SAN DIEGO – Bariatric patients are nearly 50% more likely than general surgery patients to start using opioids after their procedures and continue taking the painkillers for a year, a new study finds.

It’s not clear why bariatric patients are at higher risk of continued opioid use, nor whether they are more likely to become addicted. Still, bariatric patients are a target for “intervention, enhanced education, early referral to specialists, protocols minimizing inpatient and outpatient narcotics, opioid-free operations, system-based interventions and prescribing guidelines,” says study lead author Sanjay Mohanty, MD, a surgery resident with the Henry Ford Health System, who spoke in a presentation at the annual clinical congress of the American College of Surgeons.

There’s been little research into opioid use among bariatric patients, said Dr. Mohanty. In 2013, a retrospective study found that 8% of 11,719 bariatric patients were chronic opioid users, and more than three-quarters of those remained so after 1 year. However, that study was completed in 2010 before the height of the opioid epidemic (JAMA. 2013;310(13):1369-76).

More recently, a 2017 study found that opioid use among 1,892 bariatric patients who weren’t using at baseline grew from 5.8% at 6 months to 14.2% at 7 years. The study tracked patients until January 2015 (Surg Obes Relat Dis. 2017 Aug;13 (8):1337-46).

Opioid use after bariatric procedures is common, said the current study co-author Arthur M. Carlin, MD, FACS, FASMBS, vice-chairman of the Department of Surgery and division head of General Surgery with Henry Ford Health System, who spoke in an interview. Dr. Carlin, who’s also professor of Surgery at Wayne State University School of Medicine, said that he’s seen patients routinely take morphine via self-controlled drip in the hospital and be prescribed 20-30 pills to take home.

For the new study, researchers tracked 14,063 bariatric patients in the Michigan Bariatric Surgery Collaborative, a group of Michigan hospitals and health systems, from 2006-2017.

Of the patients, 73% were opioid-naive at baseline and 27% were users. At 1 year after procedure, overall use dropped slightly to 24%. However, 905 patients – 8.8% of the initial opioid-native group – were new and persistent opioid users.

According to Dr. Carlin, this is almost 50% higher than in patients after general surgical procedures.

These users were significantly more likely to be black (OR 1.67), less likely to have private insurance (0.76 OR), more likely to have income under $25,000 (OR 1.43), and more likely to have a mobility limitation (OR 1.78).

The researchers also found evidence linking a higher risk of new and persistent opioid use to lack of unemployment, depression, musculoskeletal disorders, tobacco use and gastric bypass procedures.

Why might bariatric patients in general be more susceptible to new and persistent opioid use? “We don’t know that answer,” Dr. Carlin said. “Maybe there’s some addiction transfer. Or maybe it’s something physiologic. We’re doing an operation on the gut, and that could have an impact on absorption.”

As for solutions, Dr. Carlin says “prescribe less, prescribe differently, be more patient-specific. We’re looking at different modalities to treat the pain such as nerve blocks during surgery, anti-inflammatories and muscle relaxants.”

And if patients aren’t using opioids in the hospital and not having that much pain, he said, physicians don’t send any pills home with them.

The next steps should include research into links between opioids and perioperative complications and surgical outcomes, the researchers suggested.

Dr. Carlin and Dr. Mohanty report no relevant disclosures.
 

 

SAN DIEGO – Bariatric patients are nearly 50% more likely than general surgery patients to start using opioids after their procedures and continue taking the painkillers for a year, a new study finds.

It’s not clear why bariatric patients are at higher risk of continued opioid use, nor whether they are more likely to become addicted. Still, bariatric patients are a target for “intervention, enhanced education, early referral to specialists, protocols minimizing inpatient and outpatient narcotics, opioid-free operations, system-based interventions and prescribing guidelines,” says study lead author Sanjay Mohanty, MD, a surgery resident with the Henry Ford Health System, who spoke in a presentation at the annual clinical congress of the American College of Surgeons.

There’s been little research into opioid use among bariatric patients, said Dr. Mohanty. In 2013, a retrospective study found that 8% of 11,719 bariatric patients were chronic opioid users, and more than three-quarters of those remained so after 1 year. However, that study was completed in 2010 before the height of the opioid epidemic (JAMA. 2013;310(13):1369-76).

More recently, a 2017 study found that opioid use among 1,892 bariatric patients who weren’t using at baseline grew from 5.8% at 6 months to 14.2% at 7 years. The study tracked patients until January 2015 (Surg Obes Relat Dis. 2017 Aug;13 (8):1337-46).

Opioid use after bariatric procedures is common, said the current study co-author Arthur M. Carlin, MD, FACS, FASMBS, vice-chairman of the Department of Surgery and division head of General Surgery with Henry Ford Health System, who spoke in an interview. Dr. Carlin, who’s also professor of Surgery at Wayne State University School of Medicine, said that he’s seen patients routinely take morphine via self-controlled drip in the hospital and be prescribed 20-30 pills to take home.

For the new study, researchers tracked 14,063 bariatric patients in the Michigan Bariatric Surgery Collaborative, a group of Michigan hospitals and health systems, from 2006-2017.

Of the patients, 73% were opioid-naive at baseline and 27% were users. At 1 year after procedure, overall use dropped slightly to 24%. However, 905 patients – 8.8% of the initial opioid-native group – were new and persistent opioid users.

According to Dr. Carlin, this is almost 50% higher than in patients after general surgical procedures.

These users were significantly more likely to be black (OR 1.67), less likely to have private insurance (0.76 OR), more likely to have income under $25,000 (OR 1.43), and more likely to have a mobility limitation (OR 1.78).

The researchers also found evidence linking a higher risk of new and persistent opioid use to lack of unemployment, depression, musculoskeletal disorders, tobacco use and gastric bypass procedures.

Why might bariatric patients in general be more susceptible to new and persistent opioid use? “We don’t know that answer,” Dr. Carlin said. “Maybe there’s some addiction transfer. Or maybe it’s something physiologic. We’re doing an operation on the gut, and that could have an impact on absorption.”

As for solutions, Dr. Carlin says “prescribe less, prescribe differently, be more patient-specific. We’re looking at different modalities to treat the pain such as nerve blocks during surgery, anti-inflammatories and muscle relaxants.”

And if patients aren’t using opioids in the hospital and not having that much pain, he said, physicians don’t send any pills home with them.

The next steps should include research into links between opioids and perioperative complications and surgical outcomes, the researchers suggested.

Dr. Carlin and Dr. Mohanty report no relevant disclosures.
 

 

SAN DIEGO – Bariatric patients are nearly 50% more likely than general surgery patients to start using opioids after their procedures and continue taking the painkillers for a year, a new study finds.

It’s not clear why bariatric patients are at higher risk of continued opioid use, nor whether they are more likely to become addicted. Still, bariatric patients are a target for “intervention, enhanced education, early referral to specialists, protocols minimizing inpatient and outpatient narcotics, opioid-free operations, system-based interventions and prescribing guidelines,” says study lead author Sanjay Mohanty, MD, a surgery resident with the Henry Ford Health System, who spoke in a presentation at the annual clinical congress of the American College of Surgeons.

There’s been little research into opioid use among bariatric patients, said Dr. Mohanty. In 2013, a retrospective study found that 8% of 11,719 bariatric patients were chronic opioid users, and more than three-quarters of those remained so after 1 year. However, that study was completed in 2010 before the height of the opioid epidemic (JAMA. 2013;310(13):1369-76).

More recently, a 2017 study found that opioid use among 1,892 bariatric patients who weren’t using at baseline grew from 5.8% at 6 months to 14.2% at 7 years. The study tracked patients until January 2015 (Surg Obes Relat Dis. 2017 Aug;13 (8):1337-46).

Opioid use after bariatric procedures is common, said the current study co-author Arthur M. Carlin, MD, FACS, FASMBS, vice-chairman of the Department of Surgery and division head of General Surgery with Henry Ford Health System, who spoke in an interview. Dr. Carlin, who’s also professor of Surgery at Wayne State University School of Medicine, said that he’s seen patients routinely take morphine via self-controlled drip in the hospital and be prescribed 20-30 pills to take home.

For the new study, researchers tracked 14,063 bariatric patients in the Michigan Bariatric Surgery Collaborative, a group of Michigan hospitals and health systems, from 2006-2017.

Of the patients, 73% were opioid-naive at baseline and 27% were users. At 1 year after procedure, overall use dropped slightly to 24%. However, 905 patients – 8.8% of the initial opioid-native group – were new and persistent opioid users.

According to Dr. Carlin, this is almost 50% higher than in patients after general surgical procedures.

These users were significantly more likely to be black (OR 1.67), less likely to have private insurance (0.76 OR), more likely to have income under $25,000 (OR 1.43), and more likely to have a mobility limitation (OR 1.78).

The researchers also found evidence linking a higher risk of new and persistent opioid use to lack of unemployment, depression, musculoskeletal disorders, tobacco use and gastric bypass procedures.

Why might bariatric patients in general be more susceptible to new and persistent opioid use? “We don’t know that answer,” Dr. Carlin said. “Maybe there’s some addiction transfer. Or maybe it’s something physiologic. We’re doing an operation on the gut, and that could have an impact on absorption.”

As for solutions, Dr. Carlin says “prescribe less, prescribe differently, be more patient-specific. We’re looking at different modalities to treat the pain such as nerve blocks during surgery, anti-inflammatories and muscle relaxants.”

And if patients aren’t using opioids in the hospital and not having that much pain, he said, physicians don’t send any pills home with them.

The next steps should include research into links between opioids and perioperative complications and surgical outcomes, the researchers suggested.

Dr. Carlin and Dr. Mohanty report no relevant disclosures.
 

 

OptiScan Biomedical Corporation announced Oct. 18 that the Food and Drug Administration has granted 510(k) clearance for the OptiScanner 5000 Glucose Monitoring System.

The clearance allows the device to be used for monitoring plasma glucose levels and determining dysglycemia in surgical intensive care unit (SICU) patients. It is a bedside glucose monitoring system that provides physicians with critical trending and tracking information to manage patient glucose levels in the ICU.

In a multi-center clinical trial in 160 surgical intensive care unit patients, results found the OptiScanner 5000 to be safe and accurate for use in patients in the SICU. The study results also showed the ability of the device to combine accurate plasma glucose measurement with the convenience of continuous, real-time bedside monitoring, and alarms which notify clinicians of excursions from the desired glucose range.

It is estimated that roughly 20% of ICU patients have pre-existing diabetes and an additional 40- to- 60% of ICU patients suffer from “stress hyperglycemia” or a temporary elevation of glucose levels, with all of these patients requiring accurate glucose monitoring to maintain glycemic control.

“There is a broad consensus in the medical community regarding the need for automated, continuous and highly accurate glucose monitoring in the ICU and my experience with the OptiScanner 5000 indicates that this device will play a critical role in delivering this enhanced level of care. I look forward to implementing this technology as soon as possible,” said Grant V. Bochicchio, MD, MPH, FACS, chief of acute and critical care surgery, and Harry Edison Professor of Surgery, Washington University School of Medicine, in a press release.

Read the full press release here.

[email protected]

 

OptiScan Biomedical Corporation announced Oct. 18 that the Food and Drug Administration has granted 510(k) clearance for the OptiScanner 5000 Glucose Monitoring System.

The clearance allows the device to be used for monitoring plasma glucose levels and determining dysglycemia in surgical intensive care unit (SICU) patients. It is a bedside glucose monitoring system that provides physicians with critical trending and tracking information to manage patient glucose levels in the ICU.

In a multi-center clinical trial in 160 surgical intensive care unit patients, results found the OptiScanner 5000 to be safe and accurate for use in patients in the SICU. The study results also showed the ability of the device to combine accurate plasma glucose measurement with the convenience of continuous, real-time bedside monitoring, and alarms which notify clinicians of excursions from the desired glucose range.

It is estimated that roughly 20% of ICU patients have pre-existing diabetes and an additional 40- to- 60% of ICU patients suffer from “stress hyperglycemia” or a temporary elevation of glucose levels, with all of these patients requiring accurate glucose monitoring to maintain glycemic control.

“There is a broad consensus in the medical community regarding the need for automated, continuous and highly accurate glucose monitoring in the ICU and my experience with the OptiScanner 5000 indicates that this device will play a critical role in delivering this enhanced level of care. I look forward to implementing this technology as soon as possible,” said Grant V. Bochicchio, MD, MPH, FACS, chief of acute and critical care surgery, and Harry Edison Professor of Surgery, Washington University School of Medicine, in a press release.

Read the full press release here.

[email protected]

 

OptiScan Biomedical Corporation announced Oct. 18 that the Food and Drug Administration has granted 510(k) clearance for the OptiScanner 5000 Glucose Monitoring System.

The clearance allows the device to be used for monitoring plasma glucose levels and determining dysglycemia in surgical intensive care unit (SICU) patients. It is a bedside glucose monitoring system that provides physicians with critical trending and tracking information to manage patient glucose levels in the ICU.

In a multi-center clinical trial in 160 surgical intensive care unit patients, results found the OptiScanner 5000 to be safe and accurate for use in patients in the SICU. The study results also showed the ability of the device to combine accurate plasma glucose measurement with the convenience of continuous, real-time bedside monitoring, and alarms which notify clinicians of excursions from the desired glucose range.

It is estimated that roughly 20% of ICU patients have pre-existing diabetes and an additional 40- to- 60% of ICU patients suffer from “stress hyperglycemia” or a temporary elevation of glucose levels, with all of these patients requiring accurate glucose monitoring to maintain glycemic control.

“There is a broad consensus in the medical community regarding the need for automated, continuous and highly accurate glucose monitoring in the ICU and my experience with the OptiScanner 5000 indicates that this device will play a critical role in delivering this enhanced level of care. I look forward to implementing this technology as soon as possible,” said Grant V. Bochicchio, MD, MPH, FACS, chief of acute and critical care surgery, and Harry Edison Professor of Surgery, Washington University School of Medicine, in a press release.

Read the full press release here.

[email protected]

 

SAN DIEGO – Surgeon preference for bouffant versus skull caps does not significantly impact superficial surgical site infection rates after accounting for surgical procedure type, results from a an analysis of a previously randomized, prospective trial showed.

“We are all aware of the current battle that is taking place over operating room attire based on the differences between the AORN [Association of periOperative Nurses] recommendations and ACS guidelines,” lead study author Shanu N. Kothari, MD, FACS, said at the annual clinical congress of the American College of Surgeons.

“To date, no strong evidence exists that bouffant caps have lower surgical site infection risk, compared to skull caps. We had an opportunity to review previously prospectively collected data at our own institution to see what impact, if any, surgical headwear has on SSI infection risk.”

In 2016, Dr. Kothari, director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc., and his associates published results from a prospective, randomized non-inferiority trial on the impact of hair removal on surgical site infection rates (J Am Coll Surg 2016;223[5]:704-11). Patients were grouped by the attending surgeons’ preferred cap choice into either bouffant or skull cap groups. Their analysis concluded that hair left on the abdomen had no impact on surgical site infection rates. “What is unique about this study is that two independent certified research nurses independently assessed every wound in that trial,” he said.

For the current study, the researchers re-examined the data by conducting a multivariate analysis to determine the influence of surgical cap choice on SSIs. Overall, 1,543 patients were included in the trial. Attending surgeons wore bouffant caps and skull caps in 39% and 61% of cases, respectively. Bouffant caps were used in 71% of colon/intestine, 42% of hernia/other, 40% of biliary cases and only 1% of foregut cases. Overall, SSIs occurred in 8% and 5% of cases in which attending surgeons wore a bouffant and skull cap, respectively (P = .016), with 6% vs. 4% classified as superficial (P = .041), 0.8% vs. 0.2% deep (P = .120), and 1% vs. 0.9% organ space (P = .790). However, when the researchers adjusted for the type of surgery and surgical approach (laparoscopic vs. open), they observed no difference in SSI rates for skull cap, compared with bouffant cap.

“Surgeon preference should dictate the choice of headwear in the operating room,” Dr. Kothari commented. “What I would encourage is perhaps a summit between thought leaders in the ACS and the AORN, [to conduct] a true review of evidence and come up with a universal guideline. There are many other issues we need to be focusing on in surgery, and this probably doesn’t have to be one of them.”

“In general, there is a complete and utter absence of any scientific evidence whatsoever for most of the things we are told to do in terms of wearing what we do in the OR,” said invited discussant E. Patchen Dellinger, MD, FACS, FIDSA, professor of surgery at the University of Washington, Seattle. “In fact, there are prospective randomized trials showing that wearing a [face] mask does not reduce surgical site infection, although I’ve been wearing a mask in the OR for approximately 48 years.”

Dr. Kothari reported having no relevant financial disclosures.

[email protected]

 

SAN DIEGO – Surgeon preference for bouffant versus skull caps does not significantly impact superficial surgical site infection rates after accounting for surgical procedure type, results from a an analysis of a previously randomized, prospective trial showed.

“We are all aware of the current battle that is taking place over operating room attire based on the differences between the AORN [Association of periOperative Nurses] recommendations and ACS guidelines,” lead study author Shanu N. Kothari, MD, FACS, said at the annual clinical congress of the American College of Surgeons.

“To date, no strong evidence exists that bouffant caps have lower surgical site infection risk, compared to skull caps. We had an opportunity to review previously prospectively collected data at our own institution to see what impact, if any, surgical headwear has on SSI infection risk.”

In 2016, Dr. Kothari, director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc., and his associates published results from a prospective, randomized non-inferiority trial on the impact of hair removal on surgical site infection rates (J Am Coll Surg 2016;223[5]:704-11). Patients were grouped by the attending surgeons’ preferred cap choice into either bouffant or skull cap groups. Their analysis concluded that hair left on the abdomen had no impact on surgical site infection rates. “What is unique about this study is that two independent certified research nurses independently assessed every wound in that trial,” he said.

For the current study, the researchers re-examined the data by conducting a multivariate analysis to determine the influence of surgical cap choice on SSIs. Overall, 1,543 patients were included in the trial. Attending surgeons wore bouffant caps and skull caps in 39% and 61% of cases, respectively. Bouffant caps were used in 71% of colon/intestine, 42% of hernia/other, 40% of biliary cases and only 1% of foregut cases. Overall, SSIs occurred in 8% and 5% of cases in which attending surgeons wore a bouffant and skull cap, respectively (P = .016), with 6% vs. 4% classified as superficial (P = .041), 0.8% vs. 0.2% deep (P = .120), and 1% vs. 0.9% organ space (P = .790). However, when the researchers adjusted for the type of surgery and surgical approach (laparoscopic vs. open), they observed no difference in SSI rates for skull cap, compared with bouffant cap.

“Surgeon preference should dictate the choice of headwear in the operating room,” Dr. Kothari commented. “What I would encourage is perhaps a summit between thought leaders in the ACS and the AORN, [to conduct] a true review of evidence and come up with a universal guideline. There are many other issues we need to be focusing on in surgery, and this probably doesn’t have to be one of them.”

“In general, there is a complete and utter absence of any scientific evidence whatsoever for most of the things we are told to do in terms of wearing what we do in the OR,” said invited discussant E. Patchen Dellinger, MD, FACS, FIDSA, professor of surgery at the University of Washington, Seattle. “In fact, there are prospective randomized trials showing that wearing a [face] mask does not reduce surgical site infection, although I’ve been wearing a mask in the OR for approximately 48 years.”

Dr. Kothari reported having no relevant financial disclosures.

[email protected]

 

SAN DIEGO – Surgeon preference for bouffant versus skull caps does not significantly impact superficial surgical site infection rates after accounting for surgical procedure type, results from a an analysis of a previously randomized, prospective trial showed.

“We are all aware of the current battle that is taking place over operating room attire based on the differences between the AORN [Association of periOperative Nurses] recommendations and ACS guidelines,” lead study author Shanu N. Kothari, MD, FACS, said at the annual clinical congress of the American College of Surgeons.

“To date, no strong evidence exists that bouffant caps have lower surgical site infection risk, compared to skull caps. We had an opportunity to review previously prospectively collected data at our own institution to see what impact, if any, surgical headwear has on SSI infection risk.”

In 2016, Dr. Kothari, director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc., and his associates published results from a prospective, randomized non-inferiority trial on the impact of hair removal on surgical site infection rates (J Am Coll Surg 2016;223[5]:704-11). Patients were grouped by the attending surgeons’ preferred cap choice into either bouffant or skull cap groups. Their analysis concluded that hair left on the abdomen had no impact on surgical site infection rates. “What is unique about this study is that two independent certified research nurses independently assessed every wound in that trial,” he said.

For the current study, the researchers re-examined the data by conducting a multivariate analysis to determine the influence of surgical cap choice on SSIs. Overall, 1,543 patients were included in the trial. Attending surgeons wore bouffant caps and skull caps in 39% and 61% of cases, respectively. Bouffant caps were used in 71% of colon/intestine, 42% of hernia/other, 40% of biliary cases and only 1% of foregut cases. Overall, SSIs occurred in 8% and 5% of cases in which attending surgeons wore a bouffant and skull cap, respectively (P = .016), with 6% vs. 4% classified as superficial (P = .041), 0.8% vs. 0.2% deep (P = .120), and 1% vs. 0.9% organ space (P = .790). However, when the researchers adjusted for the type of surgery and surgical approach (laparoscopic vs. open), they observed no difference in SSI rates for skull cap, compared with bouffant cap.

“Surgeon preference should dictate the choice of headwear in the operating room,” Dr. Kothari commented. “What I would encourage is perhaps a summit between thought leaders in the ACS and the AORN, [to conduct] a true review of evidence and come up with a universal guideline. There are many other issues we need to be focusing on in surgery, and this probably doesn’t have to be one of them.”

“In general, there is a complete and utter absence of any scientific evidence whatsoever for most of the things we are told to do in terms of wearing what we do in the OR,” said invited discussant E. Patchen Dellinger, MD, FACS, FIDSA, professor of surgery at the University of Washington, Seattle. “In fact, there are prospective randomized trials showing that wearing a [face] mask does not reduce surgical site infection, although I’ve been wearing a mask in the OR for approximately 48 years.”

Dr. Kothari reported having no relevant financial disclosures.

[email protected]

 

Female surgeons and trainees are more likely to be responsible for household activities such a childcare planning, grocery shopping, and meal planning, according to a pilot survey.

As the rates of women in the medical profession has increased so have the level of dual-professional/dual-physician relationships which presents unique challenges for working professionals including work-home conflicts which are frequently related to surgeon burnout and depression.

Dadrie Baptiste, MD, of the Indiana University School of Medicine and her colleagues conducted a pilot survey of faculty surgeons and trainees at a large university health clinic to further understand gender differences in household responsibilities. The survey was distributed 156 surgeons and 121 trainees. The response rates to the survey were high for both surgeons (81%) and trainees (96%); 77% of the surgeon respondents were men, as were 58% of the trainees. The survey gathered data on: sex, “specialty, surgical training, academic rank, academic productivity, marital status, spouse employment status, spouse profession, family size, division of household responsibilities, and career satisfaction” (J Surg Res. 2017 Oct;218:99-107). The survey revealed several key differences between men and women surgeons and trainees that affected their personal and professional life.

The survey found that female surgeons are significantly more likely to be responsible for household responsibilities such as childcare planning, grocery shopping, meal planning, and vacation planning. Conversely, the men surveyed were more likely to pass these responsibilities on to their spouses.

Women were significantly more likely than men to be married to a professional (90% versus 37%, for faculty; 82%versus 41% for trainees; they were also significantly more likely to be married to a spouse who was working full time.

Female surgeons also reported significantly lower personal (mean 3.1 vs. 3.7) and work life (mean 2.7 vs. 3.5) satisfaction compared to men, Dr. Baptiste and her colleagues reported. Although female surgeons are burdened with household responsibilities, they are still managing to produce a similar number of publications to their male colleagues. Despite having a similar number of publications, women were less likely to be on track for tenure (adjusted P less than.01) and be at a lower rank despite equivalent years of practice (interaction P less than.001) than their male colleagues.Due to the increased demands on female surgeons many are more likely to delay child-bearing until completion of medical school or residency. This leads to women surgeons having fewer children (P = .04) and younger children (P less than.001).Medical trainees appear to equally divide responsibilities. Childcare planning was a shared responsibility among female trainees as well as financial planning, although financial planning was often the primary responsibility of male surgical trainees (P = .004). Although female trainees were significantly more likely not to have children (82% vs. 33% and delay childbearing until after medical school (100% vs. 46%) or residency (77% vs. 19%) compared to men. Household chores were equally shared for female trainees, but were still seen by men trainees as a spousal responsibility (P less than.001). Vacation planning was seen as entirely sex neutral among trainees.

Similar to their surgeon counterparts, female trainees reported lower work satisfaction (mean 2.9 vs. 3.4, P = .009). But, there were no differences between male and female trainees for reported personal life or work-life balance.As the number of female surgeons rises, strategies must be implemented regarding recruitment of female faculty, according to the authors. Universities such as Stanford have implemented strategies to recruit and retain female surgeons which resulted in a 74% increase in female faculty and a 66% increase in promotion of female faculty members (Acad Med. 2014 Jun;89[6]:904-11).

“Implementation of research-driven changes in policies that facilitate successful career development and promotion will aid in equalizing [sex] disparities, lead to improvement in recruitment, and result in retention of the current and subsequent generations of surgeons” wrote Dr. Baptiste and her colleagues.All the authors of this study reported no financial conflicts of interest.

[email protected]

 

Female surgeons and trainees are more likely to be responsible for household activities such a childcare planning, grocery shopping, and meal planning, according to a pilot survey.

As the rates of women in the medical profession has increased so have the level of dual-professional/dual-physician relationships which presents unique challenges for working professionals including work-home conflicts which are frequently related to surgeon burnout and depression.

Dadrie Baptiste, MD, of the Indiana University School of Medicine and her colleagues conducted a pilot survey of faculty surgeons and trainees at a large university health clinic to further understand gender differences in household responsibilities. The survey was distributed 156 surgeons and 121 trainees. The response rates to the survey were high for both surgeons (81%) and trainees (96%); 77% of the surgeon respondents were men, as were 58% of the trainees. The survey gathered data on: sex, “specialty, surgical training, academic rank, academic productivity, marital status, spouse employment status, spouse profession, family size, division of household responsibilities, and career satisfaction” (J Surg Res. 2017 Oct;218:99-107). The survey revealed several key differences between men and women surgeons and trainees that affected their personal and professional life.

The survey found that female surgeons are significantly more likely to be responsible for household responsibilities such as childcare planning, grocery shopping, meal planning, and vacation planning. Conversely, the men surveyed were more likely to pass these responsibilities on to their spouses.

Women were significantly more likely than men to be married to a professional (90% versus 37%, for faculty; 82%versus 41% for trainees; they were also significantly more likely to be married to a spouse who was working full time.

Female surgeons also reported significantly lower personal (mean 3.1 vs. 3.7) and work life (mean 2.7 vs. 3.5) satisfaction compared to men, Dr. Baptiste and her colleagues reported. Although female surgeons are burdened with household responsibilities, they are still managing to produce a similar number of publications to their male colleagues. Despite having a similar number of publications, women were less likely to be on track for tenure (adjusted P less than.01) and be at a lower rank despite equivalent years of practice (interaction P less than.001) than their male colleagues.Due to the increased demands on female surgeons many are more likely to delay child-bearing until completion of medical school or residency. This leads to women surgeons having fewer children (P = .04) and younger children (P less than.001).Medical trainees appear to equally divide responsibilities. Childcare planning was a shared responsibility among female trainees as well as financial planning, although financial planning was often the primary responsibility of male surgical trainees (P = .004). Although female trainees were significantly more likely not to have children (82% vs. 33% and delay childbearing until after medical school (100% vs. 46%) or residency (77% vs. 19%) compared to men. Household chores were equally shared for female trainees, but were still seen by men trainees as a spousal responsibility (P less than.001). Vacation planning was seen as entirely sex neutral among trainees.

Similar to their surgeon counterparts, female trainees reported lower work satisfaction (mean 2.9 vs. 3.4, P = .009). But, there were no differences between male and female trainees for reported personal life or work-life balance.As the number of female surgeons rises, strategies must be implemented regarding recruitment of female faculty, according to the authors. Universities such as Stanford have implemented strategies to recruit and retain female surgeons which resulted in a 74% increase in female faculty and a 66% increase in promotion of female faculty members (Acad Med. 2014 Jun;89[6]:904-11).

“Implementation of research-driven changes in policies that facilitate successful career development and promotion will aid in equalizing [sex] disparities, lead to improvement in recruitment, and result in retention of the current and subsequent generations of surgeons” wrote Dr. Baptiste and her colleagues.All the authors of this study reported no financial conflicts of interest.

[email protected]

 

Female surgeons and trainees are more likely to be responsible for household activities such a childcare planning, grocery shopping, and meal planning, according to a pilot survey.

As the rates of women in the medical profession has increased so have the level of dual-professional/dual-physician relationships which presents unique challenges for working professionals including work-home conflicts which are frequently related to surgeon burnout and depression.

Dadrie Baptiste, MD, of the Indiana University School of Medicine and her colleagues conducted a pilot survey of faculty surgeons and trainees at a large university health clinic to further understand gender differences in household responsibilities. The survey was distributed 156 surgeons and 121 trainees. The response rates to the survey were high for both surgeons (81%) and trainees (96%); 77% of the surgeon respondents were men, as were 58% of the trainees. The survey gathered data on: sex, “specialty, surgical training, academic rank, academic productivity, marital status, spouse employment status, spouse profession, family size, division of household responsibilities, and career satisfaction” (J Surg Res. 2017 Oct;218:99-107). The survey revealed several key differences between men and women surgeons and trainees that affected their personal and professional life.

The survey found that female surgeons are significantly more likely to be responsible for household responsibilities such as childcare planning, grocery shopping, meal planning, and vacation planning. Conversely, the men surveyed were more likely to pass these responsibilities on to their spouses.

Women were significantly more likely than men to be married to a professional (90% versus 37%, for faculty; 82%versus 41% for trainees; they were also significantly more likely to be married to a spouse who was working full time.

Female surgeons also reported significantly lower personal (mean 3.1 vs. 3.7) and work life (mean 2.7 vs. 3.5) satisfaction compared to men, Dr. Baptiste and her colleagues reported. Although female surgeons are burdened with household responsibilities, they are still managing to produce a similar number of publications to their male colleagues. Despite having a similar number of publications, women were less likely to be on track for tenure (adjusted P less than.01) and be at a lower rank despite equivalent years of practice (interaction P less than.001) than their male colleagues.Due to the increased demands on female surgeons many are more likely to delay child-bearing until completion of medical school or residency. This leads to women surgeons having fewer children (P = .04) and younger children (P less than.001).Medical trainees appear to equally divide responsibilities. Childcare planning was a shared responsibility among female trainees as well as financial planning, although financial planning was often the primary responsibility of male surgical trainees (P = .004). Although female trainees were significantly more likely not to have children (82% vs. 33% and delay childbearing until after medical school (100% vs. 46%) or residency (77% vs. 19%) compared to men. Household chores were equally shared for female trainees, but were still seen by men trainees as a spousal responsibility (P less than.001). Vacation planning was seen as entirely sex neutral among trainees.

Similar to their surgeon counterparts, female trainees reported lower work satisfaction (mean 2.9 vs. 3.4, P = .009). But, there were no differences between male and female trainees for reported personal life or work-life balance.As the number of female surgeons rises, strategies must be implemented regarding recruitment of female faculty, according to the authors. Universities such as Stanford have implemented strategies to recruit and retain female surgeons which resulted in a 74% increase in female faculty and a 66% increase in promotion of female faculty members (Acad Med. 2014 Jun;89[6]:904-11).

“Implementation of research-driven changes in policies that facilitate successful career development and promotion will aid in equalizing [sex] disparities, lead to improvement in recruitment, and result in retention of the current and subsequent generations of surgeons” wrote Dr. Baptiste and her colleagues.All the authors of this study reported no financial conflicts of interest.

[email protected]

 

Perioperative blood transfusion (PBT) is associated with poorer outcomes among patients who underwent nephrectomy for renal cell carcinoma (RCC), according to a retrospective review of 1,159 patients.

Using multivariate analysis and controlling for potential confounders such as clinical and pathologic features, receipt of PBT was associated with significantly increased risk of tumor recurrence (HR = 2, P = .02, metastatic progression (HR = 2.5, P = .007), and death from RCC (HR = 2.5, P = .02).

Tomasz Gierygowski/Thinkstock

“Although these findings require further validation, continued efforts to minimize the use of blood products in patients with RCC are essential,” said Yasmin Abu-Ghanem, MD, of the Sheba Medical Center, Tel Hashomer, Israel, and coauthors (Urologic Onc. 2017 Oct 6. doi: http://dx.doi.org/10.1016/j.urolonc.2017.09.006).

Previous research suggests that PBT may be associated with worse oncological outcomes following cancer surgery, although the data have been inconsistent. In this study, Dr. Abu-Ghanem and colleagues conducted a retrospective study that examined effect of PBT on the prognosis of 1,159 patients who underwent radical nephrectomy or partial nephrectomy for RCC, between 1987 to 2013.

Within this cohort, 198 patients (17.1%) received a PBT, and the median follow-up was 63.2 months. Receipt of PBT was associated with a symptomatic presentation (P less than .001) and a higher rate of adverse pathological features that included larger tumors (P less than .001), high nuclear grade (P less than .001), presence of tumor necrosis (P less than .001), and capsular invasion (P less than .001). Patients who received PBT were also more likely to have undergone an open surgical procedure (P less than .05).

The authors found that receipt of a PBT was associated with significantly worse 5-year relapse free survival (81% vs. 92%, P less than .01) as well as metastatic free survival (79% vs. 93%, P less than .001). Receiving a PBT was also associated with a worse 5-year CSS (85% vs. 95%, P less than .001) and OS (73% vs. 81%, P less than .001) versus those who were not transfused.

A subgroup analysis showed that patients who underwent a partial nephrectomy also had worse outcomes if they received a PBT as compared to those who didn’t; 5-year relapse free survival was 81% vs. 90% (P = .014), CSS was 89% vs. 97% (P = .019) and OS was 82% vs. 92%, (P = .016).

There were no funding sources or author disclosures listed in the article.

 

Perioperative blood transfusion (PBT) is associated with poorer outcomes among patients who underwent nephrectomy for renal cell carcinoma (RCC), according to a retrospective review of 1,159 patients.

Using multivariate analysis and controlling for potential confounders such as clinical and pathologic features, receipt of PBT was associated with significantly increased risk of tumor recurrence (HR = 2, P = .02, metastatic progression (HR = 2.5, P = .007), and death from RCC (HR = 2.5, P = .02).

Tomasz Gierygowski/Thinkstock

“Although these findings require further validation, continued efforts to minimize the use of blood products in patients with RCC are essential,” said Yasmin Abu-Ghanem, MD, of the Sheba Medical Center, Tel Hashomer, Israel, and coauthors (Urologic Onc. 2017 Oct 6. doi: http://dx.doi.org/10.1016/j.urolonc.2017.09.006).

Previous research suggests that PBT may be associated with worse oncological outcomes following cancer surgery, although the data have been inconsistent. In this study, Dr. Abu-Ghanem and colleagues conducted a retrospective study that examined effect of PBT on the prognosis of 1,159 patients who underwent radical nephrectomy or partial nephrectomy for RCC, between 1987 to 2013.

Within this cohort, 198 patients (17.1%) received a PBT, and the median follow-up was 63.2 months. Receipt of PBT was associated with a symptomatic presentation (P less than .001) and a higher rate of adverse pathological features that included larger tumors (P less than .001), high nuclear grade (P less than .001), presence of tumor necrosis (P less than .001), and capsular invasion (P less than .001). Patients who received PBT were also more likely to have undergone an open surgical procedure (P less than .05).

The authors found that receipt of a PBT was associated with significantly worse 5-year relapse free survival (81% vs. 92%, P less than .01) as well as metastatic free survival (79% vs. 93%, P less than .001). Receiving a PBT was also associated with a worse 5-year CSS (85% vs. 95%, P less than .001) and OS (73% vs. 81%, P less than .001) versus those who were not transfused.

A subgroup analysis showed that patients who underwent a partial nephrectomy also had worse outcomes if they received a PBT as compared to those who didn’t; 5-year relapse free survival was 81% vs. 90% (P = .014), CSS was 89% vs. 97% (P = .019) and OS was 82% vs. 92%, (P = .016).

There were no funding sources or author disclosures listed in the article.

 

Perioperative blood transfusion (PBT) is associated with poorer outcomes among patients who underwent nephrectomy for renal cell carcinoma (RCC), according to a retrospective review of 1,159 patients.

Using multivariate analysis and controlling for potential confounders such as clinical and pathologic features, receipt of PBT was associated with significantly increased risk of tumor recurrence (HR = 2, P = .02, metastatic progression (HR = 2.5, P = .007), and death from RCC (HR = 2.5, P = .02).

Tomasz Gierygowski/Thinkstock

“Although these findings require further validation, continued efforts to minimize the use of blood products in patients with RCC are essential,” said Yasmin Abu-Ghanem, MD, of the Sheba Medical Center, Tel Hashomer, Israel, and coauthors (Urologic Onc. 2017 Oct 6. doi: http://dx.doi.org/10.1016/j.urolonc.2017.09.006).

Previous research suggests that PBT may be associated with worse oncological outcomes following cancer surgery, although the data have been inconsistent. In this study, Dr. Abu-Ghanem and colleagues conducted a retrospective study that examined effect of PBT on the prognosis of 1,159 patients who underwent radical nephrectomy or partial nephrectomy for RCC, between 1987 to 2013.

Within this cohort, 198 patients (17.1%) received a PBT, and the median follow-up was 63.2 months. Receipt of PBT was associated with a symptomatic presentation (P less than .001) and a higher rate of adverse pathological features that included larger tumors (P less than .001), high nuclear grade (P less than .001), presence of tumor necrosis (P less than .001), and capsular invasion (P less than .001). Patients who received PBT were also more likely to have undergone an open surgical procedure (P less than .05).

The authors found that receipt of a PBT was associated with significantly worse 5-year relapse free survival (81% vs. 92%, P less than .01) as well as metastatic free survival (79% vs. 93%, P less than .001). Receiving a PBT was also associated with a worse 5-year CSS (85% vs. 95%, P less than .001) and OS (73% vs. 81%, P less than .001) versus those who were not transfused.

A subgroup analysis showed that patients who underwent a partial nephrectomy also had worse outcomes if they received a PBT as compared to those who didn’t; 5-year relapse free survival was 81% vs. 90% (P = .014), CSS was 89% vs. 97% (P = .019) and OS was 82% vs. 92%, (P = .016).

There were no funding sources or author disclosures listed in the article.

 

NATIONAL HARBOR, MD – Hospital discharge after bariatric surgery can be significantly and meaningful accelerated by using multimodality pain control techniques that do not include patient-controlled analgesia (PCA), according to data from a two-hospital study presented at Obesity Week 2017.

“It was our impression that PCA was delaying milestones of recovery, so we prospectively evaluated this hypothesis. The result was a meaningful reduction in the length of stay without any meaningful adverse consequences,” reported Aline Van, RN, a weight loss surgery nurse navigator at Doctors Hospital, Manteca, Calif.

Ted Bosworth/Frontline Medical News

There is some irony in these results, because “we had moved to PCA as a strategy to reduce opioid use,” explained Patrick Coates, MD, who is director of metabolic bariatric surgery at Central California Bariatric Surgery, Modesto, Calif., and a coauthor. According to Dr. Coates, who performs bariatric surgery at both of the hospitals that participated in this study, “these data demonstrate that opioids can be largely avoided during recovery without any real disadvantages.”

The study was conducted because of concern that nausea and vomiting related to PCA was a common cause of discharge delay at both Doctors Hospital in Manteca (DHM) and the affiliated Doctors Medical Center (DMC) in Modesto. Led by Maria Marple, PA-C, the two-part prospective study consisted of an initial six-month evaluation of average length of stay (LOS) and a formal evaluation of the causes of delayed discharge. In the second phase, the same analyses were performed over a six-month period when PCA was halted.

At 1.83 days in one center and 1.84 days in the other, the average LOS was nearly identical during the initial six-month baseline evaluation. In the 75 patients evaluated in this period at DHC, inadequate fluid intake due to nausea and vomiting was involved in 61.7% of the cases in which discharge was delayed. At DMC, where 46 patients were evaluated in the baseline period, 47.6% of delays were due to inadequate fluid intake attributed to nausea and vomiting. In both cases, this was the most common reason for delay.

In the study period after PCA was discontinued, inadequate fluid intake remained the major cause of delayed discharges, but there were fewer discharge delays overall due to less nausea and vomiting. The average length of stay among the 104 patients treated in the study period at DHM fell to 1.64 days, while the average LOS fell to 1.66 days in the 83 patients treated at DMC. This was largely driven by a reduction in the proportion of patients with >2 days LOS, which fell from 52% to 41% at DHC (P = .04) and from 45% to 32% at DMC (P = .008).

The surgical procedures at both centers (all performed laparoscopically) included sleeve gastrectomy, gastric bypass, and duodenal switch. Although a multimodality approach is employed for postoperative pain control at both institutions, the protocols differ modestly. At DHC, acetaminophen by mouth is the primary postoperative analgesic with hydromorphone permitted if needed. At DMC, intravenous acetaminophen is used in the first 24 hours in all patients with acetaminophen/hydrocodone offered if needed.

Since the trial was completed and results analyzed, PCA has been discontinued completely at both institutions. In follow-up to date there has been a slight additional reduction in average LOS at both institutions, reaching 1.5 days at DHC and 1.61 days at DMC.

“The four to five hour average reduction in LOS following discontinuation of PCA is significant because it frees up beds at our hospital, which is run at capacity,” Ms. Van said. “When considered cumulatively, the average reduction in LOS is very meaningful.”

Although the benefits are generally attributed to reduced nausea and vomiting, which has implications for a better patient experience, Ms. Van also believes patients are having faster cognitive and physical recovery since PCA was eliminated, producing faster time to ambulation and discharge readiness.

“There really have been no negatives,” Dr. Coates confirmed. “In our experience, eliminating PCA has been better for the patients and has important implications for costs.”

Ms. Van and Dr. Coates reported no financial relationships relevant to this topic.
 

 

NATIONAL HARBOR, MD – Hospital discharge after bariatric surgery can be significantly and meaningful accelerated by using multimodality pain control techniques that do not include patient-controlled analgesia (PCA), according to data from a two-hospital study presented at Obesity Week 2017.

“It was our impression that PCA was delaying milestones of recovery, so we prospectively evaluated this hypothesis. The result was a meaningful reduction in the length of stay without any meaningful adverse consequences,” reported Aline Van, RN, a weight loss surgery nurse navigator at Doctors Hospital, Manteca, Calif.

Ted Bosworth/Frontline Medical News

There is some irony in these results, because “we had moved to PCA as a strategy to reduce opioid use,” explained Patrick Coates, MD, who is director of metabolic bariatric surgery at Central California Bariatric Surgery, Modesto, Calif., and a coauthor. According to Dr. Coates, who performs bariatric surgery at both of the hospitals that participated in this study, “these data demonstrate that opioids can be largely avoided during recovery without any real disadvantages.”

The study was conducted because of concern that nausea and vomiting related to PCA was a common cause of discharge delay at both Doctors Hospital in Manteca (DHM) and the affiliated Doctors Medical Center (DMC) in Modesto. Led by Maria Marple, PA-C, the two-part prospective study consisted of an initial six-month evaluation of average length of stay (LOS) and a formal evaluation of the causes of delayed discharge. In the second phase, the same analyses were performed over a six-month period when PCA was halted.

At 1.83 days in one center and 1.84 days in the other, the average LOS was nearly identical during the initial six-month baseline evaluation. In the 75 patients evaluated in this period at DHC, inadequate fluid intake due to nausea and vomiting was involved in 61.7% of the cases in which discharge was delayed. At DMC, where 46 patients were evaluated in the baseline period, 47.6% of delays were due to inadequate fluid intake attributed to nausea and vomiting. In both cases, this was the most common reason for delay.

In the study period after PCA was discontinued, inadequate fluid intake remained the major cause of delayed discharges, but there were fewer discharge delays overall due to less nausea and vomiting. The average length of stay among the 104 patients treated in the study period at DHM fell to 1.64 days, while the average LOS fell to 1.66 days in the 83 patients treated at DMC. This was largely driven by a reduction in the proportion of patients with >2 days LOS, which fell from 52% to 41% at DHC (P = .04) and from 45% to 32% at DMC (P = .008).

The surgical procedures at both centers (all performed laparoscopically) included sleeve gastrectomy, gastric bypass, and duodenal switch. Although a multimodality approach is employed for postoperative pain control at both institutions, the protocols differ modestly. At DHC, acetaminophen by mouth is the primary postoperative analgesic with hydromorphone permitted if needed. At DMC, intravenous acetaminophen is used in the first 24 hours in all patients with acetaminophen/hydrocodone offered if needed.

Since the trial was completed and results analyzed, PCA has been discontinued completely at both institutions. In follow-up to date there has been a slight additional reduction in average LOS at both institutions, reaching 1.5 days at DHC and 1.61 days at DMC.

“The four to five hour average reduction in LOS following discontinuation of PCA is significant because it frees up beds at our hospital, which is run at capacity,” Ms. Van said. “When considered cumulatively, the average reduction in LOS is very meaningful.”

Although the benefits are generally attributed to reduced nausea and vomiting, which has implications for a better patient experience, Ms. Van also believes patients are having faster cognitive and physical recovery since PCA was eliminated, producing faster time to ambulation and discharge readiness.

“There really have been no negatives,” Dr. Coates confirmed. “In our experience, eliminating PCA has been better for the patients and has important implications for costs.”

Ms. Van and Dr. Coates reported no financial relationships relevant to this topic.
 

 

NATIONAL HARBOR, MD – Hospital discharge after bariatric surgery can be significantly and meaningful accelerated by using multimodality pain control techniques that do not include patient-controlled analgesia (PCA), according to data from a two-hospital study presented at Obesity Week 2017.

“It was our impression that PCA was delaying milestones of recovery, so we prospectively evaluated this hypothesis. The result was a meaningful reduction in the length of stay without any meaningful adverse consequences,” reported Aline Van, RN, a weight loss surgery nurse navigator at Doctors Hospital, Manteca, Calif.

Ted Bosworth/Frontline Medical News

There is some irony in these results, because “we had moved to PCA as a strategy to reduce opioid use,” explained Patrick Coates, MD, who is director of metabolic bariatric surgery at Central California Bariatric Surgery, Modesto, Calif., and a coauthor. According to Dr. Coates, who performs bariatric surgery at both of the hospitals that participated in this study, “these data demonstrate that opioids can be largely avoided during recovery without any real disadvantages.”

The study was conducted because of concern that nausea and vomiting related to PCA was a common cause of discharge delay at both Doctors Hospital in Manteca (DHM) and the affiliated Doctors Medical Center (DMC) in Modesto. Led by Maria Marple, PA-C, the two-part prospective study consisted of an initial six-month evaluation of average length of stay (LOS) and a formal evaluation of the causes of delayed discharge. In the second phase, the same analyses were performed over a six-month period when PCA was halted.

At 1.83 days in one center and 1.84 days in the other, the average LOS was nearly identical during the initial six-month baseline evaluation. In the 75 patients evaluated in this period at DHC, inadequate fluid intake due to nausea and vomiting was involved in 61.7% of the cases in which discharge was delayed. At DMC, where 46 patients were evaluated in the baseline period, 47.6% of delays were due to inadequate fluid intake attributed to nausea and vomiting. In both cases, this was the most common reason for delay.

In the study period after PCA was discontinued, inadequate fluid intake remained the major cause of delayed discharges, but there were fewer discharge delays overall due to less nausea and vomiting. The average length of stay among the 104 patients treated in the study period at DHM fell to 1.64 days, while the average LOS fell to 1.66 days in the 83 patients treated at DMC. This was largely driven by a reduction in the proportion of patients with >2 days LOS, which fell from 52% to 41% at DHC (P = .04) and from 45% to 32% at DMC (P = .008).

The surgical procedures at both centers (all performed laparoscopically) included sleeve gastrectomy, gastric bypass, and duodenal switch. Although a multimodality approach is employed for postoperative pain control at both institutions, the protocols differ modestly. At DHC, acetaminophen by mouth is the primary postoperative analgesic with hydromorphone permitted if needed. At DMC, intravenous acetaminophen is used in the first 24 hours in all patients with acetaminophen/hydrocodone offered if needed.

Since the trial was completed and results analyzed, PCA has been discontinued completely at both institutions. In follow-up to date there has been a slight additional reduction in average LOS at both institutions, reaching 1.5 days at DHC and 1.61 days at DMC.

“The four to five hour average reduction in LOS following discontinuation of PCA is significant because it frees up beds at our hospital, which is run at capacity,” Ms. Van said. “When considered cumulatively, the average reduction in LOS is very meaningful.”

Although the benefits are generally attributed to reduced nausea and vomiting, which has implications for a better patient experience, Ms. Van also believes patients are having faster cognitive and physical recovery since PCA was eliminated, producing faster time to ambulation and discharge readiness.

“There really have been no negatives,” Dr. Coates confirmed. “In our experience, eliminating PCA has been better for the patients and has important implications for costs.”

Ms. Van and Dr. Coates reported no financial relationships relevant to this topic.
 

 

SAN DIEGO – Young adults with perinatally-acquired HIV are at an increased risk of developing hypertension, according to a study presented at IDWeek 2017, an infectious diseases conference.

With advances in HIV care and treatment increasing the lifespan of perinatally infected children, patients are seeing increased risks of HIV-associated, non-AIDS conditions like hypertension.

copyright alexskopje/Thinkstock

“Hypertension in HIV appears to be the result of an interplay between conventional risk factors and HIV specific risk factors, including direct and indirect antiretroviral toxicity (ART), immune deficiency and activation, and inflammation,” said presenter Patrick Ryscavage, MD, infectious disease specialist at the University of Maryland, Baltimore.

While the prevalence of hypertension in older HIV patients has been studied thoroughly, rates among younger, perinatal HIV populations is relatively unexplored, said Dr. Ryscavage.

Investigators examined 324 patients between the ages of 18-29 years, split between three arms for a cross sectional study: 108 patients with perinatally-acquired (PA) HIV, 108 patients with non-perinatally acquired (NPA) HIV, and 108 uninfected (UI) patients. The 3 study arms were a median age of 24 years, 95% black, and a slight majority female.

Dr. Ryscavage and fellow investigators defined systemic hypertension as two systolic blood pressure measurements greater than or equal to 140 mmHg, or diastolic measurements greater or equal to 90 mmHG within 3 months, or if a physician prescribed antihypertensive mediation.

The researchers discovered that, while UI patients had the highest prevalence of obesity, PA patients reported the highest rate of chronic kidney disease (19%) and dysplidemia (13%), compared to NPA (1% and 3% respectively) and UI (0% and 5% respectively) patients.

Hypertension prevalence was highest among PA patients, followed by NPA patients, and then UI at 23%, 10%, and 9% respectively.

Young adults with PA HIV were nearly 5 times as likely to have hypertension (aOR 4.7; CI 95% [1.9-11.5]) compared to the uninfected population, while NPA showed no significant difference compared to the uninfected (aOR 1.7; CI 95% [.7-4.6]).

Investigators checked to see if the increase in hypertension could be related to the high rate of chronic kidney disease, but were not successful.

“We found [chronic kidney disease] to be approximately one third increased odds of association with chronic kidney disease,” Dr. Ryscavage explained. “However excluding kidney disease, the prevalence odds ratios remained significant and in the context of the cross sectional study…it was difficult to establish a directional relationship between chronic kidney diseases and hypertension.”

This study was limited by using one center in West Baltimore. Also, due to a majority of patients having at least one deceased parent, investigators were not able to collect a complete family history.

Dr. Ryscavage and his colleagues are next looking for what specific factors in HIV groups are causing an increased prevalence. Meanwhile, the investigators implored other researchers to initiate studies in poorer nations where HIV is much more prevalent.

“These findings need to be explored in the developing world where we have the largest population of aging, perinatally infected patients,” said Dr. Ryscavage.

Presenters reported no relevant financial disclosures.
 

[email protected]

On Twitter @eaztweets

 

SAN DIEGO – Young adults with perinatally-acquired HIV are at an increased risk of developing hypertension, according to a study presented at IDWeek 2017, an infectious diseases conference.

With advances in HIV care and treatment increasing the lifespan of perinatally infected children, patients are seeing increased risks of HIV-associated, non-AIDS conditions like hypertension.

copyright alexskopje/Thinkstock

“Hypertension in HIV appears to be the result of an interplay between conventional risk factors and HIV specific risk factors, including direct and indirect antiretroviral toxicity (ART), immune deficiency and activation, and inflammation,” said presenter Patrick Ryscavage, MD, infectious disease specialist at the University of Maryland, Baltimore.

While the prevalence of hypertension in older HIV patients has been studied thoroughly, rates among younger, perinatal HIV populations is relatively unexplored, said Dr. Ryscavage.

Investigators examined 324 patients between the ages of 18-29 years, split between three arms for a cross sectional study: 108 patients with perinatally-acquired (PA) HIV, 108 patients with non-perinatally acquired (NPA) HIV, and 108 uninfected (UI) patients. The 3 study arms were a median age of 24 years, 95% black, and a slight majority female.

Dr. Ryscavage and fellow investigators defined systemic hypertension as two systolic blood pressure measurements greater than or equal to 140 mmHg, or diastolic measurements greater or equal to 90 mmHG within 3 months, or if a physician prescribed antihypertensive mediation.

The researchers discovered that, while UI patients had the highest prevalence of obesity, PA patients reported the highest rate of chronic kidney disease (19%) and dysplidemia (13%), compared to NPA (1% and 3% respectively) and UI (0% and 5% respectively) patients.

Hypertension prevalence was highest among PA patients, followed by NPA patients, and then UI at 23%, 10%, and 9% respectively.

Young adults with PA HIV were nearly 5 times as likely to have hypertension (aOR 4.7; CI 95% [1.9-11.5]) compared to the uninfected population, while NPA showed no significant difference compared to the uninfected (aOR 1.7; CI 95% [.7-4.6]).

Investigators checked to see if the increase in hypertension could be related to the high rate of chronic kidney disease, but were not successful.

“We found [chronic kidney disease] to be approximately one third increased odds of association with chronic kidney disease,” Dr. Ryscavage explained. “However excluding kidney disease, the prevalence odds ratios remained significant and in the context of the cross sectional study…it was difficult to establish a directional relationship between chronic kidney diseases and hypertension.”

This study was limited by using one center in West Baltimore. Also, due to a majority of patients having at least one deceased parent, investigators were not able to collect a complete family history.

Dr. Ryscavage and his colleagues are next looking for what specific factors in HIV groups are causing an increased prevalence. Meanwhile, the investigators implored other researchers to initiate studies in poorer nations where HIV is much more prevalent.

“These findings need to be explored in the developing world where we have the largest population of aging, perinatally infected patients,” said Dr. Ryscavage.

Presenters reported no relevant financial disclosures.
 

[email protected]

On Twitter @eaztweets

 

SAN DIEGO – Young adults with perinatally-acquired HIV are at an increased risk of developing hypertension, according to a study presented at IDWeek 2017, an infectious diseases conference.

With advances in HIV care and treatment increasing the lifespan of perinatally infected children, patients are seeing increased risks of HIV-associated, non-AIDS conditions like hypertension.

copyright alexskopje/Thinkstock

“Hypertension in HIV appears to be the result of an interplay between conventional risk factors and HIV specific risk factors, including direct and indirect antiretroviral toxicity (ART), immune deficiency and activation, and inflammation,” said presenter Patrick Ryscavage, MD, infectious disease specialist at the University of Maryland, Baltimore.

While the prevalence of hypertension in older HIV patients has been studied thoroughly, rates among younger, perinatal HIV populations is relatively unexplored, said Dr. Ryscavage.

Investigators examined 324 patients between the ages of 18-29 years, split between three arms for a cross sectional study: 108 patients with perinatally-acquired (PA) HIV, 108 patients with non-perinatally acquired (NPA) HIV, and 108 uninfected (UI) patients. The 3 study arms were a median age of 24 years, 95% black, and a slight majority female.

Dr. Ryscavage and fellow investigators defined systemic hypertension as two systolic blood pressure measurements greater than or equal to 140 mmHg, or diastolic measurements greater or equal to 90 mmHG within 3 months, or if a physician prescribed antihypertensive mediation.

The researchers discovered that, while UI patients had the highest prevalence of obesity, PA patients reported the highest rate of chronic kidney disease (19%) and dysplidemia (13%), compared to NPA (1% and 3% respectively) and UI (0% and 5% respectively) patients.

Hypertension prevalence was highest among PA patients, followed by NPA patients, and then UI at 23%, 10%, and 9% respectively.

Young adults with PA HIV were nearly 5 times as likely to have hypertension (aOR 4.7; CI 95% [1.9-11.5]) compared to the uninfected population, while NPA showed no significant difference compared to the uninfected (aOR 1.7; CI 95% [.7-4.6]).

Investigators checked to see if the increase in hypertension could be related to the high rate of chronic kidney disease, but were not successful.

“We found [chronic kidney disease] to be approximately one third increased odds of association with chronic kidney disease,” Dr. Ryscavage explained. “However excluding kidney disease, the prevalence odds ratios remained significant and in the context of the cross sectional study…it was difficult to establish a directional relationship between chronic kidney diseases and hypertension.”

This study was limited by using one center in West Baltimore. Also, due to a majority of patients having at least one deceased parent, investigators were not able to collect a complete family history.

Dr. Ryscavage and his colleagues are next looking for what specific factors in HIV groups are causing an increased prevalence. Meanwhile, the investigators implored other researchers to initiate studies in poorer nations where HIV is much more prevalent.

“These findings need to be explored in the developing world where we have the largest population of aging, perinatally infected patients,” said Dr. Ryscavage.

Presenters reported no relevant financial disclosures.
 

[email protected]

On Twitter @eaztweets

 

For infants with trisomy 13 or trisomy 18, congenital heart surgery is associated with a significant decrease in in-hospital mortality, according to results of a large, retrospective, multicenter cohort study.

In-hospital mortality was 45% lower in trisomy 13 patients (P = .003) and 64% lower in trisomy 18 patients (P less than.001) who underwent surgery, data show (Pediatrics 140(5); 2017. doi: https://doi.org/10.1542/peds.2017-0772).

herjua/Thinkstock

“These results suggest congenital heart surgery may be beneficial in select cases,” wrote Katherine A. Kosiv, MD, Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, and her colleagues.

The study, based on records from the 44 participating children’s hospitals represented in the Pediatric Health Information System (PHIS) database, included 1,668 newborns with trisomy 13 or 18 who were admitted within 14 days of birth. Median age at admission was less than 1 day for both groups.

Congenital heart disease was present in 925 out of 1,020 infants with trisomy 18 (91%) and 555 out of 648 with trisomy 13 (86%), the report stated.

For those infants with congenital heart disease, overall mortality was highest during the first hospital admission (63%), investigators wrote. However, for those undergoing congenital heart surgery, multivariate analysis showed decreased in-hospital mortality vs. those who had no surgery for both the trisomy 13 (30% vs. 55%, respectively, P = .003) and the trisomy 18 groups (16% vs. 44%, P less than .001).

This is not only the largest-ever study of trisomy 13 and 18 ever reported, according to the investigators, but also the first to show that higher weight, female sex, and older age at admission are associated with improved survival following congenital heart surgery among these patients. Multiple logistic regression analysis showed significant effects of these risk factors on mortality for both the trisomy 13 and 18 infant subsets, according to Dr. Kosiv and her colleagues.

These findings come at a time when many centers elect not to perform congenital heart surgery in trisomy 13 and 18 patients, the investigators wrote, noting that management is typically limited to medical strategies due to the “markedly short life expectancy” and grave prognosis associated with the condition.

Mortality was markedly decreased, but still considerably higher than what would be expected for congenital heart surgery in the general population, which is an important consideration for families and practitioners who are considering the procedure, investigators said in their report.

Nevertheless, the present findings suggest that “CHS may not be futile, at least not in the short-term, in patients with T13 and T18,” Dr. Kosiv and colleagues wrote. “Additionally, these results suggest that CHS may allow families to be able to take their children home and avoid [them] dying in the hospital.”


 

 

For infants with trisomy 13 or trisomy 18, congenital heart surgery is associated with a significant decrease in in-hospital mortality, according to results of a large, retrospective, multicenter cohort study.

In-hospital mortality was 45% lower in trisomy 13 patients (P = .003) and 64% lower in trisomy 18 patients (P less than.001) who underwent surgery, data show (Pediatrics 140(5); 2017. doi: https://doi.org/10.1542/peds.2017-0772).

herjua/Thinkstock

“These results suggest congenital heart surgery may be beneficial in select cases,” wrote Katherine A. Kosiv, MD, Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, and her colleagues.

The study, based on records from the 44 participating children’s hospitals represented in the Pediatric Health Information System (PHIS) database, included 1,668 newborns with trisomy 13 or 18 who were admitted within 14 days of birth. Median age at admission was less than 1 day for both groups.

Congenital heart disease was present in 925 out of 1,020 infants with trisomy 18 (91%) and 555 out of 648 with trisomy 13 (86%), the report stated.

For those infants with congenital heart disease, overall mortality was highest during the first hospital admission (63%), investigators wrote. However, for those undergoing congenital heart surgery, multivariate analysis showed decreased in-hospital mortality vs. those who had no surgery for both the trisomy 13 (30% vs. 55%, respectively, P = .003) and the trisomy 18 groups (16% vs. 44%, P less than .001).

This is not only the largest-ever study of trisomy 13 and 18 ever reported, according to the investigators, but also the first to show that higher weight, female sex, and older age at admission are associated with improved survival following congenital heart surgery among these patients. Multiple logistic regression analysis showed significant effects of these risk factors on mortality for both the trisomy 13 and 18 infant subsets, according to Dr. Kosiv and her colleagues.

These findings come at a time when many centers elect not to perform congenital heart surgery in trisomy 13 and 18 patients, the investigators wrote, noting that management is typically limited to medical strategies due to the “markedly short life expectancy” and grave prognosis associated with the condition.

Mortality was markedly decreased, but still considerably higher than what would be expected for congenital heart surgery in the general population, which is an important consideration for families and practitioners who are considering the procedure, investigators said in their report.

Nevertheless, the present findings suggest that “CHS may not be futile, at least not in the short-term, in patients with T13 and T18,” Dr. Kosiv and colleagues wrote. “Additionally, these results suggest that CHS may allow families to be able to take their children home and avoid [them] dying in the hospital.”


 

 

For infants with trisomy 13 or trisomy 18, congenital heart surgery is associated with a significant decrease in in-hospital mortality, according to results of a large, retrospective, multicenter cohort study.

In-hospital mortality was 45% lower in trisomy 13 patients (P = .003) and 64% lower in trisomy 18 patients (P less than.001) who underwent surgery, data show (Pediatrics 140(5); 2017. doi: https://doi.org/10.1542/peds.2017-0772).

herjua/Thinkstock

“These results suggest congenital heart surgery may be beneficial in select cases,” wrote Katherine A. Kosiv, MD, Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, and her colleagues.

The study, based on records from the 44 participating children’s hospitals represented in the Pediatric Health Information System (PHIS) database, included 1,668 newborns with trisomy 13 or 18 who were admitted within 14 days of birth. Median age at admission was less than 1 day for both groups.

Congenital heart disease was present in 925 out of 1,020 infants with trisomy 18 (91%) and 555 out of 648 with trisomy 13 (86%), the report stated.

For those infants with congenital heart disease, overall mortality was highest during the first hospital admission (63%), investigators wrote. However, for those undergoing congenital heart surgery, multivariate analysis showed decreased in-hospital mortality vs. those who had no surgery for both the trisomy 13 (30% vs. 55%, respectively, P = .003) and the trisomy 18 groups (16% vs. 44%, P less than .001).

This is not only the largest-ever study of trisomy 13 and 18 ever reported, according to the investigators, but also the first to show that higher weight, female sex, and older age at admission are associated with improved survival following congenital heart surgery among these patients. Multiple logistic regression analysis showed significant effects of these risk factors on mortality for both the trisomy 13 and 18 infant subsets, according to Dr. Kosiv and her colleagues.

These findings come at a time when many centers elect not to perform congenital heart surgery in trisomy 13 and 18 patients, the investigators wrote, noting that management is typically limited to medical strategies due to the “markedly short life expectancy” and grave prognosis associated with the condition.

Mortality was markedly decreased, but still considerably higher than what would be expected for congenital heart surgery in the general population, which is an important consideration for families and practitioners who are considering the procedure, investigators said in their report.

Nevertheless, the present findings suggest that “CHS may not be futile, at least not in the short-term, in patients with T13 and T18,” Dr. Kosiv and colleagues wrote. “Additionally, these results suggest that CHS may allow families to be able to take their children home and avoid [them] dying in the hospital.”


 

 

WASHINGTON – Limited treatment options for nonalcoholic steatohepatitis (NASH) in nonalcoholic fatty liver disease mean that NASH is the fastest-growing reason for liver transplants in the United States, but preclinical and, now, phase 2 clinical results have shown that treatment with 24-nor-ursodeoxycholic acid, otherwise known as norUDCA, can improve steatosis and liver stiffness in selected patients, a principal investigator in a European study of the treatment reported at the 2017 annual meeting of the American Association for the Study of Liver Diseases.

“The norUDCA dose of 1,500 mg resulted in significant reduction of ALT [alanine aminotransferase] within 12 weeks,” said Michael Trauner, MD, head of the division of gastroenterology and hepatology at the Medical University of Vienna, a coinventor of the drug. “The results are supported by improvement in liver stiffness and steatosis in the subsets analyzed.”

The trial involved 198 patients with NAFLD randomized to a 12-week treatment with either 500 mg or 1,500 mg norUDCA or placebo and 4 weeks of follow-up. Average ALT levels at enrollment ranged from 77.4 to 80.3 U/L, and most patients had mild or no fibrosis based on noninvasive markers (NAFLD fibrosis score) – 64.5% in the placebo group and around 80% in the two treatment groups. Rates of diabetes ranged from 6% to 15.6%.

The 1,500-mg group had an average reduction in ALT of 17.4% whereas those in the 500-mg group only had a 4.2% reduction and placebo actually had an increase of 10.4%. “The reduction of the 500-mg dose was not significant,” Dr. Trauner said. “And this was emphasized in the proportion of patients reaching ALT less than 0.8 x ULN (upper limits of normal) at the end of treatment, with about 17% of patients reaching this endpoint in the higher dose group.” Among patients in the 500-mg group, 15% achieved that level, as did 5% in the placebo group.

The therapy also had an effect on lipid levels, Dr. Trauner noted. “Surprisingly, we saw a slight increase in LDL levels, with the highest in the 1,500-mg dose,” he said. “There were no significant changes in triglycerides and HDL levels, although there were some trends for reduced triglycerides and increased HDL.” Triglycerides decreased 14.6 mg/dL on average and HDL increased 2.8 mg/dL. The slight rise in LDL, 14.6 mg/dL on average, occurred in the first 2 weeks of treatment and continued through the treatment period, but then receded after discontinuation of therapy, said Dr. Trauner. “Please note that HDL cholesterol also increased in time, and the HDL-LDL ratio remained unchanged in these patients,” he added.

During the discussion, Dr. Trauner offered a possible explanation for the change in lipid levels. “One possibility could be that a slight repression of endogenous bile acid biosynthesis and subsequent upregulation of the LDL receptor,” he said, “but the changes are really very mild and subtle.”

He also noted that liver stiffness improved in a higher proportion of patients in the treatment groups than in the placebo group – 25% and 21% of patients in the 1,500- and 500-mg groups vs. 9% under placebo. Hepatic fat fraction values also improved from 21.3% to 16.3% (relative reduction of 23.5%) from baseline to end of treatment in the 1,500-mg group in a subset of patients undergoing more extensive MRI and spectroscopy studies – a degree of reduction that other studies have shown to be predictive of histologic improvement, Dr. Trauner said. Patients in this exploratory study did not have liver biopsies.

Overall, the drug was well tolerated, Dr. Trauner said. “There were slightly higher potentially adverse drug reactions in the 1,500-mg group, mainly due to higher rate of headache, nausea, and rash,” he said. Based on these results, a phase 2b study with histologic endpoints is underway, he added.

Dr. Trauner disclosed relationships with Gilead, Albireo, Takeda, Falk Pharma, Genfit, Intercept, MSD, Novartis, Roche, and Phenex.

 

WASHINGTON – Limited treatment options for nonalcoholic steatohepatitis (NASH) in nonalcoholic fatty liver disease mean that NASH is the fastest-growing reason for liver transplants in the United States, but preclinical and, now, phase 2 clinical results have shown that treatment with 24-nor-ursodeoxycholic acid, otherwise known as norUDCA, can improve steatosis and liver stiffness in selected patients, a principal investigator in a European study of the treatment reported at the 2017 annual meeting of the American Association for the Study of Liver Diseases.

“The norUDCA dose of 1,500 mg resulted in significant reduction of ALT [alanine aminotransferase] within 12 weeks,” said Michael Trauner, MD, head of the division of gastroenterology and hepatology at the Medical University of Vienna, a coinventor of the drug. “The results are supported by improvement in liver stiffness and steatosis in the subsets analyzed.”

The trial involved 198 patients with NAFLD randomized to a 12-week treatment with either 500 mg or 1,500 mg norUDCA or placebo and 4 weeks of follow-up. Average ALT levels at enrollment ranged from 77.4 to 80.3 U/L, and most patients had mild or no fibrosis based on noninvasive markers (NAFLD fibrosis score) – 64.5% in the placebo group and around 80% in the two treatment groups. Rates of diabetes ranged from 6% to 15.6%.

The 1,500-mg group had an average reduction in ALT of 17.4% whereas those in the 500-mg group only had a 4.2% reduction and placebo actually had an increase of 10.4%. “The reduction of the 500-mg dose was not significant,” Dr. Trauner said. “And this was emphasized in the proportion of patients reaching ALT less than 0.8 x ULN (upper limits of normal) at the end of treatment, with about 17% of patients reaching this endpoint in the higher dose group.” Among patients in the 500-mg group, 15% achieved that level, as did 5% in the placebo group.

The therapy also had an effect on lipid levels, Dr. Trauner noted. “Surprisingly, we saw a slight increase in LDL levels, with the highest in the 1,500-mg dose,” he said. “There were no significant changes in triglycerides and HDL levels, although there were some trends for reduced triglycerides and increased HDL.” Triglycerides decreased 14.6 mg/dL on average and HDL increased 2.8 mg/dL. The slight rise in LDL, 14.6 mg/dL on average, occurred in the first 2 weeks of treatment and continued through the treatment period, but then receded after discontinuation of therapy, said Dr. Trauner. “Please note that HDL cholesterol also increased in time, and the HDL-LDL ratio remained unchanged in these patients,” he added.

During the discussion, Dr. Trauner offered a possible explanation for the change in lipid levels. “One possibility could be that a slight repression of endogenous bile acid biosynthesis and subsequent upregulation of the LDL receptor,” he said, “but the changes are really very mild and subtle.”

He also noted that liver stiffness improved in a higher proportion of patients in the treatment groups than in the placebo group – 25% and 21% of patients in the 1,500- and 500-mg groups vs. 9% under placebo. Hepatic fat fraction values also improved from 21.3% to 16.3% (relative reduction of 23.5%) from baseline to end of treatment in the 1,500-mg group in a subset of patients undergoing more extensive MRI and spectroscopy studies – a degree of reduction that other studies have shown to be predictive of histologic improvement, Dr. Trauner said. Patients in this exploratory study did not have liver biopsies.

Overall, the drug was well tolerated, Dr. Trauner said. “There were slightly higher potentially adverse drug reactions in the 1,500-mg group, mainly due to higher rate of headache, nausea, and rash,” he said. Based on these results, a phase 2b study with histologic endpoints is underway, he added.

Dr. Trauner disclosed relationships with Gilead, Albireo, Takeda, Falk Pharma, Genfit, Intercept, MSD, Novartis, Roche, and Phenex.

 

WASHINGTON – Limited treatment options for nonalcoholic steatohepatitis (NASH) in nonalcoholic fatty liver disease mean that NASH is the fastest-growing reason for liver transplants in the United States, but preclinical and, now, phase 2 clinical results have shown that treatment with 24-nor-ursodeoxycholic acid, otherwise known as norUDCA, can improve steatosis and liver stiffness in selected patients, a principal investigator in a European study of the treatment reported at the 2017 annual meeting of the American Association for the Study of Liver Diseases.

“The norUDCA dose of 1,500 mg resulted in significant reduction of ALT [alanine aminotransferase] within 12 weeks,” said Michael Trauner, MD, head of the division of gastroenterology and hepatology at the Medical University of Vienna, a coinventor of the drug. “The results are supported by improvement in liver stiffness and steatosis in the subsets analyzed.”

The trial involved 198 patients with NAFLD randomized to a 12-week treatment with either 500 mg or 1,500 mg norUDCA or placebo and 4 weeks of follow-up. Average ALT levels at enrollment ranged from 77.4 to 80.3 U/L, and most patients had mild or no fibrosis based on noninvasive markers (NAFLD fibrosis score) – 64.5% in the placebo group and around 80% in the two treatment groups. Rates of diabetes ranged from 6% to 15.6%.

The 1,500-mg group had an average reduction in ALT of 17.4% whereas those in the 500-mg group only had a 4.2% reduction and placebo actually had an increase of 10.4%. “The reduction of the 500-mg dose was not significant,” Dr. Trauner said. “And this was emphasized in the proportion of patients reaching ALT less than 0.8 x ULN (upper limits of normal) at the end of treatment, with about 17% of patients reaching this endpoint in the higher dose group.” Among patients in the 500-mg group, 15% achieved that level, as did 5% in the placebo group.

The therapy also had an effect on lipid levels, Dr. Trauner noted. “Surprisingly, we saw a slight increase in LDL levels, with the highest in the 1,500-mg dose,” he said. “There were no significant changes in triglycerides and HDL levels, although there were some trends for reduced triglycerides and increased HDL.” Triglycerides decreased 14.6 mg/dL on average and HDL increased 2.8 mg/dL. The slight rise in LDL, 14.6 mg/dL on average, occurred in the first 2 weeks of treatment and continued through the treatment period, but then receded after discontinuation of therapy, said Dr. Trauner. “Please note that HDL cholesterol also increased in time, and the HDL-LDL ratio remained unchanged in these patients,” he added.

During the discussion, Dr. Trauner offered a possible explanation for the change in lipid levels. “One possibility could be that a slight repression of endogenous bile acid biosynthesis and subsequent upregulation of the LDL receptor,” he said, “but the changes are really very mild and subtle.”

He also noted that liver stiffness improved in a higher proportion of patients in the treatment groups than in the placebo group – 25% and 21% of patients in the 1,500- and 500-mg groups vs. 9% under placebo. Hepatic fat fraction values also improved from 21.3% to 16.3% (relative reduction of 23.5%) from baseline to end of treatment in the 1,500-mg group in a subset of patients undergoing more extensive MRI and spectroscopy studies – a degree of reduction that other studies have shown to be predictive of histologic improvement, Dr. Trauner said. Patients in this exploratory study did not have liver biopsies.

Overall, the drug was well tolerated, Dr. Trauner said. “There were slightly higher potentially adverse drug reactions in the 1,500-mg group, mainly due to higher rate of headache, nausea, and rash,” he said. Based on these results, a phase 2b study with histologic endpoints is underway, he added.

Dr. Trauner disclosed relationships with Gilead, Albireo, Takeda, Falk Pharma, Genfit, Intercept, MSD, Novartis, Roche, and Phenex.

 

NEW ORLEANS – Attention-deficit/hyperactivity disorder and non-suicidal self-harm – cutting and head banging, for instance – strongly predicted longer seclusion and restraint episodes, sometimes past 2 hours, in a review at the University of Missouri, Columbia, pediatric inpatient psychiatric unit.

Meanwhile, children with histories of physical abuse, post-traumatic stress disorder (PTSD), or out-of-home placement were less likely to have multiple seclusion and restraint (SR) episodes during an admission, and had lower numbers of SR events overall. Perhaps hyper-vigilance due to past traumas helped them avoid situations that led to problems. Staff might also have used a lighter touch given the children’s histories.

The investigators reviewed 305 SR episodes from 2011-2014 among 92 children aged 5-18 years old. They plan to expand their study to 2009-2017 and add a prospective arm.

M. Alexander Otto/Frontline Medical News

The ultimate goal is one held by many: to “prevent seclusions and restraints because they traumatize children,” lead investigator Marwa Badawy, MD, a pediatric psychiatrist at the university, said at the American Psychiatric Association’s Institute on Psychiatric Services meeting.

It’s well known that SR, a last-ditch effort to prevent physical harm, traumatizes patients, but research on how to avoid it has mostly focused on adults. The Missouri team wants to change that by identifying the children most at risk, so that something can be done beforehand to prevent it. Maybe extra one-on-one care would help, Dr. Badawy said.

The children in the review were an average of 10.5 years old, and most were admitted for 3-7 days. Fifty-five (60%) had multiple SR episodes, 34 in a single admission and 21 across multiple admissions; 71% of the episodes were in boys, 58% in white children, 27.7% in black children, and the rest in multiracial children. Twenty-one percent of the episodes were in children with intellectual problems. ADHD and oppositional defiant disorder were the most common diagnoses, each diagnosed in more than half of the subjects.

When asked how a 5-year-old child can end up in restraints, Dr. Badawy agreed that bad parenting is a factor. Parents who don’t know any better might escalate normal behavior, and others might simply not care that much about their kids, or have much empathy. “In the 5-10 year-olds, I do think a lot of it is parenting. Neglect is the number one form of abuse,” she said, “and it causes instability in children.”

But parents aren’t always the problem. Dr. Badawy mentioned an “extremely depressed” boy who tried to hang himself again and again, at 8 years old. “His parents were supportive and focused on getting him better,” she said. It’s unknown if anything happened to him when they weren’t around.

If SR is related to children’s own behavior, and if they are able to listen to staff afterward and control it, kids seem able to avoid another episode. Those who have PTSD, or who have been through physical abuse or out-of-home placement, seemed particularly adept in the review.

Avoidance seems less likely, however, when children are set off by other kids.

Sometimes there are clues of impending trouble, like the boy who walked around whistling before he lashed out. Staff at the university quickly learned to swoop in and calm him when they heard the whistling.

The investigators had no industry disclosures.

[email protected]
 

 

NEW ORLEANS – Attention-deficit/hyperactivity disorder and non-suicidal self-harm – cutting and head banging, for instance – strongly predicted longer seclusion and restraint episodes, sometimes past 2 hours, in a review at the University of Missouri, Columbia, pediatric inpatient psychiatric unit.

Meanwhile, children with histories of physical abuse, post-traumatic stress disorder (PTSD), or out-of-home placement were less likely to have multiple seclusion and restraint (SR) episodes during an admission, and had lower numbers of SR events overall. Perhaps hyper-vigilance due to past traumas helped them avoid situations that led to problems. Staff might also have used a lighter touch given the children’s histories.

The investigators reviewed 305 SR episodes from 2011-2014 among 92 children aged 5-18 years old. They plan to expand their study to 2009-2017 and add a prospective arm.

M. Alexander Otto/Frontline Medical News

The ultimate goal is one held by many: to “prevent seclusions and restraints because they traumatize children,” lead investigator Marwa Badawy, MD, a pediatric psychiatrist at the university, said at the American Psychiatric Association’s Institute on Psychiatric Services meeting.

It’s well known that SR, a last-ditch effort to prevent physical harm, traumatizes patients, but research on how to avoid it has mostly focused on adults. The Missouri team wants to change that by identifying the children most at risk, so that something can be done beforehand to prevent it. Maybe extra one-on-one care would help, Dr. Badawy said.

The children in the review were an average of 10.5 years old, and most were admitted for 3-7 days. Fifty-five (60%) had multiple SR episodes, 34 in a single admission and 21 across multiple admissions; 71% of the episodes were in boys, 58% in white children, 27.7% in black children, and the rest in multiracial children. Twenty-one percent of the episodes were in children with intellectual problems. ADHD and oppositional defiant disorder were the most common diagnoses, each diagnosed in more than half of the subjects.

When asked how a 5-year-old child can end up in restraints, Dr. Badawy agreed that bad parenting is a factor. Parents who don’t know any better might escalate normal behavior, and others might simply not care that much about their kids, or have much empathy. “In the 5-10 year-olds, I do think a lot of it is parenting. Neglect is the number one form of abuse,” she said, “and it causes instability in children.”

But parents aren’t always the problem. Dr. Badawy mentioned an “extremely depressed” boy who tried to hang himself again and again, at 8 years old. “His parents were supportive and focused on getting him better,” she said. It’s unknown if anything happened to him when they weren’t around.

If SR is related to children’s own behavior, and if they are able to listen to staff afterward and control it, kids seem able to avoid another episode. Those who have PTSD, or who have been through physical abuse or out-of-home placement, seemed particularly adept in the review.

Avoidance seems less likely, however, when children are set off by other kids.

Sometimes there are clues of impending trouble, like the boy who walked around whistling before he lashed out. Staff at the university quickly learned to swoop in and calm him when they heard the whistling.

The investigators had no industry disclosures.

[email protected]
 

 

NEW ORLEANS – Attention-deficit/hyperactivity disorder and non-suicidal self-harm – cutting and head banging, for instance – strongly predicted longer seclusion and restraint episodes, sometimes past 2 hours, in a review at the University of Missouri, Columbia, pediatric inpatient psychiatric unit.

Meanwhile, children with histories of physical abuse, post-traumatic stress disorder (PTSD), or out-of-home placement were less likely to have multiple seclusion and restraint (SR) episodes during an admission, and had lower numbers of SR events overall. Perhaps hyper-vigilance due to past traumas helped them avoid situations that led to problems. Staff might also have used a lighter touch given the children’s histories.

The investigators reviewed 305 SR episodes from 2011-2014 among 92 children aged 5-18 years old. They plan to expand their study to 2009-2017 and add a prospective arm.

M. Alexander Otto/Frontline Medical News

The ultimate goal is one held by many: to “prevent seclusions and restraints because they traumatize children,” lead investigator Marwa Badawy, MD, a pediatric psychiatrist at the university, said at the American Psychiatric Association’s Institute on Psychiatric Services meeting.

It’s well known that SR, a last-ditch effort to prevent physical harm, traumatizes patients, but research on how to avoid it has mostly focused on adults. The Missouri team wants to change that by identifying the children most at risk, so that something can be done beforehand to prevent it. Maybe extra one-on-one care would help, Dr. Badawy said.

The children in the review were an average of 10.5 years old, and most were admitted for 3-7 days. Fifty-five (60%) had multiple SR episodes, 34 in a single admission and 21 across multiple admissions; 71% of the episodes were in boys, 58% in white children, 27.7% in black children, and the rest in multiracial children. Twenty-one percent of the episodes were in children with intellectual problems. ADHD and oppositional defiant disorder were the most common diagnoses, each diagnosed in more than half of the subjects.

When asked how a 5-year-old child can end up in restraints, Dr. Badawy agreed that bad parenting is a factor. Parents who don’t know any better might escalate normal behavior, and others might simply not care that much about their kids, or have much empathy. “In the 5-10 year-olds, I do think a lot of it is parenting. Neglect is the number one form of abuse,” she said, “and it causes instability in children.”

But parents aren’t always the problem. Dr. Badawy mentioned an “extremely depressed” boy who tried to hang himself again and again, at 8 years old. “His parents were supportive and focused on getting him better,” she said. It’s unknown if anything happened to him when they weren’t around.

If SR is related to children’s own behavior, and if they are able to listen to staff afterward and control it, kids seem able to avoid another episode. Those who have PTSD, or who have been through physical abuse or out-of-home placement, seemed particularly adept in the review.

Avoidance seems less likely, however, when children are set off by other kids.

Sometimes there are clues of impending trouble, like the boy who walked around whistling before he lashed out. Staff at the university quickly learned to swoop in and calm him when they heard the whistling.

The investigators had no industry disclosures.

[email protected]