Women experiencing syncope during pregnancy and their offspring have elevated rates of adverse outcomes that may warrant closer follow-up, a retrospective population-based cohort study finds. Risks appeared highest with first-trimester syncope.

“There are very limited data on the frequency of fainting during pregnancy,” Padma Kaul, Ph.D., senior study author and professor of medicine at the University of Alberta, Edmonton, said in a statement. “In our study, fainting during pregnancy occurred in about 1%, or 10 per 1,000 pregnancies, but appears to be increasing by 5% each year.”

“Fainting during pregnancy has previously been thought to follow a relatively benign course,” Dr. Kaul said. “The findings of our study suggest that timing of fainting during pregnancy may be important. When the faint happens early during pregnancy or multiple times during pregnancy, it may be associated with both short- and long-term health issues for the baby and the mother.”

First authors Safia Chatur, MD, of the University of Calgary (Alta.) and Sunjidatul Islam, MBBS, of the Canadian Vigour Centre, Edmonton, Alta., and associates analyzed 481,930 pregnancies occurring during 2005-2014 in the province.

Study results, reported in the Journal of the American Heart Association, showed that syncope occurred in almost 1% of pregnancies (9.7 episodes per 1,000 pregnancies) overall. Incidence increased by 5% per year during the study period.

Syncope episodes were distributed across the first trimester (32%), second trimester (44%), and third trimester (24%). Eight percent of pregnancies had more than one episode.

Compared with unaffected peers, women who experienced syncope were younger (age younger than 25 years, 35% vs. 21%; P less than .001) and more often primiparous (52% vs. 42%; P less than .001).

The rate of preterm birth was 18%, 16%, and 14% in pregnancies with an initial syncope episode during the first, second, and third trimester, respectively, compared with 15% in pregnancies without syncope (P less than .01 across groups).

With a median follow-up of about 5 years, compared with peers of syncope-free pregnancies, children of pregnancies complicated by syncope had a higher incidence of congenital anomalies (3.1% vs. 2.6%; P = .023). Incidence was highest in pregnancies with multiple episodes of syncope (5% vs. 3%; P less than .01).

In adjusted analyses that accounted for multiple pregnancies in individual women, relative to counterparts with no syncope during pregnancy, women who experienced syncope during the first trimester had higher odds of giving birth preterm (odds ratio, 1.3; P = .001) and of having an infant small for gestational age (OR, 1.2; P = .04) or with congenital anomalies (OR, 1.4; P = .036). Women with multiple syncope episodes versus none were twice as likely to have offspring with congenital anomalies (OR, 2.0; P = .003).

Relative to peers who did not experience syncope in pregnancy, women who did had higher incidences of cardiac arrhythmias (0.8% vs. 0.2%; P less than .01) and syncope episodes (1.4% vs. 0.2%; P less than .01) in the first year after delivery.

“Our data suggest that syncope during pregnancy may not be a benign occurrence,” Dr. Chatur and associates said. “More detailed clinical data are needed to identify potential causes for the observed increase in syncope during pregnancy in our study.“Whether women who experience syncope during pregnancy may benefit from closer monitoring during the obstetric and postpartum periods requires further study,” they concluded.

The investigators disclosed no relevant conflicts of interest. This study was funded by a grant from the Cardiac Arrhythmia Network of Canada.

SOURCE: Chatur S et al. J Am Heart Assoc. 2019;8:e011608.

Women experiencing syncope during pregnancy and their offspring have elevated rates of adverse outcomes that may warrant closer follow-up, a retrospective population-based cohort study finds. Risks appeared highest with first-trimester syncope.

“There are very limited data on the frequency of fainting during pregnancy,” Padma Kaul, Ph.D., senior study author and professor of medicine at the University of Alberta, Edmonton, said in a statement. “In our study, fainting during pregnancy occurred in about 1%, or 10 per 1,000 pregnancies, but appears to be increasing by 5% each year.”

“Fainting during pregnancy has previously been thought to follow a relatively benign course,” Dr. Kaul said. “The findings of our study suggest that timing of fainting during pregnancy may be important. When the faint happens early during pregnancy or multiple times during pregnancy, it may be associated with both short- and long-term health issues for the baby and the mother.”

First authors Safia Chatur, MD, of the University of Calgary (Alta.) and Sunjidatul Islam, MBBS, of the Canadian Vigour Centre, Edmonton, Alta., and associates analyzed 481,930 pregnancies occurring during 2005-2014 in the province.

Study results, reported in the Journal of the American Heart Association, showed that syncope occurred in almost 1% of pregnancies (9.7 episodes per 1,000 pregnancies) overall. Incidence increased by 5% per year during the study period.

Syncope episodes were distributed across the first trimester (32%), second trimester (44%), and third trimester (24%). Eight percent of pregnancies had more than one episode.

Compared with unaffected peers, women who experienced syncope were younger (age younger than 25 years, 35% vs. 21%; P less than .001) and more often primiparous (52% vs. 42%; P less than .001).

The rate of preterm birth was 18%, 16%, and 14% in pregnancies with an initial syncope episode during the first, second, and third trimester, respectively, compared with 15% in pregnancies without syncope (P less than .01 across groups).

With a median follow-up of about 5 years, compared with peers of syncope-free pregnancies, children of pregnancies complicated by syncope had a higher incidence of congenital anomalies (3.1% vs. 2.6%; P = .023). Incidence was highest in pregnancies with multiple episodes of syncope (5% vs. 3%; P less than .01).

In adjusted analyses that accounted for multiple pregnancies in individual women, relative to counterparts with no syncope during pregnancy, women who experienced syncope during the first trimester had higher odds of giving birth preterm (odds ratio, 1.3; P = .001) and of having an infant small for gestational age (OR, 1.2; P = .04) or with congenital anomalies (OR, 1.4; P = .036). Women with multiple syncope episodes versus none were twice as likely to have offspring with congenital anomalies (OR, 2.0; P = .003).

Relative to peers who did not experience syncope in pregnancy, women who did had higher incidences of cardiac arrhythmias (0.8% vs. 0.2%; P less than .01) and syncope episodes (1.4% vs. 0.2%; P less than .01) in the first year after delivery.

“Our data suggest that syncope during pregnancy may not be a benign occurrence,” Dr. Chatur and associates said. “More detailed clinical data are needed to identify potential causes for the observed increase in syncope during pregnancy in our study.“Whether women who experience syncope during pregnancy may benefit from closer monitoring during the obstetric and postpartum periods requires further study,” they concluded.

The investigators disclosed no relevant conflicts of interest. This study was funded by a grant from the Cardiac Arrhythmia Network of Canada.

SOURCE: Chatur S et al. J Am Heart Assoc. 2019;8:e011608.

Women experiencing syncope during pregnancy and their offspring have elevated rates of adverse outcomes that may warrant closer follow-up, a retrospective population-based cohort study finds. Risks appeared highest with first-trimester syncope.

“There are very limited data on the frequency of fainting during pregnancy,” Padma Kaul, Ph.D., senior study author and professor of medicine at the University of Alberta, Edmonton, said in a statement. “In our study, fainting during pregnancy occurred in about 1%, or 10 per 1,000 pregnancies, but appears to be increasing by 5% each year.”

“Fainting during pregnancy has previously been thought to follow a relatively benign course,” Dr. Kaul said. “The findings of our study suggest that timing of fainting during pregnancy may be important. When the faint happens early during pregnancy or multiple times during pregnancy, it may be associated with both short- and long-term health issues for the baby and the mother.”

First authors Safia Chatur, MD, of the University of Calgary (Alta.) and Sunjidatul Islam, MBBS, of the Canadian Vigour Centre, Edmonton, Alta., and associates analyzed 481,930 pregnancies occurring during 2005-2014 in the province.

Study results, reported in the Journal of the American Heart Association, showed that syncope occurred in almost 1% of pregnancies (9.7 episodes per 1,000 pregnancies) overall. Incidence increased by 5% per year during the study period.

Syncope episodes were distributed across the first trimester (32%), second trimester (44%), and third trimester (24%). Eight percent of pregnancies had more than one episode.

Compared with unaffected peers, women who experienced syncope were younger (age younger than 25 years, 35% vs. 21%; P less than .001) and more often primiparous (52% vs. 42%; P less than .001).

The rate of preterm birth was 18%, 16%, and 14% in pregnancies with an initial syncope episode during the first, second, and third trimester, respectively, compared with 15% in pregnancies without syncope (P less than .01 across groups).

With a median follow-up of about 5 years, compared with peers of syncope-free pregnancies, children of pregnancies complicated by syncope had a higher incidence of congenital anomalies (3.1% vs. 2.6%; P = .023). Incidence was highest in pregnancies with multiple episodes of syncope (5% vs. 3%; P less than .01).

In adjusted analyses that accounted for multiple pregnancies in individual women, relative to counterparts with no syncope during pregnancy, women who experienced syncope during the first trimester had higher odds of giving birth preterm (odds ratio, 1.3; P = .001) and of having an infant small for gestational age (OR, 1.2; P = .04) or with congenital anomalies (OR, 1.4; P = .036). Women with multiple syncope episodes versus none were twice as likely to have offspring with congenital anomalies (OR, 2.0; P = .003).

Relative to peers who did not experience syncope in pregnancy, women who did had higher incidences of cardiac arrhythmias (0.8% vs. 0.2%; P less than .01) and syncope episodes (1.4% vs. 0.2%; P less than .01) in the first year after delivery.

“Our data suggest that syncope during pregnancy may not be a benign occurrence,” Dr. Chatur and associates said. “More detailed clinical data are needed to identify potential causes for the observed increase in syncope during pregnancy in our study.“Whether women who experience syncope during pregnancy may benefit from closer monitoring during the obstetric and postpartum periods requires further study,” they concluded.

The investigators disclosed no relevant conflicts of interest. This study was funded by a grant from the Cardiac Arrhythmia Network of Canada.

SOURCE: Chatur S et al. J Am Heart Assoc. 2019;8:e011608.

I previously shared my concerns about the compromises some physicians are making when they consent to practicing in a telemedicine arrangement in which the system’s technical limitations prevents them from obtaining information critical to making an accurate diagnosis. In the scenarios that I described, a physician would have great difficulty being a good steward of antibiotic usage if he were willing to make a diagnosis of otitis media or strep throat without access to tympanic membrane visualization or the results of a rapid strep test.

AJ_Watt/E+

In response to my observation, I received an email from Dr. Kenneth McConnochie, a name out of my deep past from when we were teammates in college. Now a professor of pediatrics at University of Rochester (N.Y.) Medical Center, Dr. McConnochie has studied telemedicine in primary care extensively. He has thought a lot about telemedicine and more specifically about how it relates to quality. As he pointed out to me, before we can start discussing quality, we must clear up the confusion engendered by the term “telemedicine.”

I suspect that like me, whenever you look at an article or study that has “telemedicine” in its title or headline, you are never sure what you’re going to be reading about. Is it going to be a discussion of telephone triaging in a suburban primary practice or will the article describe how a pediatric cardiologist in Anchorage can follow his little patients in the Aleutians via an audio/video hookup that provides him with the ability to auscultate and review electrocardiograms and radiographic images? Dr. McConnochie suggests that by using the broader term “connected care” for care that is delivered at a distance, and by clearly specifying different types or levels, we will be one big step closer to a more meaningful way to understand the usefulness of that care.

In the conceptual framework he proposes, level 1 is text-only care because it offers the physician the least capacity for the acquisition of (1) diagnostically relevant information and (2) interpersonal connection. Phone care can provide more and videoconferencing still more. Level 4 would be what Dr. McConnochie labels “information rich” care providing the most abundant capacity. Here, think of an arrangement in which someone at the patient’s end of the connection has been trained to use an electronic otoscope that can capture an image of the child’s tympanic membrane, an electronic stethoscope that can record heart and breath sounds, and a high resolution camera to capture images of the patient’s skin, throat, and eyes, then transmit them to the child’s electronic health record (EHR) in real time. Someone in the school or day care center where the child spends his day has been taught how to obtain and process a rapid strep test. The physician who has instant access to the child’s EHR can communicate “face to face” via teleconferencing with the day care providers and with the parent who is at work to discuss the diagnosis, treatment plan, and follow-up. If any of the parties feels the exchange of information is insufficiently robust, a traditional office visit can be arranged.

The challenge of assigning value to each level care still remains. Is the level 4 scenario I just described as valuable as a face to face traditional office visit? In some situations, it is likely to be more valuable than a visit with a physician in an urgent care clinic or emergency department who has never seen the patient and/or lacks access to the EHR because her computer doesn’t interface with the primary care physician’s EHR. It certainly may be more convenient for the family.

But who is going to assign value? A connected visit may be more efficient for the patient and the parent, but will it be more costly? And who is going to pay? Dr. McConnochie’s observations should be taken seriously by those folks who assign value and pay.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

I previously shared my concerns about the compromises some physicians are making when they consent to practicing in a telemedicine arrangement in which the system’s technical limitations prevents them from obtaining information critical to making an accurate diagnosis. In the scenarios that I described, a physician would have great difficulty being a good steward of antibiotic usage if he were willing to make a diagnosis of otitis media or strep throat without access to tympanic membrane visualization or the results of a rapid strep test.

AJ_Watt/E+

In response to my observation, I received an email from Dr. Kenneth McConnochie, a name out of my deep past from when we were teammates in college. Now a professor of pediatrics at University of Rochester (N.Y.) Medical Center, Dr. McConnochie has studied telemedicine in primary care extensively. He has thought a lot about telemedicine and more specifically about how it relates to quality. As he pointed out to me, before we can start discussing quality, we must clear up the confusion engendered by the term “telemedicine.”

I suspect that like me, whenever you look at an article or study that has “telemedicine” in its title or headline, you are never sure what you’re going to be reading about. Is it going to be a discussion of telephone triaging in a suburban primary practice or will the article describe how a pediatric cardiologist in Anchorage can follow his little patients in the Aleutians via an audio/video hookup that provides him with the ability to auscultate and review electrocardiograms and radiographic images? Dr. McConnochie suggests that by using the broader term “connected care” for care that is delivered at a distance, and by clearly specifying different types or levels, we will be one big step closer to a more meaningful way to understand the usefulness of that care.

In the conceptual framework he proposes, level 1 is text-only care because it offers the physician the least capacity for the acquisition of (1) diagnostically relevant information and (2) interpersonal connection. Phone care can provide more and videoconferencing still more. Level 4 would be what Dr. McConnochie labels “information rich” care providing the most abundant capacity. Here, think of an arrangement in which someone at the patient’s end of the connection has been trained to use an electronic otoscope that can capture an image of the child’s tympanic membrane, an electronic stethoscope that can record heart and breath sounds, and a high resolution camera to capture images of the patient’s skin, throat, and eyes, then transmit them to the child’s electronic health record (EHR) in real time. Someone in the school or day care center where the child spends his day has been taught how to obtain and process a rapid strep test. The physician who has instant access to the child’s EHR can communicate “face to face” via teleconferencing with the day care providers and with the parent who is at work to discuss the diagnosis, treatment plan, and follow-up. If any of the parties feels the exchange of information is insufficiently robust, a traditional office visit can be arranged.

The challenge of assigning value to each level care still remains. Is the level 4 scenario I just described as valuable as a face to face traditional office visit? In some situations, it is likely to be more valuable than a visit with a physician in an urgent care clinic or emergency department who has never seen the patient and/or lacks access to the EHR because her computer doesn’t interface with the primary care physician’s EHR. It certainly may be more convenient for the family.

But who is going to assign value? A connected visit may be more efficient for the patient and the parent, but will it be more costly? And who is going to pay? Dr. McConnochie’s observations should be taken seriously by those folks who assign value and pay.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

I previously shared my concerns about the compromises some physicians are making when they consent to practicing in a telemedicine arrangement in which the system’s technical limitations prevents them from obtaining information critical to making an accurate diagnosis. In the scenarios that I described, a physician would have great difficulty being a good steward of antibiotic usage if he were willing to make a diagnosis of otitis media or strep throat without access to tympanic membrane visualization or the results of a rapid strep test.

AJ_Watt/E+

In response to my observation, I received an email from Dr. Kenneth McConnochie, a name out of my deep past from when we were teammates in college. Now a professor of pediatrics at University of Rochester (N.Y.) Medical Center, Dr. McConnochie has studied telemedicine in primary care extensively. He has thought a lot about telemedicine and more specifically about how it relates to quality. As he pointed out to me, before we can start discussing quality, we must clear up the confusion engendered by the term “telemedicine.”

I suspect that like me, whenever you look at an article or study that has “telemedicine” in its title or headline, you are never sure what you’re going to be reading about. Is it going to be a discussion of telephone triaging in a suburban primary practice or will the article describe how a pediatric cardiologist in Anchorage can follow his little patients in the Aleutians via an audio/video hookup that provides him with the ability to auscultate and review electrocardiograms and radiographic images? Dr. McConnochie suggests that by using the broader term “connected care” for care that is delivered at a distance, and by clearly specifying different types or levels, we will be one big step closer to a more meaningful way to understand the usefulness of that care.

In the conceptual framework he proposes, level 1 is text-only care because it offers the physician the least capacity for the acquisition of (1) diagnostically relevant information and (2) interpersonal connection. Phone care can provide more and videoconferencing still more. Level 4 would be what Dr. McConnochie labels “information rich” care providing the most abundant capacity. Here, think of an arrangement in which someone at the patient’s end of the connection has been trained to use an electronic otoscope that can capture an image of the child’s tympanic membrane, an electronic stethoscope that can record heart and breath sounds, and a high resolution camera to capture images of the patient’s skin, throat, and eyes, then transmit them to the child’s electronic health record (EHR) in real time. Someone in the school or day care center where the child spends his day has been taught how to obtain and process a rapid strep test. The physician who has instant access to the child’s EHR can communicate “face to face” via teleconferencing with the day care providers and with the parent who is at work to discuss the diagnosis, treatment plan, and follow-up. If any of the parties feels the exchange of information is insufficiently robust, a traditional office visit can be arranged.

The challenge of assigning value to each level care still remains. Is the level 4 scenario I just described as valuable as a face to face traditional office visit? In some situations, it is likely to be more valuable than a visit with a physician in an urgent care clinic or emergency department who has never seen the patient and/or lacks access to the EHR because her computer doesn’t interface with the primary care physician’s EHR. It certainly may be more convenient for the family.

But who is going to assign value? A connected visit may be more efficient for the patient and the parent, but will it be more costly? And who is going to pay? Dr. McConnochie’s observations should be taken seriously by those folks who assign value and pay.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

WASHINGTON – Implementing an alert on electronic medical records to reinforce a change in public policy appears to be having a positive effect on opioid prescriptions.

Gregory Twachtman/MDedge News

Researchers looked at prescribing patterns of doctors in the Penn Medicine health system, which straddles both the Philadelphia area and southern New Jersey, following the implementation of prescribing limits in New Jersey.

The law in question is a 5-day limit on new opioid prescriptions, which was passed in February 2017 and implemented in May 2017. Penn Medicine implemented an EMR alert in their New Jersey locations to alert physicians within the Penn Medicine system of the change in their state law 2 months after the law went into effect. Researchers looked at prescribing patterns before passage, during the transition between passage and the implementation of the EMR alert and following implementation of the EMR alert, as well as secondary outcomes such as rate of refills, telephone calls, and utilization.

“The implementation of the prescribing limit and EMR alert was associated with a decrease in the volume of opioids prescribed in acute prescriptions without changes in the rates of refills, telephone calls or utilization,” Margaret Lowenstein, MD, of the University of Pennsylvania, Philadelphia, said at the annual meeting of the Society of General Internal Medicine.

“This combination of the policy and the EMR alert may be an effective strategy to influence prescriber behavior,” she added.

Researchers compared outcomes before and after the implementation of the law in New Jersey, using prescribing patterns in Pennsylvania as the control. The cohort of patients was those with a new opioid prescription within Penn Medicine ambulatory nonteaching practices. It excluded specialties not represented in both states as well as patients with cancer, those in hospice and palliative care and those in treatment for opioid use disorder, since the law does not apply to those groups.

In New Jersey, there were 434 patients receiving new prescriptions in the 12 months prior to the implementation of the law, with 234 patients receiving new prescriptions in the 9 months after the EMR alert was implemented in New Jersey. In Pennsylvania, the cohort included 2,961 patients prior to the law going into effect and 1,677 after the EMR intervention went live in New Jersey.

For New Jersey, the morphine milligram equivalent (MME) per prescription was steady at about 350 during the period prior to the law’s implementation, but dropped to nearly 250 by the end of the postintervention period examined. In Pennsylvania, the prelaw implementation period had an MME per prescription a little higher than 200, which leveled off at around 200 during the postintervention period.

“In New Jersey, there is a significantly higher MME than in Pennsylvania and this difference persists in the transition period but what you see in the post period is a significantly greater decline in the MME per prescription in New Jersey as compared to the rate of change in Pa.,” Dr. Lowenstein said. “That difference was statistically significant.”

She said similar results were seen regarding the quantity of tablets prescribed. In New Jersey before the law’s passage, the number of tablets per prescription was close to 50, dropping down to about 35 post period. Pennsylvania saw a slight decrease from about 35 pills per prescription to about 33 during the same period.

No significant changes occurred in the other outcomes measured following implementation of the EMR alert.

Dr. Lowenstein noted that, because the transition period between the law going into effect and the implementation of the EMR alert was so short, whether the greater decreases in opioid prescriptions in New Jersey relative to Pennsylvania was because of the law alone, the EMR alert alone, or both changes is unclear.

Based on the limited amount of change in prescribing patterns during the transition period, it appears that the EMR intervention may be driving the change, “but we weren’t powered to make that determination,” she added.

Dr. Lowenstein and her colleagues reported no disclosures.

gtwachtman@mdedge.com

WASHINGTON – Implementing an alert on electronic medical records to reinforce a change in public policy appears to be having a positive effect on opioid prescriptions.

Gregory Twachtman/MDedge News

Researchers looked at prescribing patterns of doctors in the Penn Medicine health system, which straddles both the Philadelphia area and southern New Jersey, following the implementation of prescribing limits in New Jersey.

The law in question is a 5-day limit on new opioid prescriptions, which was passed in February 2017 and implemented in May 2017. Penn Medicine implemented an EMR alert in their New Jersey locations to alert physicians within the Penn Medicine system of the change in their state law 2 months after the law went into effect. Researchers looked at prescribing patterns before passage, during the transition between passage and the implementation of the EMR alert and following implementation of the EMR alert, as well as secondary outcomes such as rate of refills, telephone calls, and utilization.

“The implementation of the prescribing limit and EMR alert was associated with a decrease in the volume of opioids prescribed in acute prescriptions without changes in the rates of refills, telephone calls or utilization,” Margaret Lowenstein, MD, of the University of Pennsylvania, Philadelphia, said at the annual meeting of the Society of General Internal Medicine.

“This combination of the policy and the EMR alert may be an effective strategy to influence prescriber behavior,” she added.

Researchers compared outcomes before and after the implementation of the law in New Jersey, using prescribing patterns in Pennsylvania as the control. The cohort of patients was those with a new opioid prescription within Penn Medicine ambulatory nonteaching practices. It excluded specialties not represented in both states as well as patients with cancer, those in hospice and palliative care and those in treatment for opioid use disorder, since the law does not apply to those groups.

In New Jersey, there were 434 patients receiving new prescriptions in the 12 months prior to the implementation of the law, with 234 patients receiving new prescriptions in the 9 months after the EMR alert was implemented in New Jersey. In Pennsylvania, the cohort included 2,961 patients prior to the law going into effect and 1,677 after the EMR intervention went live in New Jersey.

For New Jersey, the morphine milligram equivalent (MME) per prescription was steady at about 350 during the period prior to the law’s implementation, but dropped to nearly 250 by the end of the postintervention period examined. In Pennsylvania, the prelaw implementation period had an MME per prescription a little higher than 200, which leveled off at around 200 during the postintervention period.

“In New Jersey, there is a significantly higher MME than in Pennsylvania and this difference persists in the transition period but what you see in the post period is a significantly greater decline in the MME per prescription in New Jersey as compared to the rate of change in Pa.,” Dr. Lowenstein said. “That difference was statistically significant.”

She said similar results were seen regarding the quantity of tablets prescribed. In New Jersey before the law’s passage, the number of tablets per prescription was close to 50, dropping down to about 35 post period. Pennsylvania saw a slight decrease from about 35 pills per prescription to about 33 during the same period.

No significant changes occurred in the other outcomes measured following implementation of the EMR alert.

Dr. Lowenstein noted that, because the transition period between the law going into effect and the implementation of the EMR alert was so short, whether the greater decreases in opioid prescriptions in New Jersey relative to Pennsylvania was because of the law alone, the EMR alert alone, or both changes is unclear.

Based on the limited amount of change in prescribing patterns during the transition period, it appears that the EMR intervention may be driving the change, “but we weren’t powered to make that determination,” she added.

Dr. Lowenstein and her colleagues reported no disclosures.

gtwachtman@mdedge.com

WASHINGTON – Implementing an alert on electronic medical records to reinforce a change in public policy appears to be having a positive effect on opioid prescriptions.

Gregory Twachtman/MDedge News

Researchers looked at prescribing patterns of doctors in the Penn Medicine health system, which straddles both the Philadelphia area and southern New Jersey, following the implementation of prescribing limits in New Jersey.

The law in question is a 5-day limit on new opioid prescriptions, which was passed in February 2017 and implemented in May 2017. Penn Medicine implemented an EMR alert in their New Jersey locations to alert physicians within the Penn Medicine system of the change in their state law 2 months after the law went into effect. Researchers looked at prescribing patterns before passage, during the transition between passage and the implementation of the EMR alert and following implementation of the EMR alert, as well as secondary outcomes such as rate of refills, telephone calls, and utilization.

“The implementation of the prescribing limit and EMR alert was associated with a decrease in the volume of opioids prescribed in acute prescriptions without changes in the rates of refills, telephone calls or utilization,” Margaret Lowenstein, MD, of the University of Pennsylvania, Philadelphia, said at the annual meeting of the Society of General Internal Medicine.

“This combination of the policy and the EMR alert may be an effective strategy to influence prescriber behavior,” she added.

Researchers compared outcomes before and after the implementation of the law in New Jersey, using prescribing patterns in Pennsylvania as the control. The cohort of patients was those with a new opioid prescription within Penn Medicine ambulatory nonteaching practices. It excluded specialties not represented in both states as well as patients with cancer, those in hospice and palliative care and those in treatment for opioid use disorder, since the law does not apply to those groups.

In New Jersey, there were 434 patients receiving new prescriptions in the 12 months prior to the implementation of the law, with 234 patients receiving new prescriptions in the 9 months after the EMR alert was implemented in New Jersey. In Pennsylvania, the cohort included 2,961 patients prior to the law going into effect and 1,677 after the EMR intervention went live in New Jersey.

For New Jersey, the morphine milligram equivalent (MME) per prescription was steady at about 350 during the period prior to the law’s implementation, but dropped to nearly 250 by the end of the postintervention period examined. In Pennsylvania, the prelaw implementation period had an MME per prescription a little higher than 200, which leveled off at around 200 during the postintervention period.

“In New Jersey, there is a significantly higher MME than in Pennsylvania and this difference persists in the transition period but what you see in the post period is a significantly greater decline in the MME per prescription in New Jersey as compared to the rate of change in Pa.,” Dr. Lowenstein said. “That difference was statistically significant.”

She said similar results were seen regarding the quantity of tablets prescribed. In New Jersey before the law’s passage, the number of tablets per prescription was close to 50, dropping down to about 35 post period. Pennsylvania saw a slight decrease from about 35 pills per prescription to about 33 during the same period.

No significant changes occurred in the other outcomes measured following implementation of the EMR alert.

Dr. Lowenstein noted that, because the transition period between the law going into effect and the implementation of the EMR alert was so short, whether the greater decreases in opioid prescriptions in New Jersey relative to Pennsylvania was because of the law alone, the EMR alert alone, or both changes is unclear.

Based on the limited amount of change in prescribing patterns during the transition period, it appears that the EMR intervention may be driving the change, “but we weren’t powered to make that determination,” she added.

Dr. Lowenstein and her colleagues reported no disclosures.

gtwachtman@mdedge.com

Kailah is a 13-year-old cisgender female with two working parents, two younger siblings, and a history of mild asthma and overweight who recently presented for a problem-focused visit related to increasing anxiety. An interview of Kailah and her parents led to a diagnosis of generalized anxiety disorder, and she was referred for cognitive-behavioral therapy (CBT) and started on a low-dose SSRI. She now presents 3 months later with decreased anxiety and is compliant with the SSRI and CBT. What next?

Positive psychology and psychiatry have emerged as scientific disciplines since Seligman et al.¹ charged the field of psychology with reclaiming its stake in helping everyday people to thrive, as well as cultivating strengths and talents at each level of society – individual, family, institutional, and beyond. This call to action revealed the shift over time from mental health care toward a focus only on mental illness. And study after study confirmed that being “not depressed,” “not anxious” and so on was not the same as flourishing.²

Returning to Kailah, from a mental-health-as-usual approach, your job may be done. Her symptoms have responded to first-line treatments. Perhaps you even tracked her symptoms with a freely available standardized assessment tool like the Screen for Child Anxiety Related Disorders (SCARED)³ and noted a significant drop in her generalized anxiety score. But how to be sure she is not just less anxious, but also experiencing well-being?

After a couple decades of research, the science of well-being has led to some consistent findings that can be translated into office practice with children and families. As with any new science, the first steps to building well-being are defining and measuring what we are talking about. I recommend the Flourishing Scale⁴ for its brevity, availability, and ease of use. It covers the domains included in Seligman’s formula for thriving: PERMA. This acronym represents a consolidation of the first decades of research on well-being, and stands for Positive Emotions, Engagement, (Positive) Relationships, Meaning, and Accomplishments. For a readable but deeper look at the science behind this, check out Seligman’s “Flourish.”⁵

With the Flourishing Scale total score as a starting point, the acronym PERMA itself can be a good rubric to guide assessment and treatment planning in the office. You can query each of the elements to understand a youth’s current status and areas for building strengths. What brings positive emotions? What activities bring a sense of harmonious engagement without self-consciousness or awareness of time (such as a flow state)? What supportive relationships exist? Where does the youth find meaning or purpose – connection to something larger than themselves (family, work, community, teams, religion, and so on)? And where does the youth derive a sense of competence or self-esteem – something they are good at (accomplishment)?

Your clinical recommendations can flow from this assessment discussion, melding the patient’s and family’s strengths and priorities with evidence-based interventions. “The Resilience Drive,” by Alexia Michiels,⁶ is a good source for the latter – each chapter has segments relating research to straightforward happiness practices. The Growing Happy card deck (available online) also has brief and usable recommendations suitable for many young people. You can use these during office visits, loan out cards, gift them to families, or recommend families purchase a deck.

Dr. Andrew J. Rosenfeld is an assistant professor in the departments of psychiatry and pediatrics at the University of Vermont Medical Center, Burlington. He said he has no relevant disclosures. Email him at pdnews@mdedge.com.

References

1. Am Psychol. 2000;55(1):5-14.

2. Am Psychol. 2007 Feb-Mar;62(2):95-108.

3. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6.

4. Soc Indic Res. 2009; 39:247-66.

5. “Flourish: A visionary new understanding of happiness and well-being” (New York: Free Press, 2011).

6. “The Resilience Drive” (Switzerland: Favre, 2017).

7. Am Psychol. 2005 Jul-Aug;60(5):410-21.

Kailah is a 13-year-old cisgender female with two working parents, two younger siblings, and a history of mild asthma and overweight who recently presented for a problem-focused visit related to increasing anxiety. An interview of Kailah and her parents led to a diagnosis of generalized anxiety disorder, and she was referred for cognitive-behavioral therapy (CBT) and started on a low-dose SSRI. She now presents 3 months later with decreased anxiety and is compliant with the SSRI and CBT. What next?

Positive psychology and psychiatry have emerged as scientific disciplines since Seligman et al.¹ charged the field of psychology with reclaiming its stake in helping everyday people to thrive, as well as cultivating strengths and talents at each level of society – individual, family, institutional, and beyond. This call to action revealed the shift over time from mental health care toward a focus only on mental illness. And study after study confirmed that being “not depressed,” “not anxious” and so on was not the same as flourishing.²

Returning to Kailah, from a mental-health-as-usual approach, your job may be done. Her symptoms have responded to first-line treatments. Perhaps you even tracked her symptoms with a freely available standardized assessment tool like the Screen for Child Anxiety Related Disorders (SCARED)³ and noted a significant drop in her generalized anxiety score. But how to be sure she is not just less anxious, but also experiencing well-being?

After a couple decades of research, the science of well-being has led to some consistent findings that can be translated into office practice with children and families. As with any new science, the first steps to building well-being are defining and measuring what we are talking about. I recommend the Flourishing Scale⁴ for its brevity, availability, and ease of use. It covers the domains included in Seligman’s formula for thriving: PERMA. This acronym represents a consolidation of the first decades of research on well-being, and stands for Positive Emotions, Engagement, (Positive) Relationships, Meaning, and Accomplishments. For a readable but deeper look at the science behind this, check out Seligman’s “Flourish.”⁵

With the Flourishing Scale total score as a starting point, the acronym PERMA itself can be a good rubric to guide assessment and treatment planning in the office. You can query each of the elements to understand a youth’s current status and areas for building strengths. What brings positive emotions? What activities bring a sense of harmonious engagement without self-consciousness or awareness of time (such as a flow state)? What supportive relationships exist? Where does the youth find meaning or purpose – connection to something larger than themselves (family, work, community, teams, religion, and so on)? And where does the youth derive a sense of competence or self-esteem – something they are good at (accomplishment)?

Your clinical recommendations can flow from this assessment discussion, melding the patient’s and family’s strengths and priorities with evidence-based interventions. “The Resilience Drive,” by Alexia Michiels,⁶ is a good source for the latter – each chapter has segments relating research to straightforward happiness practices. The Growing Happy card deck (available online) also has brief and usable recommendations suitable for many young people. You can use these during office visits, loan out cards, gift them to families, or recommend families purchase a deck.

Dr. Andrew J. Rosenfeld is an assistant professor in the departments of psychiatry and pediatrics at the University of Vermont Medical Center, Burlington. He said he has no relevant disclosures. Email him at pdnews@mdedge.com.

References

1. Am Psychol. 2000;55(1):5-14.

2. Am Psychol. 2007 Feb-Mar;62(2):95-108.

3. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6.

4. Soc Indic Res. 2009; 39:247-66.

5. “Flourish: A visionary new understanding of happiness and well-being” (New York: Free Press, 2011).

6. “The Resilience Drive” (Switzerland: Favre, 2017).

7. Am Psychol. 2005 Jul-Aug;60(5):410-21.

Kailah is a 13-year-old cisgender female with two working parents, two younger siblings, and a history of mild asthma and overweight who recently presented for a problem-focused visit related to increasing anxiety. An interview of Kailah and her parents led to a diagnosis of generalized anxiety disorder, and she was referred for cognitive-behavioral therapy (CBT) and started on a low-dose SSRI. She now presents 3 months later with decreased anxiety and is compliant with the SSRI and CBT. What next?

Positive psychology and psychiatry have emerged as scientific disciplines since Seligman et al.¹ charged the field of psychology with reclaiming its stake in helping everyday people to thrive, as well as cultivating strengths and talents at each level of society – individual, family, institutional, and beyond. This call to action revealed the shift over time from mental health care toward a focus only on mental illness. And study after study confirmed that being “not depressed,” “not anxious” and so on was not the same as flourishing.²

Returning to Kailah, from a mental-health-as-usual approach, your job may be done. Her symptoms have responded to first-line treatments. Perhaps you even tracked her symptoms with a freely available standardized assessment tool like the Screen for Child Anxiety Related Disorders (SCARED)³ and noted a significant drop in her generalized anxiety score. But how to be sure she is not just less anxious, but also experiencing well-being?

After a couple decades of research, the science of well-being has led to some consistent findings that can be translated into office practice with children and families. As with any new science, the first steps to building well-being are defining and measuring what we are talking about. I recommend the Flourishing Scale⁴ for its brevity, availability, and ease of use. It covers the domains included in Seligman’s formula for thriving: PERMA. This acronym represents a consolidation of the first decades of research on well-being, and stands for Positive Emotions, Engagement, (Positive) Relationships, Meaning, and Accomplishments. For a readable but deeper look at the science behind this, check out Seligman’s “Flourish.”⁵

With the Flourishing Scale total score as a starting point, the acronym PERMA itself can be a good rubric to guide assessment and treatment planning in the office. You can query each of the elements to understand a youth’s current status and areas for building strengths. What brings positive emotions? What activities bring a sense of harmonious engagement without self-consciousness or awareness of time (such as a flow state)? What supportive relationships exist? Where does the youth find meaning or purpose – connection to something larger than themselves (family, work, community, teams, religion, and so on)? And where does the youth derive a sense of competence or self-esteem – something they are good at (accomplishment)?

Your clinical recommendations can flow from this assessment discussion, melding the patient’s and family’s strengths and priorities with evidence-based interventions. “The Resilience Drive,” by Alexia Michiels,⁶ is a good source for the latter – each chapter has segments relating research to straightforward happiness practices. The Growing Happy card deck (available online) also has brief and usable recommendations suitable for many young people. You can use these during office visits, loan out cards, gift them to families, or recommend families purchase a deck.

Dr. Andrew J. Rosenfeld is an assistant professor in the departments of psychiatry and pediatrics at the University of Vermont Medical Center, Burlington. He said he has no relevant disclosures. Email him at pdnews@mdedge.com.

References

1. Am Psychol. 2000;55(1):5-14.

2. Am Psychol. 2007 Feb-Mar;62(2):95-108.

3. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6.

4. Soc Indic Res. 2009; 39:247-66.

5. “Flourish: A visionary new understanding of happiness and well-being” (New York: Free Press, 2011).

6. “The Resilience Drive” (Switzerland: Favre, 2017).

7. Am Psychol. 2005 Jul-Aug;60(5):410-21.

Children of parents with extensive exposure to prescription opioids appear to be nearly two times more likely to attempt suicide than children of control parents, according to an evaluation of a medical claims database from which a sample of more than 200,00 privately insured parents was evaluated.

StHelena/Getty Images

Based on data collected between the years 2010 and 2016, the study raises the possibility that rising rates of opioid prescriptions and rising rates of suicide in adolescents and children are linked, said David A. Brent, of the University of Pittsburgh, and associates.

The relationship was considered sufficiently strong that the authors recommended clinicians consider mental health screening of children whose parents are known to have had extensive opioid exposure.

Addressing both opioid use in parents and the mental health in their children “may help, at least in part, to reverse the current upward trend in mortality due to the twin epidemics of suicide and opioid overdose,” said Dr. Brent and associates, whose findings were published in JAMA Psychiatry.

From a pool of more than 1 million parents aged 30-50 years in the claims database, 121,306 parents with extensive opioid use – defined as receiving opioid prescriptions for more than 365 days between 2010 and 2016 – were matched with 121,306 controls in the same age range. Children aged 10-19 years in both groups were compared for suicide attempts.

Overall, the rate of prescription opioid use as defined for inclusion in this study was 5% in the target parent population evaluated in this claims database.

Of the 184,142 children with parents exposed to opioids, 678 (0.37%) attempted suicide versus 212 (0.14%) of the 148,395 children from the nonopioid group. Expressed as a rate per 10,000 person years, the figures were 11.7 and 5.9 for the opioid and nonopioid groups, respectively.

When translated into an odds ratio (OR), the increased risk of suicide was found to be almost twice as high (OR 1.99) among children with parents meeting the study criteria for prescription opioid use. The OR was only slightly reduced (OR 1.85) after adjustment for sex and age.

Suicide attempts overall were higher in daughters than sons and in older children (15 years of age or older) than younger (ages 10 to less than 15 years) whether or not parents were taking opioids, but the relative risk remained consistently higher across all these subgroups when comparing those whose parents were taking prescription opioids with those whose parents were not.

As in past studies, children were more likely to make a suicide attempt if they had a parent who had a history of attempting suicide. However, the authors reported a significantly elevated risk of a suicide attempt for children of prescription opioid users after adjustment for this factor as well as for child depression, parental depression, and parental substance use disorder (OR, 1.45).

The OR of a suicide attempt was not significantly higher for a suicide attempt among those children with both parents taking prescription opioids relative to opioid use in only one parent (OR 1.05).

Dr. Brent and associates acknowledged that these data do not confirm that the rising rate of prescription opioid use is linked to the recent parallel rise in suicide attempts among children. However, they did conclude that children of parents using opioid prescriptions are at risk and might be an appropriate target for suicide prevention.

“Recognition and treatment of patients with opioid use disorder, attendance to comorbid conditions in affected parents, and screening and appropriate referral of their children may help” address both major public health issues, they maintained.

The study was supported by a National Institutes of Health grant. Dr Brent reported receiving royalties from Guilford Press, eRT, and UpToDate. Dr. Gibbons has served as an expert witness in cases related to suicide involving pharmaceutical companies, such as Pfizer and GlaxoSmithKline.

SOURCE: Brent DA et al. JAMA Psychiatry. 2019 May 22 doi: 10.1001/jamapsychiatry.2019.0940.

Children of parents with extensive exposure to prescription opioids appear to be nearly two times more likely to attempt suicide than children of control parents, according to an evaluation of a medical claims database from which a sample of more than 200,00 privately insured parents was evaluated.

StHelena/Getty Images

Based on data collected between the years 2010 and 2016, the study raises the possibility that rising rates of opioid prescriptions and rising rates of suicide in adolescents and children are linked, said David A. Brent, of the University of Pittsburgh, and associates.

The relationship was considered sufficiently strong that the authors recommended clinicians consider mental health screening of children whose parents are known to have had extensive opioid exposure.

Addressing both opioid use in parents and the mental health in their children “may help, at least in part, to reverse the current upward trend in mortality due to the twin epidemics of suicide and opioid overdose,” said Dr. Brent and associates, whose findings were published in JAMA Psychiatry.

From a pool of more than 1 million parents aged 30-50 years in the claims database, 121,306 parents with extensive opioid use – defined as receiving opioid prescriptions for more than 365 days between 2010 and 2016 – were matched with 121,306 controls in the same age range. Children aged 10-19 years in both groups were compared for suicide attempts.

Overall, the rate of prescription opioid use as defined for inclusion in this study was 5% in the target parent population evaluated in this claims database.

Of the 184,142 children with parents exposed to opioids, 678 (0.37%) attempted suicide versus 212 (0.14%) of the 148,395 children from the nonopioid group. Expressed as a rate per 10,000 person years, the figures were 11.7 and 5.9 for the opioid and nonopioid groups, respectively.

When translated into an odds ratio (OR), the increased risk of suicide was found to be almost twice as high (OR 1.99) among children with parents meeting the study criteria for prescription opioid use. The OR was only slightly reduced (OR 1.85) after adjustment for sex and age.

Suicide attempts overall were higher in daughters than sons and in older children (15 years of age or older) than younger (ages 10 to less than 15 years) whether or not parents were taking opioids, but the relative risk remained consistently higher across all these subgroups when comparing those whose parents were taking prescription opioids with those whose parents were not.

As in past studies, children were more likely to make a suicide attempt if they had a parent who had a history of attempting suicide. However, the authors reported a significantly elevated risk of a suicide attempt for children of prescription opioid users after adjustment for this factor as well as for child depression, parental depression, and parental substance use disorder (OR, 1.45).

The OR of a suicide attempt was not significantly higher for a suicide attempt among those children with both parents taking prescription opioids relative to opioid use in only one parent (OR 1.05).

Dr. Brent and associates acknowledged that these data do not confirm that the rising rate of prescription opioid use is linked to the recent parallel rise in suicide attempts among children. However, they did conclude that children of parents using opioid prescriptions are at risk and might be an appropriate target for suicide prevention.

“Recognition and treatment of patients with opioid use disorder, attendance to comorbid conditions in affected parents, and screening and appropriate referral of their children may help” address both major public health issues, they maintained.

The study was supported by a National Institutes of Health grant. Dr Brent reported receiving royalties from Guilford Press, eRT, and UpToDate. Dr. Gibbons has served as an expert witness in cases related to suicide involving pharmaceutical companies, such as Pfizer and GlaxoSmithKline.

SOURCE: Brent DA et al. JAMA Psychiatry. 2019 May 22 doi: 10.1001/jamapsychiatry.2019.0940.

Children of parents with extensive exposure to prescription opioids appear to be nearly two times more likely to attempt suicide than children of control parents, according to an evaluation of a medical claims database from which a sample of more than 200,00 privately insured parents was evaluated.

StHelena/Getty Images

Based on data collected between the years 2010 and 2016, the study raises the possibility that rising rates of opioid prescriptions and rising rates of suicide in adolescents and children are linked, said David A. Brent, of the University of Pittsburgh, and associates.

The relationship was considered sufficiently strong that the authors recommended clinicians consider mental health screening of children whose parents are known to have had extensive opioid exposure.

Addressing both opioid use in parents and the mental health in their children “may help, at least in part, to reverse the current upward trend in mortality due to the twin epidemics of suicide and opioid overdose,” said Dr. Brent and associates, whose findings were published in JAMA Psychiatry.

From a pool of more than 1 million parents aged 30-50 years in the claims database, 121,306 parents with extensive opioid use – defined as receiving opioid prescriptions for more than 365 days between 2010 and 2016 – were matched with 121,306 controls in the same age range. Children aged 10-19 years in both groups were compared for suicide attempts.

Overall, the rate of prescription opioid use as defined for inclusion in this study was 5% in the target parent population evaluated in this claims database.

Of the 184,142 children with parents exposed to opioids, 678 (0.37%) attempted suicide versus 212 (0.14%) of the 148,395 children from the nonopioid group. Expressed as a rate per 10,000 person years, the figures were 11.7 and 5.9 for the opioid and nonopioid groups, respectively.

When translated into an odds ratio (OR), the increased risk of suicide was found to be almost twice as high (OR 1.99) among children with parents meeting the study criteria for prescription opioid use. The OR was only slightly reduced (OR 1.85) after adjustment for sex and age.

Suicide attempts overall were higher in daughters than sons and in older children (15 years of age or older) than younger (ages 10 to less than 15 years) whether or not parents were taking opioids, but the relative risk remained consistently higher across all these subgroups when comparing those whose parents were taking prescription opioids with those whose parents were not.

As in past studies, children were more likely to make a suicide attempt if they had a parent who had a history of attempting suicide. However, the authors reported a significantly elevated risk of a suicide attempt for children of prescription opioid users after adjustment for this factor as well as for child depression, parental depression, and parental substance use disorder (OR, 1.45).

The OR of a suicide attempt was not significantly higher for a suicide attempt among those children with both parents taking prescription opioids relative to opioid use in only one parent (OR 1.05).

Dr. Brent and associates acknowledged that these data do not confirm that the rising rate of prescription opioid use is linked to the recent parallel rise in suicide attempts among children. However, they did conclude that children of parents using opioid prescriptions are at risk and might be an appropriate target for suicide prevention.

“Recognition and treatment of patients with opioid use disorder, attendance to comorbid conditions in affected parents, and screening and appropriate referral of their children may help” address both major public health issues, they maintained.

The study was supported by a National Institutes of Health grant. Dr Brent reported receiving royalties from Guilford Press, eRT, and UpToDate. Dr. Gibbons has served as an expert witness in cases related to suicide involving pharmaceutical companies, such as Pfizer and GlaxoSmithKline.

SOURCE: Brent DA et al. JAMA Psychiatry. 2019 May 22 doi: 10.1001/jamapsychiatry.2019.0940.

Danish researchers have linked multiple factors to higher risk of first-time diabetic foot ulcers (DFUs) in patients with type 1 and type 2 diabetes, although some of the factors – older age, smoking, history of cardiovascular disease, and longer duration of diabetes – seem to indicate increased risk only in type 1 disease, according to the new study findings.

The authors suggest that since clinical information gathered from patients during routine follow-up visits often includes mention of the risk factors for first-time DFU, it could form the basis of a risk stratification process for first-time DFU that can be integrated into the electronic record system and easily incorporated into routine care.

DFU is a significant complication for both type 1 and type 2 diabetes, but no previous research has stratified the risk factors for first-time DFUs by type of diabetes, emphasized the study authors, led by Sine Hangaard, MSc, of Steno Diabetes Center Copenhagen.

For the new study, the researchers tracked 5,588 patients with type 1 diabetes and 7,113 with type 2, all of whom were treated at a hospital clinic in Denmark between 2001 and 2015. The authors noted that the patients with type 2 disease who were treated at the center were clinically more complicated and had a longer disease duration than average type 2 patients, whereas the patients with type 1 diabetes did not differ from average type 1 patients.

Several factors boosted the risk of first-time DFU in both types of disease, including high or low levels of albumin excretion, advanced diabetic retinopathy, limited or nonexistent vibration sense, symptoms of neuropathy, and absence of foot pulses per univariable regression (all P less than .01). The researchers linked the neuropathy and absences of foot pulses to especially high spikes in risk.

Female gender was protective for type 1 and type 2 disease (hazard ratios, 0.7 and 0.5, respectively; P = .0000). Various body mass index levels seemed to have no impact on risk.

Three factors that posed a higher risk for first-time DFU in type 1 disease, but not type 2, were: smoking (HR, 1.4 vs. no smoking, P = .0220), age of 60-79 years (HR, 1.7 vs. age 40-59; P = .0000), cardiovascular disease (HR, 2.2 vs. no cardiovascular disease; P = .0000), and diabetes duration of between 5 and 20 years (HR, 2.2 vs. less than 5 years; P = .0027) or 20 years or more (HR, 5.2 vs. less than 5 years; P = .0000).

The authors noted that “25% of all patients with diabetes develop DFU during their lifetime, and DFUs precede 80% of all lower leg amputations in patients with diabetes.” In addition, DFU often occurs in feet already compromised by neuropathy or peripheral vascular disease, and is therefore associated with greater risk for infection, poorer outcomes, recurrent ulceration, amputation, and increased mortality. These risks underscore the need for the earliest-possible identification of first-time DFU and timely adoption of effective, preventative strategies, they wrote.

The study was not funded. Several of the authors reported that they own shares in Novo Nordisk.

SOURCE: Hangaard S et al. Diabetes Res Clin Pract. 2019 Apr 18;151:177-86.

Danish researchers have linked multiple factors to higher risk of first-time diabetic foot ulcers (DFUs) in patients with type 1 and type 2 diabetes, although some of the factors – older age, smoking, history of cardiovascular disease, and longer duration of diabetes – seem to indicate increased risk only in type 1 disease, according to the new study findings.

The authors suggest that since clinical information gathered from patients during routine follow-up visits often includes mention of the risk factors for first-time DFU, it could form the basis of a risk stratification process for first-time DFU that can be integrated into the electronic record system and easily incorporated into routine care.

DFU is a significant complication for both type 1 and type 2 diabetes, but no previous research has stratified the risk factors for first-time DFUs by type of diabetes, emphasized the study authors, led by Sine Hangaard, MSc, of Steno Diabetes Center Copenhagen.

For the new study, the researchers tracked 5,588 patients with type 1 diabetes and 7,113 with type 2, all of whom were treated at a hospital clinic in Denmark between 2001 and 2015. The authors noted that the patients with type 2 disease who were treated at the center were clinically more complicated and had a longer disease duration than average type 2 patients, whereas the patients with type 1 diabetes did not differ from average type 1 patients.

Several factors boosted the risk of first-time DFU in both types of disease, including high or low levels of albumin excretion, advanced diabetic retinopathy, limited or nonexistent vibration sense, symptoms of neuropathy, and absence of foot pulses per univariable regression (all P less than .01). The researchers linked the neuropathy and absences of foot pulses to especially high spikes in risk.

Female gender was protective for type 1 and type 2 disease (hazard ratios, 0.7 and 0.5, respectively; P = .0000). Various body mass index levels seemed to have no impact on risk.

Three factors that posed a higher risk for first-time DFU in type 1 disease, but not type 2, were: smoking (HR, 1.4 vs. no smoking, P = .0220), age of 60-79 years (HR, 1.7 vs. age 40-59; P = .0000), cardiovascular disease (HR, 2.2 vs. no cardiovascular disease; P = .0000), and diabetes duration of between 5 and 20 years (HR, 2.2 vs. less than 5 years; P = .0027) or 20 years or more (HR, 5.2 vs. less than 5 years; P = .0000).

The authors noted that “25% of all patients with diabetes develop DFU during their lifetime, and DFUs precede 80% of all lower leg amputations in patients with diabetes.” In addition, DFU often occurs in feet already compromised by neuropathy or peripheral vascular disease, and is therefore associated with greater risk for infection, poorer outcomes, recurrent ulceration, amputation, and increased mortality. These risks underscore the need for the earliest-possible identification of first-time DFU and timely adoption of effective, preventative strategies, they wrote.

The study was not funded. Several of the authors reported that they own shares in Novo Nordisk.

SOURCE: Hangaard S et al. Diabetes Res Clin Pract. 2019 Apr 18;151:177-86.

Danish researchers have linked multiple factors to higher risk of first-time diabetic foot ulcers (DFUs) in patients with type 1 and type 2 diabetes, although some of the factors – older age, smoking, history of cardiovascular disease, and longer duration of diabetes – seem to indicate increased risk only in type 1 disease, according to the new study findings.

The authors suggest that since clinical information gathered from patients during routine follow-up visits often includes mention of the risk factors for first-time DFU, it could form the basis of a risk stratification process for first-time DFU that can be integrated into the electronic record system and easily incorporated into routine care.

DFU is a significant complication for both type 1 and type 2 diabetes, but no previous research has stratified the risk factors for first-time DFUs by type of diabetes, emphasized the study authors, led by Sine Hangaard, MSc, of Steno Diabetes Center Copenhagen.

For the new study, the researchers tracked 5,588 patients with type 1 diabetes and 7,113 with type 2, all of whom were treated at a hospital clinic in Denmark between 2001 and 2015. The authors noted that the patients with type 2 disease who were treated at the center were clinically more complicated and had a longer disease duration than average type 2 patients, whereas the patients with type 1 diabetes did not differ from average type 1 patients.

Several factors boosted the risk of first-time DFU in both types of disease, including high or low levels of albumin excretion, advanced diabetic retinopathy, limited or nonexistent vibration sense, symptoms of neuropathy, and absence of foot pulses per univariable regression (all P less than .01). The researchers linked the neuropathy and absences of foot pulses to especially high spikes in risk.

Female gender was protective for type 1 and type 2 disease (hazard ratios, 0.7 and 0.5, respectively; P = .0000). Various body mass index levels seemed to have no impact on risk.

Three factors that posed a higher risk for first-time DFU in type 1 disease, but not type 2, were: smoking (HR, 1.4 vs. no smoking, P = .0220), age of 60-79 years (HR, 1.7 vs. age 40-59; P = .0000), cardiovascular disease (HR, 2.2 vs. no cardiovascular disease; P = .0000), and diabetes duration of between 5 and 20 years (HR, 2.2 vs. less than 5 years; P = .0027) or 20 years or more (HR, 5.2 vs. less than 5 years; P = .0000).

The authors noted that “25% of all patients with diabetes develop DFU during their lifetime, and DFUs precede 80% of all lower leg amputations in patients with diabetes.” In addition, DFU often occurs in feet already compromised by neuropathy or peripheral vascular disease, and is therefore associated with greater risk for infection, poorer outcomes, recurrent ulceration, amputation, and increased mortality. These risks underscore the need for the earliest-possible identification of first-time DFU and timely adoption of effective, preventative strategies, they wrote.

The study was not funded. Several of the authors reported that they own shares in Novo Nordisk.

SOURCE: Hangaard S et al. Diabetes Res Clin Pract. 2019 Apr 18;151:177-86.

SAN FRANCISCO – The recent Food and Drug Administration approval of intranasal esketamine for treatment-resistant depression has prompted interest in using this class of drugs in other conditions, including obsessive-compulsive disorder.

“OCD is severe, and one in seven people with OCD will attempt suicide in their lifetime,” said Carolyn Rodriguez, MD, PhD, associate professor of psychiatry and behavioral sciences at Stanford (Calif.) University.

Dr. Rodriguez presented some of her research on the mechanism of action of ketamine and its potential benefits for OCD during a session at the annual meeting of the American Psychiatric Association.

OCD patients experience a lengthy delay between treatment initiation and clinical benefit, sometimes 2 to 3 months, and most don’t achieve complete symptom remission, according to Dr. Rodriguez. “To help patients, I wanted to look at therapies that could be rapid acting, and given the converging lines of evidence that glutamate may play a role as an excitatory chemical messenger that helps neurons communicate, I looked at ketamine, which blocks the glutamate receptor,” she said.

A small study published in 2013 by her group was the first randomized, clinical trial of ketamine in OCD. It included 15 adults who experienced near-constant obsessions. A single dose given over 40 minutes led to a dramatic decrease in intrusive thoughts. One week after the infusion, four of eight patients who received ketamine met the criteria for a treatment response (35% or more reduction in Yale-Brown Obsessive Compulsive Scale scores), compared with none of the seven patients in the placebo group.

Dr. Rodriguez is now preparing to conduct a new trial comparing ketamine with midazolam as an active placebo, with the intent of looking at the drug’s effects on the circuits involved in OCD. “We need a large study to see if this is something that can be replicated, and we don’t know how long the effects persist. We’re just at the tip of the iceberg with OCD. In depression, there are these large studies that have been replicated, and in OCD, at least for randomized studies, it’s just this one study (from 2013) and the one that we have coming,” Dr. Rodriguez said.

Given the severity of OCD, ketamine and esketamine have generated some excitement, especially as a bridge to other therapies, such as cognitive-behavioral therapy or selective serotonin reuptake inhibitors.

The FDA’s approval of esketamine in March further boosted interest, but Dr. Rodriguez cautions that more research needs to be done. There is also at least one potential twist to use of an inhaled version of the drug. Contamination OCD patients may be unwilling to use a spray. In fact, Dr. Rodriguez’s team had to cancel a study looking at an inhaled form of racemic ketamine in OCD because they couldn’t recruit enough subjects. “There are variants [in OCD], and that’s why it’s important to study all populations and not assume that depression studies will cover the whole spectrum of our patients,” she said.

Dr. Rodriguez has consulted for Epiodyne, Allergan, BlackThorn, and Rugen.

SAN FRANCISCO – The recent Food and Drug Administration approval of intranasal esketamine for treatment-resistant depression has prompted interest in using this class of drugs in other conditions, including obsessive-compulsive disorder.

“OCD is severe, and one in seven people with OCD will attempt suicide in their lifetime,” said Carolyn Rodriguez, MD, PhD, associate professor of psychiatry and behavioral sciences at Stanford (Calif.) University.

Dr. Rodriguez presented some of her research on the mechanism of action of ketamine and its potential benefits for OCD during a session at the annual meeting of the American Psychiatric Association.

OCD patients experience a lengthy delay between treatment initiation and clinical benefit, sometimes 2 to 3 months, and most don’t achieve complete symptom remission, according to Dr. Rodriguez. “To help patients, I wanted to look at therapies that could be rapid acting, and given the converging lines of evidence that glutamate may play a role as an excitatory chemical messenger that helps neurons communicate, I looked at ketamine, which blocks the glutamate receptor,” she said.

A small study published in 2013 by her group was the first randomized, clinical trial of ketamine in OCD. It included 15 adults who experienced near-constant obsessions. A single dose given over 40 minutes led to a dramatic decrease in intrusive thoughts. One week after the infusion, four of eight patients who received ketamine met the criteria for a treatment response (35% or more reduction in Yale-Brown Obsessive Compulsive Scale scores), compared with none of the seven patients in the placebo group.

Dr. Rodriguez is now preparing to conduct a new trial comparing ketamine with midazolam as an active placebo, with the intent of looking at the drug’s effects on the circuits involved in OCD. “We need a large study to see if this is something that can be replicated, and we don’t know how long the effects persist. We’re just at the tip of the iceberg with OCD. In depression, there are these large studies that have been replicated, and in OCD, at least for randomized studies, it’s just this one study (from 2013) and the one that we have coming,” Dr. Rodriguez said.

Given the severity of OCD, ketamine and esketamine have generated some excitement, especially as a bridge to other therapies, such as cognitive-behavioral therapy or selective serotonin reuptake inhibitors.

The FDA’s approval of esketamine in March further boosted interest, but Dr. Rodriguez cautions that more research needs to be done. There is also at least one potential twist to use of an inhaled version of the drug. Contamination OCD patients may be unwilling to use a spray. In fact, Dr. Rodriguez’s team had to cancel a study looking at an inhaled form of racemic ketamine in OCD because they couldn’t recruit enough subjects. “There are variants [in OCD], and that’s why it’s important to study all populations and not assume that depression studies will cover the whole spectrum of our patients,” she said.

Dr. Rodriguez has consulted for Epiodyne, Allergan, BlackThorn, and Rugen.

SAN FRANCISCO – The recent Food and Drug Administration approval of intranasal esketamine for treatment-resistant depression has prompted interest in using this class of drugs in other conditions, including obsessive-compulsive disorder.

“OCD is severe, and one in seven people with OCD will attempt suicide in their lifetime,” said Carolyn Rodriguez, MD, PhD, associate professor of psychiatry and behavioral sciences at Stanford (Calif.) University.

Dr. Rodriguez presented some of her research on the mechanism of action of ketamine and its potential benefits for OCD during a session at the annual meeting of the American Psychiatric Association.

OCD patients experience a lengthy delay between treatment initiation and clinical benefit, sometimes 2 to 3 months, and most don’t achieve complete symptom remission, according to Dr. Rodriguez. “To help patients, I wanted to look at therapies that could be rapid acting, and given the converging lines of evidence that glutamate may play a role as an excitatory chemical messenger that helps neurons communicate, I looked at ketamine, which blocks the glutamate receptor,” she said.

A small study published in 2013 by her group was the first randomized, clinical trial of ketamine in OCD. It included 15 adults who experienced near-constant obsessions. A single dose given over 40 minutes led to a dramatic decrease in intrusive thoughts. One week after the infusion, four of eight patients who received ketamine met the criteria for a treatment response (35% or more reduction in Yale-Brown Obsessive Compulsive Scale scores), compared with none of the seven patients in the placebo group.

Dr. Rodriguez is now preparing to conduct a new trial comparing ketamine with midazolam as an active placebo, with the intent of looking at the drug’s effects on the circuits involved in OCD. “We need a large study to see if this is something that can be replicated, and we don’t know how long the effects persist. We’re just at the tip of the iceberg with OCD. In depression, there are these large studies that have been replicated, and in OCD, at least for randomized studies, it’s just this one study (from 2013) and the one that we have coming,” Dr. Rodriguez said.

Given the severity of OCD, ketamine and esketamine have generated some excitement, especially as a bridge to other therapies, such as cognitive-behavioral therapy or selective serotonin reuptake inhibitors.

The FDA’s approval of esketamine in March further boosted interest, but Dr. Rodriguez cautions that more research needs to be done. There is also at least one potential twist to use of an inhaled version of the drug. Contamination OCD patients may be unwilling to use a spray. In fact, Dr. Rodriguez’s team had to cancel a study looking at an inhaled form of racemic ketamine in OCD because they couldn’t recruit enough subjects. “There are variants [in OCD], and that’s why it’s important to study all populations and not assume that depression studies will cover the whole spectrum of our patients,” she said.

Dr. Rodriguez has consulted for Epiodyne, Allergan, BlackThorn, and Rugen.

LAS VEGAS – A novel protocol for acute management of patients in cardiogenic shock secondary to an acute MI that started hemodynamic support prior to coronary revascularization produced an unprecedented in-hospital survival rate of 72% in 171 patients treated at any of 35 U.S. centers.

The 72% acute survival compares with historical rates of roughly 50% starting with the landmark SHOCK trial from 1999 (N Engl J Med. 1999 Aug 26;341[9]:625-34) and continuing in much more recent reports (J Am Coll Cardiol. 2017 Jan 24;69[3]:278-87)

“This is a first step toward reducing the futility in treating a disease where management has not changed for more than 20 years,” Mir B. Basir, D.O., said at the annual scientific sessions of the Society for Cardiovascular Angiography and Interventions. While Dr. Basir acknowledged that the new protocol needs further testing, as well as further improvement, a need exists to immediately implement changes in the routine management of cardiogenic shock caused by an acute MI because “50% in-hospital survival is no longer acceptable,” said Dr. Basir, an interventional cardiologist at the Henry Ford Health System in Detroit.

The National Cardiogenic Shock Initiative operates as a single-arm study with no control group. The novel management protocol used by the Initiative in the current study included the following five key best-practice steps, Dr. Basir said in a video interview:

1. Begin hemodynamic support before increasing dosages of vasopressors or inotropes.

2. Use right-heart catheterization to monitor the patient’s hemodynamics, which shows the efficacy of the hemodynamic support and guides tapering down of vasopressor and inotrope drugs.

3. Apply hemodynamic support before starting percutaneous coronary intervention (PCI).

4. Act fast, with a goal of less than 90 minutes from door to hemodynamic support. In the 171 patients that Dr. Basir reviewed, the average door-to-support time was 85 minutes.

5. Mitigate complications from the devices and vascular access.

This protocol started at four hospitals in the Detroit region, and then expanded to the National Cardiogenic Shock Initiative that now includes 68 U.S. sites and more than 200 patients treated, with another 23 U.S. hospitals about to join. The 68 active sites include 26 academic centers and 42 community hospitals. The initiative has enrolled patients who match the enrollment criteria of the SHOCK trial so that historical comparisons are possible. The initiative’s patients would be classified as class C, D, or E patients based on the society’s newly published cardiogenic shock classification scheme (Catheter Cardiovasc Interv. 2019 May 19. doi: 10.1002/ccd.28329).

“The numbers that Dr. Basir has reported are very encouraging and provocative,” commented Chandanreddy M. Devireddy, MD, an interventional cardiologist at Emory Healthcare in Atlanta. “In light of the fact that we have had few solutions for these patients, this will accelerate the discussion.”

Several barriers exist for widespread adoption of the initiative’s protocol, Dr. Basir said. The protocol requires a lot of resources and the ability to deliver this care 24/7. Currently, hemodynamic support is “greatly underused,” and right-heart catheterization is not standard of care for these patients at many U.S. centers, he noted.

A few weeks before Dr. Basir’s report at the meeting, his data from the National Cardiogenic Shock Initiative appeared in an article published online (Catheter Cardiovasc Interv. 2019 Apr 25. doi: 10.1002/ccd.28307).

mzoler@mdedge.com

LAS VEGAS – A novel protocol for acute management of patients in cardiogenic shock secondary to an acute MI that started hemodynamic support prior to coronary revascularization produced an unprecedented in-hospital survival rate of 72% in 171 patients treated at any of 35 U.S. centers.

The 72% acute survival compares with historical rates of roughly 50% starting with the landmark SHOCK trial from 1999 (N Engl J Med. 1999 Aug 26;341[9]:625-34) and continuing in much more recent reports (J Am Coll Cardiol. 2017 Jan 24;69[3]:278-87)

“This is a first step toward reducing the futility in treating a disease where management has not changed for more than 20 years,” Mir B. Basir, D.O., said at the annual scientific sessions of the Society for Cardiovascular Angiography and Interventions. While Dr. Basir acknowledged that the new protocol needs further testing, as well as further improvement, a need exists to immediately implement changes in the routine management of cardiogenic shock caused by an acute MI because “50% in-hospital survival is no longer acceptable,” said Dr. Basir, an interventional cardiologist at the Henry Ford Health System in Detroit.

The National Cardiogenic Shock Initiative operates as a single-arm study with no control group. The novel management protocol used by the Initiative in the current study included the following five key best-practice steps, Dr. Basir said in a video interview:

1. Begin hemodynamic support before increasing dosages of vasopressors or inotropes.

2. Use right-heart catheterization to monitor the patient’s hemodynamics, which shows the efficacy of the hemodynamic support and guides tapering down of vasopressor and inotrope drugs.

3. Apply hemodynamic support before starting percutaneous coronary intervention (PCI).

4. Act fast, with a goal of less than 90 minutes from door to hemodynamic support. In the 171 patients that Dr. Basir reviewed, the average door-to-support time was 85 minutes.

5. Mitigate complications from the devices and vascular access.

This protocol started at four hospitals in the Detroit region, and then expanded to the National Cardiogenic Shock Initiative that now includes 68 U.S. sites and more than 200 patients treated, with another 23 U.S. hospitals about to join. The 68 active sites include 26 academic centers and 42 community hospitals. The initiative has enrolled patients who match the enrollment criteria of the SHOCK trial so that historical comparisons are possible. The initiative’s patients would be classified as class C, D, or E patients based on the society’s newly published cardiogenic shock classification scheme (Catheter Cardiovasc Interv. 2019 May 19. doi: 10.1002/ccd.28329).

“The numbers that Dr. Basir has reported are very encouraging and provocative,” commented Chandanreddy M. Devireddy, MD, an interventional cardiologist at Emory Healthcare in Atlanta. “In light of the fact that we have had few solutions for these patients, this will accelerate the discussion.”

Several barriers exist for widespread adoption of the initiative’s protocol, Dr. Basir said. The protocol requires a lot of resources and the ability to deliver this care 24/7. Currently, hemodynamic support is “greatly underused,” and right-heart catheterization is not standard of care for these patients at many U.S. centers, he noted.

A few weeks before Dr. Basir’s report at the meeting, his data from the National Cardiogenic Shock Initiative appeared in an article published online (Catheter Cardiovasc Interv. 2019 Apr 25. doi: 10.1002/ccd.28307).

mzoler@mdedge.com

LAS VEGAS – A novel protocol for acute management of patients in cardiogenic shock secondary to an acute MI that started hemodynamic support prior to coronary revascularization produced an unprecedented in-hospital survival rate of 72% in 171 patients treated at any of 35 U.S. centers.

The 72% acute survival compares with historical rates of roughly 50% starting with the landmark SHOCK trial from 1999 (N Engl J Med. 1999 Aug 26;341[9]:625-34) and continuing in much more recent reports (J Am Coll Cardiol. 2017 Jan 24;69[3]:278-87)

“This is a first step toward reducing the futility in treating a disease where management has not changed for more than 20 years,” Mir B. Basir, D.O., said at the annual scientific sessions of the Society for Cardiovascular Angiography and Interventions. While Dr. Basir acknowledged that the new protocol needs further testing, as well as further improvement, a need exists to immediately implement changes in the routine management of cardiogenic shock caused by an acute MI because “50% in-hospital survival is no longer acceptable,” said Dr. Basir, an interventional cardiologist at the Henry Ford Health System in Detroit.

The National Cardiogenic Shock Initiative operates as a single-arm study with no control group. The novel management protocol used by the Initiative in the current study included the following five key best-practice steps, Dr. Basir said in a video interview:

1. Begin hemodynamic support before increasing dosages of vasopressors or inotropes.

2. Use right-heart catheterization to monitor the patient’s hemodynamics, which shows the efficacy of the hemodynamic support and guides tapering down of vasopressor and inotrope drugs.

3. Apply hemodynamic support before starting percutaneous coronary intervention (PCI).

4. Act fast, with a goal of less than 90 minutes from door to hemodynamic support. In the 171 patients that Dr. Basir reviewed, the average door-to-support time was 85 minutes.

5. Mitigate complications from the devices and vascular access.

This protocol started at four hospitals in the Detroit region, and then expanded to the National Cardiogenic Shock Initiative that now includes 68 U.S. sites and more than 200 patients treated, with another 23 U.S. hospitals about to join. The 68 active sites include 26 academic centers and 42 community hospitals. The initiative has enrolled patients who match the enrollment criteria of the SHOCK trial so that historical comparisons are possible. The initiative’s patients would be classified as class C, D, or E patients based on the society’s newly published cardiogenic shock classification scheme (Catheter Cardiovasc Interv. 2019 May 19. doi: 10.1002/ccd.28329).

“The numbers that Dr. Basir has reported are very encouraging and provocative,” commented Chandanreddy M. Devireddy, MD, an interventional cardiologist at Emory Healthcare in Atlanta. “In light of the fact that we have had few solutions for these patients, this will accelerate the discussion.”

Several barriers exist for widespread adoption of the initiative’s protocol, Dr. Basir said. The protocol requires a lot of resources and the ability to deliver this care 24/7. Currently, hemodynamic support is “greatly underused,” and right-heart catheterization is not standard of care for these patients at many U.S. centers, he noted.

A few weeks before Dr. Basir’s report at the meeting, his data from the National Cardiogenic Shock Initiative appeared in an article published online (Catheter Cardiovasc Interv. 2019 Apr 25. doi: 10.1002/ccd.28307).

mzoler@mdedge.com

SAN FRANCISCO – Ketamine and the more recently Food and Drug Administration–approved esketamine have generated a great deal of excitement in psychiatry over their potential to treat depression and other psychiatric disorders. However, the mechanism of action is not completely understood, and efforts are underway to better understand the drugs.

Much has been made of ketamine’s interaction with the N-methyl-D-aspartate (NMDA) receptors. One belief is that chronic stress leads to the accumulation of extracellular glutamate, which leads to a range of negative consequences. Ketamine blocks excess glutamate in the synapse and may thus reverse these downstream effects.

But it may not be so clear cut, according to Nolan Williams, MD. During a session on ketamine’s mechanism of action at the annual meeting of the American Psychiatric Association, Dr. Williams, assistant professor of psychiatry and behavioral sciences at Stanford (Calif.) University, noted that ketamine is “one of the most dirty drugs we know. It affects most neurotransmitter systems and has all sorts of downstream effects.”

Pain research has already shown that ketamine’s mechanisms can be complex. It affects the opioid system, both directly and indirectly, and an opioid receptor antagonist blocks ketamine’s pain-relieving effect.

Since opioids are also known to have antidepressant effects, it’s natural to wonder if ketamine’s mechanism also involves the opioid system. The opioid antagonist naltrexone provides a tool to study the problem. Dr. Williams reasoned that if ketamine relies in whole or in part on the opioid system for its antidepressive effect, then administering naltrexone ahead of ketamine should blunt or even eliminate its efficacy.

To examine the question, the team conducted a study of 11 patients with treatment-resistant depression. Right away, it was clear that the participants had some bias toward the treatment. “They all said the same thing to me: ‘My psychiatrist said that your study doesn’t make any sense because this is an NMDA antagonist. I’m going to get two free ketamine infusions.’ So they were preloaded with this idea that they were going to get very potent antidepressant effects (even with naltrexone),” said Dr. Williams.

The study had a crossover design and included two ketamine infusions. Participants were randomized to get either naltrexone or placebo 1 hour before the first ketamine infusion, and then were allowed to relapse back to within 20% of their baseline depression score before receiving the second ketamine infusion, when they received naltrexone or placebo, whichever hadn’t been given in the first treatment.

Of 12 who completed the study, seven responded to placebo plus ketamine treatment, and six remitted. But when they crossed over to the naltrexone arm, the result was very different: In three of four measures, there was no significant difference between the pretreatment and posttreatment results. “The same people who were almost exclusively in remission during the ketamine plus placebo condition got nothing out of ketamine plus naltrexone,” said Dr. Williams. Naltrexone had a similar negating effect on the positive response to ketamine on the suicide item of the 17-item Hamilton Rating Scale for Depression.

The researchers also looked at whether ketamine’s dissociative effect could be responsible for its activity through altering the participant’s mental state, but determined that it may be necessary for the antidepressant effect – but it is not sufficient.

“What we concluded pretty strongly was that the opioid properties of ketamine are necessary to have the antidepressive effect. We’re not saying it’s sufficient, but it appears to be quite necessary,” Dr. Williams said. He added that the results don’t mean that ketamine’s effect on NMDA is unimportant. In fact, “it’s probable that the ketamine is driving the mood in a direction, and these glutamine-related changes are probably what’s maintaining the mood in that direction,” he added.

As to the clinical impacts of his findings, Dr. Williams emphasized the need to understand the mechanisms behind the ketamine class. He pointed out that in pivotal trials of esketamine, there were six deaths, three by suicide, all of them in the esketamine group. Surprisingly, two of those who took their own lives had scored a 0 on the Columbia-Suicide Severity Scale, both at baseline and at the visit immediately preceding their deaths. The score wasn’t available for the third. “These weren’t people who were particularly dangerously suicidal. So understanding the mechanism is really important to understanding the safety of this drug, who we should give it to, and what sorts of things we should watch out for,” Dr. Williams said.

The study was funded by the National Institutes of Health, Spectrum, the Brain and Behavior Research Foundation, and Stanford Bio-X. Dr. Williams had no disclosures.
 

SAN FRANCISCO – Ketamine and the more recently Food and Drug Administration–approved esketamine have generated a great deal of excitement in psychiatry over their potential to treat depression and other psychiatric disorders. However, the mechanism of action is not completely understood, and efforts are underway to better understand the drugs.

Much has been made of ketamine’s interaction with the N-methyl-D-aspartate (NMDA) receptors. One belief is that chronic stress leads to the accumulation of extracellular glutamate, which leads to a range of negative consequences. Ketamine blocks excess glutamate in the synapse and may thus reverse these downstream effects.

But it may not be so clear cut, according to Nolan Williams, MD. During a session on ketamine’s mechanism of action at the annual meeting of the American Psychiatric Association, Dr. Williams, assistant professor of psychiatry and behavioral sciences at Stanford (Calif.) University, noted that ketamine is “one of the most dirty drugs we know. It affects most neurotransmitter systems and has all sorts of downstream effects.”

Pain research has already shown that ketamine’s mechanisms can be complex. It affects the opioid system, both directly and indirectly, and an opioid receptor antagonist blocks ketamine’s pain-relieving effect.

Since opioids are also known to have antidepressant effects, it’s natural to wonder if ketamine’s mechanism also involves the opioid system. The opioid antagonist naltrexone provides a tool to study the problem. Dr. Williams reasoned that if ketamine relies in whole or in part on the opioid system for its antidepressive effect, then administering naltrexone ahead of ketamine should blunt or even eliminate its efficacy.

To examine the question, the team conducted a study of 11 patients with treatment-resistant depression. Right away, it was clear that the participants had some bias toward the treatment. “They all said the same thing to me: ‘My psychiatrist said that your study doesn’t make any sense because this is an NMDA antagonist. I’m going to get two free ketamine infusions.’ So they were preloaded with this idea that they were going to get very potent antidepressant effects (even with naltrexone),” said Dr. Williams.

The study had a crossover design and included two ketamine infusions. Participants were randomized to get either naltrexone or placebo 1 hour before the first ketamine infusion, and then were allowed to relapse back to within 20% of their baseline depression score before receiving the second ketamine infusion, when they received naltrexone or placebo, whichever hadn’t been given in the first treatment.

Of 12 who completed the study, seven responded to placebo plus ketamine treatment, and six remitted. But when they crossed over to the naltrexone arm, the result was very different: In three of four measures, there was no significant difference between the pretreatment and posttreatment results. “The same people who were almost exclusively in remission during the ketamine plus placebo condition got nothing out of ketamine plus naltrexone,” said Dr. Williams. Naltrexone had a similar negating effect on the positive response to ketamine on the suicide item of the 17-item Hamilton Rating Scale for Depression.

The researchers also looked at whether ketamine’s dissociative effect could be responsible for its activity through altering the participant’s mental state, but determined that it may be necessary for the antidepressant effect – but it is not sufficient.

“What we concluded pretty strongly was that the opioid properties of ketamine are necessary to have the antidepressive effect. We’re not saying it’s sufficient, but it appears to be quite necessary,” Dr. Williams said. He added that the results don’t mean that ketamine’s effect on NMDA is unimportant. In fact, “it’s probable that the ketamine is driving the mood in a direction, and these glutamine-related changes are probably what’s maintaining the mood in that direction,” he added.

As to the clinical impacts of his findings, Dr. Williams emphasized the need to understand the mechanisms behind the ketamine class. He pointed out that in pivotal trials of esketamine, there were six deaths, three by suicide, all of them in the esketamine group. Surprisingly, two of those who took their own lives had scored a 0 on the Columbia-Suicide Severity Scale, both at baseline and at the visit immediately preceding their deaths. The score wasn’t available for the third. “These weren’t people who were particularly dangerously suicidal. So understanding the mechanism is really important to understanding the safety of this drug, who we should give it to, and what sorts of things we should watch out for,” Dr. Williams said.

The study was funded by the National Institutes of Health, Spectrum, the Brain and Behavior Research Foundation, and Stanford Bio-X. Dr. Williams had no disclosures.
 

SAN FRANCISCO – Ketamine and the more recently Food and Drug Administration–approved esketamine have generated a great deal of excitement in psychiatry over their potential to treat depression and other psychiatric disorders. However, the mechanism of action is not completely understood, and efforts are underway to better understand the drugs.

Much has been made of ketamine’s interaction with the N-methyl-D-aspartate (NMDA) receptors. One belief is that chronic stress leads to the accumulation of extracellular glutamate, which leads to a range of negative consequences. Ketamine blocks excess glutamate in the synapse and may thus reverse these downstream effects.

But it may not be so clear cut, according to Nolan Williams, MD. During a session on ketamine’s mechanism of action at the annual meeting of the American Psychiatric Association, Dr. Williams, assistant professor of psychiatry and behavioral sciences at Stanford (Calif.) University, noted that ketamine is “one of the most dirty drugs we know. It affects most neurotransmitter systems and has all sorts of downstream effects.”

Pain research has already shown that ketamine’s mechanisms can be complex. It affects the opioid system, both directly and indirectly, and an opioid receptor antagonist blocks ketamine’s pain-relieving effect.

Since opioids are also known to have antidepressant effects, it’s natural to wonder if ketamine’s mechanism also involves the opioid system. The opioid antagonist naltrexone provides a tool to study the problem. Dr. Williams reasoned that if ketamine relies in whole or in part on the opioid system for its antidepressive effect, then administering naltrexone ahead of ketamine should blunt or even eliminate its efficacy.

To examine the question, the team conducted a study of 11 patients with treatment-resistant depression. Right away, it was clear that the participants had some bias toward the treatment. “They all said the same thing to me: ‘My psychiatrist said that your study doesn’t make any sense because this is an NMDA antagonist. I’m going to get two free ketamine infusions.’ So they were preloaded with this idea that they were going to get very potent antidepressant effects (even with naltrexone),” said Dr. Williams.

The study had a crossover design and included two ketamine infusions. Participants were randomized to get either naltrexone or placebo 1 hour before the first ketamine infusion, and then were allowed to relapse back to within 20% of their baseline depression score before receiving the second ketamine infusion, when they received naltrexone or placebo, whichever hadn’t been given in the first treatment.

Of 12 who completed the study, seven responded to placebo plus ketamine treatment, and six remitted. But when they crossed over to the naltrexone arm, the result was very different: In three of four measures, there was no significant difference between the pretreatment and posttreatment results. “The same people who were almost exclusively in remission during the ketamine plus placebo condition got nothing out of ketamine plus naltrexone,” said Dr. Williams. Naltrexone had a similar negating effect on the positive response to ketamine on the suicide item of the 17-item Hamilton Rating Scale for Depression.

The researchers also looked at whether ketamine’s dissociative effect could be responsible for its activity through altering the participant’s mental state, but determined that it may be necessary for the antidepressant effect – but it is not sufficient.

“What we concluded pretty strongly was that the opioid properties of ketamine are necessary to have the antidepressive effect. We’re not saying it’s sufficient, but it appears to be quite necessary,” Dr. Williams said. He added that the results don’t mean that ketamine’s effect on NMDA is unimportant. In fact, “it’s probable that the ketamine is driving the mood in a direction, and these glutamine-related changes are probably what’s maintaining the mood in that direction,” he added.

As to the clinical impacts of his findings, Dr. Williams emphasized the need to understand the mechanisms behind the ketamine class. He pointed out that in pivotal trials of esketamine, there were six deaths, three by suicide, all of them in the esketamine group. Surprisingly, two of those who took their own lives had scored a 0 on the Columbia-Suicide Severity Scale, both at baseline and at the visit immediately preceding their deaths. The score wasn’t available for the third. “These weren’t people who were particularly dangerously suicidal. So understanding the mechanism is really important to understanding the safety of this drug, who we should give it to, and what sorts of things we should watch out for,” Dr. Williams said.

The study was funded by the National Institutes of Health, Spectrum, the Brain and Behavior Research Foundation, and Stanford Bio-X. Dr. Williams had no disclosures.
 

NASHVILLE, TENN. – A novel rapid urine test strongly correlates with preeclampsia, according to findings from a study of urine samples from a prospective cohort of women referred to a labor and delivery triage center to rule out the condition.

The study involved the evaluation of 349 frozen urine samples from the cohort, which included 89 preeclampsia cases (26%) as diagnosed by expert adjudication based on 2013 American College of Obstetricians and Gynecologists guidelines. Visual scoring by a blinded user at 3 minutes after application of urine to the test device for 329 available samples showed 84% test sensitivity, 77% test specificity, and 93% negative predictive value, compared with the adjudicated diagnoses, Wendy L. Davis reported during an e-poster session at ACOG’s annual clinical and scientific meeting.

Of the women in the study cohort, 52% were multiparous, 91% were overweight or obese, 38% were early preterm, 31% were late preterm, and 31% were at term. Cases were described by at least one referring physician as “particularly challenging and ambiguous,” said Ms. Davis, founder and CEO of GestVision in Groton, Conn., and colleagues.

The findings, which suggest that this rapid test holds promise as an aid in the diagnosis of preeclampsia, are important as preeclampsia-associated morbidity and mortality most often occur because of a delay or misdiagnosis, they explained, also noting that diagnostic criteria for preeclampsia are “inadequate even in best care situations.”

The test – an in vitro diagnostic device known as the GestAssured Test Kit – is being developed by GestVision based on data showing that aberrant protein misfolding and aggregation is a pathogenic feature of preeclampsia. That data initially led to development of the Congo Red Dot test as a laboratory batch test, followed by development and validation of a point-of-care version of the test to allow for better integration in clinical work flow.

The GestAssured Test Kit currently in development for commercial use is based on that technology, and the current data suggest that it has slightly higher sensitivity, slightly lower specificity, and slightly higher negative predictive value than the Congo Red Dot test.

“The GestAssured test was developed specifically for preeclampsia and has a high negative predictive value, suggesting that this device, in conjunction with ACOG task force guidelines for hypertension in pregnancy, can assist in ruling out disease in patients suspected of preeclampsia,” the investigators wrote.

“[It is] particularly useful in a triage setting where you have a complex collection of patients coming in,” Ms. Davis said during the poster presentation. “And it warrants ongoing U.S. multicenter clinical studies.”

This study was funded by GestVision and Saving Lives at Birth. Ms. Davis is an employee and shareholder of GestVision and is named as an inventor or coinventor on patents licensed for commercialization to the company.

NASHVILLE, TENN. – A novel rapid urine test strongly correlates with preeclampsia, according to findings from a study of urine samples from a prospective cohort of women referred to a labor and delivery triage center to rule out the condition.

The study involved the evaluation of 349 frozen urine samples from the cohort, which included 89 preeclampsia cases (26%) as diagnosed by expert adjudication based on 2013 American College of Obstetricians and Gynecologists guidelines. Visual scoring by a blinded user at 3 minutes after application of urine to the test device for 329 available samples showed 84% test sensitivity, 77% test specificity, and 93% negative predictive value, compared with the adjudicated diagnoses, Wendy L. Davis reported during an e-poster session at ACOG’s annual clinical and scientific meeting.

Of the women in the study cohort, 52% were multiparous, 91% were overweight or obese, 38% were early preterm, 31% were late preterm, and 31% were at term. Cases were described by at least one referring physician as “particularly challenging and ambiguous,” said Ms. Davis, founder and CEO of GestVision in Groton, Conn., and colleagues.

The findings, which suggest that this rapid test holds promise as an aid in the diagnosis of preeclampsia, are important as preeclampsia-associated morbidity and mortality most often occur because of a delay or misdiagnosis, they explained, also noting that diagnostic criteria for preeclampsia are “inadequate even in best care situations.”

The test – an in vitro diagnostic device known as the GestAssured Test Kit – is being developed by GestVision based on data showing that aberrant protein misfolding and aggregation is a pathogenic feature of preeclampsia. That data initially led to development of the Congo Red Dot test as a laboratory batch test, followed by development and validation of a point-of-care version of the test to allow for better integration in clinical work flow.

The GestAssured Test Kit currently in development for commercial use is based on that technology, and the current data suggest that it has slightly higher sensitivity, slightly lower specificity, and slightly higher negative predictive value than the Congo Red Dot test.

“The GestAssured test was developed specifically for preeclampsia and has a high negative predictive value, suggesting that this device, in conjunction with ACOG task force guidelines for hypertension in pregnancy, can assist in ruling out disease in patients suspected of preeclampsia,” the investigators wrote.

“[It is] particularly useful in a triage setting where you have a complex collection of patients coming in,” Ms. Davis said during the poster presentation. “And it warrants ongoing U.S. multicenter clinical studies.”

This study was funded by GestVision and Saving Lives at Birth. Ms. Davis is an employee and shareholder of GestVision and is named as an inventor or coinventor on patents licensed for commercialization to the company.

NASHVILLE, TENN. – A novel rapid urine test strongly correlates with preeclampsia, according to findings from a study of urine samples from a prospective cohort of women referred to a labor and delivery triage center to rule out the condition.

The study involved the evaluation of 349 frozen urine samples from the cohort, which included 89 preeclampsia cases (26%) as diagnosed by expert adjudication based on 2013 American College of Obstetricians and Gynecologists guidelines. Visual scoring by a blinded user at 3 minutes after application of urine to the test device for 329 available samples showed 84% test sensitivity, 77% test specificity, and 93% negative predictive value, compared with the adjudicated diagnoses, Wendy L. Davis reported during an e-poster session at ACOG’s annual clinical and scientific meeting.

Of the women in the study cohort, 52% were multiparous, 91% were overweight or obese, 38% were early preterm, 31% were late preterm, and 31% were at term. Cases were described by at least one referring physician as “particularly challenging and ambiguous,” said Ms. Davis, founder and CEO of GestVision in Groton, Conn., and colleagues.

The findings, which suggest that this rapid test holds promise as an aid in the diagnosis of preeclampsia, are important as preeclampsia-associated morbidity and mortality most often occur because of a delay or misdiagnosis, they explained, also noting that diagnostic criteria for preeclampsia are “inadequate even in best care situations.”

The test – an in vitro diagnostic device known as the GestAssured Test Kit – is being developed by GestVision based on data showing that aberrant protein misfolding and aggregation is a pathogenic feature of preeclampsia. That data initially led to development of the Congo Red Dot test as a laboratory batch test, followed by development and validation of a point-of-care version of the test to allow for better integration in clinical work flow.

The GestAssured Test Kit currently in development for commercial use is based on that technology, and the current data suggest that it has slightly higher sensitivity, slightly lower specificity, and slightly higher negative predictive value than the Congo Red Dot test.

“The GestAssured test was developed specifically for preeclampsia and has a high negative predictive value, suggesting that this device, in conjunction with ACOG task force guidelines for hypertension in pregnancy, can assist in ruling out disease in patients suspected of preeclampsia,” the investigators wrote.

“[It is] particularly useful in a triage setting where you have a complex collection of patients coming in,” Ms. Davis said during the poster presentation. “And it warrants ongoing U.S. multicenter clinical studies.”

This study was funded by GestVision and Saving Lives at Birth. Ms. Davis is an employee and shareholder of GestVision and is named as an inventor or coinventor on patents licensed for commercialization to the company.