Readers may recall that at the end of each calendar as opposed to fiscal year—I know it is hard to believe time exists outside the Federal system—Federal Practitioner publishes my ethics-focused version of the familiar year-end roundup. This year I am reversing the typical order of most annual rankings by putting the worst first for 2 morally salient reasons.

The first is that, sadly, it is almost always easier to identify multiple incidents that compete ignominiously for the “worst” of federal health care. Even more disappointing, it is comparatively difficult to find stories for the “best” that are of the same scale and scope as the bad news. This is not to say that every day there are not individual narratives of courage and compassion reported in US Department of Defense, US Public Health Service, and US Department of Veterans Affairs (VA), and hundreds more unsung heroes.

The second reason is that as human beings our psychology is such that we gravitate toward the worst things more powerfully and persistently than we do the best. This is in part why it is more difficult to find uplifting stories and why the demoralizing ones affect us so strongly. In an exhaustive review of the subject, psychologists Roy Baumeister and colleagues conclude that,

When equal measures of good and bad are present, however, the psychological effects of bad ones outweigh those of the good ones. This may in fact be a general principle or law of psychological phenomena, possibly reflecting the innate predispositions of the psyche or at least reflecting the almost inevitable adaptation of each individual to the exigencies of daily life.²

I am thus saving the best for last in the hope that it will be more memorable and impactful than the worst.

Unique to this year’s look-back, both the negative and the positive accounts come from the domain of end-of-life care. And unlike prior reviews where the lack of administrative vigilance and professional competence affected hundreds of patients, families, and staff, each of this year’s incidents involve a single patient.

An incident that occurred in September 2019 at a VA Community Living Center (CLC) in Georgia stood out in infamy apart from all others. It was the report of a veteran in a VA nursing home who had been bitten more than 100 times by ants crawling all over his room. He died shortly afterward. In a scene out of a horror movie tapping into the most primeval human fears, his daughter Laquana Ross described her father, a Vietnam Air Force veteran with cancer, to media and VA officials in graphic terms. “I understand mistakes happen,” she said. “I’ve had ants. But he was bit by ants two days in a row. They feasted on him.”³

In this new era of holding its senior executive service accountable, the outraged chair of the Senate Veterans Affairs Committee demanded that heads roll, and the VA acted rapidly to comply.⁴ The VA Central Office placed the network director on administrative leave, reassigned the chief medical officer, and initiated quality and safety reviews as well as an administrative investigative board to scrutinize how the parent Atlanta VA medical center managed the situation. In total, 9 officials connected to the incident were placed on leave. The VA apologized, with VA Secretary Robert Wilke zeroing in on the core values involved in the tragedy, “This is about basic humanity and dignity,” he said. “I don’t care what steps were taken to address the issues. We did not treat a vet with the dignity that he and his family deserved.”⁵ Yet it was the veteran’s daughter, with unbelievable charity, who asked the most crucial question that must be answered within the framework of a just culture if similar tragedies are not to occur in the future, “I know the staff, without a shadow of doubt, respected my dad and even loved him,” Ross said. “But what’s their ability to assess situations and fix things?”³

To begin to give Ms. Ross the answer she deserves, we must understand that the antithesis of love is not hate but indifference; of compassion, it is not cruelty but coldness. A true just culture reserves individual blame for those who have ill-will and adopts a systems perspective of organizational improvement toward most other types of errors.⁶ This means that the deplorable conditions in the CLC cannot be charged to the failure of a single staff member to fulfil their obligations but to collective collapse at many levels of the organization. Just culture is ethically laudable and far superior to the history in federal service of capricious punishment or institutional apathy that far too often were the default reactions to media exposures or congressional ire. Justice, though necessary, is not sufficient to achieve virtue. Those who work in health care also must be inspired to offer mercy, kindness, and compassion, especially in our most sacred privilege to provide care of the dying.

The best of 2019 illustrates this distinction movingly. This account also involves a Vietnam veteran, this time a Marine also dying of cancer, which happened just about a month after the earlier report. To be transparent it occurred at my home VA medical center in New Mexico. I was peripherally involved in the case as a consultant but had no role in the wondrous things that transpired. The last wish of a patient dying in the hospice unit on campus was to see his beloved dog who had been taken to the local city animal shelter when he was hospitalized because he had no friends or family to look after the companion animal. A social worker on the palliative care team called the animal shelter and explained the patient did not have much time left but wanted to see his dog before he died. Working together with support from facility leadership, shelter workers brought the dog to visit with the patient for an entire day while hospice staff cried with joy and sadness.⁷

As the epigraph for this editorial from Dame Cicely Saunders, the founder of the modern hospice movement, says, the difference between unspeakable pain and meaningful suffering can be measured in the depth of compassion caregivers show to the dying. It is this quality of mercy that in one case condemns, and in the other praises, us all as health care and administrative professionals in the service of our country. Baumeister and colleagues suggest that the human tendency to magnify the bad and minimize the good in everyday myopia may in a wider vision actually be a reason for hope:

It may be that humans and animals show heightened awareness of and responded more quickly to negative information because it signals a need for change. Hence, the adaptiveness of self-regulation partly lies in the organism’s ability to detect when response modifications are necessary and when they are unnecessary. Moreover, the lessons learned from bad events should ideally be retained permanently so that the same dangers or costs are not encountered repeatedly. Meanwhile, good events (such as those that provide a feeling of satisfaction and contentment) should ideally wear off so that the organism is motivated to continue searching for more and better outcomes.²

Let us all take this lesson into our work in 2020 so that when it comes time to write this column next year in the chilling cold of late autumn there will be more stories of light than darkness from which to choose.

Readers may recall that at the end of each calendar as opposed to fiscal year—I know it is hard to believe time exists outside the Federal system—Federal Practitioner publishes my ethics-focused version of the familiar year-end roundup. This year I am reversing the typical order of most annual rankings by putting the worst first for 2 morally salient reasons.

The first is that, sadly, it is almost always easier to identify multiple incidents that compete ignominiously for the “worst” of federal health care. Even more disappointing, it is comparatively difficult to find stories for the “best” that are of the same scale and scope as the bad news. This is not to say that every day there are not individual narratives of courage and compassion reported in US Department of Defense, US Public Health Service, and US Department of Veterans Affairs (VA), and hundreds more unsung heroes.

The second reason is that as human beings our psychology is such that we gravitate toward the worst things more powerfully and persistently than we do the best. This is in part why it is more difficult to find uplifting stories and why the demoralizing ones affect us so strongly. In an exhaustive review of the subject, psychologists Roy Baumeister and colleagues conclude that,

When equal measures of good and bad are present, however, the psychological effects of bad ones outweigh those of the good ones. This may in fact be a general principle or law of psychological phenomena, possibly reflecting the innate predispositions of the psyche or at least reflecting the almost inevitable adaptation of each individual to the exigencies of daily life.²

I am thus saving the best for last in the hope that it will be more memorable and impactful than the worst.

Unique to this year’s look-back, both the negative and the positive accounts come from the domain of end-of-life care. And unlike prior reviews where the lack of administrative vigilance and professional competence affected hundreds of patients, families, and staff, each of this year’s incidents involve a single patient.

An incident that occurred in September 2019 at a VA Community Living Center (CLC) in Georgia stood out in infamy apart from all others. It was the report of a veteran in a VA nursing home who had been bitten more than 100 times by ants crawling all over his room. He died shortly afterward. In a scene out of a horror movie tapping into the most primeval human fears, his daughter Laquana Ross described her father, a Vietnam Air Force veteran with cancer, to media and VA officials in graphic terms. “I understand mistakes happen,” she said. “I’ve had ants. But he was bit by ants two days in a row. They feasted on him.”³

In this new era of holding its senior executive service accountable, the outraged chair of the Senate Veterans Affairs Committee demanded that heads roll, and the VA acted rapidly to comply.⁴ The VA Central Office placed the network director on administrative leave, reassigned the chief medical officer, and initiated quality and safety reviews as well as an administrative investigative board to scrutinize how the parent Atlanta VA medical center managed the situation. In total, 9 officials connected to the incident were placed on leave. The VA apologized, with VA Secretary Robert Wilke zeroing in on the core values involved in the tragedy, “This is about basic humanity and dignity,” he said. “I don’t care what steps were taken to address the issues. We did not treat a vet with the dignity that he and his family deserved.”⁵ Yet it was the veteran’s daughter, with unbelievable charity, who asked the most crucial question that must be answered within the framework of a just culture if similar tragedies are not to occur in the future, “I know the staff, without a shadow of doubt, respected my dad and even loved him,” Ross said. “But what’s their ability to assess situations and fix things?”³

To begin to give Ms. Ross the answer she deserves, we must understand that the antithesis of love is not hate but indifference; of compassion, it is not cruelty but coldness. A true just culture reserves individual blame for those who have ill-will and adopts a systems perspective of organizational improvement toward most other types of errors.⁶ This means that the deplorable conditions in the CLC cannot be charged to the failure of a single staff member to fulfil their obligations but to collective collapse at many levels of the organization. Just culture is ethically laudable and far superior to the history in federal service of capricious punishment or institutional apathy that far too often were the default reactions to media exposures or congressional ire. Justice, though necessary, is not sufficient to achieve virtue. Those who work in health care also must be inspired to offer mercy, kindness, and compassion, especially in our most sacred privilege to provide care of the dying.

The best of 2019 illustrates this distinction movingly. This account also involves a Vietnam veteran, this time a Marine also dying of cancer, which happened just about a month after the earlier report. To be transparent it occurred at my home VA medical center in New Mexico. I was peripherally involved in the case as a consultant but had no role in the wondrous things that transpired. The last wish of a patient dying in the hospice unit on campus was to see his beloved dog who had been taken to the local city animal shelter when he was hospitalized because he had no friends or family to look after the companion animal. A social worker on the palliative care team called the animal shelter and explained the patient did not have much time left but wanted to see his dog before he died. Working together with support from facility leadership, shelter workers brought the dog to visit with the patient for an entire day while hospice staff cried with joy and sadness.⁷

As the epigraph for this editorial from Dame Cicely Saunders, the founder of the modern hospice movement, says, the difference between unspeakable pain and meaningful suffering can be measured in the depth of compassion caregivers show to the dying. It is this quality of mercy that in one case condemns, and in the other praises, us all as health care and administrative professionals in the service of our country. Baumeister and colleagues suggest that the human tendency to magnify the bad and minimize the good in everyday myopia may in a wider vision actually be a reason for hope:

It may be that humans and animals show heightened awareness of and responded more quickly to negative information because it signals a need for change. Hence, the adaptiveness of self-regulation partly lies in the organism’s ability to detect when response modifications are necessary and when they are unnecessary. Moreover, the lessons learned from bad events should ideally be retained permanently so that the same dangers or costs are not encountered repeatedly. Meanwhile, good events (such as those that provide a feeling of satisfaction and contentment) should ideally wear off so that the organism is motivated to continue searching for more and better outcomes.²

Let us all take this lesson into our work in 2020 so that when it comes time to write this column next year in the chilling cold of late autumn there will be more stories of light than darkness from which to choose.

Readers may recall that at the end of each calendar as opposed to fiscal year—I know it is hard to believe time exists outside the Federal system—Federal Practitioner publishes my ethics-focused version of the familiar year-end roundup. This year I am reversing the typical order of most annual rankings by putting the worst first for 2 morally salient reasons.

The first is that, sadly, it is almost always easier to identify multiple incidents that compete ignominiously for the “worst” of federal health care. Even more disappointing, it is comparatively difficult to find stories for the “best” that are of the same scale and scope as the bad news. This is not to say that every day there are not individual narratives of courage and compassion reported in US Department of Defense, US Public Health Service, and US Department of Veterans Affairs (VA), and hundreds more unsung heroes.

The second reason is that as human beings our psychology is such that we gravitate toward the worst things more powerfully and persistently than we do the best. This is in part why it is more difficult to find uplifting stories and why the demoralizing ones affect us so strongly. In an exhaustive review of the subject, psychologists Roy Baumeister and colleagues conclude that,

When equal measures of good and bad are present, however, the psychological effects of bad ones outweigh those of the good ones. This may in fact be a general principle or law of psychological phenomena, possibly reflecting the innate predispositions of the psyche or at least reflecting the almost inevitable adaptation of each individual to the exigencies of daily life.²

I am thus saving the best for last in the hope that it will be more memorable and impactful than the worst.

Unique to this year’s look-back, both the negative and the positive accounts come from the domain of end-of-life care. And unlike prior reviews where the lack of administrative vigilance and professional competence affected hundreds of patients, families, and staff, each of this year’s incidents involve a single patient.

An incident that occurred in September 2019 at a VA Community Living Center (CLC) in Georgia stood out in infamy apart from all others. It was the report of a veteran in a VA nursing home who had been bitten more than 100 times by ants crawling all over his room. He died shortly afterward. In a scene out of a horror movie tapping into the most primeval human fears, his daughter Laquana Ross described her father, a Vietnam Air Force veteran with cancer, to media and VA officials in graphic terms. “I understand mistakes happen,” she said. “I’ve had ants. But he was bit by ants two days in a row. They feasted on him.”³

In this new era of holding its senior executive service accountable, the outraged chair of the Senate Veterans Affairs Committee demanded that heads roll, and the VA acted rapidly to comply.⁴ The VA Central Office placed the network director on administrative leave, reassigned the chief medical officer, and initiated quality and safety reviews as well as an administrative investigative board to scrutinize how the parent Atlanta VA medical center managed the situation. In total, 9 officials connected to the incident were placed on leave. The VA apologized, with VA Secretary Robert Wilke zeroing in on the core values involved in the tragedy, “This is about basic humanity and dignity,” he said. “I don’t care what steps were taken to address the issues. We did not treat a vet with the dignity that he and his family deserved.”⁵ Yet it was the veteran’s daughter, with unbelievable charity, who asked the most crucial question that must be answered within the framework of a just culture if similar tragedies are not to occur in the future, “I know the staff, without a shadow of doubt, respected my dad and even loved him,” Ross said. “But what’s their ability to assess situations and fix things?”³

To begin to give Ms. Ross the answer she deserves, we must understand that the antithesis of love is not hate but indifference; of compassion, it is not cruelty but coldness. A true just culture reserves individual blame for those who have ill-will and adopts a systems perspective of organizational improvement toward most other types of errors.⁶ This means that the deplorable conditions in the CLC cannot be charged to the failure of a single staff member to fulfil their obligations but to collective collapse at many levels of the organization. Just culture is ethically laudable and far superior to the history in federal service of capricious punishment or institutional apathy that far too often were the default reactions to media exposures or congressional ire. Justice, though necessary, is not sufficient to achieve virtue. Those who work in health care also must be inspired to offer mercy, kindness, and compassion, especially in our most sacred privilege to provide care of the dying.

The best of 2019 illustrates this distinction movingly. This account also involves a Vietnam veteran, this time a Marine also dying of cancer, which happened just about a month after the earlier report. To be transparent it occurred at my home VA medical center in New Mexico. I was peripherally involved in the case as a consultant but had no role in the wondrous things that transpired. The last wish of a patient dying in the hospice unit on campus was to see his beloved dog who had been taken to the local city animal shelter when he was hospitalized because he had no friends or family to look after the companion animal. A social worker on the palliative care team called the animal shelter and explained the patient did not have much time left but wanted to see his dog before he died. Working together with support from facility leadership, shelter workers brought the dog to visit with the patient for an entire day while hospice staff cried with joy and sadness.⁷

As the epigraph for this editorial from Dame Cicely Saunders, the founder of the modern hospice movement, says, the difference between unspeakable pain and meaningful suffering can be measured in the depth of compassion caregivers show to the dying. It is this quality of mercy that in one case condemns, and in the other praises, us all as health care and administrative professionals in the service of our country. Baumeister and colleagues suggest that the human tendency to magnify the bad and minimize the good in everyday myopia may in a wider vision actually be a reason for hope:

It may be that humans and animals show heightened awareness of and responded more quickly to negative information because it signals a need for change. Hence, the adaptiveness of self-regulation partly lies in the organism’s ability to detect when response modifications are necessary and when they are unnecessary. Moreover, the lessons learned from bad events should ideally be retained permanently so that the same dangers or costs are not encountered repeatedly. Meanwhile, good events (such as those that provide a feeling of satisfaction and contentment) should ideally wear off so that the organism is motivated to continue searching for more and better outcomes.²

Let us all take this lesson into our work in 2020 so that when it comes time to write this column next year in the chilling cold of late autumn there will be more stories of light than darkness from which to choose.

Scleromyxedema, or generalized lichen myxedematosus, is a primary cutaneous mucinosis with unknown pathogenesis characterized by generalized firm, skin-colored papules and is commonly associated with an underlying monoclonal gammopathy (usually Ig-gamma paraproteinemia).

Courtesy Rachel Fayne, BA, Dr. Yumeng Li, Dr. Fabrizio Galimberti, and Dr. Brian Morrison

Scleromyxedema may have associated internal involvement, including neurologic, gastrointestinal, pulmonary, renal, cardiovascular, ophthalmological, or musculoskeletal. Histopathology demonstrates mucin in the dermis seen with Alcian blue staining, proliferation of fibroblasts, and increased collagen deposition.

The condition is chronic and progressive. Intravenous immunoglobulin is considered first-line treatment. Thalidomide and corticosteroids have been reported to also be efficacious.

Erythema elevatum diutinum (EED) is a small-vessel vasculitis that presents with asymptomatic, symmetrical nodules or plaques on extensor surfaces. It is associated with hematologic disorders, including IgA monoclonal gammopathy, as well as myeloproliferative disorders, leukemia, infections, and inflammatory bowel disease. Although its pathophysiology is not well understood, vascular immune complex deposition, repetitive inflammation, and subsequent fibrosis may play a role. On histology, there is leukocytoclastic vasculitis with polymorphonuclear cell infiltrate and fibrin deposition in the superficial and mid-dermis and onion-skin fibrosis.

EED often self-resolves within 5-10 years, although it can become chronic and recurrent. Dapsone, niacinamide, antimalarials, NSAIDs, tetracyclines, corticosteroids, colchicine, and plasmapheresis are reported treatments. This patient’s EED was recalcitrant to prednisone and responded to colchicine.

Scleromyxedema and EED are both rare, distinct cutaneous entities associated with different underlying paraproteinemias and to the best of our knowledge, have not been previously reported to coexist in a single patient.

This case and the photos were submitted by Rachel Fayne, BA; Yumeng Li, MD, MS; Fabrizio Galimberti, MD, PhD; and Brian Morrison, MD, of the department of dermatology and cutaneous surgery at the University of Miami.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to dermnews@mdedge.com.

Scleromyxedema, or generalized lichen myxedematosus, is a primary cutaneous mucinosis with unknown pathogenesis characterized by generalized firm, skin-colored papules and is commonly associated with an underlying monoclonal gammopathy (usually Ig-gamma paraproteinemia).

Courtesy Rachel Fayne, BA, Dr. Yumeng Li, Dr. Fabrizio Galimberti, and Dr. Brian Morrison

Scleromyxedema may have associated internal involvement, including neurologic, gastrointestinal, pulmonary, renal, cardiovascular, ophthalmological, or musculoskeletal. Histopathology demonstrates mucin in the dermis seen with Alcian blue staining, proliferation of fibroblasts, and increased collagen deposition.

The condition is chronic and progressive. Intravenous immunoglobulin is considered first-line treatment. Thalidomide and corticosteroids have been reported to also be efficacious.

Erythema elevatum diutinum (EED) is a small-vessel vasculitis that presents with asymptomatic, symmetrical nodules or plaques on extensor surfaces. It is associated with hematologic disorders, including IgA monoclonal gammopathy, as well as myeloproliferative disorders, leukemia, infections, and inflammatory bowel disease. Although its pathophysiology is not well understood, vascular immune complex deposition, repetitive inflammation, and subsequent fibrosis may play a role. On histology, there is leukocytoclastic vasculitis with polymorphonuclear cell infiltrate and fibrin deposition in the superficial and mid-dermis and onion-skin fibrosis.

EED often self-resolves within 5-10 years, although it can become chronic and recurrent. Dapsone, niacinamide, antimalarials, NSAIDs, tetracyclines, corticosteroids, colchicine, and plasmapheresis are reported treatments. This patient’s EED was recalcitrant to prednisone and responded to colchicine.

Scleromyxedema and EED are both rare, distinct cutaneous entities associated with different underlying paraproteinemias and to the best of our knowledge, have not been previously reported to coexist in a single patient.

This case and the photos were submitted by Rachel Fayne, BA; Yumeng Li, MD, MS; Fabrizio Galimberti, MD, PhD; and Brian Morrison, MD, of the department of dermatology and cutaneous surgery at the University of Miami.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to dermnews@mdedge.com.

Scleromyxedema, or generalized lichen myxedematosus, is a primary cutaneous mucinosis with unknown pathogenesis characterized by generalized firm, skin-colored papules and is commonly associated with an underlying monoclonal gammopathy (usually Ig-gamma paraproteinemia).

Courtesy Rachel Fayne, BA, Dr. Yumeng Li, Dr. Fabrizio Galimberti, and Dr. Brian Morrison

Scleromyxedema may have associated internal involvement, including neurologic, gastrointestinal, pulmonary, renal, cardiovascular, ophthalmological, or musculoskeletal. Histopathology demonstrates mucin in the dermis seen with Alcian blue staining, proliferation of fibroblasts, and increased collagen deposition.

The condition is chronic and progressive. Intravenous immunoglobulin is considered first-line treatment. Thalidomide and corticosteroids have been reported to also be efficacious.

Erythema elevatum diutinum (EED) is a small-vessel vasculitis that presents with asymptomatic, symmetrical nodules or plaques on extensor surfaces. It is associated with hematologic disorders, including IgA monoclonal gammopathy, as well as myeloproliferative disorders, leukemia, infections, and inflammatory bowel disease. Although its pathophysiology is not well understood, vascular immune complex deposition, repetitive inflammation, and subsequent fibrosis may play a role. On histology, there is leukocytoclastic vasculitis with polymorphonuclear cell infiltrate and fibrin deposition in the superficial and mid-dermis and onion-skin fibrosis.

EED often self-resolves within 5-10 years, although it can become chronic and recurrent. Dapsone, niacinamide, antimalarials, NSAIDs, tetracyclines, corticosteroids, colchicine, and plasmapheresis are reported treatments. This patient’s EED was recalcitrant to prednisone and responded to colchicine.

Scleromyxedema and EED are both rare, distinct cutaneous entities associated with different underlying paraproteinemias and to the best of our knowledge, have not been previously reported to coexist in a single patient.

This case and the photos were submitted by Rachel Fayne, BA; Yumeng Li, MD, MS; Fabrizio Galimberti, MD, PhD; and Brian Morrison, MD, of the department of dermatology and cutaneous surgery at the University of Miami.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to dermnews@mdedge.com.

Opioid pain management should be reserved for just 21 of the 87 most common dermatologic procedures, an expert panel of dermatologists has recommended.

sdominick/iStock/Getty Images

Rotation flaps, interpolation flaps, wedge resections, cartilage alar-batten grafts, and Mustarde flaps were among the 20 procedures that can be managed with up to 10 oral oxycodone 5-mg equivalents, according to the panel. Only the Abbe procedure might warrant dispensing up to 15 oxycodone 5-mg pills, Justin McLawhorn, MD, and colleagues wrote in the Journal of the American Academy of Dermatology. The recommended amount of opioids are in addition to nonopioid analgesics, the guidelines point out.

All the other procedures can – and should – be managed with a combination of acetaminophen and ibuprofen, either alone or in an alternating dose pattern, said Dr. McLawhorn, of the department of dermatology at the University of Oklahoma Health Sciences Center, Oklahoma City, and coauthors.

But limited opioid prescribing is an important part of healing for patients who undergo the most invasive procedures, they wrote. “The management of complications, including adequate pain control, should be tailored to each patient on a case-by-case basis. Moreover, any pain management plan should not strictly adhere to any single guideline, but rather should be formed with consideration of the expected pain from the procedure and/or closure and consider the patient’s expectations for pain control.”

The time is ripe for dermatologists to make a stand in combating the opioid crisis, according to a group email response to questions from Dr. McLawhorn, Thomas Stasko, MD, professor and chair of dermatology at the University of Oklahoma, Oklahoma City, and Lindsey Collins, MD, also of the University of Oklahoma.

“The opioid crisis has reached epidemic proportions. More than 70,000 Americans have died from an opioid overdose in 2017,” they wrote. “Moreover, recent data suggest that nearly 6% of postsurgical, opioid-naive patients become long-term users of opioids. The lack of specific evidence-based recommendations likely contributes to a wide variety in prescribing patterns and a steady supply of unused opioids. Countering the opioid crisis necessitates a restructuring of the opioid prescribing practices that addresses pain in a procedure-specific manner. These recommendations are one tool in the dermatologists’ arsenal that can be used as a reference to help guide opioid management and prevent excessive opioid prescriptions at discharge following dermatologic interventions.”

Unfortunately, they added, dermatologists have inadvertently fueled the opioid abuse fire.

“It is difficult to quantify which providers are responsible for the onslaught of opioids into our communities,” the authors wrote in the email interview. “However, we can deduce, based on recent opioid prescribing patterns, that dermatologists provide approximately 500,000 unused opioid pills to their communities on an annual basis. This is the result of a wide variation in practice patterns and narratives that have been previously circulated in an attempt to mitigate the providers’ perception of the addictive nature of opioid analgesics. Our hope is that by addressing pain in a procedure-specific manner, we can help to limit the excessive number of unused opioid pills that are provided by dermatologists and ultimately decrease the rate of opioid-related complications, including addiction and death.”

Still, patients need and deserve effective pain management after a procedure. In the guidelines, the investigators wrote that a “one-size-fits-all” approach “does not account for the mechanism of pain, the invasiveness of the procedure, or the anatomic structures that are manipulated. As a result, current guidelines cannot accurately predict the quantity of opioids that are necessary to manage postoperative pain.”

The panel brought together experts in general dermatology, dermatologic surgery, cosmetics, and phlebology to develop a consensus on opioid prescribing guidelines for 87 of the most common procedures. Everyone on the panel was a member of the American College of Mohs Surgery, American Academy of Dermatology, or the American Vein and Lymphatic Society. The panel conducted a literature review to determine which procedures might require opioids and which would not. At least 75% of the panel had to agree on a reasonable but effective opioid amount; they were then polled as to whether they might employ that recommendation in their own clinical practice.

The recommendations are aimed at patients who experienced no peri- or postoperative complications.

The panel agreed that acetaminophen and ibuprofen – alone, in combination, or with opioids – were reasonable choices for all the 87 procedures. In such instances, acetaminophen 1 g can be staggered with ibuprofen 400 mg every 4 or 8 hours.

“I think providers will encounter a mixed bag of preconceived notions regarding patients’ expectations for pain control,” Dr. McLawhorn and coauthors wrote in the interview. “The important point for providers to make is to emphasize the noninferiority of acetaminophen and/or ibuprofen in controlling acute pain for patients who are not dependent on opioids for the management of chronic pain. Our experience in caring for many surgical patients has shown that patients are usually receptive to the use of nonopioid analgesics as many are familiar with their addictive potential because of the uptick in the publicity of the opioid-related complications.”

In cases where opioids might be appropriate, the panel unanimously agreed that dose limits be imposed. For 15 of the 87 procedures, the panel recommend a maximum prescription of 10 oxycodone 5-mg equivalents. Only one other – the Abbe flap – might warrant more, with a maximum of 15 oxycodone 5-mg pills at discharge.

Sometimes called a “lip switch,” the Abbe flap is reconstruction for full-thickness lip defects. It is a composite flap that moves skin, muscle, mucosa, and blood supply from the lower lip to reconstruct a defect of the upper lip. This reconstruction attempts to respect the native anatomic landmarks of the lip and allow for a better functional outcome.

“Because of the extensive nature of the repair and the anatomic territories that are manipulated, including the suturing of the lower lip to the upper lip with delayed separation, adequate pain control may require opioid analgesics in the immediate postoperative period,” the team wrote in the interview.

The panel could not agree on pain management strategies for five other procedures: Karapandzic flaps, en bloc nail excisions, facial resurfacing with deep chemical peels, and small- or large-volume liposuction. This was partly because of a lack of personal experience. Only 8 of the 40 panelists performed Karapandzic flaps. The maximum number of 5-mg oxycodone tablets any panelist prescribed for Karapandzic flaps and en bloc nail excisions was 20.

Facial resurfacing was likewise an uncommon procedure for the panel, with just 11 members performing this using deep chemical peels. However, five of those panelists said that opioids were routinely needed for postoperative pain with a maximum of 15 oxycodone 5-mg equivalents. And just four panelists performed liposuction, for which they used a maximum of 15 oxycodone 5-mg equivalents.

“However,” they wrote in the guidelines, “these providers noted that the location where the procedure is performed strongly influences the need for opioid pain management, with small-volume removal in the neck, arms, or flanks being unlikely to require opioids for adequate pain control, whereas large-volume removal in the thighs, knees, and hips may routinely require opioids.”

Addressing patient expectations is a very important part of pain management, the panel noted. “Patients will invariably experience postoperative pain after cutaneous surgeries or other interventions, often peaking within 4 hours after surgery. Wound tension, size and type of repair, anatomical location/nerve innervation, and patient pain tolerance are all factors that contribute to postoperative discomfort and should be considered when developing a postoperative pain management plan.”

Ultimately, according to Dr. McLawhorn and coauthors, the decision to use opioids at discharge for postoperative pain control should be an individual one based on patients’ comorbidities and expectations.

“Admittedly, many of the procedures listed within the recommendations may result in a rather large or complex defect that requires an equally large or complex repair,” they wrote in the interview. “However, proper education of the patient and provider regarding the risks of addiction with the use of opioids even short term should be discussed as part of every preoperative consultation. Furthermore, the patient and the provider must discuss their expectations for postoperative pain interventions for adequate pain control.”

msullivan@mdedge.com

SOURCE: McLawhorn J et al. J Am Acad Dermatol. 2019 Nov 12. doi: 10.1016/j.jaad.2019.09.080.

Opioid pain management should be reserved for just 21 of the 87 most common dermatologic procedures, an expert panel of dermatologists has recommended.

sdominick/iStock/Getty Images

Rotation flaps, interpolation flaps, wedge resections, cartilage alar-batten grafts, and Mustarde flaps were among the 20 procedures that can be managed with up to 10 oral oxycodone 5-mg equivalents, according to the panel. Only the Abbe procedure might warrant dispensing up to 15 oxycodone 5-mg pills, Justin McLawhorn, MD, and colleagues wrote in the Journal of the American Academy of Dermatology. The recommended amount of opioids are in addition to nonopioid analgesics, the guidelines point out.

All the other procedures can – and should – be managed with a combination of acetaminophen and ibuprofen, either alone or in an alternating dose pattern, said Dr. McLawhorn, of the department of dermatology at the University of Oklahoma Health Sciences Center, Oklahoma City, and coauthors.

But limited opioid prescribing is an important part of healing for patients who undergo the most invasive procedures, they wrote. “The management of complications, including adequate pain control, should be tailored to each patient on a case-by-case basis. Moreover, any pain management plan should not strictly adhere to any single guideline, but rather should be formed with consideration of the expected pain from the procedure and/or closure and consider the patient’s expectations for pain control.”

The time is ripe for dermatologists to make a stand in combating the opioid crisis, according to a group email response to questions from Dr. McLawhorn, Thomas Stasko, MD, professor and chair of dermatology at the University of Oklahoma, Oklahoma City, and Lindsey Collins, MD, also of the University of Oklahoma.

“The opioid crisis has reached epidemic proportions. More than 70,000 Americans have died from an opioid overdose in 2017,” they wrote. “Moreover, recent data suggest that nearly 6% of postsurgical, opioid-naive patients become long-term users of opioids. The lack of specific evidence-based recommendations likely contributes to a wide variety in prescribing patterns and a steady supply of unused opioids. Countering the opioid crisis necessitates a restructuring of the opioid prescribing practices that addresses pain in a procedure-specific manner. These recommendations are one tool in the dermatologists’ arsenal that can be used as a reference to help guide opioid management and prevent excessive opioid prescriptions at discharge following dermatologic interventions.”

Unfortunately, they added, dermatologists have inadvertently fueled the opioid abuse fire.

“It is difficult to quantify which providers are responsible for the onslaught of opioids into our communities,” the authors wrote in the email interview. “However, we can deduce, based on recent opioid prescribing patterns, that dermatologists provide approximately 500,000 unused opioid pills to their communities on an annual basis. This is the result of a wide variation in practice patterns and narratives that have been previously circulated in an attempt to mitigate the providers’ perception of the addictive nature of opioid analgesics. Our hope is that by addressing pain in a procedure-specific manner, we can help to limit the excessive number of unused opioid pills that are provided by dermatologists and ultimately decrease the rate of opioid-related complications, including addiction and death.”

Still, patients need and deserve effective pain management after a procedure. In the guidelines, the investigators wrote that a “one-size-fits-all” approach “does not account for the mechanism of pain, the invasiveness of the procedure, or the anatomic structures that are manipulated. As a result, current guidelines cannot accurately predict the quantity of opioids that are necessary to manage postoperative pain.”

The panel brought together experts in general dermatology, dermatologic surgery, cosmetics, and phlebology to develop a consensus on opioid prescribing guidelines for 87 of the most common procedures. Everyone on the panel was a member of the American College of Mohs Surgery, American Academy of Dermatology, or the American Vein and Lymphatic Society. The panel conducted a literature review to determine which procedures might require opioids and which would not. At least 75% of the panel had to agree on a reasonable but effective opioid amount; they were then polled as to whether they might employ that recommendation in their own clinical practice.

The recommendations are aimed at patients who experienced no peri- or postoperative complications.

The panel agreed that acetaminophen and ibuprofen – alone, in combination, or with opioids – were reasonable choices for all the 87 procedures. In such instances, acetaminophen 1 g can be staggered with ibuprofen 400 mg every 4 or 8 hours.

“I think providers will encounter a mixed bag of preconceived notions regarding patients’ expectations for pain control,” Dr. McLawhorn and coauthors wrote in the interview. “The important point for providers to make is to emphasize the noninferiority of acetaminophen and/or ibuprofen in controlling acute pain for patients who are not dependent on opioids for the management of chronic pain. Our experience in caring for many surgical patients has shown that patients are usually receptive to the use of nonopioid analgesics as many are familiar with their addictive potential because of the uptick in the publicity of the opioid-related complications.”

In cases where opioids might be appropriate, the panel unanimously agreed that dose limits be imposed. For 15 of the 87 procedures, the panel recommend a maximum prescription of 10 oxycodone 5-mg equivalents. Only one other – the Abbe flap – might warrant more, with a maximum of 15 oxycodone 5-mg pills at discharge.

Sometimes called a “lip switch,” the Abbe flap is reconstruction for full-thickness lip defects. It is a composite flap that moves skin, muscle, mucosa, and blood supply from the lower lip to reconstruct a defect of the upper lip. This reconstruction attempts to respect the native anatomic landmarks of the lip and allow for a better functional outcome.

“Because of the extensive nature of the repair and the anatomic territories that are manipulated, including the suturing of the lower lip to the upper lip with delayed separation, adequate pain control may require opioid analgesics in the immediate postoperative period,” the team wrote in the interview.

The panel could not agree on pain management strategies for five other procedures: Karapandzic flaps, en bloc nail excisions, facial resurfacing with deep chemical peels, and small- or large-volume liposuction. This was partly because of a lack of personal experience. Only 8 of the 40 panelists performed Karapandzic flaps. The maximum number of 5-mg oxycodone tablets any panelist prescribed for Karapandzic flaps and en bloc nail excisions was 20.

Facial resurfacing was likewise an uncommon procedure for the panel, with just 11 members performing this using deep chemical peels. However, five of those panelists said that opioids were routinely needed for postoperative pain with a maximum of 15 oxycodone 5-mg equivalents. And just four panelists performed liposuction, for which they used a maximum of 15 oxycodone 5-mg equivalents.

“However,” they wrote in the guidelines, “these providers noted that the location where the procedure is performed strongly influences the need for opioid pain management, with small-volume removal in the neck, arms, or flanks being unlikely to require opioids for adequate pain control, whereas large-volume removal in the thighs, knees, and hips may routinely require opioids.”

Addressing patient expectations is a very important part of pain management, the panel noted. “Patients will invariably experience postoperative pain after cutaneous surgeries or other interventions, often peaking within 4 hours after surgery. Wound tension, size and type of repair, anatomical location/nerve innervation, and patient pain tolerance are all factors that contribute to postoperative discomfort and should be considered when developing a postoperative pain management plan.”

Ultimately, according to Dr. McLawhorn and coauthors, the decision to use opioids at discharge for postoperative pain control should be an individual one based on patients’ comorbidities and expectations.

“Admittedly, many of the procedures listed within the recommendations may result in a rather large or complex defect that requires an equally large or complex repair,” they wrote in the interview. “However, proper education of the patient and provider regarding the risks of addiction with the use of opioids even short term should be discussed as part of every preoperative consultation. Furthermore, the patient and the provider must discuss their expectations for postoperative pain interventions for adequate pain control.”

msullivan@mdedge.com

SOURCE: McLawhorn J et al. J Am Acad Dermatol. 2019 Nov 12. doi: 10.1016/j.jaad.2019.09.080.

Opioid pain management should be reserved for just 21 of the 87 most common dermatologic procedures, an expert panel of dermatologists has recommended.

sdominick/iStock/Getty Images

Rotation flaps, interpolation flaps, wedge resections, cartilage alar-batten grafts, and Mustarde flaps were among the 20 procedures that can be managed with up to 10 oral oxycodone 5-mg equivalents, according to the panel. Only the Abbe procedure might warrant dispensing up to 15 oxycodone 5-mg pills, Justin McLawhorn, MD, and colleagues wrote in the Journal of the American Academy of Dermatology. The recommended amount of opioids are in addition to nonopioid analgesics, the guidelines point out.

All the other procedures can – and should – be managed with a combination of acetaminophen and ibuprofen, either alone or in an alternating dose pattern, said Dr. McLawhorn, of the department of dermatology at the University of Oklahoma Health Sciences Center, Oklahoma City, and coauthors.

But limited opioid prescribing is an important part of healing for patients who undergo the most invasive procedures, they wrote. “The management of complications, including adequate pain control, should be tailored to each patient on a case-by-case basis. Moreover, any pain management plan should not strictly adhere to any single guideline, but rather should be formed with consideration of the expected pain from the procedure and/or closure and consider the patient’s expectations for pain control.”

The time is ripe for dermatologists to make a stand in combating the opioid crisis, according to a group email response to questions from Dr. McLawhorn, Thomas Stasko, MD, professor and chair of dermatology at the University of Oklahoma, Oklahoma City, and Lindsey Collins, MD, also of the University of Oklahoma.

“The opioid crisis has reached epidemic proportions. More than 70,000 Americans have died from an opioid overdose in 2017,” they wrote. “Moreover, recent data suggest that nearly 6% of postsurgical, opioid-naive patients become long-term users of opioids. The lack of specific evidence-based recommendations likely contributes to a wide variety in prescribing patterns and a steady supply of unused opioids. Countering the opioid crisis necessitates a restructuring of the opioid prescribing practices that addresses pain in a procedure-specific manner. These recommendations are one tool in the dermatologists’ arsenal that can be used as a reference to help guide opioid management and prevent excessive opioid prescriptions at discharge following dermatologic interventions.”

Unfortunately, they added, dermatologists have inadvertently fueled the opioid abuse fire.

“It is difficult to quantify which providers are responsible for the onslaught of opioids into our communities,” the authors wrote in the email interview. “However, we can deduce, based on recent opioid prescribing patterns, that dermatologists provide approximately 500,000 unused opioid pills to their communities on an annual basis. This is the result of a wide variation in practice patterns and narratives that have been previously circulated in an attempt to mitigate the providers’ perception of the addictive nature of opioid analgesics. Our hope is that by addressing pain in a procedure-specific manner, we can help to limit the excessive number of unused opioid pills that are provided by dermatologists and ultimately decrease the rate of opioid-related complications, including addiction and death.”

Still, patients need and deserve effective pain management after a procedure. In the guidelines, the investigators wrote that a “one-size-fits-all” approach “does not account for the mechanism of pain, the invasiveness of the procedure, or the anatomic structures that are manipulated. As a result, current guidelines cannot accurately predict the quantity of opioids that are necessary to manage postoperative pain.”

The panel brought together experts in general dermatology, dermatologic surgery, cosmetics, and phlebology to develop a consensus on opioid prescribing guidelines for 87 of the most common procedures. Everyone on the panel was a member of the American College of Mohs Surgery, American Academy of Dermatology, or the American Vein and Lymphatic Society. The panel conducted a literature review to determine which procedures might require opioids and which would not. At least 75% of the panel had to agree on a reasonable but effective opioid amount; they were then polled as to whether they might employ that recommendation in their own clinical practice.

The recommendations are aimed at patients who experienced no peri- or postoperative complications.

The panel agreed that acetaminophen and ibuprofen – alone, in combination, or with opioids – were reasonable choices for all the 87 procedures. In such instances, acetaminophen 1 g can be staggered with ibuprofen 400 mg every 4 or 8 hours.

“I think providers will encounter a mixed bag of preconceived notions regarding patients’ expectations for pain control,” Dr. McLawhorn and coauthors wrote in the interview. “The important point for providers to make is to emphasize the noninferiority of acetaminophen and/or ibuprofen in controlling acute pain for patients who are not dependent on opioids for the management of chronic pain. Our experience in caring for many surgical patients has shown that patients are usually receptive to the use of nonopioid analgesics as many are familiar with their addictive potential because of the uptick in the publicity of the opioid-related complications.”

In cases where opioids might be appropriate, the panel unanimously agreed that dose limits be imposed. For 15 of the 87 procedures, the panel recommend a maximum prescription of 10 oxycodone 5-mg equivalents. Only one other – the Abbe flap – might warrant more, with a maximum of 15 oxycodone 5-mg pills at discharge.

Sometimes called a “lip switch,” the Abbe flap is reconstruction for full-thickness lip defects. It is a composite flap that moves skin, muscle, mucosa, and blood supply from the lower lip to reconstruct a defect of the upper lip. This reconstruction attempts to respect the native anatomic landmarks of the lip and allow for a better functional outcome.

“Because of the extensive nature of the repair and the anatomic territories that are manipulated, including the suturing of the lower lip to the upper lip with delayed separation, adequate pain control may require opioid analgesics in the immediate postoperative period,” the team wrote in the interview.

The panel could not agree on pain management strategies for five other procedures: Karapandzic flaps, en bloc nail excisions, facial resurfacing with deep chemical peels, and small- or large-volume liposuction. This was partly because of a lack of personal experience. Only 8 of the 40 panelists performed Karapandzic flaps. The maximum number of 5-mg oxycodone tablets any panelist prescribed for Karapandzic flaps and en bloc nail excisions was 20.

Facial resurfacing was likewise an uncommon procedure for the panel, with just 11 members performing this using deep chemical peels. However, five of those panelists said that opioids were routinely needed for postoperative pain with a maximum of 15 oxycodone 5-mg equivalents. And just four panelists performed liposuction, for which they used a maximum of 15 oxycodone 5-mg equivalents.

“However,” they wrote in the guidelines, “these providers noted that the location where the procedure is performed strongly influences the need for opioid pain management, with small-volume removal in the neck, arms, or flanks being unlikely to require opioids for adequate pain control, whereas large-volume removal in the thighs, knees, and hips may routinely require opioids.”

Addressing patient expectations is a very important part of pain management, the panel noted. “Patients will invariably experience postoperative pain after cutaneous surgeries or other interventions, often peaking within 4 hours after surgery. Wound tension, size and type of repair, anatomical location/nerve innervation, and patient pain tolerance are all factors that contribute to postoperative discomfort and should be considered when developing a postoperative pain management plan.”

Ultimately, according to Dr. McLawhorn and coauthors, the decision to use opioids at discharge for postoperative pain control should be an individual one based on patients’ comorbidities and expectations.

“Admittedly, many of the procedures listed within the recommendations may result in a rather large or complex defect that requires an equally large or complex repair,” they wrote in the interview. “However, proper education of the patient and provider regarding the risks of addiction with the use of opioids even short term should be discussed as part of every preoperative consultation. Furthermore, the patient and the provider must discuss their expectations for postoperative pain interventions for adequate pain control.”

msullivan@mdedge.com

SOURCE: McLawhorn J et al. J Am Acad Dermatol. 2019 Nov 12. doi: 10.1016/j.jaad.2019.09.080.

A Vietnam veteran steered clear of the health care system for years, then showed up at the hospital with pneumonia and respiratory failure. He was whisked to the intensive care unit, and cancerous masses were found.

The situation – as described by Jeffrey Frank, MD, director of quality and performance at Vituity, a physician group in Emeryville, Calif. – then got worse.

“No one was there for him,” Dr. Frank said. “He’s laying in the ICU, he does not have the capacity to make decisions, let alone communicate. So the care team needs guidance.”

Too often, hospitalists find themselves in confusing situations involving patients near the end of their lives, having to determine how to go about treating a patient or withholding treatment when patients are not in a position to announce their wishes. When family is present, the health care team thinks the most sensible course of treatment is at odds with what the family wants to be done.

At the Society of Hospital Medicine 2019 Annual Conference, hospitalists with palliative care training offered advice on how to go about handling these difficult situations, which can sometimes become more manageable with certain strategies.

For situations in which there is no designated representative to speak for a patient who is unresponsive – the so-called “unbefriended patient” or “unrepresented patient” – any source of information can be valuable. And health care providers should seek out this input, Dr. Frank said.

“When there is a visitor at the bedside, and as long as they know the person, and they can start giving the medical providers some information about what the patient would have wanted, most of us will talk with that person and that’s actually a good habit,” he said.

Thirty-nine states and the District of Columbia have regulations on whom health care providers should talk to when there is no obvious representative, Dr. Frank said, noting that most of these regulations follow a classic family-tree order. But in the discouraging results of many surveys of health care providers on the subject, most clinicians say that they do not know the regulations in their state, Dr. Frank said. But he said such results betray a silver lining because clinicians say that they would be inclined to use a family tree–style hierarchy in deciding with whom they should speak about end of life decisions.

Hospitalists should at least know whether their hospital has a policy on unrepresented patients, Dr. Frank said.

“That’s your road map on how to get through consenting this patient – what am I going to do with Mr. Smith?” he said. “You may ask yourself, ‘Do I just keep treating him and treating him?’ If you have a policy at your hospital, it will protect you from liability, as well as give you a sense of process.”
 

Conflicts in communication

An even worse situation, perhaps, is one that many hospitalists have seen: A patient is teetering at the edge of life, and a spouse arrives, along with two daughters from out of state who have not seen their father in a year, said Elizabeth Gundersen, MD, director of the ethics curriculum at Florida Atlantic University, Boca Raton.

“The family requests that the medical team do everything, including intubation and attempts at resuscitation if needed,” she said. “The family says he was fine prior to this admission. Another thing I hear a lot is, ‘He was even sicker than this last year, and he got better.’ ”

Meanwhile, “the medical team consensus is that he is not going to survive this illness,” Dr. Gundersen said.

The situation is so common and problematic that it has a name – the “Daughter from California Syndrome.” (According to medical literature says, it’s called the “Daughter from Chicago Syndrome” in California.)

“This is one of the most agonizing things that happens to us in medicine,” Dr. Gundersen said. “It affects us, it affects our nurses, it affects the entire medical team. It’s agonizing when we feel like treatment has somehow turned to torture.”

Dr. Gundersen said the medical staff should avoid using the word “futile,” or similar language, with families.

“Words matter,” she said. “Inappropriate language can inadvertently convey the feeling that, ‘They’re giving up on my dad – they think it’s hopeless.’ That can make families and the medical team dig in their heels further.”

Sometimes it can be hard to define the terms of decision making. Even if the family and the medical team can agree that no “nonbeneficial treatments” should be administered, Dr. Gundersen said, what exactly does that mean? Does it mean less than a 1% chance of working; less than a 5% chance?

If the medical staff thinks a mode of care won’t be effective, but the family still insists, some states have laws that could help the medical team. In Texas, for example, if the medical team thinks the care they’re giving isn’t helping the patient, and the patient is likely going to have a poor outcome, there’s a legal process that the team can go through, Dr. Gundersen said. But even these laws are seen as potentially problematic because of concerns that they put too much power in the hands of a hospital committee.

Dr. Gundersen strongly advised getting at the root causes of a family’s apprehension. They might not have been informed early enough about the dire nature of an illness to feel they can make a decision comfortably. They also may be receiving information in a piecemeal manner or information that is inconsistent. Another common fear expressed by families is a concern over abandonment by the medical team if a decision is made to forgo a certain treatment. Also, sometimes the goals of care might not be properly detailed and discussed, she said.

But better communication can help overcome these snags, Dr. Gundersen said.

She suggested that sometimes it’s helpful to clarify things with the family, for example, what do they mean by “Do everything”?

“Does it mean ‘I want you to do everything to prolong their life even if they suffer,’ or does it mean ‘I want you do to everything that’s reasonable to try to prolong their life but not at the risk of increased suffering,’ or anywhere in between. Really just having these clarifying conversations is helpful.”

She also emphasized the importance of talking about interests, such as not wanting a patient to suffer, instead of taking positions, such as flatly recommending the withdrawal of treatment.

“It’s easy for both sides to kind of dig in their heels and not communicate effectively,” Dr. Gundersen said.
 

‘Emotional torture’

There are times when, no matter how skillfully the medical team communicates, they stand at an impasse with the family.

“This is emotional torture for us,” Dr. Gundersen said. “It’s moral distress. We kind of dread these situations. In these cases, trying to support yourself and your team emotionally is the most important thing.”

Ami Doshi, MD, director of palliative care inpatient services at Rady Children’s Hospital in San Diego, described the case of a baby girl that touched on the especially painful issues that can arise in pediatric cases. The 2-month-old girl had been born after a pregnancy affected by polyhydramnios and had an abnormal neurological exam and brain MRI, as well as congenital abnormalities. She’d been intubated for respiratory failure and was now on high-flow nasal cannula therapy. The girl was intolerant to feeding and was put on a nasojejunal feeding tube and then a gastrostomy-jejunostomy tube.

But the baby’s vomiting continued, and she had bradycardia and hypoxia so severe she needed bag mask ventilation to recover. The mother started to feel like she was “torturing” the baby.

The family decided to stop respiratory support but to continue artificial nutrition and hydration, which Dr. Doshi said, has an elevated status in the human psyche. Mentioning discontinuing feeding is fraught with complexity, she said.

“The notion of feeding is such a basic instinct, especially with a baby, that tackling the notion of discontinuing any sort of feeds, orally or tube feeds, is fraught with emotion and angst at times,” Dr. Doshi said.

The girl had respiratory events but recovered from them on her own, but the vomiting and retching continued. Eventually the artificial nutrition and hydration was stopped. But after 5 days, the medical staff began feeling uncomfortable, Dr. Doshi said. “We’re starting to hear from nurses, doctors, other people, that something just doesn’t feel right about what’s happening: ‘She seems okay,’ and, ‘Is it really okay for us to be doing this?’ and ‘Gosh, this is taking a long time.’ ”

The medical staff had, in a sense, joined the family on the emotional roller coaster.

Dr. Doshi said it’s important to remember that there is no ethical or moral distinction between withdrawing a medical intervention and withholding one.

“Stopping an intervention once it has started is no different ethically or legally than not starting it in the first place,” she said.

According to Dr. Doshi, there is a general consensus among medical societies that artificial nutrition and hydration is a medical intervention just like any other and that it should be evaluated within the same framework: Is it overly burdensome? Are we doing harm? Is it consistent with the goal of care? In so doing, be sure to respect patient autonomy and obtain informed consent.

As with so much in medicine, careful communication is a must.

“Paint a picture of what the patient’s trajectory is going to look like with and without artificial nutrition and hydration. At the end of the day, having done all of that, we’re going to ultimately respect what the patient or the surrogate decision maker decides,” Dr. Doshi said.

After assessment the data and the chances of success, and still without clarity about how to proceed, a good option might be considering a “time-limited trial” in which the medical team sits with the family and agrees on a time frame for an intervention and chooses predetermined endpoints for assessing success or failure.

“This can be very powerful to help us understand whether it is beneficial, but also – from the family’s perspective – to know everything was tried,” Dr. Doshi said.

Hospitalists should emphasize what is being added to treatment so that families don’t think only of what is being taken away, she said.

“Usually we are adding a lot – symptom management, a lot of psychosocial support. So what are all the other ways that we’re going to continue to care for the patient, even when we are withdrawing or withholding a specific intervention?” Dr. Doshi noted.

Sometimes, the best healer of distress in the midst of end of life decision making is time itself, Dr. Gundersen said.

In a condolence call, she once spoke with a family member involved in an agonizing case in which the medical team and family were at odds. Yet the man told her: “I know that you all were telling us the entire time that this was going to happen, but I guess we just had to go through our own process.”

A Vietnam veteran steered clear of the health care system for years, then showed up at the hospital with pneumonia and respiratory failure. He was whisked to the intensive care unit, and cancerous masses were found.

The situation – as described by Jeffrey Frank, MD, director of quality and performance at Vituity, a physician group in Emeryville, Calif. – then got worse.

“No one was there for him,” Dr. Frank said. “He’s laying in the ICU, he does not have the capacity to make decisions, let alone communicate. So the care team needs guidance.”

Too often, hospitalists find themselves in confusing situations involving patients near the end of their lives, having to determine how to go about treating a patient or withholding treatment when patients are not in a position to announce their wishes. When family is present, the health care team thinks the most sensible course of treatment is at odds with what the family wants to be done.

At the Society of Hospital Medicine 2019 Annual Conference, hospitalists with palliative care training offered advice on how to go about handling these difficult situations, which can sometimes become more manageable with certain strategies.

For situations in which there is no designated representative to speak for a patient who is unresponsive – the so-called “unbefriended patient” or “unrepresented patient” – any source of information can be valuable. And health care providers should seek out this input, Dr. Frank said.

“When there is a visitor at the bedside, and as long as they know the person, and they can start giving the medical providers some information about what the patient would have wanted, most of us will talk with that person and that’s actually a good habit,” he said.

Thirty-nine states and the District of Columbia have regulations on whom health care providers should talk to when there is no obvious representative, Dr. Frank said, noting that most of these regulations follow a classic family-tree order. But in the discouraging results of many surveys of health care providers on the subject, most clinicians say that they do not know the regulations in their state, Dr. Frank said. But he said such results betray a silver lining because clinicians say that they would be inclined to use a family tree–style hierarchy in deciding with whom they should speak about end of life decisions.

Hospitalists should at least know whether their hospital has a policy on unrepresented patients, Dr. Frank said.

“That’s your road map on how to get through consenting this patient – what am I going to do with Mr. Smith?” he said. “You may ask yourself, ‘Do I just keep treating him and treating him?’ If you have a policy at your hospital, it will protect you from liability, as well as give you a sense of process.”
 

Conflicts in communication

An even worse situation, perhaps, is one that many hospitalists have seen: A patient is teetering at the edge of life, and a spouse arrives, along with two daughters from out of state who have not seen their father in a year, said Elizabeth Gundersen, MD, director of the ethics curriculum at Florida Atlantic University, Boca Raton.

“The family requests that the medical team do everything, including intubation and attempts at resuscitation if needed,” she said. “The family says he was fine prior to this admission. Another thing I hear a lot is, ‘He was even sicker than this last year, and he got better.’ ”

Meanwhile, “the medical team consensus is that he is not going to survive this illness,” Dr. Gundersen said.

The situation is so common and problematic that it has a name – the “Daughter from California Syndrome.” (According to medical literature says, it’s called the “Daughter from Chicago Syndrome” in California.)

“This is one of the most agonizing things that happens to us in medicine,” Dr. Gundersen said. “It affects us, it affects our nurses, it affects the entire medical team. It’s agonizing when we feel like treatment has somehow turned to torture.”

Dr. Gundersen said the medical staff should avoid using the word “futile,” or similar language, with families.

“Words matter,” she said. “Inappropriate language can inadvertently convey the feeling that, ‘They’re giving up on my dad – they think it’s hopeless.’ That can make families and the medical team dig in their heels further.”

Sometimes it can be hard to define the terms of decision making. Even if the family and the medical team can agree that no “nonbeneficial treatments” should be administered, Dr. Gundersen said, what exactly does that mean? Does it mean less than a 1% chance of working; less than a 5% chance?

If the medical staff thinks a mode of care won’t be effective, but the family still insists, some states have laws that could help the medical team. In Texas, for example, if the medical team thinks the care they’re giving isn’t helping the patient, and the patient is likely going to have a poor outcome, there’s a legal process that the team can go through, Dr. Gundersen said. But even these laws are seen as potentially problematic because of concerns that they put too much power in the hands of a hospital committee.

Dr. Gundersen strongly advised getting at the root causes of a family’s apprehension. They might not have been informed early enough about the dire nature of an illness to feel they can make a decision comfortably. They also may be receiving information in a piecemeal manner or information that is inconsistent. Another common fear expressed by families is a concern over abandonment by the medical team if a decision is made to forgo a certain treatment. Also, sometimes the goals of care might not be properly detailed and discussed, she said.

But better communication can help overcome these snags, Dr. Gundersen said.

She suggested that sometimes it’s helpful to clarify things with the family, for example, what do they mean by “Do everything”?

“Does it mean ‘I want you to do everything to prolong their life even if they suffer,’ or does it mean ‘I want you do to everything that’s reasonable to try to prolong their life but not at the risk of increased suffering,’ or anywhere in between. Really just having these clarifying conversations is helpful.”

She also emphasized the importance of talking about interests, such as not wanting a patient to suffer, instead of taking positions, such as flatly recommending the withdrawal of treatment.

“It’s easy for both sides to kind of dig in their heels and not communicate effectively,” Dr. Gundersen said.
 

‘Emotional torture’

There are times when, no matter how skillfully the medical team communicates, they stand at an impasse with the family.

“This is emotional torture for us,” Dr. Gundersen said. “It’s moral distress. We kind of dread these situations. In these cases, trying to support yourself and your team emotionally is the most important thing.”

Ami Doshi, MD, director of palliative care inpatient services at Rady Children’s Hospital in San Diego, described the case of a baby girl that touched on the especially painful issues that can arise in pediatric cases. The 2-month-old girl had been born after a pregnancy affected by polyhydramnios and had an abnormal neurological exam and brain MRI, as well as congenital abnormalities. She’d been intubated for respiratory failure and was now on high-flow nasal cannula therapy. The girl was intolerant to feeding and was put on a nasojejunal feeding tube and then a gastrostomy-jejunostomy tube.

But the baby’s vomiting continued, and she had bradycardia and hypoxia so severe she needed bag mask ventilation to recover. The mother started to feel like she was “torturing” the baby.

The family decided to stop respiratory support but to continue artificial nutrition and hydration, which Dr. Doshi said, has an elevated status in the human psyche. Mentioning discontinuing feeding is fraught with complexity, she said.

“The notion of feeding is such a basic instinct, especially with a baby, that tackling the notion of discontinuing any sort of feeds, orally or tube feeds, is fraught with emotion and angst at times,” Dr. Doshi said.

The girl had respiratory events but recovered from them on her own, but the vomiting and retching continued. Eventually the artificial nutrition and hydration was stopped. But after 5 days, the medical staff began feeling uncomfortable, Dr. Doshi said. “We’re starting to hear from nurses, doctors, other people, that something just doesn’t feel right about what’s happening: ‘She seems okay,’ and, ‘Is it really okay for us to be doing this?’ and ‘Gosh, this is taking a long time.’ ”

The medical staff had, in a sense, joined the family on the emotional roller coaster.

Dr. Doshi said it’s important to remember that there is no ethical or moral distinction between withdrawing a medical intervention and withholding one.

“Stopping an intervention once it has started is no different ethically or legally than not starting it in the first place,” she said.

According to Dr. Doshi, there is a general consensus among medical societies that artificial nutrition and hydration is a medical intervention just like any other and that it should be evaluated within the same framework: Is it overly burdensome? Are we doing harm? Is it consistent with the goal of care? In so doing, be sure to respect patient autonomy and obtain informed consent.

As with so much in medicine, careful communication is a must.

“Paint a picture of what the patient’s trajectory is going to look like with and without artificial nutrition and hydration. At the end of the day, having done all of that, we’re going to ultimately respect what the patient or the surrogate decision maker decides,” Dr. Doshi said.

After assessment the data and the chances of success, and still without clarity about how to proceed, a good option might be considering a “time-limited trial” in which the medical team sits with the family and agrees on a time frame for an intervention and chooses predetermined endpoints for assessing success or failure.

“This can be very powerful to help us understand whether it is beneficial, but also – from the family’s perspective – to know everything was tried,” Dr. Doshi said.

Hospitalists should emphasize what is being added to treatment so that families don’t think only of what is being taken away, she said.

“Usually we are adding a lot – symptom management, a lot of psychosocial support. So what are all the other ways that we’re going to continue to care for the patient, even when we are withdrawing or withholding a specific intervention?” Dr. Doshi noted.

Sometimes, the best healer of distress in the midst of end of life decision making is time itself, Dr. Gundersen said.

In a condolence call, she once spoke with a family member involved in an agonizing case in which the medical team and family were at odds. Yet the man told her: “I know that you all were telling us the entire time that this was going to happen, but I guess we just had to go through our own process.”

A Vietnam veteran steered clear of the health care system for years, then showed up at the hospital with pneumonia and respiratory failure. He was whisked to the intensive care unit, and cancerous masses were found.

The situation – as described by Jeffrey Frank, MD, director of quality and performance at Vituity, a physician group in Emeryville, Calif. – then got worse.

“No one was there for him,” Dr. Frank said. “He’s laying in the ICU, he does not have the capacity to make decisions, let alone communicate. So the care team needs guidance.”

Too often, hospitalists find themselves in confusing situations involving patients near the end of their lives, having to determine how to go about treating a patient or withholding treatment when patients are not in a position to announce their wishes. When family is present, the health care team thinks the most sensible course of treatment is at odds with what the family wants to be done.

At the Society of Hospital Medicine 2019 Annual Conference, hospitalists with palliative care training offered advice on how to go about handling these difficult situations, which can sometimes become more manageable with certain strategies.

For situations in which there is no designated representative to speak for a patient who is unresponsive – the so-called “unbefriended patient” or “unrepresented patient” – any source of information can be valuable. And health care providers should seek out this input, Dr. Frank said.

“When there is a visitor at the bedside, and as long as they know the person, and they can start giving the medical providers some information about what the patient would have wanted, most of us will talk with that person and that’s actually a good habit,” he said.

Thirty-nine states and the District of Columbia have regulations on whom health care providers should talk to when there is no obvious representative, Dr. Frank said, noting that most of these regulations follow a classic family-tree order. But in the discouraging results of many surveys of health care providers on the subject, most clinicians say that they do not know the regulations in their state, Dr. Frank said. But he said such results betray a silver lining because clinicians say that they would be inclined to use a family tree–style hierarchy in deciding with whom they should speak about end of life decisions.

Hospitalists should at least know whether their hospital has a policy on unrepresented patients, Dr. Frank said.

“That’s your road map on how to get through consenting this patient – what am I going to do with Mr. Smith?” he said. “You may ask yourself, ‘Do I just keep treating him and treating him?’ If you have a policy at your hospital, it will protect you from liability, as well as give you a sense of process.”
 

Conflicts in communication

An even worse situation, perhaps, is one that many hospitalists have seen: A patient is teetering at the edge of life, and a spouse arrives, along with two daughters from out of state who have not seen their father in a year, said Elizabeth Gundersen, MD, director of the ethics curriculum at Florida Atlantic University, Boca Raton.

“The family requests that the medical team do everything, including intubation and attempts at resuscitation if needed,” she said. “The family says he was fine prior to this admission. Another thing I hear a lot is, ‘He was even sicker than this last year, and he got better.’ ”

Meanwhile, “the medical team consensus is that he is not going to survive this illness,” Dr. Gundersen said.

The situation is so common and problematic that it has a name – the “Daughter from California Syndrome.” (According to medical literature says, it’s called the “Daughter from Chicago Syndrome” in California.)

“This is one of the most agonizing things that happens to us in medicine,” Dr. Gundersen said. “It affects us, it affects our nurses, it affects the entire medical team. It’s agonizing when we feel like treatment has somehow turned to torture.”

Dr. Gundersen said the medical staff should avoid using the word “futile,” or similar language, with families.

“Words matter,” she said. “Inappropriate language can inadvertently convey the feeling that, ‘They’re giving up on my dad – they think it’s hopeless.’ That can make families and the medical team dig in their heels further.”

Sometimes it can be hard to define the terms of decision making. Even if the family and the medical team can agree that no “nonbeneficial treatments” should be administered, Dr. Gundersen said, what exactly does that mean? Does it mean less than a 1% chance of working; less than a 5% chance?

If the medical staff thinks a mode of care won’t be effective, but the family still insists, some states have laws that could help the medical team. In Texas, for example, if the medical team thinks the care they’re giving isn’t helping the patient, and the patient is likely going to have a poor outcome, there’s a legal process that the team can go through, Dr. Gundersen said. But even these laws are seen as potentially problematic because of concerns that they put too much power in the hands of a hospital committee.

Dr. Gundersen strongly advised getting at the root causes of a family’s apprehension. They might not have been informed early enough about the dire nature of an illness to feel they can make a decision comfortably. They also may be receiving information in a piecemeal manner or information that is inconsistent. Another common fear expressed by families is a concern over abandonment by the medical team if a decision is made to forgo a certain treatment. Also, sometimes the goals of care might not be properly detailed and discussed, she said.

But better communication can help overcome these snags, Dr. Gundersen said.

She suggested that sometimes it’s helpful to clarify things with the family, for example, what do they mean by “Do everything”?

“Does it mean ‘I want you to do everything to prolong their life even if they suffer,’ or does it mean ‘I want you do to everything that’s reasonable to try to prolong their life but not at the risk of increased suffering,’ or anywhere in between. Really just having these clarifying conversations is helpful.”

She also emphasized the importance of talking about interests, such as not wanting a patient to suffer, instead of taking positions, such as flatly recommending the withdrawal of treatment.

“It’s easy for both sides to kind of dig in their heels and not communicate effectively,” Dr. Gundersen said.
 

‘Emotional torture’

There are times when, no matter how skillfully the medical team communicates, they stand at an impasse with the family.

“This is emotional torture for us,” Dr. Gundersen said. “It’s moral distress. We kind of dread these situations. In these cases, trying to support yourself and your team emotionally is the most important thing.”

Ami Doshi, MD, director of palliative care inpatient services at Rady Children’s Hospital in San Diego, described the case of a baby girl that touched on the especially painful issues that can arise in pediatric cases. The 2-month-old girl had been born after a pregnancy affected by polyhydramnios and had an abnormal neurological exam and brain MRI, as well as congenital abnormalities. She’d been intubated for respiratory failure and was now on high-flow nasal cannula therapy. The girl was intolerant to feeding and was put on a nasojejunal feeding tube and then a gastrostomy-jejunostomy tube.

But the baby’s vomiting continued, and she had bradycardia and hypoxia so severe she needed bag mask ventilation to recover. The mother started to feel like she was “torturing” the baby.

The family decided to stop respiratory support but to continue artificial nutrition and hydration, which Dr. Doshi said, has an elevated status in the human psyche. Mentioning discontinuing feeding is fraught with complexity, she said.

“The notion of feeding is such a basic instinct, especially with a baby, that tackling the notion of discontinuing any sort of feeds, orally or tube feeds, is fraught with emotion and angst at times,” Dr. Doshi said.

The girl had respiratory events but recovered from them on her own, but the vomiting and retching continued. Eventually the artificial nutrition and hydration was stopped. But after 5 days, the medical staff began feeling uncomfortable, Dr. Doshi said. “We’re starting to hear from nurses, doctors, other people, that something just doesn’t feel right about what’s happening: ‘She seems okay,’ and, ‘Is it really okay for us to be doing this?’ and ‘Gosh, this is taking a long time.’ ”

The medical staff had, in a sense, joined the family on the emotional roller coaster.

Dr. Doshi said it’s important to remember that there is no ethical or moral distinction between withdrawing a medical intervention and withholding one.

“Stopping an intervention once it has started is no different ethically or legally than not starting it in the first place,” she said.

According to Dr. Doshi, there is a general consensus among medical societies that artificial nutrition and hydration is a medical intervention just like any other and that it should be evaluated within the same framework: Is it overly burdensome? Are we doing harm? Is it consistent with the goal of care? In so doing, be sure to respect patient autonomy and obtain informed consent.

As with so much in medicine, careful communication is a must.

“Paint a picture of what the patient’s trajectory is going to look like with and without artificial nutrition and hydration. At the end of the day, having done all of that, we’re going to ultimately respect what the patient or the surrogate decision maker decides,” Dr. Doshi said.

After assessment the data and the chances of success, and still without clarity about how to proceed, a good option might be considering a “time-limited trial” in which the medical team sits with the family and agrees on a time frame for an intervention and chooses predetermined endpoints for assessing success or failure.

“This can be very powerful to help us understand whether it is beneficial, but also – from the family’s perspective – to know everything was tried,” Dr. Doshi said.

Hospitalists should emphasize what is being added to treatment so that families don’t think only of what is being taken away, she said.

“Usually we are adding a lot – symptom management, a lot of psychosocial support. So what are all the other ways that we’re going to continue to care for the patient, even when we are withdrawing or withholding a specific intervention?” Dr. Doshi noted.

Sometimes, the best healer of distress in the midst of end of life decision making is time itself, Dr. Gundersen said.

In a condolence call, she once spoke with a family member involved in an agonizing case in which the medical team and family were at odds. Yet the man told her: “I know that you all were telling us the entire time that this was going to happen, but I guess we just had to go through our own process.”

The FP used a dermatoscope to get a better look at the lesion and recognized this as a halo nevus, which is characterized by a central nevus with a halo of depigmentation around it (arrow) and sometimes depigmentation within the nevus itself.

The halo is caused when, occasionally, the body develops an immune reaction to a nevus and its melanocytes. As cytotoxic T cells target those melanocytes, there is loss of pigment to the tissue surrounding the nevus.¹

The appearance of the central nevus, rather than the hypopigmentation, determines management strategies. A globular or homogeneous pattern seen on dermoscopy is typically indicative of a benign lesion.² An atypical pigment network or other melanoma specific structures should raise your suspicions for melanoma or atypical nevus and prompt a deep shave excision sent for pathology to rule out melanoma. A nevus without suspicious features, other than the surrounding hypopigmentation, can be managed conservatively with self-monitoring and re-evaluation.

In this case, the lesion displayed a homogeneous pattern, and the FP advised the patient to self-monitor.

‌

Images and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque, NM.

The FP used a dermatoscope to get a better look at the lesion and recognized this as a halo nevus, which is characterized by a central nevus with a halo of depigmentation around it (arrow) and sometimes depigmentation within the nevus itself.

The halo is caused when, occasionally, the body develops an immune reaction to a nevus and its melanocytes. As cytotoxic T cells target those melanocytes, there is loss of pigment to the tissue surrounding the nevus.¹

The appearance of the central nevus, rather than the hypopigmentation, determines management strategies. A globular or homogeneous pattern seen on dermoscopy is typically indicative of a benign lesion.² An atypical pigment network or other melanoma specific structures should raise your suspicions for melanoma or atypical nevus and prompt a deep shave excision sent for pathology to rule out melanoma. A nevus without suspicious features, other than the surrounding hypopigmentation, can be managed conservatively with self-monitoring and re-evaluation.

In this case, the lesion displayed a homogeneous pattern, and the FP advised the patient to self-monitor.

‌

Images and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque, NM.

The FP used a dermatoscope to get a better look at the lesion and recognized this as a halo nevus, which is characterized by a central nevus with a halo of depigmentation around it (arrow) and sometimes depigmentation within the nevus itself.

The halo is caused when, occasionally, the body develops an immune reaction to a nevus and its melanocytes. As cytotoxic T cells target those melanocytes, there is loss of pigment to the tissue surrounding the nevus.¹

The appearance of the central nevus, rather than the hypopigmentation, determines management strategies. A globular or homogeneous pattern seen on dermoscopy is typically indicative of a benign lesion.² An atypical pigment network or other melanoma specific structures should raise your suspicions for melanoma or atypical nevus and prompt a deep shave excision sent for pathology to rule out melanoma. A nevus without suspicious features, other than the surrounding hypopigmentation, can be managed conservatively with self-monitoring and re-evaluation.

In this case, the lesion displayed a homogeneous pattern, and the FP advised the patient to self-monitor.

‌

Images and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque, NM.

About 20% of patients who receive tablets containing 50 mg or 100 mg of ubrogepant for the acute treatment of migraine are pain free 2 hours later, compared with 12% of patients who receive placebo, according to phase 3 trial results published Dec. 4 in the New England Journal of Medicine. In addition, about 38% of patients who receive ubrogepant no longer have their most bothersome migraine-associated symptom, such as photophobia, phonophobia, or nausea, at 2 hours, compared with 28% of patients who receive placebo, said David W. Dodick, MD, and colleagues.

Dr. Dodick, professor of neurology at the Mayo Clinic in Phoenix, and his coauthors described efficacy and safety results from the ACHIEVE I trial. Another phase 3 study of ubrogepant, ACHIEVE II, was published in JAMA in November. That trial evaluated 25- and 50-mg doses of ubrogepant versus placebo and found rates of pain freedom and absence of the most bothersome symptom in the placebo and active treatment arms that were similar to those in ACHIEVE I.

Assessing a gepant for acute migraine treatment

Ubrogepant is an oral calcitonin gene–related peptide (CGRP) receptor antagonist. Allergan, the company developing the drug, has said it expects the Food and Drug Administration to decide in December whether to approve the drug.

To compare ubrogepant 50 mg, ubrogepant 100 mg, and placebo for the acute treatment of migraine, investigators conducted the randomized ACHIEVE I trial. Researchers enrolled 1,672 adults with migraine with or without aura. They excluded patients with clinically significant cardiovascular or cerebrovascular disease. During the trial, patients treated a single migraine attack, and they had the option to take a second dose. In all, 1,436 participants took an initial dose. Patients had an average age of 40.5 years, about 88% were women, and 82% were white.

In ACHIEVE I, the most common adverse events within 48 hours of treatment were nausea, somnolence, and dry mouth, and these events occurred more frequently in the 100-mg–dose group, Dr. Dodick and colleagues reported. Among patients who received ubrogepant, serious adverse events more than 48 hours after treatment but within 30 days of treatment included appendicitis, spontaneous abortion, pericardial effusion, and seizure. No serious adverse events occurred in the placebo group.

The authors noted that, “there was no active comparator and no evaluation of consistency of effect across multiple migraine attacks; therefore it is not possible to determine whether the drug is more or less effective than standard therapies or consistently effective with repeated use.” In addition, “safety and side-effect data from this trial were based on evaluation of a single attack, and therefore safety after repeated use cannot be inferred; an extension trial has assessed the long-term safety of ubrogepant,” they said.

The present trial was performed well, commented Alan M. Rapoport, MD. “The coprimary endpoints of pain freedom and most bothersome symptom freedom, both at 2 hours after dosing, were statistically superior for both doses of ubrogepant versus placebo,” he said. “Some of the secondary endpoints, such as pain relief at 2 hours post dose and sustained pain relief from 2 to 24 hours, were statistically better than placebo.”

“Based on this data, I suspect that the FDA would approve this gepant after appropriate safety data,” said Dr. Rapoport, clinical professor of neurology at the University of California, Los Angeles and editor-in-chief of Neurology Reviews. “Many more patients need to take this drug before we can be sure it is safe and effective.”

The CGRP therapeutic landscape

“Other gepants have been shown to be effective, although some have caused a degree of liver toxicity,” said Dr. Rapoport. “Blocking the effect of CGRP on the migraine peripheral nervous system, in this case by preventing the ligand from docking at its receptor by administering an oral CGRP receptor blocker, appears to be effective.” Researchers are studying another oral gepant for similar approval, he added.

Ubrogepant stands to join other treatments targeting CGRP.

“There are currently three, and soon to be four, injectable monoclonal antibodies against CGRP functionality, which are preventive, not acute-care drugs,” Dr. Rapoport said. “The first released was a subcutaneous injection of a CGRP receptor blocker, and the other two are subcutaneous injections of CGRP ligand blockers. The last drug will be an intravenous infusion of a ligand blocker. These recently approved migraine treatments have greatly improved the lives of many of our patients, even when other preventives have failed. I expect ubrogepant and other gepants will do the same for the acute care of migraine.”

Allergan funded the trials of ubrogepant, and some of the authors are Allergan employees and stockholders. Dr. Dodick reported consulting fees and advisory board fees from Allergan and various pharmaceutical companies.

jremaly@mdedge.com

SOURCE: Dodick DW et al. N Engl J Med. 2019;381(23):2230-41. doi: 10.1056/NEJMoa1813049.

About 20% of patients who receive tablets containing 50 mg or 100 mg of ubrogepant for the acute treatment of migraine are pain free 2 hours later, compared with 12% of patients who receive placebo, according to phase 3 trial results published Dec. 4 in the New England Journal of Medicine. In addition, about 38% of patients who receive ubrogepant no longer have their most bothersome migraine-associated symptom, such as photophobia, phonophobia, or nausea, at 2 hours, compared with 28% of patients who receive placebo, said David W. Dodick, MD, and colleagues.

Dr. Dodick, professor of neurology at the Mayo Clinic in Phoenix, and his coauthors described efficacy and safety results from the ACHIEVE I trial. Another phase 3 study of ubrogepant, ACHIEVE II, was published in JAMA in November. That trial evaluated 25- and 50-mg doses of ubrogepant versus placebo and found rates of pain freedom and absence of the most bothersome symptom in the placebo and active treatment arms that were similar to those in ACHIEVE I.

Assessing a gepant for acute migraine treatment

Ubrogepant is an oral calcitonin gene–related peptide (CGRP) receptor antagonist. Allergan, the company developing the drug, has said it expects the Food and Drug Administration to decide in December whether to approve the drug.

To compare ubrogepant 50 mg, ubrogepant 100 mg, and placebo for the acute treatment of migraine, investigators conducted the randomized ACHIEVE I trial. Researchers enrolled 1,672 adults with migraine with or without aura. They excluded patients with clinically significant cardiovascular or cerebrovascular disease. During the trial, patients treated a single migraine attack, and they had the option to take a second dose. In all, 1,436 participants took an initial dose. Patients had an average age of 40.5 years, about 88% were women, and 82% were white.

In ACHIEVE I, the most common adverse events within 48 hours of treatment were nausea, somnolence, and dry mouth, and these events occurred more frequently in the 100-mg–dose group, Dr. Dodick and colleagues reported. Among patients who received ubrogepant, serious adverse events more than 48 hours after treatment but within 30 days of treatment included appendicitis, spontaneous abortion, pericardial effusion, and seizure. No serious adverse events occurred in the placebo group.

The authors noted that, “there was no active comparator and no evaluation of consistency of effect across multiple migraine attacks; therefore it is not possible to determine whether the drug is more or less effective than standard therapies or consistently effective with repeated use.” In addition, “safety and side-effect data from this trial were based on evaluation of a single attack, and therefore safety after repeated use cannot be inferred; an extension trial has assessed the long-term safety of ubrogepant,” they said.

The present trial was performed well, commented Alan M. Rapoport, MD. “The coprimary endpoints of pain freedom and most bothersome symptom freedom, both at 2 hours after dosing, were statistically superior for both doses of ubrogepant versus placebo,” he said. “Some of the secondary endpoints, such as pain relief at 2 hours post dose and sustained pain relief from 2 to 24 hours, were statistically better than placebo.”

“Based on this data, I suspect that the FDA would approve this gepant after appropriate safety data,” said Dr. Rapoport, clinical professor of neurology at the University of California, Los Angeles and editor-in-chief of Neurology Reviews. “Many more patients need to take this drug before we can be sure it is safe and effective.”

The CGRP therapeutic landscape

“Other gepants have been shown to be effective, although some have caused a degree of liver toxicity,” said Dr. Rapoport. “Blocking the effect of CGRP on the migraine peripheral nervous system, in this case by preventing the ligand from docking at its receptor by administering an oral CGRP receptor blocker, appears to be effective.” Researchers are studying another oral gepant for similar approval, he added.

Ubrogepant stands to join other treatments targeting CGRP.

“There are currently three, and soon to be four, injectable monoclonal antibodies against CGRP functionality, which are preventive, not acute-care drugs,” Dr. Rapoport said. “The first released was a subcutaneous injection of a CGRP receptor blocker, and the other two are subcutaneous injections of CGRP ligand blockers. The last drug will be an intravenous infusion of a ligand blocker. These recently approved migraine treatments have greatly improved the lives of many of our patients, even when other preventives have failed. I expect ubrogepant and other gepants will do the same for the acute care of migraine.”

Allergan funded the trials of ubrogepant, and some of the authors are Allergan employees and stockholders. Dr. Dodick reported consulting fees and advisory board fees from Allergan and various pharmaceutical companies.

jremaly@mdedge.com

SOURCE: Dodick DW et al. N Engl J Med. 2019;381(23):2230-41. doi: 10.1056/NEJMoa1813049.

About 20% of patients who receive tablets containing 50 mg or 100 mg of ubrogepant for the acute treatment of migraine are pain free 2 hours later, compared with 12% of patients who receive placebo, according to phase 3 trial results published Dec. 4 in the New England Journal of Medicine. In addition, about 38% of patients who receive ubrogepant no longer have their most bothersome migraine-associated symptom, such as photophobia, phonophobia, or nausea, at 2 hours, compared with 28% of patients who receive placebo, said David W. Dodick, MD, and colleagues.

Dr. Dodick, professor of neurology at the Mayo Clinic in Phoenix, and his coauthors described efficacy and safety results from the ACHIEVE I trial. Another phase 3 study of ubrogepant, ACHIEVE II, was published in JAMA in November. That trial evaluated 25- and 50-mg doses of ubrogepant versus placebo and found rates of pain freedom and absence of the most bothersome symptom in the placebo and active treatment arms that were similar to those in ACHIEVE I.

Assessing a gepant for acute migraine treatment

Ubrogepant is an oral calcitonin gene–related peptide (CGRP) receptor antagonist. Allergan, the company developing the drug, has said it expects the Food and Drug Administration to decide in December whether to approve the drug.

To compare ubrogepant 50 mg, ubrogepant 100 mg, and placebo for the acute treatment of migraine, investigators conducted the randomized ACHIEVE I trial. Researchers enrolled 1,672 adults with migraine with or without aura. They excluded patients with clinically significant cardiovascular or cerebrovascular disease. During the trial, patients treated a single migraine attack, and they had the option to take a second dose. In all, 1,436 participants took an initial dose. Patients had an average age of 40.5 years, about 88% were women, and 82% were white.

In ACHIEVE I, the most common adverse events within 48 hours of treatment were nausea, somnolence, and dry mouth, and these events occurred more frequently in the 100-mg–dose group, Dr. Dodick and colleagues reported. Among patients who received ubrogepant, serious adverse events more than 48 hours after treatment but within 30 days of treatment included appendicitis, spontaneous abortion, pericardial effusion, and seizure. No serious adverse events occurred in the placebo group.

The authors noted that, “there was no active comparator and no evaluation of consistency of effect across multiple migraine attacks; therefore it is not possible to determine whether the drug is more or less effective than standard therapies or consistently effective with repeated use.” In addition, “safety and side-effect data from this trial were based on evaluation of a single attack, and therefore safety after repeated use cannot be inferred; an extension trial has assessed the long-term safety of ubrogepant,” they said.

The present trial was performed well, commented Alan M. Rapoport, MD. “The coprimary endpoints of pain freedom and most bothersome symptom freedom, both at 2 hours after dosing, were statistically superior for both doses of ubrogepant versus placebo,” he said. “Some of the secondary endpoints, such as pain relief at 2 hours post dose and sustained pain relief from 2 to 24 hours, were statistically better than placebo.”

“Based on this data, I suspect that the FDA would approve this gepant after appropriate safety data,” said Dr. Rapoport, clinical professor of neurology at the University of California, Los Angeles and editor-in-chief of Neurology Reviews. “Many more patients need to take this drug before we can be sure it is safe and effective.”

The CGRP therapeutic landscape

“Other gepants have been shown to be effective, although some have caused a degree of liver toxicity,” said Dr. Rapoport. “Blocking the effect of CGRP on the migraine peripheral nervous system, in this case by preventing the ligand from docking at its receptor by administering an oral CGRP receptor blocker, appears to be effective.” Researchers are studying another oral gepant for similar approval, he added.

Ubrogepant stands to join other treatments targeting CGRP.

“There are currently three, and soon to be four, injectable monoclonal antibodies against CGRP functionality, which are preventive, not acute-care drugs,” Dr. Rapoport said. “The first released was a subcutaneous injection of a CGRP receptor blocker, and the other two are subcutaneous injections of CGRP ligand blockers. The last drug will be an intravenous infusion of a ligand blocker. These recently approved migraine treatments have greatly improved the lives of many of our patients, even when other preventives have failed. I expect ubrogepant and other gepants will do the same for the acute care of migraine.”

Allergan funded the trials of ubrogepant, and some of the authors are Allergan employees and stockholders. Dr. Dodick reported consulting fees and advisory board fees from Allergan and various pharmaceutical companies.

jremaly@mdedge.com

SOURCE: Dodick DW et al. N Engl J Med. 2019;381(23):2230-41. doi: 10.1056/NEJMoa1813049.

Childproof your study protocols

Childproof caps on medicine bottles. Like a bank vault lock to third-rate thieves, they’re an impregnable line of defense between inquisitive little hands and heavy-duty pharmaceuticals.

miflippo/Getty Images

So, you can imagine the delight with which parents learned that their children’s education at an Illinois elementary school included a test of their ability to spring drugs from their fortress-like bottling.

In a quest to advance scientific understanding, a junior high student recruited some of the school’s kindergartners and first graders as participants in a science fair experiment. The hypothesis: “Childproof” medicine bottles were anything but.

The junior high scientist collected data on how quickly the study subjects could defeat assorted bottles. And, being a kindly soul, the adolescent researcher demonstrated techniques for achieving a state of, ahem, pharmaceutical openness.

While teachers were present during the experiment, parental permission slips were not. As any principal or institutional review board knows, informed consent is kind of a big deal.

Surprised parents learned of the experiment only when their kids deftly demonstrated their newfound pill skills. One shocked parent even shared a video of his daughter defeating a childproof lid.

Pharmacies, of course, would remind us all that their bottles are at best “child resistant,” not childproof. It’s a distinction lost on us here at the Bureau of LOTME, however. We’re desperately viewing that how-to video for tips on liberating our statins from the “child resistant” bottle our millennial pharmacist clearly superglued the cap onto.

What’s the deal with airline food?

You probably thought Jerry Seinfeld’s immortal query was rhetorical. No one actually knows what the deal is with airline food, right?

ThamKC/Getty Images

Enter Charles Platkin, PhD, JD, MPH, executive director of the Hunter College NYC Food Policy Center, and editor of DietDetective.com. Not only does he know the deal, he publishes a study detailing the healthiness of the food offered by 11 airlines every year, based on criteria such as healthy nutrients and calorie levels of meals, level of transparency, improvement and maintenance of healthy offerings, and water health.

For the 2018-2019 edition, there’s a tie at the top between Alaska Airlines and Air Canada, both scoring 4 out of 5 on Dr. Platkin’s “Health Score,” both well ahead of Delta and JetBlue in second place with a score of 2.9.

At the bottom? Southwest Airlines, with a paltry 1.7, edging out Spirit and Hawaiian Airlines.

Our personal favorite tidbit from the study has to be the poor scores in water health. Spirit managed to score a measly 1 out of 5 in the water health subscore, and several airlines were below 2. An actual quote from the study: “The quality of drinking water varies by airline, and many have provided passengers with unhealthy water. In general, it’s probably best to avoid drinking coffee and tea on board since they are made with galley water.”

While Hawaiian can take some comfort because they didn’t finish dead last, Dr. Platkin did award them his special “Shame on You” award for not providing all their nutritional information. You can try to hide, Hawaiian Airlines, but Dr. Platkin will find you.

Use the Force, Jack Nicklaus

We here at LOTME usually strive to provide an insightful and up-to-date wrap-up of the latest news on cutting-edge research, clinical breakthroughs, and impolite bodily functions. But right now, we want to talk about something really important: your golf game.

jacoblund/Getty Images

There’s an old saying in golf: Drive for show, putt for dough. That cliché may need a bit of updating, though, now that investigators in Ireland (where they are pretty serious about their golf) have brought science to the party.

Their research indicates that it may be possible for golfers to improve their putting without practicing. Without physically practicing, that is. Without going to the golf course. Just think about it: Golfers can putt better by, you know … just thinking about it.

Imagining the feel of an action without actually performing it is known as kinesthetic imagery ability, and it just might have an effect on putting, researchers from the physical education and sports sciences department at the University of Limerick and Lero, the Science Foundation Ireland Research Centre for Software, reported in Psychology of Sport and Exercise.

In a group of 44 skilled golfers, half watched video of an expert golfer putting in a lab environment “while listening to a motor imagery script consisting of short sentences describing key visual and kinesthetic feelings associated with performing the putting.” Then all the golfers took 40 putts from 15 feet in the lab.

The good kinesthetic imagers in the bunch improved their putting consistency more than subjects with poorer kinesthetic imagery ability and subjects from the nonintervention group.

So, here’s the new and improved old saying for golfers: Drive for show, use your kinesthetic imagery ability for dough. Yup, that’ll definitely catch on.

Childproof your study protocols

Childproof caps on medicine bottles. Like a bank vault lock to third-rate thieves, they’re an impregnable line of defense between inquisitive little hands and heavy-duty pharmaceuticals.

miflippo/Getty Images

So, you can imagine the delight with which parents learned that their children’s education at an Illinois elementary school included a test of their ability to spring drugs from their fortress-like bottling.

In a quest to advance scientific understanding, a junior high student recruited some of the school’s kindergartners and first graders as participants in a science fair experiment. The hypothesis: “Childproof” medicine bottles were anything but.

The junior high scientist collected data on how quickly the study subjects could defeat assorted bottles. And, being a kindly soul, the adolescent researcher demonstrated techniques for achieving a state of, ahem, pharmaceutical openness.

While teachers were present during the experiment, parental permission slips were not. As any principal or institutional review board knows, informed consent is kind of a big deal.

Surprised parents learned of the experiment only when their kids deftly demonstrated their newfound pill skills. One shocked parent even shared a video of his daughter defeating a childproof lid.

Pharmacies, of course, would remind us all that their bottles are at best “child resistant,” not childproof. It’s a distinction lost on us here at the Bureau of LOTME, however. We’re desperately viewing that how-to video for tips on liberating our statins from the “child resistant” bottle our millennial pharmacist clearly superglued the cap onto.

What’s the deal with airline food?

You probably thought Jerry Seinfeld’s immortal query was rhetorical. No one actually knows what the deal is with airline food, right?

ThamKC/Getty Images

Enter Charles Platkin, PhD, JD, MPH, executive director of the Hunter College NYC Food Policy Center, and editor of DietDetective.com. Not only does he know the deal, he publishes a study detailing the healthiness of the food offered by 11 airlines every year, based on criteria such as healthy nutrients and calorie levels of meals, level of transparency, improvement and maintenance of healthy offerings, and water health.

For the 2018-2019 edition, there’s a tie at the top between Alaska Airlines and Air Canada, both scoring 4 out of 5 on Dr. Platkin’s “Health Score,” both well ahead of Delta and JetBlue in second place with a score of 2.9.

At the bottom? Southwest Airlines, with a paltry 1.7, edging out Spirit and Hawaiian Airlines.

Our personal favorite tidbit from the study has to be the poor scores in water health. Spirit managed to score a measly 1 out of 5 in the water health subscore, and several airlines were below 2. An actual quote from the study: “The quality of drinking water varies by airline, and many have provided passengers with unhealthy water. In general, it’s probably best to avoid drinking coffee and tea on board since they are made with galley water.”

While Hawaiian can take some comfort because they didn’t finish dead last, Dr. Platkin did award them his special “Shame on You” award for not providing all their nutritional information. You can try to hide, Hawaiian Airlines, but Dr. Platkin will find you.

Use the Force, Jack Nicklaus

We here at LOTME usually strive to provide an insightful and up-to-date wrap-up of the latest news on cutting-edge research, clinical breakthroughs, and impolite bodily functions. But right now, we want to talk about something really important: your golf game.

jacoblund/Getty Images

There’s an old saying in golf: Drive for show, putt for dough. That cliché may need a bit of updating, though, now that investigators in Ireland (where they are pretty serious about their golf) have brought science to the party.

Their research indicates that it may be possible for golfers to improve their putting without practicing. Without physically practicing, that is. Without going to the golf course. Just think about it: Golfers can putt better by, you know … just thinking about it.

Imagining the feel of an action without actually performing it is known as kinesthetic imagery ability, and it just might have an effect on putting, researchers from the physical education and sports sciences department at the University of Limerick and Lero, the Science Foundation Ireland Research Centre for Software, reported in Psychology of Sport and Exercise.

In a group of 44 skilled golfers, half watched video of an expert golfer putting in a lab environment “while listening to a motor imagery script consisting of short sentences describing key visual and kinesthetic feelings associated with performing the putting.” Then all the golfers took 40 putts from 15 feet in the lab.

The good kinesthetic imagers in the bunch improved their putting consistency more than subjects with poorer kinesthetic imagery ability and subjects from the nonintervention group.

So, here’s the new and improved old saying for golfers: Drive for show, use your kinesthetic imagery ability for dough. Yup, that’ll definitely catch on.

Childproof your study protocols

Childproof caps on medicine bottles. Like a bank vault lock to third-rate thieves, they’re an impregnable line of defense between inquisitive little hands and heavy-duty pharmaceuticals.

miflippo/Getty Images

So, you can imagine the delight with which parents learned that their children’s education at an Illinois elementary school included a test of their ability to spring drugs from their fortress-like bottling.

In a quest to advance scientific understanding, a junior high student recruited some of the school’s kindergartners and first graders as participants in a science fair experiment. The hypothesis: “Childproof” medicine bottles were anything but.

The junior high scientist collected data on how quickly the study subjects could defeat assorted bottles. And, being a kindly soul, the adolescent researcher demonstrated techniques for achieving a state of, ahem, pharmaceutical openness.

While teachers were present during the experiment, parental permission slips were not. As any principal or institutional review board knows, informed consent is kind of a big deal.

Surprised parents learned of the experiment only when their kids deftly demonstrated their newfound pill skills. One shocked parent even shared a video of his daughter defeating a childproof lid.

Pharmacies, of course, would remind us all that their bottles are at best “child resistant,” not childproof. It’s a distinction lost on us here at the Bureau of LOTME, however. We’re desperately viewing that how-to video for tips on liberating our statins from the “child resistant” bottle our millennial pharmacist clearly superglued the cap onto.

What’s the deal with airline food?

You probably thought Jerry Seinfeld’s immortal query was rhetorical. No one actually knows what the deal is with airline food, right?

ThamKC/Getty Images

Enter Charles Platkin, PhD, JD, MPH, executive director of the Hunter College NYC Food Policy Center, and editor of DietDetective.com. Not only does he know the deal, he publishes a study detailing the healthiness of the food offered by 11 airlines every year, based on criteria such as healthy nutrients and calorie levels of meals, level of transparency, improvement and maintenance of healthy offerings, and water health.

For the 2018-2019 edition, there’s a tie at the top between Alaska Airlines and Air Canada, both scoring 4 out of 5 on Dr. Platkin’s “Health Score,” both well ahead of Delta and JetBlue in second place with a score of 2.9.

At the bottom? Southwest Airlines, with a paltry 1.7, edging out Spirit and Hawaiian Airlines.

Our personal favorite tidbit from the study has to be the poor scores in water health. Spirit managed to score a measly 1 out of 5 in the water health subscore, and several airlines were below 2. An actual quote from the study: “The quality of drinking water varies by airline, and many have provided passengers with unhealthy water. In general, it’s probably best to avoid drinking coffee and tea on board since they are made with galley water.”

While Hawaiian can take some comfort because they didn’t finish dead last, Dr. Platkin did award them his special “Shame on You” award for not providing all their nutritional information. You can try to hide, Hawaiian Airlines, but Dr. Platkin will find you.

Use the Force, Jack Nicklaus

We here at LOTME usually strive to provide an insightful and up-to-date wrap-up of the latest news on cutting-edge research, clinical breakthroughs, and impolite bodily functions. But right now, we want to talk about something really important: your golf game.

jacoblund/Getty Images

There’s an old saying in golf: Drive for show, putt for dough. That cliché may need a bit of updating, though, now that investigators in Ireland (where they are pretty serious about their golf) have brought science to the party.

Their research indicates that it may be possible for golfers to improve their putting without practicing. Without physically practicing, that is. Without going to the golf course. Just think about it: Golfers can putt better by, you know … just thinking about it.

Imagining the feel of an action without actually performing it is known as kinesthetic imagery ability, and it just might have an effect on putting, researchers from the physical education and sports sciences department at the University of Limerick and Lero, the Science Foundation Ireland Research Centre for Software, reported in Psychology of Sport and Exercise.

In a group of 44 skilled golfers, half watched video of an expert golfer putting in a lab environment “while listening to a motor imagery script consisting of short sentences describing key visual and kinesthetic feelings associated with performing the putting.” Then all the golfers took 40 putts from 15 feet in the lab.

The good kinesthetic imagers in the bunch improved their putting consistency more than subjects with poorer kinesthetic imagery ability and subjects from the nonintervention group.

So, here’s the new and improved old saying for golfers: Drive for show, use your kinesthetic imagery ability for dough. Yup, that’ll definitely catch on.

Whether patients aged 50 years and older with a displaced femoral neck fracture underwent total hip arthroplasty or hemiarthroplasty had no significant influence on the risk of unplanned secondary hip procedures over 2 years of follow-up. In addition, while functional outcomes modestly favored total hip arthroplasty, the rates of mortality and serious adverse events were similar between the two treatment groups.

Those are key findings from a randomized, multicenter trial of the two procedures that was carried out in 10 countries.

“The American Academy of Orthopedic Surgeons and National Institute for Health and Care Excellence guidelines recommend total hip arthroplasty in all patients with displaced femoral neck fractures who are able to ambulate independently,” a team of investigators led by Mohit Bhandari, MD, and P.J. Devereaux, MD, both from McMaster University, Hamilton, Ont., wrote in a study published in the New England Journal of Medicine. “Our findings suggest that the advantages of total hip arthroplasty may not be compelling. The limited advantages of total hip arthroplasty, as well as the possible higher risk of complications, may be particularly important in regions of the world where total hip arthroplasty is not easily accessible or is cost prohibitive.”

In the Hip Fracture Evaluation With Alternative of Total Hip Arthroplasty Versus Hemiarthroplasty (HEALTH) trial, the researchers randomly assigned 1,495 patients aged 50 years and older who had a displaced femoral neck fracture to undergo either total hip arthroplasty or hemiarthroplasty. They were eligible for the trial only if they had been able to ambulate without the assistance of another person before the hip fracture occurred. The primary endpoint was any unplanned secondary hip procedure within 24 months after the initial surgery. Secondary endpoints included death, serious adverse events, hip-related complications, health-related quality of life, function, and overall health measures. Assessments included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, pain score, stiffness score, and function score; the European Quality of Life–5 Dimensions utility index score and visual analogue scale; the 12-Item Short Form General Health Survey physical and mental component summary scores; and the Timed Up and Go scores.

The researchers found that the primary endpoint occurred in 7.9% of patients who had been randomly assigned to total hip arthroplasty and in 8.3% of those who had been randomly assigned to hemiarthroplasty (hazard ratio, 0.95; P = .79). As for secondary endpoints, mortality did not differ significantly between the two treatment groups (14.3% in the total hip arthroplasty group vs. 13.1% in the hemiarthroplasty group; P = .48), while serious adverse events occurred in 41.8% of patients in the total hip arthroplasty group versus 36.7% of those in the hemiarthroplasty group (HR, 1.16; P = .13).

In other findings, hip instability or dislocation occurred in 4.7% of patients who were assigned to total hip arthroplasty, compared with 2.4% of those who were assigned to hemiarthroplasty (HR, 2.00), while patients who underwent total hip arthroplasty had superior function as measured by the WOMAC total score, pain score, stiffness score, and function score. “These differences between the treatment groups fell below the threshold for a minimal clinically important difference for WOMAC,” the researchers wrote.

They acknowledged certain limitations of the study, including the fact that patients and endpoint assessors were unblinded in the assessments of function, “which left a possibility of bias.” In addition, 14.9% of patients were lost to follow-up for analysis of the primary endpoint.

In an accompanying editorial, Jan-Erik Gjertsen, MD, wrote that one implication of the HEALTH trial is that hemiarthroplasty may provide a satisfactory results for the majority of elderly patients with hip fractures. “Considering the nearly equal risk of secondary surgical procedures and the modest benefit in functional outcome, should we abandon the use of total hip arthroplasty in the treatment of hip fractures?” asked Dr. Gjertsen, of the department of orthopedic surgery at Haukeland University Hospital in Bergen, Norway (N Engl J Med. 2019 Dec 4. doi:10.1056/NEJMe1913800). “Even if the benefits seem smaller than we previously thought, patients with high physical demands and a long remaining life expectancy should probably still be considered for treatment with total hip arthroplasty. Yet the expected remaining lifetime of those patients who potentially could benefit most from a total hip arthroplasty is much longer than the 2-year follow-up period used in the HEALTH trial. However, the number of secondary procedures after hemiarthroplasty may increase with longer follow-up. Therefore, one hopes that the HEALTH investigators will be able to provide long-term results from their trial in the future.”

The HEALTH trial was supported by grants from the Canadian Institutes of Health, the National Institutes of Health, ZorgOnderzoek Nederland/Medische Wetenschappen, the Sophies Minde Foundation for Orthopedic Research, McMaster Surgical Associates, and Stryker Orthopedics. Dr. Bhandari reported receiving grant support and lecture fees from Sanofi, lecture fees from Pendopharm, and grant support from Acumed and Aphria. Dr. Devereaux reported receiving grant support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, Roche Diagnostics, and Siemens.

dbrunk@mdedge.com

SOURCE: Bhandari M et al. N Engl J Med. 2019 Dec 4. doi: 10.1056/NEJMoa1906190.

Whether patients aged 50 years and older with a displaced femoral neck fracture underwent total hip arthroplasty or hemiarthroplasty had no significant influence on the risk of unplanned secondary hip procedures over 2 years of follow-up. In addition, while functional outcomes modestly favored total hip arthroplasty, the rates of mortality and serious adverse events were similar between the two treatment groups.

Those are key findings from a randomized, multicenter trial of the two procedures that was carried out in 10 countries.

“The American Academy of Orthopedic Surgeons and National Institute for Health and Care Excellence guidelines recommend total hip arthroplasty in all patients with displaced femoral neck fractures who are able to ambulate independently,” a team of investigators led by Mohit Bhandari, MD, and P.J. Devereaux, MD, both from McMaster University, Hamilton, Ont., wrote in a study published in the New England Journal of Medicine. “Our findings suggest that the advantages of total hip arthroplasty may not be compelling. The limited advantages of total hip arthroplasty, as well as the possible higher risk of complications, may be particularly important in regions of the world where total hip arthroplasty is not easily accessible or is cost prohibitive.”

In the Hip Fracture Evaluation With Alternative of Total Hip Arthroplasty Versus Hemiarthroplasty (HEALTH) trial, the researchers randomly assigned 1,495 patients aged 50 years and older who had a displaced femoral neck fracture to undergo either total hip arthroplasty or hemiarthroplasty. They were eligible for the trial only if they had been able to ambulate without the assistance of another person before the hip fracture occurred. The primary endpoint was any unplanned secondary hip procedure within 24 months after the initial surgery. Secondary endpoints included death, serious adverse events, hip-related complications, health-related quality of life, function, and overall health measures. Assessments included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, pain score, stiffness score, and function score; the European Quality of Life–5 Dimensions utility index score and visual analogue scale; the 12-Item Short Form General Health Survey physical and mental component summary scores; and the Timed Up and Go scores.

The researchers found that the primary endpoint occurred in 7.9% of patients who had been randomly assigned to total hip arthroplasty and in 8.3% of those who had been randomly assigned to hemiarthroplasty (hazard ratio, 0.95; P = .79). As for secondary endpoints, mortality did not differ significantly between the two treatment groups (14.3% in the total hip arthroplasty group vs. 13.1% in the hemiarthroplasty group; P = .48), while serious adverse events occurred in 41.8% of patients in the total hip arthroplasty group versus 36.7% of those in the hemiarthroplasty group (HR, 1.16; P = .13).

In other findings, hip instability or dislocation occurred in 4.7% of patients who were assigned to total hip arthroplasty, compared with 2.4% of those who were assigned to hemiarthroplasty (HR, 2.00), while patients who underwent total hip arthroplasty had superior function as measured by the WOMAC total score, pain score, stiffness score, and function score. “These differences between the treatment groups fell below the threshold for a minimal clinically important difference for WOMAC,” the researchers wrote.

They acknowledged certain limitations of the study, including the fact that patients and endpoint assessors were unblinded in the assessments of function, “which left a possibility of bias.” In addition, 14.9% of patients were lost to follow-up for analysis of the primary endpoint.

In an accompanying editorial, Jan-Erik Gjertsen, MD, wrote that one implication of the HEALTH trial is that hemiarthroplasty may provide a satisfactory results for the majority of elderly patients with hip fractures. “Considering the nearly equal risk of secondary surgical procedures and the modest benefit in functional outcome, should we abandon the use of total hip arthroplasty in the treatment of hip fractures?” asked Dr. Gjertsen, of the department of orthopedic surgery at Haukeland University Hospital in Bergen, Norway (N Engl J Med. 2019 Dec 4. doi:10.1056/NEJMe1913800). “Even if the benefits seem smaller than we previously thought, patients with high physical demands and a long remaining life expectancy should probably still be considered for treatment with total hip arthroplasty. Yet the expected remaining lifetime of those patients who potentially could benefit most from a total hip arthroplasty is much longer than the 2-year follow-up period used in the HEALTH trial. However, the number of secondary procedures after hemiarthroplasty may increase with longer follow-up. Therefore, one hopes that the HEALTH investigators will be able to provide long-term results from their trial in the future.”

The HEALTH trial was supported by grants from the Canadian Institutes of Health, the National Institutes of Health, ZorgOnderzoek Nederland/Medische Wetenschappen, the Sophies Minde Foundation for Orthopedic Research, McMaster Surgical Associates, and Stryker Orthopedics. Dr. Bhandari reported receiving grant support and lecture fees from Sanofi, lecture fees from Pendopharm, and grant support from Acumed and Aphria. Dr. Devereaux reported receiving grant support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, Roche Diagnostics, and Siemens.

dbrunk@mdedge.com

SOURCE: Bhandari M et al. N Engl J Med. 2019 Dec 4. doi: 10.1056/NEJMoa1906190.

Whether patients aged 50 years and older with a displaced femoral neck fracture underwent total hip arthroplasty or hemiarthroplasty had no significant influence on the risk of unplanned secondary hip procedures over 2 years of follow-up. In addition, while functional outcomes modestly favored total hip arthroplasty, the rates of mortality and serious adverse events were similar between the two treatment groups.

Those are key findings from a randomized, multicenter trial of the two procedures that was carried out in 10 countries.

“The American Academy of Orthopedic Surgeons and National Institute for Health and Care Excellence guidelines recommend total hip arthroplasty in all patients with displaced femoral neck fractures who are able to ambulate independently,” a team of investigators led by Mohit Bhandari, MD, and P.J. Devereaux, MD, both from McMaster University, Hamilton, Ont., wrote in a study published in the New England Journal of Medicine. “Our findings suggest that the advantages of total hip arthroplasty may not be compelling. The limited advantages of total hip arthroplasty, as well as the possible higher risk of complications, may be particularly important in regions of the world where total hip arthroplasty is not easily accessible or is cost prohibitive.”

In the Hip Fracture Evaluation With Alternative of Total Hip Arthroplasty Versus Hemiarthroplasty (HEALTH) trial, the researchers randomly assigned 1,495 patients aged 50 years and older who had a displaced femoral neck fracture to undergo either total hip arthroplasty or hemiarthroplasty. They were eligible for the trial only if they had been able to ambulate without the assistance of another person before the hip fracture occurred. The primary endpoint was any unplanned secondary hip procedure within 24 months after the initial surgery. Secondary endpoints included death, serious adverse events, hip-related complications, health-related quality of life, function, and overall health measures. Assessments included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, pain score, stiffness score, and function score; the European Quality of Life–5 Dimensions utility index score and visual analogue scale; the 12-Item Short Form General Health Survey physical and mental component summary scores; and the Timed Up and Go scores.

The researchers found that the primary endpoint occurred in 7.9% of patients who had been randomly assigned to total hip arthroplasty and in 8.3% of those who had been randomly assigned to hemiarthroplasty (hazard ratio, 0.95; P = .79). As for secondary endpoints, mortality did not differ significantly between the two treatment groups (14.3% in the total hip arthroplasty group vs. 13.1% in the hemiarthroplasty group; P = .48), while serious adverse events occurred in 41.8% of patients in the total hip arthroplasty group versus 36.7% of those in the hemiarthroplasty group (HR, 1.16; P = .13).

In other findings, hip instability or dislocation occurred in 4.7% of patients who were assigned to total hip arthroplasty, compared with 2.4% of those who were assigned to hemiarthroplasty (HR, 2.00), while patients who underwent total hip arthroplasty had superior function as measured by the WOMAC total score, pain score, stiffness score, and function score. “These differences between the treatment groups fell below the threshold for a minimal clinically important difference for WOMAC,” the researchers wrote.

They acknowledged certain limitations of the study, including the fact that patients and endpoint assessors were unblinded in the assessments of function, “which left a possibility of bias.” In addition, 14.9% of patients were lost to follow-up for analysis of the primary endpoint.

In an accompanying editorial, Jan-Erik Gjertsen, MD, wrote that one implication of the HEALTH trial is that hemiarthroplasty may provide a satisfactory results for the majority of elderly patients with hip fractures. “Considering the nearly equal risk of secondary surgical procedures and the modest benefit in functional outcome, should we abandon the use of total hip arthroplasty in the treatment of hip fractures?” asked Dr. Gjertsen, of the department of orthopedic surgery at Haukeland University Hospital in Bergen, Norway (N Engl J Med. 2019 Dec 4. doi:10.1056/NEJMe1913800). “Even if the benefits seem smaller than we previously thought, patients with high physical demands and a long remaining life expectancy should probably still be considered for treatment with total hip arthroplasty. Yet the expected remaining lifetime of those patients who potentially could benefit most from a total hip arthroplasty is much longer than the 2-year follow-up period used in the HEALTH trial. However, the number of secondary procedures after hemiarthroplasty may increase with longer follow-up. Therefore, one hopes that the HEALTH investigators will be able to provide long-term results from their trial in the future.”

The HEALTH trial was supported by grants from the Canadian Institutes of Health, the National Institutes of Health, ZorgOnderzoek Nederland/Medische Wetenschappen, the Sophies Minde Foundation for Orthopedic Research, McMaster Surgical Associates, and Stryker Orthopedics. Dr. Bhandari reported receiving grant support and lecture fees from Sanofi, lecture fees from Pendopharm, and grant support from Acumed and Aphria. Dr. Devereaux reported receiving grant support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, Roche Diagnostics, and Siemens.

dbrunk@mdedge.com

SOURCE: Bhandari M et al. N Engl J Med. 2019 Dec 4. doi: 10.1056/NEJMoa1906190.

Mitchel L. Zoler’s article on Abstract A105, presented at Obesity Week 2019, addresses an important health concern and is timely.

Over the past 4 decades we have seen a rise in the prevalence of obesity and associated health complications, not just in the United States but across the world. The incidence of obesity (having a BMI greater than 30) was 35% for women and 31% for men in the United States, and associated deaths and disability were primarily attributed to diabetes and cardiovascular disease resulting from obesity.

This article references the benefits of bariatric/metabolic surgery in individuals with class 1 obesity. In the United States, more than half of those who meet the criteria for obesity come under the class 1 category (BMI, 30-34.9). Those in this class of obesity are at increased risk of developing diabetes, hypertension, hyperlipidemia, coronary artery disease, cerebrovascular disease, obstructive sleep apnea, polycystic ovarian syndrome, and bone and joint disorders.

There are several studies that document the significant reduction in incidence of the above cardiometabolic risks with sustained weight loss. Nonsurgical interventions in individuals with class 1 obesity through lifestyle modifications and pharmacotherapy have not demonstrated success in providing persistent weight loss or metabolic benefits. The data presented in this article are of great significance to patients and physicians alike as they highlight the long-term benefits and reversal of metabolic disorders.

Current guidelines for bariatric surgery for individuals with a BMI greater than 35 were published in 1991. Since then several safe surgical options including laparoscopic procedures, sleeve gastrectomy, and adjustable gastric banding have been developed with decreased surgical risks, morbidity, and mortality.

The International Federation for the Surgery of Obesity and Metabolic Disorders, the International Diabetes Federation, and the National Institute for Health and Care Excellence of the United Kingdom, have supported the option of bariatric surgery in class 1 obese individuals with metabolic disorders.

While lifestyle modifications with medications should be the first-line treatment for class 1 obesity, as a primary care physician I believe that, given the major changes in the surgical options, the proven long-term benefits, and the rising incidences of obesity and metabolic syndrome, it is time for the health care community, insurers, patients, and all other stakeholders to consider bariatric surgery in class 1 obese individuals as a potential and viable option.

Noel N. Deep, MD, is a general internist in a multispecialty group practice with Aspirus Antigo (Wis.) Clinic and the chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo. He is also assistant clinical professor at the Medical College of Wisconsin, Central Wisconsin Campus, Wausau, and the governor of the Wisconsin chapter of the American College of Physicians. Dr. Deep serves on the editorial advisory board of Internal Medicine News.

He made these comments in response to questions from MDedge and had no relevant disclosures.

Mitchel L. Zoler’s article on Abstract A105, presented at Obesity Week 2019, addresses an important health concern and is timely.

Over the past 4 decades we have seen a rise in the prevalence of obesity and associated health complications, not just in the United States but across the world. The incidence of obesity (having a BMI greater than 30) was 35% for women and 31% for men in the United States, and associated deaths and disability were primarily attributed to diabetes and cardiovascular disease resulting from obesity.

This article references the benefits of bariatric/metabolic surgery in individuals with class 1 obesity. In the United States, more than half of those who meet the criteria for obesity come under the class 1 category (BMI, 30-34.9). Those in this class of obesity are at increased risk of developing diabetes, hypertension, hyperlipidemia, coronary artery disease, cerebrovascular disease, obstructive sleep apnea, polycystic ovarian syndrome, and bone and joint disorders.

There are several studies that document the significant reduction in incidence of the above cardiometabolic risks with sustained weight loss. Nonsurgical interventions in individuals with class 1 obesity through lifestyle modifications and pharmacotherapy have not demonstrated success in providing persistent weight loss or metabolic benefits. The data presented in this article are of great significance to patients and physicians alike as they highlight the long-term benefits and reversal of metabolic disorders.

Current guidelines for bariatric surgery for individuals with a BMI greater than 35 were published in 1991. Since then several safe surgical options including laparoscopic procedures, sleeve gastrectomy, and adjustable gastric banding have been developed with decreased surgical risks, morbidity, and mortality.

The International Federation for the Surgery of Obesity and Metabolic Disorders, the International Diabetes Federation, and the National Institute for Health and Care Excellence of the United Kingdom, have supported the option of bariatric surgery in class 1 obese individuals with metabolic disorders.

While lifestyle modifications with medications should be the first-line treatment for class 1 obesity, as a primary care physician I believe that, given the major changes in the surgical options, the proven long-term benefits, and the rising incidences of obesity and metabolic syndrome, it is time for the health care community, insurers, patients, and all other stakeholders to consider bariatric surgery in class 1 obese individuals as a potential and viable option.

Noel N. Deep, MD, is a general internist in a multispecialty group practice with Aspirus Antigo (Wis.) Clinic and the chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo. He is also assistant clinical professor at the Medical College of Wisconsin, Central Wisconsin Campus, Wausau, and the governor of the Wisconsin chapter of the American College of Physicians. Dr. Deep serves on the editorial advisory board of Internal Medicine News.

He made these comments in response to questions from MDedge and had no relevant disclosures.

Mitchel L. Zoler’s article on Abstract A105, presented at Obesity Week 2019, addresses an important health concern and is timely.

Over the past 4 decades we have seen a rise in the prevalence of obesity and associated health complications, not just in the United States but across the world. The incidence of obesity (having a BMI greater than 30) was 35% for women and 31% for men in the United States, and associated deaths and disability were primarily attributed to diabetes and cardiovascular disease resulting from obesity.

This article references the benefits of bariatric/metabolic surgery in individuals with class 1 obesity. In the United States, more than half of those who meet the criteria for obesity come under the class 1 category (BMI, 30-34.9). Those in this class of obesity are at increased risk of developing diabetes, hypertension, hyperlipidemia, coronary artery disease, cerebrovascular disease, obstructive sleep apnea, polycystic ovarian syndrome, and bone and joint disorders.

There are several studies that document the significant reduction in incidence of the above cardiometabolic risks with sustained weight loss. Nonsurgical interventions in individuals with class 1 obesity through lifestyle modifications and pharmacotherapy have not demonstrated success in providing persistent weight loss or metabolic benefits. The data presented in this article are of great significance to patients and physicians alike as they highlight the long-term benefits and reversal of metabolic disorders.

Current guidelines for bariatric surgery for individuals with a BMI greater than 35 were published in 1991. Since then several safe surgical options including laparoscopic procedures, sleeve gastrectomy, and adjustable gastric banding have been developed with decreased surgical risks, morbidity, and mortality.

The International Federation for the Surgery of Obesity and Metabolic Disorders, the International Diabetes Federation, and the National Institute for Health and Care Excellence of the United Kingdom, have supported the option of bariatric surgery in class 1 obese individuals with metabolic disorders.

While lifestyle modifications with medications should be the first-line treatment for class 1 obesity, as a primary care physician I believe that, given the major changes in the surgical options, the proven long-term benefits, and the rising incidences of obesity and metabolic syndrome, it is time for the health care community, insurers, patients, and all other stakeholders to consider bariatric surgery in class 1 obese individuals as a potential and viable option.

Noel N. Deep, MD, is a general internist in a multispecialty group practice with Aspirus Antigo (Wis.) Clinic and the chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo. He is also assistant clinical professor at the Medical College of Wisconsin, Central Wisconsin Campus, Wausau, and the governor of the Wisconsin chapter of the American College of Physicians. Dr. Deep serves on the editorial advisory board of Internal Medicine News.

He made these comments in response to questions from MDedge and had no relevant disclosures.

Preterm birth (PTB) remains a significant public health concern and a major cause of newborn morbidity and mortality. In the United States, 1 in 10 babies are born preterm (< 37 weeks), and this rate has changed little in 30 years.¹ 

In 2011, the US Food and Drug Administration (FDA) approved progesterone supplementation—specifically, α-hydroxyprogesterone caproate (17P) injection (Makena)—to prevent recurrent PTB in women with a singleton pregnancy at high risk by virtue of a prior spontaneous PTB.² This was the first-ever FDA-approved drug for PTB prevention, and it was the first drug approved by the FDA for use in pregnancy in more than 15 years. The approval of 17P utilized the FDA's Subpart H Accelerated Approval Pathway, which applies to therapies that: 1) treat serious conditions with unmet need, and 2) demonstrate safety and efficacy on surrogate end points reasonably likely to predict clinical benefit.³ 

By voting their approval of 17P in 2011, the FDA affirmed that PTB was a serious condition with unmet need, that birth < 37 weeks was an accepted surrogate end point, and that there was compelling evidence of safety and benefit. The compelling evidence presented was a single, randomized, vehicle-controlled clinical trial conducted by the Maternal-Fetal Medicine Units (MFMU) Network, which showed significant reduction in recurrent PTB < 37 weeks (from 54.9% in the placebo group to 36.3% in the 17P group; P<.001; relative risk [RR], 0.66; 95% confidence interval [CI], 0.54-0.81).⁴ 

In 2017, the Society for Maternal-Fetal Medicine (SMFM) reaffirmed the use of 17P to prevent recurrent PTB and, that same year, it was estimated that 75% of eligible patients received 17P.^5,6 Importantly, Subpart H approval requires one or more follow-up clinical trials confirming safety and efficacy. And the FDA has the right—the responsibility—to revisit approval if such trials are either not performed or are unfavorable. 

The recently published PROLONG study by Blackwell and colleagues is this required postapproval confirmatory trial conducted to verify the clinical benefit of 17P supplementation.⁷ 

Continue to: Study design, and stunning results...

Study design, and stunning results 

PROLONG (Progestin's Role in Optimizing Neonatal Gestation) was a randomized (2:1), double-blind, vehicle-controlled, multicenter international trial (2009-2018) conducted to assess the safety and efficacy of 17P injection in 1,708 women with a singleton pregnancy and one or more prior spontaneous PTBs.⁷ Women in the active treatment group (n = 1,130) received weekly intramuscular injections of 17P, while those in the control group (n = 578) received weekly injections of inert oil vehicle. 

Results of the trial showed no significant reduction in the co-primary end points, which were PTB < 35 weeks (11.0% in the 17P group vs 11.5% in the placebo group; RR, 0.95; 95% CI, 0.71-1.26) and neonatal morbidity index (5.6% in the 17P group vs 5.0% in the placebo group; RR, 1.12; 95% CI, 0.68-1.61). There was no evidence of benefit for any subpopulation (geographic region, race, or other PTB risk factor). Maternal outcomes also were similar between the groups. No significant safety concerns were identified. 

Important differences between MFMU and PROLONG trials 

Strengths of the PROLONG trial include its randomized, placebo-controlled design, excellent follow-up rate, and use of a protocol that mirrored that of the MFMU trial. The primary limitation of PROLONG is that participants experienced a lower rate of PTB compared with those in the MFMU trial. The rate of PTB < 37 weeks was 54.9% in the control group of the MFMU trial compared with 21.9% in PROLONG. 

Given the low rate of PTB in PROLONG, the study was underpowered for the co-primary outcomes. In addition, lower rates of PTB in PROLONG compared with in the MFMU trial likely reflected different patient populations.⁸ Moreover, PROLONG was an international trial. Of the 1,708 participants, most were recruited in Russia (36%) and Ukraine (25%); only 23% were from the United States. By contrast, participants in the MFMU trial were recruited from US academic medical centers. Also, participants in the MFMU trial were significantly more likely to have a short cervix, to have a history of more than one PTB, and to be African American.

Discrepant trial results create clinical quandary 

In October 2019, the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 9-7 to withdraw approval for 17P. Committee members struggled with the conflicting data between the 2 trials and hesitated to remove a medication whose use has become standard practice. Ultimately, however, it was lack of substantial evidence of effectiveness of 17P that swayed the committee's vote. While the FDA generally follows the recommendation of an advisory committee, it is not bound to do so. 

Societies' perspectives 

So what are physicians and patients to do? It is possible that a small subgroup of women at extremely high risk for early PTB may benefit from 17P administration. SMFM stated: "...it is reasonable for providers to use 17-OHPC [17P] in women with a profile more representative of the very high-risk population reported in the Meis [MFMU] trial."⁸ Further, the American College of Obstetricians and Gynecologists (ACOG) stated in a Practice Advisory dated October 25, 2019, that "ACOG is not changing our clinical recommendations at this time... [We] will be reviewing subsequent forthcoming analyses and will issue updated clinical guidance as appropriate."⁹ 

Where we stand on 17P use going forward 

17P should be available to women who previously may have benefited from its use. However, 17P should not be recommended routinely to prevent recurrent spontaneous PTB in women with one prior PTB and no other risk factors. Of note, the PROLONG trial does not change recommendations for cervical length screening. Women with a history of a prior spontaneous PTB should undergo cervical length screening to identify those individuals who may benefit from an ultrasound-indicated cerclage.  

Preterm birth (PTB) remains a significant public health concern and a major cause of newborn morbidity and mortality. In the United States, 1 in 10 babies are born preterm (< 37 weeks), and this rate has changed little in 30 years.¹ 

In 2011, the US Food and Drug Administration (FDA) approved progesterone supplementation—specifically, α-hydroxyprogesterone caproate (17P) injection (Makena)—to prevent recurrent PTB in women with a singleton pregnancy at high risk by virtue of a prior spontaneous PTB.² This was the first-ever FDA-approved drug for PTB prevention, and it was the first drug approved by the FDA for use in pregnancy in more than 15 years. The approval of 17P utilized the FDA's Subpart H Accelerated Approval Pathway, which applies to therapies that: 1) treat serious conditions with unmet need, and 2) demonstrate safety and efficacy on surrogate end points reasonably likely to predict clinical benefit.³ 

By voting their approval of 17P in 2011, the FDA affirmed that PTB was a serious condition with unmet need, that birth < 37 weeks was an accepted surrogate end point, and that there was compelling evidence of safety and benefit. The compelling evidence presented was a single, randomized, vehicle-controlled clinical trial conducted by the Maternal-Fetal Medicine Units (MFMU) Network, which showed significant reduction in recurrent PTB < 37 weeks (from 54.9% in the placebo group to 36.3% in the 17P group; P<.001; relative risk [RR], 0.66; 95% confidence interval [CI], 0.54-0.81).⁴ 

In 2017, the Society for Maternal-Fetal Medicine (SMFM) reaffirmed the use of 17P to prevent recurrent PTB and, that same year, it was estimated that 75% of eligible patients received 17P.^5,6 Importantly, Subpart H approval requires one or more follow-up clinical trials confirming safety and efficacy. And the FDA has the right—the responsibility—to revisit approval if such trials are either not performed or are unfavorable. 

The recently published PROLONG study by Blackwell and colleagues is this required postapproval confirmatory trial conducted to verify the clinical benefit of 17P supplementation.⁷ 

Continue to: Study design, and stunning results...

Study design, and stunning results 

PROLONG (Progestin's Role in Optimizing Neonatal Gestation) was a randomized (2:1), double-blind, vehicle-controlled, multicenter international trial (2009-2018) conducted to assess the safety and efficacy of 17P injection in 1,708 women with a singleton pregnancy and one or more prior spontaneous PTBs.⁷ Women in the active treatment group (n = 1,130) received weekly intramuscular injections of 17P, while those in the control group (n = 578) received weekly injections of inert oil vehicle. 

Results of the trial showed no significant reduction in the co-primary end points, which were PTB < 35 weeks (11.0% in the 17P group vs 11.5% in the placebo group; RR, 0.95; 95% CI, 0.71-1.26) and neonatal morbidity index (5.6% in the 17P group vs 5.0% in the placebo group; RR, 1.12; 95% CI, 0.68-1.61). There was no evidence of benefit for any subpopulation (geographic region, race, or other PTB risk factor). Maternal outcomes also were similar between the groups. No significant safety concerns were identified. 

Important differences between MFMU and PROLONG trials 

Strengths of the PROLONG trial include its randomized, placebo-controlled design, excellent follow-up rate, and use of a protocol that mirrored that of the MFMU trial. The primary limitation of PROLONG is that participants experienced a lower rate of PTB compared with those in the MFMU trial. The rate of PTB < 37 weeks was 54.9% in the control group of the MFMU trial compared with 21.9% in PROLONG. 

Given the low rate of PTB in PROLONG, the study was underpowered for the co-primary outcomes. In addition, lower rates of PTB in PROLONG compared with in the MFMU trial likely reflected different patient populations.⁸ Moreover, PROLONG was an international trial. Of the 1,708 participants, most were recruited in Russia (36%) and Ukraine (25%); only 23% were from the United States. By contrast, participants in the MFMU trial were recruited from US academic medical centers. Also, participants in the MFMU trial were significantly more likely to have a short cervix, to have a history of more than one PTB, and to be African American.

Discrepant trial results create clinical quandary 

In October 2019, the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 9-7 to withdraw approval for 17P. Committee members struggled with the conflicting data between the 2 trials and hesitated to remove a medication whose use has become standard practice. Ultimately, however, it was lack of substantial evidence of effectiveness of 17P that swayed the committee's vote. While the FDA generally follows the recommendation of an advisory committee, it is not bound to do so. 

Societies' perspectives 

So what are physicians and patients to do? It is possible that a small subgroup of women at extremely high risk for early PTB may benefit from 17P administration. SMFM stated: "...it is reasonable for providers to use 17-OHPC [17P] in women with a profile more representative of the very high-risk population reported in the Meis [MFMU] trial."⁸ Further, the American College of Obstetricians and Gynecologists (ACOG) stated in a Practice Advisory dated October 25, 2019, that "ACOG is not changing our clinical recommendations at this time... [We] will be reviewing subsequent forthcoming analyses and will issue updated clinical guidance as appropriate."⁹ 

Where we stand on 17P use going forward 

17P should be available to women who previously may have benefited from its use. However, 17P should not be recommended routinely to prevent recurrent spontaneous PTB in women with one prior PTB and no other risk factors. Of note, the PROLONG trial does not change recommendations for cervical length screening. Women with a history of a prior spontaneous PTB should undergo cervical length screening to identify those individuals who may benefit from an ultrasound-indicated cerclage.  

Preterm birth (PTB) remains a significant public health concern and a major cause of newborn morbidity and mortality. In the United States, 1 in 10 babies are born preterm (< 37 weeks), and this rate has changed little in 30 years.¹ 

In 2011, the US Food and Drug Administration (FDA) approved progesterone supplementation—specifically, α-hydroxyprogesterone caproate (17P) injection (Makena)—to prevent recurrent PTB in women with a singleton pregnancy at high risk by virtue of a prior spontaneous PTB.² This was the first-ever FDA-approved drug for PTB prevention, and it was the first drug approved by the FDA for use in pregnancy in more than 15 years. The approval of 17P utilized the FDA's Subpart H Accelerated Approval Pathway, which applies to therapies that: 1) treat serious conditions with unmet need, and 2) demonstrate safety and efficacy on surrogate end points reasonably likely to predict clinical benefit.³ 

By voting their approval of 17P in 2011, the FDA affirmed that PTB was a serious condition with unmet need, that birth < 37 weeks was an accepted surrogate end point, and that there was compelling evidence of safety and benefit. The compelling evidence presented was a single, randomized, vehicle-controlled clinical trial conducted by the Maternal-Fetal Medicine Units (MFMU) Network, which showed significant reduction in recurrent PTB < 37 weeks (from 54.9% in the placebo group to 36.3% in the 17P group; P<.001; relative risk [RR], 0.66; 95% confidence interval [CI], 0.54-0.81).⁴ 

In 2017, the Society for Maternal-Fetal Medicine (SMFM) reaffirmed the use of 17P to prevent recurrent PTB and, that same year, it was estimated that 75% of eligible patients received 17P.^5,6 Importantly, Subpart H approval requires one or more follow-up clinical trials confirming safety and efficacy. And the FDA has the right—the responsibility—to revisit approval if such trials are either not performed or are unfavorable. 

The recently published PROLONG study by Blackwell and colleagues is this required postapproval confirmatory trial conducted to verify the clinical benefit of 17P supplementation.⁷ 

Continue to: Study design, and stunning results...

Study design, and stunning results 

PROLONG (Progestin's Role in Optimizing Neonatal Gestation) was a randomized (2:1), double-blind, vehicle-controlled, multicenter international trial (2009-2018) conducted to assess the safety and efficacy of 17P injection in 1,708 women with a singleton pregnancy and one or more prior spontaneous PTBs.⁷ Women in the active treatment group (n = 1,130) received weekly intramuscular injections of 17P, while those in the control group (n = 578) received weekly injections of inert oil vehicle. 

Results of the trial showed no significant reduction in the co-primary end points, which were PTB < 35 weeks (11.0% in the 17P group vs 11.5% in the placebo group; RR, 0.95; 95% CI, 0.71-1.26) and neonatal morbidity index (5.6% in the 17P group vs 5.0% in the placebo group; RR, 1.12; 95% CI, 0.68-1.61). There was no evidence of benefit for any subpopulation (geographic region, race, or other PTB risk factor). Maternal outcomes also were similar between the groups. No significant safety concerns were identified. 

Important differences between MFMU and PROLONG trials 

Strengths of the PROLONG trial include its randomized, placebo-controlled design, excellent follow-up rate, and use of a protocol that mirrored that of the MFMU trial. The primary limitation of PROLONG is that participants experienced a lower rate of PTB compared with those in the MFMU trial. The rate of PTB < 37 weeks was 54.9% in the control group of the MFMU trial compared with 21.9% in PROLONG. 

Given the low rate of PTB in PROLONG, the study was underpowered for the co-primary outcomes. In addition, lower rates of PTB in PROLONG compared with in the MFMU trial likely reflected different patient populations.⁸ Moreover, PROLONG was an international trial. Of the 1,708 participants, most were recruited in Russia (36%) and Ukraine (25%); only 23% were from the United States. By contrast, participants in the MFMU trial were recruited from US academic medical centers. Also, participants in the MFMU trial were significantly more likely to have a short cervix, to have a history of more than one PTB, and to be African American.

Discrepant trial results create clinical quandary 

In October 2019, the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 9-7 to withdraw approval for 17P. Committee members struggled with the conflicting data between the 2 trials and hesitated to remove a medication whose use has become standard practice. Ultimately, however, it was lack of substantial evidence of effectiveness of 17P that swayed the committee's vote. While the FDA generally follows the recommendation of an advisory committee, it is not bound to do so. 

Societies' perspectives 

So what are physicians and patients to do? It is possible that a small subgroup of women at extremely high risk for early PTB may benefit from 17P administration. SMFM stated: "...it is reasonable for providers to use 17-OHPC [17P] in women with a profile more representative of the very high-risk population reported in the Meis [MFMU] trial."⁸ Further, the American College of Obstetricians and Gynecologists (ACOG) stated in a Practice Advisory dated October 25, 2019, that "ACOG is not changing our clinical recommendations at this time... [We] will be reviewing subsequent forthcoming analyses and will issue updated clinical guidance as appropriate."⁹ 

Where we stand on 17P use going forward 

17P should be available to women who previously may have benefited from its use. However, 17P should not be recommended routinely to prevent recurrent spontaneous PTB in women with one prior PTB and no other risk factors. Of note, the PROLONG trial does not change recommendations for cervical length screening. Women with a history of a prior spontaneous PTB should undergo cervical length screening to identify those individuals who may benefit from an ultrasound-indicated cerclage.