Pain

Here are 5 articles from the April issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Back pain persists in one in five patients

To take the posttest, go to: https://bit.ly/2Uiod8N
Expires January 14, 2019

2. COPD linked to higher in-hospital death rates in patients with PAD

To take the posttest, go to: https://bit.ly/2TFCeJC
Expires January 22, 2019

3. Medicaid youth suicides include more females, younger kids, hanging deaths

To take the posttest, go to: https://bit.ly/2Uleyyp
Expires January 17, 2019

4. Potential antidepressant overprescribing found in 24% of elderly cohort

To take the posttest, go to: https://bit.ly/2HWwcSq
Expires January 24, 2019

5. Perceptions of liver transplantation for ALD are evolving

To take the posttest, go to: https://bit.ly/2OCANuA
Expires January 22, 2019

Here are 5 articles from the April issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Back pain persists in one in five patients

To take the posttest, go to: https://bit.ly/2Uiod8N
Expires January 14, 2019

2. COPD linked to higher in-hospital death rates in patients with PAD

To take the posttest, go to: https://bit.ly/2TFCeJC
Expires January 22, 2019

3. Medicaid youth suicides include more females, younger kids, hanging deaths

To take the posttest, go to: https://bit.ly/2Uleyyp
Expires January 17, 2019

4. Potential antidepressant overprescribing found in 24% of elderly cohort

To take the posttest, go to: https://bit.ly/2HWwcSq
Expires January 24, 2019

5. Perceptions of liver transplantation for ALD are evolving

To take the posttest, go to: https://bit.ly/2OCANuA
Expires January 22, 2019

Here are 5 articles from the April issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Back pain persists in one in five patients

To take the posttest, go to: https://bit.ly/2Uiod8N
Expires January 14, 2019

2. COPD linked to higher in-hospital death rates in patients with PAD

To take the posttest, go to: https://bit.ly/2TFCeJC
Expires January 22, 2019

3. Medicaid youth suicides include more females, younger kids, hanging deaths

To take the posttest, go to: https://bit.ly/2Uleyyp
Expires January 17, 2019

4. Potential antidepressant overprescribing found in 24% of elderly cohort

To take the posttest, go to: https://bit.ly/2HWwcSq
Expires January 24, 2019

5. Perceptions of liver transplantation for ALD are evolving

To take the posttest, go to: https://bit.ly/2OCANuA
Expires January 22, 2019

Most people who could benefit from FDA-approved medications for opioid use disorder do not receive them, and access to those treatments is not equitable, according to a new consensus study report from the National Academies of Sciences, Engineering, and Medicine.

“Methadone, buprenorphine, and extended-release naltrexone are safe and highly effective medications that are already approved by the U.S. Food and Drug Administration to treat OUD,” the report said. “These medications save lives, but the majority of people with OUD in the United States receive no treatment at all.”

The report, called “Medications for Opioid Use Disorder Save Lives,” said a critical factor in addressing the crisis is “confronting the major barriers” to using those medications. It also said additional research will be needed to address opioid use disorder among subpopulations in the United States, such as adolescents, older adults, people with comorbidities, racial and ethnic groups, and people with low socioeconomic status. The National Academies’ report was sponsored by NIDA and SAMHSA.

A few weeks before the release of National Academies report, the National Academy of Medicine (NAM) held a webinar providing details on its Action Collaborative on Countering the U.S. Opioid Epidemic. The collaborative, a partnership of public and private stakeholders, aims to address the opioid crisis through a multidisciplinary, cross-sector effort.

The collaborative is represented by federal agencies, state and local governments, health care systems, provider groups, nonprofits, payers, industry, academia, patient organizations, and communities across about 55 organizations, according to Victor J. Dzau, MD, chair of the Action Collaborative and current NAM president. Over a 2-year period, the collaborative’s goal is to accelerate progress in overcoming the opioid crisis by recognizing the challenges, research gaps, and needs of organizations involved in the crisis and “elevate and accelerate evidence-based, multisectoral, and interprofessional solutions,” he said.

“This is not a problem that can be solved by a single sector. It is truly a whole of society problem,” said Adm. Brett P. Giroir, MD, assistant secretary for health at the U.S. Department of Health and Human Services, said during the webinar. “And the only way that we are going to be able to begin making inroads to reverse the trends of this crisis is if we work together.” Dr. Giroir also serves as cochair of the steering committee for the collaborative.

In its overview of the collaborative, the NAM outlined four working groups developed through a series of surveys and planning meetings that would identify the resources that currently exist to combat the opioid epidemic and determine which resources still need to be developed. In the Health Professional Education and Training Working Group, for example, the objective is to examine what is being taught to health professionals about acute and chronic pain management at an accreditation, certification, and regulatory level to develop educational tools based around knowledge gaps in those areas and analyze how the new resources are affecting health professions after they have been adopted, said Steve Singer, PhD, vice president of education and outreach at the Accreditation Council for Graduate Medical Education and colead of the working group.“Our goal is really to provide guidance and resources across the continuum of health professions and education with an interprofessional – and patient-informed view,” he said.

The Opioid Prescribing Guidelines and Evidence Standards Working Group plans to address the disparities in prescribing and tapering guidelines for acute and chronic pain as well as identify where pain management guidelines in different specialties “cannot be justified,” based on available evidence.

“Further, we think it’s really important to not just have guidelines that will sit on a shelf, but we also want to think about how we can support implementation of these guidelines into practice ... ” said Helen Burstin, MD, MPH, executive vice president and CEO for the Council of Medical Specialty Societies and colead of the working group.

Alonzo L. Plough, PhD, MPH, vice president of research-evaluation-learning at the Robert Wood Johnson Foundation and colead of the Prevention, Treatment, and Recovery Services Working Group, explained that the goal of his group is to identify the “essential elements and components” and best practices of prevention, treatment, and recovery for OUD. He noted that, although the working group will not be able to reach all patient populations affected by OUD, it has discussed targeting vulnerable high-risk populations, such as those involved in the criminal justice system, homeless veterans, mothers, and children.

“This is an ecosystem that requires great concentration and effort to make sure that there are integrated approaches throughout the continuum that work for patients and clients from different walks of life, and I think that our overall guidance is how we can recognize and use evidence to find those approaches and build on them for guidance,” he said.

The Research, Data, and Metrics Needs Working Group is tasked with collaborating with the other groups to obtain currently available information and identify what barriers exist to greater transparency, sharing and interoperability of data as well as what gaps in research currently exist that would further the collaborative’s mission, said Kelly J. Clark, MD, MBA, of the ASAM. “It is simply critical for us to utilize the data that’s out there, to pool it into more actionable information – and then to act on it,” Dr. Clark said.

The NAM is seeking new organizations interested in joining the collaborative as a network organization, which would receive updates and provide input on the collaborative but would not be a part of the working groups.

The first public meeting of the Action Collaborative on Countering the U.S. Opioid Epidemic will take place on April 30, 2019, in Washington.

Most people who could benefit from FDA-approved medications for opioid use disorder do not receive them, and access to those treatments is not equitable, according to a new consensus study report from the National Academies of Sciences, Engineering, and Medicine.

“Methadone, buprenorphine, and extended-release naltrexone are safe and highly effective medications that are already approved by the U.S. Food and Drug Administration to treat OUD,” the report said. “These medications save lives, but the majority of people with OUD in the United States receive no treatment at all.”

The report, called “Medications for Opioid Use Disorder Save Lives,” said a critical factor in addressing the crisis is “confronting the major barriers” to using those medications. It also said additional research will be needed to address opioid use disorder among subpopulations in the United States, such as adolescents, older adults, people with comorbidities, racial and ethnic groups, and people with low socioeconomic status. The National Academies’ report was sponsored by NIDA and SAMHSA.

A few weeks before the release of National Academies report, the National Academy of Medicine (NAM) held a webinar providing details on its Action Collaborative on Countering the U.S. Opioid Epidemic. The collaborative, a partnership of public and private stakeholders, aims to address the opioid crisis through a multidisciplinary, cross-sector effort.

The collaborative is represented by federal agencies, state and local governments, health care systems, provider groups, nonprofits, payers, industry, academia, patient organizations, and communities across about 55 organizations, according to Victor J. Dzau, MD, chair of the Action Collaborative and current NAM president. Over a 2-year period, the collaborative’s goal is to accelerate progress in overcoming the opioid crisis by recognizing the challenges, research gaps, and needs of organizations involved in the crisis and “elevate and accelerate evidence-based, multisectoral, and interprofessional solutions,” he said.

“This is not a problem that can be solved by a single sector. It is truly a whole of society problem,” said Adm. Brett P. Giroir, MD, assistant secretary for health at the U.S. Department of Health and Human Services, said during the webinar. “And the only way that we are going to be able to begin making inroads to reverse the trends of this crisis is if we work together.” Dr. Giroir also serves as cochair of the steering committee for the collaborative.

In its overview of the collaborative, the NAM outlined four working groups developed through a series of surveys and planning meetings that would identify the resources that currently exist to combat the opioid epidemic and determine which resources still need to be developed. In the Health Professional Education and Training Working Group, for example, the objective is to examine what is being taught to health professionals about acute and chronic pain management at an accreditation, certification, and regulatory level to develop educational tools based around knowledge gaps in those areas and analyze how the new resources are affecting health professions after they have been adopted, said Steve Singer, PhD, vice president of education and outreach at the Accreditation Council for Graduate Medical Education and colead of the working group.“Our goal is really to provide guidance and resources across the continuum of health professions and education with an interprofessional – and patient-informed view,” he said.

The Opioid Prescribing Guidelines and Evidence Standards Working Group plans to address the disparities in prescribing and tapering guidelines for acute and chronic pain as well as identify where pain management guidelines in different specialties “cannot be justified,” based on available evidence.

“Further, we think it’s really important to not just have guidelines that will sit on a shelf, but we also want to think about how we can support implementation of these guidelines into practice ... ” said Helen Burstin, MD, MPH, executive vice president and CEO for the Council of Medical Specialty Societies and colead of the working group.

Alonzo L. Plough, PhD, MPH, vice president of research-evaluation-learning at the Robert Wood Johnson Foundation and colead of the Prevention, Treatment, and Recovery Services Working Group, explained that the goal of his group is to identify the “essential elements and components” and best practices of prevention, treatment, and recovery for OUD. He noted that, although the working group will not be able to reach all patient populations affected by OUD, it has discussed targeting vulnerable high-risk populations, such as those involved in the criminal justice system, homeless veterans, mothers, and children.

“This is an ecosystem that requires great concentration and effort to make sure that there are integrated approaches throughout the continuum that work for patients and clients from different walks of life, and I think that our overall guidance is how we can recognize and use evidence to find those approaches and build on them for guidance,” he said.

The Research, Data, and Metrics Needs Working Group is tasked with collaborating with the other groups to obtain currently available information and identify what barriers exist to greater transparency, sharing and interoperability of data as well as what gaps in research currently exist that would further the collaborative’s mission, said Kelly J. Clark, MD, MBA, of the ASAM. “It is simply critical for us to utilize the data that’s out there, to pool it into more actionable information – and then to act on it,” Dr. Clark said.

The NAM is seeking new organizations interested in joining the collaborative as a network organization, which would receive updates and provide input on the collaborative but would not be a part of the working groups.

The first public meeting of the Action Collaborative on Countering the U.S. Opioid Epidemic will take place on April 30, 2019, in Washington.

Most people who could benefit from FDA-approved medications for opioid use disorder do not receive them, and access to those treatments is not equitable, according to a new consensus study report from the National Academies of Sciences, Engineering, and Medicine.

“Methadone, buprenorphine, and extended-release naltrexone are safe and highly effective medications that are already approved by the U.S. Food and Drug Administration to treat OUD,” the report said. “These medications save lives, but the majority of people with OUD in the United States receive no treatment at all.”

The report, called “Medications for Opioid Use Disorder Save Lives,” said a critical factor in addressing the crisis is “confronting the major barriers” to using those medications. It also said additional research will be needed to address opioid use disorder among subpopulations in the United States, such as adolescents, older adults, people with comorbidities, racial and ethnic groups, and people with low socioeconomic status. The National Academies’ report was sponsored by NIDA and SAMHSA.

A few weeks before the release of National Academies report, the National Academy of Medicine (NAM) held a webinar providing details on its Action Collaborative on Countering the U.S. Opioid Epidemic. The collaborative, a partnership of public and private stakeholders, aims to address the opioid crisis through a multidisciplinary, cross-sector effort.

The collaborative is represented by federal agencies, state and local governments, health care systems, provider groups, nonprofits, payers, industry, academia, patient organizations, and communities across about 55 organizations, according to Victor J. Dzau, MD, chair of the Action Collaborative and current NAM president. Over a 2-year period, the collaborative’s goal is to accelerate progress in overcoming the opioid crisis by recognizing the challenges, research gaps, and needs of organizations involved in the crisis and “elevate and accelerate evidence-based, multisectoral, and interprofessional solutions,” he said.

“This is not a problem that can be solved by a single sector. It is truly a whole of society problem,” said Adm. Brett P. Giroir, MD, assistant secretary for health at the U.S. Department of Health and Human Services, said during the webinar. “And the only way that we are going to be able to begin making inroads to reverse the trends of this crisis is if we work together.” Dr. Giroir also serves as cochair of the steering committee for the collaborative.

In its overview of the collaborative, the NAM outlined four working groups developed through a series of surveys and planning meetings that would identify the resources that currently exist to combat the opioid epidemic and determine which resources still need to be developed. In the Health Professional Education and Training Working Group, for example, the objective is to examine what is being taught to health professionals about acute and chronic pain management at an accreditation, certification, and regulatory level to develop educational tools based around knowledge gaps in those areas and analyze how the new resources are affecting health professions after they have been adopted, said Steve Singer, PhD, vice president of education and outreach at the Accreditation Council for Graduate Medical Education and colead of the working group.“Our goal is really to provide guidance and resources across the continuum of health professions and education with an interprofessional – and patient-informed view,” he said.

The Opioid Prescribing Guidelines and Evidence Standards Working Group plans to address the disparities in prescribing and tapering guidelines for acute and chronic pain as well as identify where pain management guidelines in different specialties “cannot be justified,” based on available evidence.

“Further, we think it’s really important to not just have guidelines that will sit on a shelf, but we also want to think about how we can support implementation of these guidelines into practice ... ” said Helen Burstin, MD, MPH, executive vice president and CEO for the Council of Medical Specialty Societies and colead of the working group.

Alonzo L. Plough, PhD, MPH, vice president of research-evaluation-learning at the Robert Wood Johnson Foundation and colead of the Prevention, Treatment, and Recovery Services Working Group, explained that the goal of his group is to identify the “essential elements and components” and best practices of prevention, treatment, and recovery for OUD. He noted that, although the working group will not be able to reach all patient populations affected by OUD, it has discussed targeting vulnerable high-risk populations, such as those involved in the criminal justice system, homeless veterans, mothers, and children.

“This is an ecosystem that requires great concentration and effort to make sure that there are integrated approaches throughout the continuum that work for patients and clients from different walks of life, and I think that our overall guidance is how we can recognize and use evidence to find those approaches and build on them for guidance,” he said.

The Research, Data, and Metrics Needs Working Group is tasked with collaborating with the other groups to obtain currently available information and identify what barriers exist to greater transparency, sharing and interoperability of data as well as what gaps in research currently exist that would further the collaborative’s mission, said Kelly J. Clark, MD, MBA, of the ASAM. “It is simply critical for us to utilize the data that’s out there, to pool it into more actionable information – and then to act on it,” Dr. Clark said.

The NAM is seeking new organizations interested in joining the collaborative as a network organization, which would receive updates and provide input on the collaborative but would not be a part of the working groups.

The first public meeting of the Action Collaborative on Countering the U.S. Opioid Epidemic will take place on April 30, 2019, in Washington.

LAS VEGAS – Communicate with your pharmacists to keep nurse phone calls and empty medication-dispensing devices at bay. Watch out for overlapping medication orders. Beware of gabapentin mishaps, and embrace Tylenol – but not always.

Randy Dotinga/MDedge News

April Smith, PharmD, associate professor of pharmacy practice at Creighton University, Omaha, offered these tips about postoperative care to surgeons at the 2019 Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

“We’re probably one of the most underutilized professions you have on your team,” she said, adding that “we have to know what you’re doing to help you.”

As she explained, “if you’re going to have a new order set, let us know that, so we can be your allies in helping nurses and other people understand why we’re doing what we’re doing. I’m on the same floor, and the nurses are coming up to me and asking me questions. If I can explain to them why we’re doing these things, they’ll get on board a lot faster and save you a lot of phone calls. I know you’re surgeons and you hate that [phone calls].”

Better communication with pharmacists can also boost the stocking of enhanced-recovery medications in automatic dispensing machines, she said, so they’re ready when patients need them.

Dr. Smith offered these tips about specific postsurgery medications:

• Scopolamine is a “great drug for post-op vomiting and nausea,” Dr. Smith said. But do not use it in patients over 65, and it’s contraindicated in glaucoma. Beware of these notable side effects: Blurry vision, constipation, and urinary retention. Dexamethasone and ondansetron can be used as an alternative, she said.
• Use of the blood thinner enoxaparin after discharge may become more common as surgical stays become shorter, Dr. Smith said. She urged surgeons to keep its cost in mind: a 10-day course can be as little as $2 with Medicaid or as much as $140 (a cash price for patients without coverage).
• Make sure to adjust medications based on preoperative or intraoperative doses, she said, to avoid endangering patients by inadvertently doubling up on doses. And watch out for previous use of gabapentin, which is part of enhanced-recovery protocols. Patients who take the drug at home should be put back on their typical dose.
• Also, she warned, “don’t give gabapentin to someone who’s never had it before plus an opioid.” This, she said, can cause delirium.
• Consider starting liquids the night of surgery so patients can begin taking their home medications such as sleep, chronic pain, and psychiatric drugs. Patients will be more stable and satisfied, Dr. Smith said.
• Don’t prescribe hard-to-find medications like oxycodone oral solution or oral ketorolac. These drugs will send patients from pharmacy to pharmacy in search of them, Dr. Smith said.
• Embrace a “Meds to Beds” program if possible. These programs enlist on-site pharmacies to deliver medications to bedside for patients to take home.
• Consider Tylenol as a postoperative painkiller with scheduled doses and be aware that you can prescribe the over-the-counter adult liquid form. However, Dr. Smith cautioned that Tylenol is “not great” on an as-needed basis. Gabapentin and celecoxib (unless contraindicated) are also helpful for postop pain relief, and they’re inexpensive, she said. Three to five days should be enough in most minimally invasive surgeries.
• Don’t overprescribe opioids. “The more we prescribe, the more they will consume,” Dr. Smith said. Check the American College of Surgeons guidelines regarding the ideal number of postsurgery, 5-mg doses of oxycodone to prescribe to opioid-naive patients at discharge. No more than 10 or 15 pills are recommended for several types of general surgery (J Amer Coll Surg. 2018;227:411-8).

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Smith reports no relevant disclosures.

LAS VEGAS – Communicate with your pharmacists to keep nurse phone calls and empty medication-dispensing devices at bay. Watch out for overlapping medication orders. Beware of gabapentin mishaps, and embrace Tylenol – but not always.

Randy Dotinga/MDedge News

April Smith, PharmD, associate professor of pharmacy practice at Creighton University, Omaha, offered these tips about postoperative care to surgeons at the 2019 Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

“We’re probably one of the most underutilized professions you have on your team,” she said, adding that “we have to know what you’re doing to help you.”

As she explained, “if you’re going to have a new order set, let us know that, so we can be your allies in helping nurses and other people understand why we’re doing what we’re doing. I’m on the same floor, and the nurses are coming up to me and asking me questions. If I can explain to them why we’re doing these things, they’ll get on board a lot faster and save you a lot of phone calls. I know you’re surgeons and you hate that [phone calls].”

Better communication with pharmacists can also boost the stocking of enhanced-recovery medications in automatic dispensing machines, she said, so they’re ready when patients need them.

Dr. Smith offered these tips about specific postsurgery medications:

• Scopolamine is a “great drug for post-op vomiting and nausea,” Dr. Smith said. But do not use it in patients over 65, and it’s contraindicated in glaucoma. Beware of these notable side effects: Blurry vision, constipation, and urinary retention. Dexamethasone and ondansetron can be used as an alternative, she said.
• Use of the blood thinner enoxaparin after discharge may become more common as surgical stays become shorter, Dr. Smith said. She urged surgeons to keep its cost in mind: a 10-day course can be as little as $2 with Medicaid or as much as $140 (a cash price for patients without coverage).
• Make sure to adjust medications based on preoperative or intraoperative doses, she said, to avoid endangering patients by inadvertently doubling up on doses. And watch out for previous use of gabapentin, which is part of enhanced-recovery protocols. Patients who take the drug at home should be put back on their typical dose.
• Also, she warned, “don’t give gabapentin to someone who’s never had it before plus an opioid.” This, she said, can cause delirium.
• Consider starting liquids the night of surgery so patients can begin taking their home medications such as sleep, chronic pain, and psychiatric drugs. Patients will be more stable and satisfied, Dr. Smith said.
• Don’t prescribe hard-to-find medications like oxycodone oral solution or oral ketorolac. These drugs will send patients from pharmacy to pharmacy in search of them, Dr. Smith said.
• Embrace a “Meds to Beds” program if possible. These programs enlist on-site pharmacies to deliver medications to bedside for patients to take home.
• Consider Tylenol as a postoperative painkiller with scheduled doses and be aware that you can prescribe the over-the-counter adult liquid form. However, Dr. Smith cautioned that Tylenol is “not great” on an as-needed basis. Gabapentin and celecoxib (unless contraindicated) are also helpful for postop pain relief, and they’re inexpensive, she said. Three to five days should be enough in most minimally invasive surgeries.
• Don’t overprescribe opioids. “The more we prescribe, the more they will consume,” Dr. Smith said. Check the American College of Surgeons guidelines regarding the ideal number of postsurgery, 5-mg doses of oxycodone to prescribe to opioid-naive patients at discharge. No more than 10 or 15 pills are recommended for several types of general surgery (J Amer Coll Surg. 2018;227:411-8).

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Smith reports no relevant disclosures.

LAS VEGAS – Communicate with your pharmacists to keep nurse phone calls and empty medication-dispensing devices at bay. Watch out for overlapping medication orders. Beware of gabapentin mishaps, and embrace Tylenol – but not always.

Randy Dotinga/MDedge News

April Smith, PharmD, associate professor of pharmacy practice at Creighton University, Omaha, offered these tips about postoperative care to surgeons at the 2019 Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

“We’re probably one of the most underutilized professions you have on your team,” she said, adding that “we have to know what you’re doing to help you.”

As she explained, “if you’re going to have a new order set, let us know that, so we can be your allies in helping nurses and other people understand why we’re doing what we’re doing. I’m on the same floor, and the nurses are coming up to me and asking me questions. If I can explain to them why we’re doing these things, they’ll get on board a lot faster and save you a lot of phone calls. I know you’re surgeons and you hate that [phone calls].”

Better communication with pharmacists can also boost the stocking of enhanced-recovery medications in automatic dispensing machines, she said, so they’re ready when patients need them.

Dr. Smith offered these tips about specific postsurgery medications:

• Scopolamine is a “great drug for post-op vomiting and nausea,” Dr. Smith said. But do not use it in patients over 65, and it’s contraindicated in glaucoma. Beware of these notable side effects: Blurry vision, constipation, and urinary retention. Dexamethasone and ondansetron can be used as an alternative, she said.
• Use of the blood thinner enoxaparin after discharge may become more common as surgical stays become shorter, Dr. Smith said. She urged surgeons to keep its cost in mind: a 10-day course can be as little as $2 with Medicaid or as much as $140 (a cash price for patients without coverage).
• Make sure to adjust medications based on preoperative or intraoperative doses, she said, to avoid endangering patients by inadvertently doubling up on doses. And watch out for previous use of gabapentin, which is part of enhanced-recovery protocols. Patients who take the drug at home should be put back on their typical dose.
• Also, she warned, “don’t give gabapentin to someone who’s never had it before plus an opioid.” This, she said, can cause delirium.
• Consider starting liquids the night of surgery so patients can begin taking their home medications such as sleep, chronic pain, and psychiatric drugs. Patients will be more stable and satisfied, Dr. Smith said.
• Don’t prescribe hard-to-find medications like oxycodone oral solution or oral ketorolac. These drugs will send patients from pharmacy to pharmacy in search of them, Dr. Smith said.
• Embrace a “Meds to Beds” program if possible. These programs enlist on-site pharmacies to deliver medications to bedside for patients to take home.
• Consider Tylenol as a postoperative painkiller with scheduled doses and be aware that you can prescribe the over-the-counter adult liquid form. However, Dr. Smith cautioned that Tylenol is “not great” on an as-needed basis. Gabapentin and celecoxib (unless contraindicated) are also helpful for postop pain relief, and they’re inexpensive, she said. Three to five days should be enough in most minimally invasive surgeries.
• Don’t overprescribe opioids. “The more we prescribe, the more they will consume,” Dr. Smith said. Check the American College of Surgeons guidelines regarding the ideal number of postsurgery, 5-mg doses of oxycodone to prescribe to opioid-naive patients at discharge. No more than 10 or 15 pills are recommended for several types of general surgery (J Amer Coll Surg. 2018;227:411-8).

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Smith reports no relevant disclosures.

LAS VEGAS – Once reserved for the most obese patients, bariatric surgery is on the road to becoming an option for millions of Americans who are just a step beyond overweight, even those with a body mass index as low as 30 kg/m².

In regard to patients with lower levels of obesity, “we should be intervening in this chronic disease earlier rather than later,” said Stacy A. Brethauer, MD, professor of surgery at the Ohio State University, Columbus, in a presentation about new standards for bariatric surgery at the 2019 Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

Bariatric treatment “should be offered after nonsurgical [weight-loss] therapy has failed,” he said. “That’s not where you stop. You continue to escalate as you would for heart disease or cancer.”

As Dr. Brethauer noted, research suggests that all categories of obesity – including so-called class 1 obesity (defined as a BMI from 30.0 to 34.9 kg/m²) – boost the risk of multiple diseases, including hypertension, coronary artery disease, congestive heart failure, stroke, asthma, pulmonary embolism, gallbladder disease, several types of cancer, osteoarthritis, knee pain and chronic back pain.

“There is no question that class 1 obesity is clearly putting people at risk,” he said. “Ultimately, you can conclude from all this evidence that class 1 is a chronic disease, and it deserves to be treated effectively.”

There are, of course, various nonsurgical treatments for obesity, including diet and exercise and pharmacotherapy. However, systematic reviews have found that people find it extremely difficult to keep the weight off after 1 year regardless of the strategy they adopt.

Beyond a year, Dr. Brethauer said, “you get poor maintenance of weight control, and you get poor control of metabolic burden. You don’t have a durable efficacy.”

In the past, bariatric surgery wasn’t considered an option for patients with class 1 obesity. It’s traditionally been reserved for patients with BMIs at or above 35 kg/m². But this standard has evolved in recent years.

In 2018, Dr. Brethauer coauthored an updated position statement by the American Society for Metabolic and Bariatric Surgery that encouraged bariatric surgery in certain mildly obese patients.

“For most people with class I obesity,” the statement on bariatric surgery states, “it is clear that the nonsurgical group of therapies will not provide a durable solution to their disease of obesity.”

The statement went on to say that “surgical intervention should be considered after failure of nonsurgical treatments” in the class 1 population.

Bariatric surgery in the class 1 population does more than reduce obesity, Dr. Brethauer said. “Over the last 5 years or so, a large body of literature has emerged,” he said, and both systematic reviews and randomized trails have shown significant postsurgery improvements in comorbidities such as diabetes.

“It’s important to emphasize that these patients don’t become underweight,” he said. “The body finds a healthy set point. They don’t become underweight or malnourished because you’re operating on a lower-weight group.”

Are weight-loss operations safe in class 1 patients? The American Society for Metabolic and Bariatric Surgery statement says that research has found “bariatric surgery is associated with modest morbidity and very low mortality in patients with class I obesity.”

In fact, Dr. Brethauer said, the mortality rate in this population is “less than gallbladder surgery, less than hip surgery, less than hysterectomy, less than knee surgery – operations people are being referred for and undergoing all the time.”

He added: “The case can be made very clearly based on this data that these operations are safe in this patient population. Not only are they safe, they have durable and significant impact on comorbidities.”

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Brethauer discloses relationships with Medtronic (speaker) and GI Windows (consultant).

LAS VEGAS – Once reserved for the most obese patients, bariatric surgery is on the road to becoming an option for millions of Americans who are just a step beyond overweight, even those with a body mass index as low as 30 kg/m².

In regard to patients with lower levels of obesity, “we should be intervening in this chronic disease earlier rather than later,” said Stacy A. Brethauer, MD, professor of surgery at the Ohio State University, Columbus, in a presentation about new standards for bariatric surgery at the 2019 Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

Bariatric treatment “should be offered after nonsurgical [weight-loss] therapy has failed,” he said. “That’s not where you stop. You continue to escalate as you would for heart disease or cancer.”

As Dr. Brethauer noted, research suggests that all categories of obesity – including so-called class 1 obesity (defined as a BMI from 30.0 to 34.9 kg/m²) – boost the risk of multiple diseases, including hypertension, coronary artery disease, congestive heart failure, stroke, asthma, pulmonary embolism, gallbladder disease, several types of cancer, osteoarthritis, knee pain and chronic back pain.

“There is no question that class 1 obesity is clearly putting people at risk,” he said. “Ultimately, you can conclude from all this evidence that class 1 is a chronic disease, and it deserves to be treated effectively.”

There are, of course, various nonsurgical treatments for obesity, including diet and exercise and pharmacotherapy. However, systematic reviews have found that people find it extremely difficult to keep the weight off after 1 year regardless of the strategy they adopt.

Beyond a year, Dr. Brethauer said, “you get poor maintenance of weight control, and you get poor control of metabolic burden. You don’t have a durable efficacy.”

In the past, bariatric surgery wasn’t considered an option for patients with class 1 obesity. It’s traditionally been reserved for patients with BMIs at or above 35 kg/m². But this standard has evolved in recent years.

In 2018, Dr. Brethauer coauthored an updated position statement by the American Society for Metabolic and Bariatric Surgery that encouraged bariatric surgery in certain mildly obese patients.

“For most people with class I obesity,” the statement on bariatric surgery states, “it is clear that the nonsurgical group of therapies will not provide a durable solution to their disease of obesity.”

The statement went on to say that “surgical intervention should be considered after failure of nonsurgical treatments” in the class 1 population.

Bariatric surgery in the class 1 population does more than reduce obesity, Dr. Brethauer said. “Over the last 5 years or so, a large body of literature has emerged,” he said, and both systematic reviews and randomized trails have shown significant postsurgery improvements in comorbidities such as diabetes.

“It’s important to emphasize that these patients don’t become underweight,” he said. “The body finds a healthy set point. They don’t become underweight or malnourished because you’re operating on a lower-weight group.”

Are weight-loss operations safe in class 1 patients? The American Society for Metabolic and Bariatric Surgery statement says that research has found “bariatric surgery is associated with modest morbidity and very low mortality in patients with class I obesity.”

In fact, Dr. Brethauer said, the mortality rate in this population is “less than gallbladder surgery, less than hip surgery, less than hysterectomy, less than knee surgery – operations people are being referred for and undergoing all the time.”

He added: “The case can be made very clearly based on this data that these operations are safe in this patient population. Not only are they safe, they have durable and significant impact on comorbidities.”

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Brethauer discloses relationships with Medtronic (speaker) and GI Windows (consultant).

LAS VEGAS – Once reserved for the most obese patients, bariatric surgery is on the road to becoming an option for millions of Americans who are just a step beyond overweight, even those with a body mass index as low as 30 kg/m².

In regard to patients with lower levels of obesity, “we should be intervening in this chronic disease earlier rather than later,” said Stacy A. Brethauer, MD, professor of surgery at the Ohio State University, Columbus, in a presentation about new standards for bariatric surgery at the 2019 Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

Bariatric treatment “should be offered after nonsurgical [weight-loss] therapy has failed,” he said. “That’s not where you stop. You continue to escalate as you would for heart disease or cancer.”

As Dr. Brethauer noted, research suggests that all categories of obesity – including so-called class 1 obesity (defined as a BMI from 30.0 to 34.9 kg/m²) – boost the risk of multiple diseases, including hypertension, coronary artery disease, congestive heart failure, stroke, asthma, pulmonary embolism, gallbladder disease, several types of cancer, osteoarthritis, knee pain and chronic back pain.

“There is no question that class 1 obesity is clearly putting people at risk,” he said. “Ultimately, you can conclude from all this evidence that class 1 is a chronic disease, and it deserves to be treated effectively.”

There are, of course, various nonsurgical treatments for obesity, including diet and exercise and pharmacotherapy. However, systematic reviews have found that people find it extremely difficult to keep the weight off after 1 year regardless of the strategy they adopt.

Beyond a year, Dr. Brethauer said, “you get poor maintenance of weight control, and you get poor control of metabolic burden. You don’t have a durable efficacy.”

In the past, bariatric surgery wasn’t considered an option for patients with class 1 obesity. It’s traditionally been reserved for patients with BMIs at or above 35 kg/m². But this standard has evolved in recent years.

In 2018, Dr. Brethauer coauthored an updated position statement by the American Society for Metabolic and Bariatric Surgery that encouraged bariatric surgery in certain mildly obese patients.

“For most people with class I obesity,” the statement on bariatric surgery states, “it is clear that the nonsurgical group of therapies will not provide a durable solution to their disease of obesity.”

The statement went on to say that “surgical intervention should be considered after failure of nonsurgical treatments” in the class 1 population.

Bariatric surgery in the class 1 population does more than reduce obesity, Dr. Brethauer said. “Over the last 5 years or so, a large body of literature has emerged,” he said, and both systematic reviews and randomized trails have shown significant postsurgery improvements in comorbidities such as diabetes.

“It’s important to emphasize that these patients don’t become underweight,” he said. “The body finds a healthy set point. They don’t become underweight or malnourished because you’re operating on a lower-weight group.”

Are weight-loss operations safe in class 1 patients? The American Society for Metabolic and Bariatric Surgery statement says that research has found “bariatric surgery is associated with modest morbidity and very low mortality in patients with class I obesity.”

In fact, Dr. Brethauer said, the mortality rate in this population is “less than gallbladder surgery, less than hip surgery, less than hysterectomy, less than knee surgery – operations people are being referred for and undergoing all the time.”

He added: “The case can be made very clearly based on this data that these operations are safe in this patient population. Not only are they safe, they have durable and significant impact on comorbidities.”

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Brethauer discloses relationships with Medtronic (speaker) and GI Windows (consultant).

Many clinicians are prescribing the gabapentinoid drugs pregabalin (Lyrica) and gabapentin (Neurontin) for off-label treatment of pain, despite a lack of supporting data or approval from the Food and Drug Administration, according to investigators.

Over the past 15 years, use of gabapentinoids has tripled, a level of growth that cannot be explained by prescriptions for approved indications, reported coauthors Christopher W. Goodman, MD, and Allan S. Brett, MD, of the University of South Carolina, Columbia. Instead, clinicians are turning to gabapentinoids, partly as an option to substitute for opioids, which now have greater prescribing restrictions as a result of the current opioid crisis.

Ingram Publishing/Thinkstock

Although clinicians may cite guidelines that support off-label use of gabapentinoids for pain, the investigators warned that many of these recommendations stand on shaky ground.

“Clinicians who prescribe gabapentinoids off-label for pain should be aware of the limited evidence and should acknowledge to patients that potential benefits are uncertain for most off-label uses,” the investigators wrote in a clinical review published online March 25 in JAMA Internal Medicine.

The investigators narrowed down 677 publications to 84 papers describing the use of gabapentinoids for outpatient noncancer pain syndromes for which they are not FDA approved; 54 for gabapentin and 30 for pregabalin. In the domain of analgesia, both agents are currently FDA-approved for postherpetic neuralgia, while pregabalin is additionally approved for pain associated with fibromyalgia and neuropathic pain from diabetic neuropathy and spinal cord injury. Indications in reviewed studies ranged broadly, from conditions somewhat related to those currently approved, such as unspecified neuropathy, to dissimilar conditions, such as chronic pancreatitis and burn injury.

The investigators summarized findings from randomized clinical trials while using case studies to illustrate potential problems with off-label use. In addition, they reviewed the history of gabapentinoids and sources of recommendations for off-label use, such as guidelines and previous review articles.

Six major findings were reported: (1) evidence supporting gabapentin for diabetic neuropathy pain is “mixed at best”; (2) evidence supporting gabapentin for nondiabetic neuropathies is very limited; (3) evidence does not support gabapentinoids for radiculopathy or low back pain; (4) gabapentin has minimal benefit for fibromyalgia pain, based on minimal evidence; (5) evidence does not support gabapentinoids for acute herpes zoster pain; and (6) in almost all studies for other painful indications, gabapentinoids were ineffective or “associated with small analgesic effects that were statistically significant but of questionable clinical importance.”

Case studies complemented this overview, highlighting related clinical dilemmas that the investigators encounter “repeatedly” during inpatient and outpatient care. Along with off-label use, such as gabapentinoid prescriptions for acute sciatica, the investigators reported cases in which neuropathy was diagnosed in place of nonspecific lower body pain to facilitate gabapentin prescription. They also described apparent disregard for risks of polypharmacy in prescriptions for elderly patients and rote use of gabapentinoids in patients with diabetic neuropathy who did not have sufficient discomfort to warrant prescription.

The investigators also cited a number of problems with the language of reviews and guidelines involving gabapentinoids.

“The wording in many guidelines and review articles reinforces an inflated view of gabapentinoid effectiveness or fails to distinguish carefully between evidence-based and non–evidence-based recommendations,” they wrote, adding that clinicians may have misconceptions about neuropathic pain. “One unintended effect of the broad definition [of neuropathic pain] might be to create a mistaken perception that an effective drug for one type of neuropathic pain is effective for all neuropathic pain, regardless of underlying etiology or mechanism,” the investigators suggested.

Another facet of prescribing behavior could be explained in economic terms. Pregabalin, sold under the brand name Lyrica, is considerably more expensive than gabapentin; however, the investigators warned that the similarity of these agents does not equate with interchangeability, noting differences in bioavailability and rate of absorption.

“Unfortunately, published direct comparisons between the 2 drugs in double-blind studies of patients with chronic noncancer pain are virtually nonexistent,” the investigators wrote.

In addition to questionable effectiveness of gabapentinoids for off-label chronic noncancer pain syndromes, Dr. Goodman and Dr. Brett noted that the drugs produce a “substantial incidence of dizziness, somnolence, and gait disturbance.”

They also described a new trend of gabapentinoid abuse and diversion, which may not be surprising, considering that gabapentinoids are reported to augment opioid-induced euphoria.

“Evidence of misuse of gabapentinoids is accumulating and likely related to the opioid epidemic. A recent review article reported an overall population prevalence of gabapentinoid ‘misuse and abuse’ as high as 1%, with substantially higher prevalence noted among patients with opioid use disorders,” the investigators wrote. “This trend is troubling, particularly because concomitant use of opioids and gabapentinoids is associated with increased odds of opioid-related death. Whether these concerns apply to patients receiving long-term prescribed opioid therapy is unclear.”

In the era of the opioid crisis, the investigators acknowledged that many clinicians have serious concerns about adequately treating chronic noncancer pain.

“Comprehensive management of pain in primary care settings is difficult. It requires time and resources that are frequently unavailable,” the investigators wrote. “Many patients with chronic pain have limited or no access to high-quality pain practices or to nonpharmacologic interventions, such as cognitive behavior therapy.”

The investigators reported no external funding or conflicts of interest.

SOURCE: Goodman CW et al. JAMA Intern Med. 2019 Mar 25. doi: 10.1001/jamainternmed.2019.0086

Many clinicians are prescribing the gabapentinoid drugs pregabalin (Lyrica) and gabapentin (Neurontin) for off-label treatment of pain, despite a lack of supporting data or approval from the Food and Drug Administration, according to investigators.

Over the past 15 years, use of gabapentinoids has tripled, a level of growth that cannot be explained by prescriptions for approved indications, reported coauthors Christopher W. Goodman, MD, and Allan S. Brett, MD, of the University of South Carolina, Columbia. Instead, clinicians are turning to gabapentinoids, partly as an option to substitute for opioids, which now have greater prescribing restrictions as a result of the current opioid crisis.

Ingram Publishing/Thinkstock

Although clinicians may cite guidelines that support off-label use of gabapentinoids for pain, the investigators warned that many of these recommendations stand on shaky ground.

“Clinicians who prescribe gabapentinoids off-label for pain should be aware of the limited evidence and should acknowledge to patients that potential benefits are uncertain for most off-label uses,” the investigators wrote in a clinical review published online March 25 in JAMA Internal Medicine.

The investigators narrowed down 677 publications to 84 papers describing the use of gabapentinoids for outpatient noncancer pain syndromes for which they are not FDA approved; 54 for gabapentin and 30 for pregabalin. In the domain of analgesia, both agents are currently FDA-approved for postherpetic neuralgia, while pregabalin is additionally approved for pain associated with fibromyalgia and neuropathic pain from diabetic neuropathy and spinal cord injury. Indications in reviewed studies ranged broadly, from conditions somewhat related to those currently approved, such as unspecified neuropathy, to dissimilar conditions, such as chronic pancreatitis and burn injury.

The investigators summarized findings from randomized clinical trials while using case studies to illustrate potential problems with off-label use. In addition, they reviewed the history of gabapentinoids and sources of recommendations for off-label use, such as guidelines and previous review articles.

Six major findings were reported: (1) evidence supporting gabapentin for diabetic neuropathy pain is “mixed at best”; (2) evidence supporting gabapentin for nondiabetic neuropathies is very limited; (3) evidence does not support gabapentinoids for radiculopathy or low back pain; (4) gabapentin has minimal benefit for fibromyalgia pain, based on minimal evidence; (5) evidence does not support gabapentinoids for acute herpes zoster pain; and (6) in almost all studies for other painful indications, gabapentinoids were ineffective or “associated with small analgesic effects that were statistically significant but of questionable clinical importance.”

Case studies complemented this overview, highlighting related clinical dilemmas that the investigators encounter “repeatedly” during inpatient and outpatient care. Along with off-label use, such as gabapentinoid prescriptions for acute sciatica, the investigators reported cases in which neuropathy was diagnosed in place of nonspecific lower body pain to facilitate gabapentin prescription. They also described apparent disregard for risks of polypharmacy in prescriptions for elderly patients and rote use of gabapentinoids in patients with diabetic neuropathy who did not have sufficient discomfort to warrant prescription.

The investigators also cited a number of problems with the language of reviews and guidelines involving gabapentinoids.

“The wording in many guidelines and review articles reinforces an inflated view of gabapentinoid effectiveness or fails to distinguish carefully between evidence-based and non–evidence-based recommendations,” they wrote, adding that clinicians may have misconceptions about neuropathic pain. “One unintended effect of the broad definition [of neuropathic pain] might be to create a mistaken perception that an effective drug for one type of neuropathic pain is effective for all neuropathic pain, regardless of underlying etiology or mechanism,” the investigators suggested.

Another facet of prescribing behavior could be explained in economic terms. Pregabalin, sold under the brand name Lyrica, is considerably more expensive than gabapentin; however, the investigators warned that the similarity of these agents does not equate with interchangeability, noting differences in bioavailability and rate of absorption.

“Unfortunately, published direct comparisons between the 2 drugs in double-blind studies of patients with chronic noncancer pain are virtually nonexistent,” the investigators wrote.

In addition to questionable effectiveness of gabapentinoids for off-label chronic noncancer pain syndromes, Dr. Goodman and Dr. Brett noted that the drugs produce a “substantial incidence of dizziness, somnolence, and gait disturbance.”

They also described a new trend of gabapentinoid abuse and diversion, which may not be surprising, considering that gabapentinoids are reported to augment opioid-induced euphoria.

“Evidence of misuse of gabapentinoids is accumulating and likely related to the opioid epidemic. A recent review article reported an overall population prevalence of gabapentinoid ‘misuse and abuse’ as high as 1%, with substantially higher prevalence noted among patients with opioid use disorders,” the investigators wrote. “This trend is troubling, particularly because concomitant use of opioids and gabapentinoids is associated with increased odds of opioid-related death. Whether these concerns apply to patients receiving long-term prescribed opioid therapy is unclear.”

In the era of the opioid crisis, the investigators acknowledged that many clinicians have serious concerns about adequately treating chronic noncancer pain.

“Comprehensive management of pain in primary care settings is difficult. It requires time and resources that are frequently unavailable,” the investigators wrote. “Many patients with chronic pain have limited or no access to high-quality pain practices or to nonpharmacologic interventions, such as cognitive behavior therapy.”

The investigators reported no external funding or conflicts of interest.

SOURCE: Goodman CW et al. JAMA Intern Med. 2019 Mar 25. doi: 10.1001/jamainternmed.2019.0086

Many clinicians are prescribing the gabapentinoid drugs pregabalin (Lyrica) and gabapentin (Neurontin) for off-label treatment of pain, despite a lack of supporting data or approval from the Food and Drug Administration, according to investigators.

Over the past 15 years, use of gabapentinoids has tripled, a level of growth that cannot be explained by prescriptions for approved indications, reported coauthors Christopher W. Goodman, MD, and Allan S. Brett, MD, of the University of South Carolina, Columbia. Instead, clinicians are turning to gabapentinoids, partly as an option to substitute for opioids, which now have greater prescribing restrictions as a result of the current opioid crisis.

Ingram Publishing/Thinkstock

Although clinicians may cite guidelines that support off-label use of gabapentinoids for pain, the investigators warned that many of these recommendations stand on shaky ground.

“Clinicians who prescribe gabapentinoids off-label for pain should be aware of the limited evidence and should acknowledge to patients that potential benefits are uncertain for most off-label uses,” the investigators wrote in a clinical review published online March 25 in JAMA Internal Medicine.

The investigators narrowed down 677 publications to 84 papers describing the use of gabapentinoids for outpatient noncancer pain syndromes for which they are not FDA approved; 54 for gabapentin and 30 for pregabalin. In the domain of analgesia, both agents are currently FDA-approved for postherpetic neuralgia, while pregabalin is additionally approved for pain associated with fibromyalgia and neuropathic pain from diabetic neuropathy and spinal cord injury. Indications in reviewed studies ranged broadly, from conditions somewhat related to those currently approved, such as unspecified neuropathy, to dissimilar conditions, such as chronic pancreatitis and burn injury.

The investigators summarized findings from randomized clinical trials while using case studies to illustrate potential problems with off-label use. In addition, they reviewed the history of gabapentinoids and sources of recommendations for off-label use, such as guidelines and previous review articles.

Six major findings were reported: (1) evidence supporting gabapentin for diabetic neuropathy pain is “mixed at best”; (2) evidence supporting gabapentin for nondiabetic neuropathies is very limited; (3) evidence does not support gabapentinoids for radiculopathy or low back pain; (4) gabapentin has minimal benefit for fibromyalgia pain, based on minimal evidence; (5) evidence does not support gabapentinoids for acute herpes zoster pain; and (6) in almost all studies for other painful indications, gabapentinoids were ineffective or “associated with small analgesic effects that were statistically significant but of questionable clinical importance.”

Case studies complemented this overview, highlighting related clinical dilemmas that the investigators encounter “repeatedly” during inpatient and outpatient care. Along with off-label use, such as gabapentinoid prescriptions for acute sciatica, the investigators reported cases in which neuropathy was diagnosed in place of nonspecific lower body pain to facilitate gabapentin prescription. They also described apparent disregard for risks of polypharmacy in prescriptions for elderly patients and rote use of gabapentinoids in patients with diabetic neuropathy who did not have sufficient discomfort to warrant prescription.

The investigators also cited a number of problems with the language of reviews and guidelines involving gabapentinoids.

“The wording in many guidelines and review articles reinforces an inflated view of gabapentinoid effectiveness or fails to distinguish carefully between evidence-based and non–evidence-based recommendations,” they wrote, adding that clinicians may have misconceptions about neuropathic pain. “One unintended effect of the broad definition [of neuropathic pain] might be to create a mistaken perception that an effective drug for one type of neuropathic pain is effective for all neuropathic pain, regardless of underlying etiology or mechanism,” the investigators suggested.

Another facet of prescribing behavior could be explained in economic terms. Pregabalin, sold under the brand name Lyrica, is considerably more expensive than gabapentin; however, the investigators warned that the similarity of these agents does not equate with interchangeability, noting differences in bioavailability and rate of absorption.

“Unfortunately, published direct comparisons between the 2 drugs in double-blind studies of patients with chronic noncancer pain are virtually nonexistent,” the investigators wrote.

In addition to questionable effectiveness of gabapentinoids for off-label chronic noncancer pain syndromes, Dr. Goodman and Dr. Brett noted that the drugs produce a “substantial incidence of dizziness, somnolence, and gait disturbance.”

They also described a new trend of gabapentinoid abuse and diversion, which may not be surprising, considering that gabapentinoids are reported to augment opioid-induced euphoria.

“Evidence of misuse of gabapentinoids is accumulating and likely related to the opioid epidemic. A recent review article reported an overall population prevalence of gabapentinoid ‘misuse and abuse’ as high as 1%, with substantially higher prevalence noted among patients with opioid use disorders,” the investigators wrote. “This trend is troubling, particularly because concomitant use of opioids and gabapentinoids is associated with increased odds of opioid-related death. Whether these concerns apply to patients receiving long-term prescribed opioid therapy is unclear.”

In the era of the opioid crisis, the investigators acknowledged that many clinicians have serious concerns about adequately treating chronic noncancer pain.

“Comprehensive management of pain in primary care settings is difficult. It requires time and resources that are frequently unavailable,” the investigators wrote. “Many patients with chronic pain have limited or no access to high-quality pain practices or to nonpharmacologic interventions, such as cognitive behavior therapy.”

The investigators reported no external funding or conflicts of interest.

SOURCE: Goodman CW et al. JAMA Intern Med. 2019 Mar 25. doi: 10.1001/jamainternmed.2019.0086

ANSWER

The radiograph demonstrates a comminuted fracture of the superior end plate of L1. There is a loss of height of about 20% to 25%.

Of note, there is a lucency that appears to extend horizontally through the pedicles and into the spinous process. If this observation is accurate, then the patient would have a three-column injury. Such fractures are known as Chance fractures, and they are typically unstable and require operative intervention for stabilization.

Chance fractures are better visualized on CT. Subsequent testing confirmed a Chance fracture at the L1 level. The patient was admitted, and neurosurgical evaluation was requested.

ANSWER

The radiograph demonstrates a comminuted fracture of the superior end plate of L1. There is a loss of height of about 20% to 25%.

Of note, there is a lucency that appears to extend horizontally through the pedicles and into the spinous process. If this observation is accurate, then the patient would have a three-column injury. Such fractures are known as Chance fractures, and they are typically unstable and require operative intervention for stabilization.

Chance fractures are better visualized on CT. Subsequent testing confirmed a Chance fracture at the L1 level. The patient was admitted, and neurosurgical evaluation was requested.

ANSWER

The radiograph demonstrates a comminuted fracture of the superior end plate of L1. There is a loss of height of about 20% to 25%.

Of note, there is a lucency that appears to extend horizontally through the pedicles and into the spinous process. If this observation is accurate, then the patient would have a three-column injury. Such fractures are known as Chance fractures, and they are typically unstable and require operative intervention for stabilization.

Chance fractures are better visualized on CT. Subsequent testing confirmed a Chance fracture at the L1 level. The patient was admitted, and neurosurgical evaluation was requested.

STOWE, VT. – “The eye is intimately involved in the migraine process,” said Kathleen Digre, MD, at the annual meeting of the Headache Cooperative of New England. Specifically, she said, dry eye and photophobia are two symptoms that have biologic underpinnings, can be diagnosed, and can be treated. Dr. Digre is a professor of neurology and ophthalmology at the University of Utah, Salt Lake City, and is the current president of the American Headache Society.

Vidyard Video

Dr. Digre explained that dry eyes and migraine could have a cyclical relationship where dry eyes provoke the migraine, and the migraine may provoke the feeling of dry eye, regardless of whether it can be objectively measured.

Regarding photophobia, Dr. Digre stressed the importance of an accurate diagnosis that rules out eye disorders and other causes of photophobia. She discussed the problem of patient overreliance on dark glasses and encourages a return to light to break the cycle of dark adapting the retina.

Finally, Dr. Digre discussed how proper treatment of migraine and any associated anxiety or depression can help resolve eye issues that may be contributing to migraine.

[email protected]

STOWE, VT. – “The eye is intimately involved in the migraine process,” said Kathleen Digre, MD, at the annual meeting of the Headache Cooperative of New England. Specifically, she said, dry eye and photophobia are two symptoms that have biologic underpinnings, can be diagnosed, and can be treated. Dr. Digre is a professor of neurology and ophthalmology at the University of Utah, Salt Lake City, and is the current president of the American Headache Society.

Vidyard Video

Dr. Digre explained that dry eyes and migraine could have a cyclical relationship where dry eyes provoke the migraine, and the migraine may provoke the feeling of dry eye, regardless of whether it can be objectively measured.

Regarding photophobia, Dr. Digre stressed the importance of an accurate diagnosis that rules out eye disorders and other causes of photophobia. She discussed the problem of patient overreliance on dark glasses and encourages a return to light to break the cycle of dark adapting the retina.

Finally, Dr. Digre discussed how proper treatment of migraine and any associated anxiety or depression can help resolve eye issues that may be contributing to migraine.

[email protected]

STOWE, VT. – “The eye is intimately involved in the migraine process,” said Kathleen Digre, MD, at the annual meeting of the Headache Cooperative of New England. Specifically, she said, dry eye and photophobia are two symptoms that have biologic underpinnings, can be diagnosed, and can be treated. Dr. Digre is a professor of neurology and ophthalmology at the University of Utah, Salt Lake City, and is the current president of the American Headache Society.

Vidyard Video

Dr. Digre explained that dry eyes and migraine could have a cyclical relationship where dry eyes provoke the migraine, and the migraine may provoke the feeling of dry eye, regardless of whether it can be objectively measured.

Regarding photophobia, Dr. Digre stressed the importance of an accurate diagnosis that rules out eye disorders and other causes of photophobia. She discussed the problem of patient overreliance on dark glasses and encourages a return to light to break the cycle of dark adapting the retina.

Finally, Dr. Digre discussed how proper treatment of migraine and any associated anxiety or depression can help resolve eye issues that may be contributing to migraine.

[email protected]

STOWE, VT. – These are the early days of the “CGRP monoclonal antibody era,” Peter McAllister, MD, said in a summary of the current status of calcitonin gene-related peptide monoclonal antibodies for migraine prevention. He discussed what has been learned in the clinical trials of these drugs as well as in the first 10 months of having them on the market.

Vidyard Video

In an interview at the annual meeting of the Headache Cooperative of New England, Dr. McAllister said, “We are comforted that we have now 1-year, 3-year, and 5-year data” from clinical trials, but the sample size is small.

In the time since the first three drugs were approved, “we have probably in the ballpark of over 200,000 patients who have received a monoclonal antibody, and so far there has been nothing that makes us stop cold in our tracks and say there’s something wrong here. That is very comforting,” he said. Dr. McAllister is the medical director of the New England Institute for Neurology and Headache in Stamford, Conn.

What is still unknown, however, is the long-term safety and efficacy; what happens in a larger pool of patients taking these drugs; what happens in pregnancy and effects on the fetus; how and when to safely switch from one monoclonal antibody to another; the systemic effects of these drugs; and other concerns that may arise in postmarketing studies.

[email protected]

STOWE, VT. – These are the early days of the “CGRP monoclonal antibody era,” Peter McAllister, MD, said in a summary of the current status of calcitonin gene-related peptide monoclonal antibodies for migraine prevention. He discussed what has been learned in the clinical trials of these drugs as well as in the first 10 months of having them on the market.

Vidyard Video

In an interview at the annual meeting of the Headache Cooperative of New England, Dr. McAllister said, “We are comforted that we have now 1-year, 3-year, and 5-year data” from clinical trials, but the sample size is small.

In the time since the first three drugs were approved, “we have probably in the ballpark of over 200,000 patients who have received a monoclonal antibody, and so far there has been nothing that makes us stop cold in our tracks and say there’s something wrong here. That is very comforting,” he said. Dr. McAllister is the medical director of the New England Institute for Neurology and Headache in Stamford, Conn.

What is still unknown, however, is the long-term safety and efficacy; what happens in a larger pool of patients taking these drugs; what happens in pregnancy and effects on the fetus; how and when to safely switch from one monoclonal antibody to another; the systemic effects of these drugs; and other concerns that may arise in postmarketing studies.

[email protected]

STOWE, VT. – These are the early days of the “CGRP monoclonal antibody era,” Peter McAllister, MD, said in a summary of the current status of calcitonin gene-related peptide monoclonal antibodies for migraine prevention. He discussed what has been learned in the clinical trials of these drugs as well as in the first 10 months of having them on the market.

Vidyard Video

In an interview at the annual meeting of the Headache Cooperative of New England, Dr. McAllister said, “We are comforted that we have now 1-year, 3-year, and 5-year data” from clinical trials, but the sample size is small.

In the time since the first three drugs were approved, “we have probably in the ballpark of over 200,000 patients who have received a monoclonal antibody, and so far there has been nothing that makes us stop cold in our tracks and say there’s something wrong here. That is very comforting,” he said. Dr. McAllister is the medical director of the New England Institute for Neurology and Headache in Stamford, Conn.

What is still unknown, however, is the long-term safety and efficacy; what happens in a larger pool of patients taking these drugs; what happens in pregnancy and effects on the fetus; how and when to safely switch from one monoclonal antibody to another; the systemic effects of these drugs; and other concerns that may arise in postmarketing studies.

[email protected]

SEATTLE – People with HIV are more likely to die from an opioid overdose than the general public, according to investigators from the Centers for Disease Control and Prevention.

M.Alexander Otto/MDedge News

“We looked into this because we know persons with HIV are more likely to have chronic pain and more likely to receive opioid analgesic treatments, and receive higher doses. In addition, they are more likely to have substance use disorders and mental illness than the U.S. general populations,” CDC epidemiologist Karin A. Bosh, PhD, said at the Conference on Retroviruses and Opportunistic Infections.

To see how that played out in terms of unintentional opioid overdose deaths, they turned to the National HIV Surveillance System and focused on overdose deaths during 2011-2015, the latest data available at the time of the work.

There were 1,363 overdose deaths among persons with HIV during that period, with the rate increasing 42.7% – from 23.2/100,000 HIV patients in 2011 to 33.1/100,000 in 2015.

Although the rate of increase was comparable to the general population, the crude rate was “actually substantially higher among persons with HIV,” Dr. Bosh said. Deaths were highest among persons aged 50-59 years (41.9/100,000), whites (49.1/100,000), injection drug users (137.4/100,000), and people who live in the Northeast (60.6/100,000).

Surprisingly, there was no increase in the rate of overdose deaths among HIV patients on the West Coast, possibly because heroin there was less likely to be cut with fentanyl.

Also, the rate of opioid overdose deaths was higher among women with HIV (35.2/100,000) than among men, perhaps because women are more likely to contract HIV by injection drug use, so they are more likely to be injection drug users at baseline, while the vast majority of men are infected through male-male sex, the investigators said.

The findings underscore the importance of intensifying overdose prevention in the HIV community, and better integrating HIV and substance use disorder treatment, they concluded.

M. Alexander Otto//MDedge News

That comes down to screening people for problems, especially in the subgroups identified in the study, and connecting them to drug treatment services. If HIV and substance disorder services were in the same clinic it would help, as would an increase in the number of buprenorphine providers, according to Sheryl B. Lyss, PhD, a coinvestigator and CDC epidemiologist.

“Obviously, when substance use is addressed, people can be much more adherent with their [HIV] medications,” she noted.

The work was funded by the Centers for Disease Control and Prevention. The investigators had no relevant disclosures.

[email protected]

SOURCE: Bosh KA et al. CROI 2019, Abstract 147.

SEATTLE – People with HIV are more likely to die from an opioid overdose than the general public, according to investigators from the Centers for Disease Control and Prevention.

M.Alexander Otto/MDedge News

“We looked into this because we know persons with HIV are more likely to have chronic pain and more likely to receive opioid analgesic treatments, and receive higher doses. In addition, they are more likely to have substance use disorders and mental illness than the U.S. general populations,” CDC epidemiologist Karin A. Bosh, PhD, said at the Conference on Retroviruses and Opportunistic Infections.

To see how that played out in terms of unintentional opioid overdose deaths, they turned to the National HIV Surveillance System and focused on overdose deaths during 2011-2015, the latest data available at the time of the work.

There were 1,363 overdose deaths among persons with HIV during that period, with the rate increasing 42.7% – from 23.2/100,000 HIV patients in 2011 to 33.1/100,000 in 2015.

Although the rate of increase was comparable to the general population, the crude rate was “actually substantially higher among persons with HIV,” Dr. Bosh said. Deaths were highest among persons aged 50-59 years (41.9/100,000), whites (49.1/100,000), injection drug users (137.4/100,000), and people who live in the Northeast (60.6/100,000).

Surprisingly, there was no increase in the rate of overdose deaths among HIV patients on the West Coast, possibly because heroin there was less likely to be cut with fentanyl.

Also, the rate of opioid overdose deaths was higher among women with HIV (35.2/100,000) than among men, perhaps because women are more likely to contract HIV by injection drug use, so they are more likely to be injection drug users at baseline, while the vast majority of men are infected through male-male sex, the investigators said.

The findings underscore the importance of intensifying overdose prevention in the HIV community, and better integrating HIV and substance use disorder treatment, they concluded.

M. Alexander Otto//MDedge News

That comes down to screening people for problems, especially in the subgroups identified in the study, and connecting them to drug treatment services. If HIV and substance disorder services were in the same clinic it would help, as would an increase in the number of buprenorphine providers, according to Sheryl B. Lyss, PhD, a coinvestigator and CDC epidemiologist.

“Obviously, when substance use is addressed, people can be much more adherent with their [HIV] medications,” she noted.

The work was funded by the Centers for Disease Control and Prevention. The investigators had no relevant disclosures.

[email protected]

SOURCE: Bosh KA et al. CROI 2019, Abstract 147.

SEATTLE – People with HIV are more likely to die from an opioid overdose than the general public, according to investigators from the Centers for Disease Control and Prevention.

M.Alexander Otto/MDedge News

“We looked into this because we know persons with HIV are more likely to have chronic pain and more likely to receive opioid analgesic treatments, and receive higher doses. In addition, they are more likely to have substance use disorders and mental illness than the U.S. general populations,” CDC epidemiologist Karin A. Bosh, PhD, said at the Conference on Retroviruses and Opportunistic Infections.

To see how that played out in terms of unintentional opioid overdose deaths, they turned to the National HIV Surveillance System and focused on overdose deaths during 2011-2015, the latest data available at the time of the work.

There were 1,363 overdose deaths among persons with HIV during that period, with the rate increasing 42.7% – from 23.2/100,000 HIV patients in 2011 to 33.1/100,000 in 2015.

Although the rate of increase was comparable to the general population, the crude rate was “actually substantially higher among persons with HIV,” Dr. Bosh said. Deaths were highest among persons aged 50-59 years (41.9/100,000), whites (49.1/100,000), injection drug users (137.4/100,000), and people who live in the Northeast (60.6/100,000).

Surprisingly, there was no increase in the rate of overdose deaths among HIV patients on the West Coast, possibly because heroin there was less likely to be cut with fentanyl.

Also, the rate of opioid overdose deaths was higher among women with HIV (35.2/100,000) than among men, perhaps because women are more likely to contract HIV by injection drug use, so they are more likely to be injection drug users at baseline, while the vast majority of men are infected through male-male sex, the investigators said.

The findings underscore the importance of intensifying overdose prevention in the HIV community, and better integrating HIV and substance use disorder treatment, they concluded.

M. Alexander Otto//MDedge News

That comes down to screening people for problems, especially in the subgroups identified in the study, and connecting them to drug treatment services. If HIV and substance disorder services were in the same clinic it would help, as would an increase in the number of buprenorphine providers, according to Sheryl B. Lyss, PhD, a coinvestigator and CDC epidemiologist.

“Obviously, when substance use is addressed, people can be much more adherent with their [HIV] medications,” she noted.

The work was funded by the Centers for Disease Control and Prevention. The investigators had no relevant disclosures.

[email protected]

SOURCE: Bosh KA et al. CROI 2019, Abstract 147.

Tramadol appears to be associated with higher mortality risk among older patients with osteoarthritis when compared against common NSAIDs, according to findings from a study published online March 12 in JAMA.

KatarzynaBialasiewicz/Thinkstock

The findings from the retrospective cohort study are worth noting despite their susceptibility to confounding by indication because “tramadol is a weak opioid agonist and has been considered a potential alternative to NSAIDs and traditional opioids because of its assumed relatively lower risk of serious cardiovascular and gastrointestinal adverse effects than NSAIDs, as well as a lower risk of addiction and respiratory depression compared with other opioids,” wrote Chao Zeng, MD, PhD, of Xiangya Hospital of Central South University, Changsha, China, and his coauthors.

The investigators analyzed data from a combined total of 88,902 individuals aged 50 years and older with knee, hip, or hand osteoarthritis who were seen during 2000-2015 and had visits recorded in the United Kingdom’s The Health Improvement Network (THIN) electronic medical records database. Participants were matched on sociodemographic and lifestyle factors, as well as osteoarthritis duration, comorbidities, other prescriptions, and health care utilization prior to the index date of the study.

Over 1 year of follow-up, researchers saw a 71% higher risk of all-cause mortality in patients taking tramadol than that in seen in those taking naproxen, 88% higher than in those taking diclofenac, 70% higher than in those taking celecoxib, and about twice as high as in patients taking etoricoxib.

However, there was no significant difference in risk of all-cause mortality between tramadol and codeine, the researchers found.

The authors suggested that tramadol may have adverse effects on the neurologic system by inhibiting central serotonin and norepinephrine uptake, which could potentially lead to serotonin syndrome. They also speculated that it could increase the risk of postoperative delirium, cause fatal poisoning or respiratory depression if taken in conjunction with alcohol or other drugs, or increase the risk of hypoglycemia, hyponatremia, fractures, or falls.

The numbers of deaths from cardiovascular, gastrointestinal, infection, cancer, and respiratory diseases were all higher in the tramadol group, compared with patients taking NSAIDs, but the differences were not statistically significant because of the relatively small number of deaths, the authors said.

Overall, 44,451 patients were taking tramadol, 12,397 were taking naproxen, 6,512 were taking diclofenac, 5,674 were taking celecoxib, 2,946 were taking etoricoxib, and 16,922 were taking codeine.

Patients in the tramadol cohort were generally older, with higher body mass index, a longer duration of osteoarthritis, and had a higher prevalence of comorbidities, higher health care utilization, and more prescriptions of other medications.

The authors noted that, while the patients from each medication cohort were matched on propensity score, the results were still susceptible to confounding by indication and should be interpreted with caution.

The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Natural Science Foundation of China. One author declared funding from the National Institute on Drug Abuse during the conduct of the study and grants from Optum Labs outside the study. No other conflicts of interest were declared.

SOURCE: Zeng C et al. JAMA. 2019;321:969-82.

Tramadol appears to be associated with higher mortality risk among older patients with osteoarthritis when compared against common NSAIDs, according to findings from a study published online March 12 in JAMA.

KatarzynaBialasiewicz/Thinkstock

The findings from the retrospective cohort study are worth noting despite their susceptibility to confounding by indication because “tramadol is a weak opioid agonist and has been considered a potential alternative to NSAIDs and traditional opioids because of its assumed relatively lower risk of serious cardiovascular and gastrointestinal adverse effects than NSAIDs, as well as a lower risk of addiction and respiratory depression compared with other opioids,” wrote Chao Zeng, MD, PhD, of Xiangya Hospital of Central South University, Changsha, China, and his coauthors.

The investigators analyzed data from a combined total of 88,902 individuals aged 50 years and older with knee, hip, or hand osteoarthritis who were seen during 2000-2015 and had visits recorded in the United Kingdom’s The Health Improvement Network (THIN) electronic medical records database. Participants were matched on sociodemographic and lifestyle factors, as well as osteoarthritis duration, comorbidities, other prescriptions, and health care utilization prior to the index date of the study.

Over 1 year of follow-up, researchers saw a 71% higher risk of all-cause mortality in patients taking tramadol than that in seen in those taking naproxen, 88% higher than in those taking diclofenac, 70% higher than in those taking celecoxib, and about twice as high as in patients taking etoricoxib.

However, there was no significant difference in risk of all-cause mortality between tramadol and codeine, the researchers found.

The authors suggested that tramadol may have adverse effects on the neurologic system by inhibiting central serotonin and norepinephrine uptake, which could potentially lead to serotonin syndrome. They also speculated that it could increase the risk of postoperative delirium, cause fatal poisoning or respiratory depression if taken in conjunction with alcohol or other drugs, or increase the risk of hypoglycemia, hyponatremia, fractures, or falls.

The numbers of deaths from cardiovascular, gastrointestinal, infection, cancer, and respiratory diseases were all higher in the tramadol group, compared with patients taking NSAIDs, but the differences were not statistically significant because of the relatively small number of deaths, the authors said.

Overall, 44,451 patients were taking tramadol, 12,397 were taking naproxen, 6,512 were taking diclofenac, 5,674 were taking celecoxib, 2,946 were taking etoricoxib, and 16,922 were taking codeine.

Patients in the tramadol cohort were generally older, with higher body mass index, a longer duration of osteoarthritis, and had a higher prevalence of comorbidities, higher health care utilization, and more prescriptions of other medications.

The authors noted that, while the patients from each medication cohort were matched on propensity score, the results were still susceptible to confounding by indication and should be interpreted with caution.

The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Natural Science Foundation of China. One author declared funding from the National Institute on Drug Abuse during the conduct of the study and grants from Optum Labs outside the study. No other conflicts of interest were declared.

SOURCE: Zeng C et al. JAMA. 2019;321:969-82.

Tramadol appears to be associated with higher mortality risk among older patients with osteoarthritis when compared against common NSAIDs, according to findings from a study published online March 12 in JAMA.

KatarzynaBialasiewicz/Thinkstock

The findings from the retrospective cohort study are worth noting despite their susceptibility to confounding by indication because “tramadol is a weak opioid agonist and has been considered a potential alternative to NSAIDs and traditional opioids because of its assumed relatively lower risk of serious cardiovascular and gastrointestinal adverse effects than NSAIDs, as well as a lower risk of addiction and respiratory depression compared with other opioids,” wrote Chao Zeng, MD, PhD, of Xiangya Hospital of Central South University, Changsha, China, and his coauthors.

The investigators analyzed data from a combined total of 88,902 individuals aged 50 years and older with knee, hip, or hand osteoarthritis who were seen during 2000-2015 and had visits recorded in the United Kingdom’s The Health Improvement Network (THIN) electronic medical records database. Participants were matched on sociodemographic and lifestyle factors, as well as osteoarthritis duration, comorbidities, other prescriptions, and health care utilization prior to the index date of the study.

Over 1 year of follow-up, researchers saw a 71% higher risk of all-cause mortality in patients taking tramadol than that in seen in those taking naproxen, 88% higher than in those taking diclofenac, 70% higher than in those taking celecoxib, and about twice as high as in patients taking etoricoxib.

However, there was no significant difference in risk of all-cause mortality between tramadol and codeine, the researchers found.

The authors suggested that tramadol may have adverse effects on the neurologic system by inhibiting central serotonin and norepinephrine uptake, which could potentially lead to serotonin syndrome. They also speculated that it could increase the risk of postoperative delirium, cause fatal poisoning or respiratory depression if taken in conjunction with alcohol or other drugs, or increase the risk of hypoglycemia, hyponatremia, fractures, or falls.

The numbers of deaths from cardiovascular, gastrointestinal, infection, cancer, and respiratory diseases were all higher in the tramadol group, compared with patients taking NSAIDs, but the differences were not statistically significant because of the relatively small number of deaths, the authors said.

Overall, 44,451 patients were taking tramadol, 12,397 were taking naproxen, 6,512 were taking diclofenac, 5,674 were taking celecoxib, 2,946 were taking etoricoxib, and 16,922 were taking codeine.

Patients in the tramadol cohort were generally older, with higher body mass index, a longer duration of osteoarthritis, and had a higher prevalence of comorbidities, higher health care utilization, and more prescriptions of other medications.

The authors noted that, while the patients from each medication cohort were matched on propensity score, the results were still susceptible to confounding by indication and should be interpreted with caution.

The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Natural Science Foundation of China. One author declared funding from the National Institute on Drug Abuse during the conduct of the study and grants from Optum Labs outside the study. No other conflicts of interest were declared.

SOURCE: Zeng C et al. JAMA. 2019;321:969-82.