphetamine sulfate and prochlorperazine – promoted to help women control appetite and “relieve the emotional stress that causes overeating.” And doctors also saw ads for oral contraceptives, first approved by the Food and Drug Administration in 1960.

Ob.gyn. practice was different culturally as well. In a regular column titled “After Office Hours,” published in the Green Journal in January 1966, Dr. Malcolm S. Allan explored a relatively new idea – husband-attended deliveries. Dr. Allan, of Wesson Maternity Hospital in Springfield, Mass., explained that his hospital had conducted a nationwide survey of chiefs of obstetrics after they received a petition seeking to allow husbands into the delivery room, as well as more flexibility for fathers to room in with the mother and baby. The survey, which included responses from 267 hospitals, showed that 81% of hospitals did not allow husbands in the delivery room (Obstet Gynecol. 1966 Jan;27[1]:146-8).

After reviewing the survey results and talking to experts in the area, Dr. Allan and the leadership at Wesson decided not to allow husbands to witness deliveries. He concluded that “some patients in some of these ‘off-beat’ programs are being allowed to assume too much authority for determining the medical management of their pregnancies, while leaving the obstetrician with the responsibility for a healthy outcome.”

But in other ways, not much has changed since 1966. The March edition of “After Office Hours” bemoaned a looming manpower crisis in obstetrics (Obstet Gynecol. 1966 Mar;27[3]:449-52). Dr. Jan Schneider of the University of Michigan, Ann Arbor, wrote that even using conservative estimates of population growth, by 1970 there would be 20,000 obstetricians in the United States delivering on average of 225 babies each, a strain on the workforce. What were some of the factors? An uneven distribution of obstetricians throughout the country and increasing specialization.

In another familiar theme, Dr. Schneider urged physicians to consider team care as one part of the solution, allowing nurse midwives to provide prenatal care and perform normal deliveries under physician supervision.

Some of the clinical debates going on in 1966 are still unresolved. Consider the September 1966 issue of the Green Journal, which features an interim report on contraception with an intrauterine bow inserted immediately postpartum (Obstet Gynecol. 1966 Sep;28[3]:329-31). Five decades later, only about 12 state Medicaid programs cover the cost of insertion of an IUD immediately postpartum. And in the August 1966 issue of the Green Journal, Dr. Carl J. Pauerstein asked, “Once a Section, Always a Trial of Labor?” (Obstet Gynecol. 1966 Aug;28[2]:273-6). A look at the recent Master Class on vaginal birth after cesarean shows that those same questions are still being debated today.

So what will physicians and patients say about obstetrics and gynecology practice 50 years from now?

1966 at a glance

The Surgeon General

In a report to U.S. Surgeon General William H. Stewart titled “Protecting and Improving Health through the Radiological Sciences,” the National Advisory Committee on Radiation warned about emerging problems in the use of ionizing radiation in medicine.

Births

According to data provided by the Centers for Disease Control and Prevention, in 1966, there were 3.6 million births, for a birth rate of 18.4 and a fertility rate of 90.8; 8.4% of births were to unmarried women.

Women get organized

Courtesy of the National Organization for Women

In June, Betty Friedan, Pauli Murray, and several other women launched the National Organization for Women at a conference in Washington, D.C., with Ms. Friedan famously writing N-O-W on a paper napkin.

Medical ethics

Dr. Henry K. Beecher published an article on ethics in the New England Journal of Medicine that is credited with spurring the federal government to set rules on human experimentation and informed consent, including establishment of Institutional Review Boards.

A safety net is born

Photo courtesy of White House

On July 1, 1966, Medicare coverage began, with more than 19 million beneficiaries.

The AMA

Courtesy of the American Medical Association

The American Medical Association published the first edition of the Current Procedural Terminology (CPT) code book, creating a system of standardized terms for medical procedures used in documentation. Also in 1966, the AMA encouraged doctors to promote exercise to improve health.

Planned Parenthood

The Planned Parenthood Federation of America awarded its first Margaret Sanger Award. In 1966, four men received the award, including the Rev. Martin Luther King Jr. and President Lyndon B. Johnson.

Pregnancy testing

The first radioimmunoassay for hCG (human chorionic gonadotropin) was described by A.R. Midgley, but the test could not distinguish between hCG and luteinizing hormone. A home pregnancy test was still a decade away.

Throughout 2016, Ob.Gyn. News will celebrate its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of contraception, changes in gynecologic surgery, and the transformation of the well-woman visit. Look for these articles and more special features in the pages of Ob.Gyn. News and online at obgynnews.com.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

As Ob.Gyn. News celebrates 50 years of publication, we’re taking a look back at our first year – 1966.

Not surprisingly, medicine looked a lot different in the mid-1960s, largely driven by the culture and technology of the time. A review of the 1966 issues of Obstetrics and Gynecology (the Green Journal), offers a snapshot of the state of the science.

With scientists still struggling to develop a rapid test to detect pregnancy, researchers from the Brookdale Hospital Center in Brooklyn, N.Y., detailed the possibility of using elevated breast temperature to get faster results. They compared 50 pregnant and 50 nonpregnant women and found a consistent rise in breast temperature in all pregnant women as early as 1 week after the first missed period. In the March issue, they concluded that the use of temperature difference between the breast and a baseline area on the anterior chest wall could be a rapid, simple, and accurate pregnancy test (Obstet Gynecol. 1966 Mar;27[3]:378-80).

In August, researchers from Australia published promising data on the use of ultrasonic echoscopic examination of the uterus in late pregnancy. They found that the technology was useful in determining fetal position and possible abnormalities and could be repeated as often as necessary to observe changes and growth. The big advantage, they noted, would be the opportunity to avoid excessive fetal exposure to x-rays (Obstet Gynecol. 1966 Aug;28[2]:164-9).

Advertising directed at physicians – in both the Green Journal and in Ob.Gyn. News – provided a glimpse into the practice of medicine at the time. Ob.gyns. saw ads for products such as Eskatrol – a capsule that contained dextroamphetamine sulfate and prochlorperazine – promoted to help women control appetite and “relieve the emotional stress that causes overeating.” And doctors also saw ads for oral contraceptives, first approved by the Food and Drug Administration in 1960.

Ob.gyn. practice was different culturally as well. In a regular column titled “After Office Hours,” published in the Green Journal in January 1966, Dr. Malcolm S. Allan explored a relatively new idea – husband-attended deliveries. Dr. Allan, of Wesson Maternity Hospital in Springfield, Mass., explained that his hospital had conducted a nationwide survey of chiefs of obstetrics after they received a petition seeking to allow husbands into the delivery room, as well as more flexibility for fathers to room in with the mother and baby. The survey, which included responses from 267 hospitals, showed that 81% of hospitals did not allow husbands in the delivery room (Obstet Gynecol. 1966 Jan;27[1]:146-8).

After reviewing the survey results and talking to experts in the area, Dr. Allan and the leadership at Wesson decided not to allow husbands to witness deliveries. He concluded that “some patients in some of these ‘off-beat’ programs are being allowed to assume too much authority for determining the medical management of their pregnancies, while leaving the obstetrician with the responsibility for a healthy outcome.”

But in other ways, not much has changed since 1966. The March edition of “After Office Hours” bemoaned a looming manpower crisis in obstetrics (Obstet Gynecol. 1966 Mar;27[3]:449-52). Dr. Jan Schneider of the University of Michigan, Ann Arbor, wrote that even using conservative estimates of population growth, by 1970 there would be 20,000 obstetricians in the United States delivering on average of 225 babies each, a strain on the workforce. What were some of the factors? An uneven distribution of obstetricians throughout the country and increasing specialization.

In another familiar theme, Dr. Schneider urged physicians to consider team care as one part of the solution, allowing nurse midwives to provide prenatal care and perform normal deliveries under physician supervision.

Some of the clinical debates going on in 1966 are still unresolved. Consider the September 1966 issue of the Green Journal, which features an interim report on contraception with an intrauterine bow inserted immediately postpartum (Obstet Gynecol. 1966 Sep;28[3]:329-31). Five decades later, only about 12 state Medicaid programs cover the cost of insertion of an IUD immediately postpartum. And in the August 1966 issue of the Green Journal, Dr. Carl J. Pauerstein asked, “Once a Section, Always a Trial of Labor?” (Obstet Gynecol. 1966 Aug;28[2]:273-6). A look at the recent Master Class on vaginal birth after cesarean shows that those same questions are still being debated today.

So what will physicians and patients say about obstetrics and gynecology practice 50 years from now?

1966 at a glance

The Surgeon General

In a report to U.S. Surgeon General William H. Stewart titled “Protecting and Improving Health through the Radiological Sciences,” the National Advisory Committee on Radiation warned about emerging problems in the use of ionizing radiation in medicine.

Births

According to data provided by the Centers for Disease Control and Prevention, in 1966, there were 3.6 million births, for a birth rate of 18.4 and a fertility rate of 90.8; 8.4% of births were to unmarried women.

Women get organized

Courtesy of the National Organization for Women

In June, Betty Friedan, Pauli Murray, and several other women launched the National Organization for Women at a conference in Washington, D.C., with Ms. Friedan famously writing N-O-W on a paper napkin.

Medical ethics

Dr. Henry K. Beecher published an article on ethics in the New England Journal of Medicine that is credited with spurring the federal government to set rules on human experimentation and informed consent, including establishment of Institutional Review Boards.

A safety net is born

Photo courtesy of White House

On July 1, 1966, Medicare coverage began, with more than 19 million beneficiaries.

The AMA

Courtesy of the American Medical Association

The American Medical Association published the first edition of the Current Procedural Terminology (CPT) code book, creating a system of standardized terms for medical procedures used in documentation. Also in 1966, the AMA encouraged doctors to promote exercise to improve health.

Planned Parenthood

The Planned Parenthood Federation of America awarded its first Margaret Sanger Award. In 1966, four men received the award, including the Rev. Martin Luther King Jr. and President Lyndon B. Johnson.

Pregnancy testing

The first radioimmunoassay for hCG (human chorionic gonadotropin) was described by A.R. Midgley, but the test could not distinguish between hCG and luteinizing hormone. A home pregnancy test was still a decade away.

Throughout 2016, Ob.Gyn. News will celebrate its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of contraception, changes in gynecologic surgery, and the transformation of the well-woman visit. Look for these articles and more special features in the pages of Ob.Gyn. News and online at obgynnews.com.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

As Ob.Gyn. News celebrates 50 years of publication, we’re taking a look back at our first year – 1966.

Not surprisingly, medicine looked a lot different in the mid-1960s, largely driven by the culture and technology of the time. A review of the 1966 issues of Obstetrics and Gynecology (the Green Journal), offers a snapshot of the state of the science.

With scientists still struggling to develop a rapid test to detect pregnancy, researchers from the Brookdale Hospital Center in Brooklyn, N.Y., detailed the possibility of using elevated breast temperature to get faster results. They compared 50 pregnant and 50 nonpregnant women and found a consistent rise in breast temperature in all pregnant women as early as 1 week after the first missed period. In the March issue, they concluded that the use of temperature difference between the breast and a baseline area on the anterior chest wall could be a rapid, simple, and accurate pregnancy test (Obstet Gynecol. 1966 Mar;27[3]:378-80).

In August, researchers from Australia published promising data on the use of ultrasonic echoscopic examination of the uterus in late pregnancy. They found that the technology was useful in determining fetal position and possible abnormalities and could be repeated as often as necessary to observe changes and growth. The big advantage, they noted, would be the opportunity to avoid excessive fetal exposure to x-rays (Obstet Gynecol. 1966 Aug;28[2]:164-9).

Advertising directed at physicians – in both the Green Journal and in Ob.Gyn. News – provided a glimpse into the practice of medicine at the time. Ob.gyns. saw ads for products such as Eskatrol – a capsule that contained dextroamphetamine sulfate and prochlorperazine – promoted to help women control appetite and “relieve the emotional stress that causes overeating.” And doctors also saw ads for oral contraceptives, first approved by the Food and Drug Administration in 1960.

Ob.gyn. practice was different culturally as well. In a regular column titled “After Office Hours,” published in the Green Journal in January 1966, Dr. Malcolm S. Allan explored a relatively new idea – husband-attended deliveries. Dr. Allan, of Wesson Maternity Hospital in Springfield, Mass., explained that his hospital had conducted a nationwide survey of chiefs of obstetrics after they received a petition seeking to allow husbands into the delivery room, as well as more flexibility for fathers to room in with the mother and baby. The survey, which included responses from 267 hospitals, showed that 81% of hospitals did not allow husbands in the delivery room (Obstet Gynecol. 1966 Jan;27[1]:146-8).

After reviewing the survey results and talking to experts in the area, Dr. Allan and the leadership at Wesson decided not to allow husbands to witness deliveries. He concluded that “some patients in some of these ‘off-beat’ programs are being allowed to assume too much authority for determining the medical management of their pregnancies, while leaving the obstetrician with the responsibility for a healthy outcome.”

But in other ways, not much has changed since 1966. The March edition of “After Office Hours” bemoaned a looming manpower crisis in obstetrics (Obstet Gynecol. 1966 Mar;27[3]:449-52). Dr. Jan Schneider of the University of Michigan, Ann Arbor, wrote that even using conservative estimates of population growth, by 1970 there would be 20,000 obstetricians in the United States delivering on average of 225 babies each, a strain on the workforce. What were some of the factors? An uneven distribution of obstetricians throughout the country and increasing specialization.

In another familiar theme, Dr. Schneider urged physicians to consider team care as one part of the solution, allowing nurse midwives to provide prenatal care and perform normal deliveries under physician supervision.

Some of the clinical debates going on in 1966 are still unresolved. Consider the September 1966 issue of the Green Journal, which features an interim report on contraception with an intrauterine bow inserted immediately postpartum (Obstet Gynecol. 1966 Sep;28[3]:329-31). Five decades later, only about 12 state Medicaid programs cover the cost of insertion of an IUD immediately postpartum. And in the August 1966 issue of the Green Journal, Dr. Carl J. Pauerstein asked, “Once a Section, Always a Trial of Labor?” (Obstet Gynecol. 1966 Aug;28[2]:273-6). A look at the recent Master Class on vaginal birth after cesarean shows that those same questions are still being debated today.

So what will physicians and patients say about obstetrics and gynecology practice 50 years from now?

1966 at a glance

The Surgeon General

In a report to U.S. Surgeon General William H. Stewart titled “Protecting and Improving Health through the Radiological Sciences,” the National Advisory Committee on Radiation warned about emerging problems in the use of ionizing radiation in medicine.

Births

According to data provided by the Centers for Disease Control and Prevention, in 1966, there were 3.6 million births, for a birth rate of 18.4 and a fertility rate of 90.8; 8.4% of births were to unmarried women.

Women get organized

Courtesy of the National Organization for Women

In June, Betty Friedan, Pauli Murray, and several other women launched the National Organization for Women at a conference in Washington, D.C., with Ms. Friedan famously writing N-O-W on a paper napkin.

Medical ethics

Dr. Henry K. Beecher published an article on ethics in the New England Journal of Medicine that is credited with spurring the federal government to set rules on human experimentation and informed consent, including establishment of Institutional Review Boards.

A safety net is born

Photo courtesy of White House

On July 1, 1966, Medicare coverage began, with more than 19 million beneficiaries.

The AMA

Courtesy of the American Medical Association

The American Medical Association published the first edition of the Current Procedural Terminology (CPT) code book, creating a system of standardized terms for medical procedures used in documentation. Also in 1966, the AMA encouraged doctors to promote exercise to improve health.

Planned Parenthood

The Planned Parenthood Federation of America awarded its first Margaret Sanger Award. In 1966, four men received the award, including the Rev. Martin Luther King Jr. and President Lyndon B. Johnson.

Pregnancy testing

The first radioimmunoassay for hCG (human chorionic gonadotropin) was described by A.R. Midgley, but the test could not distinguish between hCG and luteinizing hormone. A home pregnancy test was still a decade away.

Throughout 2016, Ob.Gyn. News will celebrate its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of contraception, changes in gynecologic surgery, and the transformation of the well-woman visit. Look for these articles and more special features in the pages of Ob.Gyn. News and online at obgynnews.com.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

On October 14, 2015, the US Food and Drug Administration declined to approve tofacitinib citrate, an oral rheumatoid arthritis drug, for the treatment of moderate to severe chronic plaque psoriasis. The FDA communicated its decision to the manufacturer in the form of a complete response letter, which typically outlines concerns and conditions that must be addressed in order to gain FDA approval following initial review of an application.

A recent press release indicated that the manufacturer is committed to pursuing approval of the product based on the strength of the clinical data for its treatment of psoriasis. The FDA generally does not disclose the contents of its complete response letters, but the manufacturer reported it has been asked to provide additional safety analyses of the drug for psoriasis and that it will work closely with the agency to gain the additional approval for treatment of patients with chronic plaque psoriasis.

What’s the Issue?

With the increasing number of psoriasis drugs on the market and in the pipeline, the risk-benefit profile of all drugs needs to be evaluated very carefully. Therefore, safety is the focal issue in all new drug development. Hopefully these issues with the FDA approval of tofacitinib citrate will be worked out so that we may have another oral option for our psoriasis patients. How will this development influence your approach to new therapies?

We want to know your views! Tell us what you think.

On October 14, 2015, the US Food and Drug Administration declined to approve tofacitinib citrate, an oral rheumatoid arthritis drug, for the treatment of moderate to severe chronic plaque psoriasis. The FDA communicated its decision to the manufacturer in the form of a complete response letter, which typically outlines concerns and conditions that must be addressed in order to gain FDA approval following initial review of an application.

A recent press release indicated that the manufacturer is committed to pursuing approval of the product based on the strength of the clinical data for its treatment of psoriasis. The FDA generally does not disclose the contents of its complete response letters, but the manufacturer reported it has been asked to provide additional safety analyses of the drug for psoriasis and that it will work closely with the agency to gain the additional approval for treatment of patients with chronic plaque psoriasis.

What’s the Issue?

With the increasing number of psoriasis drugs on the market and in the pipeline, the risk-benefit profile of all drugs needs to be evaluated very carefully. Therefore, safety is the focal issue in all new drug development. Hopefully these issues with the FDA approval of tofacitinib citrate will be worked out so that we may have another oral option for our psoriasis patients. How will this development influence your approach to new therapies?

We want to know your views! Tell us what you think.

On October 14, 2015, the US Food and Drug Administration declined to approve tofacitinib citrate, an oral rheumatoid arthritis drug, for the treatment of moderate to severe chronic plaque psoriasis. The FDA communicated its decision to the manufacturer in the form of a complete response letter, which typically outlines concerns and conditions that must be addressed in order to gain FDA approval following initial review of an application.

A recent press release indicated that the manufacturer is committed to pursuing approval of the product based on the strength of the clinical data for its treatment of psoriasis. The FDA generally does not disclose the contents of its complete response letters, but the manufacturer reported it has been asked to provide additional safety analyses of the drug for psoriasis and that it will work closely with the agency to gain the additional approval for treatment of patients with chronic plaque psoriasis.

What’s the Issue?

With the increasing number of psoriasis drugs on the market and in the pipeline, the risk-benefit profile of all drugs needs to be evaluated very carefully. Therefore, safety is the focal issue in all new drug development. Hopefully these issues with the FDA approval of tofacitinib citrate will be worked out so that we may have another oral option for our psoriasis patients. How will this development influence your approach to new therapies?

We want to know your views! Tell us what you think.

More U.S. adults over the age of 65 visited an emergency department because of an infectious disease than for myocardial infarction and congestive heart failure combined, according to a new study.

Based on a nationwide ED sample, adults over 65 visited the ED just over 3.1 million times in 2012 due to infectious diseases (ID), more than three times the estimated amount for myocardial infarction and congestive heart failure. The most common diagnoses were lower respiratory infections (26.2%), urinary tract infections (25.3%), and septicemia (18.9%).

Of the 3.1 million cases brought to the ED, nearly 1.8 million cases were hospitalized, with septicemia the most common cause for hospitalization, accounting for 32.2% of ID-related hospitalizations, followed by lower respiratory infections. Septicemia was also the most common cause of mortality, accounting for 74.7% of the nearly 124,000 deaths.

“These observations underscore the importance of integrated strategies aimed at reducing ID-related morbidity and health care use of elderly adults as a national priority for research, health policy, and community action,” Dr. Tadahiro Goto of the University of Fukui (Japan) Hospital and his associates concluded.

Find the full study in the Journal of the American Geriatrics Society (2015 Dec 23. doi: 101111/jgs.13836).

lfranki@frontlinemedcom.com

More U.S. adults over the age of 65 visited an emergency department because of an infectious disease than for myocardial infarction and congestive heart failure combined, according to a new study.

Based on a nationwide ED sample, adults over 65 visited the ED just over 3.1 million times in 2012 due to infectious diseases (ID), more than three times the estimated amount for myocardial infarction and congestive heart failure. The most common diagnoses were lower respiratory infections (26.2%), urinary tract infections (25.3%), and septicemia (18.9%).

Of the 3.1 million cases brought to the ED, nearly 1.8 million cases were hospitalized, with septicemia the most common cause for hospitalization, accounting for 32.2% of ID-related hospitalizations, followed by lower respiratory infections. Septicemia was also the most common cause of mortality, accounting for 74.7% of the nearly 124,000 deaths.

“These observations underscore the importance of integrated strategies aimed at reducing ID-related morbidity and health care use of elderly adults as a national priority for research, health policy, and community action,” Dr. Tadahiro Goto of the University of Fukui (Japan) Hospital and his associates concluded.

Find the full study in the Journal of the American Geriatrics Society (2015 Dec 23. doi: 101111/jgs.13836).

lfranki@frontlinemedcom.com

More U.S. adults over the age of 65 visited an emergency department because of an infectious disease than for myocardial infarction and congestive heart failure combined, according to a new study.

Based on a nationwide ED sample, adults over 65 visited the ED just over 3.1 million times in 2012 due to infectious diseases (ID), more than three times the estimated amount for myocardial infarction and congestive heart failure. The most common diagnoses were lower respiratory infections (26.2%), urinary tract infections (25.3%), and septicemia (18.9%).

Of the 3.1 million cases brought to the ED, nearly 1.8 million cases were hospitalized, with septicemia the most common cause for hospitalization, accounting for 32.2% of ID-related hospitalizations, followed by lower respiratory infections. Septicemia was also the most common cause of mortality, accounting for 74.7% of the nearly 124,000 deaths.

“These observations underscore the importance of integrated strategies aimed at reducing ID-related morbidity and health care use of elderly adults as a national priority for research, health policy, and community action,” Dr. Tadahiro Goto of the University of Fukui (Japan) Hospital and his associates concluded.

Find the full study in the Journal of the American Geriatrics Society (2015 Dec 23. doi: 101111/jgs.13836).

lfranki@frontlinemedcom.com

LAS VEGAS – Though pyoderma gangrenosum and other neutrophilic skin disorders are rare, clinicians should include them in their differential, especially for nonhealing surgical wounds or skin “infections.”

Since these painful areas of ulceration need corticosteroid treatment, not antibiotics, for resolution, accurate diagnosis is critical for healing, Dr. J. Mark Jackson said at the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar.

In a review of pyoderma gangrenosum (PG) and its cousins at the meeting, Dr. Jackson noted that the etiology of PG is unknown, but disordered neutrophilic chemotaxis is thought to be a factor. The many different manifestations of this disease are now collectively called the “neutrophilic dermatoses,” he said.

“Pyoderma gangrenosum is a very important diagnosis to consider in the differential diagnosis for nonhealing ulcerations, as suspicion and early recognition of this debilitating condition can prevent long-term sequelae such as pain, scarring, and long-term immunosuppressive medications,” said Dr. Jackson of the department of dermatology at the University of Louisville (Ky.).

The diagnosis should be suspected in the setting of a painful cutaneous ulcer with necrolysis. The border is typically irregular, violaceous, and undermined, he said, adding that this classic undermined border is caused by the sheets of neutrophils that characterize the disease.

Noting that half of patients with PG have underlying associated conditions such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and hematologic malignancies, Dr. Jackson emphasized that systemic disease associated with PG should heighten suspicion. “Histopathologic findings may be consistent with but not diagnostic of PG,” and can include a sterile dermal neutrophilia, with or without mixed inflammation and a lymphocytic vasculitis.

“Where you biopsy is important,” he continued, emphasizing that the biopsy must capture the margin of ulceration, where the sheets of neutrophils characteristic of PG will be seen on pathology.

Courtesy Dr. J. Mark Jackson

Therapy consists of corticosteroids, with or without an immunosuppressive agent, and cessation of treatments that may continue to provoke pathergy.

Other diseases should also be considered in the differential diagnosis, including dangerous infectious causes, such as atypical mycobacteria, deep fungal infections, and staphylococcal and streptococcal infections. Squamous cell carcinoma, lymphoma, and leukemia may also present with similar lesions, as may metastatic Crohn’s disease, Dr. Jackson said. Several vasculitic and vasculopathic inflammatory conditions can also have similar appearances, including Wegener’s granulomatosis and vasoocclusive disorders such as peripheral vascular disease and cryoglobulinemia.

Classically, PG presents as painful ulcerated areas, most often on the lower extremities, that have a typical undermined border, caused by the sheets of neutrophils that characterize PG, he pointed out. PG may be mistaken for venous stasis ulcers, pressure ulcers, and cellulitis, but it doesn’t improve with antibiotics and mechanical manipulation from exfoliative dressings – and debridement may worsen the condition.

Courtesy Dr. J. Mark Jackson

For susceptible individuals, surgery may provoke a pathergic response and trigger PG at the site of the surgical wound, and dogged attempts at conventional wound care may cause continued pathergy and begin a vicious cycle, Dr. Jackson said.

Peristomal pyoderma gangrenosum is a disease subcategory that may be seen in patients whose inflammatory bowel disease has been surgically treated and who have a stoma. Patients will have ulcerating lesions around their stoma site that are often misdiagnosed and treated as infections. Some wound care therapies, such as debridement, may continue to provoke the pathergic response and worsen peristomal PG, he said.

Though associated disease is seen in up to 50% of individuals with PG, there’s no predictable timeline linking the development of PG with the course of the associated disorder. In classic PG, usually occurring on the legs, autoimmune diseases such as inflammatory bowel disease, rheumatoid arthritis or another inflammatory arthritis, and paraproteinemia may be seen. Atypical PG, occurring more commonly on the upper extremities and face, is associated with myelogenous leukemia and preleukemic states, Dr. Jackson said.

Pyoderma gangrenosum lesions improve with corticosteroid administration. Depending on disease severity and location, topical, intralesional, or systemic steroids may be used.

Adjunctive treatments for PG and other neutrophilic dermatoses can include antibiotics with anti-inflammatory properties, such as minocycline or doxycycline, dapsone, and metronidazole. Immunosuppressives such as cyclosporine, azathioprine, and mycophenolate mofetil may also help speed resolution. In some cases, skin grafts may be necessary.

Courtesy Dr. J. Mark Jackson

PG patients with Crohn’s disease or rheumatoid arthritis who are prescribed tumor necrosis factor–alpha (TNF-alpha) inhibitors for their systemic disease may also see improvement in PG lesions, Dr. Jackson said.

Other rare categories of neutrophilic dermatoses include Sweet’s syndrome, an acute febrile neutrophilic dermatosis, and neutrophilic dermatosis of the dorsum of the hand.

Neutrophilic invasion can also occur in other organs. “These extracutaneous lesions are also ‘sterile’ neutrophilic abscesses, which are often misdiagnosed as infections,” Dr. Jackson said. The most common site of extracutaneous neutrophilic infiltration is the lungs, though any organ system may be affected.

Dr. Jackson disclosed that he has received research support, honoraria, consulting fees, and other support from Abbvie, Amgen, Celgene, Dermira, Galderma, Genentech, Janssen, Lilly, Medimetriks, Merck, Novartis, Pfizer, Promius, and Top MD.

The Skin Disease Education Foundation and this news organization are owned by the same parent company.

koakes@frontlinemedcom.com

On Twitter @karioakes

LAS VEGAS – Though pyoderma gangrenosum and other neutrophilic skin disorders are rare, clinicians should include them in their differential, especially for nonhealing surgical wounds or skin “infections.”

Since these painful areas of ulceration need corticosteroid treatment, not antibiotics, for resolution, accurate diagnosis is critical for healing, Dr. J. Mark Jackson said at the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar.

In a review of pyoderma gangrenosum (PG) and its cousins at the meeting, Dr. Jackson noted that the etiology of PG is unknown, but disordered neutrophilic chemotaxis is thought to be a factor. The many different manifestations of this disease are now collectively called the “neutrophilic dermatoses,” he said.

“Pyoderma gangrenosum is a very important diagnosis to consider in the differential diagnosis for nonhealing ulcerations, as suspicion and early recognition of this debilitating condition can prevent long-term sequelae such as pain, scarring, and long-term immunosuppressive medications,” said Dr. Jackson of the department of dermatology at the University of Louisville (Ky.).

The diagnosis should be suspected in the setting of a painful cutaneous ulcer with necrolysis. The border is typically irregular, violaceous, and undermined, he said, adding that this classic undermined border is caused by the sheets of neutrophils that characterize the disease.

Noting that half of patients with PG have underlying associated conditions such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and hematologic malignancies, Dr. Jackson emphasized that systemic disease associated with PG should heighten suspicion. “Histopathologic findings may be consistent with but not diagnostic of PG,” and can include a sterile dermal neutrophilia, with or without mixed inflammation and a lymphocytic vasculitis.

“Where you biopsy is important,” he continued, emphasizing that the biopsy must capture the margin of ulceration, where the sheets of neutrophils characteristic of PG will be seen on pathology.

Courtesy Dr. J. Mark Jackson

Therapy consists of corticosteroids, with or without an immunosuppressive agent, and cessation of treatments that may continue to provoke pathergy.

Other diseases should also be considered in the differential diagnosis, including dangerous infectious causes, such as atypical mycobacteria, deep fungal infections, and staphylococcal and streptococcal infections. Squamous cell carcinoma, lymphoma, and leukemia may also present with similar lesions, as may metastatic Crohn’s disease, Dr. Jackson said. Several vasculitic and vasculopathic inflammatory conditions can also have similar appearances, including Wegener’s granulomatosis and vasoocclusive disorders such as peripheral vascular disease and cryoglobulinemia.

Classically, PG presents as painful ulcerated areas, most often on the lower extremities, that have a typical undermined border, caused by the sheets of neutrophils that characterize PG, he pointed out. PG may be mistaken for venous stasis ulcers, pressure ulcers, and cellulitis, but it doesn’t improve with antibiotics and mechanical manipulation from exfoliative dressings – and debridement may worsen the condition.

Courtesy Dr. J. Mark Jackson

For susceptible individuals, surgery may provoke a pathergic response and trigger PG at the site of the surgical wound, and dogged attempts at conventional wound care may cause continued pathergy and begin a vicious cycle, Dr. Jackson said.

Peristomal pyoderma gangrenosum is a disease subcategory that may be seen in patients whose inflammatory bowel disease has been surgically treated and who have a stoma. Patients will have ulcerating lesions around their stoma site that are often misdiagnosed and treated as infections. Some wound care therapies, such as debridement, may continue to provoke the pathergic response and worsen peristomal PG, he said.

Though associated disease is seen in up to 50% of individuals with PG, there’s no predictable timeline linking the development of PG with the course of the associated disorder. In classic PG, usually occurring on the legs, autoimmune diseases such as inflammatory bowel disease, rheumatoid arthritis or another inflammatory arthritis, and paraproteinemia may be seen. Atypical PG, occurring more commonly on the upper extremities and face, is associated with myelogenous leukemia and preleukemic states, Dr. Jackson said.

Pyoderma gangrenosum lesions improve with corticosteroid administration. Depending on disease severity and location, topical, intralesional, or systemic steroids may be used.

Adjunctive treatments for PG and other neutrophilic dermatoses can include antibiotics with anti-inflammatory properties, such as minocycline or doxycycline, dapsone, and metronidazole. Immunosuppressives such as cyclosporine, azathioprine, and mycophenolate mofetil may also help speed resolution. In some cases, skin grafts may be necessary.

Courtesy Dr. J. Mark Jackson

PG patients with Crohn’s disease or rheumatoid arthritis who are prescribed tumor necrosis factor–alpha (TNF-alpha) inhibitors for their systemic disease may also see improvement in PG lesions, Dr. Jackson said.

Other rare categories of neutrophilic dermatoses include Sweet’s syndrome, an acute febrile neutrophilic dermatosis, and neutrophilic dermatosis of the dorsum of the hand.

Neutrophilic invasion can also occur in other organs. “These extracutaneous lesions are also ‘sterile’ neutrophilic abscesses, which are often misdiagnosed as infections,” Dr. Jackson said. The most common site of extracutaneous neutrophilic infiltration is the lungs, though any organ system may be affected.

Dr. Jackson disclosed that he has received research support, honoraria, consulting fees, and other support from Abbvie, Amgen, Celgene, Dermira, Galderma, Genentech, Janssen, Lilly, Medimetriks, Merck, Novartis, Pfizer, Promius, and Top MD.

The Skin Disease Education Foundation and this news organization are owned by the same parent company.

koakes@frontlinemedcom.com

On Twitter @karioakes

LAS VEGAS – Though pyoderma gangrenosum and other neutrophilic skin disorders are rare, clinicians should include them in their differential, especially for nonhealing surgical wounds or skin “infections.”

Since these painful areas of ulceration need corticosteroid treatment, not antibiotics, for resolution, accurate diagnosis is critical for healing, Dr. J. Mark Jackson said at the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar.

In a review of pyoderma gangrenosum (PG) and its cousins at the meeting, Dr. Jackson noted that the etiology of PG is unknown, but disordered neutrophilic chemotaxis is thought to be a factor. The many different manifestations of this disease are now collectively called the “neutrophilic dermatoses,” he said.

“Pyoderma gangrenosum is a very important diagnosis to consider in the differential diagnosis for nonhealing ulcerations, as suspicion and early recognition of this debilitating condition can prevent long-term sequelae such as pain, scarring, and long-term immunosuppressive medications,” said Dr. Jackson of the department of dermatology at the University of Louisville (Ky.).

The diagnosis should be suspected in the setting of a painful cutaneous ulcer with necrolysis. The border is typically irregular, violaceous, and undermined, he said, adding that this classic undermined border is caused by the sheets of neutrophils that characterize the disease.

Noting that half of patients with PG have underlying associated conditions such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and hematologic malignancies, Dr. Jackson emphasized that systemic disease associated with PG should heighten suspicion. “Histopathologic findings may be consistent with but not diagnostic of PG,” and can include a sterile dermal neutrophilia, with or without mixed inflammation and a lymphocytic vasculitis.

“Where you biopsy is important,” he continued, emphasizing that the biopsy must capture the margin of ulceration, where the sheets of neutrophils characteristic of PG will be seen on pathology.

Courtesy Dr. J. Mark Jackson

Therapy consists of corticosteroids, with or without an immunosuppressive agent, and cessation of treatments that may continue to provoke pathergy.

Other diseases should also be considered in the differential diagnosis, including dangerous infectious causes, such as atypical mycobacteria, deep fungal infections, and staphylococcal and streptococcal infections. Squamous cell carcinoma, lymphoma, and leukemia may also present with similar lesions, as may metastatic Crohn’s disease, Dr. Jackson said. Several vasculitic and vasculopathic inflammatory conditions can also have similar appearances, including Wegener’s granulomatosis and vasoocclusive disorders such as peripheral vascular disease and cryoglobulinemia.

Classically, PG presents as painful ulcerated areas, most often on the lower extremities, that have a typical undermined border, caused by the sheets of neutrophils that characterize PG, he pointed out. PG may be mistaken for venous stasis ulcers, pressure ulcers, and cellulitis, but it doesn’t improve with antibiotics and mechanical manipulation from exfoliative dressings – and debridement may worsen the condition.

Courtesy Dr. J. Mark Jackson

For susceptible individuals, surgery may provoke a pathergic response and trigger PG at the site of the surgical wound, and dogged attempts at conventional wound care may cause continued pathergy and begin a vicious cycle, Dr. Jackson said.

Peristomal pyoderma gangrenosum is a disease subcategory that may be seen in patients whose inflammatory bowel disease has been surgically treated and who have a stoma. Patients will have ulcerating lesions around their stoma site that are often misdiagnosed and treated as infections. Some wound care therapies, such as debridement, may continue to provoke the pathergic response and worsen peristomal PG, he said.

Though associated disease is seen in up to 50% of individuals with PG, there’s no predictable timeline linking the development of PG with the course of the associated disorder. In classic PG, usually occurring on the legs, autoimmune diseases such as inflammatory bowel disease, rheumatoid arthritis or another inflammatory arthritis, and paraproteinemia may be seen. Atypical PG, occurring more commonly on the upper extremities and face, is associated with myelogenous leukemia and preleukemic states, Dr. Jackson said.

Pyoderma gangrenosum lesions improve with corticosteroid administration. Depending on disease severity and location, topical, intralesional, or systemic steroids may be used.

Adjunctive treatments for PG and other neutrophilic dermatoses can include antibiotics with anti-inflammatory properties, such as minocycline or doxycycline, dapsone, and metronidazole. Immunosuppressives such as cyclosporine, azathioprine, and mycophenolate mofetil may also help speed resolution. In some cases, skin grafts may be necessary.

Courtesy Dr. J. Mark Jackson

PG patients with Crohn’s disease or rheumatoid arthritis who are prescribed tumor necrosis factor–alpha (TNF-alpha) inhibitors for their systemic disease may also see improvement in PG lesions, Dr. Jackson said.

Other rare categories of neutrophilic dermatoses include Sweet’s syndrome, an acute febrile neutrophilic dermatosis, and neutrophilic dermatosis of the dorsum of the hand.

Neutrophilic invasion can also occur in other organs. “These extracutaneous lesions are also ‘sterile’ neutrophilic abscesses, which are often misdiagnosed as infections,” Dr. Jackson said. The most common site of extracutaneous neutrophilic infiltration is the lungs, though any organ system may be affected.

Dr. Jackson disclosed that he has received research support, honoraria, consulting fees, and other support from Abbvie, Amgen, Celgene, Dermira, Galderma, Genentech, Janssen, Lilly, Medimetriks, Merck, Novartis, Pfizer, Promius, and Top MD.

The Skin Disease Education Foundation and this news organization are owned by the same parent company.

koakes@frontlinemedcom.com

On Twitter @karioakes

When vaccinating children against influenza, inactivated and live attenuated influenza vaccines show little significant difference in effectiveness against nearly all strains of the virus, according to a new study in Pediatrics.

However, the study – which examined the effectiveness of IIV and LAIV across four consecutive influenza seasons between 2010 and 2014 – cautions that the 2013-2014 season’s A/(H1N1)pdm09 showed an uncharacteristically large gap in effectiveness favoring IIV, a discrepancy likely due to a problem with a vaccine component in LAIV. (Pediatrics. 2016;137(2):e20153279)

“We found that lower LAIV effectiveness in 2013-2014 was specific to the A/(H1N1)pdm09 vaccine component and was consistent with a previously unexamined effect during the 2010-2011 influenza season,” Jessie R. Chung of the influenza division at the Centers for Disease Control and Prevention and associates wrote, adding that the impetus for the study was the lack of available data “from observational studies after the 2009 pandemic on relative effectiveness of LAIV and IIV in children and adolescents.”

Ms. Chung* and coinvestigators enrolled children aged 2-17 years from clinics and hospitals in Michigan, New York, Pennsylvania, Tennessee, Texas, Washington, and Wisconsin during the 2010-2011, 2011-2012, 2012-2013, and 2013-2014 influenza seasons. Children brought in with symptoms of acute respiratory illness – cough, fever, or feverishness – had nasal and throat swabs collected to test for presence and type of influenza.

In total, 7,718 subjects were evaluated across the four influenza seasons, but after excluding subjects for various reasons – unknown vaccine type, indeterminate vaccine status, and inconclusive reverse transcription polymerase chain reaction results, among others – 6,819 subjects were included for vaccine effectiveness analysis, of which 2,703 were ultimately matched age appropriately and placed into IIV and LAIV cohorts for comparison. The IIV cohort consisted of 2,066 individuals (76.4%), while the LAIV cohort had 637 (23.6%).

During the 2010-2011 season, 66 of the 477 IIV subjects contracted influenza, versus 21 of 116 who received LAIV (14% vs. 18%, respectively). In the 2011-2012 season, 51 of the 499 IIV subjects (10%) contracted influenza, compared with 12 of the 152 LAIV subjects (8%). In the 2012-2013 season, 198 of the 622 IIV subjects (32%) contracted influenza, versus 61 of the 205 LAIV subjects (30%). But, in the 2013-2014 season, 36 of the 468 IIV subjects (8%) contracted influenza, versus 34 of the 164 LAIV subjects (21%).

After adjustment for age and season, the odds ratio for the 2013-2014 season was significantly higher than those of the other seasons across the entire age spectrum of 2-17 years: 2.88, compared with 1.49 (2010-2011), 0.67 (2011-2012), and 0.92 (2012-2013).

When comparing influenza type/subtype, adjusted odds ratio was 5.53 for those with A/(H1N1)pdm09 in the 2010-2011 season, compared with 2.65 for those with the same in the 2013-2014 season. Those with A/H3N2 did not show as significant a difference across seasons (2010-2013), nor did those with influenza type B (2010-2011, 2012-2013).

“We found no statistically significant difference in LAIV effectiveness compared with IIV against medically attended, laboratory-confirmed influenza illness due to A/H3N2 or B viruses,” Ms. Chung and colleagues concluded. “We found significantly higher odds of influenza A/(H1N1)pdm09 among participants vaccinated with LAIV, compared with IIV, [but] reasons for lower effectiveness of LAIV against the A/(H1N1)pdm09 virus, compared with IIV are not fully understood.”

The investigators added that “the finding appears to be specific to the A/(H1N1)pdm09 vaccine component; we did not detect any statistically significant differences in effectiveness for the other components.” Three previous randomized controlled trials indicated that trivalent LAIV was just as effective, if not more so, than IIV, making the findings of this study surprising and “unexpected,” the authors noted.

This study was supported by the CDC through cooperative agreements with a variety of universities and foundations, and funded by the National Institutes of Health. Ms. Chung and associates reported no relevant financial disclosures.

*A previous version of this story misstated Jessie Chung’s academic title. Ms. Chung holds a Master’s in public health.

dchitnis@frontlinemedcom.com

When vaccinating children against influenza, inactivated and live attenuated influenza vaccines show little significant difference in effectiveness against nearly all strains of the virus, according to a new study in Pediatrics.

However, the study – which examined the effectiveness of IIV and LAIV across four consecutive influenza seasons between 2010 and 2014 – cautions that the 2013-2014 season’s A/(H1N1)pdm09 showed an uncharacteristically large gap in effectiveness favoring IIV, a discrepancy likely due to a problem with a vaccine component in LAIV. (Pediatrics. 2016;137(2):e20153279)

“We found that lower LAIV effectiveness in 2013-2014 was specific to the A/(H1N1)pdm09 vaccine component and was consistent with a previously unexamined effect during the 2010-2011 influenza season,” Jessie R. Chung of the influenza division at the Centers for Disease Control and Prevention and associates wrote, adding that the impetus for the study was the lack of available data “from observational studies after the 2009 pandemic on relative effectiveness of LAIV and IIV in children and adolescents.”

Ms. Chung* and coinvestigators enrolled children aged 2-17 years from clinics and hospitals in Michigan, New York, Pennsylvania, Tennessee, Texas, Washington, and Wisconsin during the 2010-2011, 2011-2012, 2012-2013, and 2013-2014 influenza seasons. Children brought in with symptoms of acute respiratory illness – cough, fever, or feverishness – had nasal and throat swabs collected to test for presence and type of influenza.

In total, 7,718 subjects were evaluated across the four influenza seasons, but after excluding subjects for various reasons – unknown vaccine type, indeterminate vaccine status, and inconclusive reverse transcription polymerase chain reaction results, among others – 6,819 subjects were included for vaccine effectiveness analysis, of which 2,703 were ultimately matched age appropriately and placed into IIV and LAIV cohorts for comparison. The IIV cohort consisted of 2,066 individuals (76.4%), while the LAIV cohort had 637 (23.6%).

During the 2010-2011 season, 66 of the 477 IIV subjects contracted influenza, versus 21 of 116 who received LAIV (14% vs. 18%, respectively). In the 2011-2012 season, 51 of the 499 IIV subjects (10%) contracted influenza, compared with 12 of the 152 LAIV subjects (8%). In the 2012-2013 season, 198 of the 622 IIV subjects (32%) contracted influenza, versus 61 of the 205 LAIV subjects (30%). But, in the 2013-2014 season, 36 of the 468 IIV subjects (8%) contracted influenza, versus 34 of the 164 LAIV subjects (21%).

After adjustment for age and season, the odds ratio for the 2013-2014 season was significantly higher than those of the other seasons across the entire age spectrum of 2-17 years: 2.88, compared with 1.49 (2010-2011), 0.67 (2011-2012), and 0.92 (2012-2013).

When comparing influenza type/subtype, adjusted odds ratio was 5.53 for those with A/(H1N1)pdm09 in the 2010-2011 season, compared with 2.65 for those with the same in the 2013-2014 season. Those with A/H3N2 did not show as significant a difference across seasons (2010-2013), nor did those with influenza type B (2010-2011, 2012-2013).

“We found no statistically significant difference in LAIV effectiveness compared with IIV against medically attended, laboratory-confirmed influenza illness due to A/H3N2 or B viruses,” Ms. Chung and colleagues concluded. “We found significantly higher odds of influenza A/(H1N1)pdm09 among participants vaccinated with LAIV, compared with IIV, [but] reasons for lower effectiveness of LAIV against the A/(H1N1)pdm09 virus, compared with IIV are not fully understood.”

The investigators added that “the finding appears to be specific to the A/(H1N1)pdm09 vaccine component; we did not detect any statistically significant differences in effectiveness for the other components.” Three previous randomized controlled trials indicated that trivalent LAIV was just as effective, if not more so, than IIV, making the findings of this study surprising and “unexpected,” the authors noted.

This study was supported by the CDC through cooperative agreements with a variety of universities and foundations, and funded by the National Institutes of Health. Ms. Chung and associates reported no relevant financial disclosures.

*A previous version of this story misstated Jessie Chung’s academic title. Ms. Chung holds a Master’s in public health.

dchitnis@frontlinemedcom.com

When vaccinating children against influenza, inactivated and live attenuated influenza vaccines show little significant difference in effectiveness against nearly all strains of the virus, according to a new study in Pediatrics.

However, the study – which examined the effectiveness of IIV and LAIV across four consecutive influenza seasons between 2010 and 2014 – cautions that the 2013-2014 season’s A/(H1N1)pdm09 showed an uncharacteristically large gap in effectiveness favoring IIV, a discrepancy likely due to a problem with a vaccine component in LAIV. (Pediatrics. 2016;137(2):e20153279)

“We found that lower LAIV effectiveness in 2013-2014 was specific to the A/(H1N1)pdm09 vaccine component and was consistent with a previously unexamined effect during the 2010-2011 influenza season,” Jessie R. Chung of the influenza division at the Centers for Disease Control and Prevention and associates wrote, adding that the impetus for the study was the lack of available data “from observational studies after the 2009 pandemic on relative effectiveness of LAIV and IIV in children and adolescents.”

Ms. Chung* and coinvestigators enrolled children aged 2-17 years from clinics and hospitals in Michigan, New York, Pennsylvania, Tennessee, Texas, Washington, and Wisconsin during the 2010-2011, 2011-2012, 2012-2013, and 2013-2014 influenza seasons. Children brought in with symptoms of acute respiratory illness – cough, fever, or feverishness – had nasal and throat swabs collected to test for presence and type of influenza.

In total, 7,718 subjects were evaluated across the four influenza seasons, but after excluding subjects for various reasons – unknown vaccine type, indeterminate vaccine status, and inconclusive reverse transcription polymerase chain reaction results, among others – 6,819 subjects were included for vaccine effectiveness analysis, of which 2,703 were ultimately matched age appropriately and placed into IIV and LAIV cohorts for comparison. The IIV cohort consisted of 2,066 individuals (76.4%), while the LAIV cohort had 637 (23.6%).

During the 2010-2011 season, 66 of the 477 IIV subjects contracted influenza, versus 21 of 116 who received LAIV (14% vs. 18%, respectively). In the 2011-2012 season, 51 of the 499 IIV subjects (10%) contracted influenza, compared with 12 of the 152 LAIV subjects (8%). In the 2012-2013 season, 198 of the 622 IIV subjects (32%) contracted influenza, versus 61 of the 205 LAIV subjects (30%). But, in the 2013-2014 season, 36 of the 468 IIV subjects (8%) contracted influenza, versus 34 of the 164 LAIV subjects (21%).

After adjustment for age and season, the odds ratio for the 2013-2014 season was significantly higher than those of the other seasons across the entire age spectrum of 2-17 years: 2.88, compared with 1.49 (2010-2011), 0.67 (2011-2012), and 0.92 (2012-2013).

When comparing influenza type/subtype, adjusted odds ratio was 5.53 for those with A/(H1N1)pdm09 in the 2010-2011 season, compared with 2.65 for those with the same in the 2013-2014 season. Those with A/H3N2 did not show as significant a difference across seasons (2010-2013), nor did those with influenza type B (2010-2011, 2012-2013).

“We found no statistically significant difference in LAIV effectiveness compared with IIV against medically attended, laboratory-confirmed influenza illness due to A/H3N2 or B viruses,” Ms. Chung and colleagues concluded. “We found significantly higher odds of influenza A/(H1N1)pdm09 among participants vaccinated with LAIV, compared with IIV, [but] reasons for lower effectiveness of LAIV against the A/(H1N1)pdm09 virus, compared with IIV are not fully understood.”

The investigators added that “the finding appears to be specific to the A/(H1N1)pdm09 vaccine component; we did not detect any statistically significant differences in effectiveness for the other components.” Three previous randomized controlled trials indicated that trivalent LAIV was just as effective, if not more so, than IIV, making the findings of this study surprising and “unexpected,” the authors noted.

This study was supported by the CDC through cooperative agreements with a variety of universities and foundations, and funded by the National Institutes of Health. Ms. Chung and associates reported no relevant financial disclosures.

*A previous version of this story misstated Jessie Chung’s academic title. Ms. Chung holds a Master’s in public health.

dchitnis@frontlinemedcom.com