Babies should not be delivered before 39 0/7 weeks’ gestation by means besides spontaneous vaginal delivery, in the absence of medical indications for an earlier delivery.

Herjua/Thinkstock

“Although there are specific indications for delivery before 39 weeks of gestation, a nonmedically indicated early-term delivery should be avoided,” wrote the authors of the new opinion, developed by the American College of Obstetricians and Gynecologists committee on obstetric practice and the Society for Maternal-Fetal Medicine.

The opinion, which replaces a 2013 statement, clarifies that their recommendations include avoiding cesarean delivery, labor induction, and cervical ripening before 39 0/7 weeks of gestation, unless a medical indication exists for earlier delivery.

The new opinion statement relied, in part, on a recent systematic review finding that late-preterm and early-term children do not fare as well as do term-delivered children in a variety of cognitive and educational domains. The opinion statement acknowledges that it’s not clear why children delivered earlier are showing performance difficulties and that it is possible that medical indications for an earlier delivery contributed to the differences.

Immediate outcomes for neonates delivered in the late preterm and early term period also are worse, compared with those delivered at term, according to several studies cited in the opinion. For example, composite morbidity was higher for infants delivered at both 37 and 38 weeks gestation, compared with those delivered at 39 weeks, with adjusted odds ratios for the composite outcome of 2.1 and 1.5, respectively (N Engl J Med. 2009 Jan 8;360[2]:111-20).

And lung maturity alone should not guide delivery, wrote the authors of the opinion. “Because nonrespiratory morbidities also are increased in early-term deliveries, documentation of fetal pulmonary maturity does not justify an early nonmedically indicated delivery,” they said, adding that physicians should not perform amniocentesis to determine lung maturity in an effort to guide delivery timing.

Because intrapartum demise remains a risk as long as a woman is pregnant, the potential for adverse neonatal outcomes with early delivery has to be balanced against the risk of stillbirth with continued gestation, the opinion authors acknowledged. But, they said, this question has been addressed by “multiple studies using national population level data,” which show that “even as the gestational age at term has increased in response to efforts to reduce early elective delivery, these efforts have not adversely affected stillbirth rates nationally or even in states with the greatest reductions in early elective delivery.”

Formal programs to reduce nonmedically indicated early-term deliveries have been successful. For example, the state of South Carolina achieved a reduction of almost 50% in nonmedically indicated early-term deliveries over the course of just 1 year. The South Carolina Birth Outcomes Initiative led a collaborative effort to institute a “hard-stop” policy against nonmedically indicated early-term deliveries that resulted in an absolute 4.7% decrease in late-preterm birth during 2011-2012. Similar efforts in Oregon and Ohio have reported significant reductions as well, with no increases in adverse neonatal outcomes.

Various policy approaches have been tried to achieve a reduction in nonmedically indicated late-preterm and early-term birth. These range from awareness raising and education, to “soft-stop” policies in which health care providers agree not to deliver before 39 weeks without medical indication, to “hard-stop” policies in which hospitals prohibit the nonindicated deliveries. In one comparative outcomes study, the hard-stop policy was the most effective, with a drop from 8.2% to 1.7% in nonindicated early deliveries, but the soft-stop policy also produced a decrease from 8.4% to 3.3% (P = .007 and .025, respectively). The educational approach didn’t produce a significant drop in nonmedically indicated early deliveries (Am J Obstet Gynecol. 2010 Nov;203[5]:449.e1-6).

In a separate, preexisting statement (Obstet Gynecol. 2019;133:e151-5), ACOG has outlined the management of medically indicated late-preterm and early-term deliveries and has developed an app (www.acog.org/acogapp) as a decision tool for indicated deliveries.

Examples cited by the current opinion statement authors of medical indications for early delivery include maternal factors such as preeclampsia, gestational hypertension, and poorly controlled diabetes. Placentation problems, fetal growth restriction, and prior cesarean deliveries also may warrant earlier delivery, as may a host of other complications. If an earlier delivery is planned, the committee authors recommend full discussion with the patient and clear documentation of the indications and discussion.

koakes@mdedge.com

SOURCE: Obstet Gynecol. 2019 Feb;133[2]:e156-63.

Babies should not be delivered before 39 0/7 weeks’ gestation by means besides spontaneous vaginal delivery, in the absence of medical indications for an earlier delivery.

Herjua/Thinkstock

“Although there are specific indications for delivery before 39 weeks of gestation, a nonmedically indicated early-term delivery should be avoided,” wrote the authors of the new opinion, developed by the American College of Obstetricians and Gynecologists committee on obstetric practice and the Society for Maternal-Fetal Medicine.

The opinion, which replaces a 2013 statement, clarifies that their recommendations include avoiding cesarean delivery, labor induction, and cervical ripening before 39 0/7 weeks of gestation, unless a medical indication exists for earlier delivery.

The new opinion statement relied, in part, on a recent systematic review finding that late-preterm and early-term children do not fare as well as do term-delivered children in a variety of cognitive and educational domains. The opinion statement acknowledges that it’s not clear why children delivered earlier are showing performance difficulties and that it is possible that medical indications for an earlier delivery contributed to the differences.

Immediate outcomes for neonates delivered in the late preterm and early term period also are worse, compared with those delivered at term, according to several studies cited in the opinion. For example, composite morbidity was higher for infants delivered at both 37 and 38 weeks gestation, compared with those delivered at 39 weeks, with adjusted odds ratios for the composite outcome of 2.1 and 1.5, respectively (N Engl J Med. 2009 Jan 8;360[2]:111-20).

And lung maturity alone should not guide delivery, wrote the authors of the opinion. “Because nonrespiratory morbidities also are increased in early-term deliveries, documentation of fetal pulmonary maturity does not justify an early nonmedically indicated delivery,” they said, adding that physicians should not perform amniocentesis to determine lung maturity in an effort to guide delivery timing.

Because intrapartum demise remains a risk as long as a woman is pregnant, the potential for adverse neonatal outcomes with early delivery has to be balanced against the risk of stillbirth with continued gestation, the opinion authors acknowledged. But, they said, this question has been addressed by “multiple studies using national population level data,” which show that “even as the gestational age at term has increased in response to efforts to reduce early elective delivery, these efforts have not adversely affected stillbirth rates nationally or even in states with the greatest reductions in early elective delivery.”

Formal programs to reduce nonmedically indicated early-term deliveries have been successful. For example, the state of South Carolina achieved a reduction of almost 50% in nonmedically indicated early-term deliveries over the course of just 1 year. The South Carolina Birth Outcomes Initiative led a collaborative effort to institute a “hard-stop” policy against nonmedically indicated early-term deliveries that resulted in an absolute 4.7% decrease in late-preterm birth during 2011-2012. Similar efforts in Oregon and Ohio have reported significant reductions as well, with no increases in adverse neonatal outcomes.

Various policy approaches have been tried to achieve a reduction in nonmedically indicated late-preterm and early-term birth. These range from awareness raising and education, to “soft-stop” policies in which health care providers agree not to deliver before 39 weeks without medical indication, to “hard-stop” policies in which hospitals prohibit the nonindicated deliveries. In one comparative outcomes study, the hard-stop policy was the most effective, with a drop from 8.2% to 1.7% in nonindicated early deliveries, but the soft-stop policy also produced a decrease from 8.4% to 3.3% (P = .007 and .025, respectively). The educational approach didn’t produce a significant drop in nonmedically indicated early deliveries (Am J Obstet Gynecol. 2010 Nov;203[5]:449.e1-6).

In a separate, preexisting statement (Obstet Gynecol. 2019;133:e151-5), ACOG has outlined the management of medically indicated late-preterm and early-term deliveries and has developed an app (www.acog.org/acogapp) as a decision tool for indicated deliveries.

Examples cited by the current opinion statement authors of medical indications for early delivery include maternal factors such as preeclampsia, gestational hypertension, and poorly controlled diabetes. Placentation problems, fetal growth restriction, and prior cesarean deliveries also may warrant earlier delivery, as may a host of other complications. If an earlier delivery is planned, the committee authors recommend full discussion with the patient and clear documentation of the indications and discussion.

koakes@mdedge.com

SOURCE: Obstet Gynecol. 2019 Feb;133[2]:e156-63.

Babies should not be delivered before 39 0/7 weeks’ gestation by means besides spontaneous vaginal delivery, in the absence of medical indications for an earlier delivery.

Herjua/Thinkstock

“Although there are specific indications for delivery before 39 weeks of gestation, a nonmedically indicated early-term delivery should be avoided,” wrote the authors of the new opinion, developed by the American College of Obstetricians and Gynecologists committee on obstetric practice and the Society for Maternal-Fetal Medicine.

The opinion, which replaces a 2013 statement, clarifies that their recommendations include avoiding cesarean delivery, labor induction, and cervical ripening before 39 0/7 weeks of gestation, unless a medical indication exists for earlier delivery.

The new opinion statement relied, in part, on a recent systematic review finding that late-preterm and early-term children do not fare as well as do term-delivered children in a variety of cognitive and educational domains. The opinion statement acknowledges that it’s not clear why children delivered earlier are showing performance difficulties and that it is possible that medical indications for an earlier delivery contributed to the differences.

Immediate outcomes for neonates delivered in the late preterm and early term period also are worse, compared with those delivered at term, according to several studies cited in the opinion. For example, composite morbidity was higher for infants delivered at both 37 and 38 weeks gestation, compared with those delivered at 39 weeks, with adjusted odds ratios for the composite outcome of 2.1 and 1.5, respectively (N Engl J Med. 2009 Jan 8;360[2]:111-20).

And lung maturity alone should not guide delivery, wrote the authors of the opinion. “Because nonrespiratory morbidities also are increased in early-term deliveries, documentation of fetal pulmonary maturity does not justify an early nonmedically indicated delivery,” they said, adding that physicians should not perform amniocentesis to determine lung maturity in an effort to guide delivery timing.

Because intrapartum demise remains a risk as long as a woman is pregnant, the potential for adverse neonatal outcomes with early delivery has to be balanced against the risk of stillbirth with continued gestation, the opinion authors acknowledged. But, they said, this question has been addressed by “multiple studies using national population level data,” which show that “even as the gestational age at term has increased in response to efforts to reduce early elective delivery, these efforts have not adversely affected stillbirth rates nationally or even in states with the greatest reductions in early elective delivery.”

Formal programs to reduce nonmedically indicated early-term deliveries have been successful. For example, the state of South Carolina achieved a reduction of almost 50% in nonmedically indicated early-term deliveries over the course of just 1 year. The South Carolina Birth Outcomes Initiative led a collaborative effort to institute a “hard-stop” policy against nonmedically indicated early-term deliveries that resulted in an absolute 4.7% decrease in late-preterm birth during 2011-2012. Similar efforts in Oregon and Ohio have reported significant reductions as well, with no increases in adverse neonatal outcomes.

Various policy approaches have been tried to achieve a reduction in nonmedically indicated late-preterm and early-term birth. These range from awareness raising and education, to “soft-stop” policies in which health care providers agree not to deliver before 39 weeks without medical indication, to “hard-stop” policies in which hospitals prohibit the nonindicated deliveries. In one comparative outcomes study, the hard-stop policy was the most effective, with a drop from 8.2% to 1.7% in nonindicated early deliveries, but the soft-stop policy also produced a decrease from 8.4% to 3.3% (P = .007 and .025, respectively). The educational approach didn’t produce a significant drop in nonmedically indicated early deliveries (Am J Obstet Gynecol. 2010 Nov;203[5]:449.e1-6).

In a separate, preexisting statement (Obstet Gynecol. 2019;133:e151-5), ACOG has outlined the management of medically indicated late-preterm and early-term deliveries and has developed an app (www.acog.org/acogapp) as a decision tool for indicated deliveries.

Examples cited by the current opinion statement authors of medical indications for early delivery include maternal factors such as preeclampsia, gestational hypertension, and poorly controlled diabetes. Placentation problems, fetal growth restriction, and prior cesarean deliveries also may warrant earlier delivery, as may a host of other complications. If an earlier delivery is planned, the committee authors recommend full discussion with the patient and clear documentation of the indications and discussion.

koakes@mdedge.com

SOURCE: Obstet Gynecol. 2019 Feb;133[2]:e156-63.

DALLAS – The way Lilyana Amezcua, MD, sees it, clinicians should view race and ethnicity as health disparities when assessing individuals with multiple sclerosis.

Whites are predominately affected with MS, “but we have seen changing demographics,” said Dr. Amezcua, of the University of Southern California MS Comprehensive Care and Research Group. “Why are African Americans now at higher risk ... and why do African Americans appear to have more severe disease? Is it a biological difference ... or is it because of poor access” to health care?

At the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, Dr. Amezcua delivered a presentation entitled “Effect of Race and Ethnicity on MS Presentation and Disease Course.” She called on researchers in the field “to not just take race and ethnicity as any small variable. We need to be cognizant and use the correct methodology, depending on what [question] we want to answer. We need to better define how we ascertain race, how we ascertain ethnicity.”

Dr. Amezcua, who is also the MS fellowship program director at the Keck School of Medicine, disclosed that she receives funding from the National MS Society, the National Institutes of Health, the California Community Foundation, and Biogen.

dbrunk@mdedge.com

DALLAS – The way Lilyana Amezcua, MD, sees it, clinicians should view race and ethnicity as health disparities when assessing individuals with multiple sclerosis.

Whites are predominately affected with MS, “but we have seen changing demographics,” said Dr. Amezcua, of the University of Southern California MS Comprehensive Care and Research Group. “Why are African Americans now at higher risk ... and why do African Americans appear to have more severe disease? Is it a biological difference ... or is it because of poor access” to health care?

At the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, Dr. Amezcua delivered a presentation entitled “Effect of Race and Ethnicity on MS Presentation and Disease Course.” She called on researchers in the field “to not just take race and ethnicity as any small variable. We need to be cognizant and use the correct methodology, depending on what [question] we want to answer. We need to better define how we ascertain race, how we ascertain ethnicity.”

Dr. Amezcua, who is also the MS fellowship program director at the Keck School of Medicine, disclosed that she receives funding from the National MS Society, the National Institutes of Health, the California Community Foundation, and Biogen.

dbrunk@mdedge.com

DALLAS – The way Lilyana Amezcua, MD, sees it, clinicians should view race and ethnicity as health disparities when assessing individuals with multiple sclerosis.

Whites are predominately affected with MS, “but we have seen changing demographics,” said Dr. Amezcua, of the University of Southern California MS Comprehensive Care and Research Group. “Why are African Americans now at higher risk ... and why do African Americans appear to have more severe disease? Is it a biological difference ... or is it because of poor access” to health care?

At the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, Dr. Amezcua delivered a presentation entitled “Effect of Race and Ethnicity on MS Presentation and Disease Course.” She called on researchers in the field “to not just take race and ethnicity as any small variable. We need to be cognizant and use the correct methodology, depending on what [question] we want to answer. We need to better define how we ascertain race, how we ascertain ethnicity.”

Dr. Amezcua, who is also the MS fellowship program director at the Keck School of Medicine, disclosed that she receives funding from the National MS Society, the National Institutes of Health, the California Community Foundation, and Biogen.

dbrunk@mdedge.com

SAN DIEGO – When attempting a second extubation, improvements in weaning parameters, compared with the first extubation attempt, do not predict success. Instead, the best predictors were the values of the parameters immediately before the second attempt.

“We hypothesized that the change in parameter values was more important than the actual values right before we tried to re-extubate, and that didn’t turn out to be the case. Because it was a smaller study, we can’t say [change in values] is not useful at all, but we didn’t find a strong association. We showed that the magnitude of the effect with the number measured right before the re-extubation is probably your best bet, but you should obviously evaluate the whole clinical scenario,” commented senior author Michael David Maile, MD, assistant professor of anesthesiology at the University of Michigan, Ann Arbor.

The study was presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine by Suraj Trivedi, MD, who is currently an anesthesiology fellow at Stanford (Calif.) Medicine.

Factors such as rapid shallow breathing index (RSBI), negative inspiratory force (NIF), vital capacity (VC), and partial pressure of arterial carbon dioxide (PaCO₂) have been shown to predict success or failure of an initial extubation attempt.

There is currently little available guidance on how to proceed when a first extubation attempt fails. The researchers had anticipated that RSBI, NIF, VC, and PaCO₂ levels matching the first attempt would be associated with success the second time around.

But their retrospective study of adult patients at the University of Michigan critical care units found that only the change in RSBI values predicted success on a univariate analysis, and that association became statistically insignificant once they corrected for baseline RSBI previous to the re-extubation attempt.

“I think the biggest take-home message is that we have to figure out each attempt to extubate on its own merits. If you’re trying to extubate a patient in the ICU who has potentially been intubated and extubated multiple times, the clinical gut feeling is always that [the patient has] to be better off than the previous attempt. What we are pointing out is that it really doesn’t matter. If the parameters are all within the overall guidelines, it’s still okay to extubate, even if the absolute change in the variables is not better [than the previous attempt],” Dr. Trivedi said in an interview.

“People put a lot of emphasis on the improvement from the first to the second attempt, and this should temper that enthusiasm to put a lot of weight on the change. But I don’t think our data support that the change means nothing,” added Dr. Maile.

The study included 525 patients (42% female). Comorbidities were common: 72% had cardiac arrhythmias, 58% had hypertension, 33% had renal failure, 39% had a pulmonary disorder, and 25% had liver disease.

Univariate analyses showed associations between values of parameters immediately before the second extubation attempt and success in the second extubation attempt, including RSBI (re-extubation success, mean 53.1 vs failure, mean 68.8; P =.0002) and NIF (success, mean –41.2 vs. failure, mean –38.4; P =.036), and VC (success, mean 1009.8 vs. failure, mean 906.8; P =.017).

When the researchers examined changes in parameters between the first and second attempt, only a change in RSBI predicted success (success, value change of 7.1 vs. failure, value change of 0.05; P less than .031). But when they corrected for the RSBI value immediately before the second attempt, the difference was not statistically significant (P = .892).

The study was not funded. Dr. Maile and Dr. Trivedi have no relevant financial disclosures.

SOURCE: Trivedi S et al. CCC48 2019, Abstract 27.

SAN DIEGO – When attempting a second extubation, improvements in weaning parameters, compared with the first extubation attempt, do not predict success. Instead, the best predictors were the values of the parameters immediately before the second attempt.

“We hypothesized that the change in parameter values was more important than the actual values right before we tried to re-extubate, and that didn’t turn out to be the case. Because it was a smaller study, we can’t say [change in values] is not useful at all, but we didn’t find a strong association. We showed that the magnitude of the effect with the number measured right before the re-extubation is probably your best bet, but you should obviously evaluate the whole clinical scenario,” commented senior author Michael David Maile, MD, assistant professor of anesthesiology at the University of Michigan, Ann Arbor.

The study was presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine by Suraj Trivedi, MD, who is currently an anesthesiology fellow at Stanford (Calif.) Medicine.

Factors such as rapid shallow breathing index (RSBI), negative inspiratory force (NIF), vital capacity (VC), and partial pressure of arterial carbon dioxide (PaCO₂) have been shown to predict success or failure of an initial extubation attempt.

There is currently little available guidance on how to proceed when a first extubation attempt fails. The researchers had anticipated that RSBI, NIF, VC, and PaCO₂ levels matching the first attempt would be associated with success the second time around.

But their retrospective study of adult patients at the University of Michigan critical care units found that only the change in RSBI values predicted success on a univariate analysis, and that association became statistically insignificant once they corrected for baseline RSBI previous to the re-extubation attempt.

“I think the biggest take-home message is that we have to figure out each attempt to extubate on its own merits. If you’re trying to extubate a patient in the ICU who has potentially been intubated and extubated multiple times, the clinical gut feeling is always that [the patient has] to be better off than the previous attempt. What we are pointing out is that it really doesn’t matter. If the parameters are all within the overall guidelines, it’s still okay to extubate, even if the absolute change in the variables is not better [than the previous attempt],” Dr. Trivedi said in an interview.

“People put a lot of emphasis on the improvement from the first to the second attempt, and this should temper that enthusiasm to put a lot of weight on the change. But I don’t think our data support that the change means nothing,” added Dr. Maile.

The study included 525 patients (42% female). Comorbidities were common: 72% had cardiac arrhythmias, 58% had hypertension, 33% had renal failure, 39% had a pulmonary disorder, and 25% had liver disease.

Univariate analyses showed associations between values of parameters immediately before the second extubation attempt and success in the second extubation attempt, including RSBI (re-extubation success, mean 53.1 vs failure, mean 68.8; P =.0002) and NIF (success, mean –41.2 vs. failure, mean –38.4; P =.036), and VC (success, mean 1009.8 vs. failure, mean 906.8; P =.017).

When the researchers examined changes in parameters between the first and second attempt, only a change in RSBI predicted success (success, value change of 7.1 vs. failure, value change of 0.05; P less than .031). But when they corrected for the RSBI value immediately before the second attempt, the difference was not statistically significant (P = .892).

The study was not funded. Dr. Maile and Dr. Trivedi have no relevant financial disclosures.

SOURCE: Trivedi S et al. CCC48 2019, Abstract 27.

SAN DIEGO – When attempting a second extubation, improvements in weaning parameters, compared with the first extubation attempt, do not predict success. Instead, the best predictors were the values of the parameters immediately before the second attempt.

“We hypothesized that the change in parameter values was more important than the actual values right before we tried to re-extubate, and that didn’t turn out to be the case. Because it was a smaller study, we can’t say [change in values] is not useful at all, but we didn’t find a strong association. We showed that the magnitude of the effect with the number measured right before the re-extubation is probably your best bet, but you should obviously evaluate the whole clinical scenario,” commented senior author Michael David Maile, MD, assistant professor of anesthesiology at the University of Michigan, Ann Arbor.

The study was presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine by Suraj Trivedi, MD, who is currently an anesthesiology fellow at Stanford (Calif.) Medicine.

Factors such as rapid shallow breathing index (RSBI), negative inspiratory force (NIF), vital capacity (VC), and partial pressure of arterial carbon dioxide (PaCO₂) have been shown to predict success or failure of an initial extubation attempt.

There is currently little available guidance on how to proceed when a first extubation attempt fails. The researchers had anticipated that RSBI, NIF, VC, and PaCO₂ levels matching the first attempt would be associated with success the second time around.

But their retrospective study of adult patients at the University of Michigan critical care units found that only the change in RSBI values predicted success on a univariate analysis, and that association became statistically insignificant once they corrected for baseline RSBI previous to the re-extubation attempt.

“I think the biggest take-home message is that we have to figure out each attempt to extubate on its own merits. If you’re trying to extubate a patient in the ICU who has potentially been intubated and extubated multiple times, the clinical gut feeling is always that [the patient has] to be better off than the previous attempt. What we are pointing out is that it really doesn’t matter. If the parameters are all within the overall guidelines, it’s still okay to extubate, even if the absolute change in the variables is not better [than the previous attempt],” Dr. Trivedi said in an interview.

“People put a lot of emphasis on the improvement from the first to the second attempt, and this should temper that enthusiasm to put a lot of weight on the change. But I don’t think our data support that the change means nothing,” added Dr. Maile.

The study included 525 patients (42% female). Comorbidities were common: 72% had cardiac arrhythmias, 58% had hypertension, 33% had renal failure, 39% had a pulmonary disorder, and 25% had liver disease.

Univariate analyses showed associations between values of parameters immediately before the second extubation attempt and success in the second extubation attempt, including RSBI (re-extubation success, mean 53.1 vs failure, mean 68.8; P =.0002) and NIF (success, mean –41.2 vs. failure, mean –38.4; P =.036), and VC (success, mean 1009.8 vs. failure, mean 906.8; P =.017).

When the researchers examined changes in parameters between the first and second attempt, only a change in RSBI predicted success (success, value change of 7.1 vs. failure, value change of 0.05; P less than .031). But when they corrected for the RSBI value immediately before the second attempt, the difference was not statistically significant (P = .892).

The study was not funded. Dr. Maile and Dr. Trivedi have no relevant financial disclosures.

SOURCE: Trivedi S et al. CCC48 2019, Abstract 27.

Lawsuits against physicians declined across virtually all specialties by more than a quarter over a 10-year span, but the cost to manage legal challenges went up, a recent analysis finds.

From 2007 to 2016, the rate of claims dropped by 27% per 100 doctors from 5.1 to 3.7, according to a review of 124,000 cases by CRICO Strategies, a division of CRICO, the medical liability insurance provider for the Harvard medical community. CRICO’s database of claims contains about 30% of legal cases filed against health providers across the U.S.

For internists, the rate of lawsuits decreased by 35% between 2007 and 2016, according to CRICO data provided to MDedge News. Ob.gyns. saw a 44% drop in claims over the 10-year period, and surgeons experienced a 23% rate decrease. The analysis did not break down the rate of claims by other single subspecialists. Claims decreased by a combined 29% for cardiologists, dermatologists, endocrinologists, family physicians, gastroenterologists, hematologists/oncologists, hospitalists, infectious disease specialists, internists, nephrologists, neurologists, pulmonologists, and rheumatologists/immunologists, according to the report published in February 2019 on CRICO’s website.

The findings are consistent with prior research on claim trends, said Seth Seabury, PhD, a medical liability researcher and director of the Keck-Schaeffer Initiative for Population Health Policy at the University of Southern California, Los Angeles.

“Malpractice claim frequency has been falling pretty steadily for a while now, reflecting a number of factors including the widespread adoption of tort reform and other measures to shield physicians from malpractice risk,” Dr. Seabury said in an interview. “Interestingly, the decline seems greatest in the claims with lower potential stakes, as you see average indemnity holding flat or rising. Some of this likely reflects the unwillingness of attorneys to take cases with lower potential payouts, because of the high cost of litigating a malpractice case.”

While frequency went down, the cost to manage a legal claim went up, according to CRICO data. The price of defending a malpractice lawsuit rose an average of 3.5% annually over the 10-year period from $36,000 to $46,000. For cases that ended with no payment (indemnity) to plaintiffs, the cost to manage a case rose an average of 5% annually.

The upward trends in case management expenses are striking, particularly since the time to resolve cases has decreased, said Michelle Mello, PhD, a health research and policy professor at Stanford (Calif.) University. From 2007 to 2016, the average time to resolve a case dropped from 29 to 27 months, the CRICO report found.

“CRICO nods to disclosure and apology approaches as perhaps underlying the more encouraging trend in time to resolution, but it was surprising to me that such approaches have not translated into lower defense costs,” Dr. Mello said in an interview. “In particular, a lot is still being spent to manage cases that never result in a payment to the patient. My hope was that, as hospitals got better at communicating with patients about adverse events, including the fact that about three-quarters of them are not due to substandard care, there would be fewer claims involving such events and also less money spent dealing with such claims when they do arise.”

For cases that do end in payment, high payouts are on the rise. Cases that ended in payments of $1 million or more increased 4% over the 10-year time frame, while payments of $3 million to $11 million increased 7% annually, according to the CRICO report. Cases that ended in payment lower than $1 million dropped over the 10-year span.

The reasons behind increasing plaintiff payouts is uncertain, Dr. Seabury said.

“It’s hard to say exactly why high payouts are on the rise, as payout levels reflect a number of factors – [such as] economic damages, clinical severity, pain and suffering – that can be difficult to disentangle,” he said. “But it is probably concerning for doctors in the sense that, while claims are becoming less likely, when they do happen, it could be more catastrophic in the sense of having large damages that exceed the policy limit.”

agallegos@mdedge.com

Lawsuits against physicians declined across virtually all specialties by more than a quarter over a 10-year span, but the cost to manage legal challenges went up, a recent analysis finds.

From 2007 to 2016, the rate of claims dropped by 27% per 100 doctors from 5.1 to 3.7, according to a review of 124,000 cases by CRICO Strategies, a division of CRICO, the medical liability insurance provider for the Harvard medical community. CRICO’s database of claims contains about 30% of legal cases filed against health providers across the U.S.

For internists, the rate of lawsuits decreased by 35% between 2007 and 2016, according to CRICO data provided to MDedge News. Ob.gyns. saw a 44% drop in claims over the 10-year period, and surgeons experienced a 23% rate decrease. The analysis did not break down the rate of claims by other single subspecialists. Claims decreased by a combined 29% for cardiologists, dermatologists, endocrinologists, family physicians, gastroenterologists, hematologists/oncologists, hospitalists, infectious disease specialists, internists, nephrologists, neurologists, pulmonologists, and rheumatologists/immunologists, according to the report published in February 2019 on CRICO’s website.

The findings are consistent with prior research on claim trends, said Seth Seabury, PhD, a medical liability researcher and director of the Keck-Schaeffer Initiative for Population Health Policy at the University of Southern California, Los Angeles.

“Malpractice claim frequency has been falling pretty steadily for a while now, reflecting a number of factors including the widespread adoption of tort reform and other measures to shield physicians from malpractice risk,” Dr. Seabury said in an interview. “Interestingly, the decline seems greatest in the claims with lower potential stakes, as you see average indemnity holding flat or rising. Some of this likely reflects the unwillingness of attorneys to take cases with lower potential payouts, because of the high cost of litigating a malpractice case.”

While frequency went down, the cost to manage a legal claim went up, according to CRICO data. The price of defending a malpractice lawsuit rose an average of 3.5% annually over the 10-year period from $36,000 to $46,000. For cases that ended with no payment (indemnity) to plaintiffs, the cost to manage a case rose an average of 5% annually.

The upward trends in case management expenses are striking, particularly since the time to resolve cases has decreased, said Michelle Mello, PhD, a health research and policy professor at Stanford (Calif.) University. From 2007 to 2016, the average time to resolve a case dropped from 29 to 27 months, the CRICO report found.

“CRICO nods to disclosure and apology approaches as perhaps underlying the more encouraging trend in time to resolution, but it was surprising to me that such approaches have not translated into lower defense costs,” Dr. Mello said in an interview. “In particular, a lot is still being spent to manage cases that never result in a payment to the patient. My hope was that, as hospitals got better at communicating with patients about adverse events, including the fact that about three-quarters of them are not due to substandard care, there would be fewer claims involving such events and also less money spent dealing with such claims when they do arise.”

For cases that do end in payment, high payouts are on the rise. Cases that ended in payments of $1 million or more increased 4% over the 10-year time frame, while payments of $3 million to $11 million increased 7% annually, according to the CRICO report. Cases that ended in payment lower than $1 million dropped over the 10-year span.

The reasons behind increasing plaintiff payouts is uncertain, Dr. Seabury said.

“It’s hard to say exactly why high payouts are on the rise, as payout levels reflect a number of factors – [such as] economic damages, clinical severity, pain and suffering – that can be difficult to disentangle,” he said. “But it is probably concerning for doctors in the sense that, while claims are becoming less likely, when they do happen, it could be more catastrophic in the sense of having large damages that exceed the policy limit.”

agallegos@mdedge.com

Lawsuits against physicians declined across virtually all specialties by more than a quarter over a 10-year span, but the cost to manage legal challenges went up, a recent analysis finds.

From 2007 to 2016, the rate of claims dropped by 27% per 100 doctors from 5.1 to 3.7, according to a review of 124,000 cases by CRICO Strategies, a division of CRICO, the medical liability insurance provider for the Harvard medical community. CRICO’s database of claims contains about 30% of legal cases filed against health providers across the U.S.

For internists, the rate of lawsuits decreased by 35% between 2007 and 2016, according to CRICO data provided to MDedge News. Ob.gyns. saw a 44% drop in claims over the 10-year period, and surgeons experienced a 23% rate decrease. The analysis did not break down the rate of claims by other single subspecialists. Claims decreased by a combined 29% for cardiologists, dermatologists, endocrinologists, family physicians, gastroenterologists, hematologists/oncologists, hospitalists, infectious disease specialists, internists, nephrologists, neurologists, pulmonologists, and rheumatologists/immunologists, according to the report published in February 2019 on CRICO’s website.

The findings are consistent with prior research on claim trends, said Seth Seabury, PhD, a medical liability researcher and director of the Keck-Schaeffer Initiative for Population Health Policy at the University of Southern California, Los Angeles.

“Malpractice claim frequency has been falling pretty steadily for a while now, reflecting a number of factors including the widespread adoption of tort reform and other measures to shield physicians from malpractice risk,” Dr. Seabury said in an interview. “Interestingly, the decline seems greatest in the claims with lower potential stakes, as you see average indemnity holding flat or rising. Some of this likely reflects the unwillingness of attorneys to take cases with lower potential payouts, because of the high cost of litigating a malpractice case.”

While frequency went down, the cost to manage a legal claim went up, according to CRICO data. The price of defending a malpractice lawsuit rose an average of 3.5% annually over the 10-year period from $36,000 to $46,000. For cases that ended with no payment (indemnity) to plaintiffs, the cost to manage a case rose an average of 5% annually.

The upward trends in case management expenses are striking, particularly since the time to resolve cases has decreased, said Michelle Mello, PhD, a health research and policy professor at Stanford (Calif.) University. From 2007 to 2016, the average time to resolve a case dropped from 29 to 27 months, the CRICO report found.

“CRICO nods to disclosure and apology approaches as perhaps underlying the more encouraging trend in time to resolution, but it was surprising to me that such approaches have not translated into lower defense costs,” Dr. Mello said in an interview. “In particular, a lot is still being spent to manage cases that never result in a payment to the patient. My hope was that, as hospitals got better at communicating with patients about adverse events, including the fact that about three-quarters of them are not due to substandard care, there would be fewer claims involving such events and also less money spent dealing with such claims when they do arise.”

For cases that do end in payment, high payouts are on the rise. Cases that ended in payments of $1 million or more increased 4% over the 10-year time frame, while payments of $3 million to $11 million increased 7% annually, according to the CRICO report. Cases that ended in payment lower than $1 million dropped over the 10-year span.

The reasons behind increasing plaintiff payouts is uncertain, Dr. Seabury said.

“It’s hard to say exactly why high payouts are on the rise, as payout levels reflect a number of factors – [such as] economic damages, clinical severity, pain and suffering – that can be difficult to disentangle,” he said. “But it is probably concerning for doctors in the sense that, while claims are becoming less likely, when they do happen, it could be more catastrophic in the sense of having large damages that exceed the policy limit.”

agallegos@mdedge.com

Click here to access March 2019 Combatting Public Pathogens

Table of Contents

• Blistering Disease During the Treatment of Chronic Hepatitis C With Ledipasvir/Sofosbuvir

• Contrasting qSOFA and SIRS Criteria for Early Sepsis Identification in a Veteran Population

• Significant HbA1c Lowering in Patients Achieving a Hepatitis C Virus Cure

• Prevention and Treatment of HIV in the Military Health System, Bureau of Prisons, Indian Health Service, and VA

Click here to access March 2019 Combatting Public Pathogens

Table of Contents

• Blistering Disease During the Treatment of Chronic Hepatitis C With Ledipasvir/Sofosbuvir

• Contrasting qSOFA and SIRS Criteria for Early Sepsis Identification in a Veteran Population

• Significant HbA1c Lowering in Patients Achieving a Hepatitis C Virus Cure

• Prevention and Treatment of HIV in the Military Health System, Bureau of Prisons, Indian Health Service, and VA

Click here to access March 2019 Combatting Public Pathogens

Table of Contents

• Blistering Disease During the Treatment of Chronic Hepatitis C With Ledipasvir/Sofosbuvir

• Contrasting qSOFA and SIRS Criteria for Early Sepsis Identification in a Veteran Population

• Significant HbA1c Lowering in Patients Achieving a Hepatitis C Virus Cure

• Prevention and Treatment of HIV in the Military Health System, Bureau of Prisons, Indian Health Service, and VA

DALLAS – Ublituximab, a novel anti-CD20 antibody, rapidly and robustly depletes B cells in patients with relapsing forms of multiple sclerosis (MS), according to phase 2 trial results presented at ACTRIMS Forum 2019. Patients treated with the investigational therapy had reduced MRI activity and relapse rates during the 48-week trial, and the treatment was well tolerated, researchers said.

The monoclonal antibody targets a unique epitope on the CD20 antigen and is glycoengineered for enhanced B-cell targeting through antibody-dependent cellular cytotoxicity, said presenting author Edward Fox, MD, PhD, director of the MS Clinic of Central Texas, Round Rock. Ublituximab’s potency “may offer a benefit over currently available anti-CD20s in terms of lower doses and shorter infusion times,” Dr. Fox and his research colleagues said.

To assess the optimal dose, infusion time, safety, and tolerability of ublituximab in relapsing MS, investigators conducted a phase 2, multicenter study. The trial included 48 patients with relapsing MS; 65% were female. Patients’ average age was 40 years and average disease duration was 7.7 years. The researchers included patients with one or more confirmed relapse in the past year, two relapses in the past 2 years, or at least one active gadolinium-enhancing T1 lesion. The primary endpoint was the percentage of patients with at least a 95% reduction in peripheral CD19+ B cells within 2 weeks after the second infusion on day 15.

For their first infusions, patients received 150 mg of ublituximab over an infusion time of 1, 2, 3, or 4 hours. On day 15, patients received 450 mg or 600 mg of ublituximab over an infusion time of 1, 1.5, or 3 hours. At week 24, patients received 450 mg or 650 mg of ublituximab infused over 1 hour or 1.5 hours.

All patients met the primary endpoint of greater than 95% B-cell depletion between baseline and week 4. Median B-cell depletion was 99% at week 4, and this effect was maintained at weeks 24 and 48.

The researchers detected no T1 gadolinium-enhancing lesions at week 24 or week 48, and total T2 lesion volume decreased by 10.6% between baseline and week 48.

The most frequent adverse events were infusion-related reactions, which occurred in 48% of patients and were more common with the first infusion, particularly when the infusion time was less than 4 hours. All of the infusion-related reactions were grade 1 or 2. One grade 3 serious adverse event of fatigue was considered possibly related to ublituximab. No patients withdrew from the study because of drug-related adverse events. At week 48, 93% of the patients were relapse free, 7% had 24-week confirmed disability progression, and 17% had confirmed disability improvement.

TG Therapeutics, the company developing ublituximab, is evaluating the therapy in phase 3 trials known as ULTIMATE I and 2. The phase 3 trials are using the 450-mg dose with a first dose of 150 mg delivered over 4 hours.

Dr. Fox has disclosed research support from TG Therapeutics and other pharmaceutical companies and working as a consultant and speaker for TG Therapeutics and other companies.

jremaly@mdedge.com

SOURCE: Fox E et al. ACTRIMS Forum 2019, Abstract 66.

DALLAS – Ublituximab, a novel anti-CD20 antibody, rapidly and robustly depletes B cells in patients with relapsing forms of multiple sclerosis (MS), according to phase 2 trial results presented at ACTRIMS Forum 2019. Patients treated with the investigational therapy had reduced MRI activity and relapse rates during the 48-week trial, and the treatment was well tolerated, researchers said.

The monoclonal antibody targets a unique epitope on the CD20 antigen and is glycoengineered for enhanced B-cell targeting through antibody-dependent cellular cytotoxicity, said presenting author Edward Fox, MD, PhD, director of the MS Clinic of Central Texas, Round Rock. Ublituximab’s potency “may offer a benefit over currently available anti-CD20s in terms of lower doses and shorter infusion times,” Dr. Fox and his research colleagues said.

To assess the optimal dose, infusion time, safety, and tolerability of ublituximab in relapsing MS, investigators conducted a phase 2, multicenter study. The trial included 48 patients with relapsing MS; 65% were female. Patients’ average age was 40 years and average disease duration was 7.7 years. The researchers included patients with one or more confirmed relapse in the past year, two relapses in the past 2 years, or at least one active gadolinium-enhancing T1 lesion. The primary endpoint was the percentage of patients with at least a 95% reduction in peripheral CD19+ B cells within 2 weeks after the second infusion on day 15.

For their first infusions, patients received 150 mg of ublituximab over an infusion time of 1, 2, 3, or 4 hours. On day 15, patients received 450 mg or 600 mg of ublituximab over an infusion time of 1, 1.5, or 3 hours. At week 24, patients received 450 mg or 650 mg of ublituximab infused over 1 hour or 1.5 hours.

All patients met the primary endpoint of greater than 95% B-cell depletion between baseline and week 4. Median B-cell depletion was 99% at week 4, and this effect was maintained at weeks 24 and 48.

The researchers detected no T1 gadolinium-enhancing lesions at week 24 or week 48, and total T2 lesion volume decreased by 10.6% between baseline and week 48.

The most frequent adverse events were infusion-related reactions, which occurred in 48% of patients and were more common with the first infusion, particularly when the infusion time was less than 4 hours. All of the infusion-related reactions were grade 1 or 2. One grade 3 serious adverse event of fatigue was considered possibly related to ublituximab. No patients withdrew from the study because of drug-related adverse events. At week 48, 93% of the patients were relapse free, 7% had 24-week confirmed disability progression, and 17% had confirmed disability improvement.

TG Therapeutics, the company developing ublituximab, is evaluating the therapy in phase 3 trials known as ULTIMATE I and 2. The phase 3 trials are using the 450-mg dose with a first dose of 150 mg delivered over 4 hours.

Dr. Fox has disclosed research support from TG Therapeutics and other pharmaceutical companies and working as a consultant and speaker for TG Therapeutics and other companies.

jremaly@mdedge.com

SOURCE: Fox E et al. ACTRIMS Forum 2019, Abstract 66.

DALLAS – Ublituximab, a novel anti-CD20 antibody, rapidly and robustly depletes B cells in patients with relapsing forms of multiple sclerosis (MS), according to phase 2 trial results presented at ACTRIMS Forum 2019. Patients treated with the investigational therapy had reduced MRI activity and relapse rates during the 48-week trial, and the treatment was well tolerated, researchers said.

The monoclonal antibody targets a unique epitope on the CD20 antigen and is glycoengineered for enhanced B-cell targeting through antibody-dependent cellular cytotoxicity, said presenting author Edward Fox, MD, PhD, director of the MS Clinic of Central Texas, Round Rock. Ublituximab’s potency “may offer a benefit over currently available anti-CD20s in terms of lower doses and shorter infusion times,” Dr. Fox and his research colleagues said.

To assess the optimal dose, infusion time, safety, and tolerability of ublituximab in relapsing MS, investigators conducted a phase 2, multicenter study. The trial included 48 patients with relapsing MS; 65% were female. Patients’ average age was 40 years and average disease duration was 7.7 years. The researchers included patients with one or more confirmed relapse in the past year, two relapses in the past 2 years, or at least one active gadolinium-enhancing T1 lesion. The primary endpoint was the percentage of patients with at least a 95% reduction in peripheral CD19+ B cells within 2 weeks after the second infusion on day 15.

For their first infusions, patients received 150 mg of ublituximab over an infusion time of 1, 2, 3, or 4 hours. On day 15, patients received 450 mg or 600 mg of ublituximab over an infusion time of 1, 1.5, or 3 hours. At week 24, patients received 450 mg or 650 mg of ublituximab infused over 1 hour or 1.5 hours.

All patients met the primary endpoint of greater than 95% B-cell depletion between baseline and week 4. Median B-cell depletion was 99% at week 4, and this effect was maintained at weeks 24 and 48.

The researchers detected no T1 gadolinium-enhancing lesions at week 24 or week 48, and total T2 lesion volume decreased by 10.6% between baseline and week 48.

The most frequent adverse events were infusion-related reactions, which occurred in 48% of patients and were more common with the first infusion, particularly when the infusion time was less than 4 hours. All of the infusion-related reactions were grade 1 or 2. One grade 3 serious adverse event of fatigue was considered possibly related to ublituximab. No patients withdrew from the study because of drug-related adverse events. At week 48, 93% of the patients were relapse free, 7% had 24-week confirmed disability progression, and 17% had confirmed disability improvement.

TG Therapeutics, the company developing ublituximab, is evaluating the therapy in phase 3 trials known as ULTIMATE I and 2. The phase 3 trials are using the 450-mg dose with a first dose of 150 mg delivered over 4 hours.

Dr. Fox has disclosed research support from TG Therapeutics and other pharmaceutical companies and working as a consultant and speaker for TG Therapeutics and other companies.

jremaly@mdedge.com

SOURCE: Fox E et al. ACTRIMS Forum 2019, Abstract 66.

DALLAS – Patients with multiple sclerosis (MS) have elevated levels of specific clusters of cerebrospinal fluid (CSF) biomarkers related to astrocytes and microglia that correlated with disease severity in a blinded analysis of more than 1,000 proteins from the CSF of more than 400 patients with neuroimmunologic disease and healthy volunteers.

Jake Remaly/MDedge News

Previous studies have indicated that aberrant activation of astrocytes and microglia underlies disability progression in older patients with MS, but researchers have lacked biomarkers of these processes in living subjects. In a presentation at a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, Ruturaj R. Masvekar, PhD, described developing biomarkers of CNS cell–specific processes and examining how they relate to MS disability progression. Dr. Masvekar, a researcher at the National Institute of Allergy and Infectious Diseases, and his coinvestigators used a modified DNA aptamer assay to measure proteins in the CSF of 431 patients with neuroimmunologic diseases and healthy volunteers, followed by variable cluster analysis and in vitro modeling to define 64 clusters of CSF biomarkers that relate to CNS cell types.

The study included 42 healthy donors, 20 patients with clinically isolated syndrome, 57 patients with noninflammatory neurologic disorders, 127 patients with relapsing-remitting MS, 72 patients with secondary progressive MS, and 113 patients with primary progressive MS. In a training cohort of 217 participants, the researchers assessed how biomarkers differed between the diagnostic categories. The researchers then validated the results in an independent cohort of 214 participants.

One astrocyte-related cluster (MMP7, SERPINA3, GZMA, and CLIC1) and one microglia-related cluster (DSG2 and TNFRSF25) was significantly elevated in all MS subgroups, compared with healthy controls and patients with noninflammatory neurologic disorders.

In addition, these clusters “significantly correlated with clinical measures of disability, CNS tissue destruction, and MS severity,” Dr. Masvekar said.

The microglial cluster was significantly elevated in all MS subgroups, whereas neuronal endothelial, astrocytic, and oligodendroglial biomarker clusters were elevated only in patients with progressive MS.

“Microglial activation is present in all stages of MS, while toxic astrogliosis increases with MS duration, concomitantly with neuronal and oligodendroglial degeneration,” Dr. Masvekar said. “Microglial activation and toxic astrogliosis likely partake in CNS tissue destruction and enhance MS severity.”

This study, which was recently published in Multiple Sclerosis and Related Disorders (2019 Feb;28:34-43), was supported by the intramural research program at NIAID.

jremaly@mdedge.com

SOURCE: Masvekar RR et al. ACTRIMS Forum 2019, Abstract 281.

DALLAS – Patients with multiple sclerosis (MS) have elevated levels of specific clusters of cerebrospinal fluid (CSF) biomarkers related to astrocytes and microglia that correlated with disease severity in a blinded analysis of more than 1,000 proteins from the CSF of more than 400 patients with neuroimmunologic disease and healthy volunteers.

Jake Remaly/MDedge News

Previous studies have indicated that aberrant activation of astrocytes and microglia underlies disability progression in older patients with MS, but researchers have lacked biomarkers of these processes in living subjects. In a presentation at a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, Ruturaj R. Masvekar, PhD, described developing biomarkers of CNS cell–specific processes and examining how they relate to MS disability progression. Dr. Masvekar, a researcher at the National Institute of Allergy and Infectious Diseases, and his coinvestigators used a modified DNA aptamer assay to measure proteins in the CSF of 431 patients with neuroimmunologic diseases and healthy volunteers, followed by variable cluster analysis and in vitro modeling to define 64 clusters of CSF biomarkers that relate to CNS cell types.

The study included 42 healthy donors, 20 patients with clinically isolated syndrome, 57 patients with noninflammatory neurologic disorders, 127 patients with relapsing-remitting MS, 72 patients with secondary progressive MS, and 113 patients with primary progressive MS. In a training cohort of 217 participants, the researchers assessed how biomarkers differed between the diagnostic categories. The researchers then validated the results in an independent cohort of 214 participants.

One astrocyte-related cluster (MMP7, SERPINA3, GZMA, and CLIC1) and one microglia-related cluster (DSG2 and TNFRSF25) was significantly elevated in all MS subgroups, compared with healthy controls and patients with noninflammatory neurologic disorders.

In addition, these clusters “significantly correlated with clinical measures of disability, CNS tissue destruction, and MS severity,” Dr. Masvekar said.

The microglial cluster was significantly elevated in all MS subgroups, whereas neuronal endothelial, astrocytic, and oligodendroglial biomarker clusters were elevated only in patients with progressive MS.

“Microglial activation is present in all stages of MS, while toxic astrogliosis increases with MS duration, concomitantly with neuronal and oligodendroglial degeneration,” Dr. Masvekar said. “Microglial activation and toxic astrogliosis likely partake in CNS tissue destruction and enhance MS severity.”

This study, which was recently published in Multiple Sclerosis and Related Disorders (2019 Feb;28:34-43), was supported by the intramural research program at NIAID.

jremaly@mdedge.com

SOURCE: Masvekar RR et al. ACTRIMS Forum 2019, Abstract 281.

DALLAS – Patients with multiple sclerosis (MS) have elevated levels of specific clusters of cerebrospinal fluid (CSF) biomarkers related to astrocytes and microglia that correlated with disease severity in a blinded analysis of more than 1,000 proteins from the CSF of more than 400 patients with neuroimmunologic disease and healthy volunteers.

Jake Remaly/MDedge News

Previous studies have indicated that aberrant activation of astrocytes and microglia underlies disability progression in older patients with MS, but researchers have lacked biomarkers of these processes in living subjects. In a presentation at a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, Ruturaj R. Masvekar, PhD, described developing biomarkers of CNS cell–specific processes and examining how they relate to MS disability progression. Dr. Masvekar, a researcher at the National Institute of Allergy and Infectious Diseases, and his coinvestigators used a modified DNA aptamer assay to measure proteins in the CSF of 431 patients with neuroimmunologic diseases and healthy volunteers, followed by variable cluster analysis and in vitro modeling to define 64 clusters of CSF biomarkers that relate to CNS cell types.

The study included 42 healthy donors, 20 patients with clinically isolated syndrome, 57 patients with noninflammatory neurologic disorders, 127 patients with relapsing-remitting MS, 72 patients with secondary progressive MS, and 113 patients with primary progressive MS. In a training cohort of 217 participants, the researchers assessed how biomarkers differed between the diagnostic categories. The researchers then validated the results in an independent cohort of 214 participants.

One astrocyte-related cluster (MMP7, SERPINA3, GZMA, and CLIC1) and one microglia-related cluster (DSG2 and TNFRSF25) was significantly elevated in all MS subgroups, compared with healthy controls and patients with noninflammatory neurologic disorders.

In addition, these clusters “significantly correlated with clinical measures of disability, CNS tissue destruction, and MS severity,” Dr. Masvekar said.

The microglial cluster was significantly elevated in all MS subgroups, whereas neuronal endothelial, astrocytic, and oligodendroglial biomarker clusters were elevated only in patients with progressive MS.

“Microglial activation is present in all stages of MS, while toxic astrogliosis increases with MS duration, concomitantly with neuronal and oligodendroglial degeneration,” Dr. Masvekar said. “Microglial activation and toxic astrogliosis likely partake in CNS tissue destruction and enhance MS severity.”

This study, which was recently published in Multiple Sclerosis and Related Disorders (2019 Feb;28:34-43), was supported by the intramural research program at NIAID.

jremaly@mdedge.com

SOURCE: Masvekar RR et al. ACTRIMS Forum 2019, Abstract 281.

DALLAS – In 2 years of follow-up, about 43% of U.S. patients diagnosed with multiple sclerosis (MS) had not received disease-modifying drug (DMD) therapy, a rate that is consistent with other published studies.

The finding comes from a retrospective analysis of claims data presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “This rate of DMD treatment merits further exploration given that evidence suggests the importance of early DMD treatment initiation in patients with a confirmed diagnosis of relapsing forms of MS to help optimize the benefits of treatment,” Amy L. Phillips, PharmD, a study author, said in an interview in advance of the meeting.

Little is known about current DMD treatment patterns in U.S. patients with multiple sclerosis following an increase in the number of available DMDs in recent years, according to Dr. Phillips of the department of health economics and outcomes research at EMD Serono.

“Most previous studies have focused on self-injectable DMDs or self-injectable and infusion DMDs,” she said. “Information about the treatment patterns including oral DMDs is scarce, particularly in large population samples. The objective of our study was to describe treatment patterns and sequences of therapy among U.S. patients with MS newly initiating DMD treatment between Jan. 1, 2011 and June 30, 2015.”

Dr. Phillips, lead study author Jacqueline A. Nicholas, MD, MPH, of the OhioHealth Multiple Sclerosis Center, and their colleagues used data from the IQVIA RWD Adjudicated Claims database to identify patients who had at least two medical claims with a MS diagnosis and at least one DMD claim during the study period. Other eligibility criteria included continuous eligibility with commercial insurance 1 year before (baseline period) and 2 years after (follow-up period) initiation of the DMD, no evidence of DMD use during the baseline period, and being aged between 18 and 63 years.

Of 63,946 diagnostically eligible patients, 36,175 (57%) had a claim for a DMD. The researchers reported findings from 8,251 patients who met all of the eligibility criteria. Their mean age was 43 years, 76% were female, and the mean number of DMDs over 2 years among newly treated patients was 1.27.

The most common first-line DMD therapy was glatiramer acetate (GA, 38%), followed by intramuscular interferon beta (IM IFNb-1a, 14%), subcutaneous interferon beta (SC IFNb-1a, 14%), dimethyl fumarate (DMF, 14%), and fingolimod (9%). DMF was the most common second-line therapy (36%), followed by fingolimod (17%), GA (17%), SC IFNb-1a (8%), and IM IFNb-1a (7%).

“Numerous DMD treatment patterns observed in this study highlight the diverse patient and treatment needs,” Dr. Phillips said. “DMD treatment patterns in MS vary due to the heterogeneity of the disease, physician preferences, and patient needs and treatment goals. Patient-centered care and shared decision making has been shown to improve patient satisfaction and to encourage treatment adherence in MS.”

She acknowledged certain limitations of the study, including the fact that the analysis presents only the most common DMD treatment sequences observed in this patient population.

“Future analyses might examine less common DMD treatment sequences,” she said. “Also, more research is needed to understand how DMD treatment patterns and sequences change over time, and the factors that may be associated with DMD switching and treatment discontinuation.”

She also noted that the administrative claims data studied represent mostly patients with commercial health insurance, limiting the generalizability of the findings. Further, ICD-9 and ICD-10 codes do not distinguish between MS types.

Funding for the study was provided by EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the United States and Canada. Dr. Phillips is an employee of the company.

dbrunk@mdedge.com

SOURCE: Phillips A et al. ACTRIMS FORUM 2019, Abstract 001.

DALLAS – In 2 years of follow-up, about 43% of U.S. patients diagnosed with multiple sclerosis (MS) had not received disease-modifying drug (DMD) therapy, a rate that is consistent with other published studies.

The finding comes from a retrospective analysis of claims data presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “This rate of DMD treatment merits further exploration given that evidence suggests the importance of early DMD treatment initiation in patients with a confirmed diagnosis of relapsing forms of MS to help optimize the benefits of treatment,” Amy L. Phillips, PharmD, a study author, said in an interview in advance of the meeting.

Little is known about current DMD treatment patterns in U.S. patients with multiple sclerosis following an increase in the number of available DMDs in recent years, according to Dr. Phillips of the department of health economics and outcomes research at EMD Serono.

“Most previous studies have focused on self-injectable DMDs or self-injectable and infusion DMDs,” she said. “Information about the treatment patterns including oral DMDs is scarce, particularly in large population samples. The objective of our study was to describe treatment patterns and sequences of therapy among U.S. patients with MS newly initiating DMD treatment between Jan. 1, 2011 and June 30, 2015.”

Dr. Phillips, lead study author Jacqueline A. Nicholas, MD, MPH, of the OhioHealth Multiple Sclerosis Center, and their colleagues used data from the IQVIA RWD Adjudicated Claims database to identify patients who had at least two medical claims with a MS diagnosis and at least one DMD claim during the study period. Other eligibility criteria included continuous eligibility with commercial insurance 1 year before (baseline period) and 2 years after (follow-up period) initiation of the DMD, no evidence of DMD use during the baseline period, and being aged between 18 and 63 years.

Of 63,946 diagnostically eligible patients, 36,175 (57%) had a claim for a DMD. The researchers reported findings from 8,251 patients who met all of the eligibility criteria. Their mean age was 43 years, 76% were female, and the mean number of DMDs over 2 years among newly treated patients was 1.27.

The most common first-line DMD therapy was glatiramer acetate (GA, 38%), followed by intramuscular interferon beta (IM IFNb-1a, 14%), subcutaneous interferon beta (SC IFNb-1a, 14%), dimethyl fumarate (DMF, 14%), and fingolimod (9%). DMF was the most common second-line therapy (36%), followed by fingolimod (17%), GA (17%), SC IFNb-1a (8%), and IM IFNb-1a (7%).

“Numerous DMD treatment patterns observed in this study highlight the diverse patient and treatment needs,” Dr. Phillips said. “DMD treatment patterns in MS vary due to the heterogeneity of the disease, physician preferences, and patient needs and treatment goals. Patient-centered care and shared decision making has been shown to improve patient satisfaction and to encourage treatment adherence in MS.”

She acknowledged certain limitations of the study, including the fact that the analysis presents only the most common DMD treatment sequences observed in this patient population.

“Future analyses might examine less common DMD treatment sequences,” she said. “Also, more research is needed to understand how DMD treatment patterns and sequences change over time, and the factors that may be associated with DMD switching and treatment discontinuation.”

She also noted that the administrative claims data studied represent mostly patients with commercial health insurance, limiting the generalizability of the findings. Further, ICD-9 and ICD-10 codes do not distinguish between MS types.

Funding for the study was provided by EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the United States and Canada. Dr. Phillips is an employee of the company.

dbrunk@mdedge.com

SOURCE: Phillips A et al. ACTRIMS FORUM 2019, Abstract 001.

DALLAS – In 2 years of follow-up, about 43% of U.S. patients diagnosed with multiple sclerosis (MS) had not received disease-modifying drug (DMD) therapy, a rate that is consistent with other published studies.

The finding comes from a retrospective analysis of claims data presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “This rate of DMD treatment merits further exploration given that evidence suggests the importance of early DMD treatment initiation in patients with a confirmed diagnosis of relapsing forms of MS to help optimize the benefits of treatment,” Amy L. Phillips, PharmD, a study author, said in an interview in advance of the meeting.

Little is known about current DMD treatment patterns in U.S. patients with multiple sclerosis following an increase in the number of available DMDs in recent years, according to Dr. Phillips of the department of health economics and outcomes research at EMD Serono.

“Most previous studies have focused on self-injectable DMDs or self-injectable and infusion DMDs,” she said. “Information about the treatment patterns including oral DMDs is scarce, particularly in large population samples. The objective of our study was to describe treatment patterns and sequences of therapy among U.S. patients with MS newly initiating DMD treatment between Jan. 1, 2011 and June 30, 2015.”

Dr. Phillips, lead study author Jacqueline A. Nicholas, MD, MPH, of the OhioHealth Multiple Sclerosis Center, and their colleagues used data from the IQVIA RWD Adjudicated Claims database to identify patients who had at least two medical claims with a MS diagnosis and at least one DMD claim during the study period. Other eligibility criteria included continuous eligibility with commercial insurance 1 year before (baseline period) and 2 years after (follow-up period) initiation of the DMD, no evidence of DMD use during the baseline period, and being aged between 18 and 63 years.

Of 63,946 diagnostically eligible patients, 36,175 (57%) had a claim for a DMD. The researchers reported findings from 8,251 patients who met all of the eligibility criteria. Their mean age was 43 years, 76% were female, and the mean number of DMDs over 2 years among newly treated patients was 1.27.

The most common first-line DMD therapy was glatiramer acetate (GA, 38%), followed by intramuscular interferon beta (IM IFNb-1a, 14%), subcutaneous interferon beta (SC IFNb-1a, 14%), dimethyl fumarate (DMF, 14%), and fingolimod (9%). DMF was the most common second-line therapy (36%), followed by fingolimod (17%), GA (17%), SC IFNb-1a (8%), and IM IFNb-1a (7%).

“Numerous DMD treatment patterns observed in this study highlight the diverse patient and treatment needs,” Dr. Phillips said. “DMD treatment patterns in MS vary due to the heterogeneity of the disease, physician preferences, and patient needs and treatment goals. Patient-centered care and shared decision making has been shown to improve patient satisfaction and to encourage treatment adherence in MS.”

She acknowledged certain limitations of the study, including the fact that the analysis presents only the most common DMD treatment sequences observed in this patient population.

“Future analyses might examine less common DMD treatment sequences,” she said. “Also, more research is needed to understand how DMD treatment patterns and sequences change over time, and the factors that may be associated with DMD switching and treatment discontinuation.”

She also noted that the administrative claims data studied represent mostly patients with commercial health insurance, limiting the generalizability of the findings. Further, ICD-9 and ICD-10 codes do not distinguish between MS types.

Funding for the study was provided by EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the United States and Canada. Dr. Phillips is an employee of the company.

dbrunk@mdedge.com

SOURCE: Phillips A et al. ACTRIMS FORUM 2019, Abstract 001.

The 2018-2019 flu season may have peaked as the major nationwide measure of influenza activity held steady for the week ending Feb. 23, according to the Centers for Disease Control and Prevention. The proportion of outpatient visits for influenza-like illness (ILI) was 5.0% for the most recent reporting week, the CDC’s influenza division said in its March 1 report. The previous week’s outpatient visit rate, originally reported as 5.1%, was revised this week to 5.0% as well, suggesting that flu activity is no longer increasing.

Activity at the state level was more mixed. The number of states at level 10 on the CDC’s 1-10 scale of ILI activity stayed at 24 as Indiana and North Dakota replaced Tennessee and Wyoming, but the number of states in the high range (8-10) of the activity scale increased from 30 to 33, CDC data show.

The signs of plateauing ILI activity did not, however, extend to flu-related deaths, with 15 reported among children – the highest weekly number for the 2018-2019 season, although 11 actually occurred in previous weeks – during the week ending Feb. 23 and 289 deaths among all ages for the week ending Feb. 16, which is already more than the 268 listed the week before despite less complete reporting (82% vs. 97%), the CDC reported. Total flu-related deaths in children are now up to 56, compared with 138 at the corresponding point in the 2017-2018 season.

rfranki@mdedge.com

The 2018-2019 flu season may have peaked as the major nationwide measure of influenza activity held steady for the week ending Feb. 23, according to the Centers for Disease Control and Prevention. The proportion of outpatient visits for influenza-like illness (ILI) was 5.0% for the most recent reporting week, the CDC’s influenza division said in its March 1 report. The previous week’s outpatient visit rate, originally reported as 5.1%, was revised this week to 5.0% as well, suggesting that flu activity is no longer increasing.

Activity at the state level was more mixed. The number of states at level 10 on the CDC’s 1-10 scale of ILI activity stayed at 24 as Indiana and North Dakota replaced Tennessee and Wyoming, but the number of states in the high range (8-10) of the activity scale increased from 30 to 33, CDC data show.

The signs of plateauing ILI activity did not, however, extend to flu-related deaths, with 15 reported among children – the highest weekly number for the 2018-2019 season, although 11 actually occurred in previous weeks – during the week ending Feb. 23 and 289 deaths among all ages for the week ending Feb. 16, which is already more than the 268 listed the week before despite less complete reporting (82% vs. 97%), the CDC reported. Total flu-related deaths in children are now up to 56, compared with 138 at the corresponding point in the 2017-2018 season.

rfranki@mdedge.com

The 2018-2019 flu season may have peaked as the major nationwide measure of influenza activity held steady for the week ending Feb. 23, according to the Centers for Disease Control and Prevention. The proportion of outpatient visits for influenza-like illness (ILI) was 5.0% for the most recent reporting week, the CDC’s influenza division said in its March 1 report. The previous week’s outpatient visit rate, originally reported as 5.1%, was revised this week to 5.0% as well, suggesting that flu activity is no longer increasing.

Activity at the state level was more mixed. The number of states at level 10 on the CDC’s 1-10 scale of ILI activity stayed at 24 as Indiana and North Dakota replaced Tennessee and Wyoming, but the number of states in the high range (8-10) of the activity scale increased from 30 to 33, CDC data show.

The signs of plateauing ILI activity did not, however, extend to flu-related deaths, with 15 reported among children – the highest weekly number for the 2018-2019 season, although 11 actually occurred in previous weeks – during the week ending Feb. 23 and 289 deaths among all ages for the week ending Feb. 16, which is already more than the 268 listed the week before despite less complete reporting (82% vs. 97%), the CDC reported. Total flu-related deaths in children are now up to 56, compared with 138 at the corresponding point in the 2017-2018 season.

rfranki@mdedge.com

Among the trajectories of clinical predictors of suicide attempt, depression symptoms were the only ones linked with an increased risk of suicide attempt in young adults whose parents have mood disorders, according to a longitudinal study.

Psychiatric diagnoses are well established as predictors of suicidal behavior; however, symptoms and risk can vary over the course of illness, and it is important to identify symptoms that can change over time, wrote Nadine M. Melhem, PhD, associate professor of psychiatry at the University of Pittsburgh, and her associates. The report is in JAMA Psychiatry.

Between July 15, 1997, and Sept. 6, 2005, 663 adolescents and young adults (mean age, 23.8 years) whose parents have mood disorders were recruited and followed until Jan. 21, 2014. All participants were assessed at baseline and every year for up to 12 years (median follow-up, 8.1 years) for lifetime and current psychiatric disorders as well as suicidal ideation. In addition, participants were assessed at baseline and at each follow-up for the trajectory of depression symptoms, hopelessness, impulsivity, aggression, impulsive aggression, and irritability.

After the study period, participants were analyzed for all trajectories and separated into classes based on mean scores and variability. All trajectories except for depression had two classes, in which participants in class 2 had higher mean scores and variability; for depression, patients were separated into three classes, in which class 3 had the highest mean score and variability.

Over the study period, 71 of the 663 patients attempted suicide (10.7%), with 51 patients attempting suicide for the first time. The mean number of attempts was 1.2, and the median time from the last assessment to the attempt was 45 weeks.

Participants who attempted suicide were more likely to have class 3 depression symptoms (22.9% with vs. 27 without), class 2 impulsivity (38.8% vs. 21.7%), class 2 aggression (29.0% vs. 15.6%), class 2 impulsive aggression (76.5% vs. 52.2%), and class 2 irritability (39.4% vs. 22.7%). However, after adjustment for demographics, parental suicide attempts, and additional clinical characteristics, only class 3 depression remained associated with suicide attempts (odds ratio, 4.72; 95% confidence interval, 1.47-15.21; P = .01).

Other significant predictors of suicide attempts were younger age (OR, 0.82; 95% CI, 0.74-0.90; P less than .001), lifetime history of unipolar disorder (OR, 4.71; 95% CI, 1.63-13.58; P = .004), lifetime history of bipolar disorder (OR, 3.4; 95% CI, 0.96-12.04; P = .06), history of childhood abuse (OR, 2.98; 95% CI, 1.40-6.38; P = .01), and parental suicide attempt (OR, 2.24; 95% CI, 1.06-4.75; P = .04).

The investigators concluded that clinicians should “pay particular attention to the severity of both current and past depression and the variability in these symptoms, and monitor and treat depression symptoms over time to reduce symptom severity and fluctuation, and thus the likelihood for suicide attempt, in high-risk young adults.”

Dr. Melhem reported receiving research support from the National Institute of Mental Health, the Brain and Behavior Research Foundation, and the American Foundation for Suicide Prevention. Several other coauthors also reported conflicts of interest.

lfranki@mdedge.com

SOURCE: Melhem NM et al. JAMA Psychiatry. 2019 Feb 27. doi: 10.1001/jamapsychiatry.2018.4513.

Among the trajectories of clinical predictors of suicide attempt, depression symptoms were the only ones linked with an increased risk of suicide attempt in young adults whose parents have mood disorders, according to a longitudinal study.

Psychiatric diagnoses are well established as predictors of suicidal behavior; however, symptoms and risk can vary over the course of illness, and it is important to identify symptoms that can change over time, wrote Nadine M. Melhem, PhD, associate professor of psychiatry at the University of Pittsburgh, and her associates. The report is in JAMA Psychiatry.

Between July 15, 1997, and Sept. 6, 2005, 663 adolescents and young adults (mean age, 23.8 years) whose parents have mood disorders were recruited and followed until Jan. 21, 2014. All participants were assessed at baseline and every year for up to 12 years (median follow-up, 8.1 years) for lifetime and current psychiatric disorders as well as suicidal ideation. In addition, participants were assessed at baseline and at each follow-up for the trajectory of depression symptoms, hopelessness, impulsivity, aggression, impulsive aggression, and irritability.

After the study period, participants were analyzed for all trajectories and separated into classes based on mean scores and variability. All trajectories except for depression had two classes, in which participants in class 2 had higher mean scores and variability; for depression, patients were separated into three classes, in which class 3 had the highest mean score and variability.

Over the study period, 71 of the 663 patients attempted suicide (10.7%), with 51 patients attempting suicide for the first time. The mean number of attempts was 1.2, and the median time from the last assessment to the attempt was 45 weeks.

Participants who attempted suicide were more likely to have class 3 depression symptoms (22.9% with vs. 27 without), class 2 impulsivity (38.8% vs. 21.7%), class 2 aggression (29.0% vs. 15.6%), class 2 impulsive aggression (76.5% vs. 52.2%), and class 2 irritability (39.4% vs. 22.7%). However, after adjustment for demographics, parental suicide attempts, and additional clinical characteristics, only class 3 depression remained associated with suicide attempts (odds ratio, 4.72; 95% confidence interval, 1.47-15.21; P = .01).

Other significant predictors of suicide attempts were younger age (OR, 0.82; 95% CI, 0.74-0.90; P less than .001), lifetime history of unipolar disorder (OR, 4.71; 95% CI, 1.63-13.58; P = .004), lifetime history of bipolar disorder (OR, 3.4; 95% CI, 0.96-12.04; P = .06), history of childhood abuse (OR, 2.98; 95% CI, 1.40-6.38; P = .01), and parental suicide attempt (OR, 2.24; 95% CI, 1.06-4.75; P = .04).

The investigators concluded that clinicians should “pay particular attention to the severity of both current and past depression and the variability in these symptoms, and monitor and treat depression symptoms over time to reduce symptom severity and fluctuation, and thus the likelihood for suicide attempt, in high-risk young adults.”

Dr. Melhem reported receiving research support from the National Institute of Mental Health, the Brain and Behavior Research Foundation, and the American Foundation for Suicide Prevention. Several other coauthors also reported conflicts of interest.

lfranki@mdedge.com

SOURCE: Melhem NM et al. JAMA Psychiatry. 2019 Feb 27. doi: 10.1001/jamapsychiatry.2018.4513.

Among the trajectories of clinical predictors of suicide attempt, depression symptoms were the only ones linked with an increased risk of suicide attempt in young adults whose parents have mood disorders, according to a longitudinal study.

Psychiatric diagnoses are well established as predictors of suicidal behavior; however, symptoms and risk can vary over the course of illness, and it is important to identify symptoms that can change over time, wrote Nadine M. Melhem, PhD, associate professor of psychiatry at the University of Pittsburgh, and her associates. The report is in JAMA Psychiatry.

Between July 15, 1997, and Sept. 6, 2005, 663 adolescents and young adults (mean age, 23.8 years) whose parents have mood disorders were recruited and followed until Jan. 21, 2014. All participants were assessed at baseline and every year for up to 12 years (median follow-up, 8.1 years) for lifetime and current psychiatric disorders as well as suicidal ideation. In addition, participants were assessed at baseline and at each follow-up for the trajectory of depression symptoms, hopelessness, impulsivity, aggression, impulsive aggression, and irritability.

After the study period, participants were analyzed for all trajectories and separated into classes based on mean scores and variability. All trajectories except for depression had two classes, in which participants in class 2 had higher mean scores and variability; for depression, patients were separated into three classes, in which class 3 had the highest mean score and variability.

Over the study period, 71 of the 663 patients attempted suicide (10.7%), with 51 patients attempting suicide for the first time. The mean number of attempts was 1.2, and the median time from the last assessment to the attempt was 45 weeks.

Participants who attempted suicide were more likely to have class 3 depression symptoms (22.9% with vs. 27 without), class 2 impulsivity (38.8% vs. 21.7%), class 2 aggression (29.0% vs. 15.6%), class 2 impulsive aggression (76.5% vs. 52.2%), and class 2 irritability (39.4% vs. 22.7%). However, after adjustment for demographics, parental suicide attempts, and additional clinical characteristics, only class 3 depression remained associated with suicide attempts (odds ratio, 4.72; 95% confidence interval, 1.47-15.21; P = .01).

Other significant predictors of suicide attempts were younger age (OR, 0.82; 95% CI, 0.74-0.90; P less than .001), lifetime history of unipolar disorder (OR, 4.71; 95% CI, 1.63-13.58; P = .004), lifetime history of bipolar disorder (OR, 3.4; 95% CI, 0.96-12.04; P = .06), history of childhood abuse (OR, 2.98; 95% CI, 1.40-6.38; P = .01), and parental suicide attempt (OR, 2.24; 95% CI, 1.06-4.75; P = .04).

The investigators concluded that clinicians should “pay particular attention to the severity of both current and past depression and the variability in these symptoms, and monitor and treat depression symptoms over time to reduce symptom severity and fluctuation, and thus the likelihood for suicide attempt, in high-risk young adults.”

Dr. Melhem reported receiving research support from the National Institute of Mental Health, the Brain and Behavior Research Foundation, and the American Foundation for Suicide Prevention. Several other coauthors also reported conflicts of interest.

lfranki@mdedge.com

SOURCE: Melhem NM et al. JAMA Psychiatry. 2019 Feb 27. doi: 10.1001/jamapsychiatry.2018.4513.