Jennie Smith

A new research initiative for multiple sclerosis is seeking to recruit 20,000 people with MS – about 5% of the estimated U.S. population with the disease – by this September, and aims to change the way MS research is conducted.

The web-based initiative, called iConquerMS, was formed with the help of a nearly $1 million contract from the Patient-Centered Outcomes Research Institute, set up under the Affordable Care Act of 2010. iConquerMS is led by the Accelerated Cure Project for MS, a nonprofit research organization based in Waltham, Mass.

Among the group’s initiatives is OPT-UP, a 5-year, clinic-based study designed to compare patient outcomes from all the approved MS treatments and develop the evidence base for personalized medicine for MS. iConquerMS grew out of Accelerated Cure’s large-scale biospecimen and data repository as well as the planning phase of OPT-UP, said Robert McBurney, Ph.D., the CEO of Accelerated Cure and the principal investigator for iConquerMS.

“Patients recruited into OPT-UP could become part of iConquerMS. But OPT-UP seeks only 2,500 patients,” Dr. McBurney said, “while iConquerMS is soliciting participation from a much larger number of MS patients along with other participants, such as friends and relatives of people with MS, who want to contribute their data.”

The combination of the registry and OPT-UP “gives us the pathway to start a very long-term study of MS,” Dr. McBurney said. “Perhaps the children of people with MS will sign up as well. OPT-UP plus iConquerMS really has the possibility of becoming the Framingham of MS.” To date, iConquerMS has enrolled about 1,000 participants, who are encouraged to contribute their health information through both surveys and electronic health records.

iConquerMS joins a handful of existing MS patient registries, including the 20-year-old North American Research Committee on Multiple Sclerosis, or NARCOMS, a nonprofit registry with more than 36,000 patients, and the newly established North American Registry for Care and Research in MS, or NARCRMS. Patients Like Me, a for-profit registry founded in 2004 for people with chronic diseases, now counts about 38,000 members with MS.

June Halper, CEO of the Hackensack, N.J.-based Consortium of Multiple Sclerosis Centers, which administers NARCOMS and NARCRMS, said that while there is some sense of competition among the MS registries, there should be no dearth of patients to enroll and many opportunities to collaborate.

“We hope that not too far into this picture we will be able to work with iConquerMS,” she said. “Because the more we know about MS from the patient’s perspective, the better it’s going to be. One of the things we don’t have is any kind of comparative study comparing outcomes of one disease-modifying drug to another, and OPT-UP is seeking to do that, which is very important,” she said.

Ms. Halper said that in 1995, when the NARCOMS registry was established, “all we could do was symptomatic management, and we could treat relapses, but there were no disease-modifying therapies. We didn’t have MRI. We had rehab but we didn’t know much about it. People with MS were told to rest a lot by their neurologists.”

©Eraxion/thinkstockphotos.com

The NARCOMS surveys – now mostly online – were conducted then as mailed questionnaires. De-identified patient-reported data from NARCOMS have since generated dozens of papers with findings on smoking, Vitamin D, reproduction, depression and fatigue, comorbidities, and other subjects.

Dr. McBurney noted that the patient-centric approach is consistent with broader trends in MS clinical research favoring more nuanced measures of patient outcomes – “well beyond MRI and the 25-foot walk,” he said. “These don’t capture the whole experience, and it’s important to incorporate the patient voice in outcome measures.”

NARCOMS relies exclusively on patient-reported information, not demanding medical records or validation of disease status, though one study found that virtually all participants have an MS diagnosis, Ms. Halper said. Patients Like Me is similarly reliant on patient-reported data.

The two new initiatives, iConquerMS and NARCRMS, differ from prior registries in that they add a significant component of physician-reported data to complement the patient portal. iConquerMS, for example, requests submission of electronic health records. “The anchor of the EHR is helpful to confirm some of the information contributed by the patient, but the most important part is patient-reported health information,” Dr. McBurney said.

NARCRMS – launched as a complement to NARCOMS – focuses as much on physician reports as patient reports to create “a concurrent longitudinal database that simultaneously captures both patient-based and physician-based information,” according to its website. The site, which will incorporate imaging data, is modeled closely after an open-access Alzheimer’s disease database, the Alzheimer’s Disease Neuroimaging Initiative. Participating patients will be able to access the database to see how they compare with others.

Industry participation varies among the registries. NARCOMS does not receive money from industry except for use in selected studies, while Patients Like Me sells de-identified patient data to pharmaceutical and device manufacturers. NARCRMS allows its industry sponsors full access to its data, and iConquerMS has also received industry support.

Ms. Halper said that the proliferation of registries should bring MS research closer to that seen with other chronic diseases. While people are being diagnosed more quickly, and more treatments are available, there is still a lot of work to be done, she said. “We don’t know a heck of a lot about MS, and everybody wants to know more. We need data.”

Dr. McBurney concurred. “We’re making an impact on the early relapsing-remitting phase of the disorder, but to date no drugs have been approved for progressive MS – maybe they’re not even the same disease. We still have very little idea which patient is going to benefit from any particular treatment strategy without experiencing troubling side effects,” he said.

A new research initiative for multiple sclerosis is seeking to recruit 20,000 people with MS – about 5% of the estimated U.S. population with the disease – by this September, and aims to change the way MS research is conducted.

The web-based initiative, called iConquerMS, was formed with the help of a nearly $1 million contract from the Patient-Centered Outcomes Research Institute, set up under the Affordable Care Act of 2010. iConquerMS is led by the Accelerated Cure Project for MS, a nonprofit research organization based in Waltham, Mass.

Among the group’s initiatives is OPT-UP, a 5-year, clinic-based study designed to compare patient outcomes from all the approved MS treatments and develop the evidence base for personalized medicine for MS. iConquerMS grew out of Accelerated Cure’s large-scale biospecimen and data repository as well as the planning phase of OPT-UP, said Robert McBurney, Ph.D., the CEO of Accelerated Cure and the principal investigator for iConquerMS.

“Patients recruited into OPT-UP could become part of iConquerMS. But OPT-UP seeks only 2,500 patients,” Dr. McBurney said, “while iConquerMS is soliciting participation from a much larger number of MS patients along with other participants, such as friends and relatives of people with MS, who want to contribute their data.”

The combination of the registry and OPT-UP “gives us the pathway to start a very long-term study of MS,” Dr. McBurney said. “Perhaps the children of people with MS will sign up as well. OPT-UP plus iConquerMS really has the possibility of becoming the Framingham of MS.” To date, iConquerMS has enrolled about 1,000 participants, who are encouraged to contribute their health information through both surveys and electronic health records.

iConquerMS joins a handful of existing MS patient registries, including the 20-year-old North American Research Committee on Multiple Sclerosis, or NARCOMS, a nonprofit registry with more than 36,000 patients, and the newly established North American Registry for Care and Research in MS, or NARCRMS. Patients Like Me, a for-profit registry founded in 2004 for people with chronic diseases, now counts about 38,000 members with MS.

June Halper, CEO of the Hackensack, N.J.-based Consortium of Multiple Sclerosis Centers, which administers NARCOMS and NARCRMS, said that while there is some sense of competition among the MS registries, there should be no dearth of patients to enroll and many opportunities to collaborate.

“We hope that not too far into this picture we will be able to work with iConquerMS,” she said. “Because the more we know about MS from the patient’s perspective, the better it’s going to be. One of the things we don’t have is any kind of comparative study comparing outcomes of one disease-modifying drug to another, and OPT-UP is seeking to do that, which is very important,” she said.

Ms. Halper said that in 1995, when the NARCOMS registry was established, “all we could do was symptomatic management, and we could treat relapses, but there were no disease-modifying therapies. We didn’t have MRI. We had rehab but we didn’t know much about it. People with MS were told to rest a lot by their neurologists.”

©Eraxion/thinkstockphotos.com

The NARCOMS surveys – now mostly online – were conducted then as mailed questionnaires. De-identified patient-reported data from NARCOMS have since generated dozens of papers with findings on smoking, Vitamin D, reproduction, depression and fatigue, comorbidities, and other subjects.

Dr. McBurney noted that the patient-centric approach is consistent with broader trends in MS clinical research favoring more nuanced measures of patient outcomes – “well beyond MRI and the 25-foot walk,” he said. “These don’t capture the whole experience, and it’s important to incorporate the patient voice in outcome measures.”

NARCOMS relies exclusively on patient-reported information, not demanding medical records or validation of disease status, though one study found that virtually all participants have an MS diagnosis, Ms. Halper said. Patients Like Me is similarly reliant on patient-reported data.

The two new initiatives, iConquerMS and NARCRMS, differ from prior registries in that they add a significant component of physician-reported data to complement the patient portal. iConquerMS, for example, requests submission of electronic health records. “The anchor of the EHR is helpful to confirm some of the information contributed by the patient, but the most important part is patient-reported health information,” Dr. McBurney said.

NARCRMS – launched as a complement to NARCOMS – focuses as much on physician reports as patient reports to create “a concurrent longitudinal database that simultaneously captures both patient-based and physician-based information,” according to its website. The site, which will incorporate imaging data, is modeled closely after an open-access Alzheimer’s disease database, the Alzheimer’s Disease Neuroimaging Initiative. Participating patients will be able to access the database to see how they compare with others.

Industry participation varies among the registries. NARCOMS does not receive money from industry except for use in selected studies, while Patients Like Me sells de-identified patient data to pharmaceutical and device manufacturers. NARCRMS allows its industry sponsors full access to its data, and iConquerMS has also received industry support.

Ms. Halper said that the proliferation of registries should bring MS research closer to that seen with other chronic diseases. While people are being diagnosed more quickly, and more treatments are available, there is still a lot of work to be done, she said. “We don’t know a heck of a lot about MS, and everybody wants to know more. We need data.”

Dr. McBurney concurred. “We’re making an impact on the early relapsing-remitting phase of the disorder, but to date no drugs have been approved for progressive MS – maybe they’re not even the same disease. We still have very little idea which patient is going to benefit from any particular treatment strategy without experiencing troubling side effects,” he said.

A new research initiative for multiple sclerosis is seeking to recruit 20,000 people with MS – about 5% of the estimated U.S. population with the disease – by this September, and aims to change the way MS research is conducted.

The web-based initiative, called iConquerMS, was formed with the help of a nearly $1 million contract from the Patient-Centered Outcomes Research Institute, set up under the Affordable Care Act of 2010. iConquerMS is led by the Accelerated Cure Project for MS, a nonprofit research organization based in Waltham, Mass.

Among the group’s initiatives is OPT-UP, a 5-year, clinic-based study designed to compare patient outcomes from all the approved MS treatments and develop the evidence base for personalized medicine for MS. iConquerMS grew out of Accelerated Cure’s large-scale biospecimen and data repository as well as the planning phase of OPT-UP, said Robert McBurney, Ph.D., the CEO of Accelerated Cure and the principal investigator for iConquerMS.

“Patients recruited into OPT-UP could become part of iConquerMS. But OPT-UP seeks only 2,500 patients,” Dr. McBurney said, “while iConquerMS is soliciting participation from a much larger number of MS patients along with other participants, such as friends and relatives of people with MS, who want to contribute their data.”

The combination of the registry and OPT-UP “gives us the pathway to start a very long-term study of MS,” Dr. McBurney said. “Perhaps the children of people with MS will sign up as well. OPT-UP plus iConquerMS really has the possibility of becoming the Framingham of MS.” To date, iConquerMS has enrolled about 1,000 participants, who are encouraged to contribute their health information through both surveys and electronic health records.

iConquerMS joins a handful of existing MS patient registries, including the 20-year-old North American Research Committee on Multiple Sclerosis, or NARCOMS, a nonprofit registry with more than 36,000 patients, and the newly established North American Registry for Care and Research in MS, or NARCRMS. Patients Like Me, a for-profit registry founded in 2004 for people with chronic diseases, now counts about 38,000 members with MS.

June Halper, CEO of the Hackensack, N.J.-based Consortium of Multiple Sclerosis Centers, which administers NARCOMS and NARCRMS, said that while there is some sense of competition among the MS registries, there should be no dearth of patients to enroll and many opportunities to collaborate.

“We hope that not too far into this picture we will be able to work with iConquerMS,” she said. “Because the more we know about MS from the patient’s perspective, the better it’s going to be. One of the things we don’t have is any kind of comparative study comparing outcomes of one disease-modifying drug to another, and OPT-UP is seeking to do that, which is very important,” she said.

Ms. Halper said that in 1995, when the NARCOMS registry was established, “all we could do was symptomatic management, and we could treat relapses, but there were no disease-modifying therapies. We didn’t have MRI. We had rehab but we didn’t know much about it. People with MS were told to rest a lot by their neurologists.”

©Eraxion/thinkstockphotos.com

The NARCOMS surveys – now mostly online – were conducted then as mailed questionnaires. De-identified patient-reported data from NARCOMS have since generated dozens of papers with findings on smoking, Vitamin D, reproduction, depression and fatigue, comorbidities, and other subjects.

Dr. McBurney noted that the patient-centric approach is consistent with broader trends in MS clinical research favoring more nuanced measures of patient outcomes – “well beyond MRI and the 25-foot walk,” he said. “These don’t capture the whole experience, and it’s important to incorporate the patient voice in outcome measures.”

NARCOMS relies exclusively on patient-reported information, not demanding medical records or validation of disease status, though one study found that virtually all participants have an MS diagnosis, Ms. Halper said. Patients Like Me is similarly reliant on patient-reported data.

The two new initiatives, iConquerMS and NARCRMS, differ from prior registries in that they add a significant component of physician-reported data to complement the patient portal. iConquerMS, for example, requests submission of electronic health records. “The anchor of the EHR is helpful to confirm some of the information contributed by the patient, but the most important part is patient-reported health information,” Dr. McBurney said.

NARCRMS – launched as a complement to NARCOMS – focuses as much on physician reports as patient reports to create “a concurrent longitudinal database that simultaneously captures both patient-based and physician-based information,” according to its website. The site, which will incorporate imaging data, is modeled closely after an open-access Alzheimer’s disease database, the Alzheimer’s Disease Neuroimaging Initiative. Participating patients will be able to access the database to see how they compare with others.

Industry participation varies among the registries. NARCOMS does not receive money from industry except for use in selected studies, while Patients Like Me sells de-identified patient data to pharmaceutical and device manufacturers. NARCRMS allows its industry sponsors full access to its data, and iConquerMS has also received industry support.

Ms. Halper said that the proliferation of registries should bring MS research closer to that seen with other chronic diseases. While people are being diagnosed more quickly, and more treatments are available, there is still a lot of work to be done, she said. “We don’t know a heck of a lot about MS, and everybody wants to know more. We need data.”

Dr. McBurney concurred. “We’re making an impact on the early relapsing-remitting phase of the disorder, but to date no drugs have been approved for progressive MS – maybe they’re not even the same disease. We still have very little idea which patient is going to benefit from any particular treatment strategy without experiencing troubling side effects,” he said.

The majority of patients undergoing pancreaticoduodenectomy will not develop pancreatic fistula and may safely have drains removed on the first postoperative day, a prospective cohort study has found.

Less than 1% of patients with drain amylase levels below 600 U/L on postoperative day 1 will develop pancreatic fistula (PF). This means that in this group – which represents about 60% of PD patients – early drain removal may be a safe management option.

For their research, published online in Annals of Surgery (2015 Jan. 12 [doi:10.1097/SLA.0000000000001038), Dr. Zhi Ven Fong and colleagues at Massachusetts General Hospital and Harvard Medical School, Boston, sought to find the threshold value for drain amylase that predicts fistula, with the goal of helping guide surgeons’ decisions on drain management.

Most surgeons place intraperitoneal drains during PD to control leakage in the event that anastomoses fail. However, some surgeons have abandoned drain placement after PD out of concerns that drains can introduce infection and cause other complications, with risks increasing the longer drains are in place. Drain placement followed by amylase measurement and early removal in low-risk patients “represents a middle ground between the two practices,” Dr. Fong and colleagues wrote.

The investigators evaluated results from two cohorts of consecutive patients undergoing pancreaticoduodenectomy at their surgical center, an initial training cohort (n = 126) and a validation cohort (n = 369). Closed-suction drains were used in all patients, and drain output and amylase levels were prospectively measured daily until drain removal or patient discharge.

Results from the first cohort showed that a drain amylase level of 612 U/L or higher showed the best accuracy (86%), sensitivity (93%), and specificity (79%) in predicting fistula, compared with other established variables.

In the larger validation cohort, the 140 patients with drain amylase values of 600 or higher on postoperative day 1 saw a PF rate of 31.4% (odds ratio = 52, P < .0001). Of the 229 patients with values lower than 600, a group comprising 62.1% of the cohort, fistula developed in only two cases (0.9%). An amylase value below 600 proved a stronger predictor of the absence of PF (OR = 0.0192, P < .0001) than pancreatic gland texture (OR = 0.193, P = .002) and duct diameter (OR = 0.861, P = .835).

“We believe that the debate [over] current intraperitoneal drain management after PD should not be ‘to drain or not to drain’ but rather ‘who and when can we stop draining,’ ” Dr. Fong and colleagues wrote.

“Risk of PF is less than 1% if POD [postoperative day] 1 drain amylase level is lower than 600 U/L. We propose that in this group, which comprises more than 60% of patients, intraperitoneal drains should be removed on PODs 1 and 2, and are currently validating this strategy in our practice,” they wrote.

The investigators cautioned, however, that theirs was a one-site study at an institution whose fistula rates after PD are low, compared with historic rates. “Utilizing POD 1 drain amylase of less than 600 U/L as an early stratification of patients to guide drain removal should not be assumed to be a universally safe practice,” they wrote, until data from larger multisite studies become available.

Dr. Fong and colleagues disclosed no external funding or conflicts of interest.

The majority of patients undergoing pancreaticoduodenectomy will not develop pancreatic fistula and may safely have drains removed on the first postoperative day, a prospective cohort study has found.

Less than 1% of patients with drain amylase levels below 600 U/L on postoperative day 1 will develop pancreatic fistula (PF). This means that in this group – which represents about 60% of PD patients – early drain removal may be a safe management option.

For their research, published online in Annals of Surgery (2015 Jan. 12 [doi:10.1097/SLA.0000000000001038), Dr. Zhi Ven Fong and colleagues at Massachusetts General Hospital and Harvard Medical School, Boston, sought to find the threshold value for drain amylase that predicts fistula, with the goal of helping guide surgeons’ decisions on drain management.

Most surgeons place intraperitoneal drains during PD to control leakage in the event that anastomoses fail. However, some surgeons have abandoned drain placement after PD out of concerns that drains can introduce infection and cause other complications, with risks increasing the longer drains are in place. Drain placement followed by amylase measurement and early removal in low-risk patients “represents a middle ground between the two practices,” Dr. Fong and colleagues wrote.

The investigators evaluated results from two cohorts of consecutive patients undergoing pancreaticoduodenectomy at their surgical center, an initial training cohort (n = 126) and a validation cohort (n = 369). Closed-suction drains were used in all patients, and drain output and amylase levels were prospectively measured daily until drain removal or patient discharge.

Results from the first cohort showed that a drain amylase level of 612 U/L or higher showed the best accuracy (86%), sensitivity (93%), and specificity (79%) in predicting fistula, compared with other established variables.

In the larger validation cohort, the 140 patients with drain amylase values of 600 or higher on postoperative day 1 saw a PF rate of 31.4% (odds ratio = 52, P < .0001). Of the 229 patients with values lower than 600, a group comprising 62.1% of the cohort, fistula developed in only two cases (0.9%). An amylase value below 600 proved a stronger predictor of the absence of PF (OR = 0.0192, P < .0001) than pancreatic gland texture (OR = 0.193, P = .002) and duct diameter (OR = 0.861, P = .835).

“We believe that the debate [over] current intraperitoneal drain management after PD should not be ‘to drain or not to drain’ but rather ‘who and when can we stop draining,’ ” Dr. Fong and colleagues wrote.

“Risk of PF is less than 1% if POD [postoperative day] 1 drain amylase level is lower than 600 U/L. We propose that in this group, which comprises more than 60% of patients, intraperitoneal drains should be removed on PODs 1 and 2, and are currently validating this strategy in our practice,” they wrote.

The investigators cautioned, however, that theirs was a one-site study at an institution whose fistula rates after PD are low, compared with historic rates. “Utilizing POD 1 drain amylase of less than 600 U/L as an early stratification of patients to guide drain removal should not be assumed to be a universally safe practice,” they wrote, until data from larger multisite studies become available.

Dr. Fong and colleagues disclosed no external funding or conflicts of interest.

The majority of patients undergoing pancreaticoduodenectomy will not develop pancreatic fistula and may safely have drains removed on the first postoperative day, a prospective cohort study has found.

Less than 1% of patients with drain amylase levels below 600 U/L on postoperative day 1 will develop pancreatic fistula (PF). This means that in this group – which represents about 60% of PD patients – early drain removal may be a safe management option.

For their research, published online in Annals of Surgery (2015 Jan. 12 [doi:10.1097/SLA.0000000000001038), Dr. Zhi Ven Fong and colleagues at Massachusetts General Hospital and Harvard Medical School, Boston, sought to find the threshold value for drain amylase that predicts fistula, with the goal of helping guide surgeons’ decisions on drain management.

Most surgeons place intraperitoneal drains during PD to control leakage in the event that anastomoses fail. However, some surgeons have abandoned drain placement after PD out of concerns that drains can introduce infection and cause other complications, with risks increasing the longer drains are in place. Drain placement followed by amylase measurement and early removal in low-risk patients “represents a middle ground between the two practices,” Dr. Fong and colleagues wrote.

The investigators evaluated results from two cohorts of consecutive patients undergoing pancreaticoduodenectomy at their surgical center, an initial training cohort (n = 126) and a validation cohort (n = 369). Closed-suction drains were used in all patients, and drain output and amylase levels were prospectively measured daily until drain removal or patient discharge.

Results from the first cohort showed that a drain amylase level of 612 U/L or higher showed the best accuracy (86%), sensitivity (93%), and specificity (79%) in predicting fistula, compared with other established variables.

In the larger validation cohort, the 140 patients with drain amylase values of 600 or higher on postoperative day 1 saw a PF rate of 31.4% (odds ratio = 52, P < .0001). Of the 229 patients with values lower than 600, a group comprising 62.1% of the cohort, fistula developed in only two cases (0.9%). An amylase value below 600 proved a stronger predictor of the absence of PF (OR = 0.0192, P < .0001) than pancreatic gland texture (OR = 0.193, P = .002) and duct diameter (OR = 0.861, P = .835).

“We believe that the debate [over] current intraperitoneal drain management after PD should not be ‘to drain or not to drain’ but rather ‘who and when can we stop draining,’ ” Dr. Fong and colleagues wrote.

“Risk of PF is less than 1% if POD [postoperative day] 1 drain amylase level is lower than 600 U/L. We propose that in this group, which comprises more than 60% of patients, intraperitoneal drains should be removed on PODs 1 and 2, and are currently validating this strategy in our practice,” they wrote.

The investigators cautioned, however, that theirs was a one-site study at an institution whose fistula rates after PD are low, compared with historic rates. “Utilizing POD 1 drain amylase of less than 600 U/L as an early stratification of patients to guide drain removal should not be assumed to be a universally safe practice,” they wrote, until data from larger multisite studies become available.

Dr. Fong and colleagues disclosed no external funding or conflicts of interest.

Minimally invasive esophagectomy can be performed with low perioperative morbidity and mortality in patients with esophageal cancer, according to results from a study conducted at 17 surgical centers.

Single-site studies have shown mortality and morbidity associated with MIE to be low, compared with historic rates for open procedures; the new study, led Dr. James D. Luketich of the University of Pittsburgh, and published in advance of print in Annals of Surgery (2015 Jan. 8 [doi:10.1097/SLA.0000000000000993]), was the first to look at morbidity and mortality from minimally invasive esophagectomy (MIE) performed prospectively at multiple study sites.

Dr. Luketich and his colleagues recruited 104 patients with esophageal cancers or high-grade dysplasia and assigned them to MIE using video-assisted thorascopy and laparoscopy. Of the 95 patients who underwent the completely minimally invasive procedure as planned, 30-day mortality was 2.1%. For the broader study group, which included nine patients who received operations that differed from the study protocol, mortality was 2.9%.

Though single-site studies of MIE have seen mortality at below 2%, historic rates for open procedures have ranged from 8% to 23% in the United States, though mortality rates appear to be dropping. MIE has been shown in one randomized trial to be associated with significantly fewer pulmonary infections, compared with open procedures, and shorter hospital stays (Dig. Dis. Sci.2010;55:3031-40).

Patients in Dr. Luketich and colleagues’ study stayed a median of 2 days in intensive care and 9 days in the hospital. Serious adverse events included anastomotic leak (8.6%), acute respiratory distress syndrome (5.7%), pneumonitis (3.8%), and atrial fibrillation (2.9%).

Dr. Luketich and colleagues described the oncologic outcomes of their study as acceptable, compared with published results from open procedures. With a median follow-up of 35.8 months, estimated 3-year overall survival was 58.4% (95% confidence interval, 47.7%–67.6%), with locoregional recurrence seen in only seven patients (6.9%). This, the investigators reported, is comparable with survival results from open procedures.

“This study demonstrates the feasibility of this approach in a multicenter setting,” the investigators wrote in their analysis. “However, it should also be emphasized that the procedures were performed by credentialed surgeons with demonstrated experience in esophageal surgery and minimally invasive techniques.”

The minimally invasive approach can be adopted by other centers, Dr. Luketich and colleagues wrote, “provided that appropriate expertise with both open esophagectomy and minimally invasive techniques is available.”

The study was coordinated by the Eastern Cooperative Oncology Group and funded by grants from the National Cancer Institute, the National Institutes of Health, and the U.S. Department of Health & Human Services. Dr. Luketich and colleagues disclosed no conflicts of interest related to their research.

Minimally invasive esophagectomy can be performed with low perioperative morbidity and mortality in patients with esophageal cancer, according to results from a study conducted at 17 surgical centers.

Single-site studies have shown mortality and morbidity associated with MIE to be low, compared with historic rates for open procedures; the new study, led Dr. James D. Luketich of the University of Pittsburgh, and published in advance of print in Annals of Surgery (2015 Jan. 8 [doi:10.1097/SLA.0000000000000993]), was the first to look at morbidity and mortality from minimally invasive esophagectomy (MIE) performed prospectively at multiple study sites.

Dr. Luketich and his colleagues recruited 104 patients with esophageal cancers or high-grade dysplasia and assigned them to MIE using video-assisted thorascopy and laparoscopy. Of the 95 patients who underwent the completely minimally invasive procedure as planned, 30-day mortality was 2.1%. For the broader study group, which included nine patients who received operations that differed from the study protocol, mortality was 2.9%.

Though single-site studies of MIE have seen mortality at below 2%, historic rates for open procedures have ranged from 8% to 23% in the United States, though mortality rates appear to be dropping. MIE has been shown in one randomized trial to be associated with significantly fewer pulmonary infections, compared with open procedures, and shorter hospital stays (Dig. Dis. Sci.2010;55:3031-40).

Patients in Dr. Luketich and colleagues’ study stayed a median of 2 days in intensive care and 9 days in the hospital. Serious adverse events included anastomotic leak (8.6%), acute respiratory distress syndrome (5.7%), pneumonitis (3.8%), and atrial fibrillation (2.9%).

Dr. Luketich and colleagues described the oncologic outcomes of their study as acceptable, compared with published results from open procedures. With a median follow-up of 35.8 months, estimated 3-year overall survival was 58.4% (95% confidence interval, 47.7%–67.6%), with locoregional recurrence seen in only seven patients (6.9%). This, the investigators reported, is comparable with survival results from open procedures.

“This study demonstrates the feasibility of this approach in a multicenter setting,” the investigators wrote in their analysis. “However, it should also be emphasized that the procedures were performed by credentialed surgeons with demonstrated experience in esophageal surgery and minimally invasive techniques.”

The minimally invasive approach can be adopted by other centers, Dr. Luketich and colleagues wrote, “provided that appropriate expertise with both open esophagectomy and minimally invasive techniques is available.”

The study was coordinated by the Eastern Cooperative Oncology Group and funded by grants from the National Cancer Institute, the National Institutes of Health, and the U.S. Department of Health & Human Services. Dr. Luketich and colleagues disclosed no conflicts of interest related to their research.

Minimally invasive esophagectomy can be performed with low perioperative morbidity and mortality in patients with esophageal cancer, according to results from a study conducted at 17 surgical centers.

Single-site studies have shown mortality and morbidity associated with MIE to be low, compared with historic rates for open procedures; the new study, led Dr. James D. Luketich of the University of Pittsburgh, and published in advance of print in Annals of Surgery (2015 Jan. 8 [doi:10.1097/SLA.0000000000000993]), was the first to look at morbidity and mortality from minimally invasive esophagectomy (MIE) performed prospectively at multiple study sites.

Dr. Luketich and his colleagues recruited 104 patients with esophageal cancers or high-grade dysplasia and assigned them to MIE using video-assisted thorascopy and laparoscopy. Of the 95 patients who underwent the completely minimally invasive procedure as planned, 30-day mortality was 2.1%. For the broader study group, which included nine patients who received operations that differed from the study protocol, mortality was 2.9%.

Though single-site studies of MIE have seen mortality at below 2%, historic rates for open procedures have ranged from 8% to 23% in the United States, though mortality rates appear to be dropping. MIE has been shown in one randomized trial to be associated with significantly fewer pulmonary infections, compared with open procedures, and shorter hospital stays (Dig. Dis. Sci.2010;55:3031-40).

Patients in Dr. Luketich and colleagues’ study stayed a median of 2 days in intensive care and 9 days in the hospital. Serious adverse events included anastomotic leak (8.6%), acute respiratory distress syndrome (5.7%), pneumonitis (3.8%), and atrial fibrillation (2.9%).

Dr. Luketich and colleagues described the oncologic outcomes of their study as acceptable, compared with published results from open procedures. With a median follow-up of 35.8 months, estimated 3-year overall survival was 58.4% (95% confidence interval, 47.7%–67.6%), with locoregional recurrence seen in only seven patients (6.9%). This, the investigators reported, is comparable with survival results from open procedures.

“This study demonstrates the feasibility of this approach in a multicenter setting,” the investigators wrote in their analysis. “However, it should also be emphasized that the procedures were performed by credentialed surgeons with demonstrated experience in esophageal surgery and minimally invasive techniques.”

The minimally invasive approach can be adopted by other centers, Dr. Luketich and colleagues wrote, “provided that appropriate expertise with both open esophagectomy and minimally invasive techniques is available.”

The study was coordinated by the Eastern Cooperative Oncology Group and funded by grants from the National Cancer Institute, the National Institutes of Health, and the U.S. Department of Health & Human Services. Dr. Luketich and colleagues disclosed no conflicts of interest related to their research.

The use of a large-pore polypropylene mesh in colorectal surgery can reduce incidence of incisional hernias without contributing to wound complication risk, according to results from a randomized controlled trial.

While prophylactic polypropylene meshes have been used successfully in other types of surgeries to prevent hernias, they have been little studied in series of patients undergoing colorectal surgeries, a group for which incidence of IH is high, and particularly so with emergency procedures.

STEFANOLUNARDI/thinkstockphotos.com

For their research, published ahead of print in Annals of Surgery (Ann. Surg.2015 Jan 8 [doi: 10.1097/SLA.0000000000001116]), Dr. Miguel Ángel García-Ureña of Henares University Hospital in Madrid, and his colleagues, recruited 107 patients with elective or emergency colorectal surgeries using a midline laparotomy approach.

Patients were randomized to either standard care (n = 54, 20 emergency) or the addition of an overlay large-pore polypropylene mesh after the closure of the abdominal wall (n = 53, 17 emergency). All operations took place at the same hospital, with 12 surgeons participating.

At 24 months’ follow-up, the control group saw 17 incisional hernias (31.5%), compared with 6 (11.3%) in the study group (P = .011). No statistically significant differences were seen for incidence of surgical site infection, seroma, evisceration, or systemic complications, and no mesh rejection was seen.

Dr. García-Ureña and colleagues used a very low-weight, large-pore polypropylene mesh after initial studies suggested large-pore meshes were better tolerated in contaminated fields, and that these could be salvaged even in the case of site infection.

The study “confirms the safe use of large-pore polypropylene meshes even in contaminated and emergency surgical procedures,” the investigators wrote in their analysis, adding that the use of mesh overlay “was cost-effective due to the number needed to treat obtained: 1 IH was prevented for every 5 prophylactic meshes that were used.”

Dr. García-Ureña and colleagues cited as limitations of their study the fact that deaths and reoperations occurred in 28% of patients before follow-up ended, the inclusion of both elective and emergency cases, and that wound length was not recorded. Further studies will be needed, they said, to determine the ideal positioning of the mesh and the best type of mesh for these procedures.

The study authors declared no conflicts of interest.

The use of a large-pore polypropylene mesh in colorectal surgery can reduce incidence of incisional hernias without contributing to wound complication risk, according to results from a randomized controlled trial.

While prophylactic polypropylene meshes have been used successfully in other types of surgeries to prevent hernias, they have been little studied in series of patients undergoing colorectal surgeries, a group for which incidence of IH is high, and particularly so with emergency procedures.

STEFANOLUNARDI/thinkstockphotos.com

For their research, published ahead of print in Annals of Surgery (Ann. Surg.2015 Jan 8 [doi: 10.1097/SLA.0000000000001116]), Dr. Miguel Ángel García-Ureña of Henares University Hospital in Madrid, and his colleagues, recruited 107 patients with elective or emergency colorectal surgeries using a midline laparotomy approach.

Patients were randomized to either standard care (n = 54, 20 emergency) or the addition of an overlay large-pore polypropylene mesh after the closure of the abdominal wall (n = 53, 17 emergency). All operations took place at the same hospital, with 12 surgeons participating.

At 24 months’ follow-up, the control group saw 17 incisional hernias (31.5%), compared with 6 (11.3%) in the study group (P = .011). No statistically significant differences were seen for incidence of surgical site infection, seroma, evisceration, or systemic complications, and no mesh rejection was seen.

Dr. García-Ureña and colleagues used a very low-weight, large-pore polypropylene mesh after initial studies suggested large-pore meshes were better tolerated in contaminated fields, and that these could be salvaged even in the case of site infection.

The study “confirms the safe use of large-pore polypropylene meshes even in contaminated and emergency surgical procedures,” the investigators wrote in their analysis, adding that the use of mesh overlay “was cost-effective due to the number needed to treat obtained: 1 IH was prevented for every 5 prophylactic meshes that were used.”

Dr. García-Ureña and colleagues cited as limitations of their study the fact that deaths and reoperations occurred in 28% of patients before follow-up ended, the inclusion of both elective and emergency cases, and that wound length was not recorded. Further studies will be needed, they said, to determine the ideal positioning of the mesh and the best type of mesh for these procedures.

The study authors declared no conflicts of interest.

The use of a large-pore polypropylene mesh in colorectal surgery can reduce incidence of incisional hernias without contributing to wound complication risk, according to results from a randomized controlled trial.

While prophylactic polypropylene meshes have been used successfully in other types of surgeries to prevent hernias, they have been little studied in series of patients undergoing colorectal surgeries, a group for which incidence of IH is high, and particularly so with emergency procedures.

STEFANOLUNARDI/thinkstockphotos.com

For their research, published ahead of print in Annals of Surgery (Ann. Surg.2015 Jan 8 [doi: 10.1097/SLA.0000000000001116]), Dr. Miguel Ángel García-Ureña of Henares University Hospital in Madrid, and his colleagues, recruited 107 patients with elective or emergency colorectal surgeries using a midline laparotomy approach.

Patients were randomized to either standard care (n = 54, 20 emergency) or the addition of an overlay large-pore polypropylene mesh after the closure of the abdominal wall (n = 53, 17 emergency). All operations took place at the same hospital, with 12 surgeons participating.

At 24 months’ follow-up, the control group saw 17 incisional hernias (31.5%), compared with 6 (11.3%) in the study group (P = .011). No statistically significant differences were seen for incidence of surgical site infection, seroma, evisceration, or systemic complications, and no mesh rejection was seen.

Dr. García-Ureña and colleagues used a very low-weight, large-pore polypropylene mesh after initial studies suggested large-pore meshes were better tolerated in contaminated fields, and that these could be salvaged even in the case of site infection.

The study “confirms the safe use of large-pore polypropylene meshes even in contaminated and emergency surgical procedures,” the investigators wrote in their analysis, adding that the use of mesh overlay “was cost-effective due to the number needed to treat obtained: 1 IH was prevented for every 5 prophylactic meshes that were used.”

Dr. García-Ureña and colleagues cited as limitations of their study the fact that deaths and reoperations occurred in 28% of patients before follow-up ended, the inclusion of both elective and emergency cases, and that wound length was not recorded. Further studies will be needed, they said, to determine the ideal positioning of the mesh and the best type of mesh for these procedures.

The study authors declared no conflicts of interest.

Pseudofolliculitis barbae, a disorder better known as razor bumps, is poorly studied in women, but may have a different etiology than in men and could be indicative of underlying hormonal comorbidities, based on data from 62 men and 62 women.

T.A. Nguyen, a medical student at Montefiore Medical Center – Albert Einstein College of Medicine, New York, and colleagues sought to characterize pseudofolliculitis barbae (PFB) in women by reviewing patient files from men and women presenting with unspecified acne or diseases of hair and hair follicles. They collected information on patients’ age, laboratory findings, treatments, and comorbidities. The findings were published in the British Journal of Dermatology (2015 [doi:10.1111/bjd.13644]) .

Overall, the researchers found that only differences in hormonal disorders, such as polycystic ovarian syndrome (PCOS), hirsutism, infertility, or hypo/hypertestosteronism, and acne were statistically different between men and women.

“These results point toward hyperandrogenism, a common cause of hirsutism, acne, and virilization, as a potential mitigating factor for PFB in women,” the researchers wrote, adding that the higher prevalence of hormonal disorders in the women’s cohort “demonstrates the importance of considering hormonal influences when working-up a female patient with PFB.”

Of the 62 women, 5 had known PCOS at diagnosis, and 4 were later diagnosed. Two women saw improvement of PFB severity after starting oral contraceptives or antiandrogen agents under the care of endocrinologists.

“It is possible that these agents may provide some benefit for a subset of patients,” the researchers wrote. A quarter of the female patients in the study were treated with eflornithine hydrochloride, which inhibits hair cell growth, while fewer than 2% of males received this treatment. The investigators noted that few women were treated with oral contraceptive pills, despite their use as a first-line strategy for acne in women.

“Our study demonstrates that female patients with PFB are empirically different from their male counterparts. In women with PFB, acne and hormonal disorders are significantly more common. Despite this fact, antiandrogen agents were not considered for treatment. Further studies are needed to evaluate the use of these agents in women with PFB and to identify optimal clinical work-up and treatment algorithms,” the researchers noted.

Dr. Adam Friedman, who was the lead author, disclosed financial relationships with Onset, GSK, Galderma, Amgen, L’Oreal, Johnson & Johnson, MicroCures, Liquidia, Salvona, and Valent.

Pseudofolliculitis barbae, a disorder better known as razor bumps, is poorly studied in women, but may have a different etiology than in men and could be indicative of underlying hormonal comorbidities, based on data from 62 men and 62 women.

T.A. Nguyen, a medical student at Montefiore Medical Center – Albert Einstein College of Medicine, New York, and colleagues sought to characterize pseudofolliculitis barbae (PFB) in women by reviewing patient files from men and women presenting with unspecified acne or diseases of hair and hair follicles. They collected information on patients’ age, laboratory findings, treatments, and comorbidities. The findings were published in the British Journal of Dermatology (2015 [doi:10.1111/bjd.13644]) .

Overall, the researchers found that only differences in hormonal disorders, such as polycystic ovarian syndrome (PCOS), hirsutism, infertility, or hypo/hypertestosteronism, and acne were statistically different between men and women.

“These results point toward hyperandrogenism, a common cause of hirsutism, acne, and virilization, as a potential mitigating factor for PFB in women,” the researchers wrote, adding that the higher prevalence of hormonal disorders in the women’s cohort “demonstrates the importance of considering hormonal influences when working-up a female patient with PFB.”

Of the 62 women, 5 had known PCOS at diagnosis, and 4 were later diagnosed. Two women saw improvement of PFB severity after starting oral contraceptives or antiandrogen agents under the care of endocrinologists.

“It is possible that these agents may provide some benefit for a subset of patients,” the researchers wrote. A quarter of the female patients in the study were treated with eflornithine hydrochloride, which inhibits hair cell growth, while fewer than 2% of males received this treatment. The investigators noted that few women were treated with oral contraceptive pills, despite their use as a first-line strategy for acne in women.

“Our study demonstrates that female patients with PFB are empirically different from their male counterparts. In women with PFB, acne and hormonal disorders are significantly more common. Despite this fact, antiandrogen agents were not considered for treatment. Further studies are needed to evaluate the use of these agents in women with PFB and to identify optimal clinical work-up and treatment algorithms,” the researchers noted.

Dr. Adam Friedman, who was the lead author, disclosed financial relationships with Onset, GSK, Galderma, Amgen, L’Oreal, Johnson & Johnson, MicroCures, Liquidia, Salvona, and Valent.

Pseudofolliculitis barbae, a disorder better known as razor bumps, is poorly studied in women, but may have a different etiology than in men and could be indicative of underlying hormonal comorbidities, based on data from 62 men and 62 women.

T.A. Nguyen, a medical student at Montefiore Medical Center – Albert Einstein College of Medicine, New York, and colleagues sought to characterize pseudofolliculitis barbae (PFB) in women by reviewing patient files from men and women presenting with unspecified acne or diseases of hair and hair follicles. They collected information on patients’ age, laboratory findings, treatments, and comorbidities. The findings were published in the British Journal of Dermatology (2015 [doi:10.1111/bjd.13644]) .

Overall, the researchers found that only differences in hormonal disorders, such as polycystic ovarian syndrome (PCOS), hirsutism, infertility, or hypo/hypertestosteronism, and acne were statistically different between men and women.

“These results point toward hyperandrogenism, a common cause of hirsutism, acne, and virilization, as a potential mitigating factor for PFB in women,” the researchers wrote, adding that the higher prevalence of hormonal disorders in the women’s cohort “demonstrates the importance of considering hormonal influences when working-up a female patient with PFB.”

Of the 62 women, 5 had known PCOS at diagnosis, and 4 were later diagnosed. Two women saw improvement of PFB severity after starting oral contraceptives or antiandrogen agents under the care of endocrinologists.

“It is possible that these agents may provide some benefit for a subset of patients,” the researchers wrote. A quarter of the female patients in the study were treated with eflornithine hydrochloride, which inhibits hair cell growth, while fewer than 2% of males received this treatment. The investigators noted that few women were treated with oral contraceptive pills, despite their use as a first-line strategy for acne in women.

“Our study demonstrates that female patients with PFB are empirically different from their male counterparts. In women with PFB, acne and hormonal disorders are significantly more common. Despite this fact, antiandrogen agents were not considered for treatment. Further studies are needed to evaluate the use of these agents in women with PFB and to identify optimal clinical work-up and treatment algorithms,” the researchers noted.

Dr. Adam Friedman, who was the lead author, disclosed financial relationships with Onset, GSK, Galderma, Amgen, L’Oreal, Johnson & Johnson, MicroCures, Liquidia, Salvona, and Valent.

Officials at the Centers for Disease Control and Prevention are asking for feedback on the agency’s new draft recommendations for counseling patients and parents considering male circumcision.

The recommendations, which the CDC released on Dec. 2, cover newborns, children, adolescents, and adults.

The draft draws on evidence from randomized, controlled trials showing that circumsized adult men have a significantly lower risk of acquiring HIV and other sexually transmitted infections through vaginal sexual intercourse. The CDC also cited the prevention of urinary tract infections and penile cancer as benefits of circumcision.

The rationale for the CDC draft recommendations closely mirrors that of guidelines issued in 2012 by the American Academy of Pediatrics (AAP) and endorsed by the American College of Obstetricians and Gynecologists (Pediatrics 2012;130:585-6). The 2012 document broke from earlier guidelines that did not recommend routine circumcision of male newborns. The AAP determined that there was sufficient evidence that the health benefits outweighed the risks, to the point that any family wanting the procedure should have access to it.

The CDC’s draft recommendations urge clinicians to review the health benefits and risks of elective male circumcision, whether in newborns, adolescents, or adults, while also taking into account other factors, such as “religion, societal norms and social customs, hygiene, aesthetic preference, and ethical considerations.”

The CDC draft includes specific recommendations for counseling patients and parents of each age group.

When advising adolescent and adult men, CDC recommends:

• Counseling all sexually active patients on HIV and STI risk-reduction strategies, such as condoms, regardless of circumcision status.

• Assessing risk behaviors, HIV status, and the gender of sexual partners before discussing the risks and benefits of circumcision.

• Informing uncircumcised men and boys engaged in vaginal sexual intercourse about the partial protection against HIV afforded by male circumcision.

• Advising patients that male circumcision has not been proven to reduce HIV/STI acquisition through oral or anal sex.

When advising parents about circumcision of newborns, children, and adolescent minors, CDC recommends:

• Counseling parents before the baby is born, if possible.

• Advising that circumcised newborn males are less likely to experience urinary tract infections, balanitis, and balanoposthitis.

• Advising that neonatal circumcision is safer and less expensive than is circumcision later in childhood, with complications occurring less frequently in newborns and more frequently among children aged 1-10 years.

• Discussing the likely benefits in terms of HIV and STI protection after sexual debut.

• Advising that circumcised males appear less likely to develop penile cancer and possibly prostate cancer.

The CDC will publish the new recommendations in the Federal Register sometime after the public comment period closes and the peer review process is complete. The deadline for public comments is Jan. 16.

Officials at the Centers for Disease Control and Prevention are asking for feedback on the agency’s new draft recommendations for counseling patients and parents considering male circumcision.

The recommendations, which the CDC released on Dec. 2, cover newborns, children, adolescents, and adults.

The draft draws on evidence from randomized, controlled trials showing that circumsized adult men have a significantly lower risk of acquiring HIV and other sexually transmitted infections through vaginal sexual intercourse. The CDC also cited the prevention of urinary tract infections and penile cancer as benefits of circumcision.

The rationale for the CDC draft recommendations closely mirrors that of guidelines issued in 2012 by the American Academy of Pediatrics (AAP) and endorsed by the American College of Obstetricians and Gynecologists (Pediatrics 2012;130:585-6). The 2012 document broke from earlier guidelines that did not recommend routine circumcision of male newborns. The AAP determined that there was sufficient evidence that the health benefits outweighed the risks, to the point that any family wanting the procedure should have access to it.

The CDC’s draft recommendations urge clinicians to review the health benefits and risks of elective male circumcision, whether in newborns, adolescents, or adults, while also taking into account other factors, such as “religion, societal norms and social customs, hygiene, aesthetic preference, and ethical considerations.”

The CDC draft includes specific recommendations for counseling patients and parents of each age group.

When advising adolescent and adult men, CDC recommends:

• Counseling all sexually active patients on HIV and STI risk-reduction strategies, such as condoms, regardless of circumcision status.

• Assessing risk behaviors, HIV status, and the gender of sexual partners before discussing the risks and benefits of circumcision.

• Informing uncircumcised men and boys engaged in vaginal sexual intercourse about the partial protection against HIV afforded by male circumcision.

• Advising patients that male circumcision has not been proven to reduce HIV/STI acquisition through oral or anal sex.

When advising parents about circumcision of newborns, children, and adolescent minors, CDC recommends:

• Counseling parents before the baby is born, if possible.

• Advising that circumcised newborn males are less likely to experience urinary tract infections, balanitis, and balanoposthitis.

• Advising that neonatal circumcision is safer and less expensive than is circumcision later in childhood, with complications occurring less frequently in newborns and more frequently among children aged 1-10 years.

• Discussing the likely benefits in terms of HIV and STI protection after sexual debut.

• Advising that circumcised males appear less likely to develop penile cancer and possibly prostate cancer.

The CDC will publish the new recommendations in the Federal Register sometime after the public comment period closes and the peer review process is complete. The deadline for public comments is Jan. 16.

Officials at the Centers for Disease Control and Prevention are asking for feedback on the agency’s new draft recommendations for counseling patients and parents considering male circumcision.

The recommendations, which the CDC released on Dec. 2, cover newborns, children, adolescents, and adults.

The draft draws on evidence from randomized, controlled trials showing that circumsized adult men have a significantly lower risk of acquiring HIV and other sexually transmitted infections through vaginal sexual intercourse. The CDC also cited the prevention of urinary tract infections and penile cancer as benefits of circumcision.

The rationale for the CDC draft recommendations closely mirrors that of guidelines issued in 2012 by the American Academy of Pediatrics (AAP) and endorsed by the American College of Obstetricians and Gynecologists (Pediatrics 2012;130:585-6). The 2012 document broke from earlier guidelines that did not recommend routine circumcision of male newborns. The AAP determined that there was sufficient evidence that the health benefits outweighed the risks, to the point that any family wanting the procedure should have access to it.

The CDC’s draft recommendations urge clinicians to review the health benefits and risks of elective male circumcision, whether in newborns, adolescents, or adults, while also taking into account other factors, such as “religion, societal norms and social customs, hygiene, aesthetic preference, and ethical considerations.”

The CDC draft includes specific recommendations for counseling patients and parents of each age group.

When advising adolescent and adult men, CDC recommends:

• Counseling all sexually active patients on HIV and STI risk-reduction strategies, such as condoms, regardless of circumcision status.

• Assessing risk behaviors, HIV status, and the gender of sexual partners before discussing the risks and benefits of circumcision.

• Informing uncircumcised men and boys engaged in vaginal sexual intercourse about the partial protection against HIV afforded by male circumcision.

• Advising patients that male circumcision has not been proven to reduce HIV/STI acquisition through oral or anal sex.

When advising parents about circumcision of newborns, children, and adolescent minors, CDC recommends:

• Counseling parents before the baby is born, if possible.

• Advising that circumcised newborn males are less likely to experience urinary tract infections, balanitis, and balanoposthitis.

• Advising that neonatal circumcision is safer and less expensive than is circumcision later in childhood, with complications occurring less frequently in newborns and more frequently among children aged 1-10 years.

• Discussing the likely benefits in terms of HIV and STI protection after sexual debut.

• Advising that circumcised males appear less likely to develop penile cancer and possibly prostate cancer.

The CDC will publish the new recommendations in the Federal Register sometime after the public comment period closes and the peer review process is complete. The deadline for public comments is Jan. 16.

The Centers for Disease Control and Prevention says that 35 U.S. hospitals have been designated as Ebola treatment centers.

The hospitals, of which CDC published a list on Dec. 2, are in 12 states and the District of Columbia. The hospitals received their designations from state health departments and after on-site reviews by CDC teams.

“Ebola treatment centers are staffed, equipped, and have been assessed to have current capabilities, training, and resources to provide the complex treatment necessary to care for a person with Ebola while minimizing risk to health care workers,” the CDC said in a news release about the new centers.

More hospitals are expected to be named Ebola treatment centers in the coming weeks, the agency said. The CDC has published guidelines to hospitals and state and local health departments on the preparation of these centers, with standards for patient transportation, laboratories, personal protective equipment, and waste management, among other key areas of capability.

The CDC said that the new centers supplement the existing biocontainment facilities at Emory University Hospital in Atlanta, Nebraska Medical Center in Omaha, and the National Institutes of Health in Bethesda, Md., which will continue to play an important role in Ebola treatment – particularly in cases of medical evacuation from overseas.

Some 80% of travelers returning from Ebola-affected countries live within 200 miles of a designated Ebola treatment center, the agency affirmed, and the addition of new facilities in the weeks to come will “further broaden geographic reach.”While Texas is home to two of the designated centers, Texas Health Presbyterian, the Dallas hospital that treated the first Ebola case presenting in the United States, is not currently on the list.

The Centers for Disease Control and Prevention says that 35 U.S. hospitals have been designated as Ebola treatment centers.

The hospitals, of which CDC published a list on Dec. 2, are in 12 states and the District of Columbia. The hospitals received their designations from state health departments and after on-site reviews by CDC teams.

“Ebola treatment centers are staffed, equipped, and have been assessed to have current capabilities, training, and resources to provide the complex treatment necessary to care for a person with Ebola while minimizing risk to health care workers,” the CDC said in a news release about the new centers.

More hospitals are expected to be named Ebola treatment centers in the coming weeks, the agency said. The CDC has published guidelines to hospitals and state and local health departments on the preparation of these centers, with standards for patient transportation, laboratories, personal protective equipment, and waste management, among other key areas of capability.

The CDC said that the new centers supplement the existing biocontainment facilities at Emory University Hospital in Atlanta, Nebraska Medical Center in Omaha, and the National Institutes of Health in Bethesda, Md., which will continue to play an important role in Ebola treatment – particularly in cases of medical evacuation from overseas.

Some 80% of travelers returning from Ebola-affected countries live within 200 miles of a designated Ebola treatment center, the agency affirmed, and the addition of new facilities in the weeks to come will “further broaden geographic reach.”While Texas is home to two of the designated centers, Texas Health Presbyterian, the Dallas hospital that treated the first Ebola case presenting in the United States, is not currently on the list.

The Centers for Disease Control and Prevention says that 35 U.S. hospitals have been designated as Ebola treatment centers.

The hospitals, of which CDC published a list on Dec. 2, are in 12 states and the District of Columbia. The hospitals received their designations from state health departments and after on-site reviews by CDC teams.

“Ebola treatment centers are staffed, equipped, and have been assessed to have current capabilities, training, and resources to provide the complex treatment necessary to care for a person with Ebola while minimizing risk to health care workers,” the CDC said in a news release about the new centers.

More hospitals are expected to be named Ebola treatment centers in the coming weeks, the agency said. The CDC has published guidelines to hospitals and state and local health departments on the preparation of these centers, with standards for patient transportation, laboratories, personal protective equipment, and waste management, among other key areas of capability.

The CDC said that the new centers supplement the existing biocontainment facilities at Emory University Hospital in Atlanta, Nebraska Medical Center in Omaha, and the National Institutes of Health in Bethesda, Md., which will continue to play an important role in Ebola treatment – particularly in cases of medical evacuation from overseas.

Some 80% of travelers returning from Ebola-affected countries live within 200 miles of a designated Ebola treatment center, the agency affirmed, and the addition of new facilities in the weeks to come will “further broaden geographic reach.”While Texas is home to two of the designated centers, Texas Health Presbyterian, the Dallas hospital that treated the first Ebola case presenting in the United States, is not currently on the list.

Major new clinical guidelines for rheumatoid arthritis and spondyloarthritis will be presented at the annual meeting of the American College of Rheumatology Nov. 15-19, while other sessions will examine aspects of recently published guidelines on polymyalgia rheumatica, gout, and lupus nephritis.

The ACR’s new RA guidelines, which will include recommendations on the use of nonbiologic and biologic disease-modifying agents, as well as corticosteroids, will be presented Sunday, Nov. 16. Draft axial spondyloarthritis guidelines, which will also address the management of patients with ankylosing spondylitis, will be discussed the same day.

With the ACR’s gout guidelines, (part 1 and part 2) published in 2012, “some controversial aspects of have emerged,” said Dr. Chester V. Oddis, chair of the meeting’s planning subcommittee. Dr. Oddis highlighted a Monday, Nov. 17, session that will specifically address components of the gout recommendations that have generated concern.

Also on Monday, weaknesses of current lupus nephritis recommendations will be hashed out in a session devoted to helping clinicians recognize some of their pitfalls. Key areas of discussion will include the role of rituximab and the problem of steroid use in this difficult-to-treat patient group.

Dr. Oddis, professor of medicine in the division of rheumatology and clinical immunology at the University of Pittsburgh, pointed to certain other sessions and presentations on RA during the 5-day meeting as especially compelling.

Morbidity and mortality features in RA will be covered in two presentations at the plenary session on Sunday. Dr. Oddis advised clinicians to “stay tuned” for results from a Dutch study that evaluated treat-to-target approaches in a cohort of more than 500 RA patients. Investigators found survival rates to be comparable with those of the general population after 10 years of treat to target, regardless of medications used. Tight control had more bearing on survival than did any particular course of treatment, with no significant differences seen between the four treatment strategies studied.

Also on Sunday, other key mortality findings will be discussed from a long-term, prospective, cohort study of 121,700 women that found that those diagnosed with RA over 34 years of follow-up (n = 960) had double the risk of death from any cause, compared with women without RA. Respiratory mortality accounted for 16% of deaths among RA patients, suggesting a little-explored cause of death, and women with RA were significantly more likely to die from cardiovascular disease and cancer than were those without RA, the study found.

The comparative effectiveness and harms of biologics are a hot topic in RA, and a Monday session will review findings from registries and direct comparator trials, offering clinicians suggestions on how to best learn from the data.

Dr. Oddis also highlighted a Tuesday session on the epidemiology of cardiovascular risk in RA and clinical CV risk management in patients with RA. The aim, he said, is to demonstrate “how we can best develop a rational approach to assessing this in our practices.”

Major new clinical guidelines for rheumatoid arthritis and spondyloarthritis will be presented at the annual meeting of the American College of Rheumatology Nov. 15-19, while other sessions will examine aspects of recently published guidelines on polymyalgia rheumatica, gout, and lupus nephritis.

The ACR’s new RA guidelines, which will include recommendations on the use of nonbiologic and biologic disease-modifying agents, as well as corticosteroids, will be presented Sunday, Nov. 16. Draft axial spondyloarthritis guidelines, which will also address the management of patients with ankylosing spondylitis, will be discussed the same day.

With the ACR’s gout guidelines, (part 1 and part 2) published in 2012, “some controversial aspects of have emerged,” said Dr. Chester V. Oddis, chair of the meeting’s planning subcommittee. Dr. Oddis highlighted a Monday, Nov. 17, session that will specifically address components of the gout recommendations that have generated concern.

Also on Monday, weaknesses of current lupus nephritis recommendations will be hashed out in a session devoted to helping clinicians recognize some of their pitfalls. Key areas of discussion will include the role of rituximab and the problem of steroid use in this difficult-to-treat patient group.

Dr. Oddis, professor of medicine in the division of rheumatology and clinical immunology at the University of Pittsburgh, pointed to certain other sessions and presentations on RA during the 5-day meeting as especially compelling.

Morbidity and mortality features in RA will be covered in two presentations at the plenary session on Sunday. Dr. Oddis advised clinicians to “stay tuned” for results from a Dutch study that evaluated treat-to-target approaches in a cohort of more than 500 RA patients. Investigators found survival rates to be comparable with those of the general population after 10 years of treat to target, regardless of medications used. Tight control had more bearing on survival than did any particular course of treatment, with no significant differences seen between the four treatment strategies studied.

Also on Sunday, other key mortality findings will be discussed from a long-term, prospective, cohort study of 121,700 women that found that those diagnosed with RA over 34 years of follow-up (n = 960) had double the risk of death from any cause, compared with women without RA. Respiratory mortality accounted for 16% of deaths among RA patients, suggesting a little-explored cause of death, and women with RA were significantly more likely to die from cardiovascular disease and cancer than were those without RA, the study found.

The comparative effectiveness and harms of biologics are a hot topic in RA, and a Monday session will review findings from registries and direct comparator trials, offering clinicians suggestions on how to best learn from the data.

Dr. Oddis also highlighted a Tuesday session on the epidemiology of cardiovascular risk in RA and clinical CV risk management in patients with RA. The aim, he said, is to demonstrate “how we can best develop a rational approach to assessing this in our practices.”

Major new clinical guidelines for rheumatoid arthritis and spondyloarthritis will be presented at the annual meeting of the American College of Rheumatology Nov. 15-19, while other sessions will examine aspects of recently published guidelines on polymyalgia rheumatica, gout, and lupus nephritis.

The ACR’s new RA guidelines, which will include recommendations on the use of nonbiologic and biologic disease-modifying agents, as well as corticosteroids, will be presented Sunday, Nov. 16. Draft axial spondyloarthritis guidelines, which will also address the management of patients with ankylosing spondylitis, will be discussed the same day.

With the ACR’s gout guidelines, (part 1 and part 2) published in 2012, “some controversial aspects of have emerged,” said Dr. Chester V. Oddis, chair of the meeting’s planning subcommittee. Dr. Oddis highlighted a Monday, Nov. 17, session that will specifically address components of the gout recommendations that have generated concern.

Also on Monday, weaknesses of current lupus nephritis recommendations will be hashed out in a session devoted to helping clinicians recognize some of their pitfalls. Key areas of discussion will include the role of rituximab and the problem of steroid use in this difficult-to-treat patient group.

Dr. Oddis, professor of medicine in the division of rheumatology and clinical immunology at the University of Pittsburgh, pointed to certain other sessions and presentations on RA during the 5-day meeting as especially compelling.

Morbidity and mortality features in RA will be covered in two presentations at the plenary session on Sunday. Dr. Oddis advised clinicians to “stay tuned” for results from a Dutch study that evaluated treat-to-target approaches in a cohort of more than 500 RA patients. Investigators found survival rates to be comparable with those of the general population after 10 years of treat to target, regardless of medications used. Tight control had more bearing on survival than did any particular course of treatment, with no significant differences seen between the four treatment strategies studied.

Also on Sunday, other key mortality findings will be discussed from a long-term, prospective, cohort study of 121,700 women that found that those diagnosed with RA over 34 years of follow-up (n = 960) had double the risk of death from any cause, compared with women without RA. Respiratory mortality accounted for 16% of deaths among RA patients, suggesting a little-explored cause of death, and women with RA were significantly more likely to die from cardiovascular disease and cancer than were those without RA, the study found.

The comparative effectiveness and harms of biologics are a hot topic in RA, and a Monday session will review findings from registries and direct comparator trials, offering clinicians suggestions on how to best learn from the data.

Dr. Oddis also highlighted a Tuesday session on the epidemiology of cardiovascular risk in RA and clinical CV risk management in patients with RA. The aim, he said, is to demonstrate “how we can best develop a rational approach to assessing this in our practices.”