Musculoskeletal ultrasound training now offered in nearly all U.S. rheumatology fellowships

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Musculoskeletal ultrasound (MSUS) fellowship opportunities are growing among rheumatology programs across the country as professionals push for more standardized education, according to a survey of fellowship program directors.

Rise in use of MSUS among rheumatologists is spurring more comprehensive education for providers to acquire these skill sets, which researchers have gathered will only become more prevalent.

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“Our specialty has seen a dramatic increase in the use of point-of-care MSUS among rheumatologists as evidenced by delineation of MSUS standards of use, inclusion of MSUS-related criteria into disease classification systems, increased attendance by rheumatologists at training courses, provision of the RhMSUS certification, and the almost universal desire among fellowship training programs to integrate MSUS education into the curriculum,” wrote Karina Torralba, MD, of Loma Linda (Calif.) University, and her coinvestigators.

 

The investigators sent two surveys to 113 rheumatology fellowship program directors. In the first survey, responses from the directors of 108 programs indicated that 101 (94%) offered MSUS programs (Arthritis Care Res. 2017 Aug 4. doi: 10.1002/acr.23336).

While this number has increased dramatically since a 2013 survey showed that 60% offered MSUS programs, the new survey found that 66% of respondents would prefer for the program to be optional, as opposed to a formal part of the fellowship program.

This sentiment for nonformal education programs was mirrored in the second survey specifically targeting the 101 programs that were known to provide some sort of MSUS education.

Among the 74 program directors who responded, 30 (41%) reported having a formal curriculum, while 44 (59%) did not, citing a major barrier being a lack of interested fellows to learn the material (P = .012)

Another major barrier, according to Dr. Torralba and her colleagues, is access to faculty with enough teaching experience to properly teach MSUS skills, with 62 (84%) reporting having no or only one faculty member with MSUS certification (P = .049).

Programs without proper faculty available and even those with available faculty are choosing to outsource lessons to expensive teaching programs such as the Ultrasound School of North American Rheumatologists (USSONAR) fellowship course, according to Dr. Torralba and her associates.

“While cost of external courses can be prohibitive, (expenses for a 2- to 4-day course costs between $1,500 and $4,000), programs may augment MSUS teaching using these courses for several reasons,” according to Dr. Torralba and her colleagues. [These include] insufficient number of teaching faculty, limited time or support for faculty to deliver all educational content, inadequate confidence or competency for faculty to teach content, and utilization of external materials to bolster resources.”

While these barriers will still need addressing, according to Dr. Torralba and her colleagues, half of responders noted previous barriers such as political pushback and lack of fellow interest are starting to recede, giving more room for programs to start developing MSUS programs that researchers assert are necessary for future developing rheumatologists.

“A standardized MSUS curriculum developed and endorsed by program directors and MSUS lead educators is now reasonably within sights,” the investigators wrote. “We need to work together to proactively champion MSUS education for both faculty and fellows who desire to attain this skill set.”

This study was limited by the self-reporting nature of the survey sent, as well as the small population of the sample. Researchers were also forced to rely on program directors’ perception of how effective their MSUS programs were instead of asking those participating in the programs directly.

The researchers reported no relevant financial disclosures.

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Musculoskeletal ultrasound (MSUS) fellowship opportunities are growing among rheumatology programs across the country as professionals push for more standardized education, according to a survey of fellowship program directors.

Rise in use of MSUS among rheumatologists is spurring more comprehensive education for providers to acquire these skill sets, which researchers have gathered will only become more prevalent.

Bogdanhoda/Thinkstock
“Our specialty has seen a dramatic increase in the use of point-of-care MSUS among rheumatologists as evidenced by delineation of MSUS standards of use, inclusion of MSUS-related criteria into disease classification systems, increased attendance by rheumatologists at training courses, provision of the RhMSUS certification, and the almost universal desire among fellowship training programs to integrate MSUS education into the curriculum,” wrote Karina Torralba, MD, of Loma Linda (Calif.) University, and her coinvestigators.

 

The investigators sent two surveys to 113 rheumatology fellowship program directors. In the first survey, responses from the directors of 108 programs indicated that 101 (94%) offered MSUS programs (Arthritis Care Res. 2017 Aug 4. doi: 10.1002/acr.23336).

While this number has increased dramatically since a 2013 survey showed that 60% offered MSUS programs, the new survey found that 66% of respondents would prefer for the program to be optional, as opposed to a formal part of the fellowship program.

This sentiment for nonformal education programs was mirrored in the second survey specifically targeting the 101 programs that were known to provide some sort of MSUS education.

Among the 74 program directors who responded, 30 (41%) reported having a formal curriculum, while 44 (59%) did not, citing a major barrier being a lack of interested fellows to learn the material (P = .012)

Another major barrier, according to Dr. Torralba and her colleagues, is access to faculty with enough teaching experience to properly teach MSUS skills, with 62 (84%) reporting having no or only one faculty member with MSUS certification (P = .049).

Programs without proper faculty available and even those with available faculty are choosing to outsource lessons to expensive teaching programs such as the Ultrasound School of North American Rheumatologists (USSONAR) fellowship course, according to Dr. Torralba and her associates.

“While cost of external courses can be prohibitive, (expenses for a 2- to 4-day course costs between $1,500 and $4,000), programs may augment MSUS teaching using these courses for several reasons,” according to Dr. Torralba and her colleagues. [These include] insufficient number of teaching faculty, limited time or support for faculty to deliver all educational content, inadequate confidence or competency for faculty to teach content, and utilization of external materials to bolster resources.”

While these barriers will still need addressing, according to Dr. Torralba and her colleagues, half of responders noted previous barriers such as political pushback and lack of fellow interest are starting to recede, giving more room for programs to start developing MSUS programs that researchers assert are necessary for future developing rheumatologists.

“A standardized MSUS curriculum developed and endorsed by program directors and MSUS lead educators is now reasonably within sights,” the investigators wrote. “We need to work together to proactively champion MSUS education for both faculty and fellows who desire to attain this skill set.”

This study was limited by the self-reporting nature of the survey sent, as well as the small population of the sample. Researchers were also forced to rely on program directors’ perception of how effective their MSUS programs were instead of asking those participating in the programs directly.

The researchers reported no relevant financial disclosures.

Musculoskeletal ultrasound (MSUS) fellowship opportunities are growing among rheumatology programs across the country as professionals push for more standardized education, according to a survey of fellowship program directors.

Rise in use of MSUS among rheumatologists is spurring more comprehensive education for providers to acquire these skill sets, which researchers have gathered will only become more prevalent.

Bogdanhoda/Thinkstock
“Our specialty has seen a dramatic increase in the use of point-of-care MSUS among rheumatologists as evidenced by delineation of MSUS standards of use, inclusion of MSUS-related criteria into disease classification systems, increased attendance by rheumatologists at training courses, provision of the RhMSUS certification, and the almost universal desire among fellowship training programs to integrate MSUS education into the curriculum,” wrote Karina Torralba, MD, of Loma Linda (Calif.) University, and her coinvestigators.

 

The investigators sent two surveys to 113 rheumatology fellowship program directors. In the first survey, responses from the directors of 108 programs indicated that 101 (94%) offered MSUS programs (Arthritis Care Res. 2017 Aug 4. doi: 10.1002/acr.23336).

While this number has increased dramatically since a 2013 survey showed that 60% offered MSUS programs, the new survey found that 66% of respondents would prefer for the program to be optional, as opposed to a formal part of the fellowship program.

This sentiment for nonformal education programs was mirrored in the second survey specifically targeting the 101 programs that were known to provide some sort of MSUS education.

Among the 74 program directors who responded, 30 (41%) reported having a formal curriculum, while 44 (59%) did not, citing a major barrier being a lack of interested fellows to learn the material (P = .012)

Another major barrier, according to Dr. Torralba and her colleagues, is access to faculty with enough teaching experience to properly teach MSUS skills, with 62 (84%) reporting having no or only one faculty member with MSUS certification (P = .049).

Programs without proper faculty available and even those with available faculty are choosing to outsource lessons to expensive teaching programs such as the Ultrasound School of North American Rheumatologists (USSONAR) fellowship course, according to Dr. Torralba and her associates.

“While cost of external courses can be prohibitive, (expenses for a 2- to 4-day course costs between $1,500 and $4,000), programs may augment MSUS teaching using these courses for several reasons,” according to Dr. Torralba and her colleagues. [These include] insufficient number of teaching faculty, limited time or support for faculty to deliver all educational content, inadequate confidence or competency for faculty to teach content, and utilization of external materials to bolster resources.”

While these barriers will still need addressing, according to Dr. Torralba and her colleagues, half of responders noted previous barriers such as political pushback and lack of fellow interest are starting to recede, giving more room for programs to start developing MSUS programs that researchers assert are necessary for future developing rheumatologists.

“A standardized MSUS curriculum developed and endorsed by program directors and MSUS lead educators is now reasonably within sights,” the investigators wrote. “We need to work together to proactively champion MSUS education for both faculty and fellows who desire to attain this skill set.”

This study was limited by the self-reporting nature of the survey sent, as well as the small population of the sample. Researchers were also forced to rely on program directors’ perception of how effective their MSUS programs were instead of asking those participating in the programs directly.

The researchers reported no relevant financial disclosures.

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Key clinical point: Musculoskeletal ultrasound fellowship opportunities continue to grow, but many still have not adopted a formal or mandatory program.

Major finding: Of 108 program directors who responded to a survey, 101 (94%) offered a musculoskeletal ultrasound fellowship.

Data source: Survey of 113 rheumatology fellowship program directors gathered from the Fellowship and Residency Electronic Interactive Database Access (FREIDA) online database.

Disclosures: The investigators reported no relevant financial disclosures.

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Opioids overprescribed in elective hernia repair patients

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A patient-centered study of postoperative analgesic needs found that surgeons may be overprescribing opioids for pain management after hernia repair operations.

The growing opioid public health crisis – and potential contribution of pain control prescriptions to the crisis – has prompted empirical work on surgeons’ prescribing and actual patient use of opioids (Ann Surg. 2017 Jul 10. doi: 10.1097/SLA.0000000000002365. [Epub ahead of print];J Arthroplasty. 2017;32[8]2395-2398). Excess pain medications are thought to raise the risk of patient dependence and to be potentially diverted to nonpatients’ use. A recent study (Ann Surg. 2017;265:709-16) found that a median of 30 opioid tablets were routinely prescribed by surgeons for pain management after hernia repair.
 

 

Konstantinos Mylonas, MD, a research fellow at Massachusetts General Hospital, Boston, and his coinvestigators conducted a prospective, observational study of 185 patients who had an outpatient inguinal hernia repair between October 2015 and September 2016. Participants completed a survey on their pain levels and opioid use during the 2- to 3-week period between their procedure and follow-up appointment (Surgery. 2017 Aug 1. doi: 10.1016/j.surg.2017.06.017).

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Most of the patients (177) were male, were over age 60 (96) and underwent an open Kugel procedure (151). Each patient had local anesthesia and IV sedation.

For postop pain control, the patients were given 10 Vicodin (hydrocodone 5 mg/acetaminophen 325 mg) tablets, although all were advised that they may not require the medication but could instead use acetaminophen or ibuprofen as needed.

Of the 185 patients who were surveyed, 159 (86%) reported taking 4 or less of the 10 opioid tablets prescribed to them, with 110 (60%) reporting taking no tablets at all

While 13 (7%) of the patients did report using nine or more of the prescribed Vicodin tablets, none of the patients surveyed were still taking the pain medication within 7 days of their follow-up appointment.

When asked about how pain affected their returning to daily activities, 123 patients (66.5%) reported not having any pain interference, 42 (22.7%) mentioned slight problems, and 5 (2.7%) were noticeably affected. No patients were unable to return to their daily activities, and those 111 (75%) of the 147 patients who were employed were able to return to work within 3 days of surgery, according to the investigators.

As might be expected, those patients who experienced higher pain levels and persistent pain took more Vicodin tablets, but only one patient required a refill of the original prescription.

Patients were also not blinded to the study, which may have caused them to either take less opioid medication or not report their intake accurately. But the findings suggest that opioid prescribing could be tailored much more narrowly to patients’ needs and to individual procedures than is currently common practice. “Although our study was limited to a single procedure, performed by a single surgeon in a high-volume center, implementing patient-centered, procedure-specific opioid administration strategies may be conceivable across a variety of surgical disciplines,” the investigators concluded.

For the 750,000 inguinal hernia repairs done in the United States each year, prescribing 4 instead of 30 opioid tablets would decrease the number of opioid analgesics dispensed annually for hernia operation from 22.5 million to 3 million,” the investigators wrote. “As a result, 20 million fewer tablets per year would be available for potential diversion and abuse or as a stimulus for the start of opioid dependency.”

The researchers reported no relevant financial disclosures.

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A patient-centered study of postoperative analgesic needs found that surgeons may be overprescribing opioids for pain management after hernia repair operations.

The growing opioid public health crisis – and potential contribution of pain control prescriptions to the crisis – has prompted empirical work on surgeons’ prescribing and actual patient use of opioids (Ann Surg. 2017 Jul 10. doi: 10.1097/SLA.0000000000002365. [Epub ahead of print];J Arthroplasty. 2017;32[8]2395-2398). Excess pain medications are thought to raise the risk of patient dependence and to be potentially diverted to nonpatients’ use. A recent study (Ann Surg. 2017;265:709-16) found that a median of 30 opioid tablets were routinely prescribed by surgeons for pain management after hernia repair.
 

 

Konstantinos Mylonas, MD, a research fellow at Massachusetts General Hospital, Boston, and his coinvestigators conducted a prospective, observational study of 185 patients who had an outpatient inguinal hernia repair between October 2015 and September 2016. Participants completed a survey on their pain levels and opioid use during the 2- to 3-week period between their procedure and follow-up appointment (Surgery. 2017 Aug 1. doi: 10.1016/j.surg.2017.06.017).

copyright monkeybusinessimages/Thinkstock
Most of the patients (177) were male, were over age 60 (96) and underwent an open Kugel procedure (151). Each patient had local anesthesia and IV sedation.

For postop pain control, the patients were given 10 Vicodin (hydrocodone 5 mg/acetaminophen 325 mg) tablets, although all were advised that they may not require the medication but could instead use acetaminophen or ibuprofen as needed.

Of the 185 patients who were surveyed, 159 (86%) reported taking 4 or less of the 10 opioid tablets prescribed to them, with 110 (60%) reporting taking no tablets at all

While 13 (7%) of the patients did report using nine or more of the prescribed Vicodin tablets, none of the patients surveyed were still taking the pain medication within 7 days of their follow-up appointment.

When asked about how pain affected their returning to daily activities, 123 patients (66.5%) reported not having any pain interference, 42 (22.7%) mentioned slight problems, and 5 (2.7%) were noticeably affected. No patients were unable to return to their daily activities, and those 111 (75%) of the 147 patients who were employed were able to return to work within 3 days of surgery, according to the investigators.

As might be expected, those patients who experienced higher pain levels and persistent pain took more Vicodin tablets, but only one patient required a refill of the original prescription.

Patients were also not blinded to the study, which may have caused them to either take less opioid medication or not report their intake accurately. But the findings suggest that opioid prescribing could be tailored much more narrowly to patients’ needs and to individual procedures than is currently common practice. “Although our study was limited to a single procedure, performed by a single surgeon in a high-volume center, implementing patient-centered, procedure-specific opioid administration strategies may be conceivable across a variety of surgical disciplines,” the investigators concluded.

For the 750,000 inguinal hernia repairs done in the United States each year, prescribing 4 instead of 30 opioid tablets would decrease the number of opioid analgesics dispensed annually for hernia operation from 22.5 million to 3 million,” the investigators wrote. “As a result, 20 million fewer tablets per year would be available for potential diversion and abuse or as a stimulus for the start of opioid dependency.”

The researchers reported no relevant financial disclosures.

A patient-centered study of postoperative analgesic needs found that surgeons may be overprescribing opioids for pain management after hernia repair operations.

The growing opioid public health crisis – and potential contribution of pain control prescriptions to the crisis – has prompted empirical work on surgeons’ prescribing and actual patient use of opioids (Ann Surg. 2017 Jul 10. doi: 10.1097/SLA.0000000000002365. [Epub ahead of print];J Arthroplasty. 2017;32[8]2395-2398). Excess pain medications are thought to raise the risk of patient dependence and to be potentially diverted to nonpatients’ use. A recent study (Ann Surg. 2017;265:709-16) found that a median of 30 opioid tablets were routinely prescribed by surgeons for pain management after hernia repair.
 

 

Konstantinos Mylonas, MD, a research fellow at Massachusetts General Hospital, Boston, and his coinvestigators conducted a prospective, observational study of 185 patients who had an outpatient inguinal hernia repair between October 2015 and September 2016. Participants completed a survey on their pain levels and opioid use during the 2- to 3-week period between their procedure and follow-up appointment (Surgery. 2017 Aug 1. doi: 10.1016/j.surg.2017.06.017).

copyright monkeybusinessimages/Thinkstock
Most of the patients (177) were male, were over age 60 (96) and underwent an open Kugel procedure (151). Each patient had local anesthesia and IV sedation.

For postop pain control, the patients were given 10 Vicodin (hydrocodone 5 mg/acetaminophen 325 mg) tablets, although all were advised that they may not require the medication but could instead use acetaminophen or ibuprofen as needed.

Of the 185 patients who were surveyed, 159 (86%) reported taking 4 or less of the 10 opioid tablets prescribed to them, with 110 (60%) reporting taking no tablets at all

While 13 (7%) of the patients did report using nine or more of the prescribed Vicodin tablets, none of the patients surveyed were still taking the pain medication within 7 days of their follow-up appointment.

When asked about how pain affected their returning to daily activities, 123 patients (66.5%) reported not having any pain interference, 42 (22.7%) mentioned slight problems, and 5 (2.7%) were noticeably affected. No patients were unable to return to their daily activities, and those 111 (75%) of the 147 patients who were employed were able to return to work within 3 days of surgery, according to the investigators.

As might be expected, those patients who experienced higher pain levels and persistent pain took more Vicodin tablets, but only one patient required a refill of the original prescription.

Patients were also not blinded to the study, which may have caused them to either take less opioid medication or not report their intake accurately. But the findings suggest that opioid prescribing could be tailored much more narrowly to patients’ needs and to individual procedures than is currently common practice. “Although our study was limited to a single procedure, performed by a single surgeon in a high-volume center, implementing patient-centered, procedure-specific opioid administration strategies may be conceivable across a variety of surgical disciplines,” the investigators concluded.

For the 750,000 inguinal hernia repairs done in the United States each year, prescribing 4 instead of 30 opioid tablets would decrease the number of opioid analgesics dispensed annually for hernia operation from 22.5 million to 3 million,” the investigators wrote. “As a result, 20 million fewer tablets per year would be available for potential diversion and abuse or as a stimulus for the start of opioid dependency.”

The researchers reported no relevant financial disclosures.

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Key clinical point: Elective inguinal hernia repair patients use less than half of the opioids they are prescribed.

Major finding: Of 185 patients surveyed, 159 (86%) reported taking 4 or less opioid tablets of a 10-tablet prescription.

Data source: Observational study of 185 elective inguinal hernia repair patients between October 2015 and September 2016.

Disclosures: Investigators reported no relevant financial disclosures.

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How to make the move away from opioids for chronic noncancer pain

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Fri, 01/18/2019 - 16:58

 

Standard care of chronic noncancer pain should start moving away from chronic opioid treatment, which can put patients in greater danger of developing a substance use disorder, according to evidence presented at a meeting held by the American Pain Society and Global Academy for Medical Education.

As the effects of the U.S. opioid epidemic continue to gain public attention – recently spurring a declaration of a state of emergencyphysicians are looking for new methods to treat chronic pain responsibly without adding to the current number of opioid-related deaths.

Use of opioid therapy for pain conditions such as osteoarthritis, fibromyalgia, and migraine – once a common treatment approach – has been shown to be a dangerous breeding ground for opioid substance use disorders, and physicians would do well to re-evaluate their treatment methods, according to Edwin Salsitz, MD, assistant clinical professor at Mount Sinai Beth Israel Hospital, New York.

“Each prescriber is going to have to review this, digest it, reflect on it, and decide what they are going to do,” said Dr. Salsitz in an interview. “Base it on the Centers for Disease Control and Prevention’s guideline as a good starting point, and then individualize it for yourself and your patients.”

One of the major steps toward lowering the rate of opioid addiction through prescription is avoiding opioids as a treatment for acute pain.

“The first recommendation [of the CDC guideline] is nonpharmaceutical therapy, including physical therapy, massage therapy, acupuncture, and cognitive-behavioral therapy – and there’s a whole lot of evidence for these types of therapy,” said Dr. Salsitz. “The second option is that if you’re going to use medications, use those that aren’t opioids, like Tylenol, Motrin, and antidepressants.”

If opioids are necessary, said Dr. Salsitz, immediate-release opioids in limited prescriptions are a good way to lower the risk of addiction.

“The extended-release opioids have many more milligrams than the immediate-release opioids,” according to Dr. Salsitz. “For example, in New York state, we have a law now that says for acute pain, you cannot prescribe for more than a 7-day amount.”

That 7-day limit helps keep excess opioids out of households, he noted, making it harder for patients to share their medication with friends and family, which has proven to be the most common source for opioids during the onset of substance use disorders. In the first 12 months of use, friends and family members accounted for 55% of reported sources of opioids, according to the U.S. 2010 National Survey on Drug Use and Health.

Providers may also want to consider screening pain patients for psychological disorders, Dr. Salsitz said, as many psychological conditions are associated with a high risk of developing a substance use disorder. Patients with major depression, dysthymia, or panic disorder were 3.43, 6.51, and 5.37 times more likely, respectively, than those without to initiate a prescription for and regularly use opioids, according to a study cited by Dr. Salsitz (Arch Intern Med. 2006 Oct 23;166[19]:2087-93).

One of the largest barriers preventing providers from implementing these methods, however, is a lack of resources, particularly in rural areas with increasing rates of opioid substance use disorders and limited provider options.

While these limitations do pose a problem, physicians should not feel they can’t provide proper care, according to Dr. Salsitz. “I think that each individual provider, wherever they are located, can do a reasonable job.”

Global Academy and this news organization are owned by the same company.

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Standard care of chronic noncancer pain should start moving away from chronic opioid treatment, which can put patients in greater danger of developing a substance use disorder, according to evidence presented at a meeting held by the American Pain Society and Global Academy for Medical Education.

As the effects of the U.S. opioid epidemic continue to gain public attention – recently spurring a declaration of a state of emergencyphysicians are looking for new methods to treat chronic pain responsibly without adding to the current number of opioid-related deaths.

Use of opioid therapy for pain conditions such as osteoarthritis, fibromyalgia, and migraine – once a common treatment approach – has been shown to be a dangerous breeding ground for opioid substance use disorders, and physicians would do well to re-evaluate their treatment methods, according to Edwin Salsitz, MD, assistant clinical professor at Mount Sinai Beth Israel Hospital, New York.

“Each prescriber is going to have to review this, digest it, reflect on it, and decide what they are going to do,” said Dr. Salsitz in an interview. “Base it on the Centers for Disease Control and Prevention’s guideline as a good starting point, and then individualize it for yourself and your patients.”

One of the major steps toward lowering the rate of opioid addiction through prescription is avoiding opioids as a treatment for acute pain.

“The first recommendation [of the CDC guideline] is nonpharmaceutical therapy, including physical therapy, massage therapy, acupuncture, and cognitive-behavioral therapy – and there’s a whole lot of evidence for these types of therapy,” said Dr. Salsitz. “The second option is that if you’re going to use medications, use those that aren’t opioids, like Tylenol, Motrin, and antidepressants.”

If opioids are necessary, said Dr. Salsitz, immediate-release opioids in limited prescriptions are a good way to lower the risk of addiction.

“The extended-release opioids have many more milligrams than the immediate-release opioids,” according to Dr. Salsitz. “For example, in New York state, we have a law now that says for acute pain, you cannot prescribe for more than a 7-day amount.”

That 7-day limit helps keep excess opioids out of households, he noted, making it harder for patients to share their medication with friends and family, which has proven to be the most common source for opioids during the onset of substance use disorders. In the first 12 months of use, friends and family members accounted for 55% of reported sources of opioids, according to the U.S. 2010 National Survey on Drug Use and Health.

Providers may also want to consider screening pain patients for psychological disorders, Dr. Salsitz said, as many psychological conditions are associated with a high risk of developing a substance use disorder. Patients with major depression, dysthymia, or panic disorder were 3.43, 6.51, and 5.37 times more likely, respectively, than those without to initiate a prescription for and regularly use opioids, according to a study cited by Dr. Salsitz (Arch Intern Med. 2006 Oct 23;166[19]:2087-93).

One of the largest barriers preventing providers from implementing these methods, however, is a lack of resources, particularly in rural areas with increasing rates of opioid substance use disorders and limited provider options.

While these limitations do pose a problem, physicians should not feel they can’t provide proper care, according to Dr. Salsitz. “I think that each individual provider, wherever they are located, can do a reasonable job.”

Global Academy and this news organization are owned by the same company.

 

Standard care of chronic noncancer pain should start moving away from chronic opioid treatment, which can put patients in greater danger of developing a substance use disorder, according to evidence presented at a meeting held by the American Pain Society and Global Academy for Medical Education.

As the effects of the U.S. opioid epidemic continue to gain public attention – recently spurring a declaration of a state of emergencyphysicians are looking for new methods to treat chronic pain responsibly without adding to the current number of opioid-related deaths.

Use of opioid therapy for pain conditions such as osteoarthritis, fibromyalgia, and migraine – once a common treatment approach – has been shown to be a dangerous breeding ground for opioid substance use disorders, and physicians would do well to re-evaluate their treatment methods, according to Edwin Salsitz, MD, assistant clinical professor at Mount Sinai Beth Israel Hospital, New York.

“Each prescriber is going to have to review this, digest it, reflect on it, and decide what they are going to do,” said Dr. Salsitz in an interview. “Base it on the Centers for Disease Control and Prevention’s guideline as a good starting point, and then individualize it for yourself and your patients.”

One of the major steps toward lowering the rate of opioid addiction through prescription is avoiding opioids as a treatment for acute pain.

“The first recommendation [of the CDC guideline] is nonpharmaceutical therapy, including physical therapy, massage therapy, acupuncture, and cognitive-behavioral therapy – and there’s a whole lot of evidence for these types of therapy,” said Dr. Salsitz. “The second option is that if you’re going to use medications, use those that aren’t opioids, like Tylenol, Motrin, and antidepressants.”

If opioids are necessary, said Dr. Salsitz, immediate-release opioids in limited prescriptions are a good way to lower the risk of addiction.

“The extended-release opioids have many more milligrams than the immediate-release opioids,” according to Dr. Salsitz. “For example, in New York state, we have a law now that says for acute pain, you cannot prescribe for more than a 7-day amount.”

That 7-day limit helps keep excess opioids out of households, he noted, making it harder for patients to share their medication with friends and family, which has proven to be the most common source for opioids during the onset of substance use disorders. In the first 12 months of use, friends and family members accounted for 55% of reported sources of opioids, according to the U.S. 2010 National Survey on Drug Use and Health.

Providers may also want to consider screening pain patients for psychological disorders, Dr. Salsitz said, as many psychological conditions are associated with a high risk of developing a substance use disorder. Patients with major depression, dysthymia, or panic disorder were 3.43, 6.51, and 5.37 times more likely, respectively, than those without to initiate a prescription for and regularly use opioids, according to a study cited by Dr. Salsitz (Arch Intern Med. 2006 Oct 23;166[19]:2087-93).

One of the largest barriers preventing providers from implementing these methods, however, is a lack of resources, particularly in rural areas with increasing rates of opioid substance use disorders and limited provider options.

While these limitations do pose a problem, physicians should not feel they can’t provide proper care, according to Dr. Salsitz. “I think that each individual provider, wherever they are located, can do a reasonable job.”

Global Academy and this news organization are owned by the same company.

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A passion for education: Lonika Sood, MD

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Fri, 09/14/2018 - 11:58
Dr. Sood joins The Hospitalist Editorial Advisory Board


On top of her role as a hospitalist at the Aurora BayCare Medical Center in Green Bay, Wis., Lonika Sood, MD, FACP, is currently a candidate for a Masters in health professions education.

From her earliest training to the present day, she has maintained her passion for education, both as a student and an educator.

“I am a part of a community of practice, if you will, of other health professionals who do just this – medical education on a higher level.” Dr. Sood said. “Not only on the front lines of care, but also in designing curricula, undertaking medical education research, and holding leadership positions at medical schools and hospitals around the world.”

Dr. Lonika Sood


As one of the eight new members of The Hospitalist editorial advisory board, Dr. Sood is excited to use her role to help inform and to learn. She told us more about herself in a recent interview.
 

Q: How did you choose a career in medicine?

A: I grew up in India. I come from a family of doctors. When I was in high school, we found that we had close to 60 physicians in our family, and that number has grown quite a bit since then. At home, being around physicians, that was the language that I grew into. It was a big part of who I wanted to become when I grew up. The other part of it was that I’ve always wanted to help people and do something in one of the science fields, so this seemed like a natural choice for me.
 

Q: What made you choose hospital medicine?

A: I’ll be very honest – when I came to the United States for my residency, I wanted to become a subspecialist. I used to joke with my mentors in my residency program that every month I wanted to be a different subspecialist depending on which rotation I had or which physician really did a great job on the wards. After moving to Green Bay, Wis., I thought, “We’ll keep residency on hold for a couple of years.” Then I realized that I really liked medical education. I knew that I wanted to be a "specialist" in medical education, yet keep practicing internal medicine, which is something that I’ve always wanted to do. Being a hospitalist is like a marriage of those two passions.
 

Q: What about medical education draws you?

A: I think a large part of it was that my mother is a physician. My dad is in the merchant navy. In their midlife, they kind of fine-tuned their career paths by going into teaching, so both of them are educators, and very well accomplished in their own right. Growing up, that was a big part of what I saw myself becoming. I did not realize until later in my residency that it was my calling. Additionally, my experience of going into medicine and learning from good teachers is, in my mind, one of the things that really makes me comfortable, and happy being a doctor. I want to be able to leave that legacy for the coming generation.
 

Q: Tell us how your skills as a teacher help you when you’re working with your patients?

A: To give you an example, we have an adult internal medicine hospital, so we frequently have patients who come to the hospital for the first time. Some of our patients have not seen a physician in over 30 or 40 years. There may be many reasons for that, but they’re scared. They’re sick. They’re in a new environment. They are placing their trust in somebody else’s hands. As teachers and as doctors, it’s important for us to be compassionate, kind, and relatable to patients. We must also be able to explain to patients in their own words what is going on with their body, what might happen, and how can we help. We’re not telling patients what to do or forcing them to take our treatment recommendations, but we are helping them make informed choices. I think hospital medicine really is an incredibly powerful field that can help us relate to our patients.
 

Q: What is the best professional advice you have received in medicine?

A: I think the advice that I try to follow every day is to be humble. Try to be the best that you can be, yet stay humble, because there’s so much more that you can accomplish if you stay grounded. I think that has stuck with me. It’s come from my parents. It’s come from my mentors. And sometimes it comes from my patients, too.
 

 

 

Q: What is the worst advice you have received?

A: That’s a hard question, but an important one as well, I think. Sometimes there is a push – from society or your colleagues – to be as efficient as you can be, which is great, but we have to look at the downside of it. We sometimes don’t stop and think, or stop and be human. We’re kind of mechanical if data are all we follow.
 

Q: So where do you see yourself in the next 10 years?

A: That’s a question I try to answer daily, and I get a different answer each time. I think I do see myself continuing to provide clinical care for hospitalized patients. I see myself doing a little more in educational leadership, working with medical students and medical residents. I’m just completing my master’s in health professions education, so I’m excited to also start a career in medical education research.
 

Q: What’s the best book that you’ve read recently, and why was it the best?

A: Oh, well, it’s not a new book, and I’ve read this before, but I keep coming back to it. I don’t know if you’ve heard of Jim Corbett. He was a wildlife enthusiast in the early 20th century. He wrote a lot of books on man-eating tigers and leopards in India. My brother and I and my dad used to read these books growing up. That’s something that I’m going back to and rereading. There is a lot of rich description about Indian wildlife, and it’s something that brings back good memories.


 

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Dr. Sood joins The Hospitalist Editorial Advisory Board
Dr. Sood joins The Hospitalist Editorial Advisory Board


On top of her role as a hospitalist at the Aurora BayCare Medical Center in Green Bay, Wis., Lonika Sood, MD, FACP, is currently a candidate for a Masters in health professions education.

From her earliest training to the present day, she has maintained her passion for education, both as a student and an educator.

“I am a part of a community of practice, if you will, of other health professionals who do just this – medical education on a higher level.” Dr. Sood said. “Not only on the front lines of care, but also in designing curricula, undertaking medical education research, and holding leadership positions at medical schools and hospitals around the world.”

Dr. Lonika Sood


As one of the eight new members of The Hospitalist editorial advisory board, Dr. Sood is excited to use her role to help inform and to learn. She told us more about herself in a recent interview.
 

Q: How did you choose a career in medicine?

A: I grew up in India. I come from a family of doctors. When I was in high school, we found that we had close to 60 physicians in our family, and that number has grown quite a bit since then. At home, being around physicians, that was the language that I grew into. It was a big part of who I wanted to become when I grew up. The other part of it was that I’ve always wanted to help people and do something in one of the science fields, so this seemed like a natural choice for me.
 

Q: What made you choose hospital medicine?

A: I’ll be very honest – when I came to the United States for my residency, I wanted to become a subspecialist. I used to joke with my mentors in my residency program that every month I wanted to be a different subspecialist depending on which rotation I had or which physician really did a great job on the wards. After moving to Green Bay, Wis., I thought, “We’ll keep residency on hold for a couple of years.” Then I realized that I really liked medical education. I knew that I wanted to be a "specialist" in medical education, yet keep practicing internal medicine, which is something that I’ve always wanted to do. Being a hospitalist is like a marriage of those two passions.
 

Q: What about medical education draws you?

A: I think a large part of it was that my mother is a physician. My dad is in the merchant navy. In their midlife, they kind of fine-tuned their career paths by going into teaching, so both of them are educators, and very well accomplished in their own right. Growing up, that was a big part of what I saw myself becoming. I did not realize until later in my residency that it was my calling. Additionally, my experience of going into medicine and learning from good teachers is, in my mind, one of the things that really makes me comfortable, and happy being a doctor. I want to be able to leave that legacy for the coming generation.
 

Q: Tell us how your skills as a teacher help you when you’re working with your patients?

A: To give you an example, we have an adult internal medicine hospital, so we frequently have patients who come to the hospital for the first time. Some of our patients have not seen a physician in over 30 or 40 years. There may be many reasons for that, but they’re scared. They’re sick. They’re in a new environment. They are placing their trust in somebody else’s hands. As teachers and as doctors, it’s important for us to be compassionate, kind, and relatable to patients. We must also be able to explain to patients in their own words what is going on with their body, what might happen, and how can we help. We’re not telling patients what to do or forcing them to take our treatment recommendations, but we are helping them make informed choices. I think hospital medicine really is an incredibly powerful field that can help us relate to our patients.
 

Q: What is the best professional advice you have received in medicine?

A: I think the advice that I try to follow every day is to be humble. Try to be the best that you can be, yet stay humble, because there’s so much more that you can accomplish if you stay grounded. I think that has stuck with me. It’s come from my parents. It’s come from my mentors. And sometimes it comes from my patients, too.
 

 

 

Q: What is the worst advice you have received?

A: That’s a hard question, but an important one as well, I think. Sometimes there is a push – from society or your colleagues – to be as efficient as you can be, which is great, but we have to look at the downside of it. We sometimes don’t stop and think, or stop and be human. We’re kind of mechanical if data are all we follow.
 

Q: So where do you see yourself in the next 10 years?

A: That’s a question I try to answer daily, and I get a different answer each time. I think I do see myself continuing to provide clinical care for hospitalized patients. I see myself doing a little more in educational leadership, working with medical students and medical residents. I’m just completing my master’s in health professions education, so I’m excited to also start a career in medical education research.
 

Q: What’s the best book that you’ve read recently, and why was it the best?

A: Oh, well, it’s not a new book, and I’ve read this before, but I keep coming back to it. I don’t know if you’ve heard of Jim Corbett. He was a wildlife enthusiast in the early 20th century. He wrote a lot of books on man-eating tigers and leopards in India. My brother and I and my dad used to read these books growing up. That’s something that I’m going back to and rereading. There is a lot of rich description about Indian wildlife, and it’s something that brings back good memories.


 


On top of her role as a hospitalist at the Aurora BayCare Medical Center in Green Bay, Wis., Lonika Sood, MD, FACP, is currently a candidate for a Masters in health professions education.

From her earliest training to the present day, she has maintained her passion for education, both as a student and an educator.

“I am a part of a community of practice, if you will, of other health professionals who do just this – medical education on a higher level.” Dr. Sood said. “Not only on the front lines of care, but also in designing curricula, undertaking medical education research, and holding leadership positions at medical schools and hospitals around the world.”

Dr. Lonika Sood


As one of the eight new members of The Hospitalist editorial advisory board, Dr. Sood is excited to use her role to help inform and to learn. She told us more about herself in a recent interview.
 

Q: How did you choose a career in medicine?

A: I grew up in India. I come from a family of doctors. When I was in high school, we found that we had close to 60 physicians in our family, and that number has grown quite a bit since then. At home, being around physicians, that was the language that I grew into. It was a big part of who I wanted to become when I grew up. The other part of it was that I’ve always wanted to help people and do something in one of the science fields, so this seemed like a natural choice for me.
 

Q: What made you choose hospital medicine?

A: I’ll be very honest – when I came to the United States for my residency, I wanted to become a subspecialist. I used to joke with my mentors in my residency program that every month I wanted to be a different subspecialist depending on which rotation I had or which physician really did a great job on the wards. After moving to Green Bay, Wis., I thought, “We’ll keep residency on hold for a couple of years.” Then I realized that I really liked medical education. I knew that I wanted to be a "specialist" in medical education, yet keep practicing internal medicine, which is something that I’ve always wanted to do. Being a hospitalist is like a marriage of those two passions.
 

Q: What about medical education draws you?

A: I think a large part of it was that my mother is a physician. My dad is in the merchant navy. In their midlife, they kind of fine-tuned their career paths by going into teaching, so both of them are educators, and very well accomplished in their own right. Growing up, that was a big part of what I saw myself becoming. I did not realize until later in my residency that it was my calling. Additionally, my experience of going into medicine and learning from good teachers is, in my mind, one of the things that really makes me comfortable, and happy being a doctor. I want to be able to leave that legacy for the coming generation.
 

Q: Tell us how your skills as a teacher help you when you’re working with your patients?

A: To give you an example, we have an adult internal medicine hospital, so we frequently have patients who come to the hospital for the first time. Some of our patients have not seen a physician in over 30 or 40 years. There may be many reasons for that, but they’re scared. They’re sick. They’re in a new environment. They are placing their trust in somebody else’s hands. As teachers and as doctors, it’s important for us to be compassionate, kind, and relatable to patients. We must also be able to explain to patients in their own words what is going on with their body, what might happen, and how can we help. We’re not telling patients what to do or forcing them to take our treatment recommendations, but we are helping them make informed choices. I think hospital medicine really is an incredibly powerful field that can help us relate to our patients.
 

Q: What is the best professional advice you have received in medicine?

A: I think the advice that I try to follow every day is to be humble. Try to be the best that you can be, yet stay humble, because there’s so much more that you can accomplish if you stay grounded. I think that has stuck with me. It’s come from my parents. It’s come from my mentors. And sometimes it comes from my patients, too.
 

 

 

Q: What is the worst advice you have received?

A: That’s a hard question, but an important one as well, I think. Sometimes there is a push – from society or your colleagues – to be as efficient as you can be, which is great, but we have to look at the downside of it. We sometimes don’t stop and think, or stop and be human. We’re kind of mechanical if data are all we follow.
 

Q: So where do you see yourself in the next 10 years?

A: That’s a question I try to answer daily, and I get a different answer each time. I think I do see myself continuing to provide clinical care for hospitalized patients. I see myself doing a little more in educational leadership, working with medical students and medical residents. I’m just completing my master’s in health professions education, so I’m excited to also start a career in medical education research.
 

Q: What’s the best book that you’ve read recently, and why was it the best?

A: Oh, well, it’s not a new book, and I’ve read this before, but I keep coming back to it. I don’t know if you’ve heard of Jim Corbett. He was a wildlife enthusiast in the early 20th century. He wrote a lot of books on man-eating tigers and leopards in India. My brother and I and my dad used to read these books growing up. That’s something that I’m going back to and rereading. There is a lot of rich description about Indian wildlife, and it’s something that brings back good memories.


 

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Treating women with opioid use disorders poses unique challenges

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Fri, 01/18/2019 - 16:57

 

The opioid epidemic in the United States is reaching a boiling point, with President Trump calling it a “national emergency” and instructing his administration to use all appropriate authority to respond. Experts say that women are disproportionately affected and require unique treatment approaches.

The rate of prescription opioid–related overdoses increased by 471% among women in 2015, compared with an increase of 218% among men. Heroin deaths among women have risen at more than twice the rate among men, according to a report from the Office of Women’s Health (OWH), part of the U.S. Department of Health & Human Services.

The OWH report, released in July, paints a different picture of addiction for women than for men. Women are more likely to experience chronic pain and turn to prescription opioids for longer periods of time and in higher doses. But women also become dependent at smaller doses and in a shorter period of time. Add to this the fact that psychological and emotional distress are risk factors for opioid abuse among women, but not among men, according to the report.

BackyardProduction/Thinkstock
As evidence mounts of the disparity between women and men with opioid use disorder, clinicians are struggling to find effective treatment strategies, including for vulnerable populations such as pregnant women.

ACOG guidance

In August, the American College of Obstetricians and Gynecologists (ACOG) updated its recommendations for treatments and best practices related to opioid use among pregnant women (Obstet Gynecol. 2017;130:e81-94).

The committee opinion, developed with the American Society of Addiction Medicine, focuses on tearing down stereotypes about women with substance use disorders that could cause patients to slip through the cracks. ACOG recommended universal screening as a part of regular obstetric care, starting with the first prenatal visit.

While screening can involve laboratory testing, the recommendations focus more on creating a comfortable environment for pregnant women to share substance use history and to have a frank conversation about what treatment options are available.

“The document highlights the use of a verbal screening tool which enables the obstetric provider to have a direct conversation with the patient about their answers,” Maria Mascola, MD, an ob.gyn. at the Marshfield (Wis.) Clinic and lead author of the ACOG committee opinion, said in an interview. “It talks about substance use and then provides an opportunity to understand what substances and how much, why these substances might be bad, why this behavior should be changed, and how obstetricians can try to help the person make those changes.”

ACOG continues to recommend medication-assisted treatment (MAT) – typically with methadone or buprenorphine – as the most effective pathway for pregnant women to deal with substance use disorders. However, in cases in which the patient does not accept treatment with an opioid agonist or the treatment is unavailable, medically supervised withdrawal can be considered. ACOG cautions that relapse rates are high (from 59% to more than 90%) and that withdrawal often involves inpatient care and intensive outpatient follow-up. But recent evidence suggests medically supervised withdrawal is not associated with fetal death or preterm delivery.

“There have been some studies looking at smaller groups that have shown pregnant women going through medically supervised withdrawals and there have been some data from those studies that indicate women may be able to successfully go through this withdrawal without harm to the baby,” Dr. Mascola said. “The information we have on medically supervised withdrawal is a small amount of data, and we definitely need more before this is a primary approach.”

Access to care

Regardless of the treatment approach, the larger issue may be accessibility of care. Just 20% of adults with an opioid use disorder get the treatment and care they need each year, according to the OWH, with access and cost cited as the primary barriers to care. This problem is likely worse in rural areas.

“Rural health care is tougher. There is less access; that is an absolute truth, and it’s a burden then for those women to travel long distances to get the care they need,” Dr. Mascola said. “I think ob.gyns. should advocate for more attention in those areas where patients are underserved.”

One potential solution is for ob.gyns. to become certified in providing buprenorphine, which would allow physicians in rural areas to dispense these approved pharmacotherapies to patients who would otherwise be unable to have the proper treatment and follow-up necessary to prevent relapse, Dr. Mascola said.

There is already some federal funding available for this approach. In 2016, the Health Resources and Services Administration awarded $94 million to health centers across the country to expand substance use services, specifically increasing screening for substance use disorders, improving access to medication-assisted treatment, and training clinicians. Similarly, the Substance Abuse and Mental Health Services Administration recently announced it will allocate an additional $485 million to states through the State Targeted Response to the Opioid Crisis Grants to fund medication-assisted treatment and other services.

 

 

Unique challenges

Treating women with opioid use disorder isn’t just about identifying the best treatment approach. Social factors appear to play a larger role among women.

Courtesy Mary Lyde Parker/UNC
Dr. Hendree Jones
“Child care can be a huge barrier for engaging in treatment, which tends to be an additional challenge, more for women,” Hendrée Jones, PhD, professor of ob.gyn. at the University of North Carolina, Chapel Hill, and executive director UNC Horizons, a drug treatment program for women and drug-exposed children, said in an interview.

“Another difference with women over men is the prevalence of sexual trauma, as well as being in unhealthy relationships where the women are more likely to be enticed into leaving treatment,” she added.

Trauma among women with substance abuse disorders is prevalent, with 55%-99% of women reporting experiencing some form of trauma, compared with 36%-51% of the general population, according to the OWH report.

Beyond exploratory research, there needs to be a major shift in the public perception of opioid substance use, which currently does not approach the disorder as a chronic disease, according to Dr. Jones.

“The treatment process cannot just involve a detoxification program and then send patients off because that will commonly just end in relapse.” Dr. Jones said. “We need to approach substance use disorders with a recovery-oriented system of care in order to create a true safety net they can rely on.”

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Related Articles

 

The opioid epidemic in the United States is reaching a boiling point, with President Trump calling it a “national emergency” and instructing his administration to use all appropriate authority to respond. Experts say that women are disproportionately affected and require unique treatment approaches.

The rate of prescription opioid–related overdoses increased by 471% among women in 2015, compared with an increase of 218% among men. Heroin deaths among women have risen at more than twice the rate among men, according to a report from the Office of Women’s Health (OWH), part of the U.S. Department of Health & Human Services.

The OWH report, released in July, paints a different picture of addiction for women than for men. Women are more likely to experience chronic pain and turn to prescription opioids for longer periods of time and in higher doses. But women also become dependent at smaller doses and in a shorter period of time. Add to this the fact that psychological and emotional distress are risk factors for opioid abuse among women, but not among men, according to the report.

BackyardProduction/Thinkstock
As evidence mounts of the disparity between women and men with opioid use disorder, clinicians are struggling to find effective treatment strategies, including for vulnerable populations such as pregnant women.

ACOG guidance

In August, the American College of Obstetricians and Gynecologists (ACOG) updated its recommendations for treatments and best practices related to opioid use among pregnant women (Obstet Gynecol. 2017;130:e81-94).

The committee opinion, developed with the American Society of Addiction Medicine, focuses on tearing down stereotypes about women with substance use disorders that could cause patients to slip through the cracks. ACOG recommended universal screening as a part of regular obstetric care, starting with the first prenatal visit.

While screening can involve laboratory testing, the recommendations focus more on creating a comfortable environment for pregnant women to share substance use history and to have a frank conversation about what treatment options are available.

“The document highlights the use of a verbal screening tool which enables the obstetric provider to have a direct conversation with the patient about their answers,” Maria Mascola, MD, an ob.gyn. at the Marshfield (Wis.) Clinic and lead author of the ACOG committee opinion, said in an interview. “It talks about substance use and then provides an opportunity to understand what substances and how much, why these substances might be bad, why this behavior should be changed, and how obstetricians can try to help the person make those changes.”

ACOG continues to recommend medication-assisted treatment (MAT) – typically with methadone or buprenorphine – as the most effective pathway for pregnant women to deal with substance use disorders. However, in cases in which the patient does not accept treatment with an opioid agonist or the treatment is unavailable, medically supervised withdrawal can be considered. ACOG cautions that relapse rates are high (from 59% to more than 90%) and that withdrawal often involves inpatient care and intensive outpatient follow-up. But recent evidence suggests medically supervised withdrawal is not associated with fetal death or preterm delivery.

“There have been some studies looking at smaller groups that have shown pregnant women going through medically supervised withdrawals and there have been some data from those studies that indicate women may be able to successfully go through this withdrawal without harm to the baby,” Dr. Mascola said. “The information we have on medically supervised withdrawal is a small amount of data, and we definitely need more before this is a primary approach.”

Access to care

Regardless of the treatment approach, the larger issue may be accessibility of care. Just 20% of adults with an opioid use disorder get the treatment and care they need each year, according to the OWH, with access and cost cited as the primary barriers to care. This problem is likely worse in rural areas.

“Rural health care is tougher. There is less access; that is an absolute truth, and it’s a burden then for those women to travel long distances to get the care they need,” Dr. Mascola said. “I think ob.gyns. should advocate for more attention in those areas where patients are underserved.”

One potential solution is for ob.gyns. to become certified in providing buprenorphine, which would allow physicians in rural areas to dispense these approved pharmacotherapies to patients who would otherwise be unable to have the proper treatment and follow-up necessary to prevent relapse, Dr. Mascola said.

There is already some federal funding available for this approach. In 2016, the Health Resources and Services Administration awarded $94 million to health centers across the country to expand substance use services, specifically increasing screening for substance use disorders, improving access to medication-assisted treatment, and training clinicians. Similarly, the Substance Abuse and Mental Health Services Administration recently announced it will allocate an additional $485 million to states through the State Targeted Response to the Opioid Crisis Grants to fund medication-assisted treatment and other services.

 

 

Unique challenges

Treating women with opioid use disorder isn’t just about identifying the best treatment approach. Social factors appear to play a larger role among women.

Courtesy Mary Lyde Parker/UNC
Dr. Hendree Jones
“Child care can be a huge barrier for engaging in treatment, which tends to be an additional challenge, more for women,” Hendrée Jones, PhD, professor of ob.gyn. at the University of North Carolina, Chapel Hill, and executive director UNC Horizons, a drug treatment program for women and drug-exposed children, said in an interview.

“Another difference with women over men is the prevalence of sexual trauma, as well as being in unhealthy relationships where the women are more likely to be enticed into leaving treatment,” she added.

Trauma among women with substance abuse disorders is prevalent, with 55%-99% of women reporting experiencing some form of trauma, compared with 36%-51% of the general population, according to the OWH report.

Beyond exploratory research, there needs to be a major shift in the public perception of opioid substance use, which currently does not approach the disorder as a chronic disease, according to Dr. Jones.

“The treatment process cannot just involve a detoxification program and then send patients off because that will commonly just end in relapse.” Dr. Jones said. “We need to approach substance use disorders with a recovery-oriented system of care in order to create a true safety net they can rely on.”

 

The opioid epidemic in the United States is reaching a boiling point, with President Trump calling it a “national emergency” and instructing his administration to use all appropriate authority to respond. Experts say that women are disproportionately affected and require unique treatment approaches.

The rate of prescription opioid–related overdoses increased by 471% among women in 2015, compared with an increase of 218% among men. Heroin deaths among women have risen at more than twice the rate among men, according to a report from the Office of Women’s Health (OWH), part of the U.S. Department of Health & Human Services.

The OWH report, released in July, paints a different picture of addiction for women than for men. Women are more likely to experience chronic pain and turn to prescription opioids for longer periods of time and in higher doses. But women also become dependent at smaller doses and in a shorter period of time. Add to this the fact that psychological and emotional distress are risk factors for opioid abuse among women, but not among men, according to the report.

BackyardProduction/Thinkstock
As evidence mounts of the disparity between women and men with opioid use disorder, clinicians are struggling to find effective treatment strategies, including for vulnerable populations such as pregnant women.

ACOG guidance

In August, the American College of Obstetricians and Gynecologists (ACOG) updated its recommendations for treatments and best practices related to opioid use among pregnant women (Obstet Gynecol. 2017;130:e81-94).

The committee opinion, developed with the American Society of Addiction Medicine, focuses on tearing down stereotypes about women with substance use disorders that could cause patients to slip through the cracks. ACOG recommended universal screening as a part of regular obstetric care, starting with the first prenatal visit.

While screening can involve laboratory testing, the recommendations focus more on creating a comfortable environment for pregnant women to share substance use history and to have a frank conversation about what treatment options are available.

“The document highlights the use of a verbal screening tool which enables the obstetric provider to have a direct conversation with the patient about their answers,” Maria Mascola, MD, an ob.gyn. at the Marshfield (Wis.) Clinic and lead author of the ACOG committee opinion, said in an interview. “It talks about substance use and then provides an opportunity to understand what substances and how much, why these substances might be bad, why this behavior should be changed, and how obstetricians can try to help the person make those changes.”

ACOG continues to recommend medication-assisted treatment (MAT) – typically with methadone or buprenorphine – as the most effective pathway for pregnant women to deal with substance use disorders. However, in cases in which the patient does not accept treatment with an opioid agonist or the treatment is unavailable, medically supervised withdrawal can be considered. ACOG cautions that relapse rates are high (from 59% to more than 90%) and that withdrawal often involves inpatient care and intensive outpatient follow-up. But recent evidence suggests medically supervised withdrawal is not associated with fetal death or preterm delivery.

“There have been some studies looking at smaller groups that have shown pregnant women going through medically supervised withdrawals and there have been some data from those studies that indicate women may be able to successfully go through this withdrawal without harm to the baby,” Dr. Mascola said. “The information we have on medically supervised withdrawal is a small amount of data, and we definitely need more before this is a primary approach.”

Access to care

Regardless of the treatment approach, the larger issue may be accessibility of care. Just 20% of adults with an opioid use disorder get the treatment and care they need each year, according to the OWH, with access and cost cited as the primary barriers to care. This problem is likely worse in rural areas.

“Rural health care is tougher. There is less access; that is an absolute truth, and it’s a burden then for those women to travel long distances to get the care they need,” Dr. Mascola said. “I think ob.gyns. should advocate for more attention in those areas where patients are underserved.”

One potential solution is for ob.gyns. to become certified in providing buprenorphine, which would allow physicians in rural areas to dispense these approved pharmacotherapies to patients who would otherwise be unable to have the proper treatment and follow-up necessary to prevent relapse, Dr. Mascola said.

There is already some federal funding available for this approach. In 2016, the Health Resources and Services Administration awarded $94 million to health centers across the country to expand substance use services, specifically increasing screening for substance use disorders, improving access to medication-assisted treatment, and training clinicians. Similarly, the Substance Abuse and Mental Health Services Administration recently announced it will allocate an additional $485 million to states through the State Targeted Response to the Opioid Crisis Grants to fund medication-assisted treatment and other services.

 

 

Unique challenges

Treating women with opioid use disorder isn’t just about identifying the best treatment approach. Social factors appear to play a larger role among women.

Courtesy Mary Lyde Parker/UNC
Dr. Hendree Jones
“Child care can be a huge barrier for engaging in treatment, which tends to be an additional challenge, more for women,” Hendrée Jones, PhD, professor of ob.gyn. at the University of North Carolina, Chapel Hill, and executive director UNC Horizons, a drug treatment program for women and drug-exposed children, said in an interview.

“Another difference with women over men is the prevalence of sexual trauma, as well as being in unhealthy relationships where the women are more likely to be enticed into leaving treatment,” she added.

Trauma among women with substance abuse disorders is prevalent, with 55%-99% of women reporting experiencing some form of trauma, compared with 36%-51% of the general population, according to the OWH report.

Beyond exploratory research, there needs to be a major shift in the public perception of opioid substance use, which currently does not approach the disorder as a chronic disease, according to Dr. Jones.

“The treatment process cannot just involve a detoxification program and then send patients off because that will commonly just end in relapse.” Dr. Jones said. “We need to approach substance use disorders with a recovery-oriented system of care in order to create a true safety net they can rely on.”

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Focused on value-based care: Harry Cho, MD

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Fri, 09/14/2018 - 11:58
Dr. Cho joins The Hospitalist Editorial Advisory Board

 



Education and service have always been important for Harry Cho, MD, who recently joined the editorial advisory board of The Hospitalist.

From joining AmeriCorps as a fresh faced college graduate, to his ongoing work as assistant professor of medicine and director of quality, safety, and value for the division of hospital medicine at Mount Sinai in New York, and as senior fellow at the Lown Institute, Dr. Cho has found a passion in helping others learn.

Dr. Harry Cho
“It’s always been a part of me; I remember teaching some classes in college and starting a program in Philadelphia with my buddies,” said Dr. Cho. “I love that whole aspect. I think mentorship and teaching is essential.”

When not teaching or working with patients, Dr. Cho is committed to improving value-based medicine, a path that has lead him to create the High Value Chair Initiatives, a program dedicated to offering clinicians resources on how to reduce wasteful testing and harmful practices.

Dr. Cho said he is excited to contribute as one of eight new members of The Hospitalist editorial advisory board in 2017 and took time to tell us more about himself in a recent interview.
 

Q: Why did you choose medicine as a career?

A: Right after I finished undergrad at Cornell, I spent the summer and the following year doing AmeriCorps, which is service learning work, and I worked in the inner city of Philadelphia. I worked on after-school programs and weekend programs for inner city youth and I loved it. I was organizing and developing these programs, and I thought it was fantastic. The one thing that I thought was lacking, and I think what really drove me to get into medicine, was that at the end of the day, although I felt really connected with all the kids, I felt like I was a role model, like I was a mentor, and we had a really good connection, but I wanted something a little bit more concrete on improving outcomes. I knew we made connections, but I really wanted to know more – such as, did we reduce the dropout rate in high school for these students? I think that’s why medicine was really interesting.
 

Q: How did you end up in hospital medicine?

A: I think it’s a lot of things. I love the acuity, I love playing the quarterback in a place where a lot of things are going back and forth and you have to coordinate with others. You have to make sure you see the patient from top to bottom, the whole picture, and I love that part. I also love the action and the communication and the teamwork aspect of it.
 

Q: What part of being a hospitalist do you like the most?

A: I love the education on a daily basis: the morning rounds where you walk around for an hour or two with your team, and you teach them at the bedside, and these little pearls come up along the way. My career is positioned more within quality, value improvement, and safety, so I think that participating in the education process is really helpful. I think hospital medicine has taken over that spirit in the hospital setting, and I love that.
 

Q: Which part do you like the least?

A: I think we’re in a unique time right now. Burnout is getting a little tougher to beat. People are getting a bit more tired, and I don’t think we have a good solution to solve this. With quality improvement and the electronic medical record system, a lot of us are expected to do more. I still get queries from clinical documentation saying, “I need you to document this for billing purposes” or “I need you to document this for increasing the expected length of stay,” and doctors are not quite at the point where they can balance these requirements in an effective way. There tends to be an emphasis on “one more click,” one more thing to document, just one more thing to do on the checklist. It’s getting more complex.
 

Q: What is the most rewarding part of your work?

A: Larger scale accomplishments. When you give a talk, or teach a group of residents during morning rounds, and they look at you with wonder because you have this teaching pearl they’ve never heard before, and they think you’re a great attending – that’s very instant gratification, but there's more to be done beyond that. I’ve been co-directing in the Right Care educator program, and we have a High Value Care curriculum that we’ve been implementing across the country, and we’ve just finished our second year. There are around 60 programs involved, and it’s a great feeling. You’re not seeing actual people face to face after they’ve been taught, and you’re not getting that instant gratification. But just knowing what one of those chief residents who has implemented the program is feeling, and extrapolating across the number of programs this year alone, that makes me feel good.
 

 

 

Q: Outside of hospital work, what else are you interested in?

A: High-value care is my central aim right now. I want to expand it, and I want to do things on a national scale. We formed a High Value Care committee and I’m hoping to create new guidelines to reduce overuse, overtesting, and Choosing Wisely. Outside of medicine, I like photography. Nothing professional, but I love taking pictures, especially nature and travel. Back in the day, I used to do a lot of running and martial arts too.
 

Q: Where do you see yourself in 10 years?

A: I’m not sure if I will go the chief medical officer or chief quality officer route. That’s probably where I see myself. I definitely want to continue making bigger changes on a national scale, like implementing the overuse educator program across the country.
 

Q: What do you see as the future of hospital medicine?

A: Value-based health care is always going to get bigger as the cost of health care and the cost of overuse rises, and we start to see a lot of harms outlined in research. We’re going to be on top of it much more, because the hospital setting is complex and continues to change.

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Dr. Cho joins The Hospitalist Editorial Advisory Board
Dr. Cho joins The Hospitalist Editorial Advisory Board

 



Education and service have always been important for Harry Cho, MD, who recently joined the editorial advisory board of The Hospitalist.

From joining AmeriCorps as a fresh faced college graduate, to his ongoing work as assistant professor of medicine and director of quality, safety, and value for the division of hospital medicine at Mount Sinai in New York, and as senior fellow at the Lown Institute, Dr. Cho has found a passion in helping others learn.

Dr. Harry Cho
“It’s always been a part of me; I remember teaching some classes in college and starting a program in Philadelphia with my buddies,” said Dr. Cho. “I love that whole aspect. I think mentorship and teaching is essential.”

When not teaching or working with patients, Dr. Cho is committed to improving value-based medicine, a path that has lead him to create the High Value Chair Initiatives, a program dedicated to offering clinicians resources on how to reduce wasteful testing and harmful practices.

Dr. Cho said he is excited to contribute as one of eight new members of The Hospitalist editorial advisory board in 2017 and took time to tell us more about himself in a recent interview.
 

Q: Why did you choose medicine as a career?

A: Right after I finished undergrad at Cornell, I spent the summer and the following year doing AmeriCorps, which is service learning work, and I worked in the inner city of Philadelphia. I worked on after-school programs and weekend programs for inner city youth and I loved it. I was organizing and developing these programs, and I thought it was fantastic. The one thing that I thought was lacking, and I think what really drove me to get into medicine, was that at the end of the day, although I felt really connected with all the kids, I felt like I was a role model, like I was a mentor, and we had a really good connection, but I wanted something a little bit more concrete on improving outcomes. I knew we made connections, but I really wanted to know more – such as, did we reduce the dropout rate in high school for these students? I think that’s why medicine was really interesting.
 

Q: How did you end up in hospital medicine?

A: I think it’s a lot of things. I love the acuity, I love playing the quarterback in a place where a lot of things are going back and forth and you have to coordinate with others. You have to make sure you see the patient from top to bottom, the whole picture, and I love that part. I also love the action and the communication and the teamwork aspect of it.
 

Q: What part of being a hospitalist do you like the most?

A: I love the education on a daily basis: the morning rounds where you walk around for an hour or two with your team, and you teach them at the bedside, and these little pearls come up along the way. My career is positioned more within quality, value improvement, and safety, so I think that participating in the education process is really helpful. I think hospital medicine has taken over that spirit in the hospital setting, and I love that.
 

Q: Which part do you like the least?

A: I think we’re in a unique time right now. Burnout is getting a little tougher to beat. People are getting a bit more tired, and I don’t think we have a good solution to solve this. With quality improvement and the electronic medical record system, a lot of us are expected to do more. I still get queries from clinical documentation saying, “I need you to document this for billing purposes” or “I need you to document this for increasing the expected length of stay,” and doctors are not quite at the point where they can balance these requirements in an effective way. There tends to be an emphasis on “one more click,” one more thing to document, just one more thing to do on the checklist. It’s getting more complex.
 

Q: What is the most rewarding part of your work?

A: Larger scale accomplishments. When you give a talk, or teach a group of residents during morning rounds, and they look at you with wonder because you have this teaching pearl they’ve never heard before, and they think you’re a great attending – that’s very instant gratification, but there's more to be done beyond that. I’ve been co-directing in the Right Care educator program, and we have a High Value Care curriculum that we’ve been implementing across the country, and we’ve just finished our second year. There are around 60 programs involved, and it’s a great feeling. You’re not seeing actual people face to face after they’ve been taught, and you’re not getting that instant gratification. But just knowing what one of those chief residents who has implemented the program is feeling, and extrapolating across the number of programs this year alone, that makes me feel good.
 

 

 

Q: Outside of hospital work, what else are you interested in?

A: High-value care is my central aim right now. I want to expand it, and I want to do things on a national scale. We formed a High Value Care committee and I’m hoping to create new guidelines to reduce overuse, overtesting, and Choosing Wisely. Outside of medicine, I like photography. Nothing professional, but I love taking pictures, especially nature and travel. Back in the day, I used to do a lot of running and martial arts too.
 

Q: Where do you see yourself in 10 years?

A: I’m not sure if I will go the chief medical officer or chief quality officer route. That’s probably where I see myself. I definitely want to continue making bigger changes on a national scale, like implementing the overuse educator program across the country.
 

Q: What do you see as the future of hospital medicine?

A: Value-based health care is always going to get bigger as the cost of health care and the cost of overuse rises, and we start to see a lot of harms outlined in research. We’re going to be on top of it much more, because the hospital setting is complex and continues to change.

 



Education and service have always been important for Harry Cho, MD, who recently joined the editorial advisory board of The Hospitalist.

From joining AmeriCorps as a fresh faced college graduate, to his ongoing work as assistant professor of medicine and director of quality, safety, and value for the division of hospital medicine at Mount Sinai in New York, and as senior fellow at the Lown Institute, Dr. Cho has found a passion in helping others learn.

Dr. Harry Cho
“It’s always been a part of me; I remember teaching some classes in college and starting a program in Philadelphia with my buddies,” said Dr. Cho. “I love that whole aspect. I think mentorship and teaching is essential.”

When not teaching or working with patients, Dr. Cho is committed to improving value-based medicine, a path that has lead him to create the High Value Chair Initiatives, a program dedicated to offering clinicians resources on how to reduce wasteful testing and harmful practices.

Dr. Cho said he is excited to contribute as one of eight new members of The Hospitalist editorial advisory board in 2017 and took time to tell us more about himself in a recent interview.
 

Q: Why did you choose medicine as a career?

A: Right after I finished undergrad at Cornell, I spent the summer and the following year doing AmeriCorps, which is service learning work, and I worked in the inner city of Philadelphia. I worked on after-school programs and weekend programs for inner city youth and I loved it. I was organizing and developing these programs, and I thought it was fantastic. The one thing that I thought was lacking, and I think what really drove me to get into medicine, was that at the end of the day, although I felt really connected with all the kids, I felt like I was a role model, like I was a mentor, and we had a really good connection, but I wanted something a little bit more concrete on improving outcomes. I knew we made connections, but I really wanted to know more – such as, did we reduce the dropout rate in high school for these students? I think that’s why medicine was really interesting.
 

Q: How did you end up in hospital medicine?

A: I think it’s a lot of things. I love the acuity, I love playing the quarterback in a place where a lot of things are going back and forth and you have to coordinate with others. You have to make sure you see the patient from top to bottom, the whole picture, and I love that part. I also love the action and the communication and the teamwork aspect of it.
 

Q: What part of being a hospitalist do you like the most?

A: I love the education on a daily basis: the morning rounds where you walk around for an hour or two with your team, and you teach them at the bedside, and these little pearls come up along the way. My career is positioned more within quality, value improvement, and safety, so I think that participating in the education process is really helpful. I think hospital medicine has taken over that spirit in the hospital setting, and I love that.
 

Q: Which part do you like the least?

A: I think we’re in a unique time right now. Burnout is getting a little tougher to beat. People are getting a bit more tired, and I don’t think we have a good solution to solve this. With quality improvement and the electronic medical record system, a lot of us are expected to do more. I still get queries from clinical documentation saying, “I need you to document this for billing purposes” or “I need you to document this for increasing the expected length of stay,” and doctors are not quite at the point where they can balance these requirements in an effective way. There tends to be an emphasis on “one more click,” one more thing to document, just one more thing to do on the checklist. It’s getting more complex.
 

Q: What is the most rewarding part of your work?

A: Larger scale accomplishments. When you give a talk, or teach a group of residents during morning rounds, and they look at you with wonder because you have this teaching pearl they’ve never heard before, and they think you’re a great attending – that’s very instant gratification, but there's more to be done beyond that. I’ve been co-directing in the Right Care educator program, and we have a High Value Care curriculum that we’ve been implementing across the country, and we’ve just finished our second year. There are around 60 programs involved, and it’s a great feeling. You’re not seeing actual people face to face after they’ve been taught, and you’re not getting that instant gratification. But just knowing what one of those chief residents who has implemented the program is feeling, and extrapolating across the number of programs this year alone, that makes me feel good.
 

 

 

Q: Outside of hospital work, what else are you interested in?

A: High-value care is my central aim right now. I want to expand it, and I want to do things on a national scale. We formed a High Value Care committee and I’m hoping to create new guidelines to reduce overuse, overtesting, and Choosing Wisely. Outside of medicine, I like photography. Nothing professional, but I love taking pictures, especially nature and travel. Back in the day, I used to do a lot of running and martial arts too.
 

Q: Where do you see yourself in 10 years?

A: I’m not sure if I will go the chief medical officer or chief quality officer route. That’s probably where I see myself. I definitely want to continue making bigger changes on a national scale, like implementing the overuse educator program across the country.
 

Q: What do you see as the future of hospital medicine?

A: Value-based health care is always going to get bigger as the cost of health care and the cost of overuse rises, and we start to see a lot of harms outlined in research. We’re going to be on top of it much more, because the hospital setting is complex and continues to change.

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Oral prophylaxis and vaginal ring effective in adolescent HIV prevention

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Fri, 01/18/2019 - 16:56

 

Dapivirine vaginal ring and oral pre-exposure prophylaxis (PrEP) are effective HIV prevention measures in adolescent girls, according to two studies presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment in Paris.

These solutions could be critical in lowering the rate of HIV and AIDS in girls between the ages of 15 and 25 years, a population that has proven to be particularly vulnerable to HIV infection, researchers say.

grandeduc/Thinkstock


Females aged 15-24 years made up 20% of new HIV infections globally in 2015, even though they represented only 11% of the adult population, according to the National Institutes of Health (NIH).

“Adolescents and young people represent a growing share of people living with HIV worldwide,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID) said in a statement released by the NIH. “Science has demonstrated that the HIV prevention needs of adolescents may be different than those of adults, which is why these new study findings are so important.”

In a phase II, double-blind, placebo-controlled trial, researchers administered a 25-mg dapivirine vaginal ring to 73 patients, with a placebo group of 23 patients, gathered from six sites across the United States once every 4 weeks over a period of 24 weeks.

Patients’ ages ranged from 15 to 17 years of age and a majority were African American, with a median of three sexual partners over the course of their lifetimes.

After the 24-week period, dapivirine residual drug levels indicated a 95% adherence rate, with a reported 42% of patients in the test group reporting never having removed the vaginal ring.

Among the patients given the ring, 63% reported never feeling the ring during intercourse, while 73% of those who said they did feel the ring reported not being bothered by it.

Overall, 93% of the study population reported not being bothered by the solution, which investigators interpreted as a positive sign for the dapivirine ring as an effective HIV prevention tool.

“We are encouraged by these results of the dapivirine ring in 15- to 17-year-old girls,” Sharon Hillier, PhD, of the NIH-funded Microbicide Trials Network (MTN), said in the NIH statement. “The study has demonstrated that the ring is safe in U.S. teens, and now we need data on the safety and acceptability of the ring in African adolescent girls. The REACH study, scheduled to launch later this year, will generate [these] data.”

In a second study presented at the conference, investigators tested the safety and acceptability of daily oral Truvada (emtricitabine/tenofovir) as a PrEP solution in 148 HIV-free adolescents aged 15-19 years from two study sites in South Africa over a span of 12 months. Truvada has not yet been approved by any national regulatory body for use as oral PrEP in adolescents.

Patients were majority female (99 girls/49 boys), with 74% of the population reporting having used a condom during their last sexual encounter.

At the start of the trial, sexually transmitted infections were present in 40% of participants, a level that remained constant throughout the study.

A total of 16 (11%) participants reported grade 2 adverse effects, including headaches, nausea, abdominal pain, and skin rashes, with another 2 patients reporting weight loss during the trial, according to Katherine Gill, MBBS, of the Desmond Tutu HIV Foundation, Cape Town, South Africa.

One instance of HIV infection was reported, although the patient in question dropped out of the program 24 weeks before diagnosis.

Overall, investigators found the Truvada PrEP program to be reasonably well tolerated, with plasma tenofovir levels detectable in 57% of participants after 12 weeks, 38% after 24 weeks and 38% at the end of the study, according to Dr. Gill and her colleagues.

Both studies were funded by NIH grants. Investigators of both studies reported no relevant financial conflicts.

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Dapivirine vaginal ring and oral pre-exposure prophylaxis (PrEP) are effective HIV prevention measures in adolescent girls, according to two studies presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment in Paris.

These solutions could be critical in lowering the rate of HIV and AIDS in girls between the ages of 15 and 25 years, a population that has proven to be particularly vulnerable to HIV infection, researchers say.

grandeduc/Thinkstock


Females aged 15-24 years made up 20% of new HIV infections globally in 2015, even though they represented only 11% of the adult population, according to the National Institutes of Health (NIH).

“Adolescents and young people represent a growing share of people living with HIV worldwide,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID) said in a statement released by the NIH. “Science has demonstrated that the HIV prevention needs of adolescents may be different than those of adults, which is why these new study findings are so important.”

In a phase II, double-blind, placebo-controlled trial, researchers administered a 25-mg dapivirine vaginal ring to 73 patients, with a placebo group of 23 patients, gathered from six sites across the United States once every 4 weeks over a period of 24 weeks.

Patients’ ages ranged from 15 to 17 years of age and a majority were African American, with a median of three sexual partners over the course of their lifetimes.

After the 24-week period, dapivirine residual drug levels indicated a 95% adherence rate, with a reported 42% of patients in the test group reporting never having removed the vaginal ring.

Among the patients given the ring, 63% reported never feeling the ring during intercourse, while 73% of those who said they did feel the ring reported not being bothered by it.

Overall, 93% of the study population reported not being bothered by the solution, which investigators interpreted as a positive sign for the dapivirine ring as an effective HIV prevention tool.

“We are encouraged by these results of the dapivirine ring in 15- to 17-year-old girls,” Sharon Hillier, PhD, of the NIH-funded Microbicide Trials Network (MTN), said in the NIH statement. “The study has demonstrated that the ring is safe in U.S. teens, and now we need data on the safety and acceptability of the ring in African adolescent girls. The REACH study, scheduled to launch later this year, will generate [these] data.”

In a second study presented at the conference, investigators tested the safety and acceptability of daily oral Truvada (emtricitabine/tenofovir) as a PrEP solution in 148 HIV-free adolescents aged 15-19 years from two study sites in South Africa over a span of 12 months. Truvada has not yet been approved by any national regulatory body for use as oral PrEP in adolescents.

Patients were majority female (99 girls/49 boys), with 74% of the population reporting having used a condom during their last sexual encounter.

At the start of the trial, sexually transmitted infections were present in 40% of participants, a level that remained constant throughout the study.

A total of 16 (11%) participants reported grade 2 adverse effects, including headaches, nausea, abdominal pain, and skin rashes, with another 2 patients reporting weight loss during the trial, according to Katherine Gill, MBBS, of the Desmond Tutu HIV Foundation, Cape Town, South Africa.

One instance of HIV infection was reported, although the patient in question dropped out of the program 24 weeks before diagnosis.

Overall, investigators found the Truvada PrEP program to be reasonably well tolerated, with plasma tenofovir levels detectable in 57% of participants after 12 weeks, 38% after 24 weeks and 38% at the end of the study, according to Dr. Gill and her colleagues.

Both studies were funded by NIH grants. Investigators of both studies reported no relevant financial conflicts.

 

Dapivirine vaginal ring and oral pre-exposure prophylaxis (PrEP) are effective HIV prevention measures in adolescent girls, according to two studies presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment in Paris.

These solutions could be critical in lowering the rate of HIV and AIDS in girls between the ages of 15 and 25 years, a population that has proven to be particularly vulnerable to HIV infection, researchers say.

grandeduc/Thinkstock


Females aged 15-24 years made up 20% of new HIV infections globally in 2015, even though they represented only 11% of the adult population, according to the National Institutes of Health (NIH).

“Adolescents and young people represent a growing share of people living with HIV worldwide,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID) said in a statement released by the NIH. “Science has demonstrated that the HIV prevention needs of adolescents may be different than those of adults, which is why these new study findings are so important.”

In a phase II, double-blind, placebo-controlled trial, researchers administered a 25-mg dapivirine vaginal ring to 73 patients, with a placebo group of 23 patients, gathered from six sites across the United States once every 4 weeks over a period of 24 weeks.

Patients’ ages ranged from 15 to 17 years of age and a majority were African American, with a median of three sexual partners over the course of their lifetimes.

After the 24-week period, dapivirine residual drug levels indicated a 95% adherence rate, with a reported 42% of patients in the test group reporting never having removed the vaginal ring.

Among the patients given the ring, 63% reported never feeling the ring during intercourse, while 73% of those who said they did feel the ring reported not being bothered by it.

Overall, 93% of the study population reported not being bothered by the solution, which investigators interpreted as a positive sign for the dapivirine ring as an effective HIV prevention tool.

“We are encouraged by these results of the dapivirine ring in 15- to 17-year-old girls,” Sharon Hillier, PhD, of the NIH-funded Microbicide Trials Network (MTN), said in the NIH statement. “The study has demonstrated that the ring is safe in U.S. teens, and now we need data on the safety and acceptability of the ring in African adolescent girls. The REACH study, scheduled to launch later this year, will generate [these] data.”

In a second study presented at the conference, investigators tested the safety and acceptability of daily oral Truvada (emtricitabine/tenofovir) as a PrEP solution in 148 HIV-free adolescents aged 15-19 years from two study sites in South Africa over a span of 12 months. Truvada has not yet been approved by any national regulatory body for use as oral PrEP in adolescents.

Patients were majority female (99 girls/49 boys), with 74% of the population reporting having used a condom during their last sexual encounter.

At the start of the trial, sexually transmitted infections were present in 40% of participants, a level that remained constant throughout the study.

A total of 16 (11%) participants reported grade 2 adverse effects, including headaches, nausea, abdominal pain, and skin rashes, with another 2 patients reporting weight loss during the trial, according to Katherine Gill, MBBS, of the Desmond Tutu HIV Foundation, Cape Town, South Africa.

One instance of HIV infection was reported, although the patient in question dropped out of the program 24 weeks before diagnosis.

Overall, investigators found the Truvada PrEP program to be reasonably well tolerated, with plasma tenofovir levels detectable in 57% of participants after 12 weeks, 38% after 24 weeks and 38% at the end of the study, according to Dr. Gill and her colleagues.

Both studies were funded by NIH grants. Investigators of both studies reported no relevant financial conflicts.

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Solid organ transplantation contributes significantly to incidence of NHL among children and adolescents

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Tue, 02/14/2023 - 13:05

 

Solid organ transplant recipients contribute a disproportionate fraction of pediatric non-Hodgkin lymphoma (NHL) cases, especially diffuse large B-cell lymphoma cases (DLBCL), according to an analysis of data drawn from transplant and cancer registries.

Investigators calculated that the incidence of NHL for the pediatric transplant population was 257 times higher than the general population, after analysis from the U.S. transplant registry and 16 cancer registries from around the country between 1990 and 2012. The incidence of NHL for the pediatric transplant population was 306 cases per 100,000 person-years (95% CI, 271-344), compared to 1.19 cases per 100,000 person-years (95% CI, 1.12-1.27) in the general population. Furthermore, transplant recipients made up a much larger proportion of general population DLBCL cases (7.62%; 95% CI, 6.35%-8.88%).

In the general population, the most common subtypes were DLBCL (25% of cases), Burkitt lymphoma (24%), and precursor cell lymphoblastic lymphoma (20%). Among NHLs diagnosed in transplant recipients, 65% were DLBCL, and 9% were Burkitt lymphoma, whereas there were no cases of precursor cell lymphoblastic lymphoma, reported Elizabeth L. Yanik, PhD, of Washington University, St. Louis, and her associates (Cancer. 2017 Jul 31. doi: 10.1002/cncr.30923).

The increased risk of NHL and other cancers for organ transplant recipients is primarily the result of the immunosuppressant medications administered after transplantation, leading to an increased risk of infection-related cancers, the authors said.

“NHL cases are largely attributable to EBV [Epstein-Barr virus] infections that occur while recipients are immunosuppressed, as evidenced by the high prevalence of EBV detectable in NHL tumors and particularly in cases diagnosed during the heavily immunosuppressed period early after transplantation,” wrote Dr. Yanik and her colleagues. “Patients who experience a primary EBV infection after transplantation are particularly susceptible because transplant recipients have a higher NHL risk if they are seronegative for EBV before transplantation.”

Among those at risk, Dr. Yanik and fellow investigators found transplant patients younger than 5 years were the most susceptible to NHL, making up 19.79% of those diagnosed with DLBCL.

The proportion of NHL in solid organ transplant recipients within the entire pediatric NHL population has risen over time, from 1.66% of the NHL population during 1990-1994 to 3.73% during 2010-2012.

“This trend is driven by the rising prevalence of transplant recipients in the general population and not by increases in NHL risk among transplant recipients,” noted Dr. Yanik and her coauthors. “The proportion of NHL diagnoses attributable to transplant recipients has grown over time, and it is likely that this population will be an important source of pediatric NHL cases in the future.”

This study was partially funded by the National Cancer Institute. One coauthor reported being an employee at GRAIL Inc. No other relevant financial disclosures were reported.

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Solid organ transplant recipients contribute a disproportionate fraction of pediatric non-Hodgkin lymphoma (NHL) cases, especially diffuse large B-cell lymphoma cases (DLBCL), according to an analysis of data drawn from transplant and cancer registries.

Investigators calculated that the incidence of NHL for the pediatric transplant population was 257 times higher than the general population, after analysis from the U.S. transplant registry and 16 cancer registries from around the country between 1990 and 2012. The incidence of NHL for the pediatric transplant population was 306 cases per 100,000 person-years (95% CI, 271-344), compared to 1.19 cases per 100,000 person-years (95% CI, 1.12-1.27) in the general population. Furthermore, transplant recipients made up a much larger proportion of general population DLBCL cases (7.62%; 95% CI, 6.35%-8.88%).

In the general population, the most common subtypes were DLBCL (25% of cases), Burkitt lymphoma (24%), and precursor cell lymphoblastic lymphoma (20%). Among NHLs diagnosed in transplant recipients, 65% were DLBCL, and 9% were Burkitt lymphoma, whereas there were no cases of precursor cell lymphoblastic lymphoma, reported Elizabeth L. Yanik, PhD, of Washington University, St. Louis, and her associates (Cancer. 2017 Jul 31. doi: 10.1002/cncr.30923).

The increased risk of NHL and other cancers for organ transplant recipients is primarily the result of the immunosuppressant medications administered after transplantation, leading to an increased risk of infection-related cancers, the authors said.

“NHL cases are largely attributable to EBV [Epstein-Barr virus] infections that occur while recipients are immunosuppressed, as evidenced by the high prevalence of EBV detectable in NHL tumors and particularly in cases diagnosed during the heavily immunosuppressed period early after transplantation,” wrote Dr. Yanik and her colleagues. “Patients who experience a primary EBV infection after transplantation are particularly susceptible because transplant recipients have a higher NHL risk if they are seronegative for EBV before transplantation.”

Among those at risk, Dr. Yanik and fellow investigators found transplant patients younger than 5 years were the most susceptible to NHL, making up 19.79% of those diagnosed with DLBCL.

The proportion of NHL in solid organ transplant recipients within the entire pediatric NHL population has risen over time, from 1.66% of the NHL population during 1990-1994 to 3.73% during 2010-2012.

“This trend is driven by the rising prevalence of transplant recipients in the general population and not by increases in NHL risk among transplant recipients,” noted Dr. Yanik and her coauthors. “The proportion of NHL diagnoses attributable to transplant recipients has grown over time, and it is likely that this population will be an important source of pediatric NHL cases in the future.”

This study was partially funded by the National Cancer Institute. One coauthor reported being an employee at GRAIL Inc. No other relevant financial disclosures were reported.

 

Solid organ transplant recipients contribute a disproportionate fraction of pediatric non-Hodgkin lymphoma (NHL) cases, especially diffuse large B-cell lymphoma cases (DLBCL), according to an analysis of data drawn from transplant and cancer registries.

Investigators calculated that the incidence of NHL for the pediatric transplant population was 257 times higher than the general population, after analysis from the U.S. transplant registry and 16 cancer registries from around the country between 1990 and 2012. The incidence of NHL for the pediatric transplant population was 306 cases per 100,000 person-years (95% CI, 271-344), compared to 1.19 cases per 100,000 person-years (95% CI, 1.12-1.27) in the general population. Furthermore, transplant recipients made up a much larger proportion of general population DLBCL cases (7.62%; 95% CI, 6.35%-8.88%).

In the general population, the most common subtypes were DLBCL (25% of cases), Burkitt lymphoma (24%), and precursor cell lymphoblastic lymphoma (20%). Among NHLs diagnosed in transplant recipients, 65% were DLBCL, and 9% were Burkitt lymphoma, whereas there were no cases of precursor cell lymphoblastic lymphoma, reported Elizabeth L. Yanik, PhD, of Washington University, St. Louis, and her associates (Cancer. 2017 Jul 31. doi: 10.1002/cncr.30923).

The increased risk of NHL and other cancers for organ transplant recipients is primarily the result of the immunosuppressant medications administered after transplantation, leading to an increased risk of infection-related cancers, the authors said.

“NHL cases are largely attributable to EBV [Epstein-Barr virus] infections that occur while recipients are immunosuppressed, as evidenced by the high prevalence of EBV detectable in NHL tumors and particularly in cases diagnosed during the heavily immunosuppressed period early after transplantation,” wrote Dr. Yanik and her colleagues. “Patients who experience a primary EBV infection after transplantation are particularly susceptible because transplant recipients have a higher NHL risk if they are seronegative for EBV before transplantation.”

Among those at risk, Dr. Yanik and fellow investigators found transplant patients younger than 5 years were the most susceptible to NHL, making up 19.79% of those diagnosed with DLBCL.

The proportion of NHL in solid organ transplant recipients within the entire pediatric NHL population has risen over time, from 1.66% of the NHL population during 1990-1994 to 3.73% during 2010-2012.

“This trend is driven by the rising prevalence of transplant recipients in the general population and not by increases in NHL risk among transplant recipients,” noted Dr. Yanik and her coauthors. “The proportion of NHL diagnoses attributable to transplant recipients has grown over time, and it is likely that this population will be an important source of pediatric NHL cases in the future.”

This study was partially funded by the National Cancer Institute. One coauthor reported being an employee at GRAIL Inc. No other relevant financial disclosures were reported.

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Key clinical point: Solid organ transplant recipients contribute a disproportionate fraction of pediatric NHL cases, especially DLBCL cases.

Major finding: Incidence of NHL among the pediatric transplant population was 257 times higher at 306 cases per 100,000 person-years (95% CI, 271-344), compared to 1.19 cases per 100,000 person-years (95% CI, 1.12-1.27) in the general pediatric population.

Data source: Retrospective cohort study of children and adolescents in the U.S. transplant registry and 16 cancer registries from around the country between 1990 and 2012.

Disclosures: This study was partially funded by the National Cancer Institute. One coauthor reported being an employee at GRAIL Inc. No other relevant financial disclosures were reported.

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Inflammatory bowel disease rate higher among urban residents

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Children born in urban areas are more likely to develop inflammatory bowel disease (IBD) when they grow up than are children born in rural areas, a Canadian study showed.

With rising rates of IBD in developing nations and urbanized areas, the investigators interpreted these findings as a positive step toward further understanding, and eventually eliminating, the risk of developing IBD.

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“Exposure to the rural environment from birth was consistently associated with a strong protective association with the development of IBD later in life, whether children were exposed continuously for 1-5 years from birth,” according to Eric I. Benchimol, MD, PhD, a gastroenterologist at Children’s Hospital of Eastern Ontario, Ottawa, and his coinvestigators. “These findings demonstrate the importance of early life exposure in altering the risk of IBD, the greater magnitude of effect of this environmental risk factor on the risk of childhood-onset disease, and the importance of adequately defining rurality.”

The retrospective, population-based study gathered a total of 45,567 IBD patients: 6,662 living in rural residences and 38,905 living in urban residences in Nova Scotia, Ontario, Alberta, and Manitoba, Canada.

Patients in rural areas were on average older than urban patients (average age, 43 years vs. 40 years). Rural patients were also, on average, diagnosed later than were urban patients, with an average age at diagnosis of 42 years, compared with 38 years for urban residents.

The IBD incidence rate among urban patients was 33.16/100,000 (95% CI, 27.24-39.08), compared with 30.72/100,000 (95% CI, 23.81-37.64) among rural residents (Am J Gastroenterol. 2017 Jul 25. doi: 10.1038/ajg.2017.208).

Exposure to these environments while growing up was especially significant, with the lowest rate among children younger than 10 years in rural areas (incidence rate ratio, 0.58; 95% CI, 0.43-0.73), followed by adolescents between 10 and 17.9 years (IRR, 0.72; 95% CI, 0.64-0.81), according to investigators.

The incidence rate of IBD among rural children stayed consistent from birth through age 5 years, which may be evidence that development of IBD later in life is correlated with patients’ time in rural areas, the investigators reported.

Although Dr. Benchimol and his coauthors could not point to the exact reason for these results, they said factors such as diet and early exposure to animals, which may help develop useful bacteria that could help fight IBD development, are possible explanations.

“The mechanism by which rurality protects against IBD is uncertain, and may include dietary and lifestyle factors, environmental exposures, or segregation of individuals with different genetic risk profiles,” the investigators wrote. “These effects may be stronger in children because their gut microbiome is in evolution and may be vulnerable to changes in the first 2 years of life.”

This study was limited by certain classification factors, such as what constitutes an urban or rural area, which may have affected the outcomes. A lack of information on the effects of confounding factors, particularly ethnicity, genotype, phenotype, disease severity, or family history also limited this study, the investigators said.

The Janssen Future Leaders in IBD Program funded the study. Investigators reported receiving financial support from or holding leadership positions in the Canadian Institutes of Health Research, the Canadian Child Health Clinician Scientist program, and the Nova Scotia Health Research Foundation.

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Children born in urban areas are more likely to develop inflammatory bowel disease (IBD) when they grow up than are children born in rural areas, a Canadian study showed.

With rising rates of IBD in developing nations and urbanized areas, the investigators interpreted these findings as a positive step toward further understanding, and eventually eliminating, the risk of developing IBD.

copyright varaphoto/Thinkstock
“Exposure to the rural environment from birth was consistently associated with a strong protective association with the development of IBD later in life, whether children were exposed continuously for 1-5 years from birth,” according to Eric I. Benchimol, MD, PhD, a gastroenterologist at Children’s Hospital of Eastern Ontario, Ottawa, and his coinvestigators. “These findings demonstrate the importance of early life exposure in altering the risk of IBD, the greater magnitude of effect of this environmental risk factor on the risk of childhood-onset disease, and the importance of adequately defining rurality.”

The retrospective, population-based study gathered a total of 45,567 IBD patients: 6,662 living in rural residences and 38,905 living in urban residences in Nova Scotia, Ontario, Alberta, and Manitoba, Canada.

Patients in rural areas were on average older than urban patients (average age, 43 years vs. 40 years). Rural patients were also, on average, diagnosed later than were urban patients, with an average age at diagnosis of 42 years, compared with 38 years for urban residents.

The IBD incidence rate among urban patients was 33.16/100,000 (95% CI, 27.24-39.08), compared with 30.72/100,000 (95% CI, 23.81-37.64) among rural residents (Am J Gastroenterol. 2017 Jul 25. doi: 10.1038/ajg.2017.208).

Exposure to these environments while growing up was especially significant, with the lowest rate among children younger than 10 years in rural areas (incidence rate ratio, 0.58; 95% CI, 0.43-0.73), followed by adolescents between 10 and 17.9 years (IRR, 0.72; 95% CI, 0.64-0.81), according to investigators.

The incidence rate of IBD among rural children stayed consistent from birth through age 5 years, which may be evidence that development of IBD later in life is correlated with patients’ time in rural areas, the investigators reported.

Although Dr. Benchimol and his coauthors could not point to the exact reason for these results, they said factors such as diet and early exposure to animals, which may help develop useful bacteria that could help fight IBD development, are possible explanations.

“The mechanism by which rurality protects against IBD is uncertain, and may include dietary and lifestyle factors, environmental exposures, or segregation of individuals with different genetic risk profiles,” the investigators wrote. “These effects may be stronger in children because their gut microbiome is in evolution and may be vulnerable to changes in the first 2 years of life.”

This study was limited by certain classification factors, such as what constitutes an urban or rural area, which may have affected the outcomes. A lack of information on the effects of confounding factors, particularly ethnicity, genotype, phenotype, disease severity, or family history also limited this study, the investigators said.

The Janssen Future Leaders in IBD Program funded the study. Investigators reported receiving financial support from or holding leadership positions in the Canadian Institutes of Health Research, the Canadian Child Health Clinician Scientist program, and the Nova Scotia Health Research Foundation.

 

Children born in urban areas are more likely to develop inflammatory bowel disease (IBD) when they grow up than are children born in rural areas, a Canadian study showed.

With rising rates of IBD in developing nations and urbanized areas, the investigators interpreted these findings as a positive step toward further understanding, and eventually eliminating, the risk of developing IBD.

copyright varaphoto/Thinkstock
“Exposure to the rural environment from birth was consistently associated with a strong protective association with the development of IBD later in life, whether children were exposed continuously for 1-5 years from birth,” according to Eric I. Benchimol, MD, PhD, a gastroenterologist at Children’s Hospital of Eastern Ontario, Ottawa, and his coinvestigators. “These findings demonstrate the importance of early life exposure in altering the risk of IBD, the greater magnitude of effect of this environmental risk factor on the risk of childhood-onset disease, and the importance of adequately defining rurality.”

The retrospective, population-based study gathered a total of 45,567 IBD patients: 6,662 living in rural residences and 38,905 living in urban residences in Nova Scotia, Ontario, Alberta, and Manitoba, Canada.

Patients in rural areas were on average older than urban patients (average age, 43 years vs. 40 years). Rural patients were also, on average, diagnosed later than were urban patients, with an average age at diagnosis of 42 years, compared with 38 years for urban residents.

The IBD incidence rate among urban patients was 33.16/100,000 (95% CI, 27.24-39.08), compared with 30.72/100,000 (95% CI, 23.81-37.64) among rural residents (Am J Gastroenterol. 2017 Jul 25. doi: 10.1038/ajg.2017.208).

Exposure to these environments while growing up was especially significant, with the lowest rate among children younger than 10 years in rural areas (incidence rate ratio, 0.58; 95% CI, 0.43-0.73), followed by adolescents between 10 and 17.9 years (IRR, 0.72; 95% CI, 0.64-0.81), according to investigators.

The incidence rate of IBD among rural children stayed consistent from birth through age 5 years, which may be evidence that development of IBD later in life is correlated with patients’ time in rural areas, the investigators reported.

Although Dr. Benchimol and his coauthors could not point to the exact reason for these results, they said factors such as diet and early exposure to animals, which may help develop useful bacteria that could help fight IBD development, are possible explanations.

“The mechanism by which rurality protects against IBD is uncertain, and may include dietary and lifestyle factors, environmental exposures, or segregation of individuals with different genetic risk profiles,” the investigators wrote. “These effects may be stronger in children because their gut microbiome is in evolution and may be vulnerable to changes in the first 2 years of life.”

This study was limited by certain classification factors, such as what constitutes an urban or rural area, which may have affected the outcomes. A lack of information on the effects of confounding factors, particularly ethnicity, genotype, phenotype, disease severity, or family history also limited this study, the investigators said.

The Janssen Future Leaders in IBD Program funded the study. Investigators reported receiving financial support from or holding leadership positions in the Canadian Institutes of Health Research, the Canadian Child Health Clinician Scientist program, and the Nova Scotia Health Research Foundation.

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Key clinical point: Children who grow up in urban areas are more likely to develop inflammatory bowel disease later.

Major finding: The incidence of IBD among urban residents was 33.16/100,000 (95% CI, 27.24-39.08), compared with 30.72/100,000 (95% CI, 23.81-37.64) among rural residents.

Data source: A population-based, retrospective analysis of residents among four Canadian provinces between 1999 and 2010.

Disclosures: The Janssen Future Leaders in IBD Program sponsored the study. Investigators reported receiving financial support from or holding leadership positions in the Canadian Institutes of Health Research, the Canadian Child Health Clinician Scientist program, and the Nova Scotia Health Research Foundation.

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FDA advisory panel backs safety of new hepatitis B vaccine for adults

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The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee approved licensure for Heplisav-B, a new two-dose recombinant hepatitis B vaccination, after voting that presented data proved the vaccine to be safe for adults 18 and over.

 

At an advisory meeting, after hearing testimony from government researchers and representatives of Dynavax Technologies Corporation, the manufacturer of Heplisav-B, 11 members voted to approve the drug, 1 member voted no, and 3 abstained.

There are more than 20,000 new infections each year, with a reported increase of 21% between 2014 and 2015, according to research presented by William Schaffner, MD, professor of preventative medicine and infectious diseases at Vanderbilt University, Nashville, Tenn.

There are two approved immunizations for hepatitis B: Engerix-B, manufactured by GlaxoSmithKline, and Recombivax HB, by Merck. Both are three-dose, recombinant vaccines produced from yeast cells.

Like the current vaccines, Heplisav-B is a recombinant hepatitis B surface antigen that is derived from yeast; however, this vaccine would be administered in two doses over 1 month, as opposed to three doses over 6 months as is the schedule for currently approved vaccines. Both manufacturing representatives and approving members of the committee stressed this as an important factor due to vaccination dropout rates.

“We have a problem with hepatitis B infections in this country as well as problems with the current vaccines,“ said John Ward, MD, director of the division of viral hepatitis at the Centers for Disease Control and Prevention, “and they happen in these populations where, in terms of data, both of those audiences have problems about going for the second and third dose.”

Patients that drop out before the third dose are at high risk of infection, as only 20%-50% of adults have the appropriate seroprotection after two doses. However, only 54% of patients in a vaccine safety Datalink study reported completing the vaccination series, with 81% reporting having received two doses, according to Dr. Schaffner.

While the committee did approve the safety research as sufficient to approve use of Heplisav-B in adults 18 years and older, members of the committee had an issue with the drug’s correlation with myocardial infarction.

In one of the studies presented, Heplisav-B’s acute myocardial infarction (AMI) events (14 patients) greatly outnumbered those of Engerix-B (1 patient), presenting an AMI relative risk of 6.97.

Dynavax representatives, in response to this concern, presented intention to conduct a postmarketing analysis of the risk of MI in patients who have been administered Heplisav-B, which committee members considered to be a crucial contingency for approval.

“I would like to say I am for the approval of this vaccine, I just think as a statistician that the safety was inconclusive,” said Mei-Ling Ting Lee, PhD, director of the Biostatistics and Risk Assessment Center at the University of Maryland. “But I think for the pharmacological vigilance plan, I think that it will be good to have specific analysis for the myocardial infarction and other risks.”

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License
With approval from the Vaccines and Related Biological Products Advisory Committee, Heplisav-B will be subject to review by the FDA, after which it will seek a recommendation from the CDC’s Advisory Committee on Immunization Practices during its October 2017 meeting.

Dynavax intends to introduce the vaccine commercially in the United States by the middle of 2018, according to a press release.

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The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee approved licensure for Heplisav-B, a new two-dose recombinant hepatitis B vaccination, after voting that presented data proved the vaccine to be safe for adults 18 and over.

 

At an advisory meeting, after hearing testimony from government researchers and representatives of Dynavax Technologies Corporation, the manufacturer of Heplisav-B, 11 members voted to approve the drug, 1 member voted no, and 3 abstained.

There are more than 20,000 new infections each year, with a reported increase of 21% between 2014 and 2015, according to research presented by William Schaffner, MD, professor of preventative medicine and infectious diseases at Vanderbilt University, Nashville, Tenn.

There are two approved immunizations for hepatitis B: Engerix-B, manufactured by GlaxoSmithKline, and Recombivax HB, by Merck. Both are three-dose, recombinant vaccines produced from yeast cells.

Like the current vaccines, Heplisav-B is a recombinant hepatitis B surface antigen that is derived from yeast; however, this vaccine would be administered in two doses over 1 month, as opposed to three doses over 6 months as is the schedule for currently approved vaccines. Both manufacturing representatives and approving members of the committee stressed this as an important factor due to vaccination dropout rates.

“We have a problem with hepatitis B infections in this country as well as problems with the current vaccines,“ said John Ward, MD, director of the division of viral hepatitis at the Centers for Disease Control and Prevention, “and they happen in these populations where, in terms of data, both of those audiences have problems about going for the second and third dose.”

Patients that drop out before the third dose are at high risk of infection, as only 20%-50% of adults have the appropriate seroprotection after two doses. However, only 54% of patients in a vaccine safety Datalink study reported completing the vaccination series, with 81% reporting having received two doses, according to Dr. Schaffner.

While the committee did approve the safety research as sufficient to approve use of Heplisav-B in adults 18 years and older, members of the committee had an issue with the drug’s correlation with myocardial infarction.

In one of the studies presented, Heplisav-B’s acute myocardial infarction (AMI) events (14 patients) greatly outnumbered those of Engerix-B (1 patient), presenting an AMI relative risk of 6.97.

Dynavax representatives, in response to this concern, presented intention to conduct a postmarketing analysis of the risk of MI in patients who have been administered Heplisav-B, which committee members considered to be a crucial contingency for approval.

“I would like to say I am for the approval of this vaccine, I just think as a statistician that the safety was inconclusive,” said Mei-Ling Ting Lee, PhD, director of the Biostatistics and Risk Assessment Center at the University of Maryland. “But I think for the pharmacological vigilance plan, I think that it will be good to have specific analysis for the myocardial infarction and other risks.”

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License
With approval from the Vaccines and Related Biological Products Advisory Committee, Heplisav-B will be subject to review by the FDA, after which it will seek a recommendation from the CDC’s Advisory Committee on Immunization Practices during its October 2017 meeting.

Dynavax intends to introduce the vaccine commercially in the United States by the middle of 2018, according to a press release.


The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee approved licensure for Heplisav-B, a new two-dose recombinant hepatitis B vaccination, after voting that presented data proved the vaccine to be safe for adults 18 and over.

 

At an advisory meeting, after hearing testimony from government researchers and representatives of Dynavax Technologies Corporation, the manufacturer of Heplisav-B, 11 members voted to approve the drug, 1 member voted no, and 3 abstained.

There are more than 20,000 new infections each year, with a reported increase of 21% between 2014 and 2015, according to research presented by William Schaffner, MD, professor of preventative medicine and infectious diseases at Vanderbilt University, Nashville, Tenn.

There are two approved immunizations for hepatitis B: Engerix-B, manufactured by GlaxoSmithKline, and Recombivax HB, by Merck. Both are three-dose, recombinant vaccines produced from yeast cells.

Like the current vaccines, Heplisav-B is a recombinant hepatitis B surface antigen that is derived from yeast; however, this vaccine would be administered in two doses over 1 month, as opposed to three doses over 6 months as is the schedule for currently approved vaccines. Both manufacturing representatives and approving members of the committee stressed this as an important factor due to vaccination dropout rates.

“We have a problem with hepatitis B infections in this country as well as problems with the current vaccines,“ said John Ward, MD, director of the division of viral hepatitis at the Centers for Disease Control and Prevention, “and they happen in these populations where, in terms of data, both of those audiences have problems about going for the second and third dose.”

Patients that drop out before the third dose are at high risk of infection, as only 20%-50% of adults have the appropriate seroprotection after two doses. However, only 54% of patients in a vaccine safety Datalink study reported completing the vaccination series, with 81% reporting having received two doses, according to Dr. Schaffner.

While the committee did approve the safety research as sufficient to approve use of Heplisav-B in adults 18 years and older, members of the committee had an issue with the drug’s correlation with myocardial infarction.

In one of the studies presented, Heplisav-B’s acute myocardial infarction (AMI) events (14 patients) greatly outnumbered those of Engerix-B (1 patient), presenting an AMI relative risk of 6.97.

Dynavax representatives, in response to this concern, presented intention to conduct a postmarketing analysis of the risk of MI in patients who have been administered Heplisav-B, which committee members considered to be a crucial contingency for approval.

“I would like to say I am for the approval of this vaccine, I just think as a statistician that the safety was inconclusive,” said Mei-Ling Ting Lee, PhD, director of the Biostatistics and Risk Assessment Center at the University of Maryland. “But I think for the pharmacological vigilance plan, I think that it will be good to have specific analysis for the myocardial infarction and other risks.”

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License
With approval from the Vaccines and Related Biological Products Advisory Committee, Heplisav-B will be subject to review by the FDA, after which it will seek a recommendation from the CDC’s Advisory Committee on Immunization Practices during its October 2017 meeting.

Dynavax intends to introduce the vaccine commercially in the United States by the middle of 2018, according to a press release.

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