Researchers have used functional MRI to identify key differences between individuals with depression who respond to cognitive-behavioral therapy and those who don’t.

In a paper published in Science Advances, Filippo Queirazza, MD, PhD, and coauthors reported the outcomes of a study of 37 individuals with untreated depression who took part in an online, self-guided cognitive-behavioral therapy (CBT) program.

The participants – 18 of whom were women – attended an appointment before and 2 months after completing the therapy program, at which they were clinically evaluated by a psychiatrist, and underwent fMRI scanning. Only 26 subjects completed the program and attended the posttreatment appointment, wrote Dr. Queirazza of the Institute of Neuroscience and Psychology at the University of Glasgow, Scotland.

Overall, about half the participants responded to the CBT, and the average posttreatment improvement in the Beck Depression Inventory-II (BDI-II) score was about 62%.

To look for indication of treatment response in fMRI scanning, researchers got participants to do a series of reverse-learning tasks while they were being scanned. That activity involved learning which of two stimuli gave the highest payoff rate.

“The choice of a relevant generative model in MDD is dictated by a wealth of behavioral and neural findings, suggesting that learning from positive (reward) and negative (punishment) feedback [also known as reinforcement learning] is substantially impaired in depressed subjects,” the authors wrote.

The imaging suggested that individuals who responded showed more pretreatment neural activity in areas of the brain that deal with the acquisition and processing of feedback information, and that the level of activity was in proportion to the magnitude of their later treatment response.

They also found that activity in right striatum was best at discriminating responders from nonresponders. Based on their findings, they were able to predict responders as well as did pretreatment BDI-II scores.

“Our finding that neural activity in the right striatum is positively correlated with CBT response is consistent with a previous report that, in a group of adolescents with depression, greater pretreatment striatal responses to both anticipation and presentation of positive feedback during a monetary reward task were linked to posttreatment reduction in depression severity, particularly of anxiety symptoms,” they wrote.

The study was supported by several entities, including the Chief Scientist Office and the Dr Mortimer and Theresa Sackler Foundation. No competing interests were declared.

SOURCE: Queirazza F et al. Sci Adv. 2019 Jul 31. doi: 10.1126/sciadv.aav4962.

Researchers have used functional MRI to identify key differences between individuals with depression who respond to cognitive-behavioral therapy and those who don’t.

In a paper published in Science Advances, Filippo Queirazza, MD, PhD, and coauthors reported the outcomes of a study of 37 individuals with untreated depression who took part in an online, self-guided cognitive-behavioral therapy (CBT) program.

The participants – 18 of whom were women – attended an appointment before and 2 months after completing the therapy program, at which they were clinically evaluated by a psychiatrist, and underwent fMRI scanning. Only 26 subjects completed the program and attended the posttreatment appointment, wrote Dr. Queirazza of the Institute of Neuroscience and Psychology at the University of Glasgow, Scotland.

Overall, about half the participants responded to the CBT, and the average posttreatment improvement in the Beck Depression Inventory-II (BDI-II) score was about 62%.

To look for indication of treatment response in fMRI scanning, researchers got participants to do a series of reverse-learning tasks while they were being scanned. That activity involved learning which of two stimuli gave the highest payoff rate.

“The choice of a relevant generative model in MDD is dictated by a wealth of behavioral and neural findings, suggesting that learning from positive (reward) and negative (punishment) feedback [also known as reinforcement learning] is substantially impaired in depressed subjects,” the authors wrote.

The imaging suggested that individuals who responded showed more pretreatment neural activity in areas of the brain that deal with the acquisition and processing of feedback information, and that the level of activity was in proportion to the magnitude of their later treatment response.

They also found that activity in right striatum was best at discriminating responders from nonresponders. Based on their findings, they were able to predict responders as well as did pretreatment BDI-II scores.

“Our finding that neural activity in the right striatum is positively correlated with CBT response is consistent with a previous report that, in a group of adolescents with depression, greater pretreatment striatal responses to both anticipation and presentation of positive feedback during a monetary reward task were linked to posttreatment reduction in depression severity, particularly of anxiety symptoms,” they wrote.

The study was supported by several entities, including the Chief Scientist Office and the Dr Mortimer and Theresa Sackler Foundation. No competing interests were declared.

SOURCE: Queirazza F et al. Sci Adv. 2019 Jul 31. doi: 10.1126/sciadv.aav4962.

Researchers have used functional MRI to identify key differences between individuals with depression who respond to cognitive-behavioral therapy and those who don’t.

In a paper published in Science Advances, Filippo Queirazza, MD, PhD, and coauthors reported the outcomes of a study of 37 individuals with untreated depression who took part in an online, self-guided cognitive-behavioral therapy (CBT) program.

The participants – 18 of whom were women – attended an appointment before and 2 months after completing the therapy program, at which they were clinically evaluated by a psychiatrist, and underwent fMRI scanning. Only 26 subjects completed the program and attended the posttreatment appointment, wrote Dr. Queirazza of the Institute of Neuroscience and Psychology at the University of Glasgow, Scotland.

Overall, about half the participants responded to the CBT, and the average posttreatment improvement in the Beck Depression Inventory-II (BDI-II) score was about 62%.

To look for indication of treatment response in fMRI scanning, researchers got participants to do a series of reverse-learning tasks while they were being scanned. That activity involved learning which of two stimuli gave the highest payoff rate.

“The choice of a relevant generative model in MDD is dictated by a wealth of behavioral and neural findings, suggesting that learning from positive (reward) and negative (punishment) feedback [also known as reinforcement learning] is substantially impaired in depressed subjects,” the authors wrote.

The imaging suggested that individuals who responded showed more pretreatment neural activity in areas of the brain that deal with the acquisition and processing of feedback information, and that the level of activity was in proportion to the magnitude of their later treatment response.

They also found that activity in right striatum was best at discriminating responders from nonresponders. Based on their findings, they were able to predict responders as well as did pretreatment BDI-II scores.

“Our finding that neural activity in the right striatum is positively correlated with CBT response is consistent with a previous report that, in a group of adolescents with depression, greater pretreatment striatal responses to both anticipation and presentation of positive feedback during a monetary reward task were linked to posttreatment reduction in depression severity, particularly of anxiety symptoms,” they wrote.

The study was supported by several entities, including the Chief Scientist Office and the Dr Mortimer and Theresa Sackler Foundation. No competing interests were declared.

SOURCE: Queirazza F et al. Sci Adv. 2019 Jul 31. doi: 10.1126/sciadv.aav4962.

The human placenta does not have a microbiome, and bacterial placental infection is not a common cause of adverse pregnancy outcomes such as preeclampsia or spontaneous preterm birth, a study has found.

dimarik/Getty Images

Dr. Marcus C. de Goffau, of Wellcome Sanger Institute, Cambridge, England, and coauthors wrote that placental dysfunction is linked to a number of common adverse pregnancy outcomes, but in many cases the cause of that dysfunction is unknown.

“Several studies have used sequencing-based methods for bacterial detection (metagenomics and 16S rRNA gene amplicon sequencing), and have concluded that the placenta is physiologically colonized by a diverse population of bacteria (the ‘placental microbiome’) and that the nature of this colonization may differ between healthy and complicated pregnancies,” they wrote.

In a paper published in the July 31 edition of Nature (doi: 10.1038/s41586-019-1451-5), researchers reported the outcomes of a study involving two cohorts. The first included 80 babies delivered by prelabor caesarean section, of whom 20 were small for gestational age, 20 were delivered to mothers with preeclampsia, and 40 were matched controls. The second cohort comprised 100 patients with preeclampsia, 100 small-for-gestational-age infants, 100 preterm births, and 198 matched controls, with two controls having been used twice.

The bacterial content of the placentas was analyzed via deep metagenomic sequencing of total DNA and 16S rRNA gene amplicon sequencing in cohort 1, and 16S rRNA gene amplicon from two different kits for cohort 2’s samples. In the first cohort, samples were also spiked with Salmonella bongori as a positive control.

For cohort 1, researchers were able to detect the S. bongori in all samples, but all other bacterial signals showed clear links to different batches, which the authors said showed they were the result of contamination. This was further supported by the discovery that the Escherichia coli signal seen in a number of batches was all from the same bacterial strain.

In the second cohort, researchers found Bradyrhizobium in nearly all samples, and Burkholderia – which has been thought to play a role in preterm birth – in some samples.

However in the case of the Burkholderia, significant variation between different runs of tests was found, and both Bradyrhizobium and Burkholderia were also found in negative controls.

Researchers also saw a high prevalence of four “ecologically unexpected” bacterial groups but were able to show that these were likely contaminants from a reagent used to wash the placental samples.

The study found that vaginal organisms such as lactobacilli and vaginosis-associated bacteria were more abundant in the second cohort, where babies were delivered by a mix of vaginal, intrapartum and prelabor caesarean section, compared with the first cohort, who were all prelabor caesarean section deliveries.

The only organism that met all the criteria for a genuine placenta-associated bacterial signal was Streptococcus agalactiae, but the authors found no association between it and pregnancy outcomes.

However, they did sound a warning that the perinatal transmission of S. agalactiae from the mother’s genital tract to the neonate could be a cause of fatal sepsis in the infant.

“Further studies will be required to determine the association between the presence of the organism in the placenta and fetal or neonatal disease,” they wrote.

The researchers also found significant associations between the delivery-associated vaginal bacteria Lactobacillus iners and preeclampsia, and between Streptococcus anginosus and the Ureaplasma genus – both of which are associated with vaginosis – and preterm birth.

“We conclude that bacterial placental infection is not a major cause of placentally related complications of human pregnancy and that the human placenta does not have a resident microbiome,” the authors wrote. “Although we see no evidence of a placental microbiome, the frequency of detection of vaginal bacteria in the placenta increased after intrapartum [cesarean] section, suggesting ascending or haematogenous spread.”

The Medical Research Council and the National Institute for Health Research Cambridge Biomedical Research Centre supported the study. Five authors declared grants and support from private industry outside the submitted work.

SOURCE: de Goffau M et al. Nature. 2019 Jul 31. doi: 10.1038/s41586-019-1451-5.

The human placenta does not have a microbiome, and bacterial placental infection is not a common cause of adverse pregnancy outcomes such as preeclampsia or spontaneous preterm birth, a study has found.

dimarik/Getty Images

Dr. Marcus C. de Goffau, of Wellcome Sanger Institute, Cambridge, England, and coauthors wrote that placental dysfunction is linked to a number of common adverse pregnancy outcomes, but in many cases the cause of that dysfunction is unknown.

“Several studies have used sequencing-based methods for bacterial detection (metagenomics and 16S rRNA gene amplicon sequencing), and have concluded that the placenta is physiologically colonized by a diverse population of bacteria (the ‘placental microbiome’) and that the nature of this colonization may differ between healthy and complicated pregnancies,” they wrote.

In a paper published in the July 31 edition of Nature (doi: 10.1038/s41586-019-1451-5), researchers reported the outcomes of a study involving two cohorts. The first included 80 babies delivered by prelabor caesarean section, of whom 20 were small for gestational age, 20 were delivered to mothers with preeclampsia, and 40 were matched controls. The second cohort comprised 100 patients with preeclampsia, 100 small-for-gestational-age infants, 100 preterm births, and 198 matched controls, with two controls having been used twice.

The bacterial content of the placentas was analyzed via deep metagenomic sequencing of total DNA and 16S rRNA gene amplicon sequencing in cohort 1, and 16S rRNA gene amplicon from two different kits for cohort 2’s samples. In the first cohort, samples were also spiked with Salmonella bongori as a positive control.

For cohort 1, researchers were able to detect the S. bongori in all samples, but all other bacterial signals showed clear links to different batches, which the authors said showed they were the result of contamination. This was further supported by the discovery that the Escherichia coli signal seen in a number of batches was all from the same bacterial strain.

In the second cohort, researchers found Bradyrhizobium in nearly all samples, and Burkholderia – which has been thought to play a role in preterm birth – in some samples.

However in the case of the Burkholderia, significant variation between different runs of tests was found, and both Bradyrhizobium and Burkholderia were also found in negative controls.

Researchers also saw a high prevalence of four “ecologically unexpected” bacterial groups but were able to show that these were likely contaminants from a reagent used to wash the placental samples.

The study found that vaginal organisms such as lactobacilli and vaginosis-associated bacteria were more abundant in the second cohort, where babies were delivered by a mix of vaginal, intrapartum and prelabor caesarean section, compared with the first cohort, who were all prelabor caesarean section deliveries.

The only organism that met all the criteria for a genuine placenta-associated bacterial signal was Streptococcus agalactiae, but the authors found no association between it and pregnancy outcomes.

However, they did sound a warning that the perinatal transmission of S. agalactiae from the mother’s genital tract to the neonate could be a cause of fatal sepsis in the infant.

“Further studies will be required to determine the association between the presence of the organism in the placenta and fetal or neonatal disease,” they wrote.

The researchers also found significant associations between the delivery-associated vaginal bacteria Lactobacillus iners and preeclampsia, and between Streptococcus anginosus and the Ureaplasma genus – both of which are associated with vaginosis – and preterm birth.

“We conclude that bacterial placental infection is not a major cause of placentally related complications of human pregnancy and that the human placenta does not have a resident microbiome,” the authors wrote. “Although we see no evidence of a placental microbiome, the frequency of detection of vaginal bacteria in the placenta increased after intrapartum [cesarean] section, suggesting ascending or haematogenous spread.”

The Medical Research Council and the National Institute for Health Research Cambridge Biomedical Research Centre supported the study. Five authors declared grants and support from private industry outside the submitted work.

SOURCE: de Goffau M et al. Nature. 2019 Jul 31. doi: 10.1038/s41586-019-1451-5.

The human placenta does not have a microbiome, and bacterial placental infection is not a common cause of adverse pregnancy outcomes such as preeclampsia or spontaneous preterm birth, a study has found.

dimarik/Getty Images

Dr. Marcus C. de Goffau, of Wellcome Sanger Institute, Cambridge, England, and coauthors wrote that placental dysfunction is linked to a number of common adverse pregnancy outcomes, but in many cases the cause of that dysfunction is unknown.

“Several studies have used sequencing-based methods for bacterial detection (metagenomics and 16S rRNA gene amplicon sequencing), and have concluded that the placenta is physiologically colonized by a diverse population of bacteria (the ‘placental microbiome’) and that the nature of this colonization may differ between healthy and complicated pregnancies,” they wrote.

In a paper published in the July 31 edition of Nature (doi: 10.1038/s41586-019-1451-5), researchers reported the outcomes of a study involving two cohorts. The first included 80 babies delivered by prelabor caesarean section, of whom 20 were small for gestational age, 20 were delivered to mothers with preeclampsia, and 40 were matched controls. The second cohort comprised 100 patients with preeclampsia, 100 small-for-gestational-age infants, 100 preterm births, and 198 matched controls, with two controls having been used twice.

The bacterial content of the placentas was analyzed via deep metagenomic sequencing of total DNA and 16S rRNA gene amplicon sequencing in cohort 1, and 16S rRNA gene amplicon from two different kits for cohort 2’s samples. In the first cohort, samples were also spiked with Salmonella bongori as a positive control.

For cohort 1, researchers were able to detect the S. bongori in all samples, but all other bacterial signals showed clear links to different batches, which the authors said showed they were the result of contamination. This was further supported by the discovery that the Escherichia coli signal seen in a number of batches was all from the same bacterial strain.

In the second cohort, researchers found Bradyrhizobium in nearly all samples, and Burkholderia – which has been thought to play a role in preterm birth – in some samples.

However in the case of the Burkholderia, significant variation between different runs of tests was found, and both Bradyrhizobium and Burkholderia were also found in negative controls.

Researchers also saw a high prevalence of four “ecologically unexpected” bacterial groups but were able to show that these were likely contaminants from a reagent used to wash the placental samples.

The study found that vaginal organisms such as lactobacilli and vaginosis-associated bacteria were more abundant in the second cohort, where babies were delivered by a mix of vaginal, intrapartum and prelabor caesarean section, compared with the first cohort, who were all prelabor caesarean section deliveries.

The only organism that met all the criteria for a genuine placenta-associated bacterial signal was Streptococcus agalactiae, but the authors found no association between it and pregnancy outcomes.

However, they did sound a warning that the perinatal transmission of S. agalactiae from the mother’s genital tract to the neonate could be a cause of fatal sepsis in the infant.

“Further studies will be required to determine the association between the presence of the organism in the placenta and fetal or neonatal disease,” they wrote.

The researchers also found significant associations between the delivery-associated vaginal bacteria Lactobacillus iners and preeclampsia, and between Streptococcus anginosus and the Ureaplasma genus – both of which are associated with vaginosis – and preterm birth.

“We conclude that bacterial placental infection is not a major cause of placentally related complications of human pregnancy and that the human placenta does not have a resident microbiome,” the authors wrote. “Although we see no evidence of a placental microbiome, the frequency of detection of vaginal bacteria in the placenta increased after intrapartum [cesarean] section, suggesting ascending or haematogenous spread.”

The Medical Research Council and the National Institute for Health Research Cambridge Biomedical Research Centre supported the study. Five authors declared grants and support from private industry outside the submitted work.

SOURCE: de Goffau M et al. Nature. 2019 Jul 31. doi: 10.1038/s41586-019-1451-5.

Relapsed multiple myeloma becomes increasingly aggressive and difficult to treat with each additional TP53 alteration, according to investigators.

Findings from the study help illuminate the mechanics of myeloma disease progression and demonstrate the value of clonal competition assays, reported lead author Umair Munawar of the University Hospital Würzburg (Germany) and colleagues.

“The implications of mono-allelic TP53 lesions for the clinical outcome remain controversial, but clonal selection and evolution is a common feature of myeloma progression, and patients with TP53 wild-type or mono-allelic inactivation may present a double hit on relapse,” the investigators wrote in Blood. “Here, we addressed the hypothesis that sequential acquisition of TP53 hits lead to a gain of proliferative fitness of [multiple myeloma] cancer cells, inducing the expansion and domination of the affected clones within the patient’s bone marrow.”

The investigators used sleeping beauty and CRISPR/Cas9 techniques to create double- and single-hit multiple myeloma cell lines that were stably transfected with fluorescent proteins. By observing coculture pairings of wild-type, single-hit, and double-hit cells, the investigators found a hierarchy of proliferation that depended on the number of TP53 alterations. For instance, when double-hit cells were cocultured with wild-type cells in a 1:3 ratio, it took 21 days for the double-hit cells to reach 50% of the total culture population. Similarly, single-hit cells outcompeted wild-type cells after 38 days, while double-hit cells took 35 days to overcome the single-hit population.

Further testing showed that comparatively smaller initial populations of TP53-aberrant cells required longer to outcompete larger wild-type populations, which could explain why deeper responses in the clinic are often followed by longer periods without disease progression, the investigators suggested.

A comparison of transcriptomes between wild-type cells and TP53 mutants revealed differences in about 900 genes, including 14 signaling pathways. Specifically, downregulation impacted antigen processing and presentation, chemokine signaling, and oxidative phosphorylation.

“These differences on the transcriptomic level well reflect the biology of ultra–high risk disease,” the investigators wrote, referring to increased glucose uptake on PET, resistance to immunotherapies, and extramedullary disease.

“[This study] underscores the power of clonal competition assays to decipher the effect of genomic lesions in tumors to better understand their impact on progression and disease relapse in [multiple myeloma],” the investigators concluded.

The study was funded by Deutsche Forschungsgemeinschaft, the CDW Stiftung, and the IZKF Würzburg. The investigators reported additional support from the CRIS foundation, the German Cancer Aid, and the University of Würzburg.

SOURCE: Munawar U et al. Blood. 2019 Jul 24. doi: 10.1182/blood.2019000080.

Relapsed multiple myeloma becomes increasingly aggressive and difficult to treat with each additional TP53 alteration, according to investigators.

Findings from the study help illuminate the mechanics of myeloma disease progression and demonstrate the value of clonal competition assays, reported lead author Umair Munawar of the University Hospital Würzburg (Germany) and colleagues.

“The implications of mono-allelic TP53 lesions for the clinical outcome remain controversial, but clonal selection and evolution is a common feature of myeloma progression, and patients with TP53 wild-type or mono-allelic inactivation may present a double hit on relapse,” the investigators wrote in Blood. “Here, we addressed the hypothesis that sequential acquisition of TP53 hits lead to a gain of proliferative fitness of [multiple myeloma] cancer cells, inducing the expansion and domination of the affected clones within the patient’s bone marrow.”

The investigators used sleeping beauty and CRISPR/Cas9 techniques to create double- and single-hit multiple myeloma cell lines that were stably transfected with fluorescent proteins. By observing coculture pairings of wild-type, single-hit, and double-hit cells, the investigators found a hierarchy of proliferation that depended on the number of TP53 alterations. For instance, when double-hit cells were cocultured with wild-type cells in a 1:3 ratio, it took 21 days for the double-hit cells to reach 50% of the total culture population. Similarly, single-hit cells outcompeted wild-type cells after 38 days, while double-hit cells took 35 days to overcome the single-hit population.

Further testing showed that comparatively smaller initial populations of TP53-aberrant cells required longer to outcompete larger wild-type populations, which could explain why deeper responses in the clinic are often followed by longer periods without disease progression, the investigators suggested.

A comparison of transcriptomes between wild-type cells and TP53 mutants revealed differences in about 900 genes, including 14 signaling pathways. Specifically, downregulation impacted antigen processing and presentation, chemokine signaling, and oxidative phosphorylation.

“These differences on the transcriptomic level well reflect the biology of ultra–high risk disease,” the investigators wrote, referring to increased glucose uptake on PET, resistance to immunotherapies, and extramedullary disease.

“[This study] underscores the power of clonal competition assays to decipher the effect of genomic lesions in tumors to better understand their impact on progression and disease relapse in [multiple myeloma],” the investigators concluded.

The study was funded by Deutsche Forschungsgemeinschaft, the CDW Stiftung, and the IZKF Würzburg. The investigators reported additional support from the CRIS foundation, the German Cancer Aid, and the University of Würzburg.

SOURCE: Munawar U et al. Blood. 2019 Jul 24. doi: 10.1182/blood.2019000080.

Relapsed multiple myeloma becomes increasingly aggressive and difficult to treat with each additional TP53 alteration, according to investigators.

Findings from the study help illuminate the mechanics of myeloma disease progression and demonstrate the value of clonal competition assays, reported lead author Umair Munawar of the University Hospital Würzburg (Germany) and colleagues.

“The implications of mono-allelic TP53 lesions for the clinical outcome remain controversial, but clonal selection and evolution is a common feature of myeloma progression, and patients with TP53 wild-type or mono-allelic inactivation may present a double hit on relapse,” the investigators wrote in Blood. “Here, we addressed the hypothesis that sequential acquisition of TP53 hits lead to a gain of proliferative fitness of [multiple myeloma] cancer cells, inducing the expansion and domination of the affected clones within the patient’s bone marrow.”

The investigators used sleeping beauty and CRISPR/Cas9 techniques to create double- and single-hit multiple myeloma cell lines that were stably transfected with fluorescent proteins. By observing coculture pairings of wild-type, single-hit, and double-hit cells, the investigators found a hierarchy of proliferation that depended on the number of TP53 alterations. For instance, when double-hit cells were cocultured with wild-type cells in a 1:3 ratio, it took 21 days for the double-hit cells to reach 50% of the total culture population. Similarly, single-hit cells outcompeted wild-type cells after 38 days, while double-hit cells took 35 days to overcome the single-hit population.

Further testing showed that comparatively smaller initial populations of TP53-aberrant cells required longer to outcompete larger wild-type populations, which could explain why deeper responses in the clinic are often followed by longer periods without disease progression, the investigators suggested.

A comparison of transcriptomes between wild-type cells and TP53 mutants revealed differences in about 900 genes, including 14 signaling pathways. Specifically, downregulation impacted antigen processing and presentation, chemokine signaling, and oxidative phosphorylation.

“These differences on the transcriptomic level well reflect the biology of ultra–high risk disease,” the investigators wrote, referring to increased glucose uptake on PET, resistance to immunotherapies, and extramedullary disease.

“[This study] underscores the power of clonal competition assays to decipher the effect of genomic lesions in tumors to better understand their impact on progression and disease relapse in [multiple myeloma],” the investigators concluded.

The study was funded by Deutsche Forschungsgemeinschaft, the CDW Stiftung, and the IZKF Würzburg. The investigators reported additional support from the CRIS foundation, the German Cancer Aid, and the University of Würzburg.

SOURCE: Munawar U et al. Blood. 2019 Jul 24. doi: 10.1182/blood.2019000080.

SAN DIEGO – Authors of endoscopy clinical practice guidelines (CPGs) received many more payments from industry than they disclosed, according to a new review of publicly available data.

Additionally, many of the payments came from pharmaceutical companies or medical device manufacturers whose products were directly related to the practice guideline topic at hand, said Amir Rumann, MD, and coauthors, who presented their findings in a poster session at the annual Digestive Disease Week^®.

The researchers found that, of 581 authors listed in 38 CPGs, 127 had initially disclosed payments when the guidelines were published. A search of the federal Open Payments database, however, found that 452 of these authors had payments that they did not disclose in the CPG publication process.

For authors with undisclosed payments, the median value of the total undisclosed amounts was $2,445, from a median of 2.5 unique companies, according to records maintained by the Centers for Medicare & Medicaid Services. The interquartile range for payments was $167-$10,380.

“There is a high burden of undisclosed payments by pharmaceutical and medical device manufacturers to authors of endoscopy guidelines in the United States,” wrote Dr. Rumman and coauthors at the University of Toronto, where Dr. Rumann is a gastroenterology resident.

Of the authors who disclosed payments, 20 (16%) disclosed payments from sources directly related to the CPG in the publication. But the Open Payments database search yielded 314 (54%) disclosed payments that were judged directly related to the CPG topic at hand.

Of the 38 CPGs included in the analysis, 24 were from the American Society for Gastrointestinal Endoscopy (ASGE), and 4 were from the American Gastroenterological Association (AGA). According to the analysis performed by Dr. Rumman and his coauthors, 23 of these guidelines adhered to standards proposed by the National Academy of Medicine for development of “trustworthy” CPGs.

[email protected]

SOURCE: Rumann A et al. DDW 2019, poster Sa1004.

SAN DIEGO – Authors of endoscopy clinical practice guidelines (CPGs) received many more payments from industry than they disclosed, according to a new review of publicly available data.

Additionally, many of the payments came from pharmaceutical companies or medical device manufacturers whose products were directly related to the practice guideline topic at hand, said Amir Rumann, MD, and coauthors, who presented their findings in a poster session at the annual Digestive Disease Week^®.

The researchers found that, of 581 authors listed in 38 CPGs, 127 had initially disclosed payments when the guidelines were published. A search of the federal Open Payments database, however, found that 452 of these authors had payments that they did not disclose in the CPG publication process.

For authors with undisclosed payments, the median value of the total undisclosed amounts was $2,445, from a median of 2.5 unique companies, according to records maintained by the Centers for Medicare & Medicaid Services. The interquartile range for payments was $167-$10,380.

“There is a high burden of undisclosed payments by pharmaceutical and medical device manufacturers to authors of endoscopy guidelines in the United States,” wrote Dr. Rumman and coauthors at the University of Toronto, where Dr. Rumann is a gastroenterology resident.

Of the authors who disclosed payments, 20 (16%) disclosed payments from sources directly related to the CPG in the publication. But the Open Payments database search yielded 314 (54%) disclosed payments that were judged directly related to the CPG topic at hand.

Of the 38 CPGs included in the analysis, 24 were from the American Society for Gastrointestinal Endoscopy (ASGE), and 4 were from the American Gastroenterological Association (AGA). According to the analysis performed by Dr. Rumman and his coauthors, 23 of these guidelines adhered to standards proposed by the National Academy of Medicine for development of “trustworthy” CPGs.

[email protected]

SOURCE: Rumann A et al. DDW 2019, poster Sa1004.

SAN DIEGO – Authors of endoscopy clinical practice guidelines (CPGs) received many more payments from industry than they disclosed, according to a new review of publicly available data.

Additionally, many of the payments came from pharmaceutical companies or medical device manufacturers whose products were directly related to the practice guideline topic at hand, said Amir Rumann, MD, and coauthors, who presented their findings in a poster session at the annual Digestive Disease Week^®.

The researchers found that, of 581 authors listed in 38 CPGs, 127 had initially disclosed payments when the guidelines were published. A search of the federal Open Payments database, however, found that 452 of these authors had payments that they did not disclose in the CPG publication process.

For authors with undisclosed payments, the median value of the total undisclosed amounts was $2,445, from a median of 2.5 unique companies, according to records maintained by the Centers for Medicare & Medicaid Services. The interquartile range for payments was $167-$10,380.

“There is a high burden of undisclosed payments by pharmaceutical and medical device manufacturers to authors of endoscopy guidelines in the United States,” wrote Dr. Rumman and coauthors at the University of Toronto, where Dr. Rumann is a gastroenterology resident.

Of the authors who disclosed payments, 20 (16%) disclosed payments from sources directly related to the CPG in the publication. But the Open Payments database search yielded 314 (54%) disclosed payments that were judged directly related to the CPG topic at hand.

Of the 38 CPGs included in the analysis, 24 were from the American Society for Gastrointestinal Endoscopy (ASGE), and 4 were from the American Gastroenterological Association (AGA). According to the analysis performed by Dr. Rumman and his coauthors, 23 of these guidelines adhered to standards proposed by the National Academy of Medicine for development of “trustworthy” CPGs.

[email protected]

SOURCE: Rumann A et al. DDW 2019, poster Sa1004.

Philadelphia – The more exposure that a person without migraine has to people with the disorder, the more likely he or she is to have potentially stigmatizing attitudes toward migraine, according to an analysis presented at the annual meeting of the American Headache Society.

“We need to understand why this is true,” said Robert Shapiro, MD, PhD, professor of neurological sciences at the University of Vermont in Burlington. The finding also raises questions about which measures could successfully mitigate these stigmatizing attitudes.
 

An examination of data from OVERCOME

Stigma is a social process by which people are excluded from society because of particular traits that they have. The process encompasses stereotypes, prejudice, and discrimination. Data suggest that the level of stigma that people with migraine experience is similar to that experienced by people with epilepsy. Other data indicate that people without migraine are equally likely to hold stigmatizing attitudes toward people with migraine and people with epilepsy.

Dr. Shapiro and colleagues examined data from the Observational Survey of the Epidemiology, Treatment, and Care of Migraine (OVERCOME) study to better understand the attitudes that people without migraine have toward those who have the disorder. The data were gathered in fall 2018 through a web-based survey of a representative U.S. sample population. The researchers focused on a random sample of 2,000 people without migraine who responded to 11 questions about their attitudes toward patients with migraine. Responses described the frequency of holding attitudes and were scored on a 5-point Likert scale. The researchers categorized the responses “don’t know,” “never,” and “rarely” as “no” answers, and “sometimes,” “often,” and “very often” as “yes” answers. In addition, Dr. Shapiro and colleagues characterized each responder’s proximity to migraine according to the number of people with migraine that he or she knew (0, 1, or 2 or more) and the type of relationship (none, coworker, friend, or family member).
 

Sample was demographically representative

The demographic and socioeconomic characteristics of the study sample were similar to those of the most recent U.S. census data. The population’s mean age was 48, and 51% were female. Approximately 65% of respondents were non-Hispanic white, 14% were Hispanic, 11% were non-Hispanic black, 5% were Asian, and 5% were “other.” Approximately 45% of respondents reported that they had never known anyone with migraine. “Given the prevalence of migraine, it’s extraordinary that only 13% acknowledged that they had known two or more people with migraine,” said Dr. Shapiro. The finding raises questions about whether people with migraine have received adequate diagnoses and are aware of their disorder, he added. About 5% of the sample reported knowing only a coworker with migraine, and 37% reported knowing only one person with migraine.

About 31% of respondents thought that people with migraine use the disorder to avoid school or work commitments, and 33% thought that patients used migraine to avoid family or social commitments. Approximately 27% of respondents thought that people with migraine used it to get attention. About 45% of respondents thought that migraine should be treated easily, and 36% thought that people have migraine because of their own unhealthy behavior.

Individuals who knew people with migraine consistently held more negative attitudes toward those people, compared with those who did not know anyone with migraine. “These data are a little alarming,” said Dr. Shapiro. “They point to the difficulties that people with disabling migraine often encounter in having their experiences with the disease receive validation and understanding.”

Among the study’s strengths is the fact that it examined a large, population-based sample. The survey was conducted before many of the newer medications for migraine were available, and respondents were not likely to have been influenced by commercials that raised awareness of migraine, said Dr. Shapiro. The sample was not random, however, and the survey questions were based on the investigators’ interests, rather than on objective data. The generalizability of the results is in question, he added.

Dr. Shapiro consults for Eli Lilly, which sponsored the OVERCOME study.

[email protected]

SOURCE: Shapiro R et al. AHS 2019. Abstract OR15.

Philadelphia – The more exposure that a person without migraine has to people with the disorder, the more likely he or she is to have potentially stigmatizing attitudes toward migraine, according to an analysis presented at the annual meeting of the American Headache Society.

“We need to understand why this is true,” said Robert Shapiro, MD, PhD, professor of neurological sciences at the University of Vermont in Burlington. The finding also raises questions about which measures could successfully mitigate these stigmatizing attitudes.
 

An examination of data from OVERCOME

Stigma is a social process by which people are excluded from society because of particular traits that they have. The process encompasses stereotypes, prejudice, and discrimination. Data suggest that the level of stigma that people with migraine experience is similar to that experienced by people with epilepsy. Other data indicate that people without migraine are equally likely to hold stigmatizing attitudes toward people with migraine and people with epilepsy.

Dr. Shapiro and colleagues examined data from the Observational Survey of the Epidemiology, Treatment, and Care of Migraine (OVERCOME) study to better understand the attitudes that people without migraine have toward those who have the disorder. The data were gathered in fall 2018 through a web-based survey of a representative U.S. sample population. The researchers focused on a random sample of 2,000 people without migraine who responded to 11 questions about their attitudes toward patients with migraine. Responses described the frequency of holding attitudes and were scored on a 5-point Likert scale. The researchers categorized the responses “don’t know,” “never,” and “rarely” as “no” answers, and “sometimes,” “often,” and “very often” as “yes” answers. In addition, Dr. Shapiro and colleagues characterized each responder’s proximity to migraine according to the number of people with migraine that he or she knew (0, 1, or 2 or more) and the type of relationship (none, coworker, friend, or family member).
 

Sample was demographically representative

The demographic and socioeconomic characteristics of the study sample were similar to those of the most recent U.S. census data. The population’s mean age was 48, and 51% were female. Approximately 65% of respondents were non-Hispanic white, 14% were Hispanic, 11% were non-Hispanic black, 5% were Asian, and 5% were “other.” Approximately 45% of respondents reported that they had never known anyone with migraine. “Given the prevalence of migraine, it’s extraordinary that only 13% acknowledged that they had known two or more people with migraine,” said Dr. Shapiro. The finding raises questions about whether people with migraine have received adequate diagnoses and are aware of their disorder, he added. About 5% of the sample reported knowing only a coworker with migraine, and 37% reported knowing only one person with migraine.

About 31% of respondents thought that people with migraine use the disorder to avoid school or work commitments, and 33% thought that patients used migraine to avoid family or social commitments. Approximately 27% of respondents thought that people with migraine used it to get attention. About 45% of respondents thought that migraine should be treated easily, and 36% thought that people have migraine because of their own unhealthy behavior.

Individuals who knew people with migraine consistently held more negative attitudes toward those people, compared with those who did not know anyone with migraine. “These data are a little alarming,” said Dr. Shapiro. “They point to the difficulties that people with disabling migraine often encounter in having their experiences with the disease receive validation and understanding.”

Among the study’s strengths is the fact that it examined a large, population-based sample. The survey was conducted before many of the newer medications for migraine were available, and respondents were not likely to have been influenced by commercials that raised awareness of migraine, said Dr. Shapiro. The sample was not random, however, and the survey questions were based on the investigators’ interests, rather than on objective data. The generalizability of the results is in question, he added.

Dr. Shapiro consults for Eli Lilly, which sponsored the OVERCOME study.

[email protected]

SOURCE: Shapiro R et al. AHS 2019. Abstract OR15.

Philadelphia – The more exposure that a person without migraine has to people with the disorder, the more likely he or she is to have potentially stigmatizing attitudes toward migraine, according to an analysis presented at the annual meeting of the American Headache Society.

“We need to understand why this is true,” said Robert Shapiro, MD, PhD, professor of neurological sciences at the University of Vermont in Burlington. The finding also raises questions about which measures could successfully mitigate these stigmatizing attitudes.
 

An examination of data from OVERCOME

Stigma is a social process by which people are excluded from society because of particular traits that they have. The process encompasses stereotypes, prejudice, and discrimination. Data suggest that the level of stigma that people with migraine experience is similar to that experienced by people with epilepsy. Other data indicate that people without migraine are equally likely to hold stigmatizing attitudes toward people with migraine and people with epilepsy.

Dr. Shapiro and colleagues examined data from the Observational Survey of the Epidemiology, Treatment, and Care of Migraine (OVERCOME) study to better understand the attitudes that people without migraine have toward those who have the disorder. The data were gathered in fall 2018 through a web-based survey of a representative U.S. sample population. The researchers focused on a random sample of 2,000 people without migraine who responded to 11 questions about their attitudes toward patients with migraine. Responses described the frequency of holding attitudes and were scored on a 5-point Likert scale. The researchers categorized the responses “don’t know,” “never,” and “rarely” as “no” answers, and “sometimes,” “often,” and “very often” as “yes” answers. In addition, Dr. Shapiro and colleagues characterized each responder’s proximity to migraine according to the number of people with migraine that he or she knew (0, 1, or 2 or more) and the type of relationship (none, coworker, friend, or family member).
 

Sample was demographically representative

The demographic and socioeconomic characteristics of the study sample were similar to those of the most recent U.S. census data. The population’s mean age was 48, and 51% were female. Approximately 65% of respondents were non-Hispanic white, 14% were Hispanic, 11% were non-Hispanic black, 5% were Asian, and 5% were “other.” Approximately 45% of respondents reported that they had never known anyone with migraine. “Given the prevalence of migraine, it’s extraordinary that only 13% acknowledged that they had known two or more people with migraine,” said Dr. Shapiro. The finding raises questions about whether people with migraine have received adequate diagnoses and are aware of their disorder, he added. About 5% of the sample reported knowing only a coworker with migraine, and 37% reported knowing only one person with migraine.

About 31% of respondents thought that people with migraine use the disorder to avoid school or work commitments, and 33% thought that patients used migraine to avoid family or social commitments. Approximately 27% of respondents thought that people with migraine used it to get attention. About 45% of respondents thought that migraine should be treated easily, and 36% thought that people have migraine because of their own unhealthy behavior.

Individuals who knew people with migraine consistently held more negative attitudes toward those people, compared with those who did not know anyone with migraine. “These data are a little alarming,” said Dr. Shapiro. “They point to the difficulties that people with disabling migraine often encounter in having their experiences with the disease receive validation and understanding.”

Among the study’s strengths is the fact that it examined a large, population-based sample. The survey was conducted before many of the newer medications for migraine were available, and respondents were not likely to have been influenced by commercials that raised awareness of migraine, said Dr. Shapiro. The sample was not random, however, and the survey questions were based on the investigators’ interests, rather than on objective data. The generalizability of the results is in question, he added.

Dr. Shapiro consults for Eli Lilly, which sponsored the OVERCOME study.

[email protected]

SOURCE: Shapiro R et al. AHS 2019. Abstract OR15.

Changes are coming to the Merit-based Incentive Payment System track of the Quality Payment Program and officials at the Centers for Medicare & Medicaid Services say these revisions are aimed at making the transition to value-based care easier for physicians.

copyright roobcio/Thinkstock

The new framework for the Merit-based Incentive Payment System (MIPS) program was included as part of a proposed rule that updated both the physician fee schedule and the Quality Payment Program (QPP) for 2020. The proposed rule was posted online July 29, 2019, and is scheduled for publication in the Federal Register on Aug. 14. Comments on the rule are due on Sept. 27.

“We are overhauling the Merit-based Incentive Payment System to reduce reporting burden, making sure the measures relevant to clinicians as they move toward value-based care,” CMS Administrator Seema Verma said during a July 29 press conference. “Clinicians will now report on fewer, more meaningful measures that are aligned to their specialty or practice area, making it easier to participate in MIPS. We are looking for the public’s input on this new framework so that we can build a better program together.”

CMS is proposing a new conceptual framework called MIPS Value Pathways (MVPs), which would apply to future proposals beginning in the 2021 performance year.

“The goal is to move away from siloed activities and measures and more towards an aligned set of measure options more relevant to a clinician’s scope of practice that is meaningful to patient care,” the CMS said in a fact sheet highlighting the changes.

The framework would align and connect measures across the four performance categories (quality, cost, promoting interoperability, and improvement activities) and there would be MVP measures for different specialties.

“A clinician or group would be in one MVP associated with their specialty or with a condition, reporting on the same measures and activities as other clinicians and groups in that MVP,” according to the fact sheet.

As part of the proposed framework, the CMS aims to provide “enhanced data and feedback to clinicians.”

In the meantime, the agency is proposing other updates to the program, including adjustments to the weighting of the performance category in 2020. The quality category would drop from 45% to 40%, while the cost category would rise from 15% to 20%. No changes in the weighting of the interoperability (25%) and improvement activities (15%) are proposed.

A number of measures are altered in each of the performance categories, such as increasing the data completeness requirement in the quality category from reporting on 60% of Medicare Part B patients to 70%, changes to patient-centered medical home criteria in the improvement activities performance category, and requiring a yes/no response to the query of the Prescription Drug Monitoring Program measure in the promoting interoperability category.

The range of adjustment, by statute for the 2020 performance year, will go up to 9% (plus or minus) depending on the MIPS scoring, expanding from the 7% (plus or minus) range in the 2019 performance year.

A number of provisions of the Quality Payment Program program are proposed to have no change, including the low-volume threshold and opt-in policy, the MIPS performance period, and EHR certification requirements. No quality measures were changed based on changes to clinical guidelines.

The American Medical Association voiced support for the proposal.

“The AMA commends CMS for requesting input on a simplified option that would give physicians the choice to focus on episodes of care rather than following the current, more fragmented approach,” AMA President Patrice Harris, MD, said in a statement. “Making MIPS more clinically relevant and less burdensome is a top priority for the AMA and we believe CMS is taking an important step toward this goal.”

However, AMGA had a different take, expressing concern that MIPS is not becoming a pathway to value-based care.

The group, which represents multispecialty medical groups and integrated health systems, noted that, while the statutory range for bonus payments may be expanding, CMS is estimating that overall payment adjustment will be only 1.4%.

“In light of this significantly reduced adjustment, AMGA is concerned that MIPS is no longer a transition tool to value-based care, but instead represents a regulatory burden that does not support physician group practices and integrated systems of care that are investing in delivery models based on care coordination and improving population health,” AMGA said in a statement. “In addition, this adjustment undermines the intent of Congress to use MACRA [Medicare Access and CHIP Reauthorization Act] to move the health care system to value-based payment.”

[email protected]

Changes are coming to the Merit-based Incentive Payment System track of the Quality Payment Program and officials at the Centers for Medicare & Medicaid Services say these revisions are aimed at making the transition to value-based care easier for physicians.

copyright roobcio/Thinkstock

The new framework for the Merit-based Incentive Payment System (MIPS) program was included as part of a proposed rule that updated both the physician fee schedule and the Quality Payment Program (QPP) for 2020. The proposed rule was posted online July 29, 2019, and is scheduled for publication in the Federal Register on Aug. 14. Comments on the rule are due on Sept. 27.

“We are overhauling the Merit-based Incentive Payment System to reduce reporting burden, making sure the measures relevant to clinicians as they move toward value-based care,” CMS Administrator Seema Verma said during a July 29 press conference. “Clinicians will now report on fewer, more meaningful measures that are aligned to their specialty or practice area, making it easier to participate in MIPS. We are looking for the public’s input on this new framework so that we can build a better program together.”

CMS is proposing a new conceptual framework called MIPS Value Pathways (MVPs), which would apply to future proposals beginning in the 2021 performance year.

“The goal is to move away from siloed activities and measures and more towards an aligned set of measure options more relevant to a clinician’s scope of practice that is meaningful to patient care,” the CMS said in a fact sheet highlighting the changes.

The framework would align and connect measures across the four performance categories (quality, cost, promoting interoperability, and improvement activities) and there would be MVP measures for different specialties.

“A clinician or group would be in one MVP associated with their specialty or with a condition, reporting on the same measures and activities as other clinicians and groups in that MVP,” according to the fact sheet.

As part of the proposed framework, the CMS aims to provide “enhanced data and feedback to clinicians.”

In the meantime, the agency is proposing other updates to the program, including adjustments to the weighting of the performance category in 2020. The quality category would drop from 45% to 40%, while the cost category would rise from 15% to 20%. No changes in the weighting of the interoperability (25%) and improvement activities (15%) are proposed.

A number of measures are altered in each of the performance categories, such as increasing the data completeness requirement in the quality category from reporting on 60% of Medicare Part B patients to 70%, changes to patient-centered medical home criteria in the improvement activities performance category, and requiring a yes/no response to the query of the Prescription Drug Monitoring Program measure in the promoting interoperability category.

The range of adjustment, by statute for the 2020 performance year, will go up to 9% (plus or minus) depending on the MIPS scoring, expanding from the 7% (plus or minus) range in the 2019 performance year.

A number of provisions of the Quality Payment Program program are proposed to have no change, including the low-volume threshold and opt-in policy, the MIPS performance period, and EHR certification requirements. No quality measures were changed based on changes to clinical guidelines.

The American Medical Association voiced support for the proposal.

“The AMA commends CMS for requesting input on a simplified option that would give physicians the choice to focus on episodes of care rather than following the current, more fragmented approach,” AMA President Patrice Harris, MD, said in a statement. “Making MIPS more clinically relevant and less burdensome is a top priority for the AMA and we believe CMS is taking an important step toward this goal.”

However, AMGA had a different take, expressing concern that MIPS is not becoming a pathway to value-based care.

The group, which represents multispecialty medical groups and integrated health systems, noted that, while the statutory range for bonus payments may be expanding, CMS is estimating that overall payment adjustment will be only 1.4%.

“In light of this significantly reduced adjustment, AMGA is concerned that MIPS is no longer a transition tool to value-based care, but instead represents a regulatory burden that does not support physician group practices and integrated systems of care that are investing in delivery models based on care coordination and improving population health,” AMGA said in a statement. “In addition, this adjustment undermines the intent of Congress to use MACRA [Medicare Access and CHIP Reauthorization Act] to move the health care system to value-based payment.”

[email protected]

Changes are coming to the Merit-based Incentive Payment System track of the Quality Payment Program and officials at the Centers for Medicare & Medicaid Services say these revisions are aimed at making the transition to value-based care easier for physicians.

copyright roobcio/Thinkstock

The new framework for the Merit-based Incentive Payment System (MIPS) program was included as part of a proposed rule that updated both the physician fee schedule and the Quality Payment Program (QPP) for 2020. The proposed rule was posted online July 29, 2019, and is scheduled for publication in the Federal Register on Aug. 14. Comments on the rule are due on Sept. 27.

“We are overhauling the Merit-based Incentive Payment System to reduce reporting burden, making sure the measures relevant to clinicians as they move toward value-based care,” CMS Administrator Seema Verma said during a July 29 press conference. “Clinicians will now report on fewer, more meaningful measures that are aligned to their specialty or practice area, making it easier to participate in MIPS. We are looking for the public’s input on this new framework so that we can build a better program together.”

CMS is proposing a new conceptual framework called MIPS Value Pathways (MVPs), which would apply to future proposals beginning in the 2021 performance year.

“The goal is to move away from siloed activities and measures and more towards an aligned set of measure options more relevant to a clinician’s scope of practice that is meaningful to patient care,” the CMS said in a fact sheet highlighting the changes.

The framework would align and connect measures across the four performance categories (quality, cost, promoting interoperability, and improvement activities) and there would be MVP measures for different specialties.

“A clinician or group would be in one MVP associated with their specialty or with a condition, reporting on the same measures and activities as other clinicians and groups in that MVP,” according to the fact sheet.

As part of the proposed framework, the CMS aims to provide “enhanced data and feedback to clinicians.”

In the meantime, the agency is proposing other updates to the program, including adjustments to the weighting of the performance category in 2020. The quality category would drop from 45% to 40%, while the cost category would rise from 15% to 20%. No changes in the weighting of the interoperability (25%) and improvement activities (15%) are proposed.

A number of measures are altered in each of the performance categories, such as increasing the data completeness requirement in the quality category from reporting on 60% of Medicare Part B patients to 70%, changes to patient-centered medical home criteria in the improvement activities performance category, and requiring a yes/no response to the query of the Prescription Drug Monitoring Program measure in the promoting interoperability category.

The range of adjustment, by statute for the 2020 performance year, will go up to 9% (plus or minus) depending on the MIPS scoring, expanding from the 7% (plus or minus) range in the 2019 performance year.

A number of provisions of the Quality Payment Program program are proposed to have no change, including the low-volume threshold and opt-in policy, the MIPS performance period, and EHR certification requirements. No quality measures were changed based on changes to clinical guidelines.

The American Medical Association voiced support for the proposal.

“The AMA commends CMS for requesting input on a simplified option that would give physicians the choice to focus on episodes of care rather than following the current, more fragmented approach,” AMA President Patrice Harris, MD, said in a statement. “Making MIPS more clinically relevant and less burdensome is a top priority for the AMA and we believe CMS is taking an important step toward this goal.”

However, AMGA had a different take, expressing concern that MIPS is not becoming a pathway to value-based care.

The group, which represents multispecialty medical groups and integrated health systems, noted that, while the statutory range for bonus payments may be expanding, CMS is estimating that overall payment adjustment will be only 1.4%.

“In light of this significantly reduced adjustment, AMGA is concerned that MIPS is no longer a transition tool to value-based care, but instead represents a regulatory burden that does not support physician group practices and integrated systems of care that are investing in delivery models based on care coordination and improving population health,” AMGA said in a statement. “In addition, this adjustment undermines the intent of Congress to use MACRA [Medicare Access and CHIP Reauthorization Act] to move the health care system to value-based payment.”

[email protected]

Facial involvement and the severity of psoriasis.

Passos AN, de A Rêgo VRP, Duarte GV, Santos E Miranda RC, de O Rocha B, de F S P de Oliveira M. Int J Dermatol. 2019 Jul 26.

The aim of this cross-sectional study is to compare the severity of psoriasis, measured by the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI), in patients with and without facial lesions.

Genital Psoriasis: Impact on Quality of Life and Treatment Options.

Kelly A, Ryan C. Am J Clin Dermatol. 2019 Jul 16

Psoriasis involving the genital skin occurs in up to two-thirds of psoriasis patients but is often overlooked by physicians. Furthermore, psoriasis objective and subjective severity indexes for common plaque psoriasis often neglect the impact this small area of psoriasis can have on a patient. It can have a significant impact on patients' psychosocial function due to intrusive physical symptoms such as genital itch and pain, and a detrimental impact on sexual health and impaired relationships.

Lifestyle changes for treating psoriasis.

Ko SH, Chi CC, Yeh ML, Wang SH, Tsai YS, Hsu MY. Cochrane Database Syst Rev. 2019 Jul 16

The objective of this review is to assess the effects of lifestyle changes for psoriasis, including weight reduction, alcohol abstinence, smoking cessation, dietary modification, exercise, and other lifestyle change interventions. Dietary intervention may reduce the severity of psoriasis (low-quality evidence) and probably improves quality of life and reduces BMI (moderate-quality evidence) in obese people when compared with usual care, while combined dietary intervention and exercise programme probably improves psoriasis severity and BMI when compared with information only (moderate-quality evidence).

The Incidence Rates and Risk Factors of Parkinson's Disease in Patients with Psoriasis: A Nationwide Population-based Cohort Study.

Lee JH, Han K, Gee HY. J Am Acad Dermatol. 2019 Jul 11.

This was a nationwide population-based cohort study to determine the incidence rates and risk factors of Parkinson's disease in patients with psoriasis. The psoriasis group showed a significantly increased risk of developing Parkinson's disease. The risk of Parkinson's disease was significantly high among the psoriasis patients who were not receiving systemic therapy and was low among the psoriasis patients on systemic therapy.

Psoriasis-associated itch: etiology, assessment, impact, and management.

Pithadia DJ, Reynolds KA, Lee EB, Wu JJ. J Dermatolog Treat. 2019 Jul 5:1-9.

Pruritus, a very broad, subjective, and complex symptom, troubles the majority of patients with psoriasis. However, the subjective and multidimensional nature of the symptom renders it challenging for patients to appropriately communicate their experiences with itch to providers. This review explores current perspectives regarding the underlying mechanisms, assessment tools, burden, and treatment modalities for psoriatic pruritus. It emphasizes the significance of incorporating a standardized, thorough, and verified metric that incorporates severity, distribution, and character of pruritus as well as its effects on various aspects of quality of life. It also underscores the importance of continued research to fully understand the pathogenesis of psoriatic itch for establishment of novel, targeted therapeutics.

Facial involvement and the severity of psoriasis.

Passos AN, de A Rêgo VRP, Duarte GV, Santos E Miranda RC, de O Rocha B, de F S P de Oliveira M. Int J Dermatol. 2019 Jul 26.

The aim of this cross-sectional study is to compare the severity of psoriasis, measured by the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI), in patients with and without facial lesions.

Genital Psoriasis: Impact on Quality of Life and Treatment Options.

Kelly A, Ryan C. Am J Clin Dermatol. 2019 Jul 16

Psoriasis involving the genital skin occurs in up to two-thirds of psoriasis patients but is often overlooked by physicians. Furthermore, psoriasis objective and subjective severity indexes for common plaque psoriasis often neglect the impact this small area of psoriasis can have on a patient. It can have a significant impact on patients' psychosocial function due to intrusive physical symptoms such as genital itch and pain, and a detrimental impact on sexual health and impaired relationships.

Lifestyle changes for treating psoriasis.

Ko SH, Chi CC, Yeh ML, Wang SH, Tsai YS, Hsu MY. Cochrane Database Syst Rev. 2019 Jul 16

The objective of this review is to assess the effects of lifestyle changes for psoriasis, including weight reduction, alcohol abstinence, smoking cessation, dietary modification, exercise, and other lifestyle change interventions. Dietary intervention may reduce the severity of psoriasis (low-quality evidence) and probably improves quality of life and reduces BMI (moderate-quality evidence) in obese people when compared with usual care, while combined dietary intervention and exercise programme probably improves psoriasis severity and BMI when compared with information only (moderate-quality evidence).

The Incidence Rates and Risk Factors of Parkinson's Disease in Patients with Psoriasis: A Nationwide Population-based Cohort Study.

Lee JH, Han K, Gee HY. J Am Acad Dermatol. 2019 Jul 11.

This was a nationwide population-based cohort study to determine the incidence rates and risk factors of Parkinson's disease in patients with psoriasis. The psoriasis group showed a significantly increased risk of developing Parkinson's disease. The risk of Parkinson's disease was significantly high among the psoriasis patients who were not receiving systemic therapy and was low among the psoriasis patients on systemic therapy.

Psoriasis-associated itch: etiology, assessment, impact, and management.

Pithadia DJ, Reynolds KA, Lee EB, Wu JJ. J Dermatolog Treat. 2019 Jul 5:1-9.

Pruritus, a very broad, subjective, and complex symptom, troubles the majority of patients with psoriasis. However, the subjective and multidimensional nature of the symptom renders it challenging for patients to appropriately communicate their experiences with itch to providers. This review explores current perspectives regarding the underlying mechanisms, assessment tools, burden, and treatment modalities for psoriatic pruritus. It emphasizes the significance of incorporating a standardized, thorough, and verified metric that incorporates severity, distribution, and character of pruritus as well as its effects on various aspects of quality of life. It also underscores the importance of continued research to fully understand the pathogenesis of psoriatic itch for establishment of novel, targeted therapeutics.

Facial involvement and the severity of psoriasis.

Passos AN, de A Rêgo VRP, Duarte GV, Santos E Miranda RC, de O Rocha B, de F S P de Oliveira M. Int J Dermatol. 2019 Jul 26.

The aim of this cross-sectional study is to compare the severity of psoriasis, measured by the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI), in patients with and without facial lesions.

Genital Psoriasis: Impact on Quality of Life and Treatment Options.

Kelly A, Ryan C. Am J Clin Dermatol. 2019 Jul 16

Psoriasis involving the genital skin occurs in up to two-thirds of psoriasis patients but is often overlooked by physicians. Furthermore, psoriasis objective and subjective severity indexes for common plaque psoriasis often neglect the impact this small area of psoriasis can have on a patient. It can have a significant impact on patients' psychosocial function due to intrusive physical symptoms such as genital itch and pain, and a detrimental impact on sexual health and impaired relationships.

Lifestyle changes for treating psoriasis.

Ko SH, Chi CC, Yeh ML, Wang SH, Tsai YS, Hsu MY. Cochrane Database Syst Rev. 2019 Jul 16

The objective of this review is to assess the effects of lifestyle changes for psoriasis, including weight reduction, alcohol abstinence, smoking cessation, dietary modification, exercise, and other lifestyle change interventions. Dietary intervention may reduce the severity of psoriasis (low-quality evidence) and probably improves quality of life and reduces BMI (moderate-quality evidence) in obese people when compared with usual care, while combined dietary intervention and exercise programme probably improves psoriasis severity and BMI when compared with information only (moderate-quality evidence).

The Incidence Rates and Risk Factors of Parkinson's Disease in Patients with Psoriasis: A Nationwide Population-based Cohort Study.

Lee JH, Han K, Gee HY. J Am Acad Dermatol. 2019 Jul 11.

This was a nationwide population-based cohort study to determine the incidence rates and risk factors of Parkinson's disease in patients with psoriasis. The psoriasis group showed a significantly increased risk of developing Parkinson's disease. The risk of Parkinson's disease was significantly high among the psoriasis patients who were not receiving systemic therapy and was low among the psoriasis patients on systemic therapy.

Psoriasis-associated itch: etiology, assessment, impact, and management.

Pithadia DJ, Reynolds KA, Lee EB, Wu JJ. J Dermatolog Treat. 2019 Jul 5:1-9.

Pruritus, a very broad, subjective, and complex symptom, troubles the majority of patients with psoriasis. However, the subjective and multidimensional nature of the symptom renders it challenging for patients to appropriately communicate their experiences with itch to providers. This review explores current perspectives regarding the underlying mechanisms, assessment tools, burden, and treatment modalities for psoriatic pruritus. It emphasizes the significance of incorporating a standardized, thorough, and verified metric that incorporates severity, distribution, and character of pruritus as well as its effects on various aspects of quality of life. It also underscores the importance of continued research to fully understand the pathogenesis of psoriatic itch for establishment of novel, targeted therapeutics.

MELBOURNE – A venous thromboembolism risk score that combines clinical risk factors, such as lymphoma type and stage, along with genetic variables, could offer a better way to predict venous thromboembolism in patients with lymphoma, according to new findings presented at the International Society on Thrombosis and Haemostasis congress.

Cristina Pascual, MD, of the Hospital Universitario Gregorio Marañon in Madrid presented data from a development and validation study of a clinical-genetic risk model for thrombosis in lymphoma in 208 patients with lymphoma, 31 of whom experienced a venous thromboembolic event.

While the relationship between cancer and increased thrombosis risk is well recognized, lymphoma patients are at particularly high risk, with an estimated thrombosis incidence of 5%-10%, Dr. Pascual said.

Currently, the Khorana score is the most validated risk score for thrombosis in patients with solid tumors, using factors such as tumor site, platelet and leukocyte count, hemoglobin levels, and body mass index. However, Dr. Pascual pointed out that just 10% of the validation cohort for the Khorana score were lymphoma patients, and it had previously been found to be not as useful for that population.

More recently, researchers had developed the ThroLy score for predicting thromboembolic events specifically in patients with lymphoma, incorporating clinical variables such as mediastinal involvement and extranodal localization.

Another group took a different approach by incorporating genetic risk factors for thrombosis to create Thrombo inCode-Oncology (TiC-Onco) for solid tumors. This assessment included four genetic variants known to increase the risk of thromboembolic events in cancer patients, as well as the clinical risk factors of body mass index, family history of thrombosis, primary tumor site, and tumor stage.

Dr. Pascual and colleagues developed a unique risk factor model that combined both the ThroLy and TiC-Onco elements.

In 208 patients with lymphoma who were not receiving anticoagulant treatment, researchers identified five clinical factors that were most predictive of venous thrombosis: a history of thrombosis, immobilization for more than 3 days, lymphoma type, Ann Arbor score for lymphoma stage, and mediastinal extension.

They combined these clinical risk factors with the genetic risk factors from the TiC-Onco score to develop the TiC-Onco–associated lymphoma score (TiC-Lympho).

When validated in the same group of patients, the TiC-Lympho score had a sensitivity of 93.55%, a specificity of 54.49%, positive predictive value of 26.36%, and negative predictive value of 97.94%.

The researchers also compared TiC-Lympho’s performance with that of the ThroLy and TiC-Onco models, and found it performed better on sensitivity and negative predictive value. The area under the curve for TiC-Lympho (0.783) was significantly higher than that seen with the other two risk models.

Session chair Kate Burbury, MBBS, of the Peter MacCallum Cancer Centre in Melbourne, raised the question of how the score – and particularly the genetic risk factor assessment – might be applied in the real-world clinical setting.

In an interview, Dr. Pascual said the findings represented preliminary data only, so the model was not ready to be applied to clinical practice yet. She also stressed that this was based on retrospective data, and needed to be further validated in other cohorts of lymphoma patients.

No conflicts of interest were reported.

SOURCE: Pascual C et al. 2019 ISTH Congress, Abstract OC 41.3.

MELBOURNE – A venous thromboembolism risk score that combines clinical risk factors, such as lymphoma type and stage, along with genetic variables, could offer a better way to predict venous thromboembolism in patients with lymphoma, according to new findings presented at the International Society on Thrombosis and Haemostasis congress.

Cristina Pascual, MD, of the Hospital Universitario Gregorio Marañon in Madrid presented data from a development and validation study of a clinical-genetic risk model for thrombosis in lymphoma in 208 patients with lymphoma, 31 of whom experienced a venous thromboembolic event.

While the relationship between cancer and increased thrombosis risk is well recognized, lymphoma patients are at particularly high risk, with an estimated thrombosis incidence of 5%-10%, Dr. Pascual said.

Currently, the Khorana score is the most validated risk score for thrombosis in patients with solid tumors, using factors such as tumor site, platelet and leukocyte count, hemoglobin levels, and body mass index. However, Dr. Pascual pointed out that just 10% of the validation cohort for the Khorana score were lymphoma patients, and it had previously been found to be not as useful for that population.

More recently, researchers had developed the ThroLy score for predicting thromboembolic events specifically in patients with lymphoma, incorporating clinical variables such as mediastinal involvement and extranodal localization.

Another group took a different approach by incorporating genetic risk factors for thrombosis to create Thrombo inCode-Oncology (TiC-Onco) for solid tumors. This assessment included four genetic variants known to increase the risk of thromboembolic events in cancer patients, as well as the clinical risk factors of body mass index, family history of thrombosis, primary tumor site, and tumor stage.

Dr. Pascual and colleagues developed a unique risk factor model that combined both the ThroLy and TiC-Onco elements.

In 208 patients with lymphoma who were not receiving anticoagulant treatment, researchers identified five clinical factors that were most predictive of venous thrombosis: a history of thrombosis, immobilization for more than 3 days, lymphoma type, Ann Arbor score for lymphoma stage, and mediastinal extension.

They combined these clinical risk factors with the genetic risk factors from the TiC-Onco score to develop the TiC-Onco–associated lymphoma score (TiC-Lympho).

When validated in the same group of patients, the TiC-Lympho score had a sensitivity of 93.55%, a specificity of 54.49%, positive predictive value of 26.36%, and negative predictive value of 97.94%.

The researchers also compared TiC-Lympho’s performance with that of the ThroLy and TiC-Onco models, and found it performed better on sensitivity and negative predictive value. The area under the curve for TiC-Lympho (0.783) was significantly higher than that seen with the other two risk models.

Session chair Kate Burbury, MBBS, of the Peter MacCallum Cancer Centre in Melbourne, raised the question of how the score – and particularly the genetic risk factor assessment – might be applied in the real-world clinical setting.

In an interview, Dr. Pascual said the findings represented preliminary data only, so the model was not ready to be applied to clinical practice yet. She also stressed that this was based on retrospective data, and needed to be further validated in other cohorts of lymphoma patients.

No conflicts of interest were reported.

SOURCE: Pascual C et al. 2019 ISTH Congress, Abstract OC 41.3.

MELBOURNE – A venous thromboembolism risk score that combines clinical risk factors, such as lymphoma type and stage, along with genetic variables, could offer a better way to predict venous thromboembolism in patients with lymphoma, according to new findings presented at the International Society on Thrombosis and Haemostasis congress.

Cristina Pascual, MD, of the Hospital Universitario Gregorio Marañon in Madrid presented data from a development and validation study of a clinical-genetic risk model for thrombosis in lymphoma in 208 patients with lymphoma, 31 of whom experienced a venous thromboembolic event.

While the relationship between cancer and increased thrombosis risk is well recognized, lymphoma patients are at particularly high risk, with an estimated thrombosis incidence of 5%-10%, Dr. Pascual said.

Currently, the Khorana score is the most validated risk score for thrombosis in patients with solid tumors, using factors such as tumor site, platelet and leukocyte count, hemoglobin levels, and body mass index. However, Dr. Pascual pointed out that just 10% of the validation cohort for the Khorana score were lymphoma patients, and it had previously been found to be not as useful for that population.

More recently, researchers had developed the ThroLy score for predicting thromboembolic events specifically in patients with lymphoma, incorporating clinical variables such as mediastinal involvement and extranodal localization.

Another group took a different approach by incorporating genetic risk factors for thrombosis to create Thrombo inCode-Oncology (TiC-Onco) for solid tumors. This assessment included four genetic variants known to increase the risk of thromboembolic events in cancer patients, as well as the clinical risk factors of body mass index, family history of thrombosis, primary tumor site, and tumor stage.

Dr. Pascual and colleagues developed a unique risk factor model that combined both the ThroLy and TiC-Onco elements.

In 208 patients with lymphoma who were not receiving anticoagulant treatment, researchers identified five clinical factors that were most predictive of venous thrombosis: a history of thrombosis, immobilization for more than 3 days, lymphoma type, Ann Arbor score for lymphoma stage, and mediastinal extension.

They combined these clinical risk factors with the genetic risk factors from the TiC-Onco score to develop the TiC-Onco–associated lymphoma score (TiC-Lympho).

When validated in the same group of patients, the TiC-Lympho score had a sensitivity of 93.55%, a specificity of 54.49%, positive predictive value of 26.36%, and negative predictive value of 97.94%.

The researchers also compared TiC-Lympho’s performance with that of the ThroLy and TiC-Onco models, and found it performed better on sensitivity and negative predictive value. The area under the curve for TiC-Lympho (0.783) was significantly higher than that seen with the other two risk models.

Session chair Kate Burbury, MBBS, of the Peter MacCallum Cancer Centre in Melbourne, raised the question of how the score – and particularly the genetic risk factor assessment – might be applied in the real-world clinical setting.

In an interview, Dr. Pascual said the findings represented preliminary data only, so the model was not ready to be applied to clinical practice yet. She also stressed that this was based on retrospective data, and needed to be further validated in other cohorts of lymphoma patients.

No conflicts of interest were reported.

SOURCE: Pascual C et al. 2019 ISTH Congress, Abstract OC 41.3.

MELBOURNE – A once-daily subcutaneous treatment that inhibits the tissue factor 4 pathway inhibitor has shown significant reductions in bleeding rates in patients with hemophilia A and B, according to findings presented at the International Society on Thrombosis and Haemostasis congress.

Crystal/Wikimedia Commons/Creative Commons Attribution 2.0

Jan Astermark, MD, PhD, of the Centre for Thrombosis and Haemostasis at Lund University in Sweden, presented data from two phase 2, dose-escalation trials of the monoclonal antibody concizumab.

The explorer 5 trial involved 36 adults with severe hemophilia A without inhibitors who were started on 0.15 mg/kg of concizumab for 24 weeks. If they experienced three or more bleeds during that time, they were escalated to 0.20 mg/kg, and then to 0.25mg/kg if they experienced an additional three bleeds. The initial 24-week treatment period was then extended by more than 52 weeks.

In the explorer 4 trial, 16 adults with hemophilia A and 10 adults with hemophilia B – all with inhibitors – were initially randomized 2:1 to either 24 weeks of 0.15mg/kg of concizumab, including a loading dose, or placebo, with similar dose escalation in response to breakthrough bleeds. After 24 weeks, the study continued with a 52-week extension, during which all patients were treated with concizumab.

Both studies saw reductions in bleeding rates associated with concizumab treatment.

In patients with hemophilia A and B with inhibitors, the mean annualized bleeding rate for all bleeds declined from 20.4 to 4.5 bleeds, spontaneous bleeds declined from 18.5 to 2.5, and joint bleeds declined from 15 to 3.2. All three of the reductions were statistically significant.

Almost all patients achieved a concizumab concentration of 100 ng/mL, which was the expected level based on data from the phase 1 trial. Some patients showed anticoncizumab antibodies, but these were transient and did not appear to have any effect on clinical outcomes, according to Dr. Astermark.

Most patients also reached a normal level of thrombin generation, although Dr. Astermark noted that there were some patients with hemophilia B with inhibitors who produced a lower amount of thrombin than normal.

Despite the increase in thrombin generation, there were no thromboembolic events, and no significant safety concerns emerged during the study, he reported.

“Importantly and interestingly, all patients completing the main phase went into the extension phase of this trial, indicating that it was something they think was a contribution to their treatment,” Dr. Astermark said.

Earlier in 2019, concizumab was granted breakthrough designation by the Food and Drug Administration for the treatment of patients with hemophilia B and inhibitors, allowing it to receive an accelerated review by the agency.

“What the FDA based their decision on was the B patients with inhibitors, because this is truly a group where we do not have so many options,” Dr. Astermark said in an interview. He also noted that the subcutaneous treatment, delivered via a pen-like device, was much more convenient for patients who, until now, had required repeated intravenous infusions.

Two phase 3 trials are now scheduled, in which patients will receive a higher loading dose than what was used in the phase 2 trials.

Novo Nordisk sponsored both studies. Dr. Astermark reported consultancies and research funding unrelated to the study.

SOURCE: Astermark J et al. 2019 ISTH Congress, Abstract LB 01.1.

MELBOURNE – A once-daily subcutaneous treatment that inhibits the tissue factor 4 pathway inhibitor has shown significant reductions in bleeding rates in patients with hemophilia A and B, according to findings presented at the International Society on Thrombosis and Haemostasis congress.

Crystal/Wikimedia Commons/Creative Commons Attribution 2.0

Jan Astermark, MD, PhD, of the Centre for Thrombosis and Haemostasis at Lund University in Sweden, presented data from two phase 2, dose-escalation trials of the monoclonal antibody concizumab.

The explorer 5 trial involved 36 adults with severe hemophilia A without inhibitors who were started on 0.15 mg/kg of concizumab for 24 weeks. If they experienced three or more bleeds during that time, they were escalated to 0.20 mg/kg, and then to 0.25mg/kg if they experienced an additional three bleeds. The initial 24-week treatment period was then extended by more than 52 weeks.

In the explorer 4 trial, 16 adults with hemophilia A and 10 adults with hemophilia B – all with inhibitors – were initially randomized 2:1 to either 24 weeks of 0.15mg/kg of concizumab, including a loading dose, or placebo, with similar dose escalation in response to breakthrough bleeds. After 24 weeks, the study continued with a 52-week extension, during which all patients were treated with concizumab.

Both studies saw reductions in bleeding rates associated with concizumab treatment.

In patients with hemophilia A and B with inhibitors, the mean annualized bleeding rate for all bleeds declined from 20.4 to 4.5 bleeds, spontaneous bleeds declined from 18.5 to 2.5, and joint bleeds declined from 15 to 3.2. All three of the reductions were statistically significant.

Almost all patients achieved a concizumab concentration of 100 ng/mL, which was the expected level based on data from the phase 1 trial. Some patients showed anticoncizumab antibodies, but these were transient and did not appear to have any effect on clinical outcomes, according to Dr. Astermark.

Most patients also reached a normal level of thrombin generation, although Dr. Astermark noted that there were some patients with hemophilia B with inhibitors who produced a lower amount of thrombin than normal.

Despite the increase in thrombin generation, there were no thromboembolic events, and no significant safety concerns emerged during the study, he reported.

“Importantly and interestingly, all patients completing the main phase went into the extension phase of this trial, indicating that it was something they think was a contribution to their treatment,” Dr. Astermark said.

Earlier in 2019, concizumab was granted breakthrough designation by the Food and Drug Administration for the treatment of patients with hemophilia B and inhibitors, allowing it to receive an accelerated review by the agency.

“What the FDA based their decision on was the B patients with inhibitors, because this is truly a group where we do not have so many options,” Dr. Astermark said in an interview. He also noted that the subcutaneous treatment, delivered via a pen-like device, was much more convenient for patients who, until now, had required repeated intravenous infusions.

Two phase 3 trials are now scheduled, in which patients will receive a higher loading dose than what was used in the phase 2 trials.

Novo Nordisk sponsored both studies. Dr. Astermark reported consultancies and research funding unrelated to the study.

SOURCE: Astermark J et al. 2019 ISTH Congress, Abstract LB 01.1.

MELBOURNE – A once-daily subcutaneous treatment that inhibits the tissue factor 4 pathway inhibitor has shown significant reductions in bleeding rates in patients with hemophilia A and B, according to findings presented at the International Society on Thrombosis and Haemostasis congress.

Crystal/Wikimedia Commons/Creative Commons Attribution 2.0

Jan Astermark, MD, PhD, of the Centre for Thrombosis and Haemostasis at Lund University in Sweden, presented data from two phase 2, dose-escalation trials of the monoclonal antibody concizumab.

The explorer 5 trial involved 36 adults with severe hemophilia A without inhibitors who were started on 0.15 mg/kg of concizumab for 24 weeks. If they experienced three or more bleeds during that time, they were escalated to 0.20 mg/kg, and then to 0.25mg/kg if they experienced an additional three bleeds. The initial 24-week treatment period was then extended by more than 52 weeks.

In the explorer 4 trial, 16 adults with hemophilia A and 10 adults with hemophilia B – all with inhibitors – were initially randomized 2:1 to either 24 weeks of 0.15mg/kg of concizumab, including a loading dose, or placebo, with similar dose escalation in response to breakthrough bleeds. After 24 weeks, the study continued with a 52-week extension, during which all patients were treated with concizumab.

Both studies saw reductions in bleeding rates associated with concizumab treatment.

In patients with hemophilia A and B with inhibitors, the mean annualized bleeding rate for all bleeds declined from 20.4 to 4.5 bleeds, spontaneous bleeds declined from 18.5 to 2.5, and joint bleeds declined from 15 to 3.2. All three of the reductions were statistically significant.

Almost all patients achieved a concizumab concentration of 100 ng/mL, which was the expected level based on data from the phase 1 trial. Some patients showed anticoncizumab antibodies, but these were transient and did not appear to have any effect on clinical outcomes, according to Dr. Astermark.

Most patients also reached a normal level of thrombin generation, although Dr. Astermark noted that there were some patients with hemophilia B with inhibitors who produced a lower amount of thrombin than normal.

Despite the increase in thrombin generation, there were no thromboembolic events, and no significant safety concerns emerged during the study, he reported.

“Importantly and interestingly, all patients completing the main phase went into the extension phase of this trial, indicating that it was something they think was a contribution to their treatment,” Dr. Astermark said.

Earlier in 2019, concizumab was granted breakthrough designation by the Food and Drug Administration for the treatment of patients with hemophilia B and inhibitors, allowing it to receive an accelerated review by the agency.

“What the FDA based their decision on was the B patients with inhibitors, because this is truly a group where we do not have so many options,” Dr. Astermark said in an interview. He also noted that the subcutaneous treatment, delivered via a pen-like device, was much more convenient for patients who, until now, had required repeated intravenous infusions.

Two phase 3 trials are now scheduled, in which patients will receive a higher loading dose than what was used in the phase 2 trials.

Novo Nordisk sponsored both studies. Dr. Astermark reported consultancies and research funding unrelated to the study.

SOURCE: Astermark J et al. 2019 ISTH Congress, Abstract LB 01.1.

Physicians could be getting more money for evaluation and management (E/M) visits under a new proposal from the Centers for Medicare & Medicaid Services.

TheaDesign/Thinkstock

The increased funding is part of a proposed rule that provides the annual update to the Medicare physician fee schedule for 2020, as well as updates for the Quality Payment Program. The proposed rule was posted online July 29 and is scheduled to be published in the Federal Register on Aug. 14. Comments are due to CMS on Sept. 27.

CMS officials are seeking to increase Medicare payments to physicians starting in 2021 for E/M visits, based on recommendations from the American Medical Association’s Relative Value Scale Update Committee (AMA-RUC).

With this update, the agency will be “rewarding the time that doctors spend with patients,” CMS Administrator Seema Verma said during a July 29 teleconference with reporters.

A fact sheet highlighting changes in the proposed physician fee schedule update for 2020 notes that the agency also is looking to add a new CPT code for prolonged services time, also to commence in 2021.

“The RUC recommendations reflect a robust survey approach by the AMA, including surveying over 50 specialty types [that] demonstrate that office/outpatient E/M visits are generally more complex and require additional resources for most clinicians,” the fact sheet states.

Physicians would also get paid for care management services related to patients with a single chronic condition, rather than only patients with multiple chronic conditions, as current regulations state. There’s also a proposal to increase payments for transitional care management services provided after a Medicare patient is discharged from an inpatient stay or certain outpatient stays.

The proposed update to the physician fee schedule also puts into regulation a new benefit for opioid use disorder treatment that was authorized under the SUPPORT (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities) Act. To meet the requirements of the law, CMS has included in the proposal definitions for opioid treatment programs and opioid use disorder treatment services; enrollment policies for programs; bundled payment rates for treatment programs, with adjusters for geography and annual updates; flexibility for telehealth services; and zero beneficiary copays for a time-limited duration.

The American Medical Association praised proposed changes to documentation requirements that are included in the rule.

Patrice Harris, MD, the AMA president, said in a statement that the proposed rule “will streamline reporting requirements, reduce note bloat, improve workflow, and contribute to a better environment for health care professionals and their Medicare patients.”

The proposal also includes a modification to the physician supervision requirements for physician assistants that would give PAs “greater flexibility to practice more broadly in the current health system in accordance with state law and state scope of practice,” the fact sheet notes.

Overall, Dr. Harris appeared to have a good first impression of the proposed update, noting that the AMA is “pleased to see important policy revisions that will bring us closer to a more patient-centered health care system that promotes the key principles of affordability, accessibility, quality, and innovation.”

[email protected]

Physicians could be getting more money for evaluation and management (E/M) visits under a new proposal from the Centers for Medicare & Medicaid Services.

TheaDesign/Thinkstock

The increased funding is part of a proposed rule that provides the annual update to the Medicare physician fee schedule for 2020, as well as updates for the Quality Payment Program. The proposed rule was posted online July 29 and is scheduled to be published in the Federal Register on Aug. 14. Comments are due to CMS on Sept. 27.

CMS officials are seeking to increase Medicare payments to physicians starting in 2021 for E/M visits, based on recommendations from the American Medical Association’s Relative Value Scale Update Committee (AMA-RUC).

With this update, the agency will be “rewarding the time that doctors spend with patients,” CMS Administrator Seema Verma said during a July 29 teleconference with reporters.

A fact sheet highlighting changes in the proposed physician fee schedule update for 2020 notes that the agency also is looking to add a new CPT code for prolonged services time, also to commence in 2021.

“The RUC recommendations reflect a robust survey approach by the AMA, including surveying over 50 specialty types [that] demonstrate that office/outpatient E/M visits are generally more complex and require additional resources for most clinicians,” the fact sheet states.

Physicians would also get paid for care management services related to patients with a single chronic condition, rather than only patients with multiple chronic conditions, as current regulations state. There’s also a proposal to increase payments for transitional care management services provided after a Medicare patient is discharged from an inpatient stay or certain outpatient stays.

The proposed update to the physician fee schedule also puts into regulation a new benefit for opioid use disorder treatment that was authorized under the SUPPORT (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities) Act. To meet the requirements of the law, CMS has included in the proposal definitions for opioid treatment programs and opioid use disorder treatment services; enrollment policies for programs; bundled payment rates for treatment programs, with adjusters for geography and annual updates; flexibility for telehealth services; and zero beneficiary copays for a time-limited duration.

The American Medical Association praised proposed changes to documentation requirements that are included in the rule.

Patrice Harris, MD, the AMA president, said in a statement that the proposed rule “will streamline reporting requirements, reduce note bloat, improve workflow, and contribute to a better environment for health care professionals and their Medicare patients.”

The proposal also includes a modification to the physician supervision requirements for physician assistants that would give PAs “greater flexibility to practice more broadly in the current health system in accordance with state law and state scope of practice,” the fact sheet notes.

Overall, Dr. Harris appeared to have a good first impression of the proposed update, noting that the AMA is “pleased to see important policy revisions that will bring us closer to a more patient-centered health care system that promotes the key principles of affordability, accessibility, quality, and innovation.”

[email protected]

Physicians could be getting more money for evaluation and management (E/M) visits under a new proposal from the Centers for Medicare & Medicaid Services.

TheaDesign/Thinkstock

The increased funding is part of a proposed rule that provides the annual update to the Medicare physician fee schedule for 2020, as well as updates for the Quality Payment Program. The proposed rule was posted online July 29 and is scheduled to be published in the Federal Register on Aug. 14. Comments are due to CMS on Sept. 27.

CMS officials are seeking to increase Medicare payments to physicians starting in 2021 for E/M visits, based on recommendations from the American Medical Association’s Relative Value Scale Update Committee (AMA-RUC).

With this update, the agency will be “rewarding the time that doctors spend with patients,” CMS Administrator Seema Verma said during a July 29 teleconference with reporters.

A fact sheet highlighting changes in the proposed physician fee schedule update for 2020 notes that the agency also is looking to add a new CPT code for prolonged services time, also to commence in 2021.

“The RUC recommendations reflect a robust survey approach by the AMA, including surveying over 50 specialty types [that] demonstrate that office/outpatient E/M visits are generally more complex and require additional resources for most clinicians,” the fact sheet states.

Physicians would also get paid for care management services related to patients with a single chronic condition, rather than only patients with multiple chronic conditions, as current regulations state. There’s also a proposal to increase payments for transitional care management services provided after a Medicare patient is discharged from an inpatient stay or certain outpatient stays.

The proposed update to the physician fee schedule also puts into regulation a new benefit for opioid use disorder treatment that was authorized under the SUPPORT (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities) Act. To meet the requirements of the law, CMS has included in the proposal definitions for opioid treatment programs and opioid use disorder treatment services; enrollment policies for programs; bundled payment rates for treatment programs, with adjusters for geography and annual updates; flexibility for telehealth services; and zero beneficiary copays for a time-limited duration.

The American Medical Association praised proposed changes to documentation requirements that are included in the rule.

Patrice Harris, MD, the AMA president, said in a statement that the proposed rule “will streamline reporting requirements, reduce note bloat, improve workflow, and contribute to a better environment for health care professionals and their Medicare patients.”

The proposal also includes a modification to the physician supervision requirements for physician assistants that would give PAs “greater flexibility to practice more broadly in the current health system in accordance with state law and state scope of practice,” the fact sheet notes.

Overall, Dr. Harris appeared to have a good first impression of the proposed update, noting that the AMA is “pleased to see important policy revisions that will bring us closer to a more patient-centered health care system that promotes the key principles of affordability, accessibility, quality, and innovation.”

[email protected]