Concerns about potential risks about the use of spironolactone for acne during the COVID-19 pandemic were raised on social media last month, but spironolactone and other androgen blockers might actually protect against the virus, according to a report in the Journal of the American Academy of Dermatology.

The virus needs androgens to infect cells, and uses androgen-dependent transmembrane protease serine 2 to prime viral protein spikes to anchor onto ACE2 receptors. Without that step, the virus can’t enter cells. Androgens are the only known activator in humans, so androgen blockers like spironolactone probably short-circuit the process, said the report’s lead author Carlos Wambier, MD, PhD, of the department of dermatology at Brown University, Providence, R.I (J Am Acad Dermatol. 2020 Apr 10. doi: 10.1016/j.jaad.2020.04.032).

The lack of androgens could be a possible explanation as to why mortality is so rare among children with COVID-19, and why fatalities among men are higher than among women with COVID-19, he said in an interview.

There are a lot of androgen blocker candidates, but he said spironolactone – a mainstay of acne treatment – might well be the best for the pandemic because of its concomitant lung and heart benefits.

The message counters a post on Instagram in March from a New York City dermatologist in private practice, Ellen Marmur, MD, that raised a question about spironolactone. Concerned about the situation in New York, she reviewed the literature and found a 2005 study that reported that macrophages drawn from 10 heart failure patients had increased ACE2 activity and increased messenger RNA expression after the subjects had been on spironolactone 25 mg per day for a month.

In an interview, Adam Friedman, MD, professor and interim chair of dermatology at George Washington University, Washington, said he’s been addressing concerns about spironolactone in educational webinars because of it.

He tells his audience that “you can’t make any claims” for COVID-19 based on the 2005 study. It was a small clinical study in heart failure patients and only assessed ACE2 expression on macrophages, not respiratory, cardiac, or mesangial cells, which are the relevant locations for viral invasion and damage. In fact, there are studies showing that spironolactone reduced ACE2 in renal mesangial cells. Also of note, spironolactone has been used with no indication of virus risk since the 1950s, he pointed out. The American Academy of Dermatology has not said to stop spironolactone.

aotto@mdedge.com

Concerns about potential risks about the use of spironolactone for acne during the COVID-19 pandemic were raised on social media last month, but spironolactone and other androgen blockers might actually protect against the virus, according to a report in the Journal of the American Academy of Dermatology.

The virus needs androgens to infect cells, and uses androgen-dependent transmembrane protease serine 2 to prime viral protein spikes to anchor onto ACE2 receptors. Without that step, the virus can’t enter cells. Androgens are the only known activator in humans, so androgen blockers like spironolactone probably short-circuit the process, said the report’s lead author Carlos Wambier, MD, PhD, of the department of dermatology at Brown University, Providence, R.I (J Am Acad Dermatol. 2020 Apr 10. doi: 10.1016/j.jaad.2020.04.032).

The lack of androgens could be a possible explanation as to why mortality is so rare among children with COVID-19, and why fatalities among men are higher than among women with COVID-19, he said in an interview.

There are a lot of androgen blocker candidates, but he said spironolactone – a mainstay of acne treatment – might well be the best for the pandemic because of its concomitant lung and heart benefits.

The message counters a post on Instagram in March from a New York City dermatologist in private practice, Ellen Marmur, MD, that raised a question about spironolactone. Concerned about the situation in New York, she reviewed the literature and found a 2005 study that reported that macrophages drawn from 10 heart failure patients had increased ACE2 activity and increased messenger RNA expression after the subjects had been on spironolactone 25 mg per day for a month.

In an interview, Adam Friedman, MD, professor and interim chair of dermatology at George Washington University, Washington, said he’s been addressing concerns about spironolactone in educational webinars because of it.

He tells his audience that “you can’t make any claims” for COVID-19 based on the 2005 study. It was a small clinical study in heart failure patients and only assessed ACE2 expression on macrophages, not respiratory, cardiac, or mesangial cells, which are the relevant locations for viral invasion and damage. In fact, there are studies showing that spironolactone reduced ACE2 in renal mesangial cells. Also of note, spironolactone has been used with no indication of virus risk since the 1950s, he pointed out. The American Academy of Dermatology has not said to stop spironolactone.

aotto@mdedge.com

Concerns about potential risks about the use of spironolactone for acne during the COVID-19 pandemic were raised on social media last month, but spironolactone and other androgen blockers might actually protect against the virus, according to a report in the Journal of the American Academy of Dermatology.

The virus needs androgens to infect cells, and uses androgen-dependent transmembrane protease serine 2 to prime viral protein spikes to anchor onto ACE2 receptors. Without that step, the virus can’t enter cells. Androgens are the only known activator in humans, so androgen blockers like spironolactone probably short-circuit the process, said the report’s lead author Carlos Wambier, MD, PhD, of the department of dermatology at Brown University, Providence, R.I (J Am Acad Dermatol. 2020 Apr 10. doi: 10.1016/j.jaad.2020.04.032).

The lack of androgens could be a possible explanation as to why mortality is so rare among children with COVID-19, and why fatalities among men are higher than among women with COVID-19, he said in an interview.

There are a lot of androgen blocker candidates, but he said spironolactone – a mainstay of acne treatment – might well be the best for the pandemic because of its concomitant lung and heart benefits.

The message counters a post on Instagram in March from a New York City dermatologist in private practice, Ellen Marmur, MD, that raised a question about spironolactone. Concerned about the situation in New York, she reviewed the literature and found a 2005 study that reported that macrophages drawn from 10 heart failure patients had increased ACE2 activity and increased messenger RNA expression after the subjects had been on spironolactone 25 mg per day for a month.

In an interview, Adam Friedman, MD, professor and interim chair of dermatology at George Washington University, Washington, said he’s been addressing concerns about spironolactone in educational webinars because of it.

He tells his audience that “you can’t make any claims” for COVID-19 based on the 2005 study. It was a small clinical study in heart failure patients and only assessed ACE2 expression on macrophages, not respiratory, cardiac, or mesangial cells, which are the relevant locations for viral invasion and damage. In fact, there are studies showing that spironolactone reduced ACE2 in renal mesangial cells. Also of note, spironolactone has been used with no indication of virus risk since the 1950s, he pointed out. The American Academy of Dermatology has not said to stop spironolactone.

aotto@mdedge.com

We have all as providers experienced the tragic stillbirth of a term fetus for one of our patients. Too often no fetal movement was felt for days, but the patient never called. Or the patient did call, but the nonstress test (NST) was reactive or the ultrasound showed normal growth and fluid or the biophysical profile (BPP) was 8/8. Yet the patient still presented with a stillborn fetus a day later. Was the first patient simply so fearful of the likely deceased child within her that she did not call? Or did she simply not know to report it because she was not educated about what decreased fetal movement could mean? Could the second example have been prevented even though the testing was normal? I believe both scenarios could have been prevented with better education for both providers and patients.

The national stillbirth rate has remained relatively stagnant since 2000, despite many improvements in guidelines for the management of higher risk pregnancies.¹ We follow the growth of these pregnancies, do NSTs, and often induce these patients prior to the due date. We do this in the hope of having a healthy mom and baby. However, an analysis of 614 stillbirth cases and 1,816 control deliveries found that 81% of patients presenting with a stillborn baby had no risks factors that required additional monitoring.² Nearly 66% of 1,714 patients with a late stillbirth reported decreased fetal movement, no fetal movement, or a concerning increase in fetal movement in the days leading up to their baby’s death.³ Studies have suggested that persistent decreased fetal movement has an odds ratio for stillbirth of 4.51,⁴ which is higher than hypertensive disease and diabetes for this same outcome by nearly a factor of two. Yet there are no formal guidelines on education for patients or management of this chief complaint.

We assess fetal movement at every prenatal visit but patients who experienced stillbirth will say they didn’t know why. This is because as a culture and a profession we are afraid to talk about such a taboo subject as stillbirth. We are afraid we will scare our patients if we tell them that a decrease in fetal movement or no fetal movement may be because their baby is at risk for this dreaded complication. On one level this argument makes sense, but as soon as the baby is born we give parents plenty of education and advice to keep their children safe. Telling a parent to remove all bedding, put their baby on their back, and keep their baby from being too warm to prevent sudden infant death syndrome (SIDS) is very scary. However, this education is necessary. If moms simply know the reason why we ask about fetal movements, they may not wait 2 days before they call. We must have faith that pregnant women can handle this education about decreased fetal movement.

Next most important is our response to the complaint of decreased fetal movement. Often when the NST is reactive or the ultrasound is normal, we assume the baby is at no risk and we reassure the mother that everything is fine. We often tell moms the false myth that babies slow down at the end or advise kick counts after this complaint despite studies failing to show their utility. Because the education about kick count is frequency is what matters, a mother may not call if there is a change in pattern or strength – even if she is very worried about this. A baby may “pass” a kick count, but a mom still may be very worried, yet she will not call because the baby “passed.”

Protocols from the United Kingdom and Australia focus on the assumption that the complaint of decreased fetal movement may be the only warning sign of impending stillbirth. Harvey Kliman, MD, PhD, director of reproductive and placental research unit at Yale University, New Haven, Conn. said an analogy to this is a car driving 55 miles per hour despite only 10 miles of gas being left in the tank.* The car is running fine even when it is almost out of gas. That may be why we all have seen a fetus with recent reassuring tests in the last few days who presents stillborn. Perhaps the only warning sign is decreased fetal movement – not a nonreactive NST or low score BPP. Placental insufficiency is often the cause of initially unexplained stillbirth, far more common than “cord accidents.” If we liken the placenta to the “gas tank” for the pregnancy, then decreased fetal movement may be the “low gas” signal on the dashboard. After this patient has a reactive NST and/or reassuring ultrasound, we need to ask her if she is reassured. Data from a study of 380 women found that women who had a gut instinct that something was wrong were 23 times more likely to experience a stillbirth, according to the unadjusted odds ratio from the logistic regression model.⁵ We should follow up closely with moms who are not reassured and consider induction if they are over 39 weeks. We should tell every mom who presents with a concern about fetal movement that she did the right thing, and we want to hear from her again immediately if the movement is decreased again or persists. We cannot make women feel silly for calling. We should do an ultrasound for worried moms even if the NST is reactive to make sure we are not missing oligohydramnios or fetal growth restriction; the latter is the biggest known risk factor for stillbirth. We also should perform an ultrasound for moms with risk factors for stillbirth such as advanced maternal age or black race.

Dr. Florescue is an ob.gyn. in private practice at Women Gynecology and Childbirth Associates in Rochester, N.Y. She delivers babies at Highland Hospital in Rochester. She has no relevant financial disclosures.
 

References

1. The Lancet. 2016, Jan 18;387(10018):587-603.

2. JAMA. 2011 Dec 14;306(22):2469-79.

3. BMC Pregnancy Childbirth. 2015 Aug 15;15:172.

4. BMJ Open. 2018 Jul 6;8(7):e020031.

5. Midwifery. 2018 Jul;62:171-6.

6. The Lancet. 2016, Jan 18;387(10019):691-702.

*This article was updated on 5/4/2020.

We have all as providers experienced the tragic stillbirth of a term fetus for one of our patients. Too often no fetal movement was felt for days, but the patient never called. Or the patient did call, but the nonstress test (NST) was reactive or the ultrasound showed normal growth and fluid or the biophysical profile (BPP) was 8/8. Yet the patient still presented with a stillborn fetus a day later. Was the first patient simply so fearful of the likely deceased child within her that she did not call? Or did she simply not know to report it because she was not educated about what decreased fetal movement could mean? Could the second example have been prevented even though the testing was normal? I believe both scenarios could have been prevented with better education for both providers and patients.

The national stillbirth rate has remained relatively stagnant since 2000, despite many improvements in guidelines for the management of higher risk pregnancies.¹ We follow the growth of these pregnancies, do NSTs, and often induce these patients prior to the due date. We do this in the hope of having a healthy mom and baby. However, an analysis of 614 stillbirth cases and 1,816 control deliveries found that 81% of patients presenting with a stillborn baby had no risks factors that required additional monitoring.² Nearly 66% of 1,714 patients with a late stillbirth reported decreased fetal movement, no fetal movement, or a concerning increase in fetal movement in the days leading up to their baby’s death.³ Studies have suggested that persistent decreased fetal movement has an odds ratio for stillbirth of 4.51,⁴ which is higher than hypertensive disease and diabetes for this same outcome by nearly a factor of two. Yet there are no formal guidelines on education for patients or management of this chief complaint.

We assess fetal movement at every prenatal visit but patients who experienced stillbirth will say they didn’t know why. This is because as a culture and a profession we are afraid to talk about such a taboo subject as stillbirth. We are afraid we will scare our patients if we tell them that a decrease in fetal movement or no fetal movement may be because their baby is at risk for this dreaded complication. On one level this argument makes sense, but as soon as the baby is born we give parents plenty of education and advice to keep their children safe. Telling a parent to remove all bedding, put their baby on their back, and keep their baby from being too warm to prevent sudden infant death syndrome (SIDS) is very scary. However, this education is necessary. If moms simply know the reason why we ask about fetal movements, they may not wait 2 days before they call. We must have faith that pregnant women can handle this education about decreased fetal movement.

Next most important is our response to the complaint of decreased fetal movement. Often when the NST is reactive or the ultrasound is normal, we assume the baby is at no risk and we reassure the mother that everything is fine. We often tell moms the false myth that babies slow down at the end or advise kick counts after this complaint despite studies failing to show their utility. Because the education about kick count is frequency is what matters, a mother may not call if there is a change in pattern or strength – even if she is very worried about this. A baby may “pass” a kick count, but a mom still may be very worried, yet she will not call because the baby “passed.”

Protocols from the United Kingdom and Australia focus on the assumption that the complaint of decreased fetal movement may be the only warning sign of impending stillbirth. Harvey Kliman, MD, PhD, director of reproductive and placental research unit at Yale University, New Haven, Conn. said an analogy to this is a car driving 55 miles per hour despite only 10 miles of gas being left in the tank.* The car is running fine even when it is almost out of gas. That may be why we all have seen a fetus with recent reassuring tests in the last few days who presents stillborn. Perhaps the only warning sign is decreased fetal movement – not a nonreactive NST or low score BPP. Placental insufficiency is often the cause of initially unexplained stillbirth, far more common than “cord accidents.” If we liken the placenta to the “gas tank” for the pregnancy, then decreased fetal movement may be the “low gas” signal on the dashboard. After this patient has a reactive NST and/or reassuring ultrasound, we need to ask her if she is reassured. Data from a study of 380 women found that women who had a gut instinct that something was wrong were 23 times more likely to experience a stillbirth, according to the unadjusted odds ratio from the logistic regression model.⁵ We should follow up closely with moms who are not reassured and consider induction if they are over 39 weeks. We should tell every mom who presents with a concern about fetal movement that she did the right thing, and we want to hear from her again immediately if the movement is decreased again or persists. We cannot make women feel silly for calling. We should do an ultrasound for worried moms even if the NST is reactive to make sure we are not missing oligohydramnios or fetal growth restriction; the latter is the biggest known risk factor for stillbirth. We also should perform an ultrasound for moms with risk factors for stillbirth such as advanced maternal age or black race.

Dr. Florescue is an ob.gyn. in private practice at Women Gynecology and Childbirth Associates in Rochester, N.Y. She delivers babies at Highland Hospital in Rochester. She has no relevant financial disclosures.
 

References

1. The Lancet. 2016, Jan 18;387(10018):587-603.

2. JAMA. 2011 Dec 14;306(22):2469-79.

3. BMC Pregnancy Childbirth. 2015 Aug 15;15:172.

4. BMJ Open. 2018 Jul 6;8(7):e020031.

5. Midwifery. 2018 Jul;62:171-6.

6. The Lancet. 2016, Jan 18;387(10019):691-702.

*This article was updated on 5/4/2020.

We have all as providers experienced the tragic stillbirth of a term fetus for one of our patients. Too often no fetal movement was felt for days, but the patient never called. Or the patient did call, but the nonstress test (NST) was reactive or the ultrasound showed normal growth and fluid or the biophysical profile (BPP) was 8/8. Yet the patient still presented with a stillborn fetus a day later. Was the first patient simply so fearful of the likely deceased child within her that she did not call? Or did she simply not know to report it because she was not educated about what decreased fetal movement could mean? Could the second example have been prevented even though the testing was normal? I believe both scenarios could have been prevented with better education for both providers and patients.

The national stillbirth rate has remained relatively stagnant since 2000, despite many improvements in guidelines for the management of higher risk pregnancies.¹ We follow the growth of these pregnancies, do NSTs, and often induce these patients prior to the due date. We do this in the hope of having a healthy mom and baby. However, an analysis of 614 stillbirth cases and 1,816 control deliveries found that 81% of patients presenting with a stillborn baby had no risks factors that required additional monitoring.² Nearly 66% of 1,714 patients with a late stillbirth reported decreased fetal movement, no fetal movement, or a concerning increase in fetal movement in the days leading up to their baby’s death.³ Studies have suggested that persistent decreased fetal movement has an odds ratio for stillbirth of 4.51,⁴ which is higher than hypertensive disease and diabetes for this same outcome by nearly a factor of two. Yet there are no formal guidelines on education for patients or management of this chief complaint.

We assess fetal movement at every prenatal visit but patients who experienced stillbirth will say they didn’t know why. This is because as a culture and a profession we are afraid to talk about such a taboo subject as stillbirth. We are afraid we will scare our patients if we tell them that a decrease in fetal movement or no fetal movement may be because their baby is at risk for this dreaded complication. On one level this argument makes sense, but as soon as the baby is born we give parents plenty of education and advice to keep their children safe. Telling a parent to remove all bedding, put their baby on their back, and keep their baby from being too warm to prevent sudden infant death syndrome (SIDS) is very scary. However, this education is necessary. If moms simply know the reason why we ask about fetal movements, they may not wait 2 days before they call. We must have faith that pregnant women can handle this education about decreased fetal movement.

Next most important is our response to the complaint of decreased fetal movement. Often when the NST is reactive or the ultrasound is normal, we assume the baby is at no risk and we reassure the mother that everything is fine. We often tell moms the false myth that babies slow down at the end or advise kick counts after this complaint despite studies failing to show their utility. Because the education about kick count is frequency is what matters, a mother may not call if there is a change in pattern or strength – even if she is very worried about this. A baby may “pass” a kick count, but a mom still may be very worried, yet she will not call because the baby “passed.”

Protocols from the United Kingdom and Australia focus on the assumption that the complaint of decreased fetal movement may be the only warning sign of impending stillbirth. Harvey Kliman, MD, PhD, director of reproductive and placental research unit at Yale University, New Haven, Conn. said an analogy to this is a car driving 55 miles per hour despite only 10 miles of gas being left in the tank.* The car is running fine even when it is almost out of gas. That may be why we all have seen a fetus with recent reassuring tests in the last few days who presents stillborn. Perhaps the only warning sign is decreased fetal movement – not a nonreactive NST or low score BPP. Placental insufficiency is often the cause of initially unexplained stillbirth, far more common than “cord accidents.” If we liken the placenta to the “gas tank” for the pregnancy, then decreased fetal movement may be the “low gas” signal on the dashboard. After this patient has a reactive NST and/or reassuring ultrasound, we need to ask her if she is reassured. Data from a study of 380 women found that women who had a gut instinct that something was wrong were 23 times more likely to experience a stillbirth, according to the unadjusted odds ratio from the logistic regression model.⁵ We should follow up closely with moms who are not reassured and consider induction if they are over 39 weeks. We should tell every mom who presents with a concern about fetal movement that she did the right thing, and we want to hear from her again immediately if the movement is decreased again or persists. We cannot make women feel silly for calling. We should do an ultrasound for worried moms even if the NST is reactive to make sure we are not missing oligohydramnios or fetal growth restriction; the latter is the biggest known risk factor for stillbirth. We also should perform an ultrasound for moms with risk factors for stillbirth such as advanced maternal age or black race.

Dr. Florescue is an ob.gyn. in private practice at Women Gynecology and Childbirth Associates in Rochester, N.Y. She delivers babies at Highland Hospital in Rochester. She has no relevant financial disclosures.
 

References

1. The Lancet. 2016, Jan 18;387(10018):587-603.

2. JAMA. 2011 Dec 14;306(22):2469-79.

3. BMC Pregnancy Childbirth. 2015 Aug 15;15:172.

4. BMJ Open. 2018 Jul 6;8(7):e020031.

5. Midwifery. 2018 Jul;62:171-6.

6. The Lancet. 2016, Jan 18;387(10019):691-702.

*This article was updated on 5/4/2020.

Application of enhanced recovery after surgery (ERAS) protocols significantly reduced the use of opioids, as well as hospital stays and hospital costs, based on data from cohorts of women before and after the introduction of the protocols.

selimaksan/E+

The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

ERAS protocols have been introduced in surgical specialties including colorectal, urologic, gynecologic, and hepatobiliary – with noted benefits to patients and the health care system, wrote Nnamdi I. Gwacham, DO, of Saint Barnabas Medical Center, Livingston, N.J., and colleagues.

The researchers explored the impact of ERAS on reduction in opioid use after cesarean sections at a community teaching hospital in a retrospective study also published in Obstetrics & Gynecology.

The study population included a historical cohort of 2,109 patients from 2018 before the establishment of the ERAS pathway and 1,463 patients since the ERAS pathway was established in 2019.*

Significantly fewer patients in the ERAS group required opioids, compared with the historical group (1,766 vs. 341). A total of 8,082 opioid units were used before the introduction of the ERAS pathway, compared with 803 units used since its introduction, Dr. Gwacham and associates reported. The study was a Donald F. Richardson Prize Paper.

The ERAS pathway consisted of received transversus abdominis plane blocks in the immediate postoperative period (given to 98% of the patients), and all patients were started on “a scheduled multimodal analgesia with a combination of ibuprofen, acetaminophen, and dextromethorphan until discharge,” the researchers wrote. Patients received opioids only if their pain was not well controlled with the ERAS protocol.

In addition, patients who received ERAS had significantly shorter hospital stays than the historical group (3.19 days vs. 2.63 days) and incurred a significantly lower average direct cost ($4,290 vs. $3,957).

The groups were not significantly different in age, race, or body mass index.

“Given the current opioid epidemic in America, researching ways to reduce their use is an urgent matter,” Angela Martin, MD, of the University of Kansas, Kansas City, said in an interview.

She thought the study findings were to be expected based on research in other areas. “Given the trends and ability to reduced opioid use with ERAS in other specialties, it does not surprise me that women recovering from cesarean sections are similar.”

The take-home message for clinicians: “Begin thinking outside of the box when it comes to pain control,” emphasized Dr. Martin, who was not a part of this study. “Opioids don’t have to be the first line medications for postoperative pain management.”

She added that additional directions for research could include the patient perspective on postoperative pain management after a cesarean delivery. “Alternative options to opioids would be even more enticing if the inpatient experience was also improved,” said Dr. Martin, who is a member of the Ob.Gyn News editorial advisory board.

The researchers had no financial conflicts to disclose. Dr. Martin had no relevant financial disclosures.

SOURCE: Gwacham NI et al. Obstet Gynecol. 2020 May;135:2S. doi: 10.1097/01.AOG.0000662880.08512.6b.

*This article was updated on 4/29/2020.

Application of enhanced recovery after surgery (ERAS) protocols significantly reduced the use of opioids, as well as hospital stays and hospital costs, based on data from cohorts of women before and after the introduction of the protocols.

selimaksan/E+

The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

ERAS protocols have been introduced in surgical specialties including colorectal, urologic, gynecologic, and hepatobiliary – with noted benefits to patients and the health care system, wrote Nnamdi I. Gwacham, DO, of Saint Barnabas Medical Center, Livingston, N.J., and colleagues.

The researchers explored the impact of ERAS on reduction in opioid use after cesarean sections at a community teaching hospital in a retrospective study also published in Obstetrics & Gynecology.

The study population included a historical cohort of 2,109 patients from 2018 before the establishment of the ERAS pathway and 1,463 patients since the ERAS pathway was established in 2019.*

Significantly fewer patients in the ERAS group required opioids, compared with the historical group (1,766 vs. 341). A total of 8,082 opioid units were used before the introduction of the ERAS pathway, compared with 803 units used since its introduction, Dr. Gwacham and associates reported. The study was a Donald F. Richardson Prize Paper.

The ERAS pathway consisted of received transversus abdominis plane blocks in the immediate postoperative period (given to 98% of the patients), and all patients were started on “a scheduled multimodal analgesia with a combination of ibuprofen, acetaminophen, and dextromethorphan until discharge,” the researchers wrote. Patients received opioids only if their pain was not well controlled with the ERAS protocol.

In addition, patients who received ERAS had significantly shorter hospital stays than the historical group (3.19 days vs. 2.63 days) and incurred a significantly lower average direct cost ($4,290 vs. $3,957).

The groups were not significantly different in age, race, or body mass index.

“Given the current opioid epidemic in America, researching ways to reduce their use is an urgent matter,” Angela Martin, MD, of the University of Kansas, Kansas City, said in an interview.

She thought the study findings were to be expected based on research in other areas. “Given the trends and ability to reduced opioid use with ERAS in other specialties, it does not surprise me that women recovering from cesarean sections are similar.”

The take-home message for clinicians: “Begin thinking outside of the box when it comes to pain control,” emphasized Dr. Martin, who was not a part of this study. “Opioids don’t have to be the first line medications for postoperative pain management.”

She added that additional directions for research could include the patient perspective on postoperative pain management after a cesarean delivery. “Alternative options to opioids would be even more enticing if the inpatient experience was also improved,” said Dr. Martin, who is a member of the Ob.Gyn News editorial advisory board.

The researchers had no financial conflicts to disclose. Dr. Martin had no relevant financial disclosures.

SOURCE: Gwacham NI et al. Obstet Gynecol. 2020 May;135:2S. doi: 10.1097/01.AOG.0000662880.08512.6b.

*This article was updated on 4/29/2020.

Application of enhanced recovery after surgery (ERAS) protocols significantly reduced the use of opioids, as well as hospital stays and hospital costs, based on data from cohorts of women before and after the introduction of the protocols.

selimaksan/E+

The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

ERAS protocols have been introduced in surgical specialties including colorectal, urologic, gynecologic, and hepatobiliary – with noted benefits to patients and the health care system, wrote Nnamdi I. Gwacham, DO, of Saint Barnabas Medical Center, Livingston, N.J., and colleagues.

The researchers explored the impact of ERAS on reduction in opioid use after cesarean sections at a community teaching hospital in a retrospective study also published in Obstetrics & Gynecology.

The study population included a historical cohort of 2,109 patients from 2018 before the establishment of the ERAS pathway and 1,463 patients since the ERAS pathway was established in 2019.*

Significantly fewer patients in the ERAS group required opioids, compared with the historical group (1,766 vs. 341). A total of 8,082 opioid units were used before the introduction of the ERAS pathway, compared with 803 units used since its introduction, Dr. Gwacham and associates reported. The study was a Donald F. Richardson Prize Paper.

The ERAS pathway consisted of received transversus abdominis plane blocks in the immediate postoperative period (given to 98% of the patients), and all patients were started on “a scheduled multimodal analgesia with a combination of ibuprofen, acetaminophen, and dextromethorphan until discharge,” the researchers wrote. Patients received opioids only if their pain was not well controlled with the ERAS protocol.

In addition, patients who received ERAS had significantly shorter hospital stays than the historical group (3.19 days vs. 2.63 days) and incurred a significantly lower average direct cost ($4,290 vs. $3,957).

The groups were not significantly different in age, race, or body mass index.

“Given the current opioid epidemic in America, researching ways to reduce their use is an urgent matter,” Angela Martin, MD, of the University of Kansas, Kansas City, said in an interview.

She thought the study findings were to be expected based on research in other areas. “Given the trends and ability to reduced opioid use with ERAS in other specialties, it does not surprise me that women recovering from cesarean sections are similar.”

The take-home message for clinicians: “Begin thinking outside of the box when it comes to pain control,” emphasized Dr. Martin, who was not a part of this study. “Opioids don’t have to be the first line medications for postoperative pain management.”

She added that additional directions for research could include the patient perspective on postoperative pain management after a cesarean delivery. “Alternative options to opioids would be even more enticing if the inpatient experience was also improved,” said Dr. Martin, who is a member of the Ob.Gyn News editorial advisory board.

The researchers had no financial conflicts to disclose. Dr. Martin had no relevant financial disclosures.

SOURCE: Gwacham NI et al. Obstet Gynecol. 2020 May;135:2S. doi: 10.1097/01.AOG.0000662880.08512.6b.

*This article was updated on 4/29/2020.

Enrollment in a supportive oncodermatology program was associated with improved quality of life in patients who experienced dermatologic effects from cancer therapy, according to a cross-sectional survey of participants.

The average quality of life score prior to program participation in 34 adult patients enrolled in the George Washington University Supportive Oncodermatology Clinic who responded to the survey was 6.5, indicating a moderate effect of their dermatologic symptoms on quality of life. After the beginning of treatment, the average score declined significantly to 3.8, indicating a small effect of the symptoms on quality of life, Leora Aizman, a medical student at George Washington University, Washington, and colleagues reported in the Journal of Drugs in Dermatology.

“On average, [quality of life] total scores were significantly reduced by 2.7 points after joining the supportive oncodermatology clinic,” the authors wrote.

Decreases were seen across all quality of life categories, including physical symptoms, embarrassment, clothes, social/leisure, work/school, and close relationships; the only score that didn’t decrease significantly was for physical symptoms of itch, pain, or soreness (1.43 vs. 1.1 before and after therapy), whereas the category that showed the greatest difference was embarrassment about the dermatologic condition (1.57 vs. 0.83 before and after therapy).

As for satisfaction with the program, the average participant satisfaction score was 4.15, indicating satisfaction with the program. The lowest – an average of 3.67, indicating neutral to satisfied – was related to the effects of the program on treatment adherence.

Survey respondents were adults aged over 18 years who received dermatologic care between the opening of the clinic in May 2017 and Nov. 1, 2019. The online survey included questions adapted from the Dermatology Life Quality Index and Patient Satisfaction Questionnaire.

The findings, though limited by the potential for recall bias and other factors inherent in a survey-based study, suggest that participation in a comprehensive, supportive program could be of benefit for cancer patients experiencing dermatologic conditions from cancer treatment, the authors wrote, explaining that such conditions can be disabling and are associated with negative psychosocial effects. In fact, more than half of all cancer patients experience treatment interruption because of such events.

The findings also underscore the importance of a close partnerships between dermatologists and oncologists as nearly 90% of the surveyed patients were referred to the clinic by their oncologist, the authors wrote. However, the uncertainty that survey respondents experienced with respect to the effects of program participation on treatment adherence highlights a need for further study.

“Our results highlight that supportive oncodermatology interventions improve the psychosocial wellness of patients but require further research on evidence-based preventive and active management strategies,” they wrote.

Additionally, more work is needed to “optimize treatment of secondary toxicities and allow for the continuation of life-prolonging anticancer therapy,” they noted, adding that “prospective, multicenter studies on the management of [dermatologic adverse events] are critical to better understand the effectiveness of these clinics.”

This study was funded by a La Roche–Posay grant. Ms. Aizman reported having no disclosures. One coauthor reported relationships involving consulting and/or honoraria with several companies, including La Roche–Posay.

sworcester@mdedge.com

SOURCE: Aizman L et al. J Drugs Dermatol. 2020 Apr 17. doi: 10.36849/JDD.2020.5040.

Enrollment in a supportive oncodermatology program was associated with improved quality of life in patients who experienced dermatologic effects from cancer therapy, according to a cross-sectional survey of participants.

The average quality of life score prior to program participation in 34 adult patients enrolled in the George Washington University Supportive Oncodermatology Clinic who responded to the survey was 6.5, indicating a moderate effect of their dermatologic symptoms on quality of life. After the beginning of treatment, the average score declined significantly to 3.8, indicating a small effect of the symptoms on quality of life, Leora Aizman, a medical student at George Washington University, Washington, and colleagues reported in the Journal of Drugs in Dermatology.

“On average, [quality of life] total scores were significantly reduced by 2.7 points after joining the supportive oncodermatology clinic,” the authors wrote.

Decreases were seen across all quality of life categories, including physical symptoms, embarrassment, clothes, social/leisure, work/school, and close relationships; the only score that didn’t decrease significantly was for physical symptoms of itch, pain, or soreness (1.43 vs. 1.1 before and after therapy), whereas the category that showed the greatest difference was embarrassment about the dermatologic condition (1.57 vs. 0.83 before and after therapy).

As for satisfaction with the program, the average participant satisfaction score was 4.15, indicating satisfaction with the program. The lowest – an average of 3.67, indicating neutral to satisfied – was related to the effects of the program on treatment adherence.

Survey respondents were adults aged over 18 years who received dermatologic care between the opening of the clinic in May 2017 and Nov. 1, 2019. The online survey included questions adapted from the Dermatology Life Quality Index and Patient Satisfaction Questionnaire.

The findings, though limited by the potential for recall bias and other factors inherent in a survey-based study, suggest that participation in a comprehensive, supportive program could be of benefit for cancer patients experiencing dermatologic conditions from cancer treatment, the authors wrote, explaining that such conditions can be disabling and are associated with negative psychosocial effects. In fact, more than half of all cancer patients experience treatment interruption because of such events.

The findings also underscore the importance of a close partnerships between dermatologists and oncologists as nearly 90% of the surveyed patients were referred to the clinic by their oncologist, the authors wrote. However, the uncertainty that survey respondents experienced with respect to the effects of program participation on treatment adherence highlights a need for further study.

“Our results highlight that supportive oncodermatology interventions improve the psychosocial wellness of patients but require further research on evidence-based preventive and active management strategies,” they wrote.

Additionally, more work is needed to “optimize treatment of secondary toxicities and allow for the continuation of life-prolonging anticancer therapy,” they noted, adding that “prospective, multicenter studies on the management of [dermatologic adverse events] are critical to better understand the effectiveness of these clinics.”

This study was funded by a La Roche–Posay grant. Ms. Aizman reported having no disclosures. One coauthor reported relationships involving consulting and/or honoraria with several companies, including La Roche–Posay.

sworcester@mdedge.com

SOURCE: Aizman L et al. J Drugs Dermatol. 2020 Apr 17. doi: 10.36849/JDD.2020.5040.

Enrollment in a supportive oncodermatology program was associated with improved quality of life in patients who experienced dermatologic effects from cancer therapy, according to a cross-sectional survey of participants.

The average quality of life score prior to program participation in 34 adult patients enrolled in the George Washington University Supportive Oncodermatology Clinic who responded to the survey was 6.5, indicating a moderate effect of their dermatologic symptoms on quality of life. After the beginning of treatment, the average score declined significantly to 3.8, indicating a small effect of the symptoms on quality of life, Leora Aizman, a medical student at George Washington University, Washington, and colleagues reported in the Journal of Drugs in Dermatology.

“On average, [quality of life] total scores were significantly reduced by 2.7 points after joining the supportive oncodermatology clinic,” the authors wrote.

Decreases were seen across all quality of life categories, including physical symptoms, embarrassment, clothes, social/leisure, work/school, and close relationships; the only score that didn’t decrease significantly was for physical symptoms of itch, pain, or soreness (1.43 vs. 1.1 before and after therapy), whereas the category that showed the greatest difference was embarrassment about the dermatologic condition (1.57 vs. 0.83 before and after therapy).

As for satisfaction with the program, the average participant satisfaction score was 4.15, indicating satisfaction with the program. The lowest – an average of 3.67, indicating neutral to satisfied – was related to the effects of the program on treatment adherence.

Survey respondents were adults aged over 18 years who received dermatologic care between the opening of the clinic in May 2017 and Nov. 1, 2019. The online survey included questions adapted from the Dermatology Life Quality Index and Patient Satisfaction Questionnaire.

The findings, though limited by the potential for recall bias and other factors inherent in a survey-based study, suggest that participation in a comprehensive, supportive program could be of benefit for cancer patients experiencing dermatologic conditions from cancer treatment, the authors wrote, explaining that such conditions can be disabling and are associated with negative psychosocial effects. In fact, more than half of all cancer patients experience treatment interruption because of such events.

The findings also underscore the importance of a close partnerships between dermatologists and oncologists as nearly 90% of the surveyed patients were referred to the clinic by their oncologist, the authors wrote. However, the uncertainty that survey respondents experienced with respect to the effects of program participation on treatment adherence highlights a need for further study.

“Our results highlight that supportive oncodermatology interventions improve the psychosocial wellness of patients but require further research on evidence-based preventive and active management strategies,” they wrote.

Additionally, more work is needed to “optimize treatment of secondary toxicities and allow for the continuation of life-prolonging anticancer therapy,” they noted, adding that “prospective, multicenter studies on the management of [dermatologic adverse events] are critical to better understand the effectiveness of these clinics.”

This study was funded by a La Roche–Posay grant. Ms. Aizman reported having no disclosures. One coauthor reported relationships involving consulting and/or honoraria with several companies, including La Roche–Posay.

sworcester@mdedge.com

SOURCE: Aizman L et al. J Drugs Dermatol. 2020 Apr 17. doi: 10.36849/JDD.2020.5040.

Read Now

Acute migraine onset results in 1.2 million emergency room visits and costs Americans $36 billion in health care expenditures annually, with the additional financial toll of 157 million lost workdays and unknown damage incurred by associated psychologic comorbidities.

In this supplement, Robert Cowan, MD discusses the latest understanding of acute migraine etiology, as well as updates in diagnostics, clinical trial design, and treatment options.

Read Now

Read Now

Acute migraine onset results in 1.2 million emergency room visits and costs Americans $36 billion in health care expenditures annually, with the additional financial toll of 157 million lost workdays and unknown damage incurred by associated psychologic comorbidities.

In this supplement, Robert Cowan, MD discusses the latest understanding of acute migraine etiology, as well as updates in diagnostics, clinical trial design, and treatment options.

Read Now

Read Now

Acute migraine onset results in 1.2 million emergency room visits and costs Americans $36 billion in health care expenditures annually, with the additional financial toll of 157 million lost workdays and unknown damage incurred by associated psychologic comorbidities.

In this supplement, Robert Cowan, MD discusses the latest understanding of acute migraine etiology, as well as updates in diagnostics, clinical trial design, and treatment options.

Read Now

Vaginal cleansing before cesarean delivery was successfully implemented – and significantly decreased the rate of surgical site infections (SSI) – in a quality improvement study done at Thomas Jefferson University Hospital in Philadelphia.

“Our goal was not to prove that vaginal preparation [before cesarean section] works, because that’s already been shown in large randomized, controlled trials, but to show that we can implement it and that we can see the same results in real life,” lead investigator Johanna Quist-Nelson, MD, said in an interview.

Dr. Quist-Nelson, a third-year fellow at the hospital and the department of obstetrics and gynecology at Sidney Kimmel Medical College, Philadelphia, was scheduled to present the findings at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

Resident and staff physicians as well as nursing and operating room staff were educated/reminded through a multipronged intervention about the benefits of vaginal cleansing with a sponge stick preparation of 10% povidone-iodine solution (Betadine) – and later about the potential benefits of intravenous azithromycin – immediately before cesarean delivery for women in labor and women with ruptured membranes.

Dr. Quist-Nelson and coinvestigators compared three periods of time: 12 months preintervention, 14 months with vaginal cleansing promoted for infection prophylaxis, and 16 months of instructions for both vaginal cleansing and intravenous azithromycin. The three periods captured 1,033 patients. The researchers used control charts – a tool “often used in implementation science,” she said – to analyze monthly data and assess trends for SSI rates and for compliance.

The rate of SSI – as defined by the Centers for Disease Control and Prevention – decreased by 33%, they found, from 23% to 15%. The drop occurred mainly 4 months into the vaginal cleansing portion of the study and was sustained during the following 26 months. The addition of intravenous azithromycin education did not result in any further change in the SSI rate, Dr. Quist-Nelson and associates reported in the study – the abstract for which was published in Obstetrics & Gynecology. It won a third-place prize among the papers on current clinical and basic investigation.

Compliance with the vaginal cleansing protocol increased from 60% at the start of the vaginal cleansing phase to 85% 1 year later. Azithromycin compliance rose to 75% over the third phase of the intervention.

Vaginal cleansing has received attention at Thomas Jefferson for several years. In 2017, researchers there collaborated with investigators in Italy on a systemic review and meta-analysis which concluded that women who received vaginal cleansing before cesarean delivery – most commonly with 10% povidine-iodine – had a significantly lower incidence of endometritis (Obstet Gynecol. 2017 Sep;130[3]:527-38).

A subgroup analysis showed that the benefit of vaginal cleansing was limited to “those women who have a cesarean section after their water breaks or when they’re in labor,” Dr. Quist-Nelson said.

Azithromycin similarly was found to reduce the risk of postoperative infection in women undergoing nonelective cesarean deliveries in a randomized trial published in 2016 (N Engl J Med. 2016 Sep 29;375[13]:1231-41). While the new quality improvement study did not suggest any additional benefit to intravenous azithromycin, “we continue to offer it [at our hospital] because it has been shown [in prior research] to be beneficial and because our study wasn’t [designed] to show benefit,” Dr. Quist-Nelson said.

The quality improvement intervention included hands-on training on vaginal cleansing for resident physicians and e-mail reminders for physician staff, and daily reviews for 1 week on intravenous azithromycin for resident physicians and EMR “best practice advisory” reminders for physician staff. “We also wrote a protocol available online, and put reminders in our OR notes, as well as trained the nursing staff and OR staff,” she said.

Catherine Cansino, MD, MPH, of the University of California, Davis, said in an interview that SSI rates are “problematic [in obstetrics], not only because of morbidity but also potential cost because of rehospitalization.” The study shows that vaginal cleansing “is absolutely a good target for quality improvement,” she said. “It’s promising, and very exciting to see something like this have such a dramatic positive result.” Dr. Cansino, who is a member of the Ob.Gyn News editorial advisory board, was not involved in this study.

Thomas Jefferson Hospital has had relatively high SSI rates, Dr. Quist-Nelson noted.

Dr. Quist-Nelson and coinvestigators did not report any potential conflicts of interest. Dr. Cansino also did not report any potential conflicts of interest.
 

SOURCE: Quist-Nelson J et al. Obstet. Gynecol. 2020 May;135:1S. doi: 10.1097/01.AOG.0000662876.23603.13.

Vaginal cleansing before cesarean delivery was successfully implemented – and significantly decreased the rate of surgical site infections (SSI) – in a quality improvement study done at Thomas Jefferson University Hospital in Philadelphia.

“Our goal was not to prove that vaginal preparation [before cesarean section] works, because that’s already been shown in large randomized, controlled trials, but to show that we can implement it and that we can see the same results in real life,” lead investigator Johanna Quist-Nelson, MD, said in an interview.

Dr. Quist-Nelson, a third-year fellow at the hospital and the department of obstetrics and gynecology at Sidney Kimmel Medical College, Philadelphia, was scheduled to present the findings at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

Resident and staff physicians as well as nursing and operating room staff were educated/reminded through a multipronged intervention about the benefits of vaginal cleansing with a sponge stick preparation of 10% povidone-iodine solution (Betadine) – and later about the potential benefits of intravenous azithromycin – immediately before cesarean delivery for women in labor and women with ruptured membranes.

Dr. Quist-Nelson and coinvestigators compared three periods of time: 12 months preintervention, 14 months with vaginal cleansing promoted for infection prophylaxis, and 16 months of instructions for both vaginal cleansing and intravenous azithromycin. The three periods captured 1,033 patients. The researchers used control charts – a tool “often used in implementation science,” she said – to analyze monthly data and assess trends for SSI rates and for compliance.

The rate of SSI – as defined by the Centers for Disease Control and Prevention – decreased by 33%, they found, from 23% to 15%. The drop occurred mainly 4 months into the vaginal cleansing portion of the study and was sustained during the following 26 months. The addition of intravenous azithromycin education did not result in any further change in the SSI rate, Dr. Quist-Nelson and associates reported in the study – the abstract for which was published in Obstetrics & Gynecology. It won a third-place prize among the papers on current clinical and basic investigation.

Compliance with the vaginal cleansing protocol increased from 60% at the start of the vaginal cleansing phase to 85% 1 year later. Azithromycin compliance rose to 75% over the third phase of the intervention.

Vaginal cleansing has received attention at Thomas Jefferson for several years. In 2017, researchers there collaborated with investigators in Italy on a systemic review and meta-analysis which concluded that women who received vaginal cleansing before cesarean delivery – most commonly with 10% povidine-iodine – had a significantly lower incidence of endometritis (Obstet Gynecol. 2017 Sep;130[3]:527-38).

A subgroup analysis showed that the benefit of vaginal cleansing was limited to “those women who have a cesarean section after their water breaks or when they’re in labor,” Dr. Quist-Nelson said.

Azithromycin similarly was found to reduce the risk of postoperative infection in women undergoing nonelective cesarean deliveries in a randomized trial published in 2016 (N Engl J Med. 2016 Sep 29;375[13]:1231-41). While the new quality improvement study did not suggest any additional benefit to intravenous azithromycin, “we continue to offer it [at our hospital] because it has been shown [in prior research] to be beneficial and because our study wasn’t [designed] to show benefit,” Dr. Quist-Nelson said.

The quality improvement intervention included hands-on training on vaginal cleansing for resident physicians and e-mail reminders for physician staff, and daily reviews for 1 week on intravenous azithromycin for resident physicians and EMR “best practice advisory” reminders for physician staff. “We also wrote a protocol available online, and put reminders in our OR notes, as well as trained the nursing staff and OR staff,” she said.

Catherine Cansino, MD, MPH, of the University of California, Davis, said in an interview that SSI rates are “problematic [in obstetrics], not only because of morbidity but also potential cost because of rehospitalization.” The study shows that vaginal cleansing “is absolutely a good target for quality improvement,” she said. “It’s promising, and very exciting to see something like this have such a dramatic positive result.” Dr. Cansino, who is a member of the Ob.Gyn News editorial advisory board, was not involved in this study.

Thomas Jefferson Hospital has had relatively high SSI rates, Dr. Quist-Nelson noted.

Dr. Quist-Nelson and coinvestigators did not report any potential conflicts of interest. Dr. Cansino also did not report any potential conflicts of interest.
 

SOURCE: Quist-Nelson J et al. Obstet. Gynecol. 2020 May;135:1S. doi: 10.1097/01.AOG.0000662876.23603.13.

Vaginal cleansing before cesarean delivery was successfully implemented – and significantly decreased the rate of surgical site infections (SSI) – in a quality improvement study done at Thomas Jefferson University Hospital in Philadelphia.

“Our goal was not to prove that vaginal preparation [before cesarean section] works, because that’s already been shown in large randomized, controlled trials, but to show that we can implement it and that we can see the same results in real life,” lead investigator Johanna Quist-Nelson, MD, said in an interview.

Dr. Quist-Nelson, a third-year fellow at the hospital and the department of obstetrics and gynecology at Sidney Kimmel Medical College, Philadelphia, was scheduled to present the findings at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

Resident and staff physicians as well as nursing and operating room staff were educated/reminded through a multipronged intervention about the benefits of vaginal cleansing with a sponge stick preparation of 10% povidone-iodine solution (Betadine) – and later about the potential benefits of intravenous azithromycin – immediately before cesarean delivery for women in labor and women with ruptured membranes.

Dr. Quist-Nelson and coinvestigators compared three periods of time: 12 months preintervention, 14 months with vaginal cleansing promoted for infection prophylaxis, and 16 months of instructions for both vaginal cleansing and intravenous azithromycin. The three periods captured 1,033 patients. The researchers used control charts – a tool “often used in implementation science,” she said – to analyze monthly data and assess trends for SSI rates and for compliance.

The rate of SSI – as defined by the Centers for Disease Control and Prevention – decreased by 33%, they found, from 23% to 15%. The drop occurred mainly 4 months into the vaginal cleansing portion of the study and was sustained during the following 26 months. The addition of intravenous azithromycin education did not result in any further change in the SSI rate, Dr. Quist-Nelson and associates reported in the study – the abstract for which was published in Obstetrics & Gynecology. It won a third-place prize among the papers on current clinical and basic investigation.

Compliance with the vaginal cleansing protocol increased from 60% at the start of the vaginal cleansing phase to 85% 1 year later. Azithromycin compliance rose to 75% over the third phase of the intervention.

Vaginal cleansing has received attention at Thomas Jefferson for several years. In 2017, researchers there collaborated with investigators in Italy on a systemic review and meta-analysis which concluded that women who received vaginal cleansing before cesarean delivery – most commonly with 10% povidine-iodine – had a significantly lower incidence of endometritis (Obstet Gynecol. 2017 Sep;130[3]:527-38).

A subgroup analysis showed that the benefit of vaginal cleansing was limited to “those women who have a cesarean section after their water breaks or when they’re in labor,” Dr. Quist-Nelson said.

Azithromycin similarly was found to reduce the risk of postoperative infection in women undergoing nonelective cesarean deliveries in a randomized trial published in 2016 (N Engl J Med. 2016 Sep 29;375[13]:1231-41). While the new quality improvement study did not suggest any additional benefit to intravenous azithromycin, “we continue to offer it [at our hospital] because it has been shown [in prior research] to be beneficial and because our study wasn’t [designed] to show benefit,” Dr. Quist-Nelson said.

The quality improvement intervention included hands-on training on vaginal cleansing for resident physicians and e-mail reminders for physician staff, and daily reviews for 1 week on intravenous azithromycin for resident physicians and EMR “best practice advisory” reminders for physician staff. “We also wrote a protocol available online, and put reminders in our OR notes, as well as trained the nursing staff and OR staff,” she said.

Catherine Cansino, MD, MPH, of the University of California, Davis, said in an interview that SSI rates are “problematic [in obstetrics], not only because of morbidity but also potential cost because of rehospitalization.” The study shows that vaginal cleansing “is absolutely a good target for quality improvement,” she said. “It’s promising, and very exciting to see something like this have such a dramatic positive result.” Dr. Cansino, who is a member of the Ob.Gyn News editorial advisory board, was not involved in this study.

Thomas Jefferson Hospital has had relatively high SSI rates, Dr. Quist-Nelson noted.

Dr. Quist-Nelson and coinvestigators did not report any potential conflicts of interest. Dr. Cansino also did not report any potential conflicts of interest.
 

SOURCE: Quist-Nelson J et al. Obstet. Gynecol. 2020 May;135:1S. doi: 10.1097/01.AOG.0000662876.23603.13.

To the Editor:

Lymphomatoid papulosis is a rare chronic skin disorder characterized by recurrent, self-healing crops of papulonodular eruptions, often resembling cutaneous T-cell lymphoma.¹ Oral bexarotene, a retinoid X receptor–selective retinoid, can be used to control the disease.^2,3 Lichen planopilaris (LPP) is a type of cicatricial alopecia characterized by irreversible hair loss, perifollicular inflammation, and follicular hyperkeratosis, commonly affecting the scalp vertex in adults.⁴ We report a case of a patient with lymphomatoid papulosis who was treated with bexarotene and subsequently developed LPP. We also discuss a proposed mechanism by which bexarotene may have influenced the onset of LPP.

A 35-year-old woman who was previously healthy initially presented with recurrent pruritic papular eruptions on the flank, axillae, and groin of several months’ duration. The lesions appeared as 2-mm, flat-topped, violaceous papules. The patient had no known drug allergies, no medical or family history of skin disease, and was only taking 3000 mg/d of omega-3 fatty acids (fish oil). Histopathologic examination of a biopsy specimen from the inner thigh showed enlarged, atypical, dermal lymphocytes that were CD30⁺ (Figure 1). These findings were consistent with lymphomatoid papulosis. As she had undergone tubal ligation several years prior, she was prescribed oral bexarotene 300 mg once daily in addition to triamcinolone cream 0.1% twice daily, as needed. Symptoms were well controlled on this regimen.

Although the exact mechanism of LPP is not fully understood, studies have suggested that cellular lipid metabolism may be responsible for the inflammation of the pilosebaceous unit.^4-11 Hyperlipidemia is the most common side effect of oral bexarotene, typically occurring within the first 2 to 4 weeks of treatment.^3,12 Considering the insights into the role of lipid regulation on LPP pathogenesis, it is reasonable to suspect that the dyslipidemia caused by bexarotene may have triggered the onset of LPP in our patient. The patient’s lipid values mostly remained within reference range throughout the course of treatment, though she did have elevation of triglycerides around the onset of LPP. Dyslipidemia has been reported in patients with lichen planus but not in patients with LPP. One case-control study showed no dyslipidemia in patients with LPP, but the triglyceride levels were not tracked over time and patients had varying durations since onset of disease at presentation.^9-11,13 In our case, we were fortunate to have this information, and it may suggest an interaction between lipid dysregulation and the development of LPP. It would be interesting to explore this further in a larger patient population and to evaluate if control of dyslipidemia reduces progression of disease as it appears to have done for our patient.

To the Editor:

Lymphomatoid papulosis is a rare chronic skin disorder characterized by recurrent, self-healing crops of papulonodular eruptions, often resembling cutaneous T-cell lymphoma.¹ Oral bexarotene, a retinoid X receptor–selective retinoid, can be used to control the disease.^2,3 Lichen planopilaris (LPP) is a type of cicatricial alopecia characterized by irreversible hair loss, perifollicular inflammation, and follicular hyperkeratosis, commonly affecting the scalp vertex in adults.⁴ We report a case of a patient with lymphomatoid papulosis who was treated with bexarotene and subsequently developed LPP. We also discuss a proposed mechanism by which bexarotene may have influenced the onset of LPP.

A 35-year-old woman who was previously healthy initially presented with recurrent pruritic papular eruptions on the flank, axillae, and groin of several months’ duration. The lesions appeared as 2-mm, flat-topped, violaceous papules. The patient had no known drug allergies, no medical or family history of skin disease, and was only taking 3000 mg/d of omega-3 fatty acids (fish oil). Histopathologic examination of a biopsy specimen from the inner thigh showed enlarged, atypical, dermal lymphocytes that were CD30⁺ (Figure 1). These findings were consistent with lymphomatoid papulosis. As she had undergone tubal ligation several years prior, she was prescribed oral bexarotene 300 mg once daily in addition to triamcinolone cream 0.1% twice daily, as needed. Symptoms were well controlled on this regimen.

Although the exact mechanism of LPP is not fully understood, studies have suggested that cellular lipid metabolism may be responsible for the inflammation of the pilosebaceous unit.^4-11 Hyperlipidemia is the most common side effect of oral bexarotene, typically occurring within the first 2 to 4 weeks of treatment.^3,12 Considering the insights into the role of lipid regulation on LPP pathogenesis, it is reasonable to suspect that the dyslipidemia caused by bexarotene may have triggered the onset of LPP in our patient. The patient’s lipid values mostly remained within reference range throughout the course of treatment, though she did have elevation of triglycerides around the onset of LPP. Dyslipidemia has been reported in patients with lichen planus but not in patients with LPP. One case-control study showed no dyslipidemia in patients with LPP, but the triglyceride levels were not tracked over time and patients had varying durations since onset of disease at presentation.^9-11,13 In our case, we were fortunate to have this information, and it may suggest an interaction between lipid dysregulation and the development of LPP. It would be interesting to explore this further in a larger patient population and to evaluate if control of dyslipidemia reduces progression of disease as it appears to have done for our patient.

To the Editor:

Lymphomatoid papulosis is a rare chronic skin disorder characterized by recurrent, self-healing crops of papulonodular eruptions, often resembling cutaneous T-cell lymphoma.¹ Oral bexarotene, a retinoid X receptor–selective retinoid, can be used to control the disease.^2,3 Lichen planopilaris (LPP) is a type of cicatricial alopecia characterized by irreversible hair loss, perifollicular inflammation, and follicular hyperkeratosis, commonly affecting the scalp vertex in adults.⁴ We report a case of a patient with lymphomatoid papulosis who was treated with bexarotene and subsequently developed LPP. We also discuss a proposed mechanism by which bexarotene may have influenced the onset of LPP.

A 35-year-old woman who was previously healthy initially presented with recurrent pruritic papular eruptions on the flank, axillae, and groin of several months’ duration. The lesions appeared as 2-mm, flat-topped, violaceous papules. The patient had no known drug allergies, no medical or family history of skin disease, and was only taking 3000 mg/d of omega-3 fatty acids (fish oil). Histopathologic examination of a biopsy specimen from the inner thigh showed enlarged, atypical, dermal lymphocytes that were CD30⁺ (Figure 1). These findings were consistent with lymphomatoid papulosis. As she had undergone tubal ligation several years prior, she was prescribed oral bexarotene 300 mg once daily in addition to triamcinolone cream 0.1% twice daily, as needed. Symptoms were well controlled on this regimen.

Although the exact mechanism of LPP is not fully understood, studies have suggested that cellular lipid metabolism may be responsible for the inflammation of the pilosebaceous unit.^4-11 Hyperlipidemia is the most common side effect of oral bexarotene, typically occurring within the first 2 to 4 weeks of treatment.^3,12 Considering the insights into the role of lipid regulation on LPP pathogenesis, it is reasonable to suspect that the dyslipidemia caused by bexarotene may have triggered the onset of LPP in our patient. The patient’s lipid values mostly remained within reference range throughout the course of treatment, though she did have elevation of triglycerides around the onset of LPP. Dyslipidemia has been reported in patients with lichen planus but not in patients with LPP. One case-control study showed no dyslipidemia in patients with LPP, but the triglyceride levels were not tracked over time and patients had varying durations since onset of disease at presentation.^9-11,13 In our case, we were fortunate to have this information, and it may suggest an interaction between lipid dysregulation and the development of LPP. It would be interesting to explore this further in a larger patient population and to evaluate if control of dyslipidemia reduces progression of disease as it appears to have done for our patient.

The nonmetropolitan, largely rural, areas of the United States have fewer ICU beds than do urban areas, but their populations may be at higher risk for COVID-19 complications, according to the Kaiser Family Foundation.

rfranki@mdedge.com

The nonmetropolitan, largely rural, areas of the United States have fewer ICU beds than do urban areas, but their populations may be at higher risk for COVID-19 complications, according to the Kaiser Family Foundation.

rfranki@mdedge.com

The nonmetropolitan, largely rural, areas of the United States have fewer ICU beds than do urban areas, but their populations may be at higher risk for COVID-19 complications, according to the Kaiser Family Foundation.

rfranki@mdedge.com

Although the 2010 Patient Protection and Affordable Care Act attempted to close the coverage gap for prescription drugs, a new study has found that yearly price increases for expensive treatments like rheumatoid arthritis biologics have kept out-of-pocket spending high for patients enrolled in Medicare Part D.

“As the coverage gap is now considered closed, our results suggest a need for out-of-pocket maximums in the catastrophic phase to limit older Americans’ yearly financial burden and allow them to better estimate their annual drug costs,” wrote coauthors Alexandra Erath and Stacie B. Dusetzina, PhD, of Vanderbilt University in Nashville, Tenn. The study was published in JAMA Network Open.

To determine if closing the Medicare Part D coverage gap lowered out-of-pocket costs as anticipated, the researchers embarked on a cross-sectional study of Medicare data from the first quarter of each calendar year from 2010 to 2019. They analyzed the costs of 17 RA biologic drug and strength combinations, calculating the median point-of-sale price per fill for each drug and adjusting for medical inflation.

From 2010 to 2019, the median price per fill increased for all 17 drugs studied. With the exception of the 100-mg/1-mL golimumab (Simponi) autoinjector, every drug that had been on the market for 5 years or longer had a price increase of more than 20%. For the six drugs that have been on the market since 2010 – 200 mg of certolizumab pegol (Cimzia), 25 mg of etanercept (Enbrel), 50 mg of etanercept, 20 mg/0.4 mL of adalimumab (Humira), 40 mg/0.8 mL of adalimumab, and 50 mg/0.5 mL of golimumab – the median list price increased by a mean of 160% (standard deviation [SD], 17%; range, 136%-180%).

Mean (SD) annual out-of-pocket spending for those six drugs did decrease from $6,108 (SD, $234; range, $5,647-6,282) in 2010 to $4,801 (SD, $620; range, $3,594-$5,196) in 2019. However, the most significant decrease actually occurred between 2010 and 2011, when out-of-pocket spending dropped to $4,026 because the Affordable Care Act’s 50% manufacturer rebate for brand-name drugs filled in the coverage gap. This meant there was actually a mean increase of 19% in out-of-pocket costs from 2011 to 2019.

“This is the same story as the EpiPen,” said Maria Greenwald, MD, of Desert Medical Advances in Palm Desert, Calif., in an interview. “Patients have to have it, so you’re going to pay $600 even if you used to pay $50. Why do pharmaceutical companies keep raising their prices? Because they can. There’s no cap on list prices. And these drugs are miracles. They’re the difference between a high quality of life and being bound to a wheelchair. These patients don’t sleep without them. They’ll do whatever they can to pay for them, and so the prices continue to go up.”

This study reinforces the need for physicians to advocate for affordable biologics across the board, wrote Joel Lexchin, MD, of York University in Toronto in an accompanying editorial (doi: 10.1001/jamanetworkopen.2020.4753).

“Price increases for biologics do not only affect patients with rheumatologic conditions,” Dr. Lexchin noted, citing how the cost of multiple sclerosis therapies increased by thousands of dollars from the mid-1990s to 2013. In addition, although biologics make up a single-digit percentage of prescriptions in the United States, he highlighted that “they are responsible for $120 billion or 37% of net drug spending and, since 2014, for 93% of the overall growth in total spending.”

When it comes to potential solutions, he said that Medicare should negotiate directly with drug companies, that substitutions with biosimilars should become mandatory whenever possible, and that pharmaceutical companies should publicly validate their alleged research and development expenses. “Biologics can be transformational treatments,” he wrote, “but only if they are affordable at both the individual and societal levels.”

The authors shared their study’s potential limitations, including relying on list prices that do not factor in rebates and focusing on a single biologic filled every month rather than all treatments filled under Medicare, which could “result in our underestimating out-of-pocket spending by patients.” In addition, although a growing RA biosimilar market could increase price competition and lower costs, they added that progress in that area is limited by “aggressive litigation by the biologic manufacturers and an insufficient number of competitors to markedly affect price.”

The study was supported by the Commonwealth Fund and the Leukemia and Lymphoma Society. Dr. Dusetzina reported receiving grants from Arnold Ventures and personal fees from the Institute for Clinical and Economic Review.

SOURCE: Erath A et al. JAMA Netw Open. 2020 Apr 27. doi: 10.1001/jamanetworkopen.2020.3969.

Although the 2010 Patient Protection and Affordable Care Act attempted to close the coverage gap for prescription drugs, a new study has found that yearly price increases for expensive treatments like rheumatoid arthritis biologics have kept out-of-pocket spending high for patients enrolled in Medicare Part D.

“As the coverage gap is now considered closed, our results suggest a need for out-of-pocket maximums in the catastrophic phase to limit older Americans’ yearly financial burden and allow them to better estimate their annual drug costs,” wrote coauthors Alexandra Erath and Stacie B. Dusetzina, PhD, of Vanderbilt University in Nashville, Tenn. The study was published in JAMA Network Open.

To determine if closing the Medicare Part D coverage gap lowered out-of-pocket costs as anticipated, the researchers embarked on a cross-sectional study of Medicare data from the first quarter of each calendar year from 2010 to 2019. They analyzed the costs of 17 RA biologic drug and strength combinations, calculating the median point-of-sale price per fill for each drug and adjusting for medical inflation.

From 2010 to 2019, the median price per fill increased for all 17 drugs studied. With the exception of the 100-mg/1-mL golimumab (Simponi) autoinjector, every drug that had been on the market for 5 years or longer had a price increase of more than 20%. For the six drugs that have been on the market since 2010 – 200 mg of certolizumab pegol (Cimzia), 25 mg of etanercept (Enbrel), 50 mg of etanercept, 20 mg/0.4 mL of adalimumab (Humira), 40 mg/0.8 mL of adalimumab, and 50 mg/0.5 mL of golimumab – the median list price increased by a mean of 160% (standard deviation [SD], 17%; range, 136%-180%).

Mean (SD) annual out-of-pocket spending for those six drugs did decrease from $6,108 (SD, $234; range, $5,647-6,282) in 2010 to $4,801 (SD, $620; range, $3,594-$5,196) in 2019. However, the most significant decrease actually occurred between 2010 and 2011, when out-of-pocket spending dropped to $4,026 because the Affordable Care Act’s 50% manufacturer rebate for brand-name drugs filled in the coverage gap. This meant there was actually a mean increase of 19% in out-of-pocket costs from 2011 to 2019.

“This is the same story as the EpiPen,” said Maria Greenwald, MD, of Desert Medical Advances in Palm Desert, Calif., in an interview. “Patients have to have it, so you’re going to pay $600 even if you used to pay $50. Why do pharmaceutical companies keep raising their prices? Because they can. There’s no cap on list prices. And these drugs are miracles. They’re the difference between a high quality of life and being bound to a wheelchair. These patients don’t sleep without them. They’ll do whatever they can to pay for them, and so the prices continue to go up.”

This study reinforces the need for physicians to advocate for affordable biologics across the board, wrote Joel Lexchin, MD, of York University in Toronto in an accompanying editorial (doi: 10.1001/jamanetworkopen.2020.4753).

“Price increases for biologics do not only affect patients with rheumatologic conditions,” Dr. Lexchin noted, citing how the cost of multiple sclerosis therapies increased by thousands of dollars from the mid-1990s to 2013. In addition, although biologics make up a single-digit percentage of prescriptions in the United States, he highlighted that “they are responsible for $120 billion or 37% of net drug spending and, since 2014, for 93% of the overall growth in total spending.”

When it comes to potential solutions, he said that Medicare should negotiate directly with drug companies, that substitutions with biosimilars should become mandatory whenever possible, and that pharmaceutical companies should publicly validate their alleged research and development expenses. “Biologics can be transformational treatments,” he wrote, “but only if they are affordable at both the individual and societal levels.”

The authors shared their study’s potential limitations, including relying on list prices that do not factor in rebates and focusing on a single biologic filled every month rather than all treatments filled under Medicare, which could “result in our underestimating out-of-pocket spending by patients.” In addition, although a growing RA biosimilar market could increase price competition and lower costs, they added that progress in that area is limited by “aggressive litigation by the biologic manufacturers and an insufficient number of competitors to markedly affect price.”

The study was supported by the Commonwealth Fund and the Leukemia and Lymphoma Society. Dr. Dusetzina reported receiving grants from Arnold Ventures and personal fees from the Institute for Clinical and Economic Review.

SOURCE: Erath A et al. JAMA Netw Open. 2020 Apr 27. doi: 10.1001/jamanetworkopen.2020.3969.

Although the 2010 Patient Protection and Affordable Care Act attempted to close the coverage gap for prescription drugs, a new study has found that yearly price increases for expensive treatments like rheumatoid arthritis biologics have kept out-of-pocket spending high for patients enrolled in Medicare Part D.

“As the coverage gap is now considered closed, our results suggest a need for out-of-pocket maximums in the catastrophic phase to limit older Americans’ yearly financial burden and allow them to better estimate their annual drug costs,” wrote coauthors Alexandra Erath and Stacie B. Dusetzina, PhD, of Vanderbilt University in Nashville, Tenn. The study was published in JAMA Network Open.

To determine if closing the Medicare Part D coverage gap lowered out-of-pocket costs as anticipated, the researchers embarked on a cross-sectional study of Medicare data from the first quarter of each calendar year from 2010 to 2019. They analyzed the costs of 17 RA biologic drug and strength combinations, calculating the median point-of-sale price per fill for each drug and adjusting for medical inflation.

From 2010 to 2019, the median price per fill increased for all 17 drugs studied. With the exception of the 100-mg/1-mL golimumab (Simponi) autoinjector, every drug that had been on the market for 5 years or longer had a price increase of more than 20%. For the six drugs that have been on the market since 2010 – 200 mg of certolizumab pegol (Cimzia), 25 mg of etanercept (Enbrel), 50 mg of etanercept, 20 mg/0.4 mL of adalimumab (Humira), 40 mg/0.8 mL of adalimumab, and 50 mg/0.5 mL of golimumab – the median list price increased by a mean of 160% (standard deviation [SD], 17%; range, 136%-180%).

Mean (SD) annual out-of-pocket spending for those six drugs did decrease from $6,108 (SD, $234; range, $5,647-6,282) in 2010 to $4,801 (SD, $620; range, $3,594-$5,196) in 2019. However, the most significant decrease actually occurred between 2010 and 2011, when out-of-pocket spending dropped to $4,026 because the Affordable Care Act’s 50% manufacturer rebate for brand-name drugs filled in the coverage gap. This meant there was actually a mean increase of 19% in out-of-pocket costs from 2011 to 2019.

“This is the same story as the EpiPen,” said Maria Greenwald, MD, of Desert Medical Advances in Palm Desert, Calif., in an interview. “Patients have to have it, so you’re going to pay $600 even if you used to pay $50. Why do pharmaceutical companies keep raising their prices? Because they can. There’s no cap on list prices. And these drugs are miracles. They’re the difference between a high quality of life and being bound to a wheelchair. These patients don’t sleep without them. They’ll do whatever they can to pay for them, and so the prices continue to go up.”

This study reinforces the need for physicians to advocate for affordable biologics across the board, wrote Joel Lexchin, MD, of York University in Toronto in an accompanying editorial (doi: 10.1001/jamanetworkopen.2020.4753).

“Price increases for biologics do not only affect patients with rheumatologic conditions,” Dr. Lexchin noted, citing how the cost of multiple sclerosis therapies increased by thousands of dollars from the mid-1990s to 2013. In addition, although biologics make up a single-digit percentage of prescriptions in the United States, he highlighted that “they are responsible for $120 billion or 37% of net drug spending and, since 2014, for 93% of the overall growth in total spending.”

When it comes to potential solutions, he said that Medicare should negotiate directly with drug companies, that substitutions with biosimilars should become mandatory whenever possible, and that pharmaceutical companies should publicly validate their alleged research and development expenses. “Biologics can be transformational treatments,” he wrote, “but only if they are affordable at both the individual and societal levels.”

The authors shared their study’s potential limitations, including relying on list prices that do not factor in rebates and focusing on a single biologic filled every month rather than all treatments filled under Medicare, which could “result in our underestimating out-of-pocket spending by patients.” In addition, although a growing RA biosimilar market could increase price competition and lower costs, they added that progress in that area is limited by “aggressive litigation by the biologic manufacturers and an insufficient number of competitors to markedly affect price.”

The study was supported by the Commonwealth Fund and the Leukemia and Lymphoma Society. Dr. Dusetzina reported receiving grants from Arnold Ventures and personal fees from the Institute for Clinical and Economic Review.

SOURCE: Erath A et al. JAMA Netw Open. 2020 Apr 27. doi: 10.1001/jamanetworkopen.2020.3969.

The hospitalist admitted a 56-year-old man with hypertension and hyperlipidemia to the general medical unit for community-­acquired pneumonia and started him on appropriate antimicrobial therapy. On the evening of admission, the nurse woke the patient to take his vital signs and noted a fever of 39.1°C (102.4°F). The patient had a pulse of 90 beats per minute, normal blood pressure, and a stable supplemental oxygen requirement via nasal cannula. The nurse noted an oral acetaminophen “as needed” order for fever. She woke the patient again to administer acetaminophen and notified the hospitalist.

Hospitalists frequently encounter febrile patients. According to one large hospital survey, fever occurs in 25% of pediatric and 31% of adult medical patients.¹ Fever in hospitalized patients most commonly results from infection, but autoimmune disease, malignancy, and an array of other inflammatory conditions cause fevers as well.¹

Defined as an elevated body temperature resulting from a raised hypothalamic set point², hospitalists often treat fever with acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs). These routinely administered medications act centrally to temporarily lower the hypothalamic set point and relieve fever.^2,3 Standard hospital admission order sets commonly include an as-needed antipyretic every 4 to 6 hours for treatment of fever, regardless of the presence of fever-related symptoms.

Fever is differentiated from hyperthermia, where temperature increases because of dysregulated peripheral processes despite a normal hypothalamic set point.² Examples of hyperthermia include heat stroke, malignant hyperthermia, and neuroleptic malignant syndrome. Notably, antipyretic medications have no effect on hyperthermia, but physical means, such as cooling blankets, can lead to temperature reduction.²

Hospitalists prescribe antipyretic medication to alleviate fever-­related symptoms, including headache, chills and sweats, and joint and muscle aches.³ While researchers have sparingly studied this practice, available evidence and experience suggest that fever-related symptoms decline in parallel with defervescence after administration of acetaminophen or NSAIDs in both adult and pediatric populations.^4,5 One randomized, controlled, double-blind study of nearly 400 adult outpatients in Germany with febrile upper respiratory tract infections showed that both aspirin and acetaminophen bested the placebo in reducing fever and associated headache, achiness, and discomfort over a span of 6 hours.⁴ In another study, this time with pediatric patients hospitalized with fever and uncomplicated respiratory tract infections, patients who received acetaminophen had statistically significant improvements in activity, alertness, mood, comfort, appetite, and fluid intake 6 hours after receiving that therapy.⁵

Physicians, nurses, and caregivers also commonly believe that fever is inherently noxious and that treatment of infection-­related fever contributes to fighting the infection itself.^2,3,6 The pediatric literature describes parents, caretakers, and clinicians who suffer from “fever phobia,” the worry that fevers contribute to long-term neurologic complications, recurrent febrile seizures, and death.^6,7

Finally, healthcare providers administer antipyretic medication to mitigate the demand fever places on the cardiovascular and pulmonary systems.³ An elevated temperature increases the body’s metabolic rate, oxygen consumption, and cardiac output that critically ill patients who have acute and/or chronic compromise to those systems may not tolerate. For example, patients requiring pressor support for hemodynamic shock or mechanical ventilation for respiratory failure may not tolerate an elevated temperature.⁸

Fever serves as an adaptive host response to infection, boosting innate and adaptive immunity in a multitude of ways.⁸ In animal models, fever slows the replication of pathogenic bacteria and enhances the activity of antibiotic agents.⁸ In vitro studies demonstrate that fever increases mobility of leukocytes, phagocytic activity, and proliferation of T cells.⁸ Retrospective case-control studies of patients hospitalized with severe bacterial illnesses, including gram-negative bacteremia, spontaneous bacterial peritonitis, and community-­acquired pneumonia, found that patients with a documented febrile response had increased survival compared with those who remained afebrile during the infection.⁹ In addition, a large retrospective cohort study of septic ICU patients found a progressive decline in mortality in association with increasing peak temperature on the day of ICU admission.¹⁰

In addition to the above studies supporting the important role of fever in fighting infection, recent evidence definitively demonstrates no mortality or morbidity benefit of using antipyretic medications in infected patients. A 2017 meta-analysis that included eight observational and eight randomized studies, totaling 18,939 adult septic ICU patients, demonstrated no difference in hospital and 28-day mortality in patients treated with antipyretics vs those who were not.¹¹ The authors again found no mortality benefit with antipyretic use when separately analyzing data from only the randomized controlled trials (1,507 patients) or when stratifying patients based on the type of antipyretic received (acetaminophen, NSAIDs, or physical cooling).¹¹ They reported no differences in predefined secondary outcomes of shock reversal or nosocomial infections. The authors commented that these robust results likely would not change even with more data from additional trials. In children, a recent meta-analysis of three randomized controlled trials (540 patients) did not find the use of acetaminophen, ibuprofen, or diclofenac effective in preventing febrile seizures.¹²Pediatric practice guidelines consistently recommend using antipyretic medication to alleviate discomfort caused by fever and not solely to reduce temperature.^13,14

Antipyretic agents interfere with the effectiveness of the body’s immune response, as demonstrated in a number of infectious diseases.^2,15-18 Two randomized controlled studies conducted in healthy adult volunteers challenged with rhinovirus reported increased viral shedding and decreased antibody response in those subjects who received aspirin or acetaminophen, compared with those given placebo.^15,16 In another randomized controlled trial conducted in African children with malaria, paracetamol use delayed parasite clearance by 16 hours.¹⁷ A large case-control study correlated the use of NSAIDs with an increased risk of severe skin and soft-tissue complications in children with varicella and in adults with varicella zoster. ¹⁸ The international scientific community has raised concerns about worse outcomes with NSAID use in patients with COVID-19, the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); NSAIDs should be avoided in stable patients with COVID-19 until more data are available. ¹⁹

Additional risks and potential harms accompany antipyretic fever therapy. First, NSAIDs or acetaminophen may adversely affect patients with renal or hepatic insufficiency.^2,3 Second, masking fevers may impair the clinician’s ability to diagnose or evaluate response to treatment. Third, unnecessarily waking a sleeping patient to check temperature or administer unneeded antipyretics can contribute to hospital-associated problems, including delirium, insomnia, and falls. Treating these iatrogenic problems in turn may require additional medications or interventions. These unintended consequences may potentially prolong hospital stays, increase medication errors and polypharmacy, and detract from a patient’s overall healing and recovery.

While the use of antipyretic medications improves fever-­related symptoms, it comes at the cost of blunting a protective host response and exposes patients to medication risks without providing a clinical benefit. In sleeping, asymptomatic, or minimally symptomatic hospitalized patients, the risks of administering antipyretic medications clearly outweigh the benefits.

Treatment with antipyretic medication can alleviate fever-­related symptoms in those patients who have significant headache, body aches, chills, or sweats and in pediatric patients with notable malaise, irritability, or poor oral intake. Debate continues on the use of antipyretics in the ICU setting when managing critically ill patients with severe cardiopulmonary compromise who may not tolerate the additional hemodynamic strain a fever produces (eg, patients with shock requiring vasopressor support or respiratory failure requiring mechanical ventilation). Remember, decrease body temperature in hyperthermia syndromes by physical means.

Withhold antipyretic medication (ie, allow permissive fever) in well-appearing general medical patients with asymptomatic infection-related fevers. In patients who tolerate fever with minimal or no symptoms, potential benefits of permissive fever include decreased time to infection resolution and/or decreased risk of hospital-acquired infections. This may result in shorter hospital stays and significant cost savings. If we do not treat patients with asymptomatic fevers, then it follows that we should not check overnight temperatures in hospitalized patients sleeping comfortably.

• Do not order as-needed antipyretic medication for stable patients on general medical units with infection solely to reduce temperature or achieve normothermia.
• Only treat infected febrile patients with antipyretic medications for fever-related symptoms (headache, chills, or body aches or, in pediatric patients, irritability, malaise, or poor oral intake).
• Treat pathologically elevated temperatures (ie, hyperthermia syndromes) with physical measures because antipyretic medications will be ineffective.

In the clinical scenario, the hospitalist admitted the patient in stable condition for treatment of a community-acquired pneumonia. He mounted a febrile response to infection, which suggests that his active immune system may aid in recovery. The nurse noted the fever while the patient slept comfortably without fever-related symptoms.

After discussing these facts with the patient’s concerned nurse, the clinician should discontinue the order for as-needed acetaminophen for fever and instead recommend permissive fever without administration of antipyretic medication. This may facilitate recovery, avoid unnecessary polypharmacy, and allow the medical care team to follow his fever curve to ensure that the infection is adequately treated. If the patient develops bothersome fever-related symptoms, the hospitalist can reasonably treat with a single-dose of acetaminophen or NSAID.

Do you think this is a low-value practice? Is this truly a “Thing We Do for No Reason^™”? Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking it on Facebook. We invite you to propose ideas for other “Things We Do for No Reason” topics by emailing TWDFNR@hospitalmedicine.org.

The hospitalist admitted a 56-year-old man with hypertension and hyperlipidemia to the general medical unit for community-­acquired pneumonia and started him on appropriate antimicrobial therapy. On the evening of admission, the nurse woke the patient to take his vital signs and noted a fever of 39.1°C (102.4°F). The patient had a pulse of 90 beats per minute, normal blood pressure, and a stable supplemental oxygen requirement via nasal cannula. The nurse noted an oral acetaminophen “as needed” order for fever. She woke the patient again to administer acetaminophen and notified the hospitalist.

Hospitalists frequently encounter febrile patients. According to one large hospital survey, fever occurs in 25% of pediatric and 31% of adult medical patients.¹ Fever in hospitalized patients most commonly results from infection, but autoimmune disease, malignancy, and an array of other inflammatory conditions cause fevers as well.¹

Defined as an elevated body temperature resulting from a raised hypothalamic set point², hospitalists often treat fever with acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs). These routinely administered medications act centrally to temporarily lower the hypothalamic set point and relieve fever.^2,3 Standard hospital admission order sets commonly include an as-needed antipyretic every 4 to 6 hours for treatment of fever, regardless of the presence of fever-related symptoms.

Fever is differentiated from hyperthermia, where temperature increases because of dysregulated peripheral processes despite a normal hypothalamic set point.² Examples of hyperthermia include heat stroke, malignant hyperthermia, and neuroleptic malignant syndrome. Notably, antipyretic medications have no effect on hyperthermia, but physical means, such as cooling blankets, can lead to temperature reduction.²

Hospitalists prescribe antipyretic medication to alleviate fever-­related symptoms, including headache, chills and sweats, and joint and muscle aches.³ While researchers have sparingly studied this practice, available evidence and experience suggest that fever-related symptoms decline in parallel with defervescence after administration of acetaminophen or NSAIDs in both adult and pediatric populations.^4,5 One randomized, controlled, double-blind study of nearly 400 adult outpatients in Germany with febrile upper respiratory tract infections showed that both aspirin and acetaminophen bested the placebo in reducing fever and associated headache, achiness, and discomfort over a span of 6 hours.⁴ In another study, this time with pediatric patients hospitalized with fever and uncomplicated respiratory tract infections, patients who received acetaminophen had statistically significant improvements in activity, alertness, mood, comfort, appetite, and fluid intake 6 hours after receiving that therapy.⁵

Physicians, nurses, and caregivers also commonly believe that fever is inherently noxious and that treatment of infection-­related fever contributes to fighting the infection itself.^2,3,6 The pediatric literature describes parents, caretakers, and clinicians who suffer from “fever phobia,” the worry that fevers contribute to long-term neurologic complications, recurrent febrile seizures, and death.^6,7

Finally, healthcare providers administer antipyretic medication to mitigate the demand fever places on the cardiovascular and pulmonary systems.³ An elevated temperature increases the body’s metabolic rate, oxygen consumption, and cardiac output that critically ill patients who have acute and/or chronic compromise to those systems may not tolerate. For example, patients requiring pressor support for hemodynamic shock or mechanical ventilation for respiratory failure may not tolerate an elevated temperature.⁸

Fever serves as an adaptive host response to infection, boosting innate and adaptive immunity in a multitude of ways.⁸ In animal models, fever slows the replication of pathogenic bacteria and enhances the activity of antibiotic agents.⁸ In vitro studies demonstrate that fever increases mobility of leukocytes, phagocytic activity, and proliferation of T cells.⁸ Retrospective case-control studies of patients hospitalized with severe bacterial illnesses, including gram-negative bacteremia, spontaneous bacterial peritonitis, and community-­acquired pneumonia, found that patients with a documented febrile response had increased survival compared with those who remained afebrile during the infection.⁹ In addition, a large retrospective cohort study of septic ICU patients found a progressive decline in mortality in association with increasing peak temperature on the day of ICU admission.¹⁰

In addition to the above studies supporting the important role of fever in fighting infection, recent evidence definitively demonstrates no mortality or morbidity benefit of using antipyretic medications in infected patients. A 2017 meta-analysis that included eight observational and eight randomized studies, totaling 18,939 adult septic ICU patients, demonstrated no difference in hospital and 28-day mortality in patients treated with antipyretics vs those who were not.¹¹ The authors again found no mortality benefit with antipyretic use when separately analyzing data from only the randomized controlled trials (1,507 patients) or when stratifying patients based on the type of antipyretic received (acetaminophen, NSAIDs, or physical cooling).¹¹ They reported no differences in predefined secondary outcomes of shock reversal or nosocomial infections. The authors commented that these robust results likely would not change even with more data from additional trials. In children, a recent meta-analysis of three randomized controlled trials (540 patients) did not find the use of acetaminophen, ibuprofen, or diclofenac effective in preventing febrile seizures.¹²Pediatric practice guidelines consistently recommend using antipyretic medication to alleviate discomfort caused by fever and not solely to reduce temperature.^13,14

Antipyretic agents interfere with the effectiveness of the body’s immune response, as demonstrated in a number of infectious diseases.^2,15-18 Two randomized controlled studies conducted in healthy adult volunteers challenged with rhinovirus reported increased viral shedding and decreased antibody response in those subjects who received aspirin or acetaminophen, compared with those given placebo.^15,16 In another randomized controlled trial conducted in African children with malaria, paracetamol use delayed parasite clearance by 16 hours.¹⁷ A large case-control study correlated the use of NSAIDs with an increased risk of severe skin and soft-tissue complications in children with varicella and in adults with varicella zoster. ¹⁸ The international scientific community has raised concerns about worse outcomes with NSAID use in patients with COVID-19, the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); NSAIDs should be avoided in stable patients with COVID-19 until more data are available. ¹⁹

Additional risks and potential harms accompany antipyretic fever therapy. First, NSAIDs or acetaminophen may adversely affect patients with renal or hepatic insufficiency.^2,3 Second, masking fevers may impair the clinician’s ability to diagnose or evaluate response to treatment. Third, unnecessarily waking a sleeping patient to check temperature or administer unneeded antipyretics can contribute to hospital-associated problems, including delirium, insomnia, and falls. Treating these iatrogenic problems in turn may require additional medications or interventions. These unintended consequences may potentially prolong hospital stays, increase medication errors and polypharmacy, and detract from a patient’s overall healing and recovery.

While the use of antipyretic medications improves fever-­related symptoms, it comes at the cost of blunting a protective host response and exposes patients to medication risks without providing a clinical benefit. In sleeping, asymptomatic, or minimally symptomatic hospitalized patients, the risks of administering antipyretic medications clearly outweigh the benefits.

Treatment with antipyretic medication can alleviate fever-­related symptoms in those patients who have significant headache, body aches, chills, or sweats and in pediatric patients with notable malaise, irritability, or poor oral intake. Debate continues on the use of antipyretics in the ICU setting when managing critically ill patients with severe cardiopulmonary compromise who may not tolerate the additional hemodynamic strain a fever produces (eg, patients with shock requiring vasopressor support or respiratory failure requiring mechanical ventilation). Remember, decrease body temperature in hyperthermia syndromes by physical means.

Withhold antipyretic medication (ie, allow permissive fever) in well-appearing general medical patients with asymptomatic infection-related fevers. In patients who tolerate fever with minimal or no symptoms, potential benefits of permissive fever include decreased time to infection resolution and/or decreased risk of hospital-acquired infections. This may result in shorter hospital stays and significant cost savings. If we do not treat patients with asymptomatic fevers, then it follows that we should not check overnight temperatures in hospitalized patients sleeping comfortably.

• Do not order as-needed antipyretic medication for stable patients on general medical units with infection solely to reduce temperature or achieve normothermia.
• Only treat infected febrile patients with antipyretic medications for fever-related symptoms (headache, chills, or body aches or, in pediatric patients, irritability, malaise, or poor oral intake).
• Treat pathologically elevated temperatures (ie, hyperthermia syndromes) with physical measures because antipyretic medications will be ineffective.

In the clinical scenario, the hospitalist admitted the patient in stable condition for treatment of a community-acquired pneumonia. He mounted a febrile response to infection, which suggests that his active immune system may aid in recovery. The nurse noted the fever while the patient slept comfortably without fever-related symptoms.

After discussing these facts with the patient’s concerned nurse, the clinician should discontinue the order for as-needed acetaminophen for fever and instead recommend permissive fever without administration of antipyretic medication. This may facilitate recovery, avoid unnecessary polypharmacy, and allow the medical care team to follow his fever curve to ensure that the infection is adequately treated. If the patient develops bothersome fever-related symptoms, the hospitalist can reasonably treat with a single-dose of acetaminophen or NSAID.

Do you think this is a low-value practice? Is this truly a “Thing We Do for No Reason^™”? Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking it on Facebook. We invite you to propose ideas for other “Things We Do for No Reason” topics by emailing TWDFNR@hospitalmedicine.org.

The hospitalist admitted a 56-year-old man with hypertension and hyperlipidemia to the general medical unit for community-­acquired pneumonia and started him on appropriate antimicrobial therapy. On the evening of admission, the nurse woke the patient to take his vital signs and noted a fever of 39.1°C (102.4°F). The patient had a pulse of 90 beats per minute, normal blood pressure, and a stable supplemental oxygen requirement via nasal cannula. The nurse noted an oral acetaminophen “as needed” order for fever. She woke the patient again to administer acetaminophen and notified the hospitalist.

Hospitalists frequently encounter febrile patients. According to one large hospital survey, fever occurs in 25% of pediatric and 31% of adult medical patients.¹ Fever in hospitalized patients most commonly results from infection, but autoimmune disease, malignancy, and an array of other inflammatory conditions cause fevers as well.¹

Defined as an elevated body temperature resulting from a raised hypothalamic set point², hospitalists often treat fever with acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs). These routinely administered medications act centrally to temporarily lower the hypothalamic set point and relieve fever.^2,3 Standard hospital admission order sets commonly include an as-needed antipyretic every 4 to 6 hours for treatment of fever, regardless of the presence of fever-related symptoms.

Fever is differentiated from hyperthermia, where temperature increases because of dysregulated peripheral processes despite a normal hypothalamic set point.² Examples of hyperthermia include heat stroke, malignant hyperthermia, and neuroleptic malignant syndrome. Notably, antipyretic medications have no effect on hyperthermia, but physical means, such as cooling blankets, can lead to temperature reduction.²

Hospitalists prescribe antipyretic medication to alleviate fever-­related symptoms, including headache, chills and sweats, and joint and muscle aches.³ While researchers have sparingly studied this practice, available evidence and experience suggest that fever-related symptoms decline in parallel with defervescence after administration of acetaminophen or NSAIDs in both adult and pediatric populations.^4,5 One randomized, controlled, double-blind study of nearly 400 adult outpatients in Germany with febrile upper respiratory tract infections showed that both aspirin and acetaminophen bested the placebo in reducing fever and associated headache, achiness, and discomfort over a span of 6 hours.⁴ In another study, this time with pediatric patients hospitalized with fever and uncomplicated respiratory tract infections, patients who received acetaminophen had statistically significant improvements in activity, alertness, mood, comfort, appetite, and fluid intake 6 hours after receiving that therapy.⁵

Physicians, nurses, and caregivers also commonly believe that fever is inherently noxious and that treatment of infection-­related fever contributes to fighting the infection itself.^2,3,6 The pediatric literature describes parents, caretakers, and clinicians who suffer from “fever phobia,” the worry that fevers contribute to long-term neurologic complications, recurrent febrile seizures, and death.^6,7

Finally, healthcare providers administer antipyretic medication to mitigate the demand fever places on the cardiovascular and pulmonary systems.³ An elevated temperature increases the body’s metabolic rate, oxygen consumption, and cardiac output that critically ill patients who have acute and/or chronic compromise to those systems may not tolerate. For example, patients requiring pressor support for hemodynamic shock or mechanical ventilation for respiratory failure may not tolerate an elevated temperature.⁸

Fever serves as an adaptive host response to infection, boosting innate and adaptive immunity in a multitude of ways.⁸ In animal models, fever slows the replication of pathogenic bacteria and enhances the activity of antibiotic agents.⁸ In vitro studies demonstrate that fever increases mobility of leukocytes, phagocytic activity, and proliferation of T cells.⁸ Retrospective case-control studies of patients hospitalized with severe bacterial illnesses, including gram-negative bacteremia, spontaneous bacterial peritonitis, and community-­acquired pneumonia, found that patients with a documented febrile response had increased survival compared with those who remained afebrile during the infection.⁹ In addition, a large retrospective cohort study of septic ICU patients found a progressive decline in mortality in association with increasing peak temperature on the day of ICU admission.¹⁰

In addition to the above studies supporting the important role of fever in fighting infection, recent evidence definitively demonstrates no mortality or morbidity benefit of using antipyretic medications in infected patients. A 2017 meta-analysis that included eight observational and eight randomized studies, totaling 18,939 adult septic ICU patients, demonstrated no difference in hospital and 28-day mortality in patients treated with antipyretics vs those who were not.¹¹ The authors again found no mortality benefit with antipyretic use when separately analyzing data from only the randomized controlled trials (1,507 patients) or when stratifying patients based on the type of antipyretic received (acetaminophen, NSAIDs, or physical cooling).¹¹ They reported no differences in predefined secondary outcomes of shock reversal or nosocomial infections. The authors commented that these robust results likely would not change even with more data from additional trials. In children, a recent meta-analysis of three randomized controlled trials (540 patients) did not find the use of acetaminophen, ibuprofen, or diclofenac effective in preventing febrile seizures.¹²Pediatric practice guidelines consistently recommend using antipyretic medication to alleviate discomfort caused by fever and not solely to reduce temperature.^13,14

Antipyretic agents interfere with the effectiveness of the body’s immune response, as demonstrated in a number of infectious diseases.^2,15-18 Two randomized controlled studies conducted in healthy adult volunteers challenged with rhinovirus reported increased viral shedding and decreased antibody response in those subjects who received aspirin or acetaminophen, compared with those given placebo.^15,16 In another randomized controlled trial conducted in African children with malaria, paracetamol use delayed parasite clearance by 16 hours.¹⁷ A large case-control study correlated the use of NSAIDs with an increased risk of severe skin and soft-tissue complications in children with varicella and in adults with varicella zoster. ¹⁸ The international scientific community has raised concerns about worse outcomes with NSAID use in patients with COVID-19, the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); NSAIDs should be avoided in stable patients with COVID-19 until more data are available. ¹⁹

Additional risks and potential harms accompany antipyretic fever therapy. First, NSAIDs or acetaminophen may adversely affect patients with renal or hepatic insufficiency.^2,3 Second, masking fevers may impair the clinician’s ability to diagnose or evaluate response to treatment. Third, unnecessarily waking a sleeping patient to check temperature or administer unneeded antipyretics can contribute to hospital-associated problems, including delirium, insomnia, and falls. Treating these iatrogenic problems in turn may require additional medications or interventions. These unintended consequences may potentially prolong hospital stays, increase medication errors and polypharmacy, and detract from a patient’s overall healing and recovery.

While the use of antipyretic medications improves fever-­related symptoms, it comes at the cost of blunting a protective host response and exposes patients to medication risks without providing a clinical benefit. In sleeping, asymptomatic, or minimally symptomatic hospitalized patients, the risks of administering antipyretic medications clearly outweigh the benefits.

Treatment with antipyretic medication can alleviate fever-­related symptoms in those patients who have significant headache, body aches, chills, or sweats and in pediatric patients with notable malaise, irritability, or poor oral intake. Debate continues on the use of antipyretics in the ICU setting when managing critically ill patients with severe cardiopulmonary compromise who may not tolerate the additional hemodynamic strain a fever produces (eg, patients with shock requiring vasopressor support or respiratory failure requiring mechanical ventilation). Remember, decrease body temperature in hyperthermia syndromes by physical means.

Withhold antipyretic medication (ie, allow permissive fever) in well-appearing general medical patients with asymptomatic infection-related fevers. In patients who tolerate fever with minimal or no symptoms, potential benefits of permissive fever include decreased time to infection resolution and/or decreased risk of hospital-acquired infections. This may result in shorter hospital stays and significant cost savings. If we do not treat patients with asymptomatic fevers, then it follows that we should not check overnight temperatures in hospitalized patients sleeping comfortably.

• Do not order as-needed antipyretic medication for stable patients on general medical units with infection solely to reduce temperature or achieve normothermia.
• Only treat infected febrile patients with antipyretic medications for fever-related symptoms (headache, chills, or body aches or, in pediatric patients, irritability, malaise, or poor oral intake).
• Treat pathologically elevated temperatures (ie, hyperthermia syndromes) with physical measures because antipyretic medications will be ineffective.

In the clinical scenario, the hospitalist admitted the patient in stable condition for treatment of a community-acquired pneumonia. He mounted a febrile response to infection, which suggests that his active immune system may aid in recovery. The nurse noted the fever while the patient slept comfortably without fever-related symptoms.

After discussing these facts with the patient’s concerned nurse, the clinician should discontinue the order for as-needed acetaminophen for fever and instead recommend permissive fever without administration of antipyretic medication. This may facilitate recovery, avoid unnecessary polypharmacy, and allow the medical care team to follow his fever curve to ensure that the infection is adequately treated. If the patient develops bothersome fever-related symptoms, the hospitalist can reasonably treat with a single-dose of acetaminophen or NSAID.

Do you think this is a low-value practice? Is this truly a “Thing We Do for No Reason^™”? Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking it on Facebook. We invite you to propose ideas for other “Things We Do for No Reason” topics by emailing TWDFNR@hospitalmedicine.org.