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Expert panel reaches consensus on hernia management recommendations
Those are key conclusions from a consensus statement based on a systematic review of existing evidence in the medical literature about ventral hernia management that were published in the January 2017 issue of the Annals of Surgery.
“Despite ventral hernias (VH) being one of the most common pathologies seen by clinicians, significant variability in management exists,” wrote the researchers, led by Mike K. Liang, MD, of the University of Texas Health Science Center at Houston. “Surveys of clinicians and review of nationwide databases of patients undergoing elective ventral hernia repair (VHR) demonstrate substantial heterogeneity in patient selection and clinical practice.”
The panelists agreed that complications with VHR increase in obese patients (grade A evidence), current smokers (grade A), and in patients with glycosylated hemoglobin A1c (HbA1c) of 6.5% or greater (grade B). They did not recommend elective VHR in patients with a body mass index of 50 kg/m2 or greater (grade C), in current smokers (grade A), or patients with an HbA1c of 8.0% or greater (grade B). They also agreed that patients with a BMI of 30-50 kg/m2 or an HbA1c level of 6.5%-8.0% require individualized interventions to reduce surgical risk (grade C, grade B, respectively). The panelists considered nonoperative management to have a low risk of short-term morbidity (grade C) and they recommended mesh reinforcement for repair of hernias 2 cm or greater in size (grade A).
The panelists failed to reach agreement on several areas where high-quality data were limited, including mesh type. “Categories include ultra-light weight, light-weight, mid-weight, heavy-weight, and super-heavy weight, though precise definitions for each category are variable,” authors of the consensus statement wrote. “Randomized controlled trials are needed to compare synthetic, biological, and bioabsorbable meshes in all VH types and clinical settings.”
The authors of the consensus statement also called for further high-quality studies to better assess the management of VH in complex patients, which they defined as those presenting acutely, patients with cirrhosis, patients with inflammatory bowel disease, and patients who are pregnant.
The authors acknowledged certain limitations of the statement, including the fact that not all VH experts were included on the consensus panel. “However, the panel consisted of a large group of national experts with a primary practice focus of VHR,” they wrote. “The panelists have diverse views and unique areas of knowledge in the realm of hernia repair. The differing backgrounds among panelists was intended to make the guidelines that were developed more generalizable, as there is a wide variety of experience and skill level in the surgical community. In addition, there are no objective criteria to define an ‘expert’ in VH management.”
This work was supported by the Center for Clinical and Translational Sciences. The authors reported having no financial disclosures.
[email protected]
Those are key conclusions from a consensus statement based on a systematic review of existing evidence in the medical literature about ventral hernia management that were published in the January 2017 issue of the Annals of Surgery.
“Despite ventral hernias (VH) being one of the most common pathologies seen by clinicians, significant variability in management exists,” wrote the researchers, led by Mike K. Liang, MD, of the University of Texas Health Science Center at Houston. “Surveys of clinicians and review of nationwide databases of patients undergoing elective ventral hernia repair (VHR) demonstrate substantial heterogeneity in patient selection and clinical practice.”
The panelists agreed that complications with VHR increase in obese patients (grade A evidence), current smokers (grade A), and in patients with glycosylated hemoglobin A1c (HbA1c) of 6.5% or greater (grade B). They did not recommend elective VHR in patients with a body mass index of 50 kg/m2 or greater (grade C), in current smokers (grade A), or patients with an HbA1c of 8.0% or greater (grade B). They also agreed that patients with a BMI of 30-50 kg/m2 or an HbA1c level of 6.5%-8.0% require individualized interventions to reduce surgical risk (grade C, grade B, respectively). The panelists considered nonoperative management to have a low risk of short-term morbidity (grade C) and they recommended mesh reinforcement for repair of hernias 2 cm or greater in size (grade A).
The panelists failed to reach agreement on several areas where high-quality data were limited, including mesh type. “Categories include ultra-light weight, light-weight, mid-weight, heavy-weight, and super-heavy weight, though precise definitions for each category are variable,” authors of the consensus statement wrote. “Randomized controlled trials are needed to compare synthetic, biological, and bioabsorbable meshes in all VH types and clinical settings.”
The authors of the consensus statement also called for further high-quality studies to better assess the management of VH in complex patients, which they defined as those presenting acutely, patients with cirrhosis, patients with inflammatory bowel disease, and patients who are pregnant.
The authors acknowledged certain limitations of the statement, including the fact that not all VH experts were included on the consensus panel. “However, the panel consisted of a large group of national experts with a primary practice focus of VHR,” they wrote. “The panelists have diverse views and unique areas of knowledge in the realm of hernia repair. The differing backgrounds among panelists was intended to make the guidelines that were developed more generalizable, as there is a wide variety of experience and skill level in the surgical community. In addition, there are no objective criteria to define an ‘expert’ in VH management.”
This work was supported by the Center for Clinical and Translational Sciences. The authors reported having no financial disclosures.
[email protected]
Those are key conclusions from a consensus statement based on a systematic review of existing evidence in the medical literature about ventral hernia management that were published in the January 2017 issue of the Annals of Surgery.
“Despite ventral hernias (VH) being one of the most common pathologies seen by clinicians, significant variability in management exists,” wrote the researchers, led by Mike K. Liang, MD, of the University of Texas Health Science Center at Houston. “Surveys of clinicians and review of nationwide databases of patients undergoing elective ventral hernia repair (VHR) demonstrate substantial heterogeneity in patient selection and clinical practice.”
The panelists agreed that complications with VHR increase in obese patients (grade A evidence), current smokers (grade A), and in patients with glycosylated hemoglobin A1c (HbA1c) of 6.5% or greater (grade B). They did not recommend elective VHR in patients with a body mass index of 50 kg/m2 or greater (grade C), in current smokers (grade A), or patients with an HbA1c of 8.0% or greater (grade B). They also agreed that patients with a BMI of 30-50 kg/m2 or an HbA1c level of 6.5%-8.0% require individualized interventions to reduce surgical risk (grade C, grade B, respectively). The panelists considered nonoperative management to have a low risk of short-term morbidity (grade C) and they recommended mesh reinforcement for repair of hernias 2 cm or greater in size (grade A).
The panelists failed to reach agreement on several areas where high-quality data were limited, including mesh type. “Categories include ultra-light weight, light-weight, mid-weight, heavy-weight, and super-heavy weight, though precise definitions for each category are variable,” authors of the consensus statement wrote. “Randomized controlled trials are needed to compare synthetic, biological, and bioabsorbable meshes in all VH types and clinical settings.”
The authors of the consensus statement also called for further high-quality studies to better assess the management of VH in complex patients, which they defined as those presenting acutely, patients with cirrhosis, patients with inflammatory bowel disease, and patients who are pregnant.
The authors acknowledged certain limitations of the statement, including the fact that not all VH experts were included on the consensus panel. “However, the panel consisted of a large group of national experts with a primary practice focus of VHR,” they wrote. “The panelists have diverse views and unique areas of knowledge in the realm of hernia repair. The differing backgrounds among panelists was intended to make the guidelines that were developed more generalizable, as there is a wide variety of experience and skill level in the surgical community. In addition, there are no objective criteria to define an ‘expert’ in VH management.”
This work was supported by the Center for Clinical and Translational Sciences. The authors reported having no financial disclosures.
[email protected]
FROM ANNALS OF SURGERY
Esophageal cancers: Apples and oranges wrongly lumped together
Genomic analysis suggests that esophageal adenocarcinoma (EAC) and esophageal squamous cell carcinoma (ESCC) are two separate diseases that should not be combined in clinical trials and may benefit from different treatments, according to the results of a molecular study of 559 esophageal and gastric carcinoma tumors obtained from around the world.
The comprehensive molecular analysis comprised 164 esophageal tumors, 359 gastric adenocarcinomas, and 36 additional adenocarcinomas spanning the gastroesophageal junction.
The results of their analysis “call into question the premise of envisioning esophageal carcinoma as a single entity” and “argue against approaches that combine EAC and ESCC for clinical trials of neoadjuvant, adjuvant, or systemic therapies,” wrote the members of The Cancer Genome Atlas Research Network under the coordination of the National Cancer Institute and the National Human Genome Research Institute project.
The researchers evaluated the 164 esophageal carcinomas using integrated clustering of somatic copy number aberrations, DNA methylation, mRNA, and microRNA expression.
Gene expression analysis showed EACs had increased E-cadherin (CDH1) signaling and upregulation of ARF6 and FOXA pathways, which regulate E-cadherin. In contrast, ESCCs showed upregulation of Wnt, syndecan; p63 pathways, which are essential for squamous epithelial cell differentiation, were also upregulated. “These data suggest the presence of lineage-specific alterations that drive progression in EACs and ESCCs,” according to the researchers.
Somatic genome alterations showed that many of the same genetic pathways were altered in both EAC and ESCC, but the specific genes affected were dissimilar, suggesting distinct pathophysiologies between the two types of cancer. This could signal the need for different treatment approaches and led the researchers to caution against lumping EAC and ESCC in the same clinical trials.
Molecular subtype analysis of the ESCC cancers showed three molecular subtypes: ESCC1 (50 tumors), ESCC2 (36) and ESCC3 (4), distinguished by their mutation types. ESCC1, for example, was characterized by alterations in the NRF2 pathway, mutations in which are associated with poor prognosis and resistance to chemotherapy.
The three subtypes also showed trends for geographic associations, with Vietnamese patients (the only Asian population studied) showing a predominance of ESCC1 (27/41), and all 4 ESCC3 tumors being derived from United States patients.
The researchers also evaluated the molecular association between ESCC and human papillomavirus (HPV), which has been shown to have a pathogenic role in cervical SCC and head and neck (HN)SCC. They found that ESCC mRNA sequencing showed that ESCC-HPV transcript levels were similar to HPV-negative HNSCC tumors, diminishing the likelihood of an etiological role for HPV in ESCC.
In evaluating EACs in comparison to chromosomal instability (CIN) gastric cancers, the researchers found “clear similarity between chromosomal aberrations” in the two cancer types, with a stronger similarity between EAC and CIN gastric cancers than between EAC and ESCC, further differentiating the two esophageal cancers.
“The notable molecular similarity between EACs and CIN gastric cancers provides indirect support for gastric origin of Barrett’s esophagus and EAC and indicates that we may view GEA [gastroesophageal adenocarcinoma] as a singular entity, analogous to colorectal adenocarcinoma,” the authors added.
A notable anatomic gradient showed up in the progression of DNA methylation as seen from proximal to distal GEA-CIN tumors, with the most frequent hypermethylation seen in EACs, compared with gastric CIN cancers, a significant difference.
“These molecular data show that EAC and ESCC are distinct in their molecular characteristics across all platforms tested. ESCC emerges as a disease more reminiscent of other SCCs than of EAC, which itself bears striking resemblance to CIN gastric cancer,” the researchers concluded.
The authors reported that they had no competing financial interests.
This article published in Nature summarizes an integrated genomic analysis of esophageal cancer with careful comparisons to other cancers in the neighborhood (head and neck, lung, and gastric cancer). While clinically apparent to physicians taking care of esophageal cancer throughout the world, these analyses confirm that esophageal squamous cell cancer and esophageal adenocarcinoma are essentially two different diseases with distinct genomic characteristics. This has an important implication in clinical trial design: These pathologies should not be analyzed together, but instead should be studied distinctly.
In addition to the above major conclusion, several other features deserve to be noted. First, esophageal cancer does not seem to be associated with HPV as the HPV transcript levels in these tumors resemble those in HPV-negative head and neck cancers. Second, there are significant differences in the genomic characteristics of esophageal squamous cell cancer depending on geographic location. Third, esophageal adenocarcinoma is most like one particular molecular variant of gastric cancer (chromosomal instability type) and as one moves from the gastric antrum to the esophagus, there is an enrichment of this type of cancer. Such a gradient is found in methylation patterns as well, suggesting a similar cell of origin between gastric and esophageal cancers.
This study brings into focus the overarching theme that cancers may soon be treated based on molecular characteristics rather than anatomic location and clinical trials may have to be grouped based on genetic changes rather than organ systems.
Sai Yendamuri, MD, FACS, is an attending surgeon at the department of thoracic surgery, and director, Thoracic Surgery Research Laboratory, and an associate professor of oncology at Roswell Park Cancer Institute, Buffalo, N.Y.
This article published in Nature summarizes an integrated genomic analysis of esophageal cancer with careful comparisons to other cancers in the neighborhood (head and neck, lung, and gastric cancer). While clinically apparent to physicians taking care of esophageal cancer throughout the world, these analyses confirm that esophageal squamous cell cancer and esophageal adenocarcinoma are essentially two different diseases with distinct genomic characteristics. This has an important implication in clinical trial design: These pathologies should not be analyzed together, but instead should be studied distinctly.
In addition to the above major conclusion, several other features deserve to be noted. First, esophageal cancer does not seem to be associated with HPV as the HPV transcript levels in these tumors resemble those in HPV-negative head and neck cancers. Second, there are significant differences in the genomic characteristics of esophageal squamous cell cancer depending on geographic location. Third, esophageal adenocarcinoma is most like one particular molecular variant of gastric cancer (chromosomal instability type) and as one moves from the gastric antrum to the esophagus, there is an enrichment of this type of cancer. Such a gradient is found in methylation patterns as well, suggesting a similar cell of origin between gastric and esophageal cancers.
This study brings into focus the overarching theme that cancers may soon be treated based on molecular characteristics rather than anatomic location and clinical trials may have to be grouped based on genetic changes rather than organ systems.
Sai Yendamuri, MD, FACS, is an attending surgeon at the department of thoracic surgery, and director, Thoracic Surgery Research Laboratory, and an associate professor of oncology at Roswell Park Cancer Institute, Buffalo, N.Y.
This article published in Nature summarizes an integrated genomic analysis of esophageal cancer with careful comparisons to other cancers in the neighborhood (head and neck, lung, and gastric cancer). While clinically apparent to physicians taking care of esophageal cancer throughout the world, these analyses confirm that esophageal squamous cell cancer and esophageal adenocarcinoma are essentially two different diseases with distinct genomic characteristics. This has an important implication in clinical trial design: These pathologies should not be analyzed together, but instead should be studied distinctly.
In addition to the above major conclusion, several other features deserve to be noted. First, esophageal cancer does not seem to be associated with HPV as the HPV transcript levels in these tumors resemble those in HPV-negative head and neck cancers. Second, there are significant differences in the genomic characteristics of esophageal squamous cell cancer depending on geographic location. Third, esophageal adenocarcinoma is most like one particular molecular variant of gastric cancer (chromosomal instability type) and as one moves from the gastric antrum to the esophagus, there is an enrichment of this type of cancer. Such a gradient is found in methylation patterns as well, suggesting a similar cell of origin between gastric and esophageal cancers.
This study brings into focus the overarching theme that cancers may soon be treated based on molecular characteristics rather than anatomic location and clinical trials may have to be grouped based on genetic changes rather than organ systems.
Sai Yendamuri, MD, FACS, is an attending surgeon at the department of thoracic surgery, and director, Thoracic Surgery Research Laboratory, and an associate professor of oncology at Roswell Park Cancer Institute, Buffalo, N.Y.
Genomic analysis suggests that esophageal adenocarcinoma (EAC) and esophageal squamous cell carcinoma (ESCC) are two separate diseases that should not be combined in clinical trials and may benefit from different treatments, according to the results of a molecular study of 559 esophageal and gastric carcinoma tumors obtained from around the world.
The comprehensive molecular analysis comprised 164 esophageal tumors, 359 gastric adenocarcinomas, and 36 additional adenocarcinomas spanning the gastroesophageal junction.
The results of their analysis “call into question the premise of envisioning esophageal carcinoma as a single entity” and “argue against approaches that combine EAC and ESCC for clinical trials of neoadjuvant, adjuvant, or systemic therapies,” wrote the members of The Cancer Genome Atlas Research Network under the coordination of the National Cancer Institute and the National Human Genome Research Institute project.
The researchers evaluated the 164 esophageal carcinomas using integrated clustering of somatic copy number aberrations, DNA methylation, mRNA, and microRNA expression.
Gene expression analysis showed EACs had increased E-cadherin (CDH1) signaling and upregulation of ARF6 and FOXA pathways, which regulate E-cadherin. In contrast, ESCCs showed upregulation of Wnt, syndecan; p63 pathways, which are essential for squamous epithelial cell differentiation, were also upregulated. “These data suggest the presence of lineage-specific alterations that drive progression in EACs and ESCCs,” according to the researchers.
Somatic genome alterations showed that many of the same genetic pathways were altered in both EAC and ESCC, but the specific genes affected were dissimilar, suggesting distinct pathophysiologies between the two types of cancer. This could signal the need for different treatment approaches and led the researchers to caution against lumping EAC and ESCC in the same clinical trials.
Molecular subtype analysis of the ESCC cancers showed three molecular subtypes: ESCC1 (50 tumors), ESCC2 (36) and ESCC3 (4), distinguished by their mutation types. ESCC1, for example, was characterized by alterations in the NRF2 pathway, mutations in which are associated with poor prognosis and resistance to chemotherapy.
The three subtypes also showed trends for geographic associations, with Vietnamese patients (the only Asian population studied) showing a predominance of ESCC1 (27/41), and all 4 ESCC3 tumors being derived from United States patients.
The researchers also evaluated the molecular association between ESCC and human papillomavirus (HPV), which has been shown to have a pathogenic role in cervical SCC and head and neck (HN)SCC. They found that ESCC mRNA sequencing showed that ESCC-HPV transcript levels were similar to HPV-negative HNSCC tumors, diminishing the likelihood of an etiological role for HPV in ESCC.
In evaluating EACs in comparison to chromosomal instability (CIN) gastric cancers, the researchers found “clear similarity between chromosomal aberrations” in the two cancer types, with a stronger similarity between EAC and CIN gastric cancers than between EAC and ESCC, further differentiating the two esophageal cancers.
“The notable molecular similarity between EACs and CIN gastric cancers provides indirect support for gastric origin of Barrett’s esophagus and EAC and indicates that we may view GEA [gastroesophageal adenocarcinoma] as a singular entity, analogous to colorectal adenocarcinoma,” the authors added.
A notable anatomic gradient showed up in the progression of DNA methylation as seen from proximal to distal GEA-CIN tumors, with the most frequent hypermethylation seen in EACs, compared with gastric CIN cancers, a significant difference.
“These molecular data show that EAC and ESCC are distinct in their molecular characteristics across all platforms tested. ESCC emerges as a disease more reminiscent of other SCCs than of EAC, which itself bears striking resemblance to CIN gastric cancer,” the researchers concluded.
The authors reported that they had no competing financial interests.
Genomic analysis suggests that esophageal adenocarcinoma (EAC) and esophageal squamous cell carcinoma (ESCC) are two separate diseases that should not be combined in clinical trials and may benefit from different treatments, according to the results of a molecular study of 559 esophageal and gastric carcinoma tumors obtained from around the world.
The comprehensive molecular analysis comprised 164 esophageal tumors, 359 gastric adenocarcinomas, and 36 additional adenocarcinomas spanning the gastroesophageal junction.
The results of their analysis “call into question the premise of envisioning esophageal carcinoma as a single entity” and “argue against approaches that combine EAC and ESCC for clinical trials of neoadjuvant, adjuvant, or systemic therapies,” wrote the members of The Cancer Genome Atlas Research Network under the coordination of the National Cancer Institute and the National Human Genome Research Institute project.
The researchers evaluated the 164 esophageal carcinomas using integrated clustering of somatic copy number aberrations, DNA methylation, mRNA, and microRNA expression.
Gene expression analysis showed EACs had increased E-cadherin (CDH1) signaling and upregulation of ARF6 and FOXA pathways, which regulate E-cadherin. In contrast, ESCCs showed upregulation of Wnt, syndecan; p63 pathways, which are essential for squamous epithelial cell differentiation, were also upregulated. “These data suggest the presence of lineage-specific alterations that drive progression in EACs and ESCCs,” according to the researchers.
Somatic genome alterations showed that many of the same genetic pathways were altered in both EAC and ESCC, but the specific genes affected were dissimilar, suggesting distinct pathophysiologies between the two types of cancer. This could signal the need for different treatment approaches and led the researchers to caution against lumping EAC and ESCC in the same clinical trials.
Molecular subtype analysis of the ESCC cancers showed three molecular subtypes: ESCC1 (50 tumors), ESCC2 (36) and ESCC3 (4), distinguished by their mutation types. ESCC1, for example, was characterized by alterations in the NRF2 pathway, mutations in which are associated with poor prognosis and resistance to chemotherapy.
The three subtypes also showed trends for geographic associations, with Vietnamese patients (the only Asian population studied) showing a predominance of ESCC1 (27/41), and all 4 ESCC3 tumors being derived from United States patients.
The researchers also evaluated the molecular association between ESCC and human papillomavirus (HPV), which has been shown to have a pathogenic role in cervical SCC and head and neck (HN)SCC. They found that ESCC mRNA sequencing showed that ESCC-HPV transcript levels were similar to HPV-negative HNSCC tumors, diminishing the likelihood of an etiological role for HPV in ESCC.
In evaluating EACs in comparison to chromosomal instability (CIN) gastric cancers, the researchers found “clear similarity between chromosomal aberrations” in the two cancer types, with a stronger similarity between EAC and CIN gastric cancers than between EAC and ESCC, further differentiating the two esophageal cancers.
“The notable molecular similarity between EACs and CIN gastric cancers provides indirect support for gastric origin of Barrett’s esophagus and EAC and indicates that we may view GEA [gastroesophageal adenocarcinoma] as a singular entity, analogous to colorectal adenocarcinoma,” the authors added.
A notable anatomic gradient showed up in the progression of DNA methylation as seen from proximal to distal GEA-CIN tumors, with the most frequent hypermethylation seen in EACs, compared with gastric CIN cancers, a significant difference.
“These molecular data show that EAC and ESCC are distinct in their molecular characteristics across all platforms tested. ESCC emerges as a disease more reminiscent of other SCCs than of EAC, which itself bears striking resemblance to CIN gastric cancer,” the researchers concluded.
The authors reported that they had no competing financial interests.
FROM NATURE
Key clinical point:
Major finding: Molecular analysis showed esophageal squamous cell carcinoma is more like other squamous cell carcinomas than esophageal adenocarcinoma, which itself resembles chromosomal-instability gastric cancer.
Data source: A molecular study of 559 esophageal and gastric carcinoma tumors obtained from around the world.
Disclosures: The authors reported that they had no competing financial interests.
Scleroligation procedure proposed for gastroesophageal varices
In the treatment of gastroesophageal varices, scleroligation – a hybrid procedure that combines sclerotherapy and band ligation – performed as well as did band ligation, but required fewer sessions and had a shorter overall treatment duration. Sclerotherapy involves the injection of sclerosant to prompt occlusion of the varices, while ligation involves banding the varices to cut off blood flow.
The new approach combines them. The researchers ligated the varix 3-5 cm from the gastroesophageal junction and injected the sclerosant into the varix, below the ligated section. They reasoned that ligation should increase the contact time between the sclerosant and endothelial cells, and thus improve efficacy.
He noted that in the United States, band ligation is the standard of therapy, and the new study won’t change that. “These preliminary results from a single center are quite promising, and if they can be confirmed in a larger, multicenter trial, then this is something that can be added to our therapeutic armamentarium,” said Dr. Kwo.
Band ligation replaced sclerotherapy as the preferred treatment for gastroesophageal varices because it has equal efficacy but fewer severe side effects. However, it also suffers from a higher rate of recurrence because the bands cannot destroy deeper varices and perforating veins.
The combination technique, scleroligation, has been demonstrated in the treatment of esophageal varices, which prompted the authors’ investigation into gastroesophageal varices.
At a single center, the researchers recruited 120 patients with cirrhosis and acute gastroesophageal variceal bleeding above the gastroesophageal junction. They were randomized 1:1 to undergo endoscopic band ligation (EBL) or scleroligation (SL).
On average, 15.6 weeks were required to obliterate the varices in the EBL group versus 8.64 weeks in the SL group (P less than .001). The EBL group required an average of 3.43 sessions to reach that endpoint, compared with 2.22 sessions in the SL group (P less than .001). The EBL group required an average of 13.72 bands per patient, compared with 8.88 bands in the SL group (P less than .001). The EBL group also had a higher average number of units of blood transfused (2.30 vs 1.53; P less than .001).
No patients in either group experienced perforation, chest empyema, pericardial effusion, or strictures.
The good safety outcomes may be related to the small volume of sclerosant used, just 2 mL. “It’s probably because of their meticulous approach that they were able to reduce the complications that we have historically seen with sclerotherapy alone,” said Dr. Kwo.
There was no difference in the number of rebleeds or recurrences at follow-up, total cost, mortality due to rebleeding, or 12-month survival.
No funding source was disclosed. The authors reported no financial disclosures.
In the treatment of gastroesophageal varices, scleroligation – a hybrid procedure that combines sclerotherapy and band ligation – performed as well as did band ligation, but required fewer sessions and had a shorter overall treatment duration. Sclerotherapy involves the injection of sclerosant to prompt occlusion of the varices, while ligation involves banding the varices to cut off blood flow.
The new approach combines them. The researchers ligated the varix 3-5 cm from the gastroesophageal junction and injected the sclerosant into the varix, below the ligated section. They reasoned that ligation should increase the contact time between the sclerosant and endothelial cells, and thus improve efficacy.
He noted that in the United States, band ligation is the standard of therapy, and the new study won’t change that. “These preliminary results from a single center are quite promising, and if they can be confirmed in a larger, multicenter trial, then this is something that can be added to our therapeutic armamentarium,” said Dr. Kwo.
Band ligation replaced sclerotherapy as the preferred treatment for gastroesophageal varices because it has equal efficacy but fewer severe side effects. However, it also suffers from a higher rate of recurrence because the bands cannot destroy deeper varices and perforating veins.
The combination technique, scleroligation, has been demonstrated in the treatment of esophageal varices, which prompted the authors’ investigation into gastroesophageal varices.
At a single center, the researchers recruited 120 patients with cirrhosis and acute gastroesophageal variceal bleeding above the gastroesophageal junction. They were randomized 1:1 to undergo endoscopic band ligation (EBL) or scleroligation (SL).
On average, 15.6 weeks were required to obliterate the varices in the EBL group versus 8.64 weeks in the SL group (P less than .001). The EBL group required an average of 3.43 sessions to reach that endpoint, compared with 2.22 sessions in the SL group (P less than .001). The EBL group required an average of 13.72 bands per patient, compared with 8.88 bands in the SL group (P less than .001). The EBL group also had a higher average number of units of blood transfused (2.30 vs 1.53; P less than .001).
No patients in either group experienced perforation, chest empyema, pericardial effusion, or strictures.
The good safety outcomes may be related to the small volume of sclerosant used, just 2 mL. “It’s probably because of their meticulous approach that they were able to reduce the complications that we have historically seen with sclerotherapy alone,” said Dr. Kwo.
There was no difference in the number of rebleeds or recurrences at follow-up, total cost, mortality due to rebleeding, or 12-month survival.
No funding source was disclosed. The authors reported no financial disclosures.
In the treatment of gastroesophageal varices, scleroligation – a hybrid procedure that combines sclerotherapy and band ligation – performed as well as did band ligation, but required fewer sessions and had a shorter overall treatment duration. Sclerotherapy involves the injection of sclerosant to prompt occlusion of the varices, while ligation involves banding the varices to cut off blood flow.
The new approach combines them. The researchers ligated the varix 3-5 cm from the gastroesophageal junction and injected the sclerosant into the varix, below the ligated section. They reasoned that ligation should increase the contact time between the sclerosant and endothelial cells, and thus improve efficacy.
He noted that in the United States, band ligation is the standard of therapy, and the new study won’t change that. “These preliminary results from a single center are quite promising, and if they can be confirmed in a larger, multicenter trial, then this is something that can be added to our therapeutic armamentarium,” said Dr. Kwo.
Band ligation replaced sclerotherapy as the preferred treatment for gastroesophageal varices because it has equal efficacy but fewer severe side effects. However, it also suffers from a higher rate of recurrence because the bands cannot destroy deeper varices and perforating veins.
The combination technique, scleroligation, has been demonstrated in the treatment of esophageal varices, which prompted the authors’ investigation into gastroesophageal varices.
At a single center, the researchers recruited 120 patients with cirrhosis and acute gastroesophageal variceal bleeding above the gastroesophageal junction. They were randomized 1:1 to undergo endoscopic band ligation (EBL) or scleroligation (SL).
On average, 15.6 weeks were required to obliterate the varices in the EBL group versus 8.64 weeks in the SL group (P less than .001). The EBL group required an average of 3.43 sessions to reach that endpoint, compared with 2.22 sessions in the SL group (P less than .001). The EBL group required an average of 13.72 bands per patient, compared with 8.88 bands in the SL group (P less than .001). The EBL group also had a higher average number of units of blood transfused (2.30 vs 1.53; P less than .001).
No patients in either group experienced perforation, chest empyema, pericardial effusion, or strictures.
The good safety outcomes may be related to the small volume of sclerosant used, just 2 mL. “It’s probably because of their meticulous approach that they were able to reduce the complications that we have historically seen with sclerotherapy alone,” said Dr. Kwo.
There was no difference in the number of rebleeds or recurrences at follow-up, total cost, mortality due to rebleeding, or 12-month survival.
No funding source was disclosed. The authors reported no financial disclosures.
FROM GASTROINTESTINAL ENDOSCOPY
Key clinical point:
Major finding: Scleroligation required 2.22 sessions on average, compared with 3.43 for endoscopic band ligation.
Data source: Single-center randomized trial of 120 patients.
Disclosures: No funding source was disclosed. The authors reported no financial disclosures.
Double-dose influenza vaccine effective against type B strains
A double-dose inactivated quadrivalent influenza vaccine (IIV4) could be administered to all children aged 6-35 months, as it not only offers the best protection against influenza type B, but it also allows for simplifying the current vaccination schedule considerably.
“The introduction of IIV4 provides an opportunity to review long-accepted practices in administration of influenza vaccines,” explained Varsha K. Jain, MD, formerly employed by GlaxoSmithKline Vaccines, King of Prussia, Pa., and associates.
Giving a lower dose to young children was planned to reduce reactogenicity and febrile convulsions observed with the whole virus vaccines that were in use in the 1970s. But young children have a variable immune response to lower doses, especially against vaccine B strains, they noted (J Ped Infect Dis. 2017 Jan 6. doi: 10.1093/jpids/piw068).
Dr. Jain and coauthors enrolled 2,430 children aged 6-35 months during the 2014-2015 influenza season in the United States and Mexico in this phase III study. Children were randomized into one of two cohorts: one cohort received a standard-doze IIV4 vaccination, while the other received a double-dose. Data on age (6-17 months, 18-35 months), health care center, and influenza primer status also were taken into consideration.
The standard-dose vaccine contained 7.5 mcg of A/California/7/2009 (A/H1N1), A/Texas/50/2012 (A/H3N2), B/Brisbane/60/2008 (B/Victoria), and B/Massachusetts/2/2012 (B/Yamagata), while the double-dose vaccine contained 15 mcg, or twice the amount each, of the same strains. The former was developed by Sanofi Pasteur and the latter by GSK Vaccines.
Primed children who completed the study numbered 1,173; 586 received the standard-dose and 587 received the double-dose. On the unprimed side, 868 completed the study: 442 standard-dose and 426 double-dose. Each dose’s immunogenic noninferiority was quantified by calculating the geometric mean titer (GMT) ratio.
“Immunogenicity was higher in the double-dose group compared with the standard-dose group, particularly against vaccine B strains in children 6-17 months of age and unprimed children,” Dr. Vain and associates said. Both vaccines performed well against the influenza B strain, with the double-dose yielding a GMT of 1.89 against the B/Yamagata strain and 2.13 against the B/Victoria in children aged 6-17 months. Across the entire age spectrum of the study population, unprimed children registered a GMT of 1.85 and 2.04 against the same strains, respectively. For comparison, none of the A strains in any cohort based on age or primed/unprimed registered a GMT above 1.5.
“Increased protection against influenza B [would] be a beneficial clinical outcome [and] use of the same vaccine dose for all eligible ages would also simplify the annual influenza vaccine campaign and reduce cost and logistic complexity,” the authors concluded. “This study provides evidence to support a change in clinical practice to use [double-dose IIV4] in all children 6 months of age and older, once that dosing for a vaccine product has been approved.”
Dr. Jain now is employed by the Bill and Melinda Gates Foundation.
Dr. Jain and several coauthors disclosed ties to GlaxoSmithKline, which funded the study.
A double-dose inactivated quadrivalent influenza vaccine (IIV4) could be administered to all children aged 6-35 months, as it not only offers the best protection against influenza type B, but it also allows for simplifying the current vaccination schedule considerably.
“The introduction of IIV4 provides an opportunity to review long-accepted practices in administration of influenza vaccines,” explained Varsha K. Jain, MD, formerly employed by GlaxoSmithKline Vaccines, King of Prussia, Pa., and associates.
Giving a lower dose to young children was planned to reduce reactogenicity and febrile convulsions observed with the whole virus vaccines that were in use in the 1970s. But young children have a variable immune response to lower doses, especially against vaccine B strains, they noted (J Ped Infect Dis. 2017 Jan 6. doi: 10.1093/jpids/piw068).
Dr. Jain and coauthors enrolled 2,430 children aged 6-35 months during the 2014-2015 influenza season in the United States and Mexico in this phase III study. Children were randomized into one of two cohorts: one cohort received a standard-doze IIV4 vaccination, while the other received a double-dose. Data on age (6-17 months, 18-35 months), health care center, and influenza primer status also were taken into consideration.
The standard-dose vaccine contained 7.5 mcg of A/California/7/2009 (A/H1N1), A/Texas/50/2012 (A/H3N2), B/Brisbane/60/2008 (B/Victoria), and B/Massachusetts/2/2012 (B/Yamagata), while the double-dose vaccine contained 15 mcg, or twice the amount each, of the same strains. The former was developed by Sanofi Pasteur and the latter by GSK Vaccines.
Primed children who completed the study numbered 1,173; 586 received the standard-dose and 587 received the double-dose. On the unprimed side, 868 completed the study: 442 standard-dose and 426 double-dose. Each dose’s immunogenic noninferiority was quantified by calculating the geometric mean titer (GMT) ratio.
“Immunogenicity was higher in the double-dose group compared with the standard-dose group, particularly against vaccine B strains in children 6-17 months of age and unprimed children,” Dr. Vain and associates said. Both vaccines performed well against the influenza B strain, with the double-dose yielding a GMT of 1.89 against the B/Yamagata strain and 2.13 against the B/Victoria in children aged 6-17 months. Across the entire age spectrum of the study population, unprimed children registered a GMT of 1.85 and 2.04 against the same strains, respectively. For comparison, none of the A strains in any cohort based on age or primed/unprimed registered a GMT above 1.5.
“Increased protection against influenza B [would] be a beneficial clinical outcome [and] use of the same vaccine dose for all eligible ages would also simplify the annual influenza vaccine campaign and reduce cost and logistic complexity,” the authors concluded. “This study provides evidence to support a change in clinical practice to use [double-dose IIV4] in all children 6 months of age and older, once that dosing for a vaccine product has been approved.”
Dr. Jain now is employed by the Bill and Melinda Gates Foundation.
Dr. Jain and several coauthors disclosed ties to GlaxoSmithKline, which funded the study.
A double-dose inactivated quadrivalent influenza vaccine (IIV4) could be administered to all children aged 6-35 months, as it not only offers the best protection against influenza type B, but it also allows for simplifying the current vaccination schedule considerably.
“The introduction of IIV4 provides an opportunity to review long-accepted practices in administration of influenza vaccines,” explained Varsha K. Jain, MD, formerly employed by GlaxoSmithKline Vaccines, King of Prussia, Pa., and associates.
Giving a lower dose to young children was planned to reduce reactogenicity and febrile convulsions observed with the whole virus vaccines that were in use in the 1970s. But young children have a variable immune response to lower doses, especially against vaccine B strains, they noted (J Ped Infect Dis. 2017 Jan 6. doi: 10.1093/jpids/piw068).
Dr. Jain and coauthors enrolled 2,430 children aged 6-35 months during the 2014-2015 influenza season in the United States and Mexico in this phase III study. Children were randomized into one of two cohorts: one cohort received a standard-doze IIV4 vaccination, while the other received a double-dose. Data on age (6-17 months, 18-35 months), health care center, and influenza primer status also were taken into consideration.
The standard-dose vaccine contained 7.5 mcg of A/California/7/2009 (A/H1N1), A/Texas/50/2012 (A/H3N2), B/Brisbane/60/2008 (B/Victoria), and B/Massachusetts/2/2012 (B/Yamagata), while the double-dose vaccine contained 15 mcg, or twice the amount each, of the same strains. The former was developed by Sanofi Pasteur and the latter by GSK Vaccines.
Primed children who completed the study numbered 1,173; 586 received the standard-dose and 587 received the double-dose. On the unprimed side, 868 completed the study: 442 standard-dose and 426 double-dose. Each dose’s immunogenic noninferiority was quantified by calculating the geometric mean titer (GMT) ratio.
“Immunogenicity was higher in the double-dose group compared with the standard-dose group, particularly against vaccine B strains in children 6-17 months of age and unprimed children,” Dr. Vain and associates said. Both vaccines performed well against the influenza B strain, with the double-dose yielding a GMT of 1.89 against the B/Yamagata strain and 2.13 against the B/Victoria in children aged 6-17 months. Across the entire age spectrum of the study population, unprimed children registered a GMT of 1.85 and 2.04 against the same strains, respectively. For comparison, none of the A strains in any cohort based on age or primed/unprimed registered a GMT above 1.5.
“Increased protection against influenza B [would] be a beneficial clinical outcome [and] use of the same vaccine dose for all eligible ages would also simplify the annual influenza vaccine campaign and reduce cost and logistic complexity,” the authors concluded. “This study provides evidence to support a change in clinical practice to use [double-dose IIV4] in all children 6 months of age and older, once that dosing for a vaccine product has been approved.”
Dr. Jain now is employed by the Bill and Melinda Gates Foundation.
Dr. Jain and several coauthors disclosed ties to GlaxoSmithKline, which funded the study.
FROM THE JOURNAL OF THE PEDIATRIC INFECTIOUS DISEASES SOCIETY
Key clinical point:
Major finding: Geometric mean titer (GMT) ratios showed that the double-dose IIV4 vaccine was the most effective against influenza type B in children aged 6-17 months (GMT = 1.89) and in unprimed children aged 6-35 months (GMT = 1.85).
Data source: Phase III, randomized trial of 2,041 children aged 6-35 months.
Disclosures: Dr. Jain and several coauthors disclosed ties to GlaxoSmithKline, which funded the study.
Switch from fingolimod to alemtuzumab might trigger MS relapse
Nine relapsing multiple sclerosis patients had significant and unexpected disease activity within 12 months of switching from fingolimod to alemtuzumab, according to a report from six European neuroscience centers.
The centers treated 174 patients with alemtuzumab (Lemtrada); 36 had been on fingolimod (Gilenya) beforehand. “Therefore, these nine patients ... represent 25% of the fingolimod-alemtuzumab cohort,” said investigators led by Mark Willis, MBBCh, a clinical research fellow at Cardiff University, Wales (Neurol Neuroimmunol Neuroinflamm. 2017 Jan 10. doi: 10.1212/NXI.0000000000000320).
“Careful consideration needs to be given to mode of action of individual therapies and sequential treatment effects,” the team concluded.
The nine patients were on fingolimod for 5-33 months, but it wasn’t working well so they were started on alemtuzumab following a median fingolimod washout period of 6 weeks. Eight patients had at least one clinical relapse within 12 months of the first alemtuzumab infusion cycle; the median time to relapse following alemtuzumab induction was 4.5 months. All nine patients had radiologic evidence of new disease activity.
Five patients had lymphocyte counts below normal when started on alemtuzumab.
Fingolimod has a half-life of 6-9 days, so “lymphocytes would be expected to normalize 2-4 weeks after discontinuation. However, there are case reports of prolonged lymphopenia following prolonged drug exposure, up to 37 months after discontinuation.” It has “been suggested that patients continue on an alternative [disease-modifying treatment] after fingolimod discontinuation, preferably until peripheral lymphocyte counts have normalized.” However, “there is currently no consensus as to which subsequent therapeutic agent is optimal,” the investigators said.
Despite the presence of disease activity in the first 12 months, all nine patients went on to the second planned infusion of alemtuzumab; eight were relapse free during a mean follow-up of 6 months after the second treatment cycle. Four of seven were radiologically stable, but three had new T2 lesions and one with a single new gadolinium-enhancing lesion.
Even so, the findings offers “some support to the hypothesis that, after a period, sequestrated lymphocytes eventually become available for depletion by alemtuzumab,” the researchers noted.
The mean age of the patients when diagnosed with MS was 21 years. The median disease duration to alemtuzumab treatment was 94 months.
There was no external funding. Dr. Willis had no disclosures. Other researchers reported ties to a number of companies, including Genzyme, maker of alemtuzumab, and Novartis, fingolimod’s maker.
Nine relapsing multiple sclerosis patients had significant and unexpected disease activity within 12 months of switching from fingolimod to alemtuzumab, according to a report from six European neuroscience centers.
The centers treated 174 patients with alemtuzumab (Lemtrada); 36 had been on fingolimod (Gilenya) beforehand. “Therefore, these nine patients ... represent 25% of the fingolimod-alemtuzumab cohort,” said investigators led by Mark Willis, MBBCh, a clinical research fellow at Cardiff University, Wales (Neurol Neuroimmunol Neuroinflamm. 2017 Jan 10. doi: 10.1212/NXI.0000000000000320).
“Careful consideration needs to be given to mode of action of individual therapies and sequential treatment effects,” the team concluded.
The nine patients were on fingolimod for 5-33 months, but it wasn’t working well so they were started on alemtuzumab following a median fingolimod washout period of 6 weeks. Eight patients had at least one clinical relapse within 12 months of the first alemtuzumab infusion cycle; the median time to relapse following alemtuzumab induction was 4.5 months. All nine patients had radiologic evidence of new disease activity.
Five patients had lymphocyte counts below normal when started on alemtuzumab.
Fingolimod has a half-life of 6-9 days, so “lymphocytes would be expected to normalize 2-4 weeks after discontinuation. However, there are case reports of prolonged lymphopenia following prolonged drug exposure, up to 37 months after discontinuation.” It has “been suggested that patients continue on an alternative [disease-modifying treatment] after fingolimod discontinuation, preferably until peripheral lymphocyte counts have normalized.” However, “there is currently no consensus as to which subsequent therapeutic agent is optimal,” the investigators said.
Despite the presence of disease activity in the first 12 months, all nine patients went on to the second planned infusion of alemtuzumab; eight were relapse free during a mean follow-up of 6 months after the second treatment cycle. Four of seven were radiologically stable, but three had new T2 lesions and one with a single new gadolinium-enhancing lesion.
Even so, the findings offers “some support to the hypothesis that, after a period, sequestrated lymphocytes eventually become available for depletion by alemtuzumab,” the researchers noted.
The mean age of the patients when diagnosed with MS was 21 years. The median disease duration to alemtuzumab treatment was 94 months.
There was no external funding. Dr. Willis had no disclosures. Other researchers reported ties to a number of companies, including Genzyme, maker of alemtuzumab, and Novartis, fingolimod’s maker.
Nine relapsing multiple sclerosis patients had significant and unexpected disease activity within 12 months of switching from fingolimod to alemtuzumab, according to a report from six European neuroscience centers.
The centers treated 174 patients with alemtuzumab (Lemtrada); 36 had been on fingolimod (Gilenya) beforehand. “Therefore, these nine patients ... represent 25% of the fingolimod-alemtuzumab cohort,” said investigators led by Mark Willis, MBBCh, a clinical research fellow at Cardiff University, Wales (Neurol Neuroimmunol Neuroinflamm. 2017 Jan 10. doi: 10.1212/NXI.0000000000000320).
“Careful consideration needs to be given to mode of action of individual therapies and sequential treatment effects,” the team concluded.
The nine patients were on fingolimod for 5-33 months, but it wasn’t working well so they were started on alemtuzumab following a median fingolimod washout period of 6 weeks. Eight patients had at least one clinical relapse within 12 months of the first alemtuzumab infusion cycle; the median time to relapse following alemtuzumab induction was 4.5 months. All nine patients had radiologic evidence of new disease activity.
Five patients had lymphocyte counts below normal when started on alemtuzumab.
Fingolimod has a half-life of 6-9 days, so “lymphocytes would be expected to normalize 2-4 weeks after discontinuation. However, there are case reports of prolonged lymphopenia following prolonged drug exposure, up to 37 months after discontinuation.” It has “been suggested that patients continue on an alternative [disease-modifying treatment] after fingolimod discontinuation, preferably until peripheral lymphocyte counts have normalized.” However, “there is currently no consensus as to which subsequent therapeutic agent is optimal,” the investigators said.
Despite the presence of disease activity in the first 12 months, all nine patients went on to the second planned infusion of alemtuzumab; eight were relapse free during a mean follow-up of 6 months after the second treatment cycle. Four of seven were radiologically stable, but three had new T2 lesions and one with a single new gadolinium-enhancing lesion.
Even so, the findings offers “some support to the hypothesis that, after a period, sequestrated lymphocytes eventually become available for depletion by alemtuzumab,” the researchers noted.
The mean age of the patients when diagnosed with MS was 21 years. The median disease duration to alemtuzumab treatment was 94 months.
There was no external funding. Dr. Willis had no disclosures. Other researchers reported ties to a number of companies, including Genzyme, maker of alemtuzumab, and Novartis, fingolimod’s maker.
FROM NEUROLOGY: NEUROIMMUNOLOGY AND NEUROINFLAMMATION
Fixed combination topical shows promise for psoriasis
MIAMI – In an ongoing drive to identify an alternative to the mainstay treatment of psoriasis with topical corticosteroids, researchers evaluated a fixed-dose combination of halobetasol propionate 0.01% and tazarotene 0.045% lotion compared to its monads and vehicle in 212 people with moderate to severe psoriasis.
After 8 weeks of once-daily applications, combination therapy yielded significantly greater reductions in erythema, plaque elevation, and scaling at the target lesion, compared with the other groups in the phase II trial. The investigators also reported at safety profile consistent with halobetasol propionate or tazarotene monotherapy, meaning no new safety concerns emerged with the combination.
Participants were randomized to the combination, halobetasol propionate alone, tazarotene monotherapy, or vehicle in the multicenter, double blind study.
Efficacy evaluation
At 8 weeks, 53% of the combination group achieved treatment success, defined as at least a 2-point gain in Investigator’s Global Assessment of Disease Severity and a score of “clear” or “almost clear.” In contrast, 33% of the halobetasol propionate group, 19% in the tazarotene, and 10% of the vehicle only group achieved those endpoints in the intent-to-treat-analysis. The difference in efficacy between the combination group and vehicle was statistically significant (P less than .001).
On individual clinical efficacy measures, more than half of the patients in the combination treatment group achieved at least a 2-point improvement from baseline: 54% for erythema, 68% for plaque elevation, 65% for scaling. Each of these outcomes was significantly superior compared to the tazarotene or vehicle group (P less than or equal to .001).
“I was not surprised by the findings as the drugs work by complimentary mechanisms of action – so combination therapy should be effective,” Dr. Stein Gold said.
At baseline, IGA severity score of 3 was most common in each group and for each psoriasis sign at the target lesions. In each group, the mean age of participants ranged from 48 to 56 years; the proportion of men ranged from 59% to 68%; and 87% to 95% were white. The median target lesion sizes ranged from 25 to 32 cm2.
Safety outcomes
One patient in the vehicle-only group died. Three other participants experienced serious adverse events – one in each of the noncombination groups. None of these events were related to the study medications, the investigators noted. Application site reactions were the most common treatment-associated adverse events. Some skin atrophy was reported.
“These results show that the fixed combination of halobetasol propionate and tazarotene was effective and well tolerated,” said Dr. Stein Gold, who serves as division head of dermatology at Henry Ford Health System, West Bloomfield, Mich. “This would be a nice addition to our treatment armamentarium for patients with plaque psoriasis.”
Dr. Stein Gold is a speaker, consultant, and study investigator for Valeant Pharmaceuticals, which supported the study.
MIAMI – In an ongoing drive to identify an alternative to the mainstay treatment of psoriasis with topical corticosteroids, researchers evaluated a fixed-dose combination of halobetasol propionate 0.01% and tazarotene 0.045% lotion compared to its monads and vehicle in 212 people with moderate to severe psoriasis.
After 8 weeks of once-daily applications, combination therapy yielded significantly greater reductions in erythema, plaque elevation, and scaling at the target lesion, compared with the other groups in the phase II trial. The investigators also reported at safety profile consistent with halobetasol propionate or tazarotene monotherapy, meaning no new safety concerns emerged with the combination.
Participants were randomized to the combination, halobetasol propionate alone, tazarotene monotherapy, or vehicle in the multicenter, double blind study.
Efficacy evaluation
At 8 weeks, 53% of the combination group achieved treatment success, defined as at least a 2-point gain in Investigator’s Global Assessment of Disease Severity and a score of “clear” or “almost clear.” In contrast, 33% of the halobetasol propionate group, 19% in the tazarotene, and 10% of the vehicle only group achieved those endpoints in the intent-to-treat-analysis. The difference in efficacy between the combination group and vehicle was statistically significant (P less than .001).
On individual clinical efficacy measures, more than half of the patients in the combination treatment group achieved at least a 2-point improvement from baseline: 54% for erythema, 68% for plaque elevation, 65% for scaling. Each of these outcomes was significantly superior compared to the tazarotene or vehicle group (P less than or equal to .001).
“I was not surprised by the findings as the drugs work by complimentary mechanisms of action – so combination therapy should be effective,” Dr. Stein Gold said.
At baseline, IGA severity score of 3 was most common in each group and for each psoriasis sign at the target lesions. In each group, the mean age of participants ranged from 48 to 56 years; the proportion of men ranged from 59% to 68%; and 87% to 95% were white. The median target lesion sizes ranged from 25 to 32 cm2.
Safety outcomes
One patient in the vehicle-only group died. Three other participants experienced serious adverse events – one in each of the noncombination groups. None of these events were related to the study medications, the investigators noted. Application site reactions were the most common treatment-associated adverse events. Some skin atrophy was reported.
“These results show that the fixed combination of halobetasol propionate and tazarotene was effective and well tolerated,” said Dr. Stein Gold, who serves as division head of dermatology at Henry Ford Health System, West Bloomfield, Mich. “This would be a nice addition to our treatment armamentarium for patients with plaque psoriasis.”
Dr. Stein Gold is a speaker, consultant, and study investigator for Valeant Pharmaceuticals, which supported the study.
MIAMI – In an ongoing drive to identify an alternative to the mainstay treatment of psoriasis with topical corticosteroids, researchers evaluated a fixed-dose combination of halobetasol propionate 0.01% and tazarotene 0.045% lotion compared to its monads and vehicle in 212 people with moderate to severe psoriasis.
After 8 weeks of once-daily applications, combination therapy yielded significantly greater reductions in erythema, plaque elevation, and scaling at the target lesion, compared with the other groups in the phase II trial. The investigators also reported at safety profile consistent with halobetasol propionate or tazarotene monotherapy, meaning no new safety concerns emerged with the combination.
Participants were randomized to the combination, halobetasol propionate alone, tazarotene monotherapy, or vehicle in the multicenter, double blind study.
Efficacy evaluation
At 8 weeks, 53% of the combination group achieved treatment success, defined as at least a 2-point gain in Investigator’s Global Assessment of Disease Severity and a score of “clear” or “almost clear.” In contrast, 33% of the halobetasol propionate group, 19% in the tazarotene, and 10% of the vehicle only group achieved those endpoints in the intent-to-treat-analysis. The difference in efficacy between the combination group and vehicle was statistically significant (P less than .001).
On individual clinical efficacy measures, more than half of the patients in the combination treatment group achieved at least a 2-point improvement from baseline: 54% for erythema, 68% for plaque elevation, 65% for scaling. Each of these outcomes was significantly superior compared to the tazarotene or vehicle group (P less than or equal to .001).
“I was not surprised by the findings as the drugs work by complimentary mechanisms of action – so combination therapy should be effective,” Dr. Stein Gold said.
At baseline, IGA severity score of 3 was most common in each group and for each psoriasis sign at the target lesions. In each group, the mean age of participants ranged from 48 to 56 years; the proportion of men ranged from 59% to 68%; and 87% to 95% were white. The median target lesion sizes ranged from 25 to 32 cm2.
Safety outcomes
One patient in the vehicle-only group died. Three other participants experienced serious adverse events – one in each of the noncombination groups. None of these events were related to the study medications, the investigators noted. Application site reactions were the most common treatment-associated adverse events. Some skin atrophy was reported.
“These results show that the fixed combination of halobetasol propionate and tazarotene was effective and well tolerated,” said Dr. Stein Gold, who serves as division head of dermatology at Henry Ford Health System, West Bloomfield, Mich. “This would be a nice addition to our treatment armamentarium for patients with plaque psoriasis.”
Dr. Stein Gold is a speaker, consultant, and study investigator for Valeant Pharmaceuticals, which supported the study.
AT ODAC 2017
Key clinical point: A fixed dose combination of topical halobetasol propionate 0.01% and tazarotene 0.045% proved superior to either monotherapy or vehicle.
Major finding: Treatment success was achieved by 53% of a combination group compared with 33% of a halobetasol propionate group, 19% of a tazarotene group, and 10% of the vehicle-only group in an intent-to-treat-analysis.
Data source: A multicenter, randomized, double blind phase II study of 212 people with moderate to severe psoriasis.
Disclosures: Dr. Stein Gold is a speaker, consultant, and study investigator for Valeant Pharmaceuticals, which supported the study.
CKD death rate highest in Mexico
A global measure of chronic kidney disease dropped by 3.9% from 2005 to 2015, but CKD remains a top-10 burden in 63 countries, according to the Global Burden of Disease 2015 study.
The age-standardized rate of years of life lost (YLL) for CKD dropped by 3.9%, even though its global YLL rank rose from 21st to 17th and total CKD mortality was up by almost 32%, the Global Burden of Disease 2015 Mortality and Causes of Death Collaborators reported (Lancet. 2016 Oct 8;388[10053]:1459-544). The increase in the number of deaths comes largely “because of improved estimates within countries with large populations such as China, India, and Russia,” the collaborators pointed out.
“In 2015, Latin America had the highest chronic kidney disease death rates in the world. Within Mexico, the country with the highest chronic kidney disease death rate, more than half of patients with incident end-stage renal disease have an underlying diagnosis of diabetes mellitus,” the investigators wrote.
The study is funded by the Bill & Melinda Gates Foundation.
A global measure of chronic kidney disease dropped by 3.9% from 2005 to 2015, but CKD remains a top-10 burden in 63 countries, according to the Global Burden of Disease 2015 study.
The age-standardized rate of years of life lost (YLL) for CKD dropped by 3.9%, even though its global YLL rank rose from 21st to 17th and total CKD mortality was up by almost 32%, the Global Burden of Disease 2015 Mortality and Causes of Death Collaborators reported (Lancet. 2016 Oct 8;388[10053]:1459-544). The increase in the number of deaths comes largely “because of improved estimates within countries with large populations such as China, India, and Russia,” the collaborators pointed out.
“In 2015, Latin America had the highest chronic kidney disease death rates in the world. Within Mexico, the country with the highest chronic kidney disease death rate, more than half of patients with incident end-stage renal disease have an underlying diagnosis of diabetes mellitus,” the investigators wrote.
The study is funded by the Bill & Melinda Gates Foundation.
A global measure of chronic kidney disease dropped by 3.9% from 2005 to 2015, but CKD remains a top-10 burden in 63 countries, according to the Global Burden of Disease 2015 study.
The age-standardized rate of years of life lost (YLL) for CKD dropped by 3.9%, even though its global YLL rank rose from 21st to 17th and total CKD mortality was up by almost 32%, the Global Burden of Disease 2015 Mortality and Causes of Death Collaborators reported (Lancet. 2016 Oct 8;388[10053]:1459-544). The increase in the number of deaths comes largely “because of improved estimates within countries with large populations such as China, India, and Russia,” the collaborators pointed out.
“In 2015, Latin America had the highest chronic kidney disease death rates in the world. Within Mexico, the country with the highest chronic kidney disease death rate, more than half of patients with incident end-stage renal disease have an underlying diagnosis of diabetes mellitus,” the investigators wrote.
The study is funded by the Bill & Melinda Gates Foundation.
FROM THE LANCET
Atrial fib management pathway lowers hospital admissions
ORLANDO – An atrial fibrillation treatment pathway designed specifically to reduce the proportion of patients with this complaint who are admitted to the hospital from the emergency department was found remarkably effective in a pilot study presented at the annual International AF Symposium.
“In this single-center observational study, a multidisciplinary AF pathway was associated with fivefold reduction in admission rate and 2.5-fold reduction in length of stay for those who were admitted,” reported Jeremy N. Ruskin, MD.
Relative to many other countries, admission rates for AF in the United States are “extremely high,” according to Dr. Ruskin, director of the cardiac arrhythmia service at Massachusetts General Hospital, Boston. Citing 2013 figures from the Nationwide Emergency Department Sample (NEDS) database, rates ranged between 60% and 80% by geographic region with an average of about 66%. In contrast and as an example of lower rates elsewhere, fewer than 40% of AF patients with similar characteristics presenting at emergency departments in Ontario, Can., were admitted. Similarly low admission rates have been reported in Europe.
The AF pathway tested in the study at Mass General was developed through collaboration between electrophysiologists and emergency department physicians. It is suitable for patients presenting with a primary complaint of AF without concomitant diseases, such as sepsis or myocardial infarction. Patients were entered into this study after it was shown that AF was the chief complaint. The first step was to determine whether participants were best suited to a rhythm control or rate control strategy.
“The rhythm control group was anticoagulated and then underwent expedited cardioversion with TEE (transesophageal echocardiogram) if necessary. The rate control group was anticoagulated and then given appropriate pharmacologic therapy,” Dr. Ruskin explained. Once patients were on treatment, an electrophysiologist and an emergency room physician evaluated response. Stable patients were discharged; unstable patients were admitted.
In this nonrandomized observational study conducted over a 1-year period, 94 patients were managed with the AF pathway. Admissions and outcomes in this group were compared with 265 patients who received usual care.
Only 16% of those managed through the AF pathway were admitted versus 80% (P less than .001) in the usual care group. Among those admitted, length of stay was shorter in patients managed along the AF pathway relative to usual care (32 vs. 85 hours; P = .002). Dr. Ruskin also reported that both the cardioversion rate and the proportion of patients discharged on novel oral anticoagulation drugs were higher in the AF pathway group.
The reductions in hospital admissions would be expected to translate into large reductions in costs, particularly as follow-up showed no difference in return visits to the hospital between those entered into the AF pathway relative to those who received routine care, according to Dr. Ruskin. Emphasizing the cost burden of AF admissions, he noted that the estimated charges for the more than 300,000 AF admissions in U.S. hospitals in 2013 exceeded $7 billion.
Currently, there are no guidelines for managing AF in the emergency department, and there is wide variation in practice among centers, according to Dr. Ruskin. He provided data from the NEDS database demonstrating highly significant variations in rates of admission by geographic region (for example, rates were more than 10% higher in the northeast vs. the west) and hospital type (for example, rates were twice as high in metropolitan than nonmetropolitan hospitals).
In the NEDS database, various patient characteristics were associated with increased odds ratios for admission. These included hypertension (OR, 2.3), valvular disease (OR, 3.6), and congestive heart failure (OR, 3.7). However, Dr. Ruskin indicated that patients with these or other characteristics associated with increased likelihood of admission, such as older age, have better outcomes with hospitalization.
The data from this initial observational study were recently published (Am J Cardiol. 2016 Jul 1;118[1]:64-71), and a larger prospective study with this AF pathway is already underway at both Mass General and at Brigham and Women’s Hospital, Boston. If the data confirm that AF admissions can be safely reduced through this pathway, Dr. Ruskin anticipates that implementation will be adopted at other hospitals in the Harvard system.
Dr. Ruskin reported financial relationships with Cardiome, Daiichi Sankyo, Gilead, InCarda Therapeutics, InfoBionic, Laguna Medical, Medtronic, Pfizer, and Portola.
ORLANDO – An atrial fibrillation treatment pathway designed specifically to reduce the proportion of patients with this complaint who are admitted to the hospital from the emergency department was found remarkably effective in a pilot study presented at the annual International AF Symposium.
“In this single-center observational study, a multidisciplinary AF pathway was associated with fivefold reduction in admission rate and 2.5-fold reduction in length of stay for those who were admitted,” reported Jeremy N. Ruskin, MD.
Relative to many other countries, admission rates for AF in the United States are “extremely high,” according to Dr. Ruskin, director of the cardiac arrhythmia service at Massachusetts General Hospital, Boston. Citing 2013 figures from the Nationwide Emergency Department Sample (NEDS) database, rates ranged between 60% and 80% by geographic region with an average of about 66%. In contrast and as an example of lower rates elsewhere, fewer than 40% of AF patients with similar characteristics presenting at emergency departments in Ontario, Can., were admitted. Similarly low admission rates have been reported in Europe.
The AF pathway tested in the study at Mass General was developed through collaboration between electrophysiologists and emergency department physicians. It is suitable for patients presenting with a primary complaint of AF without concomitant diseases, such as sepsis or myocardial infarction. Patients were entered into this study after it was shown that AF was the chief complaint. The first step was to determine whether participants were best suited to a rhythm control or rate control strategy.
“The rhythm control group was anticoagulated and then underwent expedited cardioversion with TEE (transesophageal echocardiogram) if necessary. The rate control group was anticoagulated and then given appropriate pharmacologic therapy,” Dr. Ruskin explained. Once patients were on treatment, an electrophysiologist and an emergency room physician evaluated response. Stable patients were discharged; unstable patients were admitted.
In this nonrandomized observational study conducted over a 1-year period, 94 patients were managed with the AF pathway. Admissions and outcomes in this group were compared with 265 patients who received usual care.
Only 16% of those managed through the AF pathway were admitted versus 80% (P less than .001) in the usual care group. Among those admitted, length of stay was shorter in patients managed along the AF pathway relative to usual care (32 vs. 85 hours; P = .002). Dr. Ruskin also reported that both the cardioversion rate and the proportion of patients discharged on novel oral anticoagulation drugs were higher in the AF pathway group.
The reductions in hospital admissions would be expected to translate into large reductions in costs, particularly as follow-up showed no difference in return visits to the hospital between those entered into the AF pathway relative to those who received routine care, according to Dr. Ruskin. Emphasizing the cost burden of AF admissions, he noted that the estimated charges for the more than 300,000 AF admissions in U.S. hospitals in 2013 exceeded $7 billion.
Currently, there are no guidelines for managing AF in the emergency department, and there is wide variation in practice among centers, according to Dr. Ruskin. He provided data from the NEDS database demonstrating highly significant variations in rates of admission by geographic region (for example, rates were more than 10% higher in the northeast vs. the west) and hospital type (for example, rates were twice as high in metropolitan than nonmetropolitan hospitals).
In the NEDS database, various patient characteristics were associated with increased odds ratios for admission. These included hypertension (OR, 2.3), valvular disease (OR, 3.6), and congestive heart failure (OR, 3.7). However, Dr. Ruskin indicated that patients with these or other characteristics associated with increased likelihood of admission, such as older age, have better outcomes with hospitalization.
The data from this initial observational study were recently published (Am J Cardiol. 2016 Jul 1;118[1]:64-71), and a larger prospective study with this AF pathway is already underway at both Mass General and at Brigham and Women’s Hospital, Boston. If the data confirm that AF admissions can be safely reduced through this pathway, Dr. Ruskin anticipates that implementation will be adopted at other hospitals in the Harvard system.
Dr. Ruskin reported financial relationships with Cardiome, Daiichi Sankyo, Gilead, InCarda Therapeutics, InfoBionic, Laguna Medical, Medtronic, Pfizer, and Portola.
ORLANDO – An atrial fibrillation treatment pathway designed specifically to reduce the proportion of patients with this complaint who are admitted to the hospital from the emergency department was found remarkably effective in a pilot study presented at the annual International AF Symposium.
“In this single-center observational study, a multidisciplinary AF pathway was associated with fivefold reduction in admission rate and 2.5-fold reduction in length of stay for those who were admitted,” reported Jeremy N. Ruskin, MD.
Relative to many other countries, admission rates for AF in the United States are “extremely high,” according to Dr. Ruskin, director of the cardiac arrhythmia service at Massachusetts General Hospital, Boston. Citing 2013 figures from the Nationwide Emergency Department Sample (NEDS) database, rates ranged between 60% and 80% by geographic region with an average of about 66%. In contrast and as an example of lower rates elsewhere, fewer than 40% of AF patients with similar characteristics presenting at emergency departments in Ontario, Can., were admitted. Similarly low admission rates have been reported in Europe.
The AF pathway tested in the study at Mass General was developed through collaboration between electrophysiologists and emergency department physicians. It is suitable for patients presenting with a primary complaint of AF without concomitant diseases, such as sepsis or myocardial infarction. Patients were entered into this study after it was shown that AF was the chief complaint. The first step was to determine whether participants were best suited to a rhythm control or rate control strategy.
“The rhythm control group was anticoagulated and then underwent expedited cardioversion with TEE (transesophageal echocardiogram) if necessary. The rate control group was anticoagulated and then given appropriate pharmacologic therapy,” Dr. Ruskin explained. Once patients were on treatment, an electrophysiologist and an emergency room physician evaluated response. Stable patients were discharged; unstable patients were admitted.
In this nonrandomized observational study conducted over a 1-year period, 94 patients were managed with the AF pathway. Admissions and outcomes in this group were compared with 265 patients who received usual care.
Only 16% of those managed through the AF pathway were admitted versus 80% (P less than .001) in the usual care group. Among those admitted, length of stay was shorter in patients managed along the AF pathway relative to usual care (32 vs. 85 hours; P = .002). Dr. Ruskin also reported that both the cardioversion rate and the proportion of patients discharged on novel oral anticoagulation drugs were higher in the AF pathway group.
The reductions in hospital admissions would be expected to translate into large reductions in costs, particularly as follow-up showed no difference in return visits to the hospital between those entered into the AF pathway relative to those who received routine care, according to Dr. Ruskin. Emphasizing the cost burden of AF admissions, he noted that the estimated charges for the more than 300,000 AF admissions in U.S. hospitals in 2013 exceeded $7 billion.
Currently, there are no guidelines for managing AF in the emergency department, and there is wide variation in practice among centers, according to Dr. Ruskin. He provided data from the NEDS database demonstrating highly significant variations in rates of admission by geographic region (for example, rates were more than 10% higher in the northeast vs. the west) and hospital type (for example, rates were twice as high in metropolitan than nonmetropolitan hospitals).
In the NEDS database, various patient characteristics were associated with increased odds ratios for admission. These included hypertension (OR, 2.3), valvular disease (OR, 3.6), and congestive heart failure (OR, 3.7). However, Dr. Ruskin indicated that patients with these or other characteristics associated with increased likelihood of admission, such as older age, have better outcomes with hospitalization.
The data from this initial observational study were recently published (Am J Cardiol. 2016 Jul 1;118[1]:64-71), and a larger prospective study with this AF pathway is already underway at both Mass General and at Brigham and Women’s Hospital, Boston. If the data confirm that AF admissions can be safely reduced through this pathway, Dr. Ruskin anticipates that implementation will be adopted at other hospitals in the Harvard system.
Dr. Ruskin reported financial relationships with Cardiome, Daiichi Sankyo, Gilead, InCarda Therapeutics, InfoBionic, Laguna Medical, Medtronic, Pfizer, and Portola.
Key clinical point: An atrial fibrillation (AF) treatment pathway in the emergency department reduces hospital admission rates.
Major finding: Once implemented, the AF hospital admission rate at one institution fell significantly, from 80% to 16%.
Data source: Prospective observational study.
Disclosures: Dr. Ruskin reports financial relationships with Cardiome, Daiichi Sankyo, Gilead, InCarda Therapeutics, InfoBionic, Laguna Medical, Medtronic, Pfizer, and Portola.
21 Medicare health plans warned to fix provider directory errors
Federal officials this month warned 21 Medicare Advantage insurers with high rates of errors in their online network directories that they could face heavy fines or have to stop enrolling people if the problems are not fixed by Feb. 6.
Among the plans that were cited are Blue Cross Blue Shield of Michigan, Highmark of Pennsylvania, SCAN Health Plan of California as well as some regional plans owned by national carriers such as UnitedHealthcare and Humana.
The action follows the government’s first in-depth review of the accuracy of Medicare Advantage provider directories, which consumers and advocates have complained about for years. More than 17 million Americans, or nearly a third of Medicare beneficiaries, get coverage through private Medicare Advantage plans.
The Centers for Medicare & Medicaid Services in October reported some of the results of the audit, but they had not released names or statistics from the individual plans.
“Because Medicare Advantage members rely on provider directories to locate an in-network provider, these inaccuracies pose a significant access-to-care barrier,” Medicare officials wrote in a report outlining the problems.
Unlike traditional Medicare, the private Medicare plans typically restrict beneficiaries to a network of doctors and hospitals.
Piedmont Community Health Plan, a small Medicare plan with about 5,200 members in southwest Virginia, had the highest rate of inaccuracies among the 54 insurers examined. Officials found errors in the listings of 87 of 108 doctors checked in Piedmont’s directory, according to the report. Most of the errors involved providing the wrong locations for doctors and doctors who should not have been listed. Piedmont officials did not return calls for comment.
Piedmont and two other plans with the highest error rates – a WellCare plan in Illinois and Emblem Health’s ConnectiCare subsidiary – were required by Medicare to submit specific business plans detailing how they intend to address the issue.
The individual plans receiving warning letters cover more than 1.4 million beneficiaries. Most operate in numerous states, although CMS generally limited its review to a specific state or geographic area.
The federal review focused on primary care doctors, cardiologists, ophthalmologists, and oncologists. It involved individual calls to check on the listings for 108 doctors in each health plan. “We encountered several instances where a call to a provider’s office resulted in determining that the provider had been retired or deceased for a long period of time, sometimes years,” the report said.
Almost half of the 5,832 doctors listed had incorrect information, including wrong addresses and wrong phone numbers. Most health plans had inaccurate information for 30%-60% of their providers’ offices, the report said. The report blamed the insurers for failing to do enough to keep their directories accurate.
“We saw a general lack of internal audit and testing of directory accuracy among many” Medicare Advantage organizations, the report said.
CMS’ survey found the most error-prone listings involved doctors with multiple offices that did not serve health plan members at each location.
The health plans were sent the warning letters Jan. 6 and given 30 days to fix the mistakes or face possible fines or sanctions, which could include suspending marketing and enrollment. CMS officials said the report was not issued before the annual open enrollment period – which ended Dec. 7 – because of the need to allow the health plans to review the findings before the report was made public.
Medicare Advantage members have until Feb. 14 to disenroll and join traditional Medicare but after that they are locked into their plan for the rest of the year. Seniors may be able to request permission to change plans on a case-by-case basis by calling 800-MEDICARE.
Another 32 companies with less serious mistakes also received letters saying their directories did not comply with a rule that took effect last year requiring plans to contact doctors and other providers every 3 months and to update their online directories in “real time.”
ConnectiCare spokeswoman Kimberly Kann acknowledged the difficulties. “Keeping these directories up to date is a two-way street and we are working with doctors and other medical professionals to continue providing quality service,” she said.
WellCare spokeswoman Crystal Warwell Walker said the Tampa, Fla.–based company took the survey results seriously. “We modified our data gathering techniques and online reporting options to ensure that when more than one address is listed for a provider, that provider is practicing at that location on a routine basis and access to care is not compromised,” she said.
CMS is continuing its investigation of provider directories this year and expects to examine all 300 companies by end of 2018.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Federal officials this month warned 21 Medicare Advantage insurers with high rates of errors in their online network directories that they could face heavy fines or have to stop enrolling people if the problems are not fixed by Feb. 6.
Among the plans that were cited are Blue Cross Blue Shield of Michigan, Highmark of Pennsylvania, SCAN Health Plan of California as well as some regional plans owned by national carriers such as UnitedHealthcare and Humana.
The action follows the government’s first in-depth review of the accuracy of Medicare Advantage provider directories, which consumers and advocates have complained about for years. More than 17 million Americans, or nearly a third of Medicare beneficiaries, get coverage through private Medicare Advantage plans.
The Centers for Medicare & Medicaid Services in October reported some of the results of the audit, but they had not released names or statistics from the individual plans.
“Because Medicare Advantage members rely on provider directories to locate an in-network provider, these inaccuracies pose a significant access-to-care barrier,” Medicare officials wrote in a report outlining the problems.
Unlike traditional Medicare, the private Medicare plans typically restrict beneficiaries to a network of doctors and hospitals.
Piedmont Community Health Plan, a small Medicare plan with about 5,200 members in southwest Virginia, had the highest rate of inaccuracies among the 54 insurers examined. Officials found errors in the listings of 87 of 108 doctors checked in Piedmont’s directory, according to the report. Most of the errors involved providing the wrong locations for doctors and doctors who should not have been listed. Piedmont officials did not return calls for comment.
Piedmont and two other plans with the highest error rates – a WellCare plan in Illinois and Emblem Health’s ConnectiCare subsidiary – were required by Medicare to submit specific business plans detailing how they intend to address the issue.
The individual plans receiving warning letters cover more than 1.4 million beneficiaries. Most operate in numerous states, although CMS generally limited its review to a specific state or geographic area.
The federal review focused on primary care doctors, cardiologists, ophthalmologists, and oncologists. It involved individual calls to check on the listings for 108 doctors in each health plan. “We encountered several instances where a call to a provider’s office resulted in determining that the provider had been retired or deceased for a long period of time, sometimes years,” the report said.
Almost half of the 5,832 doctors listed had incorrect information, including wrong addresses and wrong phone numbers. Most health plans had inaccurate information for 30%-60% of their providers’ offices, the report said. The report blamed the insurers for failing to do enough to keep their directories accurate.
“We saw a general lack of internal audit and testing of directory accuracy among many” Medicare Advantage organizations, the report said.
CMS’ survey found the most error-prone listings involved doctors with multiple offices that did not serve health plan members at each location.
The health plans were sent the warning letters Jan. 6 and given 30 days to fix the mistakes or face possible fines or sanctions, which could include suspending marketing and enrollment. CMS officials said the report was not issued before the annual open enrollment period – which ended Dec. 7 – because of the need to allow the health plans to review the findings before the report was made public.
Medicare Advantage members have until Feb. 14 to disenroll and join traditional Medicare but after that they are locked into their plan for the rest of the year. Seniors may be able to request permission to change plans on a case-by-case basis by calling 800-MEDICARE.
Another 32 companies with less serious mistakes also received letters saying their directories did not comply with a rule that took effect last year requiring plans to contact doctors and other providers every 3 months and to update their online directories in “real time.”
ConnectiCare spokeswoman Kimberly Kann acknowledged the difficulties. “Keeping these directories up to date is a two-way street and we are working with doctors and other medical professionals to continue providing quality service,” she said.
WellCare spokeswoman Crystal Warwell Walker said the Tampa, Fla.–based company took the survey results seriously. “We modified our data gathering techniques and online reporting options to ensure that when more than one address is listed for a provider, that provider is practicing at that location on a routine basis and access to care is not compromised,” she said.
CMS is continuing its investigation of provider directories this year and expects to examine all 300 companies by end of 2018.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Federal officials this month warned 21 Medicare Advantage insurers with high rates of errors in their online network directories that they could face heavy fines or have to stop enrolling people if the problems are not fixed by Feb. 6.
Among the plans that were cited are Blue Cross Blue Shield of Michigan, Highmark of Pennsylvania, SCAN Health Plan of California as well as some regional plans owned by national carriers such as UnitedHealthcare and Humana.
The action follows the government’s first in-depth review of the accuracy of Medicare Advantage provider directories, which consumers and advocates have complained about for years. More than 17 million Americans, or nearly a third of Medicare beneficiaries, get coverage through private Medicare Advantage plans.
The Centers for Medicare & Medicaid Services in October reported some of the results of the audit, but they had not released names or statistics from the individual plans.
“Because Medicare Advantage members rely on provider directories to locate an in-network provider, these inaccuracies pose a significant access-to-care barrier,” Medicare officials wrote in a report outlining the problems.
Unlike traditional Medicare, the private Medicare plans typically restrict beneficiaries to a network of doctors and hospitals.
Piedmont Community Health Plan, a small Medicare plan with about 5,200 members in southwest Virginia, had the highest rate of inaccuracies among the 54 insurers examined. Officials found errors in the listings of 87 of 108 doctors checked in Piedmont’s directory, according to the report. Most of the errors involved providing the wrong locations for doctors and doctors who should not have been listed. Piedmont officials did not return calls for comment.
Piedmont and two other plans with the highest error rates – a WellCare plan in Illinois and Emblem Health’s ConnectiCare subsidiary – were required by Medicare to submit specific business plans detailing how they intend to address the issue.
The individual plans receiving warning letters cover more than 1.4 million beneficiaries. Most operate in numerous states, although CMS generally limited its review to a specific state or geographic area.
The federal review focused on primary care doctors, cardiologists, ophthalmologists, and oncologists. It involved individual calls to check on the listings for 108 doctors in each health plan. “We encountered several instances where a call to a provider’s office resulted in determining that the provider had been retired or deceased for a long period of time, sometimes years,” the report said.
Almost half of the 5,832 doctors listed had incorrect information, including wrong addresses and wrong phone numbers. Most health plans had inaccurate information for 30%-60% of their providers’ offices, the report said. The report blamed the insurers for failing to do enough to keep their directories accurate.
“We saw a general lack of internal audit and testing of directory accuracy among many” Medicare Advantage organizations, the report said.
CMS’ survey found the most error-prone listings involved doctors with multiple offices that did not serve health plan members at each location.
The health plans were sent the warning letters Jan. 6 and given 30 days to fix the mistakes or face possible fines or sanctions, which could include suspending marketing and enrollment. CMS officials said the report was not issued before the annual open enrollment period – which ended Dec. 7 – because of the need to allow the health plans to review the findings before the report was made public.
Medicare Advantage members have until Feb. 14 to disenroll and join traditional Medicare but after that they are locked into their plan for the rest of the year. Seniors may be able to request permission to change plans on a case-by-case basis by calling 800-MEDICARE.
Another 32 companies with less serious mistakes also received letters saying their directories did not comply with a rule that took effect last year requiring plans to contact doctors and other providers every 3 months and to update their online directories in “real time.”
ConnectiCare spokeswoman Kimberly Kann acknowledged the difficulties. “Keeping these directories up to date is a two-way street and we are working with doctors and other medical professionals to continue providing quality service,” she said.
WellCare spokeswoman Crystal Warwell Walker said the Tampa, Fla.–based company took the survey results seriously. “We modified our data gathering techniques and online reporting options to ensure that when more than one address is listed for a provider, that provider is practicing at that location on a routine basis and access to care is not compromised,” she said.
CMS is continuing its investigation of provider directories this year and expects to examine all 300 companies by end of 2018.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Ultrashort course antibiotics may be enough in stable VAP
Ultrashort courses of antibiotics led to similar outcomes as longer durations of therapy among adults with suspected ventilator-associated pneumonia but minimal and stable ventilator settings, according to a large retrospective observational study.
The duration of antibiotic therapy did not significantly affect the time to extubation alive (hazard ratio, 1.2; 95% CI, 1.0-1.4), time to hospital discharge (HR, 1.1; 95% CI, 0.9-1.3), rates of ventilator death (HR, 0.8; 95% CI, 0.6-1.2), or rates of hospital death (HR, 1.0; 95% CI, 0.8-1.31).), said Michael Klompas, MD, and his associates at Harvard Medical School in Boston. If confirmed, the findings would support surveillance of serial ventilator settings to “identify candidates for early antibiotic discontinuation,” the investigators reported (Clin Infect Dis. 2016 Dec 29. doi: 10.1093/cid/ciw870).
Suspected respiratory infections account for up to 70% of ICU antibiotic prescriptions, a “substantial fraction” of which may be unnecessary, the researchers said. “The predilection to overprescribe antibiotics for patients with possible ventilator-associated pneumonia (VAP) is not due to poor clinical skills per se, but rather the tension between practice guidelines that encourage early and aggressive prescribing [and] the difficulty [of] accurately diagnosing VAP,” they wrote. While withholding antibiotics in suspected VAP is “unrealistic” and can contribute to mortality, observing clinical trajectories and stopping antibiotics early when appropriate “may be more promising,” they added.
To test that idea, the researchers studied 1,290 cases of suspected VAP treated at Brigham and Women’s Hospital between 2006 and 2014. On the day antibiotics were started and during each of the next 2 days, all patients had a daily minimum positive end-expiratory pressure (PEEP) of no more than 5 cm H2O and a daily minimum fraction of inspired oxygen (FiO2) of no more than 40%.
A total of 259 patients received 1-3 days of antibiotics, while 1,031 patients received more than 3 days of therapy. These two groups were similar demographically, clinically, and in terms of comorbidities. Point estimates tended to favor ultrashort course antibiotics, but no association reached statistical significance in the overall analysis or in subgroups based on confirmed VAP diagnosis, confirmed pathogenic infection, or propensity-matched pairs.
The results suggest “that patients with suspected VAP but minimal and stable ventilator settings can be adequately managed with very short courses of antibiotics,” Dr. Klompas and his associates concluded. “If these findings are confirmed, assessing ventilator settings may prove to be a simple and objective strategy to identify potential candidates for early antibiotic discontinuation.”
The work was supported by the Centers for Disease Control and Prevention’s Prevention Epicenters Program. The investigators had no relevant financial disclosures.
Ultrashort courses of antibiotics led to similar outcomes as longer durations of therapy among adults with suspected ventilator-associated pneumonia but minimal and stable ventilator settings, according to a large retrospective observational study.
The duration of antibiotic therapy did not significantly affect the time to extubation alive (hazard ratio, 1.2; 95% CI, 1.0-1.4), time to hospital discharge (HR, 1.1; 95% CI, 0.9-1.3), rates of ventilator death (HR, 0.8; 95% CI, 0.6-1.2), or rates of hospital death (HR, 1.0; 95% CI, 0.8-1.31).), said Michael Klompas, MD, and his associates at Harvard Medical School in Boston. If confirmed, the findings would support surveillance of serial ventilator settings to “identify candidates for early antibiotic discontinuation,” the investigators reported (Clin Infect Dis. 2016 Dec 29. doi: 10.1093/cid/ciw870).
Suspected respiratory infections account for up to 70% of ICU antibiotic prescriptions, a “substantial fraction” of which may be unnecessary, the researchers said. “The predilection to overprescribe antibiotics for patients with possible ventilator-associated pneumonia (VAP) is not due to poor clinical skills per se, but rather the tension between practice guidelines that encourage early and aggressive prescribing [and] the difficulty [of] accurately diagnosing VAP,” they wrote. While withholding antibiotics in suspected VAP is “unrealistic” and can contribute to mortality, observing clinical trajectories and stopping antibiotics early when appropriate “may be more promising,” they added.
To test that idea, the researchers studied 1,290 cases of suspected VAP treated at Brigham and Women’s Hospital between 2006 and 2014. On the day antibiotics were started and during each of the next 2 days, all patients had a daily minimum positive end-expiratory pressure (PEEP) of no more than 5 cm H2O and a daily minimum fraction of inspired oxygen (FiO2) of no more than 40%.
A total of 259 patients received 1-3 days of antibiotics, while 1,031 patients received more than 3 days of therapy. These two groups were similar demographically, clinically, and in terms of comorbidities. Point estimates tended to favor ultrashort course antibiotics, but no association reached statistical significance in the overall analysis or in subgroups based on confirmed VAP diagnosis, confirmed pathogenic infection, or propensity-matched pairs.
The results suggest “that patients with suspected VAP but minimal and stable ventilator settings can be adequately managed with very short courses of antibiotics,” Dr. Klompas and his associates concluded. “If these findings are confirmed, assessing ventilator settings may prove to be a simple and objective strategy to identify potential candidates for early antibiotic discontinuation.”
The work was supported by the Centers for Disease Control and Prevention’s Prevention Epicenters Program. The investigators had no relevant financial disclosures.
Ultrashort courses of antibiotics led to similar outcomes as longer durations of therapy among adults with suspected ventilator-associated pneumonia but minimal and stable ventilator settings, according to a large retrospective observational study.
The duration of antibiotic therapy did not significantly affect the time to extubation alive (hazard ratio, 1.2; 95% CI, 1.0-1.4), time to hospital discharge (HR, 1.1; 95% CI, 0.9-1.3), rates of ventilator death (HR, 0.8; 95% CI, 0.6-1.2), or rates of hospital death (HR, 1.0; 95% CI, 0.8-1.31).), said Michael Klompas, MD, and his associates at Harvard Medical School in Boston. If confirmed, the findings would support surveillance of serial ventilator settings to “identify candidates for early antibiotic discontinuation,” the investigators reported (Clin Infect Dis. 2016 Dec 29. doi: 10.1093/cid/ciw870).
Suspected respiratory infections account for up to 70% of ICU antibiotic prescriptions, a “substantial fraction” of which may be unnecessary, the researchers said. “The predilection to overprescribe antibiotics for patients with possible ventilator-associated pneumonia (VAP) is not due to poor clinical skills per se, but rather the tension between practice guidelines that encourage early and aggressive prescribing [and] the difficulty [of] accurately diagnosing VAP,” they wrote. While withholding antibiotics in suspected VAP is “unrealistic” and can contribute to mortality, observing clinical trajectories and stopping antibiotics early when appropriate “may be more promising,” they added.
To test that idea, the researchers studied 1,290 cases of suspected VAP treated at Brigham and Women’s Hospital between 2006 and 2014. On the day antibiotics were started and during each of the next 2 days, all patients had a daily minimum positive end-expiratory pressure (PEEP) of no more than 5 cm H2O and a daily minimum fraction of inspired oxygen (FiO2) of no more than 40%.
A total of 259 patients received 1-3 days of antibiotics, while 1,031 patients received more than 3 days of therapy. These two groups were similar demographically, clinically, and in terms of comorbidities. Point estimates tended to favor ultrashort course antibiotics, but no association reached statistical significance in the overall analysis or in subgroups based on confirmed VAP diagnosis, confirmed pathogenic infection, or propensity-matched pairs.
The results suggest “that patients with suspected VAP but minimal and stable ventilator settings can be adequately managed with very short courses of antibiotics,” Dr. Klompas and his associates concluded. “If these findings are confirmed, assessing ventilator settings may prove to be a simple and objective strategy to identify potential candidates for early antibiotic discontinuation.”
The work was supported by the Centers for Disease Control and Prevention’s Prevention Epicenters Program. The investigators had no relevant financial disclosures.
Key clinical point: Ultrashort antibiotic courses yielded outcomes that were similar to those with longer courses in patients with suspected ventilator-associated pneumonia but minimal and stable ventilator settings.
Major finding: The groups did not significantly differ based on time to extubation alive (hazard ratio, 1.2), time to hospital discharge (HR, 1.1; 95% CI, 0.9-1.3), rates of ventilator death (HR, 0.8; 95% CI, 0.6-1.2), or rates of hospital death (HR, 1.0; 95% CI, 0.8-1.31).
Data source: A single-center retrospective observational study of 1,290 patients with suspected ventilator-associated pneumonia.
Disclosures: The work was supported by the Centers for Disease Control and Prevention’s Prevention Epicenters Program. The investigators had no relevant financial disclosures.