ORLANDO – While some women report new-onset pelvic pain after placement of an Essure sterilization device, results of a retrospective study suggest this pain is actually associated with placement of the device in about 1% of cases.

Among 1,430 women who had an Essure micro-insert (Bayer) placed at a tertiary care hospital in Canada from June 2002 to June 2013, 62 secondary surgeries were performed, including some for removal of fallopian tubes and removal of the device.

In total, 27 patients reported new-onset pelvic pain after Essure placement and another 11 reported worsening of previous pain. Upon further workup, 15 of the 27 women in the new-onset pain group had another possible explanation for their pain, including surgical or pathology findings of endometriosis or adenomyosis. The investigators concluded there was a link between the pain and the device in just 12 (0.8%) of the women.

Among these dozen patients, the investigators linked the pain in eight women to perforation or migration of the Essure device. Investigators found no other obvious cause for the new-onset pain in the remaining four patients and attributed it to the Essure device.

Courtesy Bayer

Does removal help?

In a recently published case series of 29 women who had their Essure device removed laparoscopically because of pain, 23 reported relief following excision (Contraception. 2016 Aug;94[2]:190-2).

“Again, a subset had misplaced inserts or had another condition such as endometriosis,” Dr. Robinson said.

The majority of women whose pain resolved with removal of the devices reported their pain early on, so there is an important takeaway from this,” Dr. Robinson said. “We need to listen to our patients when they report pain shortly after device placement … and respond to that.”

Dr. Robinson advised physicians to be ready to surgically remove the device if that is warranted. “I think a lot of people doing these procedures are not comfortable taking their patient back to the operating room or don’t know who to send them to,” he said. “If you are going to place the device, you should be able to take it out or know someone who can.”
 

The bigger picture

Even though the Essure device is not frequently the cause of pelvic pain, physicians needs to be aware that some patients are likely to assume that it is.

Dr. Robinson pointed to a case in which a woman who had the Essure micro-insert placed 7 years earlier presented with a complaint of a bilateral tingling sensation over the course of 6 months. Online research led her to suspect Essure as the cause of her symptoms. However, on further investigation, it turned out she had relatively high levels of lead in her system from leaky pipes in her home. “It wasn’t an Essure issue,” he said. “But because it’s out there, people will jump to the conclusion that the foreign body is likely the cause of their problem.”

Ob.gyns. should become familiar with websites such as essureproblems.webs.com, which chronicle problems patients have reported with the device, he said.

When talking to patients, start with informed consent and listen to their concerns, Dr. Robinson advised. As part of the counseling about Essure permanent birth control, discuss the risks and benefits of alternatives, such as laparoscopic tubal ligation, long-acting reversible contraception, and vasectomy.

“I took the time to listen to the FDA hearing in Sept 2015 and … it moved me to listen to those patients, and I’ve been a huge advocate of Essure sterilization. I felt for a while I would never do another tubal ligation,” Dr. Robinson said. “But when you listen to patients who have real complaints, what sticks out in your mind is so many of these people are upset because no one took them seriously and listened to them.”

ORLANDO – While some women report new-onset pelvic pain after placement of an Essure sterilization device, results of a retrospective study suggest this pain is actually associated with placement of the device in about 1% of cases.

Among 1,430 women who had an Essure micro-insert (Bayer) placed at a tertiary care hospital in Canada from June 2002 to June 2013, 62 secondary surgeries were performed, including some for removal of fallopian tubes and removal of the device.

In total, 27 patients reported new-onset pelvic pain after Essure placement and another 11 reported worsening of previous pain. Upon further workup, 15 of the 27 women in the new-onset pain group had another possible explanation for their pain, including surgical or pathology findings of endometriosis or adenomyosis. The investigators concluded there was a link between the pain and the device in just 12 (0.8%) of the women.

Among these dozen patients, the investigators linked the pain in eight women to perforation or migration of the Essure device. Investigators found no other obvious cause for the new-onset pain in the remaining four patients and attributed it to the Essure device.

Courtesy Bayer

Does removal help?

In a recently published case series of 29 women who had their Essure device removed laparoscopically because of pain, 23 reported relief following excision (Contraception. 2016 Aug;94[2]:190-2).

“Again, a subset had misplaced inserts or had another condition such as endometriosis,” Dr. Robinson said.

The majority of women whose pain resolved with removal of the devices reported their pain early on, so there is an important takeaway from this,” Dr. Robinson said. “We need to listen to our patients when they report pain shortly after device placement … and respond to that.”

Dr. Robinson advised physicians to be ready to surgically remove the device if that is warranted. “I think a lot of people doing these procedures are not comfortable taking their patient back to the operating room or don’t know who to send them to,” he said. “If you are going to place the device, you should be able to take it out or know someone who can.”
 

The bigger picture

Even though the Essure device is not frequently the cause of pelvic pain, physicians needs to be aware that some patients are likely to assume that it is.

Dr. Robinson pointed to a case in which a woman who had the Essure micro-insert placed 7 years earlier presented with a complaint of a bilateral tingling sensation over the course of 6 months. Online research led her to suspect Essure as the cause of her symptoms. However, on further investigation, it turned out she had relatively high levels of lead in her system from leaky pipes in her home. “It wasn’t an Essure issue,” he said. “But because it’s out there, people will jump to the conclusion that the foreign body is likely the cause of their problem.”

Ob.gyns. should become familiar with websites such as essureproblems.webs.com, which chronicle problems patients have reported with the device, he said.

When talking to patients, start with informed consent and listen to their concerns, Dr. Robinson advised. As part of the counseling about Essure permanent birth control, discuss the risks and benefits of alternatives, such as laparoscopic tubal ligation, long-acting reversible contraception, and vasectomy.

“I took the time to listen to the FDA hearing in Sept 2015 and … it moved me to listen to those patients, and I’ve been a huge advocate of Essure sterilization. I felt for a while I would never do another tubal ligation,” Dr. Robinson said. “But when you listen to patients who have real complaints, what sticks out in your mind is so many of these people are upset because no one took them seriously and listened to them.”

ORLANDO – While some women report new-onset pelvic pain after placement of an Essure sterilization device, results of a retrospective study suggest this pain is actually associated with placement of the device in about 1% of cases.

Among 1,430 women who had an Essure micro-insert (Bayer) placed at a tertiary care hospital in Canada from June 2002 to June 2013, 62 secondary surgeries were performed, including some for removal of fallopian tubes and removal of the device.

In total, 27 patients reported new-onset pelvic pain after Essure placement and another 11 reported worsening of previous pain. Upon further workup, 15 of the 27 women in the new-onset pain group had another possible explanation for their pain, including surgical or pathology findings of endometriosis or adenomyosis. The investigators concluded there was a link between the pain and the device in just 12 (0.8%) of the women.

Among these dozen patients, the investigators linked the pain in eight women to perforation or migration of the Essure device. Investigators found no other obvious cause for the new-onset pain in the remaining four patients and attributed it to the Essure device.

Courtesy Bayer

Does removal help?

In a recently published case series of 29 women who had their Essure device removed laparoscopically because of pain, 23 reported relief following excision (Contraception. 2016 Aug;94[2]:190-2).

“Again, a subset had misplaced inserts or had another condition such as endometriosis,” Dr. Robinson said.

The majority of women whose pain resolved with removal of the devices reported their pain early on, so there is an important takeaway from this,” Dr. Robinson said. “We need to listen to our patients when they report pain shortly after device placement … and respond to that.”

Dr. Robinson advised physicians to be ready to surgically remove the device if that is warranted. “I think a lot of people doing these procedures are not comfortable taking their patient back to the operating room or don’t know who to send them to,” he said. “If you are going to place the device, you should be able to take it out or know someone who can.”
 

The bigger picture

Even though the Essure device is not frequently the cause of pelvic pain, physicians needs to be aware that some patients are likely to assume that it is.

Dr. Robinson pointed to a case in which a woman who had the Essure micro-insert placed 7 years earlier presented with a complaint of a bilateral tingling sensation over the course of 6 months. Online research led her to suspect Essure as the cause of her symptoms. However, on further investigation, it turned out she had relatively high levels of lead in her system from leaky pipes in her home. “It wasn’t an Essure issue,” he said. “But because it’s out there, people will jump to the conclusion that the foreign body is likely the cause of their problem.”

Ob.gyns. should become familiar with websites such as essureproblems.webs.com, which chronicle problems patients have reported with the device, he said.

When talking to patients, start with informed consent and listen to their concerns, Dr. Robinson advised. As part of the counseling about Essure permanent birth control, discuss the risks and benefits of alternatives, such as laparoscopic tubal ligation, long-acting reversible contraception, and vasectomy.

“I took the time to listen to the FDA hearing in Sept 2015 and … it moved me to listen to those patients, and I’ve been a huge advocate of Essure sterilization. I felt for a while I would never do another tubal ligation,” Dr. Robinson said. “But when you listen to patients who have real complaints, what sticks out in your mind is so many of these people are upset because no one took them seriously and listened to them.”

For Beth Drolet, MD, a pediatric dermatologist in Wisconsin, the tremendous impact oral propranolol has had on the treatment of severe infantile hemangioma is written on the faces of children diagnosed with the condition in recent years.

“You can tell which drugs the kids were on by their age,” said Dr. Drolet, professor of dermatology and pediatrics at the Medical College of Wisconsin, Milwaukee. “If they were born before 2008, before we used this medication, those kids have had multiple surgeries and are still not looking that good. But we rarely see that in the kids born after.”

• Caution parents about side effects. Cardiac side effects have been “extraordinarily rare,” Dr. Drolet said. “We have seen problems with wheezing and, very rarely, severe hypoglycemia,” which can be prevented by educating the family. While it’s uncommon for the medication alone to produce wheezing, this may occur when a respiratory infection and propranolol combine to stress the body, she noted.

In some cases, physicians prescribe albuterol for wheezing without realizing that it will interact with propranolol, she added. “One is a beta-blocker, and the other is a beta-antagonist. They completely cancel each other out.”

To prevent hypoglycemia, Dr. Frieden said she recommends that children be fed every 6 hours if they’re under 6 months old or every 8 hours if they’re over 6 months of age. And Dr. Drolet said she advises parents to stop propranolol when their infants are sick.

A major focus of an educational video provided by Dr. Drolet’s clinic is advising parents “to stop the medication if the infant is not eating regularly, vomiting, or has diarrhea. It interferes with how you respond to low blood sugar if you’re not eating,” she said. “That surprised us. Now that we’ve been teaching parents about when to call us, that’s been pretty preventable.”

Minor side effects include cold hands and feet and sleep disturbances such as sleepiness and apparent nightmares, Dr. Frieden pointed out.

• Monitor guidelines regarding safety and protocols. “Over time, we’re getting more and more expertise,” Dr. Drolet said. For example, her clinic no longer performs ECGs on babies who take the medication because research has suggested they are not needed.

• Spend time developing an education program for parents. Dr. Drolet’s clinic provides the educational video to teach parents about how oral propranolol is used. “We haven’t done that for any other drugs,” she said. “But we want to make sure we aren’t overdosing it. We’ve been very careful about our parent education to prevent that.”

Guidelines on the diagnosis and management of infantile hemangioma were published in 2015 in Pediatrics (2015 Oct;136[4]:e1060-104).

Dr. Frieden has consulted for Pierre Fabre Dermatologie, the manufacturer of the oral propranolol product, marketed as Hemangeol. Dr. Drolet has received an investigator-initiated grant from the company.

For Beth Drolet, MD, a pediatric dermatologist in Wisconsin, the tremendous impact oral propranolol has had on the treatment of severe infantile hemangioma is written on the faces of children diagnosed with the condition in recent years.

“You can tell which drugs the kids were on by their age,” said Dr. Drolet, professor of dermatology and pediatrics at the Medical College of Wisconsin, Milwaukee. “If they were born before 2008, before we used this medication, those kids have had multiple surgeries and are still not looking that good. But we rarely see that in the kids born after.”

• Caution parents about side effects. Cardiac side effects have been “extraordinarily rare,” Dr. Drolet said. “We have seen problems with wheezing and, very rarely, severe hypoglycemia,” which can be prevented by educating the family. While it’s uncommon for the medication alone to produce wheezing, this may occur when a respiratory infection and propranolol combine to stress the body, she noted.

In some cases, physicians prescribe albuterol for wheezing without realizing that it will interact with propranolol, she added. “One is a beta-blocker, and the other is a beta-antagonist. They completely cancel each other out.”

To prevent hypoglycemia, Dr. Frieden said she recommends that children be fed every 6 hours if they’re under 6 months old or every 8 hours if they’re over 6 months of age. And Dr. Drolet said she advises parents to stop propranolol when their infants are sick.

A major focus of an educational video provided by Dr. Drolet’s clinic is advising parents “to stop the medication if the infant is not eating regularly, vomiting, or has diarrhea. It interferes with how you respond to low blood sugar if you’re not eating,” she said. “That surprised us. Now that we’ve been teaching parents about when to call us, that’s been pretty preventable.”

Minor side effects include cold hands and feet and sleep disturbances such as sleepiness and apparent nightmares, Dr. Frieden pointed out.

• Monitor guidelines regarding safety and protocols. “Over time, we’re getting more and more expertise,” Dr. Drolet said. For example, her clinic no longer performs ECGs on babies who take the medication because research has suggested they are not needed.

• Spend time developing an education program for parents. Dr. Drolet’s clinic provides the educational video to teach parents about how oral propranolol is used. “We haven’t done that for any other drugs,” she said. “But we want to make sure we aren’t overdosing it. We’ve been very careful about our parent education to prevent that.”

Guidelines on the diagnosis and management of infantile hemangioma were published in 2015 in Pediatrics (2015 Oct;136[4]:e1060-104).

Dr. Frieden has consulted for Pierre Fabre Dermatologie, the manufacturer of the oral propranolol product, marketed as Hemangeol. Dr. Drolet has received an investigator-initiated grant from the company.

For Beth Drolet, MD, a pediatric dermatologist in Wisconsin, the tremendous impact oral propranolol has had on the treatment of severe infantile hemangioma is written on the faces of children diagnosed with the condition in recent years.

“You can tell which drugs the kids were on by their age,” said Dr. Drolet, professor of dermatology and pediatrics at the Medical College of Wisconsin, Milwaukee. “If they were born before 2008, before we used this medication, those kids have had multiple surgeries and are still not looking that good. But we rarely see that in the kids born after.”

• Caution parents about side effects. Cardiac side effects have been “extraordinarily rare,” Dr. Drolet said. “We have seen problems with wheezing and, very rarely, severe hypoglycemia,” which can be prevented by educating the family. While it’s uncommon for the medication alone to produce wheezing, this may occur when a respiratory infection and propranolol combine to stress the body, she noted.

In some cases, physicians prescribe albuterol for wheezing without realizing that it will interact with propranolol, she added. “One is a beta-blocker, and the other is a beta-antagonist. They completely cancel each other out.”

To prevent hypoglycemia, Dr. Frieden said she recommends that children be fed every 6 hours if they’re under 6 months old or every 8 hours if they’re over 6 months of age. And Dr. Drolet said she advises parents to stop propranolol when their infants are sick.

A major focus of an educational video provided by Dr. Drolet’s clinic is advising parents “to stop the medication if the infant is not eating regularly, vomiting, or has diarrhea. It interferes with how you respond to low blood sugar if you’re not eating,” she said. “That surprised us. Now that we’ve been teaching parents about when to call us, that’s been pretty preventable.”

Minor side effects include cold hands and feet and sleep disturbances such as sleepiness and apparent nightmares, Dr. Frieden pointed out.

• Monitor guidelines regarding safety and protocols. “Over time, we’re getting more and more expertise,” Dr. Drolet said. For example, her clinic no longer performs ECGs on babies who take the medication because research has suggested they are not needed.

• Spend time developing an education program for parents. Dr. Drolet’s clinic provides the educational video to teach parents about how oral propranolol is used. “We haven’t done that for any other drugs,” she said. “But we want to make sure we aren’t overdosing it. We’ve been very careful about our parent education to prevent that.”

Guidelines on the diagnosis and management of infantile hemangioma were published in 2015 in Pediatrics (2015 Oct;136[4]:e1060-104).

Dr. Frieden has consulted for Pierre Fabre Dermatologie, the manufacturer of the oral propranolol product, marketed as Hemangeol. Dr. Drolet has received an investigator-initiated grant from the company.

Routine ECG screening in infants before they receive propranolol for hemangiomas is “not likely to be an effective screening tool in patients with otherwise normal physical examination and family history” and may even cause harmful delays in treatment, study authors concluded.

“As previously published guidelines suggest, it is likely that an indication-driven ECG strategy is a better approach, because there is a low incidence of ECG abnormalities that would limit propranolol use in children,” wrote Kevin B. Yarbrough, MD, a dermatologist at Phoenix Children’s Hospital, and his associates. The results “support published guidelines for propranolol initiation and are congruent with findings from other investigators” (Pediatr Dermatol. 2016 Nov;33[6]:615-20).

In the retrospective study, Dr. Yarbrough and his associates tracked 162 patients (median age, 5.2 months) who underwent routine ECG screening at several clinics before propranolol treatment for hemangiomas from 2008 to 2013. The ECGs were read as abnormal in 69 cases (43%); the most common abnormality was left ventricular hypertrophy (16 patients), followed by right ventricular hypertrophy (8), sinus bradycardia (6), and sinus tachycardia (5).

Cardiologists cleared all 69 patients for propranolol treatment, which they received. “No patients in our cohort experienced an adverse effect during treatment that could have been predicted or prevented by ECG before initiation of the propranolol,” the authors wrote.

“Routine ECG adds to the cost of treating hemangiomas and leads to unnecessary consultations and testing. Even more importantly, abnormalities detected on ECG can lead to delays in treatment initiation, which in turn can lead to greater patient morbidity, as seen in the case of our patient whose hemangioma ulcerated while awaiting cardiology consultation,” they added.

Still, they noted that ECG tests should still be performed on “infants with bradycardia or cardiac arrhythmia found during initial physical examination, a family history of congenital heart disease or arrhythmias, and a maternal history of connective tissue disease.”

Study funding information was not provided. One of the study authors reported that he was a clinical investigator for Pierre Fabre Dermatologie, the manufacturer of the oral propranolol product Hemangeol.

Routine ECG screening in infants before they receive propranolol for hemangiomas is “not likely to be an effective screening tool in patients with otherwise normal physical examination and family history” and may even cause harmful delays in treatment, study authors concluded.

“As previously published guidelines suggest, it is likely that an indication-driven ECG strategy is a better approach, because there is a low incidence of ECG abnormalities that would limit propranolol use in children,” wrote Kevin B. Yarbrough, MD, a dermatologist at Phoenix Children’s Hospital, and his associates. The results “support published guidelines for propranolol initiation and are congruent with findings from other investigators” (Pediatr Dermatol. 2016 Nov;33[6]:615-20).

In the retrospective study, Dr. Yarbrough and his associates tracked 162 patients (median age, 5.2 months) who underwent routine ECG screening at several clinics before propranolol treatment for hemangiomas from 2008 to 2013. The ECGs were read as abnormal in 69 cases (43%); the most common abnormality was left ventricular hypertrophy (16 patients), followed by right ventricular hypertrophy (8), sinus bradycardia (6), and sinus tachycardia (5).

Cardiologists cleared all 69 patients for propranolol treatment, which they received. “No patients in our cohort experienced an adverse effect during treatment that could have been predicted or prevented by ECG before initiation of the propranolol,” the authors wrote.

“Routine ECG adds to the cost of treating hemangiomas and leads to unnecessary consultations and testing. Even more importantly, abnormalities detected on ECG can lead to delays in treatment initiation, which in turn can lead to greater patient morbidity, as seen in the case of our patient whose hemangioma ulcerated while awaiting cardiology consultation,” they added.

Still, they noted that ECG tests should still be performed on “infants with bradycardia or cardiac arrhythmia found during initial physical examination, a family history of congenital heart disease or arrhythmias, and a maternal history of connective tissue disease.”

Study funding information was not provided. One of the study authors reported that he was a clinical investigator for Pierre Fabre Dermatologie, the manufacturer of the oral propranolol product Hemangeol.

Routine ECG screening in infants before they receive propranolol for hemangiomas is “not likely to be an effective screening tool in patients with otherwise normal physical examination and family history” and may even cause harmful delays in treatment, study authors concluded.

“As previously published guidelines suggest, it is likely that an indication-driven ECG strategy is a better approach, because there is a low incidence of ECG abnormalities that would limit propranolol use in children,” wrote Kevin B. Yarbrough, MD, a dermatologist at Phoenix Children’s Hospital, and his associates. The results “support published guidelines for propranolol initiation and are congruent with findings from other investigators” (Pediatr Dermatol. 2016 Nov;33[6]:615-20).

In the retrospective study, Dr. Yarbrough and his associates tracked 162 patients (median age, 5.2 months) who underwent routine ECG screening at several clinics before propranolol treatment for hemangiomas from 2008 to 2013. The ECGs were read as abnormal in 69 cases (43%); the most common abnormality was left ventricular hypertrophy (16 patients), followed by right ventricular hypertrophy (8), sinus bradycardia (6), and sinus tachycardia (5).

Cardiologists cleared all 69 patients for propranolol treatment, which they received. “No patients in our cohort experienced an adverse effect during treatment that could have been predicted or prevented by ECG before initiation of the propranolol,” the authors wrote.

“Routine ECG adds to the cost of treating hemangiomas and leads to unnecessary consultations and testing. Even more importantly, abnormalities detected on ECG can lead to delays in treatment initiation, which in turn can lead to greater patient morbidity, as seen in the case of our patient whose hemangioma ulcerated while awaiting cardiology consultation,” they added.

Still, they noted that ECG tests should still be performed on “infants with bradycardia or cardiac arrhythmia found during initial physical examination, a family history of congenital heart disease or arrhythmias, and a maternal history of connective tissue disease.”

Study funding information was not provided. One of the study authors reported that he was a clinical investigator for Pierre Fabre Dermatologie, the manufacturer of the oral propranolol product Hemangeol.

NEW ORLEANS – Longer follow-up has not altered initial negative findings of the randomized phase II TIME trial, which tested the efficacy of early intracoronary stem cell therapy, given on day 3 or 7 after an ST-segment acute MI (STEMI). However, loss of the sickest patients from follow-up may have influenced the findings.

“When TIME (Transplantation in Myocardial Infarction Evaluation) was developed several years ago, the optimal timing for cell delivery following myocardial infarction was not known and had not been directly tested in a prospective clinical trial,” explained lead investigator Jay H. Traverse, MD, director of research at the Minneapolis Heart Institute Foundation and a senior consulting cardiologist at the Abbott Northwestern Hospital, Minneapolis.

Challenges to research

Two challenging issues seen in many trials of cell therapy for cardiovascular disease are their underpowered nature and the changing natural history of the disease, according to session comoderator Timothy D. Henry, MD, head of cardiology at Cedars-Sinai in Los Angeles.

“One of the things with the TIME trial that’s striking, really, is that even though these are high-risk patients, there was almost no mortality in 2 years,” he commented. “Second of all... there were no differences in ejection fraction, but that’s because you are missing 30% of people. And your missing 30% of people are the sick people, so of course if you are just going to follow normal people for 2 years, you’re going to have normal results.”

“What you are seeing is a little bit illusory because all the sick patients got ICDs and we could no longer image them at that time,” Dr. Traverse agreed. “That will be less of an issue in some of our future trials that we have started now, like CONCERT and SENECA, where we are now able to do MRI analysis of people with devices. So that will certainly help.”

Nonetheless, all trials in similar patient populations are plagued by substantial rates of dropout over time and faced with improving outcomes generally, because of better medical therapy, he acknowledged. “You can see as far as the natural history, even taking into account the ICD changes that would have lowered volumes, people are pretty stable on medical therapy. Their ejection fractions and volumes out to 2 years were really quite stable. We have certainly impacted that.”

That issue raises the question of whether investigators should be using other endpoints going forward, according to session panelist Doris A. Taylor, PhD, director of Regenerative Medicine Research at the Texas Heart Institute in Houston.

“One of the things I’ve seen over and over in this field is constantly evolving questions about which endpoints we should follow and what constitutes positive effects,” she commented. “So given the natural history, what are the endpoints we should be using?”

“Patients don’t care what their ejection fraction is per se. But they want to know if they have to get an ICD or if they will be hospitalized for heart failure, and their family is affected if they die,” Dr. Traverse replied. “We definitely need these hard endpoints. The problem is that you need so many patients with these hard endpoints that [the trials] are just financially not very doable. So that’s a big issue.”

Trial details

Patients enrolled in TIME had a first anterior STEMI, underwent reperfusion by angioplasty and stenting, and had LV dysfunction with an ejection fraction of 45% or lower. They all received either autologous bone marrow mononuclear cells or placebo on day 3 or day 7 after their MI by intracoronary infusion.

Of the initial 120 randomized patients, 10 patients were lost to follow-up because of receipt of an ICD, 3 had died (1 each from cardiovascular causes, pancreatitis, and hemorrhagic stroke), 7 were lost to follow-up for other reasons, and 15 had acquired other contraindications to MRI, according to Dr. Traverse.

At 2 years, the remaining patients in both the cell therapy and placebo groups had roughly 5% absolute increases in LV ejection fraction from baseline and roughly 45% reductions in infarct size from baseline, with no significant differences between groups.

When all patients were combined, about half were determined to have had microvascular obstruction at baseline. This finding was an adverse prognostic factor, associated with poorer recovery of LV function over time, greater adverse LV remodeling, and a higher likelihood of receiving an ICD, Dr. Traverse reported.

He has received a research grant from the National Heart, Lung, and Blood Institute, which sponsored the TIME trial.

NEW ORLEANS – Longer follow-up has not altered initial negative findings of the randomized phase II TIME trial, which tested the efficacy of early intracoronary stem cell therapy, given on day 3 or 7 after an ST-segment acute MI (STEMI). However, loss of the sickest patients from follow-up may have influenced the findings.

“When TIME (Transplantation in Myocardial Infarction Evaluation) was developed several years ago, the optimal timing for cell delivery following myocardial infarction was not known and had not been directly tested in a prospective clinical trial,” explained lead investigator Jay H. Traverse, MD, director of research at the Minneapolis Heart Institute Foundation and a senior consulting cardiologist at the Abbott Northwestern Hospital, Minneapolis.

Challenges to research

Two challenging issues seen in many trials of cell therapy for cardiovascular disease are their underpowered nature and the changing natural history of the disease, according to session comoderator Timothy D. Henry, MD, head of cardiology at Cedars-Sinai in Los Angeles.

“One of the things with the TIME trial that’s striking, really, is that even though these are high-risk patients, there was almost no mortality in 2 years,” he commented. “Second of all... there were no differences in ejection fraction, but that’s because you are missing 30% of people. And your missing 30% of people are the sick people, so of course if you are just going to follow normal people for 2 years, you’re going to have normal results.”

“What you are seeing is a little bit illusory because all the sick patients got ICDs and we could no longer image them at that time,” Dr. Traverse agreed. “That will be less of an issue in some of our future trials that we have started now, like CONCERT and SENECA, where we are now able to do MRI analysis of people with devices. So that will certainly help.”

Nonetheless, all trials in similar patient populations are plagued by substantial rates of dropout over time and faced with improving outcomes generally, because of better medical therapy, he acknowledged. “You can see as far as the natural history, even taking into account the ICD changes that would have lowered volumes, people are pretty stable on medical therapy. Their ejection fractions and volumes out to 2 years were really quite stable. We have certainly impacted that.”

That issue raises the question of whether investigators should be using other endpoints going forward, according to session panelist Doris A. Taylor, PhD, director of Regenerative Medicine Research at the Texas Heart Institute in Houston.

“One of the things I’ve seen over and over in this field is constantly evolving questions about which endpoints we should follow and what constitutes positive effects,” she commented. “So given the natural history, what are the endpoints we should be using?”

“Patients don’t care what their ejection fraction is per se. But they want to know if they have to get an ICD or if they will be hospitalized for heart failure, and their family is affected if they die,” Dr. Traverse replied. “We definitely need these hard endpoints. The problem is that you need so many patients with these hard endpoints that [the trials] are just financially not very doable. So that’s a big issue.”

Trial details

Patients enrolled in TIME had a first anterior STEMI, underwent reperfusion by angioplasty and stenting, and had LV dysfunction with an ejection fraction of 45% or lower. They all received either autologous bone marrow mononuclear cells or placebo on day 3 or day 7 after their MI by intracoronary infusion.

Of the initial 120 randomized patients, 10 patients were lost to follow-up because of receipt of an ICD, 3 had died (1 each from cardiovascular causes, pancreatitis, and hemorrhagic stroke), 7 were lost to follow-up for other reasons, and 15 had acquired other contraindications to MRI, according to Dr. Traverse.

At 2 years, the remaining patients in both the cell therapy and placebo groups had roughly 5% absolute increases in LV ejection fraction from baseline and roughly 45% reductions in infarct size from baseline, with no significant differences between groups.

When all patients were combined, about half were determined to have had microvascular obstruction at baseline. This finding was an adverse prognostic factor, associated with poorer recovery of LV function over time, greater adverse LV remodeling, and a higher likelihood of receiving an ICD, Dr. Traverse reported.

He has received a research grant from the National Heart, Lung, and Blood Institute, which sponsored the TIME trial.

NEW ORLEANS – Longer follow-up has not altered initial negative findings of the randomized phase II TIME trial, which tested the efficacy of early intracoronary stem cell therapy, given on day 3 or 7 after an ST-segment acute MI (STEMI). However, loss of the sickest patients from follow-up may have influenced the findings.

“When TIME (Transplantation in Myocardial Infarction Evaluation) was developed several years ago, the optimal timing for cell delivery following myocardial infarction was not known and had not been directly tested in a prospective clinical trial,” explained lead investigator Jay H. Traverse, MD, director of research at the Minneapolis Heart Institute Foundation and a senior consulting cardiologist at the Abbott Northwestern Hospital, Minneapolis.

Challenges to research

Two challenging issues seen in many trials of cell therapy for cardiovascular disease are their underpowered nature and the changing natural history of the disease, according to session comoderator Timothy D. Henry, MD, head of cardiology at Cedars-Sinai in Los Angeles.

“One of the things with the TIME trial that’s striking, really, is that even though these are high-risk patients, there was almost no mortality in 2 years,” he commented. “Second of all... there were no differences in ejection fraction, but that’s because you are missing 30% of people. And your missing 30% of people are the sick people, so of course if you are just going to follow normal people for 2 years, you’re going to have normal results.”

“What you are seeing is a little bit illusory because all the sick patients got ICDs and we could no longer image them at that time,” Dr. Traverse agreed. “That will be less of an issue in some of our future trials that we have started now, like CONCERT and SENECA, where we are now able to do MRI analysis of people with devices. So that will certainly help.”

Nonetheless, all trials in similar patient populations are plagued by substantial rates of dropout over time and faced with improving outcomes generally, because of better medical therapy, he acknowledged. “You can see as far as the natural history, even taking into account the ICD changes that would have lowered volumes, people are pretty stable on medical therapy. Their ejection fractions and volumes out to 2 years were really quite stable. We have certainly impacted that.”

That issue raises the question of whether investigators should be using other endpoints going forward, according to session panelist Doris A. Taylor, PhD, director of Regenerative Medicine Research at the Texas Heart Institute in Houston.

“One of the things I’ve seen over and over in this field is constantly evolving questions about which endpoints we should follow and what constitutes positive effects,” she commented. “So given the natural history, what are the endpoints we should be using?”

“Patients don’t care what their ejection fraction is per se. But they want to know if they have to get an ICD or if they will be hospitalized for heart failure, and their family is affected if they die,” Dr. Traverse replied. “We definitely need these hard endpoints. The problem is that you need so many patients with these hard endpoints that [the trials] are just financially not very doable. So that’s a big issue.”

Trial details

Patients enrolled in TIME had a first anterior STEMI, underwent reperfusion by angioplasty and stenting, and had LV dysfunction with an ejection fraction of 45% or lower. They all received either autologous bone marrow mononuclear cells or placebo on day 3 or day 7 after their MI by intracoronary infusion.

Of the initial 120 randomized patients, 10 patients were lost to follow-up because of receipt of an ICD, 3 had died (1 each from cardiovascular causes, pancreatitis, and hemorrhagic stroke), 7 were lost to follow-up for other reasons, and 15 had acquired other contraindications to MRI, according to Dr. Traverse.

At 2 years, the remaining patients in both the cell therapy and placebo groups had roughly 5% absolute increases in LV ejection fraction from baseline and roughly 45% reductions in infarct size from baseline, with no significant differences between groups.

When all patients were combined, about half were determined to have had microvascular obstruction at baseline. This finding was an adverse prognostic factor, associated with poorer recovery of LV function over time, greater adverse LV remodeling, and a higher likelihood of receiving an ICD, Dr. Traverse reported.

He has received a research grant from the National Heart, Lung, and Blood Institute, which sponsored the TIME trial.

WASHINGTON – Many patients with systemic lupus erythematosus may not be getting lipid testing or statin prescriptions despite having risk factors and even frank cardiovascular conditions, according to a large Medicaid database study presented at the annual meeting of the American College of Rheumatology.

The study found that systemic lupus erythematosus (SLE) patients were half as likely to get a lipid screening and 77% less likely to get a statin prescription, compared with patients with diabetes, a group that has a similarly elevated baseline CV disease risk.

This is concerning because it has been shown in several studies that SLE patients have higher rates of CV events than do age- and sex-matched patients with diabetes, and hyperlipidemia has been associated with CV disease in SLE patients. However, no studies have directly demonstrated reduced CV disease risk with statin use in SLE patients, unlike the general population and in those with diabetes, and so no clear guidelines exist, said lead study author Sarah Chen, MD, a rheumatology fellow at Brigham and Women’s Hospital, Boston.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

WASHINGTON – Many patients with systemic lupus erythematosus may not be getting lipid testing or statin prescriptions despite having risk factors and even frank cardiovascular conditions, according to a large Medicaid database study presented at the annual meeting of the American College of Rheumatology.

The study found that systemic lupus erythematosus (SLE) patients were half as likely to get a lipid screening and 77% less likely to get a statin prescription, compared with patients with diabetes, a group that has a similarly elevated baseline CV disease risk.

This is concerning because it has been shown in several studies that SLE patients have higher rates of CV events than do age- and sex-matched patients with diabetes, and hyperlipidemia has been associated with CV disease in SLE patients. However, no studies have directly demonstrated reduced CV disease risk with statin use in SLE patients, unlike the general population and in those with diabetes, and so no clear guidelines exist, said lead study author Sarah Chen, MD, a rheumatology fellow at Brigham and Women’s Hospital, Boston.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

WASHINGTON – Many patients with systemic lupus erythematosus may not be getting lipid testing or statin prescriptions despite having risk factors and even frank cardiovascular conditions, according to a large Medicaid database study presented at the annual meeting of the American College of Rheumatology.

The study found that systemic lupus erythematosus (SLE) patients were half as likely to get a lipid screening and 77% less likely to get a statin prescription, compared with patients with diabetes, a group that has a similarly elevated baseline CV disease risk.

This is concerning because it has been shown in several studies that SLE patients have higher rates of CV events than do age- and sex-matched patients with diabetes, and hyperlipidemia has been associated with CV disease in SLE patients. However, no studies have directly demonstrated reduced CV disease risk with statin use in SLE patients, unlike the general population and in those with diabetes, and so no clear guidelines exist, said lead study author Sarah Chen, MD, a rheumatology fellow at Brigham and Women’s Hospital, Boston.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

WASHINGTON – The lipid changes induced by tocilizumab do not translate into an increased risk of heart attack or stroke in patients with rheumatoid arthritis, a 5-year postmarketing study has determined.

Patients taking the drug experienced quick and dramatic increases in low-density lipoprotein cholesterol: 12% in just 4 weeks. But when compared against patients taking etanercept, they showed no significant increases in stroke, heart attack, heart failure hospitalization, or cardiac death, Jon Giles, MD, said at the annual meeting of the American College of Rheumatology.

Tocilizumab’s profound effects on lipids have been confirmed in all of its pivotal trials, with average across-the-board increases of 17%-25% in total cholesterol, low-and high-density cholesterol, and triglycerides. ENTRACTE is the first trial, however, to compare its cardiovascular safety profile to that of another RA medication.

The study comprised 3,080 patients with active, seropositive RA from 353 centers across 31 countries. The mean age of the patients was 61 years. All patients had at least one cardiovascular risk factor, including current smoking (30%), hypertension (71%), or diabetes (18%). About a quarter were already taking a statin, and about 5% had a history of heart attack, stroke, or coronary revascularization.

They were randomized to open-label tocilizumab 8 mg/kg infused every 4 weeks or etanercept 50 mg injected weekly. The mean follow-up reported was 3.5 years, but some patients had full 5-year data. “This was plenty of time to see early atherothrombotic complications if they were going to develop,” Dr. Giles said.

The primary endpoint was a composite of major cardiovascular outcomes including cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Secondary outcomes included individual components of the primary endpoint, as well as all-cause mortality, heart failure hospitalization, fatal and nonfatal myocardial infarction and stroke, and lipid levels.

By week 4, LDL-cholesterol levels had risen by almost 12% in the tocilizumab group. This moderated somewhat, but stayed elevated, reaching 9% above baseline by week 144. In contrast, LDL-cholesterol in the etanercept group was virtually unchanged throughout the study.

In the intent-to-treat analysis, there were 161 occurrences of the composite outcome: 83 in the tocilizumab group and 78 in the etanercept group (hazard ratio, 1.05). This was not a significant difference. The event rate was 1.70 per 100 person-years in the etanercept group and 1.82 in the tocilizumab group – also not significantly different.

The individual secondary endpoints were almost identical in each group: cardiovascular death, 35 with etanercept vs. 36 with tocilizumab; nonfatal MI, 31 vs. 28; nonfatal stroke, 15 vs. 24; and all-cause mortality, 64 in each group. A multivariate regression analysis showed no significantly increased risks associated with tocilizumab in any of the secondary endpoints. The rates and types of adverse events were also similar.

Because this was a safety study, the investigators were interested in the uncertainty in their estimate of risk, Dr. Giles said in an interview.

“The study was designed to exclude at most an 80% increase in cardiovascular events for the patients treated with tocilizumab, compared with etanercept. What we determined was that we could exclude with 95% certainty that if a much larger sample of similar patients was studied, the risk of such events in the tocilizumab group would not exceed a 43% higher rate at the extreme. Notably, the degree of uncertainty included the possibility that the event rate could be lower in the tocilizumab group, compared with those treated with etanercept.”

Dr. Giles reported receiving consulting fees from Genentech, which markets tocilizumab. All other authors also disclosed financial relationships with Genentech or its parent company, Roche. Four authors were employees of Roche/Genentech.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

WASHINGTON – The lipid changes induced by tocilizumab do not translate into an increased risk of heart attack or stroke in patients with rheumatoid arthritis, a 5-year postmarketing study has determined.

Patients taking the drug experienced quick and dramatic increases in low-density lipoprotein cholesterol: 12% in just 4 weeks. But when compared against patients taking etanercept, they showed no significant increases in stroke, heart attack, heart failure hospitalization, or cardiac death, Jon Giles, MD, said at the annual meeting of the American College of Rheumatology.

Tocilizumab’s profound effects on lipids have been confirmed in all of its pivotal trials, with average across-the-board increases of 17%-25% in total cholesterol, low-and high-density cholesterol, and triglycerides. ENTRACTE is the first trial, however, to compare its cardiovascular safety profile to that of another RA medication.

The study comprised 3,080 patients with active, seropositive RA from 353 centers across 31 countries. The mean age of the patients was 61 years. All patients had at least one cardiovascular risk factor, including current smoking (30%), hypertension (71%), or diabetes (18%). About a quarter were already taking a statin, and about 5% had a history of heart attack, stroke, or coronary revascularization.

They were randomized to open-label tocilizumab 8 mg/kg infused every 4 weeks or etanercept 50 mg injected weekly. The mean follow-up reported was 3.5 years, but some patients had full 5-year data. “This was plenty of time to see early atherothrombotic complications if they were going to develop,” Dr. Giles said.

The primary endpoint was a composite of major cardiovascular outcomes including cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Secondary outcomes included individual components of the primary endpoint, as well as all-cause mortality, heart failure hospitalization, fatal and nonfatal myocardial infarction and stroke, and lipid levels.

By week 4, LDL-cholesterol levels had risen by almost 12% in the tocilizumab group. This moderated somewhat, but stayed elevated, reaching 9% above baseline by week 144. In contrast, LDL-cholesterol in the etanercept group was virtually unchanged throughout the study.

In the intent-to-treat analysis, there were 161 occurrences of the composite outcome: 83 in the tocilizumab group and 78 in the etanercept group (hazard ratio, 1.05). This was not a significant difference. The event rate was 1.70 per 100 person-years in the etanercept group and 1.82 in the tocilizumab group – also not significantly different.

The individual secondary endpoints were almost identical in each group: cardiovascular death, 35 with etanercept vs. 36 with tocilizumab; nonfatal MI, 31 vs. 28; nonfatal stroke, 15 vs. 24; and all-cause mortality, 64 in each group. A multivariate regression analysis showed no significantly increased risks associated with tocilizumab in any of the secondary endpoints. The rates and types of adverse events were also similar.

Because this was a safety study, the investigators were interested in the uncertainty in their estimate of risk, Dr. Giles said in an interview.

“The study was designed to exclude at most an 80% increase in cardiovascular events for the patients treated with tocilizumab, compared with etanercept. What we determined was that we could exclude with 95% certainty that if a much larger sample of similar patients was studied, the risk of such events in the tocilizumab group would not exceed a 43% higher rate at the extreme. Notably, the degree of uncertainty included the possibility that the event rate could be lower in the tocilizumab group, compared with those treated with etanercept.”

Dr. Giles reported receiving consulting fees from Genentech, which markets tocilizumab. All other authors also disclosed financial relationships with Genentech or its parent company, Roche. Four authors were employees of Roche/Genentech.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

WASHINGTON – The lipid changes induced by tocilizumab do not translate into an increased risk of heart attack or stroke in patients with rheumatoid arthritis, a 5-year postmarketing study has determined.

Patients taking the drug experienced quick and dramatic increases in low-density lipoprotein cholesterol: 12% in just 4 weeks. But when compared against patients taking etanercept, they showed no significant increases in stroke, heart attack, heart failure hospitalization, or cardiac death, Jon Giles, MD, said at the annual meeting of the American College of Rheumatology.

Tocilizumab’s profound effects on lipids have been confirmed in all of its pivotal trials, with average across-the-board increases of 17%-25% in total cholesterol, low-and high-density cholesterol, and triglycerides. ENTRACTE is the first trial, however, to compare its cardiovascular safety profile to that of another RA medication.

The study comprised 3,080 patients with active, seropositive RA from 353 centers across 31 countries. The mean age of the patients was 61 years. All patients had at least one cardiovascular risk factor, including current smoking (30%), hypertension (71%), or diabetes (18%). About a quarter were already taking a statin, and about 5% had a history of heart attack, stroke, or coronary revascularization.

They were randomized to open-label tocilizumab 8 mg/kg infused every 4 weeks or etanercept 50 mg injected weekly. The mean follow-up reported was 3.5 years, but some patients had full 5-year data. “This was plenty of time to see early atherothrombotic complications if they were going to develop,” Dr. Giles said.

The primary endpoint was a composite of major cardiovascular outcomes including cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Secondary outcomes included individual components of the primary endpoint, as well as all-cause mortality, heart failure hospitalization, fatal and nonfatal myocardial infarction and stroke, and lipid levels.

By week 4, LDL-cholesterol levels had risen by almost 12% in the tocilizumab group. This moderated somewhat, but stayed elevated, reaching 9% above baseline by week 144. In contrast, LDL-cholesterol in the etanercept group was virtually unchanged throughout the study.

In the intent-to-treat analysis, there were 161 occurrences of the composite outcome: 83 in the tocilizumab group and 78 in the etanercept group (hazard ratio, 1.05). This was not a significant difference. The event rate was 1.70 per 100 person-years in the etanercept group and 1.82 in the tocilizumab group – also not significantly different.

The individual secondary endpoints were almost identical in each group: cardiovascular death, 35 with etanercept vs. 36 with tocilizumab; nonfatal MI, 31 vs. 28; nonfatal stroke, 15 vs. 24; and all-cause mortality, 64 in each group. A multivariate regression analysis showed no significantly increased risks associated with tocilizumab in any of the secondary endpoints. The rates and types of adverse events were also similar.

Because this was a safety study, the investigators were interested in the uncertainty in their estimate of risk, Dr. Giles said in an interview.

“The study was designed to exclude at most an 80% increase in cardiovascular events for the patients treated with tocilizumab, compared with etanercept. What we determined was that we could exclude with 95% certainty that if a much larger sample of similar patients was studied, the risk of such events in the tocilizumab group would not exceed a 43% higher rate at the extreme. Notably, the degree of uncertainty included the possibility that the event rate could be lower in the tocilizumab group, compared with those treated with etanercept.”

Dr. Giles reported receiving consulting fees from Genentech, which markets tocilizumab. All other authors also disclosed financial relationships with Genentech or its parent company, Roche. Four authors were employees of Roche/Genentech.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

Time was critical. He needed surgery right away to remove his gallbladder. But for that, he needed a surgeon.

“There was a surgeon on call, but the surgeon was not picking up the phone,” Dr. Singh says. “I’m scratching my head. Why is the surgeon not calling back? Where is the surgeon? Did the pager get lost? What if the patient has a bad outcome?”

Eventually, Dr. Singh had to give up on the on-call surgeon, and the patient was flown to a hospital 45 miles away in downtown Sacramento. His surgery had been delayed for almost 12 hours.

The man lived largely due to good luck, Dr. Singh says. The unresponsive surgeon had disciplinary proceedings started against his license but retired rather than face the consequences.

Today, hospitalists at Sutter Amador no longer have to anxiously wait for those responses to emergency pages. It’s one of many hospitals that have turned to a “surgicalist” model, with a surgeon always on hand at the hospital. Surgicalists perform both emergency procedures and procedures that are tied to a hospital admission, without which a patient can’t be discharged. Although it is growing in popularity, the model is still only seen in a small fraction of hospitals.

The model is widely supported by hospitalists because it brings several advantages, mainly a greater availability of the surgeon for consult.

“We don’t have to hunt them down, trying to call their office, trying to see if they’re available to call back,” says Dr. Singh, who is now also the chair of medical staff performance at Sutter Amador and adds that the change has helped with his job satisfaction.

A Clear Delineation

Arrangements between hospitalists and surgicalists vary depending on the hospital, but there typically are clearly delineated criteria on who cares for whom, with the more urgent surgical cases tending to fall under the surgicalists’ care and those with less urgent problems, even though surgery might be involved, tending to go to hospitalists.

When a surgery-related question or the need for actual surgery arises, the model calls for a quick response time from the surgicalist. Hospitalists and surgicalists collaborate on ways to reduce length of stay and prevent readmissions since they share the same institutional goals. Hospitalists are also more in tune with the needs of the surgeons, for instance, not feeding a patient who is going to need quick surgery and not administering blood thinners when a surgery is imminent unless there’s an overriding reason not to do so.

One advantage of this collaboration is that a hospitalist working alongside a surgicalist can get extra surgery-related guidance even when surgery probably isn’t needed, says John Nelson, MD, MHM, a hospitalist at Overlake Medical Center in Bellevue, Wash., a hospitalist management consultant, and a past president of SHM.

“Maybe the opinion of a general surgeon could be useful, but maybe I can get along without it because the general surgeons are busy. It’s going to be hard for them to find time to see this patient, and they’re not going to be very interested in it,” he says. “But if instead I have a surgical hospitalist who’s there all day, it’s much less of a bother for them to come by and take a look at my patient.”

Remaining Challenges

The model is not without its hurdles. When surgicalists are on a 24-hour shift, the patients will see a new one each day, sometimes prompting them to ask, “Who’s my doctor?” Also, complex cases can pose a challenge as they move from one surgicalist to another day to day.

John Maa, MD, who wrote a seminal paper on surgicalists in 2007 based on an early surgicalist model he started at San Mateo Medical Center in California,1 says he is now concerned that the principles he helped make popular—the absorption of surgeons into a system as they work hand in hand with other hospital staff all the time—might be eroding. Some small staffing companies are calling themselves surgicalists, promising fast response times, but are actually locum tenens surgeons under a surgicalist guise, he says.

Properly rolled out, surgicalist programs mean a much better working relationship between hospitalists and surgeons, says Lynette Scherer, MD, FACS, chief medical officer at Surgical Affiliates Management Group in Sacramento. The company, founded in 1996, employs about 200 surgeons, twice as many as three years ago, Dr. Scherer says, but the company declined to share what that amounts to in full-time equivalent positions.

“The hospitalists know all of our algorithms, and they know when to call us,” Dr. Scherer says. “We share the patients on the inpatient side as we need to. We keep the ones that are appropriate for us, and they keep the ones that are appropriate for them.”

The details depend on the hospital, she says.

“Whenever we go to a new site, we sit down with the hospitalist team and say, ‘What do you need here?’ And our admitting grids are different based on what the different needs of the hospitals are.”

To stay on top of complex cases with very sick patients, the medical director rounds with the team nearly every day to help guide that care, Dr. Scherer says.

At Sutter Amador, the arrival of the surgicalist model has helped shorten the length of stay by almost one day for surgery admissions, Dr. Singh says.

Reported outcomes, however, seem to be mixed.

In 2008, Sutter Medical Center in Sacramento switched from a nine-surgeon call panel to four surgeons who covered the acute-care surgery service in 24-hour shifts. Researchers looked at outcomes from 2007, before the new model was adopted, and from the four subsequent years. The results were published in 2014 in the Journal of the American College of Surgeons.2

The total number of operations rose significantly, with 497 performed in 2007 and 640 in 2011. The percentage of cases with complications also fell significantly, from 21% in 2007 to 12% in 2011, with a low of 11% in 2010.

But the mortality rate rose significantly, from 1.4% in 2007 to 2.2% in 2011, with a high of 4.1% in 2008. The study authors note that the mortality rate ultimately fell back to levels not statistically significantly higher than the rate before the service. They suggested the spike could have been due to a greater willingness by the service to treat severely ill patients and due to the “immaturity” of the service in its earlier years. The percentage of cases with a readmission fell from 6.4% in 2007 to 4.7% in 2011, with a low of 3% in 2009, but that change wasn’t quite statistically significant.

“The data’s really bearing out that emergency patients are different in terms of the care they demand,” Dr. Scherer says. “So the patient with alcoholic cirrhosis who presents with a hole in his colon is very different than somebody who presents for an elective colon resection. And you can really reduce complications when you have a team of educated people taking care of these patients.”

Dr. Nelson says adopting the model “just means you’re a smoother operator and you can provide better service to people.” He adds that for any hospital that is getting poor surgical coverage and is paying for it, “it might make sense to consider it.”

Thomas R. Collins is a freelance medical writer based in Florida.

References

1. Maa J, Carter JT, Gosnell JE, Wachter R, Harris HW. The surgical hospitalist: a new model for emergency surgical care. J Am Coll Surg. 2007;205(5):704-711.
2. O’Mara MS, Scherer L, Wisner D, Owens LJ. Sustainability and success of the acute care surgery model in the nontrauma setting. J Am Coll Surg. 2014;219(1):90-98.

 

For a Model That Many Say Makes Sense, Why Not More Growth?

Surgicalists and hospitalists say that collaboration between the two groups of specialists brings a smoother process, generates better outcomes, and offers greater job satisfaction.

 

So why hasn’t the surgicalist field exploded? About 10 years ago, that’s what was predicted. In 2007, John Nelson, MD, MHM, a hospitalist at Overlake Medical Center in Bellevue, Wash., a hospitalist management consultant, and a past president of SHM, wrote an article saying the field could be close to a “surge” similar to the medical hospitalist explosion.1

 

It’s not known how many of the nation’s roughly 5,600 hospitals use a surgicalist model. There is no association for surgicalists, who are also sometimes called “surgical hospitalists.”

 

But according to Dr. Nelson’s anecdotal impressions, the number could range from 300 to 800 hospitals, he says. That would mean it is in place only in roughly 10% of U.S. hospitals.

 

Expansion of the field has been slowed by cost and politics.

 

Most hospitals don’t have enough surgeons to pull off a surgicalist program, and adding the right number of surgeons costs money, Dr. Nelson says.

 

And at smaller community hospitals that have used on-call surgeons for years, it’s a thorny issue. Those surgeons often get a call stipend for being on call. If surgeons don’t have a full slate of elective surgeries, they could rely on that on-call pay and resist the adoption of the surgicalist model, which would mean losing that pay, Dr. Nelson says.

 

“Some of the surgeons in the community might say, ‘I don’t really like ED call, but I have to keep doing it because of the stipend. I depend on it for my income,’” he says.

 

Even those who wouldn’t mind losing that on-call pay might not be enthusiastic about a move to a surgicalist model because it would bring more general surgeons into the region.

 

Some, Dr. Nelson says, might say, “How do I know that in two years they aren’t stealing my referrals? The new surgical hospitalist is also a potential competitor for referrals I depend on.”

 

And other surgeons might resist simply because they like the professional gratification of emergency surgery work, he says.

 

According to John Maa, MD, who wrote a seminal paper on surgicalists in 2007 based on an early surgicalist model he started at San Mateo Medical Center in California,2 “In a lot of academic centers that didn’t pay call stipend, this was just very simple for them to implement some model of this. … Once you try to send someone to an established group where there was already someone taking call, that became very controversial, and I’ve seen litigation result from that.”

 

Trauma surgeons resisted the model, at least in part, because of semantics: The term “surgical hospitalist” was too similar to “medical hospitalist,” and they worried it might imply a lack of surgical training, says Dr. Maa.

 

For now, the typical assessment of the model that Dr. Nelson hears is: “They’ve thought about it, they may in the future, but no, they don’t have one.”

 

“It’s not growing as fast as the medical hospitalist idea did,” he says. “But it is growing. It’s not going to go away, but it’s still relatively small.”

 

—Thomas R. Collins

 

References

 

 

 

 

1. Nelson J. The surgical surge. The Hospitalist website. Accessed October 25, 2016.
2. Maa J, Carter JT, Gosnell JE, Wachter R, Harris HW. The surgical hospitalist: a new model for emergency surgical care. J Am Coll Surg. 2007 ;205(5):704-711.

 

Time was critical. He needed surgery right away to remove his gallbladder. But for that, he needed a surgeon.

“There was a surgeon on call, but the surgeon was not picking up the phone,” Dr. Singh says. “I’m scratching my head. Why is the surgeon not calling back? Where is the surgeon? Did the pager get lost? What if the patient has a bad outcome?”

Eventually, Dr. Singh had to give up on the on-call surgeon, and the patient was flown to a hospital 45 miles away in downtown Sacramento. His surgery had been delayed for almost 12 hours.

The man lived largely due to good luck, Dr. Singh says. The unresponsive surgeon had disciplinary proceedings started against his license but retired rather than face the consequences.

Today, hospitalists at Sutter Amador no longer have to anxiously wait for those responses to emergency pages. It’s one of many hospitals that have turned to a “surgicalist” model, with a surgeon always on hand at the hospital. Surgicalists perform both emergency procedures and procedures that are tied to a hospital admission, without which a patient can’t be discharged. Although it is growing in popularity, the model is still only seen in a small fraction of hospitals.

The model is widely supported by hospitalists because it brings several advantages, mainly a greater availability of the surgeon for consult.

“We don’t have to hunt them down, trying to call their office, trying to see if they’re available to call back,” says Dr. Singh, who is now also the chair of medical staff performance at Sutter Amador and adds that the change has helped with his job satisfaction.

A Clear Delineation

Arrangements between hospitalists and surgicalists vary depending on the hospital, but there typically are clearly delineated criteria on who cares for whom, with the more urgent surgical cases tending to fall under the surgicalists’ care and those with less urgent problems, even though surgery might be involved, tending to go to hospitalists.

When a surgery-related question or the need for actual surgery arises, the model calls for a quick response time from the surgicalist. Hospitalists and surgicalists collaborate on ways to reduce length of stay and prevent readmissions since they share the same institutional goals. Hospitalists are also more in tune with the needs of the surgeons, for instance, not feeding a patient who is going to need quick surgery and not administering blood thinners when a surgery is imminent unless there’s an overriding reason not to do so.

One advantage of this collaboration is that a hospitalist working alongside a surgicalist can get extra surgery-related guidance even when surgery probably isn’t needed, says John Nelson, MD, MHM, a hospitalist at Overlake Medical Center in Bellevue, Wash., a hospitalist management consultant, and a past president of SHM.

“Maybe the opinion of a general surgeon could be useful, but maybe I can get along without it because the general surgeons are busy. It’s going to be hard for them to find time to see this patient, and they’re not going to be very interested in it,” he says. “But if instead I have a surgical hospitalist who’s there all day, it’s much less of a bother for them to come by and take a look at my patient.”

Remaining Challenges

The model is not without its hurdles. When surgicalists are on a 24-hour shift, the patients will see a new one each day, sometimes prompting them to ask, “Who’s my doctor?” Also, complex cases can pose a challenge as they move from one surgicalist to another day to day.

John Maa, MD, who wrote a seminal paper on surgicalists in 2007 based on an early surgicalist model he started at San Mateo Medical Center in California,1 says he is now concerned that the principles he helped make popular—the absorption of surgeons into a system as they work hand in hand with other hospital staff all the time—might be eroding. Some small staffing companies are calling themselves surgicalists, promising fast response times, but are actually locum tenens surgeons under a surgicalist guise, he says.

Properly rolled out, surgicalist programs mean a much better working relationship between hospitalists and surgeons, says Lynette Scherer, MD, FACS, chief medical officer at Surgical Affiliates Management Group in Sacramento. The company, founded in 1996, employs about 200 surgeons, twice as many as three years ago, Dr. Scherer says, but the company declined to share what that amounts to in full-time equivalent positions.

“The hospitalists know all of our algorithms, and they know when to call us,” Dr. Scherer says. “We share the patients on the inpatient side as we need to. We keep the ones that are appropriate for us, and they keep the ones that are appropriate for them.”

The details depend on the hospital, she says.

“Whenever we go to a new site, we sit down with the hospitalist team and say, ‘What do you need here?’ And our admitting grids are different based on what the different needs of the hospitals are.”

To stay on top of complex cases with very sick patients, the medical director rounds with the team nearly every day to help guide that care, Dr. Scherer says.

At Sutter Amador, the arrival of the surgicalist model has helped shorten the length of stay by almost one day for surgery admissions, Dr. Singh says.

Reported outcomes, however, seem to be mixed.

In 2008, Sutter Medical Center in Sacramento switched from a nine-surgeon call panel to four surgeons who covered the acute-care surgery service in 24-hour shifts. Researchers looked at outcomes from 2007, before the new model was adopted, and from the four subsequent years. The results were published in 2014 in the Journal of the American College of Surgeons.2

The total number of operations rose significantly, with 497 performed in 2007 and 640 in 2011. The percentage of cases with complications also fell significantly, from 21% in 2007 to 12% in 2011, with a low of 11% in 2010.

But the mortality rate rose significantly, from 1.4% in 2007 to 2.2% in 2011, with a high of 4.1% in 2008. The study authors note that the mortality rate ultimately fell back to levels not statistically significantly higher than the rate before the service. They suggested the spike could have been due to a greater willingness by the service to treat severely ill patients and due to the “immaturity” of the service in its earlier years. The percentage of cases with a readmission fell from 6.4% in 2007 to 4.7% in 2011, with a low of 3% in 2009, but that change wasn’t quite statistically significant.

“The data’s really bearing out that emergency patients are different in terms of the care they demand,” Dr. Scherer says. “So the patient with alcoholic cirrhosis who presents with a hole in his colon is very different than somebody who presents for an elective colon resection. And you can really reduce complications when you have a team of educated people taking care of these patients.”

Dr. Nelson says adopting the model “just means you’re a smoother operator and you can provide better service to people.” He adds that for any hospital that is getting poor surgical coverage and is paying for it, “it might make sense to consider it.”

Thomas R. Collins is a freelance medical writer based in Florida.

References

1. Maa J, Carter JT, Gosnell JE, Wachter R, Harris HW. The surgical hospitalist: a new model for emergency surgical care. J Am Coll Surg. 2007;205(5):704-711.
2. O’Mara MS, Scherer L, Wisner D, Owens LJ. Sustainability and success of the acute care surgery model in the nontrauma setting. J Am Coll Surg. 2014;219(1):90-98.

 

For a Model That Many Say Makes Sense, Why Not More Growth?

Surgicalists and hospitalists say that collaboration between the two groups of specialists brings a smoother process, generates better outcomes, and offers greater job satisfaction.

 

So why hasn’t the surgicalist field exploded? About 10 years ago, that’s what was predicted. In 2007, John Nelson, MD, MHM, a hospitalist at Overlake Medical Center in Bellevue, Wash., a hospitalist management consultant, and a past president of SHM, wrote an article saying the field could be close to a “surge” similar to the medical hospitalist explosion.1

 

It’s not known how many of the nation’s roughly 5,600 hospitals use a surgicalist model. There is no association for surgicalists, who are also sometimes called “surgical hospitalists.”

 

But according to Dr. Nelson’s anecdotal impressions, the number could range from 300 to 800 hospitals, he says. That would mean it is in place only in roughly 10% of U.S. hospitals.

 

Expansion of the field has been slowed by cost and politics.

 

Most hospitals don’t have enough surgeons to pull off a surgicalist program, and adding the right number of surgeons costs money, Dr. Nelson says.

 

And at smaller community hospitals that have used on-call surgeons for years, it’s a thorny issue. Those surgeons often get a call stipend for being on call. If surgeons don’t have a full slate of elective surgeries, they could rely on that on-call pay and resist the adoption of the surgicalist model, which would mean losing that pay, Dr. Nelson says.

 

“Some of the surgeons in the community might say, ‘I don’t really like ED call, but I have to keep doing it because of the stipend. I depend on it for my income,’” he says.

 

Even those who wouldn’t mind losing that on-call pay might not be enthusiastic about a move to a surgicalist model because it would bring more general surgeons into the region.

 

Some, Dr. Nelson says, might say, “How do I know that in two years they aren’t stealing my referrals? The new surgical hospitalist is also a potential competitor for referrals I depend on.”

 

And other surgeons might resist simply because they like the professional gratification of emergency surgery work, he says.

 

According to John Maa, MD, who wrote a seminal paper on surgicalists in 2007 based on an early surgicalist model he started at San Mateo Medical Center in California,2 “In a lot of academic centers that didn’t pay call stipend, this was just very simple for them to implement some model of this. … Once you try to send someone to an established group where there was already someone taking call, that became very controversial, and I’ve seen litigation result from that.”

 

Trauma surgeons resisted the model, at least in part, because of semantics: The term “surgical hospitalist” was too similar to “medical hospitalist,” and they worried it might imply a lack of surgical training, says Dr. Maa.

 

For now, the typical assessment of the model that Dr. Nelson hears is: “They’ve thought about it, they may in the future, but no, they don’t have one.”

 

“It’s not growing as fast as the medical hospitalist idea did,” he says. “But it is growing. It’s not going to go away, but it’s still relatively small.”

 

—Thomas R. Collins

 

References

 

 

 

 

1. Nelson J. The surgical surge. The Hospitalist website. Accessed October 25, 2016.
2. Maa J, Carter JT, Gosnell JE, Wachter R, Harris HW. The surgical hospitalist: a new model for emergency surgical care. J Am Coll Surg. 2007 ;205(5):704-711.

 

Time was critical. He needed surgery right away to remove his gallbladder. But for that, he needed a surgeon.

“There was a surgeon on call, but the surgeon was not picking up the phone,” Dr. Singh says. “I’m scratching my head. Why is the surgeon not calling back? Where is the surgeon? Did the pager get lost? What if the patient has a bad outcome?”

Eventually, Dr. Singh had to give up on the on-call surgeon, and the patient was flown to a hospital 45 miles away in downtown Sacramento. His surgery had been delayed for almost 12 hours.

The man lived largely due to good luck, Dr. Singh says. The unresponsive surgeon had disciplinary proceedings started against his license but retired rather than face the consequences.

Today, hospitalists at Sutter Amador no longer have to anxiously wait for those responses to emergency pages. It’s one of many hospitals that have turned to a “surgicalist” model, with a surgeon always on hand at the hospital. Surgicalists perform both emergency procedures and procedures that are tied to a hospital admission, without which a patient can’t be discharged. Although it is growing in popularity, the model is still only seen in a small fraction of hospitals.

The model is widely supported by hospitalists because it brings several advantages, mainly a greater availability of the surgeon for consult.

“We don’t have to hunt them down, trying to call their office, trying to see if they’re available to call back,” says Dr. Singh, who is now also the chair of medical staff performance at Sutter Amador and adds that the change has helped with his job satisfaction.

A Clear Delineation

Arrangements between hospitalists and surgicalists vary depending on the hospital, but there typically are clearly delineated criteria on who cares for whom, with the more urgent surgical cases tending to fall under the surgicalists’ care and those with less urgent problems, even though surgery might be involved, tending to go to hospitalists.

When a surgery-related question or the need for actual surgery arises, the model calls for a quick response time from the surgicalist. Hospitalists and surgicalists collaborate on ways to reduce length of stay and prevent readmissions since they share the same institutional goals. Hospitalists are also more in tune with the needs of the surgeons, for instance, not feeding a patient who is going to need quick surgery and not administering blood thinners when a surgery is imminent unless there’s an overriding reason not to do so.

One advantage of this collaboration is that a hospitalist working alongside a surgicalist can get extra surgery-related guidance even when surgery probably isn’t needed, says John Nelson, MD, MHM, a hospitalist at Overlake Medical Center in Bellevue, Wash., a hospitalist management consultant, and a past president of SHM.

“Maybe the opinion of a general surgeon could be useful, but maybe I can get along without it because the general surgeons are busy. It’s going to be hard for them to find time to see this patient, and they’re not going to be very interested in it,” he says. “But if instead I have a surgical hospitalist who’s there all day, it’s much less of a bother for them to come by and take a look at my patient.”

Remaining Challenges

The model is not without its hurdles. When surgicalists are on a 24-hour shift, the patients will see a new one each day, sometimes prompting them to ask, “Who’s my doctor?” Also, complex cases can pose a challenge as they move from one surgicalist to another day to day.

John Maa, MD, who wrote a seminal paper on surgicalists in 2007 based on an early surgicalist model he started at San Mateo Medical Center in California,1 says he is now concerned that the principles he helped make popular—the absorption of surgeons into a system as they work hand in hand with other hospital staff all the time—might be eroding. Some small staffing companies are calling themselves surgicalists, promising fast response times, but are actually locum tenens surgeons under a surgicalist guise, he says.

Properly rolled out, surgicalist programs mean a much better working relationship between hospitalists and surgeons, says Lynette Scherer, MD, FACS, chief medical officer at Surgical Affiliates Management Group in Sacramento. The company, founded in 1996, employs about 200 surgeons, twice as many as three years ago, Dr. Scherer says, but the company declined to share what that amounts to in full-time equivalent positions.

“The hospitalists know all of our algorithms, and they know when to call us,” Dr. Scherer says. “We share the patients on the inpatient side as we need to. We keep the ones that are appropriate for us, and they keep the ones that are appropriate for them.”

The details depend on the hospital, she says.

“Whenever we go to a new site, we sit down with the hospitalist team and say, ‘What do you need here?’ And our admitting grids are different based on what the different needs of the hospitals are.”

To stay on top of complex cases with very sick patients, the medical director rounds with the team nearly every day to help guide that care, Dr. Scherer says.

At Sutter Amador, the arrival of the surgicalist model has helped shorten the length of stay by almost one day for surgery admissions, Dr. Singh says.

Reported outcomes, however, seem to be mixed.

In 2008, Sutter Medical Center in Sacramento switched from a nine-surgeon call panel to four surgeons who covered the acute-care surgery service in 24-hour shifts. Researchers looked at outcomes from 2007, before the new model was adopted, and from the four subsequent years. The results were published in 2014 in the Journal of the American College of Surgeons.2

The total number of operations rose significantly, with 497 performed in 2007 and 640 in 2011. The percentage of cases with complications also fell significantly, from 21% in 2007 to 12% in 2011, with a low of 11% in 2010.

But the mortality rate rose significantly, from 1.4% in 2007 to 2.2% in 2011, with a high of 4.1% in 2008. The study authors note that the mortality rate ultimately fell back to levels not statistically significantly higher than the rate before the service. They suggested the spike could have been due to a greater willingness by the service to treat severely ill patients and due to the “immaturity” of the service in its earlier years. The percentage of cases with a readmission fell from 6.4% in 2007 to 4.7% in 2011, with a low of 3% in 2009, but that change wasn’t quite statistically significant.

“The data’s really bearing out that emergency patients are different in terms of the care they demand,” Dr. Scherer says. “So the patient with alcoholic cirrhosis who presents with a hole in his colon is very different than somebody who presents for an elective colon resection. And you can really reduce complications when you have a team of educated people taking care of these patients.”

Dr. Nelson says adopting the model “just means you’re a smoother operator and you can provide better service to people.” He adds that for any hospital that is getting poor surgical coverage and is paying for it, “it might make sense to consider it.”

Thomas R. Collins is a freelance medical writer based in Florida.

References

1. Maa J, Carter JT, Gosnell JE, Wachter R, Harris HW. The surgical hospitalist: a new model for emergency surgical care. J Am Coll Surg. 2007;205(5):704-711.
2. O’Mara MS, Scherer L, Wisner D, Owens LJ. Sustainability and success of the acute care surgery model in the nontrauma setting. J Am Coll Surg. 2014;219(1):90-98.

 

For a Model That Many Say Makes Sense, Why Not More Growth?

Surgicalists and hospitalists say that collaboration between the two groups of specialists brings a smoother process, generates better outcomes, and offers greater job satisfaction.

 

So why hasn’t the surgicalist field exploded? About 10 years ago, that’s what was predicted. In 2007, John Nelson, MD, MHM, a hospitalist at Overlake Medical Center in Bellevue, Wash., a hospitalist management consultant, and a past president of SHM, wrote an article saying the field could be close to a “surge” similar to the medical hospitalist explosion.1

 

It’s not known how many of the nation’s roughly 5,600 hospitals use a surgicalist model. There is no association for surgicalists, who are also sometimes called “surgical hospitalists.”

 

But according to Dr. Nelson’s anecdotal impressions, the number could range from 300 to 800 hospitals, he says. That would mean it is in place only in roughly 10% of U.S. hospitals.

 

Expansion of the field has been slowed by cost and politics.

 

Most hospitals don’t have enough surgeons to pull off a surgicalist program, and adding the right number of surgeons costs money, Dr. Nelson says.

 

And at smaller community hospitals that have used on-call surgeons for years, it’s a thorny issue. Those surgeons often get a call stipend for being on call. If surgeons don’t have a full slate of elective surgeries, they could rely on that on-call pay and resist the adoption of the surgicalist model, which would mean losing that pay, Dr. Nelson says.

 

“Some of the surgeons in the community might say, ‘I don’t really like ED call, but I have to keep doing it because of the stipend. I depend on it for my income,’” he says.

 

Even those who wouldn’t mind losing that on-call pay might not be enthusiastic about a move to a surgicalist model because it would bring more general surgeons into the region.

 

Some, Dr. Nelson says, might say, “How do I know that in two years they aren’t stealing my referrals? The new surgical hospitalist is also a potential competitor for referrals I depend on.”

 

And other surgeons might resist simply because they like the professional gratification of emergency surgery work, he says.

 

According to John Maa, MD, who wrote a seminal paper on surgicalists in 2007 based on an early surgicalist model he started at San Mateo Medical Center in California,2 “In a lot of academic centers that didn’t pay call stipend, this was just very simple for them to implement some model of this. … Once you try to send someone to an established group where there was already someone taking call, that became very controversial, and I’ve seen litigation result from that.”

 

Trauma surgeons resisted the model, at least in part, because of semantics: The term “surgical hospitalist” was too similar to “medical hospitalist,” and they worried it might imply a lack of surgical training, says Dr. Maa.

 

For now, the typical assessment of the model that Dr. Nelson hears is: “They’ve thought about it, they may in the future, but no, they don’t have one.”

 

“It’s not growing as fast as the medical hospitalist idea did,” he says. “But it is growing. It’s not going to go away, but it’s still relatively small.”

 

—Thomas R. Collins

 

References

 

 

 

 

1. Nelson J. The surgical surge. The Hospitalist website. Accessed October 25, 2016.
2. Maa J, Carter JT, Gosnell JE, Wachter R, Harris HW. The surgical hospitalist: a new model for emergency surgical care. J Am Coll Surg. 2007 ;205(5):704-711.

 

WASHINGTON – Prenatal exposure to tumor necrosis factor–inhibiting drugs does not significantly increase the risk of a serious antenatal infection in infants born to women taking the drugs for rheumatoid arthritis, according to a large database study.

Researchers from McGill University, Montreal, and the University of Alabama at Birmingham who conducted the study did find a higher rate of serious infections among infants born to users of a tumor necrosis factor inhibitor (TNFi), especially among those exposed to infliximab, but after adjustment for maternal age and other antirheumatic drugs, the risk was not statistically significant.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

WASHINGTON – Prenatal exposure to tumor necrosis factor–inhibiting drugs does not significantly increase the risk of a serious antenatal infection in infants born to women taking the drugs for rheumatoid arthritis, according to a large database study.

Researchers from McGill University, Montreal, and the University of Alabama at Birmingham who conducted the study did find a higher rate of serious infections among infants born to users of a tumor necrosis factor inhibitor (TNFi), especially among those exposed to infliximab, but after adjustment for maternal age and other antirheumatic drugs, the risk was not statistically significant.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

WASHINGTON – Prenatal exposure to tumor necrosis factor–inhibiting drugs does not significantly increase the risk of a serious antenatal infection in infants born to women taking the drugs for rheumatoid arthritis, according to a large database study.

Researchers from McGill University, Montreal, and the University of Alabama at Birmingham who conducted the study did find a higher rate of serious infections among infants born to users of a tumor necrosis factor inhibitor (TNFi), especially among those exposed to infliximab, but after adjustment for maternal age and other antirheumatic drugs, the risk was not statistically significant.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

As healers trained to address some of the psychosocial issues facing our patients, we need to understand various forms of domestic violence – and what we can do to stop it. One form, honor killings, remains pervasive across the globe.

In a sample of 856 ninth-grade students from 14 schools in Amman, Jordan, for example, about 40% of boys and 20% of girls believed that killing a daughter, sister, or wife who had dishonored the family was justified (Aggress Behav. 2013 Sep-Oct;39[5]:405-17). The schools were representative of students from different religions, socioeconomic statuses, and upbringings. The proportions are broadly in line with the religious affiliation of Jordanians, with 92% of the population identifying themselves as Muslims, 6% as Christians, and 2% as affiliated with other religions.1 However, researchers found that support for honor killings was more widespread among adolescents from poorer and more traditional family backgrounds.

What are honor killings?

According to Sally Elakkary, MD, and her colleagues, honor killings are “violence implicated against a female for the deviancy of her activities from the traditional cultural norms.”2 The perpetrators in these crimes are usually male relatives but may be other family members, including women. Males also can be victims of honor crimes. For example, a male can become a victim if he is the female’s lover in an extramarital relationship or if he is homosexual.

Most honor killings are reported from countries in the Maghreb region of North Africa; the Middle East (Palestine, Lebanon, Syria, Jordan, and Turkey); and Western and Central Asia (Iraq, Pakistan, Afghanistan, and India). However, honor killings also occur in countries with strong minorities from those origins. A report3 published in 2000 by the United Nations Population Fund estimated that 5,000 honor killings were carried out worldwide per year, with the largest absolute numbers reported for Pakistan and India (about 1,000 cases per year in each country).

Until the 1960s in the United States, penal codes in some states, such as Georgia, New Mexico, Texas, and Utah, justified a husband killing his wife’s lover. In those states, the law was formulated to protect the male’s honor. Honor killings are culture-based practices that are supported indirectly by that country’s legal system. In a recent New York Times op-ed4 piece, Bina Shah stated that “upending misogynistic tribal codes is the real key to finally ending the most egregious gender crime.” The Pakistan Parliament recently stiffened the punishment for honor killings. The new anti–honor killing law mandates a minimum lifetime jail sentence for perpetrators and closes a legal loophole that allowed an honor killer to walk free if the family of the victim forgave him.

However, in rural areas, a Pakistani woman accused of violating family or tribal honor can be sentenced to death by an informal village court or a gathering of tribal elders. Women have been killed by stoning, shooting, or being buried alive. Sometimes, the woman’s relatives condemn her to death without a trial. Women are killed for reasons such as wanting to marry of their own choice, divorcing abusive husbands, or speaking to a man or boy outside the family; “in one case, four young girls who were filmed dancing in a rain shower were executed by their cousin for immorality,” Ms. Shah said.

Range of behaviors

Abusive behavior can take many forms, including:

• Isolating a person from her friends and family.

• Depriving her of basic needs.

• Monitoring her time.

• Monitoring her use of online communication tools or spyware.

• Taking control over aspects of her everyday life, such as where she can go, whom she can see, what she can wear, and when she can sleep.

• Depriving her of access to support services, such as specialist support or medical services.

• Repeatedly putting her down, such as telling her that she is worthless.

• Enforcing rules and activities that humiliate, degrade, or dehumanize the victim.

• Forcing the victim to take part in criminal activity such as shoplifting, and neglecting or abusing children to encourage self-blame and prevent disclosure to authorities.

• Abusing finances, including controlling resources so that the person is allowed only a punitive allowance.

• Threatening to hurt or kill her.

• Threatening a child.

• Threatening to reveal or publish private information (for example, threatening to “out” someone).

• Assaulting the person.

• Causing criminal damage (such as destruction of household goods).

• Engaging in rape.

• Preventing a person from having access to transportation or from working.

New domestic violence law in the United Kingdom

Meanwhile, domestic violence laws in England and Wales now consider emotional and psychological abuse as legally actionable. The new legislation targets those who subject spouses, partners, and family members to psychological and emotional torment, but stop short of violence. The new law5 follows a Home Office consultation showing that 85% of participants said the existing law did not provide sufficient protection and a Citizens Advice report showing a 24% rise in people seeking advice for domestic abuse.

The new law falls under the Serious Crime Act 2015 of England and Wales. The act creates a new offense of “controlling or coercive behavior in intimate or familial relationships.” The act states: “The new offence closes a gap in the law around patterns of controlling or coercive behavior in an ongoing relationship between intimate partners or family members.”

Breaking the law carries a maximum sentence of 5 years’ imprisonment, a fine, or both. The behavior must have had a “serious effect” on the victim, meaning that it has caused the victim to fear violence will be used against them on “at least two occasions,” or it has had a “substantial adverse effect on the victim’s day to day activities.”

The alleged perpetrator must have known that his behavior would have a serious effect on the victim, or the behavior must have been such that he “ought to have known” it would have that effect.

The new law includes honor-based violence, female genital mutilation, and forced marriage. The law explicitly states that the victim may fear that the perpetrator has asked another person to commit violence against them, thus including family honor killings.

Gendered nature of domestic controlling or coercive behavior

While all legislation is gender neutral, women and girls are disproportionately affected by crimes of domestic violence and abuse. Women from black and minority ethnic backgrounds may experience barriers to reporting, such as a distrust of the police, concerns about racism, language barriers, concerns about family finding out, or fear of rejection by the wider community. A victim might be fearful about her children being taken away if she makes a report. Lesbian, gay, bisexual, and transgender individuals in relationships may be subjected to threats to reveal sexual orientation to family or others.

Interestingly, the U.K. guidelines state that victims of controlling or coercive behavior may not recognize themselves as victims. Therefore, it is important that the new offense be considered by the police and other authorities in attendance at all call-outs. Police are encouraged to ask questions about rules, decision making, norms, and fear in the relationship, rather than just what happened. The guidelines provide specific comments about handling perpetrators who are described as being “particularly adept” at manipulating professionals, agencies, and systems, and may use a range of tactics in relation to this offense, including targeting people who might be vulnerable (there may be evidence of this from previous relationships) and using the system against the victim by making false or vexatious allegations to agencies.

The Authorized Professional Practice on Investigating Domestic Abuse issued by the College of Policing states: “A manipulative perpetrator may be trying to draw the police into colluding with their coercive control of the victim. Police officers must avoid playing into the primary perpetrator’s hands and take account of all available evidence when making the decision to arrest.” Such evidence includes attempting to frustrate or interfere with the police investigation; making counterallegations against the victim; and using threats of manipulation against the victim – such as telling the victim that he will make a counterallegation against her, that the victim will not be believed by the police or other agencies, that he will inform social services, or that he will inform immigration officials where the victim does not have a right to remain.

How can psychiatrists raise awareness?

• Individual change. Abusive controlling behavior can have its origin in childhood psychological experiences, in the same way that honor killings and wife beating can have their roots in the perpetrator’s cultural experience. As a child, the adult perpetrator may have been a direct victim of violence or may have been a witness to domestic violence. Controlling abusive behavior also can occur as a choice in perpetrators with personality disorders unrelated to childhood experiences. It can occur in a person with both exposure and personality disorder. It is important to understand the origins and reasoning behind the behavior in order to understand how best to intervene.

If the behavior is based on the childhood experience of the prevailing sociocultural practice, the psychiatrist can explore values and beliefs, identifying those that are based on family and cultural factors. Beliefs that have been present during a person’s entire life can appear as the unexamined “background” of their lives. Bringing those beliefs to the fore can allow discussion. For example, does the individual hold the belief that women are possessions? What is the basis of holding such a belief? How does he account for the differences between societies?

• Family change. Individuals in the family may differ in their support of honor killings. Those who do not support honor killings may have difficulty speaking out for fear of becoming a future target. When we meet with families who have a belief in honor killings, we can discuss how patriarchal societies have encouraged families to maintain a firm hand on the behavior of their members. This practice encourages repression of women’s individuality and also may consider women to be possessions. Patriarchal societies control their populations by supporting values and beliefs in their citizens that support the patriarchal structure. In this way, they can exert social control easily by having members of the society act as enforcers. Open and clear discussion with families about the ways in which cultural practice affects individual behavior may allow families that are unsure to explore alternative new beliefs.

Families must understand that, under U.S. law, perpetrators of honor killings and domestic violence can be prosecuted.

• System change. According to the U.S. Justice Department, 9 out of 10 honor killings were victims who had become “too Westernized.” Leaders of the American Muslim community and members of the Council on American-Islamic Relations have condemned all honor killings, stating that the practice stems from sexism and tribal behavior that predates the religion. In February 2009, after the high-profile killing of Aasiya Zubair Hassan in New York, Muslim leaders began a nationwide effort entitled, “Imams Speak Out: Domestic Violence Will Not Be Tolerated in Our Communities,” asking all imams and religious leaders to discuss domestic violence in their weekly sermon or their Friday prayer services. The group, “Muslim Men Against Domestic Violence,” was founded soon after the murder, which came just a few days after she had filed for divorce. (After a 3-week trial, Mrs. Hassan’s estranged husband, Muzzammil “Mo” Hassan, was found guilty of second-degree murder and received a 25-year to life sentence).

Our laws reflect our values as a society. As citizens, we must actively work for the enforcement of domestic violence laws. Our mental health organizations can support the training of police and health agencies to identify victims and perpetrators.

References

1. The World Factbook, Central Intelligence Agency, 2009.

2 Forensic Sci Med Pathol. 2014;10(1):76-82.

3. “Lives Together, Worlds Apart: Men and Women in a Time of Change,” United Nations Population Fund report, 2000.

4. “Pakistan’s Honor-Killing Law Isn’t Enough,” The New York Times, Oct. 27, 2016.

5. “Controlling or Coercive Behaviour in an Intimate or Family Relationship,” Home Office, December 2015.

Dr. Heru is professor of psychiatry at the University of Colorado Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose.

As healers trained to address some of the psychosocial issues facing our patients, we need to understand various forms of domestic violence – and what we can do to stop it. One form, honor killings, remains pervasive across the globe.

In a sample of 856 ninth-grade students from 14 schools in Amman, Jordan, for example, about 40% of boys and 20% of girls believed that killing a daughter, sister, or wife who had dishonored the family was justified (Aggress Behav. 2013 Sep-Oct;39[5]:405-17). The schools were representative of students from different religions, socioeconomic statuses, and upbringings. The proportions are broadly in line with the religious affiliation of Jordanians, with 92% of the population identifying themselves as Muslims, 6% as Christians, and 2% as affiliated with other religions.1 However, researchers found that support for honor killings was more widespread among adolescents from poorer and more traditional family backgrounds.

What are honor killings?

According to Sally Elakkary, MD, and her colleagues, honor killings are “violence implicated against a female for the deviancy of her activities from the traditional cultural norms.”2 The perpetrators in these crimes are usually male relatives but may be other family members, including women. Males also can be victims of honor crimes. For example, a male can become a victim if he is the female’s lover in an extramarital relationship or if he is homosexual.

Most honor killings are reported from countries in the Maghreb region of North Africa; the Middle East (Palestine, Lebanon, Syria, Jordan, and Turkey); and Western and Central Asia (Iraq, Pakistan, Afghanistan, and India). However, honor killings also occur in countries with strong minorities from those origins. A report3 published in 2000 by the United Nations Population Fund estimated that 5,000 honor killings were carried out worldwide per year, with the largest absolute numbers reported for Pakistan and India (about 1,000 cases per year in each country).

Until the 1960s in the United States, penal codes in some states, such as Georgia, New Mexico, Texas, and Utah, justified a husband killing his wife’s lover. In those states, the law was formulated to protect the male’s honor. Honor killings are culture-based practices that are supported indirectly by that country’s legal system. In a recent New York Times op-ed4 piece, Bina Shah stated that “upending misogynistic tribal codes is the real key to finally ending the most egregious gender crime.” The Pakistan Parliament recently stiffened the punishment for honor killings. The new anti–honor killing law mandates a minimum lifetime jail sentence for perpetrators and closes a legal loophole that allowed an honor killer to walk free if the family of the victim forgave him.

However, in rural areas, a Pakistani woman accused of violating family or tribal honor can be sentenced to death by an informal village court or a gathering of tribal elders. Women have been killed by stoning, shooting, or being buried alive. Sometimes, the woman’s relatives condemn her to death without a trial. Women are killed for reasons such as wanting to marry of their own choice, divorcing abusive husbands, or speaking to a man or boy outside the family; “in one case, four young girls who were filmed dancing in a rain shower were executed by their cousin for immorality,” Ms. Shah said.

Range of behaviors

Abusive behavior can take many forms, including:

• Isolating a person from her friends and family.

• Depriving her of basic needs.

• Monitoring her time.

• Monitoring her use of online communication tools or spyware.

• Taking control over aspects of her everyday life, such as where she can go, whom she can see, what she can wear, and when she can sleep.

• Depriving her of access to support services, such as specialist support or medical services.

• Repeatedly putting her down, such as telling her that she is worthless.

• Enforcing rules and activities that humiliate, degrade, or dehumanize the victim.

• Forcing the victim to take part in criminal activity such as shoplifting, and neglecting or abusing children to encourage self-blame and prevent disclosure to authorities.

• Abusing finances, including controlling resources so that the person is allowed only a punitive allowance.

• Threatening to hurt or kill her.

• Threatening a child.

• Threatening to reveal or publish private information (for example, threatening to “out” someone).

• Assaulting the person.

• Causing criminal damage (such as destruction of household goods).

• Engaging in rape.

• Preventing a person from having access to transportation or from working.

New domestic violence law in the United Kingdom

Meanwhile, domestic violence laws in England and Wales now consider emotional and psychological abuse as legally actionable. The new legislation targets those who subject spouses, partners, and family members to psychological and emotional torment, but stop short of violence. The new law5 follows a Home Office consultation showing that 85% of participants said the existing law did not provide sufficient protection and a Citizens Advice report showing a 24% rise in people seeking advice for domestic abuse.

The new law falls under the Serious Crime Act 2015 of England and Wales. The act creates a new offense of “controlling or coercive behavior in intimate or familial relationships.” The act states: “The new offence closes a gap in the law around patterns of controlling or coercive behavior in an ongoing relationship between intimate partners or family members.”

Breaking the law carries a maximum sentence of 5 years’ imprisonment, a fine, or both. The behavior must have had a “serious effect” on the victim, meaning that it has caused the victim to fear violence will be used against them on “at least two occasions,” or it has had a “substantial adverse effect on the victim’s day to day activities.”

The alleged perpetrator must have known that his behavior would have a serious effect on the victim, or the behavior must have been such that he “ought to have known” it would have that effect.

The new law includes honor-based violence, female genital mutilation, and forced marriage. The law explicitly states that the victim may fear that the perpetrator has asked another person to commit violence against them, thus including family honor killings.

Gendered nature of domestic controlling or coercive behavior

While all legislation is gender neutral, women and girls are disproportionately affected by crimes of domestic violence and abuse. Women from black and minority ethnic backgrounds may experience barriers to reporting, such as a distrust of the police, concerns about racism, language barriers, concerns about family finding out, or fear of rejection by the wider community. A victim might be fearful about her children being taken away if she makes a report. Lesbian, gay, bisexual, and transgender individuals in relationships may be subjected to threats to reveal sexual orientation to family or others.

Interestingly, the U.K. guidelines state that victims of controlling or coercive behavior may not recognize themselves as victims. Therefore, it is important that the new offense be considered by the police and other authorities in attendance at all call-outs. Police are encouraged to ask questions about rules, decision making, norms, and fear in the relationship, rather than just what happened. The guidelines provide specific comments about handling perpetrators who are described as being “particularly adept” at manipulating professionals, agencies, and systems, and may use a range of tactics in relation to this offense, including targeting people who might be vulnerable (there may be evidence of this from previous relationships) and using the system against the victim by making false or vexatious allegations to agencies.

The Authorized Professional Practice on Investigating Domestic Abuse issued by the College of Policing states: “A manipulative perpetrator may be trying to draw the police into colluding with their coercive control of the victim. Police officers must avoid playing into the primary perpetrator’s hands and take account of all available evidence when making the decision to arrest.” Such evidence includes attempting to frustrate or interfere with the police investigation; making counterallegations against the victim; and using threats of manipulation against the victim – such as telling the victim that he will make a counterallegation against her, that the victim will not be believed by the police or other agencies, that he will inform social services, or that he will inform immigration officials where the victim does not have a right to remain.

How can psychiatrists raise awareness?

• Individual change. Abusive controlling behavior can have its origin in childhood psychological experiences, in the same way that honor killings and wife beating can have their roots in the perpetrator’s cultural experience. As a child, the adult perpetrator may have been a direct victim of violence or may have been a witness to domestic violence. Controlling abusive behavior also can occur as a choice in perpetrators with personality disorders unrelated to childhood experiences. It can occur in a person with both exposure and personality disorder. It is important to understand the origins and reasoning behind the behavior in order to understand how best to intervene.

If the behavior is based on the childhood experience of the prevailing sociocultural practice, the psychiatrist can explore values and beliefs, identifying those that are based on family and cultural factors. Beliefs that have been present during a person’s entire life can appear as the unexamined “background” of their lives. Bringing those beliefs to the fore can allow discussion. For example, does the individual hold the belief that women are possessions? What is the basis of holding such a belief? How does he account for the differences between societies?

• Family change. Individuals in the family may differ in their support of honor killings. Those who do not support honor killings may have difficulty speaking out for fear of becoming a future target. When we meet with families who have a belief in honor killings, we can discuss how patriarchal societies have encouraged families to maintain a firm hand on the behavior of their members. This practice encourages repression of women’s individuality and also may consider women to be possessions. Patriarchal societies control their populations by supporting values and beliefs in their citizens that support the patriarchal structure. In this way, they can exert social control easily by having members of the society act as enforcers. Open and clear discussion with families about the ways in which cultural practice affects individual behavior may allow families that are unsure to explore alternative new beliefs.

Families must understand that, under U.S. law, perpetrators of honor killings and domestic violence can be prosecuted.

• System change. According to the U.S. Justice Department, 9 out of 10 honor killings were victims who had become “too Westernized.” Leaders of the American Muslim community and members of the Council on American-Islamic Relations have condemned all honor killings, stating that the practice stems from sexism and tribal behavior that predates the religion. In February 2009, after the high-profile killing of Aasiya Zubair Hassan in New York, Muslim leaders began a nationwide effort entitled, “Imams Speak Out: Domestic Violence Will Not Be Tolerated in Our Communities,” asking all imams and religious leaders to discuss domestic violence in their weekly sermon or their Friday prayer services. The group, “Muslim Men Against Domestic Violence,” was founded soon after the murder, which came just a few days after she had filed for divorce. (After a 3-week trial, Mrs. Hassan’s estranged husband, Muzzammil “Mo” Hassan, was found guilty of second-degree murder and received a 25-year to life sentence).

Our laws reflect our values as a society. As citizens, we must actively work for the enforcement of domestic violence laws. Our mental health organizations can support the training of police and health agencies to identify victims and perpetrators.

References

1. The World Factbook, Central Intelligence Agency, 2009.

2 Forensic Sci Med Pathol. 2014;10(1):76-82.

3. “Lives Together, Worlds Apart: Men and Women in a Time of Change,” United Nations Population Fund report, 2000.

4. “Pakistan’s Honor-Killing Law Isn’t Enough,” The New York Times, Oct. 27, 2016.

5. “Controlling or Coercive Behaviour in an Intimate or Family Relationship,” Home Office, December 2015.

Dr. Heru is professor of psychiatry at the University of Colorado Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose.

As healers trained to address some of the psychosocial issues facing our patients, we need to understand various forms of domestic violence – and what we can do to stop it. One form, honor killings, remains pervasive across the globe.

In a sample of 856 ninth-grade students from 14 schools in Amman, Jordan, for example, about 40% of boys and 20% of girls believed that killing a daughter, sister, or wife who had dishonored the family was justified (Aggress Behav. 2013 Sep-Oct;39[5]:405-17). The schools were representative of students from different religions, socioeconomic statuses, and upbringings. The proportions are broadly in line with the religious affiliation of Jordanians, with 92% of the population identifying themselves as Muslims, 6% as Christians, and 2% as affiliated with other religions.1 However, researchers found that support for honor killings was more widespread among adolescents from poorer and more traditional family backgrounds.

What are honor killings?

According to Sally Elakkary, MD, and her colleagues, honor killings are “violence implicated against a female for the deviancy of her activities from the traditional cultural norms.”2 The perpetrators in these crimes are usually male relatives but may be other family members, including women. Males also can be victims of honor crimes. For example, a male can become a victim if he is the female’s lover in an extramarital relationship or if he is homosexual.

Most honor killings are reported from countries in the Maghreb region of North Africa; the Middle East (Palestine, Lebanon, Syria, Jordan, and Turkey); and Western and Central Asia (Iraq, Pakistan, Afghanistan, and India). However, honor killings also occur in countries with strong minorities from those origins. A report3 published in 2000 by the United Nations Population Fund estimated that 5,000 honor killings were carried out worldwide per year, with the largest absolute numbers reported for Pakistan and India (about 1,000 cases per year in each country).

Until the 1960s in the United States, penal codes in some states, such as Georgia, New Mexico, Texas, and Utah, justified a husband killing his wife’s lover. In those states, the law was formulated to protect the male’s honor. Honor killings are culture-based practices that are supported indirectly by that country’s legal system. In a recent New York Times op-ed4 piece, Bina Shah stated that “upending misogynistic tribal codes is the real key to finally ending the most egregious gender crime.” The Pakistan Parliament recently stiffened the punishment for honor killings. The new anti–honor killing law mandates a minimum lifetime jail sentence for perpetrators and closes a legal loophole that allowed an honor killer to walk free if the family of the victim forgave him.

However, in rural areas, a Pakistani woman accused of violating family or tribal honor can be sentenced to death by an informal village court or a gathering of tribal elders. Women have been killed by stoning, shooting, or being buried alive. Sometimes, the woman’s relatives condemn her to death without a trial. Women are killed for reasons such as wanting to marry of their own choice, divorcing abusive husbands, or speaking to a man or boy outside the family; “in one case, four young girls who were filmed dancing in a rain shower were executed by their cousin for immorality,” Ms. Shah said.

Range of behaviors

Abusive behavior can take many forms, including:

• Isolating a person from her friends and family.

• Depriving her of basic needs.

• Monitoring her time.

• Monitoring her use of online communication tools or spyware.

• Taking control over aspects of her everyday life, such as where she can go, whom she can see, what she can wear, and when she can sleep.

• Depriving her of access to support services, such as specialist support or medical services.

• Repeatedly putting her down, such as telling her that she is worthless.

• Enforcing rules and activities that humiliate, degrade, or dehumanize the victim.

• Forcing the victim to take part in criminal activity such as shoplifting, and neglecting or abusing children to encourage self-blame and prevent disclosure to authorities.

• Abusing finances, including controlling resources so that the person is allowed only a punitive allowance.

• Threatening to hurt or kill her.

• Threatening a child.

• Threatening to reveal or publish private information (for example, threatening to “out” someone).

• Assaulting the person.

• Causing criminal damage (such as destruction of household goods).

• Engaging in rape.

• Preventing a person from having access to transportation or from working.

New domestic violence law in the United Kingdom

Meanwhile, domestic violence laws in England and Wales now consider emotional and psychological abuse as legally actionable. The new legislation targets those who subject spouses, partners, and family members to psychological and emotional torment, but stop short of violence. The new law5 follows a Home Office consultation showing that 85% of participants said the existing law did not provide sufficient protection and a Citizens Advice report showing a 24% rise in people seeking advice for domestic abuse.

The new law falls under the Serious Crime Act 2015 of England and Wales. The act creates a new offense of “controlling or coercive behavior in intimate or familial relationships.” The act states: “The new offence closes a gap in the law around patterns of controlling or coercive behavior in an ongoing relationship between intimate partners or family members.”

Breaking the law carries a maximum sentence of 5 years’ imprisonment, a fine, or both. The behavior must have had a “serious effect” on the victim, meaning that it has caused the victim to fear violence will be used against them on “at least two occasions,” or it has had a “substantial adverse effect on the victim’s day to day activities.”

The alleged perpetrator must have known that his behavior would have a serious effect on the victim, or the behavior must have been such that he “ought to have known” it would have that effect.

The new law includes honor-based violence, female genital mutilation, and forced marriage. The law explicitly states that the victim may fear that the perpetrator has asked another person to commit violence against them, thus including family honor killings.

Gendered nature of domestic controlling or coercive behavior

While all legislation is gender neutral, women and girls are disproportionately affected by crimes of domestic violence and abuse. Women from black and minority ethnic backgrounds may experience barriers to reporting, such as a distrust of the police, concerns about racism, language barriers, concerns about family finding out, or fear of rejection by the wider community. A victim might be fearful about her children being taken away if she makes a report. Lesbian, gay, bisexual, and transgender individuals in relationships may be subjected to threats to reveal sexual orientation to family or others.

Interestingly, the U.K. guidelines state that victims of controlling or coercive behavior may not recognize themselves as victims. Therefore, it is important that the new offense be considered by the police and other authorities in attendance at all call-outs. Police are encouraged to ask questions about rules, decision making, norms, and fear in the relationship, rather than just what happened. The guidelines provide specific comments about handling perpetrators who are described as being “particularly adept” at manipulating professionals, agencies, and systems, and may use a range of tactics in relation to this offense, including targeting people who might be vulnerable (there may be evidence of this from previous relationships) and using the system against the victim by making false or vexatious allegations to agencies.

The Authorized Professional Practice on Investigating Domestic Abuse issued by the College of Policing states: “A manipulative perpetrator may be trying to draw the police into colluding with their coercive control of the victim. Police officers must avoid playing into the primary perpetrator’s hands and take account of all available evidence when making the decision to arrest.” Such evidence includes attempting to frustrate or interfere with the police investigation; making counterallegations against the victim; and using threats of manipulation against the victim – such as telling the victim that he will make a counterallegation against her, that the victim will not be believed by the police or other agencies, that he will inform social services, or that he will inform immigration officials where the victim does not have a right to remain.

How can psychiatrists raise awareness?

• Individual change. Abusive controlling behavior can have its origin in childhood psychological experiences, in the same way that honor killings and wife beating can have their roots in the perpetrator’s cultural experience. As a child, the adult perpetrator may have been a direct victim of violence or may have been a witness to domestic violence. Controlling abusive behavior also can occur as a choice in perpetrators with personality disorders unrelated to childhood experiences. It can occur in a person with both exposure and personality disorder. It is important to understand the origins and reasoning behind the behavior in order to understand how best to intervene.

If the behavior is based on the childhood experience of the prevailing sociocultural practice, the psychiatrist can explore values and beliefs, identifying those that are based on family and cultural factors. Beliefs that have been present during a person’s entire life can appear as the unexamined “background” of their lives. Bringing those beliefs to the fore can allow discussion. For example, does the individual hold the belief that women are possessions? What is the basis of holding such a belief? How does he account for the differences between societies?

• Family change. Individuals in the family may differ in their support of honor killings. Those who do not support honor killings may have difficulty speaking out for fear of becoming a future target. When we meet with families who have a belief in honor killings, we can discuss how patriarchal societies have encouraged families to maintain a firm hand on the behavior of their members. This practice encourages repression of women’s individuality and also may consider women to be possessions. Patriarchal societies control their populations by supporting values and beliefs in their citizens that support the patriarchal structure. In this way, they can exert social control easily by having members of the society act as enforcers. Open and clear discussion with families about the ways in which cultural practice affects individual behavior may allow families that are unsure to explore alternative new beliefs.

Families must understand that, under U.S. law, perpetrators of honor killings and domestic violence can be prosecuted.

• System change. According to the U.S. Justice Department, 9 out of 10 honor killings were victims who had become “too Westernized.” Leaders of the American Muslim community and members of the Council on American-Islamic Relations have condemned all honor killings, stating that the practice stems from sexism and tribal behavior that predates the religion. In February 2009, after the high-profile killing of Aasiya Zubair Hassan in New York, Muslim leaders began a nationwide effort entitled, “Imams Speak Out: Domestic Violence Will Not Be Tolerated in Our Communities,” asking all imams and religious leaders to discuss domestic violence in their weekly sermon or their Friday prayer services. The group, “Muslim Men Against Domestic Violence,” was founded soon after the murder, which came just a few days after she had filed for divorce. (After a 3-week trial, Mrs. Hassan’s estranged husband, Muzzammil “Mo” Hassan, was found guilty of second-degree murder and received a 25-year to life sentence).

Our laws reflect our values as a society. As citizens, we must actively work for the enforcement of domestic violence laws. Our mental health organizations can support the training of police and health agencies to identify victims and perpetrators.

References

1. The World Factbook, Central Intelligence Agency, 2009.

2 Forensic Sci Med Pathol. 2014;10(1):76-82.

3. “Lives Together, Worlds Apart: Men and Women in a Time of Change,” United Nations Population Fund report, 2000.

4. “Pakistan’s Honor-Killing Law Isn’t Enough,” The New York Times, Oct. 27, 2016.

5. “Controlling or Coercive Behaviour in an Intimate or Family Relationship,” Home Office, December 2015.

Dr. Heru is professor of psychiatry at the University of Colorado Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose.

CORONADO, CALIF. – When elderly patients are appropriately triaged, they can be selectively admitted to non–intensive care wards with acceptable outcomes, results from a single-center study showed.

“Trauma centers across the United States are caring for elderly trauma patients with greater frequency,” researchers led by Marc D. Trust, MD, wrote in an abstract presented during a poster session at the annual meeting of the Western Surgical Association.

“Previous literature showed improved outcomes in this population from aggressive care and invasive monitoring. This may have led to an increased utilization of intensive care resources for these patients,” they noted.

copyright Andrei Malov/Thinkstock

dbrunk@frontlinemedcom.com

CORONADO, CALIF. – When elderly patients are appropriately triaged, they can be selectively admitted to non–intensive care wards with acceptable outcomes, results from a single-center study showed.

“Trauma centers across the United States are caring for elderly trauma patients with greater frequency,” researchers led by Marc D. Trust, MD, wrote in an abstract presented during a poster session at the annual meeting of the Western Surgical Association.

“Previous literature showed improved outcomes in this population from aggressive care and invasive monitoring. This may have led to an increased utilization of intensive care resources for these patients,” they noted.

copyright Andrei Malov/Thinkstock

dbrunk@frontlinemedcom.com

CORONADO, CALIF. – When elderly patients are appropriately triaged, they can be selectively admitted to non–intensive care wards with acceptable outcomes, results from a single-center study showed.

“Trauma centers across the United States are caring for elderly trauma patients with greater frequency,” researchers led by Marc D. Trust, MD, wrote in an abstract presented during a poster session at the annual meeting of the Western Surgical Association.

“Previous literature showed improved outcomes in this population from aggressive care and invasive monitoring. This may have led to an increased utilization of intensive care resources for these patients,” they noted.

copyright Andrei Malov/Thinkstock

dbrunk@frontlinemedcom.com