BOSTON – Noninvasive vagus nerve stimulation (nVNS) proved safe and effective for the treatment of episodic cluster headaches in the pivotal, multicenter ACT2 study.

The findings confirmed those of the ACT1 study – and together, the results led to the April 18 approval by the Food and Drug Administration of the gammaCore stimulation device for the treatment of episodic cluster headaches (eCH).

In ACT2, nVNS was used to treat 495 cluster headache attacks in 50 patients randomized to the treatment group, and a sham treatment was used for 400 attacks in 52 patients. The proportion of patients who achieved pain freedom within 15 minutes (responders) was 13.5% with stimulation, compared with 11.5% with the sham treatment (odds ratio, 1.22).

sworcester@frontlinemedcom.com

BOSTON – Noninvasive vagus nerve stimulation (nVNS) proved safe and effective for the treatment of episodic cluster headaches in the pivotal, multicenter ACT2 study.

The findings confirmed those of the ACT1 study – and together, the results led to the April 18 approval by the Food and Drug Administration of the gammaCore stimulation device for the treatment of episodic cluster headaches (eCH).

In ACT2, nVNS was used to treat 495 cluster headache attacks in 50 patients randomized to the treatment group, and a sham treatment was used for 400 attacks in 52 patients. The proportion of patients who achieved pain freedom within 15 minutes (responders) was 13.5% with stimulation, compared with 11.5% with the sham treatment (odds ratio, 1.22).

sworcester@frontlinemedcom.com

BOSTON – Noninvasive vagus nerve stimulation (nVNS) proved safe and effective for the treatment of episodic cluster headaches in the pivotal, multicenter ACT2 study.

The findings confirmed those of the ACT1 study – and together, the results led to the April 18 approval by the Food and Drug Administration of the gammaCore stimulation device for the treatment of episodic cluster headaches (eCH).

In ACT2, nVNS was used to treat 495 cluster headache attacks in 50 patients randomized to the treatment group, and a sham treatment was used for 400 attacks in 52 patients. The proportion of patients who achieved pain freedom within 15 minutes (responders) was 13.5% with stimulation, compared with 11.5% with the sham treatment (odds ratio, 1.22).

sworcester@frontlinemedcom.com

BOSTON – High quality wedge resection results in higher survival for patients with early stage non–small cell lung cancer when compared with stereotactic body radiation therapy, according to new research.

The analysis, reported at the annual meeting of the American Association for Thoracic Surgery, evaluated the treatment of 7,337 patients in the National Cancer Database with clinical T1-T2, N0, M0 non–small cell lung cancer who were treated with either wedge resection or stereotactic body radiation therapy from 2005 to 2012.

In this video, Varun Puri, MD, of Washington University, St. Louis, discusses the study and the significance of the findings.

agallegos@frontlinemedcom.com

On Twitter @legal_med

BOSTON – High quality wedge resection results in higher survival for patients with early stage non–small cell lung cancer when compared with stereotactic body radiation therapy, according to new research.

The analysis, reported at the annual meeting of the American Association for Thoracic Surgery, evaluated the treatment of 7,337 patients in the National Cancer Database with clinical T1-T2, N0, M0 non–small cell lung cancer who were treated with either wedge resection or stereotactic body radiation therapy from 2005 to 2012.

In this video, Varun Puri, MD, of Washington University, St. Louis, discusses the study and the significance of the findings.

agallegos@frontlinemedcom.com

On Twitter @legal_med

BOSTON – High quality wedge resection results in higher survival for patients with early stage non–small cell lung cancer when compared with stereotactic body radiation therapy, according to new research.

The analysis, reported at the annual meeting of the American Association for Thoracic Surgery, evaluated the treatment of 7,337 patients in the National Cancer Database with clinical T1-T2, N0, M0 non–small cell lung cancer who were treated with either wedge resection or stereotactic body radiation therapy from 2005 to 2012.

In this video, Varun Puri, MD, of Washington University, St. Louis, discusses the study and the significance of the findings.

agallegos@frontlinemedcom.com

On Twitter @legal_med

A Potent Neurotoxin

The FDA first approved botulinum toxin in 1989 for the treatment of strabismus, blepharospasm, and hemifacial spasm. Early reports also described its use in cervical dystonia, spasmodic dysphonia, oral mandibular dystonia, focal hand dystonia, and focal leg and truncal dystonias.

Four preparations of botulinum toxin—three serotype A (ie, onabotulinumtoxinA, abobotulinumtoxinA, and incobotulinumtoxinA) and one serotype B (rimabotulinumtoxinB)—are available in the United States. A 2008 evidence-based review assessed the level of evidence for botulinum toxin in movement disorders, including blepharospasm (level B), hemifacial spasm (level C), cervical dystonia (level A), upper focal limb dystonia (level B), lower focal limb dystonia (level C), and adductor laryngeal dystonia (level B). An update in 2016 incorporated additional trials for cervical dystonia and blepharospasm, and the authors separated the level of evidence by toxin type for those indications. A paucity of class I trials limits the strength of the evidence for certain indications, but botulinum toxin still is the treatment of choice for those indications, Dr. Comella said.

Blepharospasm

Studies have found that as many as 90% of patients with blepharospasm improve with botulinum toxin treatment. As in other indications, however, the treatment effect may not be sustained between injections. A retrospective chart review of 41 patients with primary blepharospasm and 23 patients with secondary blepharospasm found that the patient-reported duration of treatment benefit was less than 10 weeks. Yet early studies of immunoresistance with botulinum toxin treatment led to a recommendation that injections be given 12 weeks apart. “Perhaps we are overdoing this 12-week rule,” Dr. Comella said. “In some patients, in order to maintain their functional capacity, we may want to consider injecting sooner.” Additional research is needed to determine optimal dosing intervals.

The development of neutralizing antibodies with current formulations of botulinum toxin appears to be rare, and the effects of neutralizing antibodies are not well understood, Dr. Comella said. Brin et al studied the immunogenicity of onabotulinumtoxinA in 326 patients with cervical dystonia who received a median of nine treatments over an average of 2.5 years. Four patients (1.2%) developed neutralizing antibodies, and one of the four patients who developed neutralizing antibodies continued to respond to treatment.

Cervical Dystonia Registries

CD PROBE, a registry study of patients who received onabotulinumtoxinA for cervical dystonia, enrolled 1,046 patients. Overall, 26.2% of patients experienced adverse events, most commonly mild to moderate muscle weakness and dysphagia. Over three injection series, 52% of the patients discontinued the study. The ANCHOR-CD registry study of abobotulinumtoxinA had a discontinuation rate of 36.6%. “If [botulinum toxin] is such an effective treatment in controlled clinical trials … why did these patients discontinue [therapy]?”

Dr. Comella and Kailash Bhatia, MD, DM, Professor of Clinical Neurology at University College London, conducted an international survey of self-identified patients with cervical dystonia to assess patients’ perceptions of their illness and its management. Of the more than 900 patients who were receiving botulinum toxin, 56% were fairly or very satisfied with the treatment, whereas 25% were fairly or very dissatisfied.

A survey by Sethi et al of 136 patients with cervical dystonia found that 51% were very satisfied and 43% were somewhat satisfied with botulinum toxin treatment, but 45% would prefer a treatment cycle of 10 weeks or fewer. “The benefits of the injection wore out before the next injection was permitted,” Dr. Comella said. “That gave them two to three weeks of not doing very well, which caused some dissatisfaction.”

Evidente et al studied the effect of flexible injection intervals in the two pivotal trials of incobotulinumtoxinA for blepharospasm and cervical dystonia. After an initial double-blind, placebo-controlled period, dosing intervals became flexible during a 68-week open-label extension. During that time, patients could request treatment after a six-week interval, and physicians would administer the treatment at that time if a patient’s dystonia was at a certain level of severity. Among patients with blepharospasm, 26.5% of treatments were administered at less than 10 weeks during the flexible dosing period. Among patients with cervical dystonia, 29.5% of treatments were administered at less than 10 weeks. Flexible dosing was well tolerated, and no additional safety concerns were observed when treatment was given sooner than 12 weeks after the last injection, compared with treatment given after 12 or more weeks.

Limb Dystonia

In limb dystonia, mostly occupational dystonias have been studied, including writer’s cramp and musician’s dystonia. The most frequent adverse event with botulinum toxin is weakness, which may lead to discontinuation. In a 2007 study of abobotulinumtoxinA for writer’s cramp that used continuation of treatment as the primary outcome, 70% of patients who received active treatment continued treatment, compared with 32% of patients in the placebo group. Hand weakness occurred in about 90% of patients in the active treatment group, however, compared with 25% of patients in the placebo group, and 25% of patients in the active treatment group discontinued because of hand weakness.

Neurologists adjust a patient’s injections based on the patient’s response to the previous treatment, so treatment may become more beneficial as neurologists optimize the injection pattern and dosing.

Why Might Treatment Fail?

Injection of botulinum toxin into the wrong muscle may be a common reason for lack of efficacy. Stress-induced exacerbation or inadequate dose may be other reasons for treatment failure. Uncommon reasons for lack of efficacy include change in dystonia and immunoresistance. In addition, patients may discontinue treatment because of the expense or inconvenience, Dr. Comella said.

Neurologists should help set realistic expectations for treatment. “We must manage patient expectations. It is not a cure. This may not restore you to perfect movement,” Dr. Comella said. “Too often we tell them how well they are going to do without giving them a more realistic view.”

Future Directions

Neurologists need better long-term outcome data to understand the effects of botulinum toxin in dystonia, and telemedicine may be an ideal way to assess the treatment’s long-term efficacy, Dr. Comella said. Remote evaluations could supplement in-person evaluations and avoid reliance on patients’ retrospective reports.

An investigational formulation of botulinum toxin, daxibotulinumtoxinA, is being developed by Revance Pharmaceuticals. It contains a peptide excipient that is designed to produce a longer treatment effect. A phase II open-label study is evaluating the formulation in patients with cervical dystonia, said Dr. Comella, who is one of the study investigators. One cohort of 12 patients received between 100 units and 200 units of the neurotoxin. The patients’ mean Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score change from baseline was 33% at 24 weeks. Investigators observed a clinically meaningful benefit by Week 2. The preliminary results are promising, but “we have much more work to do before this [formulation] could be available to us,” Dr. Comella said.

—Jake Remaly

Suggested Reading

Brin MF, Comella CL, Jankovic J, et al. Long-term treatment with botulinum toxin type A in cervical dystonia has low immunogenicity by mouse protection assay. Mov Disord. 2008;23(10):1353-1360.

Comella C, Bhatia K. An international survey of patients with cervical dystonia. J Neurol. 2015;262(4):837-848.

Evidente VG, Truong D, Jankovic J, et al. IncobotulinumtoxinA (Xeomin) injected for blepharospasm or cervical dystonia according to patient needs is well tolerated. J Neurol Sci. 2014;346(1-2):116-120.

Jankovic J, Adler CH, Charles D, et al. Primary results from the cervical dystonia patient registry for observation of onabotulinumtoxina efficacy (CD PROBE). J Neurol Sci. 2015;349(1-2):84-93.

Kruisdijk JJ, Koelman JH, Ongerboer de Visser BW, et al. Botulinum toxin for writer’s cramp: a randomised, placebo-controlled trial and 1-year follow-up. J Neurol Neurosurg Psychiatry. 2007;78(3):264-270.

Martinez-Ramirez D, Giugni JC, Hastings E, et al. Comparable botulinum toxin outcomes between primary and secondary blepharospasm: A retrospective analysis. Tremor Other Hyperkinet Mov (NY). 2014;4:286.

Sethi KD, Rodriguez R, Olayinka B. Satisfaction with botulinum toxin treatment: a cross-sectional survey of patients with cervical dystonia. J Med Econ. 2012;15(3):419-423.

Simpson DM, Blitzer A, Brashear A, et al. Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2008;70(19):1699-1706.

Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016;86(19):1818-1826.

A Potent Neurotoxin

The FDA first approved botulinum toxin in 1989 for the treatment of strabismus, blepharospasm, and hemifacial spasm. Early reports also described its use in cervical dystonia, spasmodic dysphonia, oral mandibular dystonia, focal hand dystonia, and focal leg and truncal dystonias.

Four preparations of botulinum toxin—three serotype A (ie, onabotulinumtoxinA, abobotulinumtoxinA, and incobotulinumtoxinA) and one serotype B (rimabotulinumtoxinB)—are available in the United States. A 2008 evidence-based review assessed the level of evidence for botulinum toxin in movement disorders, including blepharospasm (level B), hemifacial spasm (level C), cervical dystonia (level A), upper focal limb dystonia (level B), lower focal limb dystonia (level C), and adductor laryngeal dystonia (level B). An update in 2016 incorporated additional trials for cervical dystonia and blepharospasm, and the authors separated the level of evidence by toxin type for those indications. A paucity of class I trials limits the strength of the evidence for certain indications, but botulinum toxin still is the treatment of choice for those indications, Dr. Comella said.

Blepharospasm

Studies have found that as many as 90% of patients with blepharospasm improve with botulinum toxin treatment. As in other indications, however, the treatment effect may not be sustained between injections. A retrospective chart review of 41 patients with primary blepharospasm and 23 patients with secondary blepharospasm found that the patient-reported duration of treatment benefit was less than 10 weeks. Yet early studies of immunoresistance with botulinum toxin treatment led to a recommendation that injections be given 12 weeks apart. “Perhaps we are overdoing this 12-week rule,” Dr. Comella said. “In some patients, in order to maintain their functional capacity, we may want to consider injecting sooner.” Additional research is needed to determine optimal dosing intervals.

The development of neutralizing antibodies with current formulations of botulinum toxin appears to be rare, and the effects of neutralizing antibodies are not well understood, Dr. Comella said. Brin et al studied the immunogenicity of onabotulinumtoxinA in 326 patients with cervical dystonia who received a median of nine treatments over an average of 2.5 years. Four patients (1.2%) developed neutralizing antibodies, and one of the four patients who developed neutralizing antibodies continued to respond to treatment.

Cervical Dystonia Registries

CD PROBE, a registry study of patients who received onabotulinumtoxinA for cervical dystonia, enrolled 1,046 patients. Overall, 26.2% of patients experienced adverse events, most commonly mild to moderate muscle weakness and dysphagia. Over three injection series, 52% of the patients discontinued the study. The ANCHOR-CD registry study of abobotulinumtoxinA had a discontinuation rate of 36.6%. “If [botulinum toxin] is such an effective treatment in controlled clinical trials … why did these patients discontinue [therapy]?”

Dr. Comella and Kailash Bhatia, MD, DM, Professor of Clinical Neurology at University College London, conducted an international survey of self-identified patients with cervical dystonia to assess patients’ perceptions of their illness and its management. Of the more than 900 patients who were receiving botulinum toxin, 56% were fairly or very satisfied with the treatment, whereas 25% were fairly or very dissatisfied.

A survey by Sethi et al of 136 patients with cervical dystonia found that 51% were very satisfied and 43% were somewhat satisfied with botulinum toxin treatment, but 45% would prefer a treatment cycle of 10 weeks or fewer. “The benefits of the injection wore out before the next injection was permitted,” Dr. Comella said. “That gave them two to three weeks of not doing very well, which caused some dissatisfaction.”

Evidente et al studied the effect of flexible injection intervals in the two pivotal trials of incobotulinumtoxinA for blepharospasm and cervical dystonia. After an initial double-blind, placebo-controlled period, dosing intervals became flexible during a 68-week open-label extension. During that time, patients could request treatment after a six-week interval, and physicians would administer the treatment at that time if a patient’s dystonia was at a certain level of severity. Among patients with blepharospasm, 26.5% of treatments were administered at less than 10 weeks during the flexible dosing period. Among patients with cervical dystonia, 29.5% of treatments were administered at less than 10 weeks. Flexible dosing was well tolerated, and no additional safety concerns were observed when treatment was given sooner than 12 weeks after the last injection, compared with treatment given after 12 or more weeks.

Limb Dystonia

In limb dystonia, mostly occupational dystonias have been studied, including writer’s cramp and musician’s dystonia. The most frequent adverse event with botulinum toxin is weakness, which may lead to discontinuation. In a 2007 study of abobotulinumtoxinA for writer’s cramp that used continuation of treatment as the primary outcome, 70% of patients who received active treatment continued treatment, compared with 32% of patients in the placebo group. Hand weakness occurred in about 90% of patients in the active treatment group, however, compared with 25% of patients in the placebo group, and 25% of patients in the active treatment group discontinued because of hand weakness.

Neurologists adjust a patient’s injections based on the patient’s response to the previous treatment, so treatment may become more beneficial as neurologists optimize the injection pattern and dosing.

Why Might Treatment Fail?

Injection of botulinum toxin into the wrong muscle may be a common reason for lack of efficacy. Stress-induced exacerbation or inadequate dose may be other reasons for treatment failure. Uncommon reasons for lack of efficacy include change in dystonia and immunoresistance. In addition, patients may discontinue treatment because of the expense or inconvenience, Dr. Comella said.

Neurologists should help set realistic expectations for treatment. “We must manage patient expectations. It is not a cure. This may not restore you to perfect movement,” Dr. Comella said. “Too often we tell them how well they are going to do without giving them a more realistic view.”

Future Directions

Neurologists need better long-term outcome data to understand the effects of botulinum toxin in dystonia, and telemedicine may be an ideal way to assess the treatment’s long-term efficacy, Dr. Comella said. Remote evaluations could supplement in-person evaluations and avoid reliance on patients’ retrospective reports.

An investigational formulation of botulinum toxin, daxibotulinumtoxinA, is being developed by Revance Pharmaceuticals. It contains a peptide excipient that is designed to produce a longer treatment effect. A phase II open-label study is evaluating the formulation in patients with cervical dystonia, said Dr. Comella, who is one of the study investigators. One cohort of 12 patients received between 100 units and 200 units of the neurotoxin. The patients’ mean Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score change from baseline was 33% at 24 weeks. Investigators observed a clinically meaningful benefit by Week 2. The preliminary results are promising, but “we have much more work to do before this [formulation] could be available to us,” Dr. Comella said.

—Jake Remaly

Suggested Reading

Brin MF, Comella CL, Jankovic J, et al. Long-term treatment with botulinum toxin type A in cervical dystonia has low immunogenicity by mouse protection assay. Mov Disord. 2008;23(10):1353-1360.

Comella C, Bhatia K. An international survey of patients with cervical dystonia. J Neurol. 2015;262(4):837-848.

Evidente VG, Truong D, Jankovic J, et al. IncobotulinumtoxinA (Xeomin) injected for blepharospasm or cervical dystonia according to patient needs is well tolerated. J Neurol Sci. 2014;346(1-2):116-120.

Jankovic J, Adler CH, Charles D, et al. Primary results from the cervical dystonia patient registry for observation of onabotulinumtoxina efficacy (CD PROBE). J Neurol Sci. 2015;349(1-2):84-93.

Kruisdijk JJ, Koelman JH, Ongerboer de Visser BW, et al. Botulinum toxin for writer’s cramp: a randomised, placebo-controlled trial and 1-year follow-up. J Neurol Neurosurg Psychiatry. 2007;78(3):264-270.

Martinez-Ramirez D, Giugni JC, Hastings E, et al. Comparable botulinum toxin outcomes between primary and secondary blepharospasm: A retrospective analysis. Tremor Other Hyperkinet Mov (NY). 2014;4:286.

Sethi KD, Rodriguez R, Olayinka B. Satisfaction with botulinum toxin treatment: a cross-sectional survey of patients with cervical dystonia. J Med Econ. 2012;15(3):419-423.

Simpson DM, Blitzer A, Brashear A, et al. Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2008;70(19):1699-1706.

Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016;86(19):1818-1826.

A Potent Neurotoxin

The FDA first approved botulinum toxin in 1989 for the treatment of strabismus, blepharospasm, and hemifacial spasm. Early reports also described its use in cervical dystonia, spasmodic dysphonia, oral mandibular dystonia, focal hand dystonia, and focal leg and truncal dystonias.

Four preparations of botulinum toxin—three serotype A (ie, onabotulinumtoxinA, abobotulinumtoxinA, and incobotulinumtoxinA) and one serotype B (rimabotulinumtoxinB)—are available in the United States. A 2008 evidence-based review assessed the level of evidence for botulinum toxin in movement disorders, including blepharospasm (level B), hemifacial spasm (level C), cervical dystonia (level A), upper focal limb dystonia (level B), lower focal limb dystonia (level C), and adductor laryngeal dystonia (level B). An update in 2016 incorporated additional trials for cervical dystonia and blepharospasm, and the authors separated the level of evidence by toxin type for those indications. A paucity of class I trials limits the strength of the evidence for certain indications, but botulinum toxin still is the treatment of choice for those indications, Dr. Comella said.

Blepharospasm

Studies have found that as many as 90% of patients with blepharospasm improve with botulinum toxin treatment. As in other indications, however, the treatment effect may not be sustained between injections. A retrospective chart review of 41 patients with primary blepharospasm and 23 patients with secondary blepharospasm found that the patient-reported duration of treatment benefit was less than 10 weeks. Yet early studies of immunoresistance with botulinum toxin treatment led to a recommendation that injections be given 12 weeks apart. “Perhaps we are overdoing this 12-week rule,” Dr. Comella said. “In some patients, in order to maintain their functional capacity, we may want to consider injecting sooner.” Additional research is needed to determine optimal dosing intervals.

The development of neutralizing antibodies with current formulations of botulinum toxin appears to be rare, and the effects of neutralizing antibodies are not well understood, Dr. Comella said. Brin et al studied the immunogenicity of onabotulinumtoxinA in 326 patients with cervical dystonia who received a median of nine treatments over an average of 2.5 years. Four patients (1.2%) developed neutralizing antibodies, and one of the four patients who developed neutralizing antibodies continued to respond to treatment.

Cervical Dystonia Registries

CD PROBE, a registry study of patients who received onabotulinumtoxinA for cervical dystonia, enrolled 1,046 patients. Overall, 26.2% of patients experienced adverse events, most commonly mild to moderate muscle weakness and dysphagia. Over three injection series, 52% of the patients discontinued the study. The ANCHOR-CD registry study of abobotulinumtoxinA had a discontinuation rate of 36.6%. “If [botulinum toxin] is such an effective treatment in controlled clinical trials … why did these patients discontinue [therapy]?”

Dr. Comella and Kailash Bhatia, MD, DM, Professor of Clinical Neurology at University College London, conducted an international survey of self-identified patients with cervical dystonia to assess patients’ perceptions of their illness and its management. Of the more than 900 patients who were receiving botulinum toxin, 56% were fairly or very satisfied with the treatment, whereas 25% were fairly or very dissatisfied.

A survey by Sethi et al of 136 patients with cervical dystonia found that 51% were very satisfied and 43% were somewhat satisfied with botulinum toxin treatment, but 45% would prefer a treatment cycle of 10 weeks or fewer. “The benefits of the injection wore out before the next injection was permitted,” Dr. Comella said. “That gave them two to three weeks of not doing very well, which caused some dissatisfaction.”

Evidente et al studied the effect of flexible injection intervals in the two pivotal trials of incobotulinumtoxinA for blepharospasm and cervical dystonia. After an initial double-blind, placebo-controlled period, dosing intervals became flexible during a 68-week open-label extension. During that time, patients could request treatment after a six-week interval, and physicians would administer the treatment at that time if a patient’s dystonia was at a certain level of severity. Among patients with blepharospasm, 26.5% of treatments were administered at less than 10 weeks during the flexible dosing period. Among patients with cervical dystonia, 29.5% of treatments were administered at less than 10 weeks. Flexible dosing was well tolerated, and no additional safety concerns were observed when treatment was given sooner than 12 weeks after the last injection, compared with treatment given after 12 or more weeks.

Limb Dystonia

In limb dystonia, mostly occupational dystonias have been studied, including writer’s cramp and musician’s dystonia. The most frequent adverse event with botulinum toxin is weakness, which may lead to discontinuation. In a 2007 study of abobotulinumtoxinA for writer’s cramp that used continuation of treatment as the primary outcome, 70% of patients who received active treatment continued treatment, compared with 32% of patients in the placebo group. Hand weakness occurred in about 90% of patients in the active treatment group, however, compared with 25% of patients in the placebo group, and 25% of patients in the active treatment group discontinued because of hand weakness.

Neurologists adjust a patient’s injections based on the patient’s response to the previous treatment, so treatment may become more beneficial as neurologists optimize the injection pattern and dosing.

Why Might Treatment Fail?

Injection of botulinum toxin into the wrong muscle may be a common reason for lack of efficacy. Stress-induced exacerbation or inadequate dose may be other reasons for treatment failure. Uncommon reasons for lack of efficacy include change in dystonia and immunoresistance. In addition, patients may discontinue treatment because of the expense or inconvenience, Dr. Comella said.

Neurologists should help set realistic expectations for treatment. “We must manage patient expectations. It is not a cure. This may not restore you to perfect movement,” Dr. Comella said. “Too often we tell them how well they are going to do without giving them a more realistic view.”

Future Directions

Neurologists need better long-term outcome data to understand the effects of botulinum toxin in dystonia, and telemedicine may be an ideal way to assess the treatment’s long-term efficacy, Dr. Comella said. Remote evaluations could supplement in-person evaluations and avoid reliance on patients’ retrospective reports.

An investigational formulation of botulinum toxin, daxibotulinumtoxinA, is being developed by Revance Pharmaceuticals. It contains a peptide excipient that is designed to produce a longer treatment effect. A phase II open-label study is evaluating the formulation in patients with cervical dystonia, said Dr. Comella, who is one of the study investigators. One cohort of 12 patients received between 100 units and 200 units of the neurotoxin. The patients’ mean Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score change from baseline was 33% at 24 weeks. Investigators observed a clinically meaningful benefit by Week 2. The preliminary results are promising, but “we have much more work to do before this [formulation] could be available to us,” Dr. Comella said.

—Jake Remaly

Suggested Reading

Brin MF, Comella CL, Jankovic J, et al. Long-term treatment with botulinum toxin type A in cervical dystonia has low immunogenicity by mouse protection assay. Mov Disord. 2008;23(10):1353-1360.

Comella C, Bhatia K. An international survey of patients with cervical dystonia. J Neurol. 2015;262(4):837-848.

Evidente VG, Truong D, Jankovic J, et al. IncobotulinumtoxinA (Xeomin) injected for blepharospasm or cervical dystonia according to patient needs is well tolerated. J Neurol Sci. 2014;346(1-2):116-120.

Jankovic J, Adler CH, Charles D, et al. Primary results from the cervical dystonia patient registry for observation of onabotulinumtoxina efficacy (CD PROBE). J Neurol Sci. 2015;349(1-2):84-93.

Kruisdijk JJ, Koelman JH, Ongerboer de Visser BW, et al. Botulinum toxin for writer’s cramp: a randomised, placebo-controlled trial and 1-year follow-up. J Neurol Neurosurg Psychiatry. 2007;78(3):264-270.

Martinez-Ramirez D, Giugni JC, Hastings E, et al. Comparable botulinum toxin outcomes between primary and secondary blepharospasm: A retrospective analysis. Tremor Other Hyperkinet Mov (NY). 2014;4:286.

Sethi KD, Rodriguez R, Olayinka B. Satisfaction with botulinum toxin treatment: a cross-sectional survey of patients with cervical dystonia. J Med Econ. 2012;15(3):419-423.

Simpson DM, Blitzer A, Brashear A, et al. Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2008;70(19):1699-1706.

Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016;86(19):1818-1826.

Truncal vagotomy may be associated with a reduced risk of incident Parkinson’s disease, according to data published online ahead of print April 26 in Neurology. Selective vagotomy, however, is not associated with risk of Parkinson’s disease. These findings provide support for the theory that Parkinson’s disease begins in the gut and spreads to the brain via the vagus nerve, according to the authors.

Braak et al have hypothesized that Lewy pathology in Parkinson’s disease may start in peripheral nerves, such as the enteric nervous system, and spread to the CNS in a way similar to the propagation of prions. Researchers have found Lewy-type deposition in the gut of people with prodromal Parkinson’s disease. In addition, resection of the vagus nerve before administration of rotenone, which prompts alpha-synuclein accumulation, stopped the spread of parkinsonian pathology in mice.

To examine whether vagotomy decreases the risk of Parkinson’s disease, Bojing Liu, a doctoral student at the Karolinska Institutet in Stockholm, and colleagues conducted a matched-cohort study using data from nationwide Swedish registers. The investigators identified 9,430 patients who underwent vagotomy (3,445 truncal, 5,978 selective, and seven unknown) between 1970 and 2010. Eligible participants were born before 1970 and lived in Sweden without a diagnosis of Parkinson’s disease before vagotomy. To each of these patients, the researchers individually matched 377,200 reference individuals from the general population by sex and year of birth in a 40:1 ratio. Participants were followed up from the date of vagotomy until Parkinson’s disease diagnosis, death, emigration out of Sweden, or December 31, 2010, whichever occurred first.

Participants’ mean age at index date was 54. The investigators identified 4,930 cases of Parkinson’s disease during follow-up, and mean age at diagnosis was 76. Although the study groups were otherwise well balanced, proportionally more patients who underwent vagotomy were born outside Sweden, compared with controls. Participants who underwent truncal vagotomy were older than those who underwent selective vagotomy and older than controls.

Ms. Liu and colleagues did not find an association between vagotomy and Parkinson’s disease overall. They did, however, observe a lower risk of Parkinson’s disease more than five years after truncal vagotomy (hazard ratio [HR], 0.59) and more than 10 years after truncal vagotomy (HR, 0.62). Selective vagotomy was not associated with Parkinson’s disease risk in any of the analyses.

“Our observation of the temporal relationship is consistent with the possibility that Parkinson’s disease pathology may start at multiple sites of the peripheral nervous system. Therefore, even truncal vagotomy may delay rather than eliminate the risk for Parkinson’s disease,” said Ms. Liu and colleagues. She acknowledged that she and her colleagues were unable to control for potential individual confounders such as smoking, coffee consumption, or genetic factors.

“If the observed association is confirmed and proven to be biologic, we expect the results could be generalized to populations in other parts of the world,” Ms. Liu continued. “These data provide preliminary and indirect support for the Braak and prion-like hypotheses for Parkinson’s disease prodromal development.”

—Erik Greb

Suggested Reading

Liu B, Fang F, Pedersen NL, et al. Vagotomy and Parkinson disease: A Swedish register-based matched-cohort study. Neurology. 2017 Apr 26 [Epub ahead of print].

Truncal vagotomy may be associated with a reduced risk of incident Parkinson’s disease, according to data published online ahead of print April 26 in Neurology. Selective vagotomy, however, is not associated with risk of Parkinson’s disease. These findings provide support for the theory that Parkinson’s disease begins in the gut and spreads to the brain via the vagus nerve, according to the authors.

Braak et al have hypothesized that Lewy pathology in Parkinson’s disease may start in peripheral nerves, such as the enteric nervous system, and spread to the CNS in a way similar to the propagation of prions. Researchers have found Lewy-type deposition in the gut of people with prodromal Parkinson’s disease. In addition, resection of the vagus nerve before administration of rotenone, which prompts alpha-synuclein accumulation, stopped the spread of parkinsonian pathology in mice.

To examine whether vagotomy decreases the risk of Parkinson’s disease, Bojing Liu, a doctoral student at the Karolinska Institutet in Stockholm, and colleagues conducted a matched-cohort study using data from nationwide Swedish registers. The investigators identified 9,430 patients who underwent vagotomy (3,445 truncal, 5,978 selective, and seven unknown) between 1970 and 2010. Eligible participants were born before 1970 and lived in Sweden without a diagnosis of Parkinson’s disease before vagotomy. To each of these patients, the researchers individually matched 377,200 reference individuals from the general population by sex and year of birth in a 40:1 ratio. Participants were followed up from the date of vagotomy until Parkinson’s disease diagnosis, death, emigration out of Sweden, or December 31, 2010, whichever occurred first.

Participants’ mean age at index date was 54. The investigators identified 4,930 cases of Parkinson’s disease during follow-up, and mean age at diagnosis was 76. Although the study groups were otherwise well balanced, proportionally more patients who underwent vagotomy were born outside Sweden, compared with controls. Participants who underwent truncal vagotomy were older than those who underwent selective vagotomy and older than controls.

Ms. Liu and colleagues did not find an association between vagotomy and Parkinson’s disease overall. They did, however, observe a lower risk of Parkinson’s disease more than five years after truncal vagotomy (hazard ratio [HR], 0.59) and more than 10 years after truncal vagotomy (HR, 0.62). Selective vagotomy was not associated with Parkinson’s disease risk in any of the analyses.

“Our observation of the temporal relationship is consistent with the possibility that Parkinson’s disease pathology may start at multiple sites of the peripheral nervous system. Therefore, even truncal vagotomy may delay rather than eliminate the risk for Parkinson’s disease,” said Ms. Liu and colleagues. She acknowledged that she and her colleagues were unable to control for potential individual confounders such as smoking, coffee consumption, or genetic factors.

“If the observed association is confirmed and proven to be biologic, we expect the results could be generalized to populations in other parts of the world,” Ms. Liu continued. “These data provide preliminary and indirect support for the Braak and prion-like hypotheses for Parkinson’s disease prodromal development.”

—Erik Greb

Suggested Reading

Liu B, Fang F, Pedersen NL, et al. Vagotomy and Parkinson disease: A Swedish register-based matched-cohort study. Neurology. 2017 Apr 26 [Epub ahead of print].

Truncal vagotomy may be associated with a reduced risk of incident Parkinson’s disease, according to data published online ahead of print April 26 in Neurology. Selective vagotomy, however, is not associated with risk of Parkinson’s disease. These findings provide support for the theory that Parkinson’s disease begins in the gut and spreads to the brain via the vagus nerve, according to the authors.

Braak et al have hypothesized that Lewy pathology in Parkinson’s disease may start in peripheral nerves, such as the enteric nervous system, and spread to the CNS in a way similar to the propagation of prions. Researchers have found Lewy-type deposition in the gut of people with prodromal Parkinson’s disease. In addition, resection of the vagus nerve before administration of rotenone, which prompts alpha-synuclein accumulation, stopped the spread of parkinsonian pathology in mice.

To examine whether vagotomy decreases the risk of Parkinson’s disease, Bojing Liu, a doctoral student at the Karolinska Institutet in Stockholm, and colleagues conducted a matched-cohort study using data from nationwide Swedish registers. The investigators identified 9,430 patients who underwent vagotomy (3,445 truncal, 5,978 selective, and seven unknown) between 1970 and 2010. Eligible participants were born before 1970 and lived in Sweden without a diagnosis of Parkinson’s disease before vagotomy. To each of these patients, the researchers individually matched 377,200 reference individuals from the general population by sex and year of birth in a 40:1 ratio. Participants were followed up from the date of vagotomy until Parkinson’s disease diagnosis, death, emigration out of Sweden, or December 31, 2010, whichever occurred first.

Participants’ mean age at index date was 54. The investigators identified 4,930 cases of Parkinson’s disease during follow-up, and mean age at diagnosis was 76. Although the study groups were otherwise well balanced, proportionally more patients who underwent vagotomy were born outside Sweden, compared with controls. Participants who underwent truncal vagotomy were older than those who underwent selective vagotomy and older than controls.

Ms. Liu and colleagues did not find an association between vagotomy and Parkinson’s disease overall. They did, however, observe a lower risk of Parkinson’s disease more than five years after truncal vagotomy (hazard ratio [HR], 0.59) and more than 10 years after truncal vagotomy (HR, 0.62). Selective vagotomy was not associated with Parkinson’s disease risk in any of the analyses.

“Our observation of the temporal relationship is consistent with the possibility that Parkinson’s disease pathology may start at multiple sites of the peripheral nervous system. Therefore, even truncal vagotomy may delay rather than eliminate the risk for Parkinson’s disease,” said Ms. Liu and colleagues. She acknowledged that she and her colleagues were unable to control for potential individual confounders such as smoking, coffee consumption, or genetic factors.

“If the observed association is confirmed and proven to be biologic, we expect the results could be generalized to populations in other parts of the world,” Ms. Liu continued. “These data provide preliminary and indirect support for the Braak and prion-like hypotheses for Parkinson’s disease prodromal development.”

—Erik Greb

Suggested Reading

Liu B, Fang F, Pedersen NL, et al. Vagotomy and Parkinson disease: A Swedish register-based matched-cohort study. Neurology. 2017 Apr 26 [Epub ahead of print].

Are foodborne illness outbreaks more common now, or are we simply better at detection? Have the foods and sources associated with foodborne illness changed? Two recent Centers for Disease Control & Prevention reports provide insight.^1,2 In 2016, the Foodborne Diseases Active Surveillance Network (FoodNet) detected 24,029 infections, 5,212 hospitalizations, and 98 fatalities.¹ FoodNet has 10 sites serving 49 million people (15% of the U.S. population). These 2016 numbers changed only modestly from the 3 prior years.

The big two

The most frequent 2016 foodborne pathogens were Campylobacter and Salmonella, at approximately 8,000 illnesses each, detected by traditional cultures or culture-independent diagnostic tests (CIDTs). (See table.) CIDTs are relatively new molecular-based, mostly multiplex assays that test for more than a dozen pathogens in one assay.

The runners-up

Most of the remainder of the 2016 foodborne illnesses were caused by Shigella, with nearly 3,000 cases; shigatoxin-producing Escherichia coli (STEC), with nearly 2,000 cases; and Cryptosporidium, also with nearly 2,000 cases. (See table.)

Hemolytic uremic syndrome (HUS)

HUS rates, mostly resulting from E. coli 0157 H7 in meat, did not vary from 2013 to 2016, with a total 62 pediatric HUS cases in FoodNet (0.56 /100,000 population). Slightly over half (56%) occurred in children under 5 years old at 1.18 per 100,000 population.

Does CIDT increase detection rates?

Detection of the “big two” did not change from 2013 to 2016 or over the past 2 decades. That said, Campylobacter detection was actually down 11% if considering only culture-confirmed cases. That is, if we do not count detections made exclusively by CIDT.

This is important because CIDT – now supplanting culture in many laboratories – identifies pathogens not likely detected by standard culture because culture is generally selective and CIDT is more sensitive. CIDT can increase detection rates (solo and multiple pathogens), even if illnesses do not really increase. The CDC suggested that this contributed to increased STEC and Yersinia detection in 2016. Some would not have been detected if only culture had been utilized.

Viable bacterial/viral isolates are not available from CIDT. A replicating pathogen is needed to characterize shifting/emerging pathogen strains (for example, analysis for mutations or new pathogens via sequencing or antimicrobial susceptibility testing).

To compensate, some CIDT-using laboratories perform “reflex cultures.” CIDT positive specimens also are cultured to provide viable isolates. However, this adds cost to an already costly CIDT test.

The role of imported food

Surveillance systems, such as the Foodborne Disease Outbreak Surveillance System, also track imported foodborne illness. Despite an approximately 50% decrease in overall U.S. foodborne outbreaks since 2000, imported food-related outbreaks increased to 195 during 2006-2014 from 54 during 1996-2004, with 10,685 illnesses, 1,017 hospitalizations, and 19 deaths since 2009. Also, imported food-related outbreaks rose from a mean 3 per year pre-2000 to a mean 18 per year during 2009-2014. Most imported food outbreaks (86% of total) had three causes: scombroid toxin (42% of total), Salmonella (33%), and hepatitis A virus (11%).

Geographic source, outbreak locations

The origin was known in 91% of outbreaks. Latin America and the Caribbean were most common, followed by Asia.³ Main contributing countries were Mexico (42 outbreaks), Indonesia (17) and Canada (11).

Contaminated fish/shellfish originated from all regions except Europe, most commonly from Asia (the majority of fish/shellfish outbreaks were from Indonesia, Vietnam, China, Philippines, Taiwan, and Thailand) with smaller contributions from the Bahamas and Ecuador.

Contaminated produce originated from all regions, mostly (64%) from Mexico and the Americas (Chile, Guatemala, and Honduras). All but one dairy outbreak originated in Latin America/the Caribbean.³ Outbreaks occurred in 31 states, most commonly California (30), Florida (25), and New York (16). Additionally, 43 (22%) were multistate outbreaks.

Conclusions

Outbreaks from domestic foods decreased, but those from imported foods increased. This makes sense given recent increases in outbreak-prone food imports, such as seafood/fish and produce.

To reduce overall foodborne illness outbreaks, governmental agencies need to:

• Develop/enforce regulations that promote proper growing, handling, and processing of foods.
• Strengthen surveillance networks and share standard culture and molecular detection/characterization protocols to identify outbreaks as close to real time as possible.
• Ensure rapid traceability not only to country of origin but to an exact farm or seafood/fish harvesting entity.
• Provide rapid public knowledge of outbreaks and origins, plus outbreak-specific recommendations to control/minimize resultant illnesses.

Individuals can help protect themselves by avoiding inadequately washed or incompletely cooked foods or foods of uncertain origin.

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics, Kansas City, Mo. He said he had no relevant financial disclosures. Email him at pdnews@frontlinemedcom.com.

References

1. MMWR. 2017 Apr 21;66(15):397-403.

2. Emerg Infect Dis. 2017 Mar;23(3):525-8.

3. Technical appendix in Emerg Infect Dis. 2017 Mar;23(3):525-8.

Are foodborne illness outbreaks more common now, or are we simply better at detection? Have the foods and sources associated with foodborne illness changed? Two recent Centers for Disease Control & Prevention reports provide insight.^1,2 In 2016, the Foodborne Diseases Active Surveillance Network (FoodNet) detected 24,029 infections, 5,212 hospitalizations, and 98 fatalities.¹ FoodNet has 10 sites serving 49 million people (15% of the U.S. population). These 2016 numbers changed only modestly from the 3 prior years.

The big two

The most frequent 2016 foodborne pathogens were Campylobacter and Salmonella, at approximately 8,000 illnesses each, detected by traditional cultures or culture-independent diagnostic tests (CIDTs). (See table.) CIDTs are relatively new molecular-based, mostly multiplex assays that test for more than a dozen pathogens in one assay.

The runners-up

Most of the remainder of the 2016 foodborne illnesses were caused by Shigella, with nearly 3,000 cases; shigatoxin-producing Escherichia coli (STEC), with nearly 2,000 cases; and Cryptosporidium, also with nearly 2,000 cases. (See table.)

Hemolytic uremic syndrome (HUS)

HUS rates, mostly resulting from E. coli 0157 H7 in meat, did not vary from 2013 to 2016, with a total 62 pediatric HUS cases in FoodNet (0.56 /100,000 population). Slightly over half (56%) occurred in children under 5 years old at 1.18 per 100,000 population.

Does CIDT increase detection rates?

Detection of the “big two” did not change from 2013 to 2016 or over the past 2 decades. That said, Campylobacter detection was actually down 11% if considering only culture-confirmed cases. That is, if we do not count detections made exclusively by CIDT.

This is important because CIDT – now supplanting culture in many laboratories – identifies pathogens not likely detected by standard culture because culture is generally selective and CIDT is more sensitive. CIDT can increase detection rates (solo and multiple pathogens), even if illnesses do not really increase. The CDC suggested that this contributed to increased STEC and Yersinia detection in 2016. Some would not have been detected if only culture had been utilized.

Viable bacterial/viral isolates are not available from CIDT. A replicating pathogen is needed to characterize shifting/emerging pathogen strains (for example, analysis for mutations or new pathogens via sequencing or antimicrobial susceptibility testing).

To compensate, some CIDT-using laboratories perform “reflex cultures.” CIDT positive specimens also are cultured to provide viable isolates. However, this adds cost to an already costly CIDT test.

The role of imported food

Surveillance systems, such as the Foodborne Disease Outbreak Surveillance System, also track imported foodborne illness. Despite an approximately 50% decrease in overall U.S. foodborne outbreaks since 2000, imported food-related outbreaks increased to 195 during 2006-2014 from 54 during 1996-2004, with 10,685 illnesses, 1,017 hospitalizations, and 19 deaths since 2009. Also, imported food-related outbreaks rose from a mean 3 per year pre-2000 to a mean 18 per year during 2009-2014. Most imported food outbreaks (86% of total) had three causes: scombroid toxin (42% of total), Salmonella (33%), and hepatitis A virus (11%).

Geographic source, outbreak locations

The origin was known in 91% of outbreaks. Latin America and the Caribbean were most common, followed by Asia.³ Main contributing countries were Mexico (42 outbreaks), Indonesia (17) and Canada (11).

Contaminated fish/shellfish originated from all regions except Europe, most commonly from Asia (the majority of fish/shellfish outbreaks were from Indonesia, Vietnam, China, Philippines, Taiwan, and Thailand) with smaller contributions from the Bahamas and Ecuador.

Contaminated produce originated from all regions, mostly (64%) from Mexico and the Americas (Chile, Guatemala, and Honduras). All but one dairy outbreak originated in Latin America/the Caribbean.³ Outbreaks occurred in 31 states, most commonly California (30), Florida (25), and New York (16). Additionally, 43 (22%) were multistate outbreaks.

Conclusions

Outbreaks from domestic foods decreased, but those from imported foods increased. This makes sense given recent increases in outbreak-prone food imports, such as seafood/fish and produce.

To reduce overall foodborne illness outbreaks, governmental agencies need to:

• Develop/enforce regulations that promote proper growing, handling, and processing of foods.
• Strengthen surveillance networks and share standard culture and molecular detection/characterization protocols to identify outbreaks as close to real time as possible.
• Ensure rapid traceability not only to country of origin but to an exact farm or seafood/fish harvesting entity.
• Provide rapid public knowledge of outbreaks and origins, plus outbreak-specific recommendations to control/minimize resultant illnesses.

Individuals can help protect themselves by avoiding inadequately washed or incompletely cooked foods or foods of uncertain origin.

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics, Kansas City, Mo. He said he had no relevant financial disclosures. Email him at pdnews@frontlinemedcom.com.

References

1. MMWR. 2017 Apr 21;66(15):397-403.

2. Emerg Infect Dis. 2017 Mar;23(3):525-8.

3. Technical appendix in Emerg Infect Dis. 2017 Mar;23(3):525-8.

Are foodborne illness outbreaks more common now, or are we simply better at detection? Have the foods and sources associated with foodborne illness changed? Two recent Centers for Disease Control & Prevention reports provide insight.^1,2 In 2016, the Foodborne Diseases Active Surveillance Network (FoodNet) detected 24,029 infections, 5,212 hospitalizations, and 98 fatalities.¹ FoodNet has 10 sites serving 49 million people (15% of the U.S. population). These 2016 numbers changed only modestly from the 3 prior years.

The big two

The most frequent 2016 foodborne pathogens were Campylobacter and Salmonella, at approximately 8,000 illnesses each, detected by traditional cultures or culture-independent diagnostic tests (CIDTs). (See table.) CIDTs are relatively new molecular-based, mostly multiplex assays that test for more than a dozen pathogens in one assay.

The runners-up

Most of the remainder of the 2016 foodborne illnesses were caused by Shigella, with nearly 3,000 cases; shigatoxin-producing Escherichia coli (STEC), with nearly 2,000 cases; and Cryptosporidium, also with nearly 2,000 cases. (See table.)

Hemolytic uremic syndrome (HUS)

HUS rates, mostly resulting from E. coli 0157 H7 in meat, did not vary from 2013 to 2016, with a total 62 pediatric HUS cases in FoodNet (0.56 /100,000 population). Slightly over half (56%) occurred in children under 5 years old at 1.18 per 100,000 population.

Does CIDT increase detection rates?

Detection of the “big two” did not change from 2013 to 2016 or over the past 2 decades. That said, Campylobacter detection was actually down 11% if considering only culture-confirmed cases. That is, if we do not count detections made exclusively by CIDT.

This is important because CIDT – now supplanting culture in many laboratories – identifies pathogens not likely detected by standard culture because culture is generally selective and CIDT is more sensitive. CIDT can increase detection rates (solo and multiple pathogens), even if illnesses do not really increase. The CDC suggested that this contributed to increased STEC and Yersinia detection in 2016. Some would not have been detected if only culture had been utilized.

Viable bacterial/viral isolates are not available from CIDT. A replicating pathogen is needed to characterize shifting/emerging pathogen strains (for example, analysis for mutations or new pathogens via sequencing or antimicrobial susceptibility testing).

To compensate, some CIDT-using laboratories perform “reflex cultures.” CIDT positive specimens also are cultured to provide viable isolates. However, this adds cost to an already costly CIDT test.

The role of imported food

Surveillance systems, such as the Foodborne Disease Outbreak Surveillance System, also track imported foodborne illness. Despite an approximately 50% decrease in overall U.S. foodborne outbreaks since 2000, imported food-related outbreaks increased to 195 during 2006-2014 from 54 during 1996-2004, with 10,685 illnesses, 1,017 hospitalizations, and 19 deaths since 2009. Also, imported food-related outbreaks rose from a mean 3 per year pre-2000 to a mean 18 per year during 2009-2014. Most imported food outbreaks (86% of total) had three causes: scombroid toxin (42% of total), Salmonella (33%), and hepatitis A virus (11%).

Geographic source, outbreak locations

The origin was known in 91% of outbreaks. Latin America and the Caribbean were most common, followed by Asia.³ Main contributing countries were Mexico (42 outbreaks), Indonesia (17) and Canada (11).

Contaminated fish/shellfish originated from all regions except Europe, most commonly from Asia (the majority of fish/shellfish outbreaks were from Indonesia, Vietnam, China, Philippines, Taiwan, and Thailand) with smaller contributions from the Bahamas and Ecuador.

Contaminated produce originated from all regions, mostly (64%) from Mexico and the Americas (Chile, Guatemala, and Honduras). All but one dairy outbreak originated in Latin America/the Caribbean.³ Outbreaks occurred in 31 states, most commonly California (30), Florida (25), and New York (16). Additionally, 43 (22%) were multistate outbreaks.

Conclusions

Outbreaks from domestic foods decreased, but those from imported foods increased. This makes sense given recent increases in outbreak-prone food imports, such as seafood/fish and produce.

To reduce overall foodborne illness outbreaks, governmental agencies need to:

• Develop/enforce regulations that promote proper growing, handling, and processing of foods.
• Strengthen surveillance networks and share standard culture and molecular detection/characterization protocols to identify outbreaks as close to real time as possible.
• Ensure rapid traceability not only to country of origin but to an exact farm or seafood/fish harvesting entity.
• Provide rapid public knowledge of outbreaks and origins, plus outbreak-specific recommendations to control/minimize resultant illnesses.

Individuals can help protect themselves by avoiding inadequately washed or incompletely cooked foods or foods of uncertain origin.

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics, Kansas City, Mo. He said he had no relevant financial disclosures. Email him at pdnews@frontlinemedcom.com.

References

1. MMWR. 2017 Apr 21;66(15):397-403.

2. Emerg Infect Dis. 2017 Mar;23(3):525-8.

3. Technical appendix in Emerg Infect Dis. 2017 Mar;23(3):525-8.

BOSTON – Data show a marked bias in referral patterns for coronary revascularization in stand-alone interventional cardiology units lacking a heart team.

More patients underwent percutaneous coronary intervention (PCI) in hospitals without on-site cardiac surgery than patients at hospitals with on-site cardiac surgery, according to the analysis presented at the annual meeting of the American Association for Thoracic Surgery. The multivariate logistic regression analysis showed that the absence of on-site cardiac surgery and a heart team was an independent predictor for PCI.

In this video, Ehud Raanani, MD, of Tel Aviv University in Israel discusses referral patterns for coronary revascularization in stand-alone interventional cardiology units lacking a heart team and how this phenomenon could affect patients.

agallegos@frontlinemedcom.com

On Twitter @legal_med

BOSTON – Data show a marked bias in referral patterns for coronary revascularization in stand-alone interventional cardiology units lacking a heart team.

More patients underwent percutaneous coronary intervention (PCI) in hospitals without on-site cardiac surgery than patients at hospitals with on-site cardiac surgery, according to the analysis presented at the annual meeting of the American Association for Thoracic Surgery. The multivariate logistic regression analysis showed that the absence of on-site cardiac surgery and a heart team was an independent predictor for PCI.

In this video, Ehud Raanani, MD, of Tel Aviv University in Israel discusses referral patterns for coronary revascularization in stand-alone interventional cardiology units lacking a heart team and how this phenomenon could affect patients.

agallegos@frontlinemedcom.com

On Twitter @legal_med

BOSTON – Data show a marked bias in referral patterns for coronary revascularization in stand-alone interventional cardiology units lacking a heart team.

More patients underwent percutaneous coronary intervention (PCI) in hospitals without on-site cardiac surgery than patients at hospitals with on-site cardiac surgery, according to the analysis presented at the annual meeting of the American Association for Thoracic Surgery. The multivariate logistic regression analysis showed that the absence of on-site cardiac surgery and a heart team was an independent predictor for PCI.

In this video, Ehud Raanani, MD, of Tel Aviv University in Israel discusses referral patterns for coronary revascularization in stand-alone interventional cardiology units lacking a heart team and how this phenomenon could affect patients.

agallegos@frontlinemedcom.com

On Twitter @legal_med

VANCOUVER – Interdisciplinary care for women with deep dyspareunia led to a reduction in severe cases, but had no effect on superficial dyspareunia, a study showed.

The findings were measured after 1 year in a treatment program that included laparoscopic surgery, hormonal suppression, biofeedback, pelvic floor physiotherapy, cognitive-behavioral therapy, and mindfulness-based therapy.

About half of women with endometriosis experience deep dyspareunia, which can have a strong, negative impact on quality of life and relationships, Paul Yong, MD, PhD, reported at the World Congress on Endometriosis. For women who do not respond to surgical or medical interventions, interdisciplinary approaches that address the biopsychosocial aspect of pain in endometriosis could be of benefit, he said.

VANCOUVER – Interdisciplinary care for women with deep dyspareunia led to a reduction in severe cases, but had no effect on superficial dyspareunia, a study showed.

The findings were measured after 1 year in a treatment program that included laparoscopic surgery, hormonal suppression, biofeedback, pelvic floor physiotherapy, cognitive-behavioral therapy, and mindfulness-based therapy.

About half of women with endometriosis experience deep dyspareunia, which can have a strong, negative impact on quality of life and relationships, Paul Yong, MD, PhD, reported at the World Congress on Endometriosis. For women who do not respond to surgical or medical interventions, interdisciplinary approaches that address the biopsychosocial aspect of pain in endometriosis could be of benefit, he said.

VANCOUVER – Interdisciplinary care for women with deep dyspareunia led to a reduction in severe cases, but had no effect on superficial dyspareunia, a study showed.

The findings were measured after 1 year in a treatment program that included laparoscopic surgery, hormonal suppression, biofeedback, pelvic floor physiotherapy, cognitive-behavioral therapy, and mindfulness-based therapy.

About half of women with endometriosis experience deep dyspareunia, which can have a strong, negative impact on quality of life and relationships, Paul Yong, MD, PhD, reported at the World Congress on Endometriosis. For women who do not respond to surgical or medical interventions, interdisciplinary approaches that address the biopsychosocial aspect of pain in endometriosis could be of benefit, he said.

PORTLAND, ORE. – Among white men, the presence of at least one cutaneous nevus measuring 3 mm or more significantly predicted death from melanoma, in an adjusted analysis of a large prospective cohort study.

Mole count also predicted melanoma death among white women, but the association reached statistical significance only when women had at least three cutaneous nevi measuring 3 mm or more, Eunyoung Cho, ScD, said at the annual meeting of the Society for Investigative Dermatology. The reasons why these associations varied by sex is unclear, although previous studies have documented higher rates of melanoma death among men than among women, and even male physicians tend to seek health care less frequently than their female counterparts, Dr. Cho said in her poster presentation.

PORTLAND, ORE. – Among white men, the presence of at least one cutaneous nevus measuring 3 mm or more significantly predicted death from melanoma, in an adjusted analysis of a large prospective cohort study.

Mole count also predicted melanoma death among white women, but the association reached statistical significance only when women had at least three cutaneous nevi measuring 3 mm or more, Eunyoung Cho, ScD, said at the annual meeting of the Society for Investigative Dermatology. The reasons why these associations varied by sex is unclear, although previous studies have documented higher rates of melanoma death among men than among women, and even male physicians tend to seek health care less frequently than their female counterparts, Dr. Cho said in her poster presentation.

PORTLAND, ORE. – Among white men, the presence of at least one cutaneous nevus measuring 3 mm or more significantly predicted death from melanoma, in an adjusted analysis of a large prospective cohort study.

Mole count also predicted melanoma death among white women, but the association reached statistical significance only when women had at least three cutaneous nevi measuring 3 mm or more, Eunyoung Cho, ScD, said at the annual meeting of the Society for Investigative Dermatology. The reasons why these associations varied by sex is unclear, although previous studies have documented higher rates of melanoma death among men than among women, and even male physicians tend to seek health care less frequently than their female counterparts, Dr. Cho said in her poster presentation.

Patients buying health insurance through an Affordable Care Act health insurance exchange will no longer have to complete the transaction via HealthCare.gov.

The move is intended to help bring stability to the health insurance market, Seema Verma, administrator of the Centers for Medicare & Medicaid Services, said in a statement.

“It is common sense to make it as simple and easy as possible for consumers to shop for and access health coverage,” she said. “It is time to get the federal government out of the way and give patients the best tools to make their own health care decision.”

The change will take effect with the open enrollment period for the 2018 coverage year.

Since the beginning of the health insurance exchanges, patients were required to complete their coverage applications via HealthCare.gov. Feedback from users indicated that “the process was confusing and made it harder to complete the application,” Ms. Verma said in a statement.

The move comes as the Republican-led Congress and the Trump Administration seek to repeal and replace the ACA. This move would deemphasize the government’s role in providing coverage as consumers could potentially avoid contact with HealthCare.gov altogether if they are using a third party to purchase coverage.

gtwachtman@frontlinemedcom.com

Patients buying health insurance through an Affordable Care Act health insurance exchange will no longer have to complete the transaction via HealthCare.gov.

The move is intended to help bring stability to the health insurance market, Seema Verma, administrator of the Centers for Medicare & Medicaid Services, said in a statement.

“It is common sense to make it as simple and easy as possible for consumers to shop for and access health coverage,” she said. “It is time to get the federal government out of the way and give patients the best tools to make their own health care decision.”

The change will take effect with the open enrollment period for the 2018 coverage year.

Since the beginning of the health insurance exchanges, patients were required to complete their coverage applications via HealthCare.gov. Feedback from users indicated that “the process was confusing and made it harder to complete the application,” Ms. Verma said in a statement.

The move comes as the Republican-led Congress and the Trump Administration seek to repeal and replace the ACA. This move would deemphasize the government’s role in providing coverage as consumers could potentially avoid contact with HealthCare.gov altogether if they are using a third party to purchase coverage.

gtwachtman@frontlinemedcom.com

Patients buying health insurance through an Affordable Care Act health insurance exchange will no longer have to complete the transaction via HealthCare.gov.

The move is intended to help bring stability to the health insurance market, Seema Verma, administrator of the Centers for Medicare & Medicaid Services, said in a statement.

“It is common sense to make it as simple and easy as possible for consumers to shop for and access health coverage,” she said. “It is time to get the federal government out of the way and give patients the best tools to make their own health care decision.”

The change will take effect with the open enrollment period for the 2018 coverage year.

Since the beginning of the health insurance exchanges, patients were required to complete their coverage applications via HealthCare.gov. Feedback from users indicated that “the process was confusing and made it harder to complete the application,” Ms. Verma said in a statement.

The move comes as the Republican-led Congress and the Trump Administration seek to repeal and replace the ACA. This move would deemphasize the government’s role in providing coverage as consumers could potentially avoid contact with HealthCare.gov altogether if they are using a third party to purchase coverage.

gtwachtman@frontlinemedcom.com

As telemedicine gains momentum, more health providers are moving from stand-alone programs to system-wide approaches.

In a survey of 436 U.S. health care executives, physicians, nurses, hospitals, and other health professionals, 25% of respondents with a telemedicine program began with a departmental approach but are now shifting to an enterprise system, 39% had an established enterprise system, and 36% remain with a departmental basis.

The survey of health care professionals’ priorities, objectives, challenges, and telemedicine models of care was conducted between December 2016 and January 2017 for REACH Health, a telemedicine software company.

Fifty-one percent of respondents reported that telemedicine is a top priority or high priority, a decrease from last year’s survey in which 66% of respondents said so. This shift could be linked to a continuing evolution and maturation of telemedicine as more programs move from ad-hoc project status to mainstream service, according to the report.

The telemedicine features most valuable to health providers were clinical documentation, the ability to send documentation to/from the electronic medical record, and the ability to analyze consult data. For the second year, health providers rated their top three telemedicine objectives as: improving patient outcomes, improving patient convenience, and increasing patient engagement.

Overall, health providers responded that the possible repeal and replacement of the Affordable Care Act would be positive for telemedicine. Forty-one percent of respondents said that patient adoption and the use of telemedicine would increase with ACA repeal/replace and 40% of health providers said that internal adoption and use of telemedicine would rise with replacement of the health law.

Just under half (47%) said they were uncertain how health care law changes would impact telemedicine parity laws, and 45% were unsure how repeal and replace would affect Medicare and Medicaid reimbursement for telemedicine services.

agallegos@frontlinemedcom.com

On Twitter @legal_med

As telemedicine gains momentum, more health providers are moving from stand-alone programs to system-wide approaches.

In a survey of 436 U.S. health care executives, physicians, nurses, hospitals, and other health professionals, 25% of respondents with a telemedicine program began with a departmental approach but are now shifting to an enterprise system, 39% had an established enterprise system, and 36% remain with a departmental basis.

The survey of health care professionals’ priorities, objectives, challenges, and telemedicine models of care was conducted between December 2016 and January 2017 for REACH Health, a telemedicine software company.

Fifty-one percent of respondents reported that telemedicine is a top priority or high priority, a decrease from last year’s survey in which 66% of respondents said so. This shift could be linked to a continuing evolution and maturation of telemedicine as more programs move from ad-hoc project status to mainstream service, according to the report.

The telemedicine features most valuable to health providers were clinical documentation, the ability to send documentation to/from the electronic medical record, and the ability to analyze consult data. For the second year, health providers rated their top three telemedicine objectives as: improving patient outcomes, improving patient convenience, and increasing patient engagement.

Overall, health providers responded that the possible repeal and replacement of the Affordable Care Act would be positive for telemedicine. Forty-one percent of respondents said that patient adoption and the use of telemedicine would increase with ACA repeal/replace and 40% of health providers said that internal adoption and use of telemedicine would rise with replacement of the health law.

Just under half (47%) said they were uncertain how health care law changes would impact telemedicine parity laws, and 45% were unsure how repeal and replace would affect Medicare and Medicaid reimbursement for telemedicine services.

agallegos@frontlinemedcom.com

On Twitter @legal_med

As telemedicine gains momentum, more health providers are moving from stand-alone programs to system-wide approaches.

In a survey of 436 U.S. health care executives, physicians, nurses, hospitals, and other health professionals, 25% of respondents with a telemedicine program began with a departmental approach but are now shifting to an enterprise system, 39% had an established enterprise system, and 36% remain with a departmental basis.

The survey of health care professionals’ priorities, objectives, challenges, and telemedicine models of care was conducted between December 2016 and January 2017 for REACH Health, a telemedicine software company.

Fifty-one percent of respondents reported that telemedicine is a top priority or high priority, a decrease from last year’s survey in which 66% of respondents said so. This shift could be linked to a continuing evolution and maturation of telemedicine as more programs move from ad-hoc project status to mainstream service, according to the report.

The telemedicine features most valuable to health providers were clinical documentation, the ability to send documentation to/from the electronic medical record, and the ability to analyze consult data. For the second year, health providers rated their top three telemedicine objectives as: improving patient outcomes, improving patient convenience, and increasing patient engagement.

Overall, health providers responded that the possible repeal and replacement of the Affordable Care Act would be positive for telemedicine. Forty-one percent of respondents said that patient adoption and the use of telemedicine would increase with ACA repeal/replace and 40% of health providers said that internal adoption and use of telemedicine would rise with replacement of the health law.

Just under half (47%) said they were uncertain how health care law changes would impact telemedicine parity laws, and 45% were unsure how repeal and replace would affect Medicare and Medicaid reimbursement for telemedicine services.

agallegos@frontlinemedcom.com

On Twitter @legal_med