NEW ORLEANS – Researchers are organizing a master trial in an attempt to improve the treatment of pediatric acute myeloid leukemia (AML).

The Pediatric Acute Leukemia (PedAL) trial is an effort to collect data on all pediatric AML patients. The plan is to use these data to match patients to clinical trials, better understand pediatric AML, and bring new treatments to this population.

E. Anders Kolb, MD, of Nemours Center for Cancer and Blood Disorders in Wilmington, Del., described the initiative at the annual meeting of the American Society of Pediatric Hematology/Oncology.

Dr. Kolb noted that several drugs have been approved to treat adult AML in the last 2 years, but most of them are not approved for use in children.

“What we see in childhood AML is a lot different than what we see in adult AML, and this challenges the paradigm that we have traditionally followed where we use the adult as the 'preclinical model' for pediatric AML,” he said. “I think we are learning more and more that children have a unique disease, unique targets, and need unique therapies.”

The PedAL initiative is an attempt to address these unique needs. PedAL is part of the Leukemia & Lymphoma Society’s Children’s Initiative, and it involves researchers from academic centers and the Children’s Oncology Group.

The PedAL initiative includes preclinical, biomarker, and informatics research, as well as the master clinical trial. The main goal of the master trial is to collect genomic, proteomic, metabolomic, flow cytometry, and clinical data from all children with AML and use these data to match patients to clinical trials.

The PedAL trial will leverage Project:EveryChild, an effort by the Children’s Oncology Group to study every child with cancer. Each child enrolled in this program has an identification number that follows the child through all clinical interventions.

The goal is that Project:EveryChild will capture all pediatric AML patients at the time of diagnosis, although patients can join the project at any time. Then, sequencing, clinical, and other data will be collected from these patients and stored in a data commons.

If patients relapse after standard or other therapies, the GEARBOX algorithm (genomic eligibility algorithm at relapse for better outcomes) can be used to match the patient’s information to clinical trial eligibility criteria and provide a list of appropriate trials.

Dr. Kolb said this process should reduce logistical barriers and get relapsed patients to trials more quickly. Additionally, the data collected through PedAL should help researchers design better trials for pediatric patients with relapsed AML.

“Ultimately, we’ll create the largest data set that will give us a better understanding of all the risks and benefits associated with postrelapse AML,” Dr. Kolb said. “No matter what happens to the patient, no matter where that patient enrolls, we’re going to have the capacity to collect data and present that data to the community for analysis for improved understanding of outcomes.”

Dr. Kolb and his colleagues are already working with researchers in Europe and Japan to make this a global effort and create an international data commons. In addition, the researchers are planning to collaborate with the pharmaceutical industry to unite efforts in pediatric AML drug development.

“We can’t just test drugs in kids because they worked in adults,” Dr. Kolb said. “We really need to maintain the integrity of the science and ask relevant questions in children but do so with the intent to make sure these drugs are licensed for use in kids.”

Dr. Kolb reported having no conflicts of interest. The PedAL trial is sponsored by the Leukemia & Lymphoma Society.

[email protected]

NEW ORLEANS – Researchers are organizing a master trial in an attempt to improve the treatment of pediatric acute myeloid leukemia (AML).

The Pediatric Acute Leukemia (PedAL) trial is an effort to collect data on all pediatric AML patients. The plan is to use these data to match patients to clinical trials, better understand pediatric AML, and bring new treatments to this population.

E. Anders Kolb, MD, of Nemours Center for Cancer and Blood Disorders in Wilmington, Del., described the initiative at the annual meeting of the American Society of Pediatric Hematology/Oncology.

Dr. Kolb noted that several drugs have been approved to treat adult AML in the last 2 years, but most of them are not approved for use in children.

“What we see in childhood AML is a lot different than what we see in adult AML, and this challenges the paradigm that we have traditionally followed where we use the adult as the 'preclinical model' for pediatric AML,” he said. “I think we are learning more and more that children have a unique disease, unique targets, and need unique therapies.”

The PedAL initiative is an attempt to address these unique needs. PedAL is part of the Leukemia & Lymphoma Society’s Children’s Initiative, and it involves researchers from academic centers and the Children’s Oncology Group.

The PedAL initiative includes preclinical, biomarker, and informatics research, as well as the master clinical trial. The main goal of the master trial is to collect genomic, proteomic, metabolomic, flow cytometry, and clinical data from all children with AML and use these data to match patients to clinical trials.

The PedAL trial will leverage Project:EveryChild, an effort by the Children’s Oncology Group to study every child with cancer. Each child enrolled in this program has an identification number that follows the child through all clinical interventions.

The goal is that Project:EveryChild will capture all pediatric AML patients at the time of diagnosis, although patients can join the project at any time. Then, sequencing, clinical, and other data will be collected from these patients and stored in a data commons.

If patients relapse after standard or other therapies, the GEARBOX algorithm (genomic eligibility algorithm at relapse for better outcomes) can be used to match the patient’s information to clinical trial eligibility criteria and provide a list of appropriate trials.

Dr. Kolb said this process should reduce logistical barriers and get relapsed patients to trials more quickly. Additionally, the data collected through PedAL should help researchers design better trials for pediatric patients with relapsed AML.

“Ultimately, we’ll create the largest data set that will give us a better understanding of all the risks and benefits associated with postrelapse AML,” Dr. Kolb said. “No matter what happens to the patient, no matter where that patient enrolls, we’re going to have the capacity to collect data and present that data to the community for analysis for improved understanding of outcomes.”

Dr. Kolb and his colleagues are already working with researchers in Europe and Japan to make this a global effort and create an international data commons. In addition, the researchers are planning to collaborate with the pharmaceutical industry to unite efforts in pediatric AML drug development.

“We can’t just test drugs in kids because they worked in adults,” Dr. Kolb said. “We really need to maintain the integrity of the science and ask relevant questions in children but do so with the intent to make sure these drugs are licensed for use in kids.”

Dr. Kolb reported having no conflicts of interest. The PedAL trial is sponsored by the Leukemia & Lymphoma Society.

[email protected]

NEW ORLEANS – Researchers are organizing a master trial in an attempt to improve the treatment of pediatric acute myeloid leukemia (AML).

The Pediatric Acute Leukemia (PedAL) trial is an effort to collect data on all pediatric AML patients. The plan is to use these data to match patients to clinical trials, better understand pediatric AML, and bring new treatments to this population.

E. Anders Kolb, MD, of Nemours Center for Cancer and Blood Disorders in Wilmington, Del., described the initiative at the annual meeting of the American Society of Pediatric Hematology/Oncology.

Dr. Kolb noted that several drugs have been approved to treat adult AML in the last 2 years, but most of them are not approved for use in children.

“What we see in childhood AML is a lot different than what we see in adult AML, and this challenges the paradigm that we have traditionally followed where we use the adult as the 'preclinical model' for pediatric AML,” he said. “I think we are learning more and more that children have a unique disease, unique targets, and need unique therapies.”

The PedAL initiative is an attempt to address these unique needs. PedAL is part of the Leukemia & Lymphoma Society’s Children’s Initiative, and it involves researchers from academic centers and the Children’s Oncology Group.

The PedAL initiative includes preclinical, biomarker, and informatics research, as well as the master clinical trial. The main goal of the master trial is to collect genomic, proteomic, metabolomic, flow cytometry, and clinical data from all children with AML and use these data to match patients to clinical trials.

The PedAL trial will leverage Project:EveryChild, an effort by the Children’s Oncology Group to study every child with cancer. Each child enrolled in this program has an identification number that follows the child through all clinical interventions.

The goal is that Project:EveryChild will capture all pediatric AML patients at the time of diagnosis, although patients can join the project at any time. Then, sequencing, clinical, and other data will be collected from these patients and stored in a data commons.

If patients relapse after standard or other therapies, the GEARBOX algorithm (genomic eligibility algorithm at relapse for better outcomes) can be used to match the patient’s information to clinical trial eligibility criteria and provide a list of appropriate trials.

Dr. Kolb said this process should reduce logistical barriers and get relapsed patients to trials more quickly. Additionally, the data collected through PedAL should help researchers design better trials for pediatric patients with relapsed AML.

“Ultimately, we’ll create the largest data set that will give us a better understanding of all the risks and benefits associated with postrelapse AML,” Dr. Kolb said. “No matter what happens to the patient, no matter where that patient enrolls, we’re going to have the capacity to collect data and present that data to the community for analysis for improved understanding of outcomes.”

Dr. Kolb and his colleagues are already working with researchers in Europe and Japan to make this a global effort and create an international data commons. In addition, the researchers are planning to collaborate with the pharmaceutical industry to unite efforts in pediatric AML drug development.

“We can’t just test drugs in kids because they worked in adults,” Dr. Kolb said. “We really need to maintain the integrity of the science and ask relevant questions in children but do so with the intent to make sure these drugs are licensed for use in kids.”

Dr. Kolb reported having no conflicts of interest. The PedAL trial is sponsored by the Leukemia & Lymphoma Society.

[email protected]

BALTIMORE – Over the past 2 years, Northwell Health, a large medical system in the metropolitan New York area, increased cytomegalovirus screening for infants who fail hearing tests from 6.6% to 95% at five of its birth hospitals, according to a presentation at the Pediatric Academic Societies annual meeting.

Three cases of congenital cytomegalovirus (CMV) have been picked up so far. The plan is to roll the program out to all 10 of the system’s birth hospitals, where over 40,000 children are born each year.

“We feel very satisfied and proud” of the progress that’s been made at Northwell in such a short time, said Alia Chauhan, MD, a Northwell pediatrician who presented the findings.

Northwell launched its “Hearing Plus” program in 2017 to catch the infection before infants leave the hospital. Several other health systems around the country have launched similar programs, and a handful of states – including New York – now require CMV screening for infants who fail mandated hearing tests.

The issue is gaining traction because hearing loss is often the only sign of congenital CMV, so it’s a bellwether for infection. Screening children with hearing loss is an easy way to pick it up early, so steps can be taken to prevent problems down the road. As it is, congenital CMV is the leading nongenetic cause of hearing loss in infants, accounting for at least 10% of cases.

The Northwell program kicked off with an education campaign to build consensus among pediatricians, hospitalists, and nurses. A flyer was made about CMV screening for moms whose infants fail hearing tests, printed in both English and Spanish.

Initially, the program used urine PCR [polymerase chain reaction] to screen for CMV, but waiting for infants to produce a sample often delayed discharge, so a switch was soon made to saliva swab PCRs, which take seconds, with urine PCR held in reserve to confirm positive swabs.

To streamline the process, a standing order was added to the electronic records system so nurses could order saliva PCRs without having to get physician approval. “I think [that] was one of the biggest things that’s helped us,” Dr. Chauhan said.

Children who test positive must have urine confirmation within 21 days of birth; most are long gone from the hospital by then and have to be called back in. “We haven’t lost anyone to follow-up, but it can be stressful trying to get someone to come back,” she said.

Six of 449 infants have screened positive on saliva – three were false positives with negative urine screens. Of the three confirmed cases, two infants later turned out to have normal hearing on repeat testing and were otherwise asymptomatic.

These days, Dr. Chauhan said, if children have a positive saliva PCR but later turn out to have normal hearing, and are otherwise free of symptoms with no CMV risk factors, “we are not confirming with urine.”

Dr. Chauhan did not have any disclosures. No funding source was mentioned.

[email protected]

SOURCE: Chauhan A et al. PAS 2019. Abstract 306

BALTIMORE – Over the past 2 years, Northwell Health, a large medical system in the metropolitan New York area, increased cytomegalovirus screening for infants who fail hearing tests from 6.6% to 95% at five of its birth hospitals, according to a presentation at the Pediatric Academic Societies annual meeting.

Three cases of congenital cytomegalovirus (CMV) have been picked up so far. The plan is to roll the program out to all 10 of the system’s birth hospitals, where over 40,000 children are born each year.

“We feel very satisfied and proud” of the progress that’s been made at Northwell in such a short time, said Alia Chauhan, MD, a Northwell pediatrician who presented the findings.

Northwell launched its “Hearing Plus” program in 2017 to catch the infection before infants leave the hospital. Several other health systems around the country have launched similar programs, and a handful of states – including New York – now require CMV screening for infants who fail mandated hearing tests.

The issue is gaining traction because hearing loss is often the only sign of congenital CMV, so it’s a bellwether for infection. Screening children with hearing loss is an easy way to pick it up early, so steps can be taken to prevent problems down the road. As it is, congenital CMV is the leading nongenetic cause of hearing loss in infants, accounting for at least 10% of cases.

The Northwell program kicked off with an education campaign to build consensus among pediatricians, hospitalists, and nurses. A flyer was made about CMV screening for moms whose infants fail hearing tests, printed in both English and Spanish.

Initially, the program used urine PCR [polymerase chain reaction] to screen for CMV, but waiting for infants to produce a sample often delayed discharge, so a switch was soon made to saliva swab PCRs, which take seconds, with urine PCR held in reserve to confirm positive swabs.

To streamline the process, a standing order was added to the electronic records system so nurses could order saliva PCRs without having to get physician approval. “I think [that] was one of the biggest things that’s helped us,” Dr. Chauhan said.

Children who test positive must have urine confirmation within 21 days of birth; most are long gone from the hospital by then and have to be called back in. “We haven’t lost anyone to follow-up, but it can be stressful trying to get someone to come back,” she said.

Six of 449 infants have screened positive on saliva – three were false positives with negative urine screens. Of the three confirmed cases, two infants later turned out to have normal hearing on repeat testing and were otherwise asymptomatic.

These days, Dr. Chauhan said, if children have a positive saliva PCR but later turn out to have normal hearing, and are otherwise free of symptoms with no CMV risk factors, “we are not confirming with urine.”

Dr. Chauhan did not have any disclosures. No funding source was mentioned.

[email protected]

SOURCE: Chauhan A et al. PAS 2019. Abstract 306

BALTIMORE – Over the past 2 years, Northwell Health, a large medical system in the metropolitan New York area, increased cytomegalovirus screening for infants who fail hearing tests from 6.6% to 95% at five of its birth hospitals, according to a presentation at the Pediatric Academic Societies annual meeting.

Three cases of congenital cytomegalovirus (CMV) have been picked up so far. The plan is to roll the program out to all 10 of the system’s birth hospitals, where over 40,000 children are born each year.

“We feel very satisfied and proud” of the progress that’s been made at Northwell in such a short time, said Alia Chauhan, MD, a Northwell pediatrician who presented the findings.

Northwell launched its “Hearing Plus” program in 2017 to catch the infection before infants leave the hospital. Several other health systems around the country have launched similar programs, and a handful of states – including New York – now require CMV screening for infants who fail mandated hearing tests.

The issue is gaining traction because hearing loss is often the only sign of congenital CMV, so it’s a bellwether for infection. Screening children with hearing loss is an easy way to pick it up early, so steps can be taken to prevent problems down the road. As it is, congenital CMV is the leading nongenetic cause of hearing loss in infants, accounting for at least 10% of cases.

The Northwell program kicked off with an education campaign to build consensus among pediatricians, hospitalists, and nurses. A flyer was made about CMV screening for moms whose infants fail hearing tests, printed in both English and Spanish.

Initially, the program used urine PCR [polymerase chain reaction] to screen for CMV, but waiting for infants to produce a sample often delayed discharge, so a switch was soon made to saliva swab PCRs, which take seconds, with urine PCR held in reserve to confirm positive swabs.

To streamline the process, a standing order was added to the electronic records system so nurses could order saliva PCRs without having to get physician approval. “I think [that] was one of the biggest things that’s helped us,” Dr. Chauhan said.

Children who test positive must have urine confirmation within 21 days of birth; most are long gone from the hospital by then and have to be called back in. “We haven’t lost anyone to follow-up, but it can be stressful trying to get someone to come back,” she said.

Six of 449 infants have screened positive on saliva – three were false positives with negative urine screens. Of the three confirmed cases, two infants later turned out to have normal hearing on repeat testing and were otherwise asymptomatic.

These days, Dr. Chauhan said, if children have a positive saliva PCR but later turn out to have normal hearing, and are otherwise free of symptoms with no CMV risk factors, “we are not confirming with urine.”

Dr. Chauhan did not have any disclosures. No funding source was mentioned.

[email protected]

SOURCE: Chauhan A et al. PAS 2019. Abstract 306

PHILADELPHIA – The benefit of deutetrabenazine treatment of tardive dyskinesia is maintained over the long term and may increase over time, according to results of an open-label extension study reported at the annual meeting of the American Academy of Neurology.

The mean Abnormal Involuntary Movement Scale (AIMS) score in the study continued to increase over 3 years of treatment with this VMAT2 inhibitor, which was safe and well tolerated over the course of the study, said investigator Robert A. Hauser, MD, MBA, director of the Parkinson’s and Movement Disorder Center and professor in the department of neurology at the University of South Florida in Tampa.

The apparent improvement over time was “fascinating” to observe, Dr. Hauser said. The finding deserves further study to identify potential confounders, such as rater bias over time or placebo effects, and if those “trivial” causes can be ruled out to determine a potential mechanism of action.

“I will also say that the mechanism may not be that important if we can really show this important clinical effect,” he said. “So I think this needs more work.”

The FDA approved deutetrabenazine (Austedo, Teva) for tardive dyskinesia treatment based on ARM-TD and AIM-TD, two randomized, double-blind, placebo-controlled trials. Those studies demonstrated improvements in AIMS scores for the VMAT2 inhibitor versus placebo, with low rates of adverse events and discontinuations, Dr. Hauser said.

Dr. Hauser presented results up to week 145 from C-20, an ongoing, 3-year, open-label extension study designed to evaluate the agent’s long-term safety and efficacy.

A total of 343 patients from ARM-TD and AIM-TD rolled over directly into C-20, started at 12 mg/day of deutetrabenazine, and titrated until adequate tardive dyskinesia control was achieved, up to 48 mg/day. Sixty percent of the patients had psychotic disorders as the background comorbid illness, while 40% had mood disorders, according to the interim report.

The mean AIMS score was 10.9 at baseline, 6.0 at 54 weeks, 5.8 at 106 weeks, and 4.1 at 145 weeks, the report showed. The corresponding change in AIMS score decreased from baseline for patients who remained in the study, from –4.8 at 54 weeks to –5.6 at 106 weeks and –7.0 at 145 weeks.*

A subsequent completer analysis showed that the apparent improvement in efficacy over the long term was not due to poor responders dropping out over time, Dr. Hauser said.

“I think the data clearly show the benefit is maintained, and intriguingly, I think they suggest that there may be increasing benefit over time,” he added.

The treatment was safe and well tolerated in long-term use. The most common adverse events were anxiety, somnolence, fatigue, insomnia, and headache. Adverse events did not increase in frequency from the parent studies to the open-label study, he noted.

The study was sponsored by Teva Pharmaceuticals. Dr. Hauser reported disclosures related to Teva, AbbVie, AstraZeneca, Biotie Thrapies, Cynapsus Therapeutics, Neurocrine Biosciences, Sunovion Pharmaceuticals, and Pfizer, among others.

SOURCE: Hauser RA et al. AAN 2019. Abstract S4.009.

*Correction, 6/26/19 An earlier version of this article mischaracterized changes in the mean Abnormal Involuntary Movement Scale scores during treatment.  

PHILADELPHIA – The benefit of deutetrabenazine treatment of tardive dyskinesia is maintained over the long term and may increase over time, according to results of an open-label extension study reported at the annual meeting of the American Academy of Neurology.

The mean Abnormal Involuntary Movement Scale (AIMS) score in the study continued to increase over 3 years of treatment with this VMAT2 inhibitor, which was safe and well tolerated over the course of the study, said investigator Robert A. Hauser, MD, MBA, director of the Parkinson’s and Movement Disorder Center and professor in the department of neurology at the University of South Florida in Tampa.

The apparent improvement over time was “fascinating” to observe, Dr. Hauser said. The finding deserves further study to identify potential confounders, such as rater bias over time or placebo effects, and if those “trivial” causes can be ruled out to determine a potential mechanism of action.

“I will also say that the mechanism may not be that important if we can really show this important clinical effect,” he said. “So I think this needs more work.”

The FDA approved deutetrabenazine (Austedo, Teva) for tardive dyskinesia treatment based on ARM-TD and AIM-TD, two randomized, double-blind, placebo-controlled trials. Those studies demonstrated improvements in AIMS scores for the VMAT2 inhibitor versus placebo, with low rates of adverse events and discontinuations, Dr. Hauser said.

Dr. Hauser presented results up to week 145 from C-20, an ongoing, 3-year, open-label extension study designed to evaluate the agent’s long-term safety and efficacy.

A total of 343 patients from ARM-TD and AIM-TD rolled over directly into C-20, started at 12 mg/day of deutetrabenazine, and titrated until adequate tardive dyskinesia control was achieved, up to 48 mg/day. Sixty percent of the patients had psychotic disorders as the background comorbid illness, while 40% had mood disorders, according to the interim report.

The mean AIMS score was 10.9 at baseline, 6.0 at 54 weeks, 5.8 at 106 weeks, and 4.1 at 145 weeks, the report showed. The corresponding change in AIMS score decreased from baseline for patients who remained in the study, from –4.8 at 54 weeks to –5.6 at 106 weeks and –7.0 at 145 weeks.*

A subsequent completer analysis showed that the apparent improvement in efficacy over the long term was not due to poor responders dropping out over time, Dr. Hauser said.

“I think the data clearly show the benefit is maintained, and intriguingly, I think they suggest that there may be increasing benefit over time,” he added.

The treatment was safe and well tolerated in long-term use. The most common adverse events were anxiety, somnolence, fatigue, insomnia, and headache. Adverse events did not increase in frequency from the parent studies to the open-label study, he noted.

The study was sponsored by Teva Pharmaceuticals. Dr. Hauser reported disclosures related to Teva, AbbVie, AstraZeneca, Biotie Thrapies, Cynapsus Therapeutics, Neurocrine Biosciences, Sunovion Pharmaceuticals, and Pfizer, among others.

SOURCE: Hauser RA et al. AAN 2019. Abstract S4.009.

*Correction, 6/26/19 An earlier version of this article mischaracterized changes in the mean Abnormal Involuntary Movement Scale scores during treatment.  

PHILADELPHIA – The benefit of deutetrabenazine treatment of tardive dyskinesia is maintained over the long term and may increase over time, according to results of an open-label extension study reported at the annual meeting of the American Academy of Neurology.

The mean Abnormal Involuntary Movement Scale (AIMS) score in the study continued to increase over 3 years of treatment with this VMAT2 inhibitor, which was safe and well tolerated over the course of the study, said investigator Robert A. Hauser, MD, MBA, director of the Parkinson’s and Movement Disorder Center and professor in the department of neurology at the University of South Florida in Tampa.

The apparent improvement over time was “fascinating” to observe, Dr. Hauser said. The finding deserves further study to identify potential confounders, such as rater bias over time or placebo effects, and if those “trivial” causes can be ruled out to determine a potential mechanism of action.

“I will also say that the mechanism may not be that important if we can really show this important clinical effect,” he said. “So I think this needs more work.”

The FDA approved deutetrabenazine (Austedo, Teva) for tardive dyskinesia treatment based on ARM-TD and AIM-TD, two randomized, double-blind, placebo-controlled trials. Those studies demonstrated improvements in AIMS scores for the VMAT2 inhibitor versus placebo, with low rates of adverse events and discontinuations, Dr. Hauser said.

Dr. Hauser presented results up to week 145 from C-20, an ongoing, 3-year, open-label extension study designed to evaluate the agent’s long-term safety and efficacy.

A total of 343 patients from ARM-TD and AIM-TD rolled over directly into C-20, started at 12 mg/day of deutetrabenazine, and titrated until adequate tardive dyskinesia control was achieved, up to 48 mg/day. Sixty percent of the patients had psychotic disorders as the background comorbid illness, while 40% had mood disorders, according to the interim report.

The mean AIMS score was 10.9 at baseline, 6.0 at 54 weeks, 5.8 at 106 weeks, and 4.1 at 145 weeks, the report showed. The corresponding change in AIMS score decreased from baseline for patients who remained in the study, from –4.8 at 54 weeks to –5.6 at 106 weeks and –7.0 at 145 weeks.*

A subsequent completer analysis showed that the apparent improvement in efficacy over the long term was not due to poor responders dropping out over time, Dr. Hauser said.

“I think the data clearly show the benefit is maintained, and intriguingly, I think they suggest that there may be increasing benefit over time,” he added.

The treatment was safe and well tolerated in long-term use. The most common adverse events were anxiety, somnolence, fatigue, insomnia, and headache. Adverse events did not increase in frequency from the parent studies to the open-label study, he noted.

The study was sponsored by Teva Pharmaceuticals. Dr. Hauser reported disclosures related to Teva, AbbVie, AstraZeneca, Biotie Thrapies, Cynapsus Therapeutics, Neurocrine Biosciences, Sunovion Pharmaceuticals, and Pfizer, among others.

SOURCE: Hauser RA et al. AAN 2019. Abstract S4.009.

*Correction, 6/26/19 An earlier version of this article mischaracterized changes in the mean Abnormal Involuntary Movement Scale scores during treatment.  

NEW ORLEANS – People diagnosed with atrial fibrillation by screening with a wearable ECG patch had significantly fewer emergency department visits or hospital admissions, compared with similar people diagnosed with atrial fibrillation by usual-care surveillance in an observational study with 5,109 total participants.

People diagnosed with atrial fibrillation (AFib) through screening had a statistically significant 80% relative cut in hospitalizations and a 65% cut in emergency department visits during 12 months of follow-up, compared with controls in the study who had their AFib identified and diagnosed as part of routine practice, Steven R. Steinhubl, MD, said at the annual meeting of the American College of Cardiology.

Mitchel L. Zoler/MDedge News

The data also showed no difference between the screened and control patients identified with AFib in the average number of cardiologist consultations during a year of follow-up, and a trend that missed statistical significance for 16% fewer primary care physician visits in Afib patients diagnosed by screening rather than by routine surveillance.

These findings provided some insight into the potential clinical impact of AFib screening in at-risk people. Dr. Steinhubl and his associates plan to report on the incidence of strokes and MIs in the two study subgroups after 3 years of follow-up, but he noted that preliminary findings for these two outcomes after 1 year indicated that active screening for AFib also had reduced these rates, compared with waiting for the arrhythmia to become apparent by emergence of symptoms.

The data came from the mSToPS (mHealth Screening to Prevent Strokes) study, which randomized 2,659 U.S. residents enrolled in a large health plan who had risk factors for AFib to either immediate or delayed arrhythmia assessment by ECG patches. Half the participants used a patch for about 14 days immediately and then a second time 3 months later, while the other half waited 4 months and then wore an ECG patch for 2 weeks and again 3 months later. The primary endpoint, first reported at the ACC annual meeting a year before and subsequently published, was the incidence of newly diagnosed AFib during the first 4 months in the actively monitored cohort, compared with a cohort followed by usual care. The results showed that screening identified AFib in 3.9% of people, while no screening and usual-practice follow-up identified a 0.9% incidence of AFib, showing that screening worked better for AFib case identification (JAMA. 2018 Jul 10;320[2]:146-55).

To examine the clinical impact of screening and an increased incidence of diagnosed AFib cases, Dr. Steinhubl and his associates focused on 1,725 of the original 2,659 patients who underwent ECG patch assessment, either immediate or delayed, and continued through 12 months of follow-up, and compared them with 3,384 matched controls who never underwent ECG patch screening but were also followed for 12 months for incident AFib identified during routine care and surveillance. This resulted in a cumulative incidence of newly diagnosed AFib of 6.3% in those who had worn two ECG patches and 2.3% among the matched controls.

During follow-up, use of various interventions was more common among the screened people than the controls. Initiation of anticoagulation treatment started in 4.0% of the entire screened group, compared with 1.9% of the controls, The screened people also had a 0.9% rate of receiving a pacemaker or defibrillator, a 0.8% rate of starting on treatment with an antiarrhythmic drug, and a 0.3% rate of undergoing catheter ablation, compared with none, 0.3%, and one of the controls, respectively, said Dr. Steinhubl, director of digital medicine at the Scripps Research Translational Institute in La Jolla, Calif.

The mSToPS study was funded by Janssen. Dr. Steinhubl has received research funding from DynoSense, EasyG, Janssen, the Qualcomm Foundation, and Striv.

[email protected]

SOURCE: Steinhubl SR et al. J Am Coll Cardiol. 2019 Mar 12;73(9)suppl 1:296.

NEW ORLEANS – People diagnosed with atrial fibrillation by screening with a wearable ECG patch had significantly fewer emergency department visits or hospital admissions, compared with similar people diagnosed with atrial fibrillation by usual-care surveillance in an observational study with 5,109 total participants.

People diagnosed with atrial fibrillation (AFib) through screening had a statistically significant 80% relative cut in hospitalizations and a 65% cut in emergency department visits during 12 months of follow-up, compared with controls in the study who had their AFib identified and diagnosed as part of routine practice, Steven R. Steinhubl, MD, said at the annual meeting of the American College of Cardiology.

Mitchel L. Zoler/MDedge News

The data also showed no difference between the screened and control patients identified with AFib in the average number of cardiologist consultations during a year of follow-up, and a trend that missed statistical significance for 16% fewer primary care physician visits in Afib patients diagnosed by screening rather than by routine surveillance.

These findings provided some insight into the potential clinical impact of AFib screening in at-risk people. Dr. Steinhubl and his associates plan to report on the incidence of strokes and MIs in the two study subgroups after 3 years of follow-up, but he noted that preliminary findings for these two outcomes after 1 year indicated that active screening for AFib also had reduced these rates, compared with waiting for the arrhythmia to become apparent by emergence of symptoms.

The data came from the mSToPS (mHealth Screening to Prevent Strokes) study, which randomized 2,659 U.S. residents enrolled in a large health plan who had risk factors for AFib to either immediate or delayed arrhythmia assessment by ECG patches. Half the participants used a patch for about 14 days immediately and then a second time 3 months later, while the other half waited 4 months and then wore an ECG patch for 2 weeks and again 3 months later. The primary endpoint, first reported at the ACC annual meeting a year before and subsequently published, was the incidence of newly diagnosed AFib during the first 4 months in the actively monitored cohort, compared with a cohort followed by usual care. The results showed that screening identified AFib in 3.9% of people, while no screening and usual-practice follow-up identified a 0.9% incidence of AFib, showing that screening worked better for AFib case identification (JAMA. 2018 Jul 10;320[2]:146-55).

To examine the clinical impact of screening and an increased incidence of diagnosed AFib cases, Dr. Steinhubl and his associates focused on 1,725 of the original 2,659 patients who underwent ECG patch assessment, either immediate or delayed, and continued through 12 months of follow-up, and compared them with 3,384 matched controls who never underwent ECG patch screening but were also followed for 12 months for incident AFib identified during routine care and surveillance. This resulted in a cumulative incidence of newly diagnosed AFib of 6.3% in those who had worn two ECG patches and 2.3% among the matched controls.

During follow-up, use of various interventions was more common among the screened people than the controls. Initiation of anticoagulation treatment started in 4.0% of the entire screened group, compared with 1.9% of the controls, The screened people also had a 0.9% rate of receiving a pacemaker or defibrillator, a 0.8% rate of starting on treatment with an antiarrhythmic drug, and a 0.3% rate of undergoing catheter ablation, compared with none, 0.3%, and one of the controls, respectively, said Dr. Steinhubl, director of digital medicine at the Scripps Research Translational Institute in La Jolla, Calif.

The mSToPS study was funded by Janssen. Dr. Steinhubl has received research funding from DynoSense, EasyG, Janssen, the Qualcomm Foundation, and Striv.

[email protected]

SOURCE: Steinhubl SR et al. J Am Coll Cardiol. 2019 Mar 12;73(9)suppl 1:296.

NEW ORLEANS – People diagnosed with atrial fibrillation by screening with a wearable ECG patch had significantly fewer emergency department visits or hospital admissions, compared with similar people diagnosed with atrial fibrillation by usual-care surveillance in an observational study with 5,109 total participants.

People diagnosed with atrial fibrillation (AFib) through screening had a statistically significant 80% relative cut in hospitalizations and a 65% cut in emergency department visits during 12 months of follow-up, compared with controls in the study who had their AFib identified and diagnosed as part of routine practice, Steven R. Steinhubl, MD, said at the annual meeting of the American College of Cardiology.

Mitchel L. Zoler/MDedge News

The data also showed no difference between the screened and control patients identified with AFib in the average number of cardiologist consultations during a year of follow-up, and a trend that missed statistical significance for 16% fewer primary care physician visits in Afib patients diagnosed by screening rather than by routine surveillance.

These findings provided some insight into the potential clinical impact of AFib screening in at-risk people. Dr. Steinhubl and his associates plan to report on the incidence of strokes and MIs in the two study subgroups after 3 years of follow-up, but he noted that preliminary findings for these two outcomes after 1 year indicated that active screening for AFib also had reduced these rates, compared with waiting for the arrhythmia to become apparent by emergence of symptoms.

The data came from the mSToPS (mHealth Screening to Prevent Strokes) study, which randomized 2,659 U.S. residents enrolled in a large health plan who had risk factors for AFib to either immediate or delayed arrhythmia assessment by ECG patches. Half the participants used a patch for about 14 days immediately and then a second time 3 months later, while the other half waited 4 months and then wore an ECG patch for 2 weeks and again 3 months later. The primary endpoint, first reported at the ACC annual meeting a year before and subsequently published, was the incidence of newly diagnosed AFib during the first 4 months in the actively monitored cohort, compared with a cohort followed by usual care. The results showed that screening identified AFib in 3.9% of people, while no screening and usual-practice follow-up identified a 0.9% incidence of AFib, showing that screening worked better for AFib case identification (JAMA. 2018 Jul 10;320[2]:146-55).

To examine the clinical impact of screening and an increased incidence of diagnosed AFib cases, Dr. Steinhubl and his associates focused on 1,725 of the original 2,659 patients who underwent ECG patch assessment, either immediate or delayed, and continued through 12 months of follow-up, and compared them with 3,384 matched controls who never underwent ECG patch screening but were also followed for 12 months for incident AFib identified during routine care and surveillance. This resulted in a cumulative incidence of newly diagnosed AFib of 6.3% in those who had worn two ECG patches and 2.3% among the matched controls.

During follow-up, use of various interventions was more common among the screened people than the controls. Initiation of anticoagulation treatment started in 4.0% of the entire screened group, compared with 1.9% of the controls, The screened people also had a 0.9% rate of receiving a pacemaker or defibrillator, a 0.8% rate of starting on treatment with an antiarrhythmic drug, and a 0.3% rate of undergoing catheter ablation, compared with none, 0.3%, and one of the controls, respectively, said Dr. Steinhubl, director of digital medicine at the Scripps Research Translational Institute in La Jolla, Calif.

The mSToPS study was funded by Janssen. Dr. Steinhubl has received research funding from DynoSense, EasyG, Janssen, the Qualcomm Foundation, and Striv.

[email protected]

SOURCE: Steinhubl SR et al. J Am Coll Cardiol. 2019 Mar 12;73(9)suppl 1:296.

NEW ORLEANS – A next-generation sequencing (NGS) test for pathogen detection demonstrated higher sensitivity than conventional testing methods in a cohort of diverse pediatric patients, according to researchers.

The NGS test, which detects sequences of circulating cell-free DNA in plasma, detected pathogens with 92% sensitivity, compared with 64% sensitivity for all conventional testing methods combined (P less than .01).

Jennifer Smith/MDedge News

Results

Of the 100 NGS tests evaluated, 70 were positive for any organism, and 56 of these were deemed clinically relevant.

“What I think is quite remarkable is that, of those clinically relevant organisms, tests on 14, which is 25% of those, were able to identify clinically relevant or pathogenic organisms when no other conventional testing modality was able to identify them,” Dr. Rossoff said. “And these were often in patients who underwent invasive procedures to try to get at the source of their infectious disease.”

In fact, the study included 42 patients who underwent 54 invasive diagnostic procedures, and 32 of those procedures could have been avoided based on positive NGS results, according to Dr. Rossoff and her colleagues.

Dr. Rossoff noted that the most common sites of infection were the bloodstream and respiratory tract, but the NGS test was able to identify pathogens in the bone, skin, cerebrospinal fluid, and urinary tract. She also pointed out that NGS results were available “in a fairly timely manner,” as 86% of test results were available within 48 hours of sample receipt.

Dr. Rossoff and her colleagues did not receive any funding for this study, but they were previously involved in a study funded by Karius, the company that commercialized the NGS test.

[email protected]

SOURCE: Rossoff J et al. ASPHO 2019. Abstract 439.
 

NEW ORLEANS – A next-generation sequencing (NGS) test for pathogen detection demonstrated higher sensitivity than conventional testing methods in a cohort of diverse pediatric patients, according to researchers.

The NGS test, which detects sequences of circulating cell-free DNA in plasma, detected pathogens with 92% sensitivity, compared with 64% sensitivity for all conventional testing methods combined (P less than .01).

Jennifer Smith/MDedge News

Results

Of the 100 NGS tests evaluated, 70 were positive for any organism, and 56 of these were deemed clinically relevant.

“What I think is quite remarkable is that, of those clinically relevant organisms, tests on 14, which is 25% of those, were able to identify clinically relevant or pathogenic organisms when no other conventional testing modality was able to identify them,” Dr. Rossoff said. “And these were often in patients who underwent invasive procedures to try to get at the source of their infectious disease.”

In fact, the study included 42 patients who underwent 54 invasive diagnostic procedures, and 32 of those procedures could have been avoided based on positive NGS results, according to Dr. Rossoff and her colleagues.

Dr. Rossoff noted that the most common sites of infection were the bloodstream and respiratory tract, but the NGS test was able to identify pathogens in the bone, skin, cerebrospinal fluid, and urinary tract. She also pointed out that NGS results were available “in a fairly timely manner,” as 86% of test results were available within 48 hours of sample receipt.

Dr. Rossoff and her colleagues did not receive any funding for this study, but they were previously involved in a study funded by Karius, the company that commercialized the NGS test.

[email protected]

SOURCE: Rossoff J et al. ASPHO 2019. Abstract 439.
 

NEW ORLEANS – A next-generation sequencing (NGS) test for pathogen detection demonstrated higher sensitivity than conventional testing methods in a cohort of diverse pediatric patients, according to researchers.

The NGS test, which detects sequences of circulating cell-free DNA in plasma, detected pathogens with 92% sensitivity, compared with 64% sensitivity for all conventional testing methods combined (P less than .01).

Jennifer Smith/MDedge News

Results

Of the 100 NGS tests evaluated, 70 were positive for any organism, and 56 of these were deemed clinically relevant.

“What I think is quite remarkable is that, of those clinically relevant organisms, tests on 14, which is 25% of those, were able to identify clinically relevant or pathogenic organisms when no other conventional testing modality was able to identify them,” Dr. Rossoff said. “And these were often in patients who underwent invasive procedures to try to get at the source of their infectious disease.”

In fact, the study included 42 patients who underwent 54 invasive diagnostic procedures, and 32 of those procedures could have been avoided based on positive NGS results, according to Dr. Rossoff and her colleagues.

Dr. Rossoff noted that the most common sites of infection were the bloodstream and respiratory tract, but the NGS test was able to identify pathogens in the bone, skin, cerebrospinal fluid, and urinary tract. She also pointed out that NGS results were available “in a fairly timely manner,” as 86% of test results were available within 48 hours of sample receipt.

Dr. Rossoff and her colleagues did not receive any funding for this study, but they were previously involved in a study funded by Karius, the company that commercialized the NGS test.

[email protected]

SOURCE: Rossoff J et al. ASPHO 2019. Abstract 439.
 

LOS ANGELES – The 69-year-old woman with a history of type 2 diabetes had persistent hypoglycemia despite treatment with hydrocortisone, dextrose, and glucagon. Doctors in South Carolina worried about insulinoma and planned to launch an intra-arterial calcium stimulation test. But the medical team wasn’t quite certain it had the correct diagnosis.

Then along came a suspicious nurse who uncovered the truth: The patient had used syringes and vials of insulin socked away in a cosmetics bag. The diagnosis? An unusual, but not entirely rare, case of factitious hypoglycemia. That doesn’t mean her condition was fictional. Instead, it means she created it herself.

Randy Dotinga/MDedge News

• In any case of hypoglycemia, consider the possibility that the patient has factitious hypoglycemia. In every patient, he said, do a drug screen for sulfonylureas. “Now that we have multiple classes of diabetes drugs, most of which have a risk for hypoglycemia, one has to have a lab capable of measuring all of them. And that is not easy. It’s not just ‘draw the blood and send to your corner lab.’ ”
• Patients with factitious hypoglycemia don’t tend to have predictable dips in blood sugar during fasting or after meals. Instead, their symptoms are chaotic. “It all depends on when they’re taking [insulin],” he said.
• Patients with factitious hypoglycemia don’t seem ill, but those with insulinomas do. “Patients with insulinomas are totally incapable of living normal lives. They’re incapacitated. Their lives are so disrupted that some of them need ‘babysitters’,” Dr. Service said. If they “get the tumor removed, they are cured. Then they are back to the normal life.”
• Beware that patients may not realize they’re taking a medication that causes factitious hypoglycemia. It’s common, Dr. Service said, for a patient to accidentally take his or her spouse’s medication because of a mix-up.

Ultimately, the goal is to catch factitious hypoglycemia in time. Some physicians haven’t been so fortunate. “They only get to the right answer,” he said, “after the patient has recovered from surgery.”

LOS ANGELES – The 69-year-old woman with a history of type 2 diabetes had persistent hypoglycemia despite treatment with hydrocortisone, dextrose, and glucagon. Doctors in South Carolina worried about insulinoma and planned to launch an intra-arterial calcium stimulation test. But the medical team wasn’t quite certain it had the correct diagnosis.

Then along came a suspicious nurse who uncovered the truth: The patient had used syringes and vials of insulin socked away in a cosmetics bag. The diagnosis? An unusual, but not entirely rare, case of factitious hypoglycemia. That doesn’t mean her condition was fictional. Instead, it means she created it herself.

Randy Dotinga/MDedge News

• In any case of hypoglycemia, consider the possibility that the patient has factitious hypoglycemia. In every patient, he said, do a drug screen for sulfonylureas. “Now that we have multiple classes of diabetes drugs, most of which have a risk for hypoglycemia, one has to have a lab capable of measuring all of them. And that is not easy. It’s not just ‘draw the blood and send to your corner lab.’ ”
• Patients with factitious hypoglycemia don’t tend to have predictable dips in blood sugar during fasting or after meals. Instead, their symptoms are chaotic. “It all depends on when they’re taking [insulin],” he said.
• Patients with factitious hypoglycemia don’t seem ill, but those with insulinomas do. “Patients with insulinomas are totally incapable of living normal lives. They’re incapacitated. Their lives are so disrupted that some of them need ‘babysitters’,” Dr. Service said. If they “get the tumor removed, they are cured. Then they are back to the normal life.”
• Beware that patients may not realize they’re taking a medication that causes factitious hypoglycemia. It’s common, Dr. Service said, for a patient to accidentally take his or her spouse’s medication because of a mix-up.

Ultimately, the goal is to catch factitious hypoglycemia in time. Some physicians haven’t been so fortunate. “They only get to the right answer,” he said, “after the patient has recovered from surgery.”

LOS ANGELES – The 69-year-old woman with a history of type 2 diabetes had persistent hypoglycemia despite treatment with hydrocortisone, dextrose, and glucagon. Doctors in South Carolina worried about insulinoma and planned to launch an intra-arterial calcium stimulation test. But the medical team wasn’t quite certain it had the correct diagnosis.

Then along came a suspicious nurse who uncovered the truth: The patient had used syringes and vials of insulin socked away in a cosmetics bag. The diagnosis? An unusual, but not entirely rare, case of factitious hypoglycemia. That doesn’t mean her condition was fictional. Instead, it means she created it herself.

Randy Dotinga/MDedge News

• In any case of hypoglycemia, consider the possibility that the patient has factitious hypoglycemia. In every patient, he said, do a drug screen for sulfonylureas. “Now that we have multiple classes of diabetes drugs, most of which have a risk for hypoglycemia, one has to have a lab capable of measuring all of them. And that is not easy. It’s not just ‘draw the blood and send to your corner lab.’ ”
• Patients with factitious hypoglycemia don’t tend to have predictable dips in blood sugar during fasting or after meals. Instead, their symptoms are chaotic. “It all depends on when they’re taking [insulin],” he said.
• Patients with factitious hypoglycemia don’t seem ill, but those with insulinomas do. “Patients with insulinomas are totally incapable of living normal lives. They’re incapacitated. Their lives are so disrupted that some of them need ‘babysitters’,” Dr. Service said. If they “get the tumor removed, they are cured. Then they are back to the normal life.”
• Beware that patients may not realize they’re taking a medication that causes factitious hypoglycemia. It’s common, Dr. Service said, for a patient to accidentally take his or her spouse’s medication because of a mix-up.

Ultimately, the goal is to catch factitious hypoglycemia in time. Some physicians haven’t been so fortunate. “They only get to the right answer,” he said, “after the patient has recovered from surgery.”

PHILADELPHIA – Among patients with multiple sclerosis (MS), consumption of sugar-sweetened beverages such as soda, juice, and sweetened tea and coffee may be associated with more severe disability, according to a cross-sectional study presented at the annual meeting of the American Academy of Neurology. Overall diet quality, however, is not associated with disability, the study showed.

The results do not establish that sugary drinks cause disability, and the potential association needs to be confirmed in larger, longitudinal studies, the researchers said. Nevertheless, “we do know that sodas have no nutritional value, and people with MS may want to consider reducing or eliminating them from their diet,” study lead author Elisa Meier-Gerdingh, MD, of St. Josef Hospital in Bochum, Germany, said in a written statement.

American Heart Association

Diet may influence metabolic comorbidities, immune function, oxidative stress, and gut microbiota in patients with MS, but data about diet’s effects on MS progression are limited, the researchers said.

To examine dietary intake and disability in patients with MS, Dr. Meier-Gerdingh and her colleagues conducted a cross-sectional study of 135 participants with MS who were treated at a large referral center in Germany. Participants had a mean age of 44.6 years and mean body mass index of 24.5. Mean disease duration was 13.8 years, and 73% were women. Participants completed a 102-item food frequency questionnaire, which the investigators used to calculate each participant’s Dietary Approaches to Stop Hypertension (DASH) score. The score is a composite measure of dietary quality that favorably scores intake of fruits, vegetables, nuts and legumes, whole grains, and dairy and unfavorably scores intake of sodium, sugar-sweetened beverages, and red and processed meats.

“We chose to study the DASH diet because adherence to the DASH diet is associated with lower risk of other chronic diseases like high blood pressure, diabetes, and cardiovascular diseases,” Dr. Meier-Gerdingh said.

The researchers considered severe disability to be an Expanded Disability Status Scale (EDSS) score of 6 or greater. They assessed the association between overall DASH scores and disability status using logistic regression models that adjusted for age, sex, body mass index, smoking, and symptom duration. They also assessed the association between disability and each nutritional component of the DASH score.

In all, 30 participants had severe disability. “Overall DASH scores were not associated with disability status,” Dr. Meier-Gerdingh and her colleagues said. When they looked at individual DASH score components, patients with higher intakes of sugar-sweetened beverages had a higher risk of severe disability (P for trend = .01). Participants in the highest quartile consumed about 290 calories of sugar-sweetened beverages per day on average, compared with 7 calories per day for patients in the lowest quartile. The top quartile had an average EDSS of 4.1, and the bottom quartile had an average EDSS of 3.4. Other DASH score components were not associated with disability status.

Dr. Meier-Gerdingh had no disclosures. Her coauthors reported research support and personal compensation from pharmaceutical companies.

[email protected]

SOURCE: Meier-Gerdingh E et al. AAN 2019, Abstract P4.2-063.

PHILADELPHIA – Among patients with multiple sclerosis (MS), consumption of sugar-sweetened beverages such as soda, juice, and sweetened tea and coffee may be associated with more severe disability, according to a cross-sectional study presented at the annual meeting of the American Academy of Neurology. Overall diet quality, however, is not associated with disability, the study showed.

The results do not establish that sugary drinks cause disability, and the potential association needs to be confirmed in larger, longitudinal studies, the researchers said. Nevertheless, “we do know that sodas have no nutritional value, and people with MS may want to consider reducing or eliminating them from their diet,” study lead author Elisa Meier-Gerdingh, MD, of St. Josef Hospital in Bochum, Germany, said in a written statement.

American Heart Association

Diet may influence metabolic comorbidities, immune function, oxidative stress, and gut microbiota in patients with MS, but data about diet’s effects on MS progression are limited, the researchers said.

To examine dietary intake and disability in patients with MS, Dr. Meier-Gerdingh and her colleagues conducted a cross-sectional study of 135 participants with MS who were treated at a large referral center in Germany. Participants had a mean age of 44.6 years and mean body mass index of 24.5. Mean disease duration was 13.8 years, and 73% were women. Participants completed a 102-item food frequency questionnaire, which the investigators used to calculate each participant’s Dietary Approaches to Stop Hypertension (DASH) score. The score is a composite measure of dietary quality that favorably scores intake of fruits, vegetables, nuts and legumes, whole grains, and dairy and unfavorably scores intake of sodium, sugar-sweetened beverages, and red and processed meats.

“We chose to study the DASH diet because adherence to the DASH diet is associated with lower risk of other chronic diseases like high blood pressure, diabetes, and cardiovascular diseases,” Dr. Meier-Gerdingh said.

The researchers considered severe disability to be an Expanded Disability Status Scale (EDSS) score of 6 or greater. They assessed the association between overall DASH scores and disability status using logistic regression models that adjusted for age, sex, body mass index, smoking, and symptom duration. They also assessed the association between disability and each nutritional component of the DASH score.

In all, 30 participants had severe disability. “Overall DASH scores were not associated with disability status,” Dr. Meier-Gerdingh and her colleagues said. When they looked at individual DASH score components, patients with higher intakes of sugar-sweetened beverages had a higher risk of severe disability (P for trend = .01). Participants in the highest quartile consumed about 290 calories of sugar-sweetened beverages per day on average, compared with 7 calories per day for patients in the lowest quartile. The top quartile had an average EDSS of 4.1, and the bottom quartile had an average EDSS of 3.4. Other DASH score components were not associated with disability status.

Dr. Meier-Gerdingh had no disclosures. Her coauthors reported research support and personal compensation from pharmaceutical companies.

[email protected]

SOURCE: Meier-Gerdingh E et al. AAN 2019, Abstract P4.2-063.

PHILADELPHIA – Among patients with multiple sclerosis (MS), consumption of sugar-sweetened beverages such as soda, juice, and sweetened tea and coffee may be associated with more severe disability, according to a cross-sectional study presented at the annual meeting of the American Academy of Neurology. Overall diet quality, however, is not associated with disability, the study showed.

The results do not establish that sugary drinks cause disability, and the potential association needs to be confirmed in larger, longitudinal studies, the researchers said. Nevertheless, “we do know that sodas have no nutritional value, and people with MS may want to consider reducing or eliminating them from their diet,” study lead author Elisa Meier-Gerdingh, MD, of St. Josef Hospital in Bochum, Germany, said in a written statement.

American Heart Association

Diet may influence metabolic comorbidities, immune function, oxidative stress, and gut microbiota in patients with MS, but data about diet’s effects on MS progression are limited, the researchers said.

To examine dietary intake and disability in patients with MS, Dr. Meier-Gerdingh and her colleagues conducted a cross-sectional study of 135 participants with MS who were treated at a large referral center in Germany. Participants had a mean age of 44.6 years and mean body mass index of 24.5. Mean disease duration was 13.8 years, and 73% were women. Participants completed a 102-item food frequency questionnaire, which the investigators used to calculate each participant’s Dietary Approaches to Stop Hypertension (DASH) score. The score is a composite measure of dietary quality that favorably scores intake of fruits, vegetables, nuts and legumes, whole grains, and dairy and unfavorably scores intake of sodium, sugar-sweetened beverages, and red and processed meats.

“We chose to study the DASH diet because adherence to the DASH diet is associated with lower risk of other chronic diseases like high blood pressure, diabetes, and cardiovascular diseases,” Dr. Meier-Gerdingh said.

The researchers considered severe disability to be an Expanded Disability Status Scale (EDSS) score of 6 or greater. They assessed the association between overall DASH scores and disability status using logistic regression models that adjusted for age, sex, body mass index, smoking, and symptom duration. They also assessed the association between disability and each nutritional component of the DASH score.

In all, 30 participants had severe disability. “Overall DASH scores were not associated with disability status,” Dr. Meier-Gerdingh and her colleagues said. When they looked at individual DASH score components, patients with higher intakes of sugar-sweetened beverages had a higher risk of severe disability (P for trend = .01). Participants in the highest quartile consumed about 290 calories of sugar-sweetened beverages per day on average, compared with 7 calories per day for patients in the lowest quartile. The top quartile had an average EDSS of 4.1, and the bottom quartile had an average EDSS of 3.4. Other DASH score components were not associated with disability status.

Dr. Meier-Gerdingh had no disclosures. Her coauthors reported research support and personal compensation from pharmaceutical companies.

[email protected]

SOURCE: Meier-Gerdingh E et al. AAN 2019, Abstract P4.2-063.

Preventing low oxygen, low blood pressure, and hyperventilation in people with head injury has been shown to improve survival, according to observational studies. The guidelines for prehospital management of traumatic brain injury (TBI), developed in 2000, were updated in 2007 to reflect those findings. But are they being followed? And if followed, do they help?

The Excellence in Prehospital Injury Care (EPIC) study, the first time the guidelines were assessed in real-world conditions, trained EMS responders in Arizona and compared patient outcomes before and after the guideline implementation.

The study researchers found “a therapeutic sweet spot” in that the guidelines had an “enormous impact” on people with severe TBI. Implementing the guidelines did not affect overall survival of the entire group, which included > 21,000 patients with moderate, severe, and critical injuries. But further analysis showed that they helped double the survival rate of people with severe TBI and tripled the survival rate in severe TBI patients who had to have a breathing tube inserted by EMS personnel.

Daniel Spaite, MD, who led the study, said the patients with moderate injuries would most likely have survived anyway, and those in critical condition may have had injuries too serious to overcome.

The guidelines also were associated with an overall increase in survival to hospital admission.

According to Bentley Bobrow, MD, co-principal investigator, “It was exciting to see such dramatic outcomes resulting from a simple 2-hour training session with EMS personnel.”

The study “demonstrates the significance of conducting studies in real-world settings and brings a strong evidence base to the guidelines,” said Patrick Bellgowan, PhD, program director at the National Institute of Neurological Disorders and Stroke, which supported the study. “It suggests we can systematically increase the chances of saving lives of thousands of people who suffer severe traumatic brain injuries.”

Preventing low oxygen, low blood pressure, and hyperventilation in people with head injury has been shown to improve survival, according to observational studies. The guidelines for prehospital management of traumatic brain injury (TBI), developed in 2000, were updated in 2007 to reflect those findings. But are they being followed? And if followed, do they help?

The Excellence in Prehospital Injury Care (EPIC) study, the first time the guidelines were assessed in real-world conditions, trained EMS responders in Arizona and compared patient outcomes before and after the guideline implementation.

The study researchers found “a therapeutic sweet spot” in that the guidelines had an “enormous impact” on people with severe TBI. Implementing the guidelines did not affect overall survival of the entire group, which included > 21,000 patients with moderate, severe, and critical injuries. But further analysis showed that they helped double the survival rate of people with severe TBI and tripled the survival rate in severe TBI patients who had to have a breathing tube inserted by EMS personnel.

Daniel Spaite, MD, who led the study, said the patients with moderate injuries would most likely have survived anyway, and those in critical condition may have had injuries too serious to overcome.

The guidelines also were associated with an overall increase in survival to hospital admission.

According to Bentley Bobrow, MD, co-principal investigator, “It was exciting to see such dramatic outcomes resulting from a simple 2-hour training session with EMS personnel.”

The study “demonstrates the significance of conducting studies in real-world settings and brings a strong evidence base to the guidelines,” said Patrick Bellgowan, PhD, program director at the National Institute of Neurological Disorders and Stroke, which supported the study. “It suggests we can systematically increase the chances of saving lives of thousands of people who suffer severe traumatic brain injuries.”

Preventing low oxygen, low blood pressure, and hyperventilation in people with head injury has been shown to improve survival, according to observational studies. The guidelines for prehospital management of traumatic brain injury (TBI), developed in 2000, were updated in 2007 to reflect those findings. But are they being followed? And if followed, do they help?

The Excellence in Prehospital Injury Care (EPIC) study, the first time the guidelines were assessed in real-world conditions, trained EMS responders in Arizona and compared patient outcomes before and after the guideline implementation.

The study researchers found “a therapeutic sweet spot” in that the guidelines had an “enormous impact” on people with severe TBI. Implementing the guidelines did not affect overall survival of the entire group, which included > 21,000 patients with moderate, severe, and critical injuries. But further analysis showed that they helped double the survival rate of people with severe TBI and tripled the survival rate in severe TBI patients who had to have a breathing tube inserted by EMS personnel.

Daniel Spaite, MD, who led the study, said the patients with moderate injuries would most likely have survived anyway, and those in critical condition may have had injuries too serious to overcome.

The guidelines also were associated with an overall increase in survival to hospital admission.

According to Bentley Bobrow, MD, co-principal investigator, “It was exciting to see such dramatic outcomes resulting from a simple 2-hour training session with EMS personnel.”

The study “demonstrates the significance of conducting studies in real-world settings and brings a strong evidence base to the guidelines,” said Patrick Bellgowan, PhD, program director at the National Institute of Neurological Disorders and Stroke, which supported the study. “It suggests we can systematically increase the chances of saving lives of thousands of people who suffer severe traumatic brain injuries.”

Two new guidelines from the American College of Rheumatology provide updated recommendations for patients with juvenile idiopathic arthritis and JIA-associated uveitis while attempting to address gaps in the clinical screening, monitoring, and treatment of these diseases.

The first guideline – which was published simultaneously in Arthritis Care & Research and Arthritis & Rheumatology – offered 39 recommendations for treating children and adolescents with JIA and nonsystemic polyarthritis, sacroiliitis, and enthesitis. Due to the low quality of the supporting evidence, 31 of the recommendations were labeled as conditional.

“While these recommendations are intended to address common clinical situations, all treatment decisions must be individualized, with consideration of the unique aspects of each patient’s presentation, medical history, and preferences,” wrote first author Sarah Ringold, MD, of Seattle Children’s Hospital and her coauthors.

These recommendations serve as updates to an initial set on JIA treatment in 2011 and a 2013 addition on the treatment of systemic arthritis. In addition, the ACR has since adopted the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to generate its recommendations, which was described in an interview with Dr. Ringold as providing “greater transparency around the decisions made during the recommendation development process.”

“An important difference from the 2011 guidelines is that is that initial NSAID monotherapy is no longer recommended for children with polyarthritis, given the established benefits of early initiation of DMARD [disease-modifying antirheumatic drug] therapy for these patients,” she added. “In addition, these guidelines also support inactive disease as a treatment goal for children with polyarthritis, with treatment escalation recommended for patients with low disease activity.”

As general recommendations for patients with JIA and polyarthritis, the coauthors strongly recommend using triamcinolone hexacetonide over triamcinolone acetonide for intraarticular glucocorticoid injections, along with using infliximab in combination with a DMARD. Despite the quality of the supporting evidence being very low, they also strongly recommend against adding chronic low-dose glucocorticoids to treatment because of well-known adverse effects like growth suppression, weight gain, osteopenia, and cataract.

Other strong recommendations include choosing treatment with an NSAID in children and adolescents with JIA and active sacroiliitis; adding a tumor necrosis factor inhibitor (TNFi) rather than continued NSAID monotherapy and avoiding methotrexate monotherapy in children and adolescents with active sacroiliitis despite NSAIDs; and choosing NSAID treatment in children and adolescents with JIA and active enthesitis.

Recommendations on JIA with associated uveitis

The second guideline – also published in Arthritis Care & Research and Arthritis & Rheumatology – focused on the screening, monitoring, and treatment of JIA with associated uveitis. Their 19 recommendations serve as updates to 2006 recommendations from the American Academy of Pediatrics on routine ophthalmic screening in children with arthritis and 2012 recommendations from the German Uveitis in Childhood Study Group on proposed ophthalmic screening schedules, neither of which addressed the monitoring of children with an established diagnosis of uveitis or the treatment of uveitis.

“Although the quality of evidence was very low, and most recommendations were therefore conditional, this guideline fills an important clinical gap in the care of children with JIA-associated uveitis and may be updated as better evidence becomes available,” wrote first author Sheila T. Angeles-Han, MD, of the Cincinnati Children’s Hospital Medical Center and her coauthors.

Their strong recommendations include ophthalmic monitoring at least every 3 months in children and adolescents with JIA and controlled uveitis on stable therapy; monitoring within 1 month after each change of topical glucocorticoids in patients who are tapering or discontinuing that treatment; and monitoring within 2 months of changing systemic therapy for patients who are tapering or discontinuing that treatment.

They also strongly recommend education on the warning signs of acute anterior uveitis for children and adolescents with spondyloarthritis, along with tapering topical glucocorticoids before systemic therapy in children and adolescents with JIA and chronic anterior uveitis who are still on 1-2 drops a day of glucocorticoids.

“Our biggest message is that it is critical that uveitis is controlled, since persistent active uveitis can lead to sight-threatening complications and permanent vision loss,” Dr. Angeles-Han said in an interview. “It is important that ocular inflammation is controlled early, exposure to long-term topical glucocorticoids is limited, and that systemic treatment is started promptly.

“We also emphasize that close communication and collaboration between pediatric rheumatologists and ophthalmologists is important to ensure optimal vision outcomes,” she added.

These guidelines also factored in feedback from a patient and parent panel, particularly in regard to recommendations with a low level of supporting evidence.

“This partnership highlighted the importance of incorporating parent and patient preferences into treatment decisions and the need for shared decision-making approaches,” Dr. Ringold said.

Both guidelines were supported by the American College of Rheumatology and the Arthritis Foundation. Several authors reported support from the National Institutes of Health, the Rheumatology Research Foundation, and the Fundación Bechara. Several authors also reported receiving consulting and speaking fees, along with research grants, from numerous pharmaceutical companies.

SOURCES: Ringold S et al. Arthritis Care Res. 2019 Apr 25. doi: 10.1002/acr.23870 ; Angeles-Han ST et al. Arthritis Care Res. 2019 Apr 25. doi: 10.1002/acr.23871 .

Two new guidelines from the American College of Rheumatology provide updated recommendations for patients with juvenile idiopathic arthritis and JIA-associated uveitis while attempting to address gaps in the clinical screening, monitoring, and treatment of these diseases.

The first guideline – which was published simultaneously in Arthritis Care & Research and Arthritis & Rheumatology – offered 39 recommendations for treating children and adolescents with JIA and nonsystemic polyarthritis, sacroiliitis, and enthesitis. Due to the low quality of the supporting evidence, 31 of the recommendations were labeled as conditional.

“While these recommendations are intended to address common clinical situations, all treatment decisions must be individualized, with consideration of the unique aspects of each patient’s presentation, medical history, and preferences,” wrote first author Sarah Ringold, MD, of Seattle Children’s Hospital and her coauthors.

These recommendations serve as updates to an initial set on JIA treatment in 2011 and a 2013 addition on the treatment of systemic arthritis. In addition, the ACR has since adopted the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to generate its recommendations, which was described in an interview with Dr. Ringold as providing “greater transparency around the decisions made during the recommendation development process.”

“An important difference from the 2011 guidelines is that is that initial NSAID monotherapy is no longer recommended for children with polyarthritis, given the established benefits of early initiation of DMARD [disease-modifying antirheumatic drug] therapy for these patients,” she added. “In addition, these guidelines also support inactive disease as a treatment goal for children with polyarthritis, with treatment escalation recommended for patients with low disease activity.”

As general recommendations for patients with JIA and polyarthritis, the coauthors strongly recommend using triamcinolone hexacetonide over triamcinolone acetonide for intraarticular glucocorticoid injections, along with using infliximab in combination with a DMARD. Despite the quality of the supporting evidence being very low, they also strongly recommend against adding chronic low-dose glucocorticoids to treatment because of well-known adverse effects like growth suppression, weight gain, osteopenia, and cataract.

Other strong recommendations include choosing treatment with an NSAID in children and adolescents with JIA and active sacroiliitis; adding a tumor necrosis factor inhibitor (TNFi) rather than continued NSAID monotherapy and avoiding methotrexate monotherapy in children and adolescents with active sacroiliitis despite NSAIDs; and choosing NSAID treatment in children and adolescents with JIA and active enthesitis.

Recommendations on JIA with associated uveitis

The second guideline – also published in Arthritis Care & Research and Arthritis & Rheumatology – focused on the screening, monitoring, and treatment of JIA with associated uveitis. Their 19 recommendations serve as updates to 2006 recommendations from the American Academy of Pediatrics on routine ophthalmic screening in children with arthritis and 2012 recommendations from the German Uveitis in Childhood Study Group on proposed ophthalmic screening schedules, neither of which addressed the monitoring of children with an established diagnosis of uveitis or the treatment of uveitis.

“Although the quality of evidence was very low, and most recommendations were therefore conditional, this guideline fills an important clinical gap in the care of children with JIA-associated uveitis and may be updated as better evidence becomes available,” wrote first author Sheila T. Angeles-Han, MD, of the Cincinnati Children’s Hospital Medical Center and her coauthors.

Their strong recommendations include ophthalmic monitoring at least every 3 months in children and adolescents with JIA and controlled uveitis on stable therapy; monitoring within 1 month after each change of topical glucocorticoids in patients who are tapering or discontinuing that treatment; and monitoring within 2 months of changing systemic therapy for patients who are tapering or discontinuing that treatment.

They also strongly recommend education on the warning signs of acute anterior uveitis for children and adolescents with spondyloarthritis, along with tapering topical glucocorticoids before systemic therapy in children and adolescents with JIA and chronic anterior uveitis who are still on 1-2 drops a day of glucocorticoids.

“Our biggest message is that it is critical that uveitis is controlled, since persistent active uveitis can lead to sight-threatening complications and permanent vision loss,” Dr. Angeles-Han said in an interview. “It is important that ocular inflammation is controlled early, exposure to long-term topical glucocorticoids is limited, and that systemic treatment is started promptly.

“We also emphasize that close communication and collaboration between pediatric rheumatologists and ophthalmologists is important to ensure optimal vision outcomes,” she added.

These guidelines also factored in feedback from a patient and parent panel, particularly in regard to recommendations with a low level of supporting evidence.

“This partnership highlighted the importance of incorporating parent and patient preferences into treatment decisions and the need for shared decision-making approaches,” Dr. Ringold said.

Both guidelines were supported by the American College of Rheumatology and the Arthritis Foundation. Several authors reported support from the National Institutes of Health, the Rheumatology Research Foundation, and the Fundación Bechara. Several authors also reported receiving consulting and speaking fees, along with research grants, from numerous pharmaceutical companies.

SOURCES: Ringold S et al. Arthritis Care Res. 2019 Apr 25. doi: 10.1002/acr.23870 ; Angeles-Han ST et al. Arthritis Care Res. 2019 Apr 25. doi: 10.1002/acr.23871 .

Two new guidelines from the American College of Rheumatology provide updated recommendations for patients with juvenile idiopathic arthritis and JIA-associated uveitis while attempting to address gaps in the clinical screening, monitoring, and treatment of these diseases.

The first guideline – which was published simultaneously in Arthritis Care & Research and Arthritis & Rheumatology – offered 39 recommendations for treating children and adolescents with JIA and nonsystemic polyarthritis, sacroiliitis, and enthesitis. Due to the low quality of the supporting evidence, 31 of the recommendations were labeled as conditional.

“While these recommendations are intended to address common clinical situations, all treatment decisions must be individualized, with consideration of the unique aspects of each patient’s presentation, medical history, and preferences,” wrote first author Sarah Ringold, MD, of Seattle Children’s Hospital and her coauthors.

These recommendations serve as updates to an initial set on JIA treatment in 2011 and a 2013 addition on the treatment of systemic arthritis. In addition, the ACR has since adopted the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to generate its recommendations, which was described in an interview with Dr. Ringold as providing “greater transparency around the decisions made during the recommendation development process.”

“An important difference from the 2011 guidelines is that is that initial NSAID monotherapy is no longer recommended for children with polyarthritis, given the established benefits of early initiation of DMARD [disease-modifying antirheumatic drug] therapy for these patients,” she added. “In addition, these guidelines also support inactive disease as a treatment goal for children with polyarthritis, with treatment escalation recommended for patients with low disease activity.”

As general recommendations for patients with JIA and polyarthritis, the coauthors strongly recommend using triamcinolone hexacetonide over triamcinolone acetonide for intraarticular glucocorticoid injections, along with using infliximab in combination with a DMARD. Despite the quality of the supporting evidence being very low, they also strongly recommend against adding chronic low-dose glucocorticoids to treatment because of well-known adverse effects like growth suppression, weight gain, osteopenia, and cataract.

Other strong recommendations include choosing treatment with an NSAID in children and adolescents with JIA and active sacroiliitis; adding a tumor necrosis factor inhibitor (TNFi) rather than continued NSAID monotherapy and avoiding methotrexate monotherapy in children and adolescents with active sacroiliitis despite NSAIDs; and choosing NSAID treatment in children and adolescents with JIA and active enthesitis.

Recommendations on JIA with associated uveitis

The second guideline – also published in Arthritis Care & Research and Arthritis & Rheumatology – focused on the screening, monitoring, and treatment of JIA with associated uveitis. Their 19 recommendations serve as updates to 2006 recommendations from the American Academy of Pediatrics on routine ophthalmic screening in children with arthritis and 2012 recommendations from the German Uveitis in Childhood Study Group on proposed ophthalmic screening schedules, neither of which addressed the monitoring of children with an established diagnosis of uveitis or the treatment of uveitis.

“Although the quality of evidence was very low, and most recommendations were therefore conditional, this guideline fills an important clinical gap in the care of children with JIA-associated uveitis and may be updated as better evidence becomes available,” wrote first author Sheila T. Angeles-Han, MD, of the Cincinnati Children’s Hospital Medical Center and her coauthors.

Their strong recommendations include ophthalmic monitoring at least every 3 months in children and adolescents with JIA and controlled uveitis on stable therapy; monitoring within 1 month after each change of topical glucocorticoids in patients who are tapering or discontinuing that treatment; and monitoring within 2 months of changing systemic therapy for patients who are tapering or discontinuing that treatment.

They also strongly recommend education on the warning signs of acute anterior uveitis for children and adolescents with spondyloarthritis, along with tapering topical glucocorticoids before systemic therapy in children and adolescents with JIA and chronic anterior uveitis who are still on 1-2 drops a day of glucocorticoids.

“Our biggest message is that it is critical that uveitis is controlled, since persistent active uveitis can lead to sight-threatening complications and permanent vision loss,” Dr. Angeles-Han said in an interview. “It is important that ocular inflammation is controlled early, exposure to long-term topical glucocorticoids is limited, and that systemic treatment is started promptly.

“We also emphasize that close communication and collaboration between pediatric rheumatologists and ophthalmologists is important to ensure optimal vision outcomes,” she added.

These guidelines also factored in feedback from a patient and parent panel, particularly in regard to recommendations with a low level of supporting evidence.

“This partnership highlighted the importance of incorporating parent and patient preferences into treatment decisions and the need for shared decision-making approaches,” Dr. Ringold said.

Both guidelines were supported by the American College of Rheumatology and the Arthritis Foundation. Several authors reported support from the National Institutes of Health, the Rheumatology Research Foundation, and the Fundación Bechara. Several authors also reported receiving consulting and speaking fees, along with research grants, from numerous pharmaceutical companies.

SOURCES: Ringold S et al. Arthritis Care Res. 2019 Apr 25. doi: 10.1002/acr.23870 ; Angeles-Han ST et al. Arthritis Care Res. 2019 Apr 25. doi: 10.1002/acr.23871 .

PHILADELPHIA – A prognostic score for acute ischemic stroke that incorporates copeptin levels, age, recanalization, and National Institutes of Health Stroke Scale score has been externally validated and accurately predicts unfavorable outcome, according to research presented at the annual meeting of the American Academy of Neurology.

Although the four-item score could not be validated for mortality prediction, it had reasonable accuracy for predicting unfavorable functional outcome, defined as disability or mortality 3 months after ischemic stroke, Gian Marco De Marchis, MD, of the department of neurology and the stroke center at University Hospital Basel (Switzerland), said in a presentation.

“The use of a biomarker increases prognostic accuracy, allowing us to personalize prognosis in the frame of individualized, precision medicine,” Dr. De Marchis said.

Copeptin has been linked to disability and mortality at 3 months in two independent, large cohort studies of patients with ischemic stroke, he said.

The four-item prognostic score devised by Dr. De Marchis and his coinvestigators, which they call the CoRisk score, was developed based on a derivation cohort of 319 acute ischemic stroke patients and a validation cohort including another 783 patients in the Copeptin for Risk Stratification in Acute Stroke Patients (CoRisk) Study.

Diagnostic accuracy was 82% for the endpoint of unfavorable functional outcome at 3 months, according to Dr. De Marchis.

“The observed outcomes matched well with the expected outcomes,” he said in his presentation.

Further analyses demonstrated that the addition of copeptin indeed contributed to the diagnostic accuracy of the score, improving the classification for 46%; in other words, about half of the patients were reclassified based on addition of the biomarker data.

By contrast, the score is not well suited to predict mortality alone at 3 months, the results of the analyses showed.

The algorithm used to calculate the score based on its four variables is somewhat complex, but available as a free app and online calculator, Dr. De Marchis said.

Dr. De Marchis and his coauthors had nothing to disclose related to their study. A full report on the study was published ahead of print on March 1 in Neurology.

SOURCE: De Marchis GM et al. AAN 2019, Abstract S47.001.

PHILADELPHIA – A prognostic score for acute ischemic stroke that incorporates copeptin levels, age, recanalization, and National Institutes of Health Stroke Scale score has been externally validated and accurately predicts unfavorable outcome, according to research presented at the annual meeting of the American Academy of Neurology.

Although the four-item score could not be validated for mortality prediction, it had reasonable accuracy for predicting unfavorable functional outcome, defined as disability or mortality 3 months after ischemic stroke, Gian Marco De Marchis, MD, of the department of neurology and the stroke center at University Hospital Basel (Switzerland), said in a presentation.

“The use of a biomarker increases prognostic accuracy, allowing us to personalize prognosis in the frame of individualized, precision medicine,” Dr. De Marchis said.

Copeptin has been linked to disability and mortality at 3 months in two independent, large cohort studies of patients with ischemic stroke, he said.

The four-item prognostic score devised by Dr. De Marchis and his coinvestigators, which they call the CoRisk score, was developed based on a derivation cohort of 319 acute ischemic stroke patients and a validation cohort including another 783 patients in the Copeptin for Risk Stratification in Acute Stroke Patients (CoRisk) Study.

Diagnostic accuracy was 82% for the endpoint of unfavorable functional outcome at 3 months, according to Dr. De Marchis.

“The observed outcomes matched well with the expected outcomes,” he said in his presentation.

Further analyses demonstrated that the addition of copeptin indeed contributed to the diagnostic accuracy of the score, improving the classification for 46%; in other words, about half of the patients were reclassified based on addition of the biomarker data.

By contrast, the score is not well suited to predict mortality alone at 3 months, the results of the analyses showed.

The algorithm used to calculate the score based on its four variables is somewhat complex, but available as a free app and online calculator, Dr. De Marchis said.

Dr. De Marchis and his coauthors had nothing to disclose related to their study. A full report on the study was published ahead of print on March 1 in Neurology.

SOURCE: De Marchis GM et al. AAN 2019, Abstract S47.001.

PHILADELPHIA – A prognostic score for acute ischemic stroke that incorporates copeptin levels, age, recanalization, and National Institutes of Health Stroke Scale score has been externally validated and accurately predicts unfavorable outcome, according to research presented at the annual meeting of the American Academy of Neurology.

Although the four-item score could not be validated for mortality prediction, it had reasonable accuracy for predicting unfavorable functional outcome, defined as disability or mortality 3 months after ischemic stroke, Gian Marco De Marchis, MD, of the department of neurology and the stroke center at University Hospital Basel (Switzerland), said in a presentation.

“The use of a biomarker increases prognostic accuracy, allowing us to personalize prognosis in the frame of individualized, precision medicine,” Dr. De Marchis said.

Copeptin has been linked to disability and mortality at 3 months in two independent, large cohort studies of patients with ischemic stroke, he said.

The four-item prognostic score devised by Dr. De Marchis and his coinvestigators, which they call the CoRisk score, was developed based on a derivation cohort of 319 acute ischemic stroke patients and a validation cohort including another 783 patients in the Copeptin for Risk Stratification in Acute Stroke Patients (CoRisk) Study.

Diagnostic accuracy was 82% for the endpoint of unfavorable functional outcome at 3 months, according to Dr. De Marchis.

“The observed outcomes matched well with the expected outcomes,” he said in his presentation.

Further analyses demonstrated that the addition of copeptin indeed contributed to the diagnostic accuracy of the score, improving the classification for 46%; in other words, about half of the patients were reclassified based on addition of the biomarker data.

By contrast, the score is not well suited to predict mortality alone at 3 months, the results of the analyses showed.

The algorithm used to calculate the score based on its four variables is somewhat complex, but available as a free app and online calculator, Dr. De Marchis said.

Dr. De Marchis and his coauthors had nothing to disclose related to their study. A full report on the study was published ahead of print on March 1 in Neurology.

SOURCE: De Marchis GM et al. AAN 2019, Abstract S47.001.