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Disordered eating behavior may put adolescents at greater risk for both depression and peer bullying, data from a longitudinal study of 612 teens show.

“Questions remain as to whether clinically significant disordered eating behavior is an antecedent or consequent of bullying by peers among adolescent girls and boys,” wrote Kirsty S. Lee, PhD, and Tracy Vaillancourt, PhD, of the University of Ottawa.

In a study published online April 11 in JAMA Psychiatry, the researchers reviewed data on adolescents aged 13-17 years who were enrolled in the McMaster Teen Study, a longitudinal study of Canadian teens examining bullying, academic achievement, and mental health. The average age of the study participants was 13 years; 54% were girls, and 71% were white.

At each annual follow-up during the 5-year study period, bullying was significantly concurrently associated with both disordered eating behavior (such as vomiting after eating) and depressive symptoms (P less than .01). In addition, disordered eating was significantly longitudinally associated with depression at every time point (P less than .02) and with peer bullying at two points (P less than .04) during the 5-year study (grades 8-9 and grades 10-11). However, no longitudinal association appeared between peer bullying and depression.

The participants completed a questionnaire each year between grades 7 and 11. The researchers assessed eating disordered behavior using the Short Screen for Eating Disorders; bullying was assessed by providing the teens with a standard definition of bullying to accompany questions about their experiences. Depression was assessed via the Behavior Assessment System for Children, second edition. A cascade model was used to show the relationships among the factors over time.

Lisa Quarfoth/Thinkstock

SOURCE: Lee KS and Vaillancourt T. JAMA Psychiatry 2018 Apr 11. doi: 10.1001/jamapsychiatry.2018.0284.

Disordered eating behavior may put adolescents at greater risk for both depression and peer bullying, data from a longitudinal study of 612 teens show.

“Questions remain as to whether clinically significant disordered eating behavior is an antecedent or consequent of bullying by peers among adolescent girls and boys,” wrote Kirsty S. Lee, PhD, and Tracy Vaillancourt, PhD, of the University of Ottawa.

In a study published online April 11 in JAMA Psychiatry, the researchers reviewed data on adolescents aged 13-17 years who were enrolled in the McMaster Teen Study, a longitudinal study of Canadian teens examining bullying, academic achievement, and mental health. The average age of the study participants was 13 years; 54% were girls, and 71% were white.

At each annual follow-up during the 5-year study period, bullying was significantly concurrently associated with both disordered eating behavior (such as vomiting after eating) and depressive symptoms (P less than .01). In addition, disordered eating was significantly longitudinally associated with depression at every time point (P less than .02) and with peer bullying at two points (P less than .04) during the 5-year study (grades 8-9 and grades 10-11). However, no longitudinal association appeared between peer bullying and depression.

The participants completed a questionnaire each year between grades 7 and 11. The researchers assessed eating disordered behavior using the Short Screen for Eating Disorders; bullying was assessed by providing the teens with a standard definition of bullying to accompany questions about their experiences. Depression was assessed via the Behavior Assessment System for Children, second edition. A cascade model was used to show the relationships among the factors over time.

Lisa Quarfoth/Thinkstock

SOURCE: Lee KS and Vaillancourt T. JAMA Psychiatry 2018 Apr 11. doi: 10.1001/jamapsychiatry.2018.0284.

Disordered eating behavior may put adolescents at greater risk for both depression and peer bullying, data from a longitudinal study of 612 teens show.

“Questions remain as to whether clinically significant disordered eating behavior is an antecedent or consequent of bullying by peers among adolescent girls and boys,” wrote Kirsty S. Lee, PhD, and Tracy Vaillancourt, PhD, of the University of Ottawa.

In a study published online April 11 in JAMA Psychiatry, the researchers reviewed data on adolescents aged 13-17 years who were enrolled in the McMaster Teen Study, a longitudinal study of Canadian teens examining bullying, academic achievement, and mental health. The average age of the study participants was 13 years; 54% were girls, and 71% were white.

At each annual follow-up during the 5-year study period, bullying was significantly concurrently associated with both disordered eating behavior (such as vomiting after eating) and depressive symptoms (P less than .01). In addition, disordered eating was significantly longitudinally associated with depression at every time point (P less than .02) and with peer bullying at two points (P less than .04) during the 5-year study (grades 8-9 and grades 10-11). However, no longitudinal association appeared between peer bullying and depression.

The participants completed a questionnaire each year between grades 7 and 11. The researchers assessed eating disordered behavior using the Short Screen for Eating Disorders; bullying was assessed by providing the teens with a standard definition of bullying to accompany questions about their experiences. Depression was assessed via the Behavior Assessment System for Children, second edition. A cascade model was used to show the relationships among the factors over time.

Lisa Quarfoth/Thinkstock

SOURCE: Lee KS and Vaillancourt T. JAMA Psychiatry 2018 Apr 11. doi: 10.1001/jamapsychiatry.2018.0284.

Experts have established a severity index for inflammatory bowel disease (IBD), according to results of an analysis published in the journal Gut (doi: 10.1136/gutjnl-2016-312648).

The index, conceived by a panel of IBD specialists from the International Organization for the Study of Inflammatory Bowel Diseases, is a step toward the standardization of disease severity definitions in ulcerative colitis and Crohn’s disease.

The panel determined 16 severity attributes for Crohn’s disease and 13 for ulcerative colitis. The analysis found that, in Crohn’s disease, mucosal lesions, fistulas, and abscesses were the greatest contributors to disease severity at 15.8%, 10.9%, and 9.7%, respectively. In ulcerative colitis, 18.1% of disease severity was attributed to mucosal lesions, 14% to impact on daily activities, and 11.2% to C-reactive protein, wrote Corey A. Siegel, MD, MS, of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his coauthors.

Investigators used a PubMed literature search to identify three broad elements of disease severity: impact of disease symptoms on daily activities, inflammatory burden, and disease course.

A panel of 16 experts then conducted a series of votes to determine which attributes within each domain would be used to assess disease severity. Two sets of attributes were defined as disease markers in Crohn’s disease and ulcerative colitis.

A type of conjoint analysis called adaptive choice-based conjoint was then performed to ascertain how different clinical factors influenced specialists’ decision making and impressions of disease severity.

A series of questions was asked, with each response determining subsequent questions, until “ample consistency” was found in their choices.

SOURCE: Siegel CA et al. Gut. 2018 Feb;67(2):244-54.

AGA patient education materials can help your IBD patients better understand and manage their disease. Learn more at www.gastro.org/IBD

Experts have established a severity index for inflammatory bowel disease (IBD), according to results of an analysis published in the journal Gut (doi: 10.1136/gutjnl-2016-312648).

The index, conceived by a panel of IBD specialists from the International Organization for the Study of Inflammatory Bowel Diseases, is a step toward the standardization of disease severity definitions in ulcerative colitis and Crohn’s disease.

The panel determined 16 severity attributes for Crohn’s disease and 13 for ulcerative colitis. The analysis found that, in Crohn’s disease, mucosal lesions, fistulas, and abscesses were the greatest contributors to disease severity at 15.8%, 10.9%, and 9.7%, respectively. In ulcerative colitis, 18.1% of disease severity was attributed to mucosal lesions, 14% to impact on daily activities, and 11.2% to C-reactive protein, wrote Corey A. Siegel, MD, MS, of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his coauthors.

Investigators used a PubMed literature search to identify three broad elements of disease severity: impact of disease symptoms on daily activities, inflammatory burden, and disease course.

A panel of 16 experts then conducted a series of votes to determine which attributes within each domain would be used to assess disease severity. Two sets of attributes were defined as disease markers in Crohn’s disease and ulcerative colitis.

A type of conjoint analysis called adaptive choice-based conjoint was then performed to ascertain how different clinical factors influenced specialists’ decision making and impressions of disease severity.

A series of questions was asked, with each response determining subsequent questions, until “ample consistency” was found in their choices.

SOURCE: Siegel CA et al. Gut. 2018 Feb;67(2):244-54.

AGA patient education materials can help your IBD patients better understand and manage their disease. Learn more at www.gastro.org/IBD

Experts have established a severity index for inflammatory bowel disease (IBD), according to results of an analysis published in the journal Gut (doi: 10.1136/gutjnl-2016-312648).

The index, conceived by a panel of IBD specialists from the International Organization for the Study of Inflammatory Bowel Diseases, is a step toward the standardization of disease severity definitions in ulcerative colitis and Crohn’s disease.

The panel determined 16 severity attributes for Crohn’s disease and 13 for ulcerative colitis. The analysis found that, in Crohn’s disease, mucosal lesions, fistulas, and abscesses were the greatest contributors to disease severity at 15.8%, 10.9%, and 9.7%, respectively. In ulcerative colitis, 18.1% of disease severity was attributed to mucosal lesions, 14% to impact on daily activities, and 11.2% to C-reactive protein, wrote Corey A. Siegel, MD, MS, of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his coauthors.

Investigators used a PubMed literature search to identify three broad elements of disease severity: impact of disease symptoms on daily activities, inflammatory burden, and disease course.

A panel of 16 experts then conducted a series of votes to determine which attributes within each domain would be used to assess disease severity. Two sets of attributes were defined as disease markers in Crohn’s disease and ulcerative colitis.

A type of conjoint analysis called adaptive choice-based conjoint was then performed to ascertain how different clinical factors influenced specialists’ decision making and impressions of disease severity.

A series of questions was asked, with each response determining subsequent questions, until “ample consistency” was found in their choices.

SOURCE: Siegel CA et al. Gut. 2018 Feb;67(2):244-54.

AGA patient education materials can help your IBD patients better understand and manage their disease. Learn more at www.gastro.org/IBD

Like most California institutions performing deliveries, St. Joseph Hospital in Orange, California, started releasing 2016 maternal quality metrics internally at first. Data for the first 9 months of 2016 were distributed in December 2016. These metrics depend on a denominator based on the number of deliveries attributed to each obstetrician.

• I was very pleased to see that I ranked first in the vaginal birth after cesarean (VBAC) rate at 36.8%.
• I also was pleased that I ranked the fourth lowest, at 15.9%, for my cesarean delivery rate in the low-risk, nulliparous term singleton vertex (NTSV) population.
• I was neither pleased nor displeased that I ranked number 29 of 31 physicians at 59.1% (39/66) for the episiotomy rate. The denominator range was 1 to 287. I knew I would hear about this! Sure enough, a medical director asked me how 2 of my metrics could be so good, yet the third be so abysmal.

After the release of the data and the somewhat humorous chastisement by the medical director, I decided to try complying with the new American College of Obstetricians and Gynecologists (ACOG) guidelines¹ again beginning in January 2017.

A little personal history

Allow me to date myself. I completed my residency in 1981 and was Board Certified in 1984. My wife refers to me as a “Dinosaur!” As an ObGyn in solo practice, I take my own call.

During my training, episiotomies were commonly performed but were not always necessary. We were taught to not perform an episiotomy if the patient could safely and easily deliver without one. However, if clinically indicated, an episiotomy should be performed. If a 3rd- or 4th-degree laceration occurred, we were taught to anatomically repair it. Nowadays in my practice, these lacerations are rare in conjunction with an episiotomy, and with a controlled delivery of the fetal head.

Our nursing staff will tell you that I resist change. However, I usually attempt and often do adapt the latest national guidelines into my practice. Although I did not agree when restrictive episiotomies became a national goal a few years ago, I tried to adhere to the new national episiotomy recommendations.¹ I am meticulous: a standard episiotomy repair that does not involve excessive bleeding usually takes 20 minutes to restore normal anatomy with a simple, straightforward, layered closure.

My episiotomy performance record

In 2015, I restricted my use of episiotomies. When I did not perform one, the patient usually experienced lacerations. These were labial or periurethral as well as complex 3-dimensional “Z” or “Y” shaped vaginal/perineal lacerations, not just the 1st- and 2nd-degree perineal lacerations to which the literature refers.

The problems associated with complex, geometric vaginal lacerations are multifactorial:

• Lacerations occur at multiple locations.
• Significant bleeding often occurs. Because the lacerations are in multiple locations, the bleeding cannot be addressed easily, quickly, or at once.
• Visualization is difficult because of the bleeding, thus further prolonging the repair.
• These lacerations are often deeper than an episiotomy would have been and are very friable as all the layers have been stretched to their breaking point before tearing.
• Sometimes the lacerations include avulsion of the hymen with extensive bleeding.
• Difficult-to-repair lacerations can tear upon suturing, requiring layer upon layer of sutures at the same site. Future scarring and vaginal stricture leading to sexual dysfunction are concerns.
• At times, the friability and bleeding is so brisk that once the bleeding is controlled and the episiotomy is partially repaired, I can see that it is has not been an anatomic repair. I then have to take it down and re-do the repair with an obscured field from bleeding again!
• Some repairs are so fragile that when I express retained blood from the uterus and upper vagina after completing the repair, the tissue tears, bleeds, and requires additional restoration.
• These tears usually require an hour to repair and achieve hemostasis. At times, an assistant and a retractor are necessary.

After 2015, when I spent the year complying with the new guidelines, I returned to my original protocol: I performed an episiotomy only when I thought the patient was going to experience a significant laceration. I did not perform an episiotomy if I thought the mother could deliver easily without one. That is how I attained the 59.1% episiotomy rate in 2016.

Another try

After the 2016 hospital data were released, I decided to comply with the new guidelines¹ again beginning in January 2017. Here I share the details of 3 deliveries that occurred in 2017:

1. A 30-year-old woman (G2P1) planned to have a repeat cesarean delivery. At 38 3/7 weeks’ gestation, she was admitted in active labor with the cervix dilated to 5 cm. She requested a VBAC. After successful vaginal delivery without episiotomy of a 7 lb 5 oz infant, there were bilateral periurethral and right labia minora abrasions/lacerations.
2. A 21-year-old woman (G1P0) at 40 4/7 weeks’ gestation was admitted in early labor. The cervix was 2-cm dilated and 70% effaced after spontaneous rupture of membranes. I exercised my clinical judgment and performed a midline episiotomy. A 9 lb 3 oz infant was delivered by vaginal delivery.
3. A 16-year-old woman (G1P0) at 41 weeks’ gestation was admitted for induction of labor with an unripe cervix. I was delayed, and the laborist performed a vaginal delivery after 1 attempt at vacuum extraction and no episiotomy. The 7 lb 3 oz baby had Apgar scores of 4 and 9 at 1 and 5 minutes, respectively. There was significant bleeding from bilateral vaginal lacerations with bilateral hymeneal avulsions.

What is the benefit?

Are we really benefitting our patients by restricting the use of episiotomy? Consider these questions:

• Should we delay the mother’s bonding with her baby for an hour’s complex repair versus 20 minutes for a simple, layered episiotomy repair?
• In a busy labor and delivery unit, should resources be tied up for this extra time? With all due respect to the national experts advocating this recommendation, are they in the trenches performing deliveries and spending hours repairing complex lacerations?
• Should we not use our clinical judgment instead of allowing the mother to experience an extensive vaginal/perineal laceration after a vaginal delivery of a 9- or 10-lb baby?
• Where are the long-term data showing that it is better for a woman to stretch and attenuate her perineal and vaginal muscles to the breaking point, and then tear?
• Do all the additional sutures lead to vaginal scarring, vaginal stricture, and sexual dysfunction in later years?
• Which protocol better enables the mother to maintain pelvic organ support and avoid pelvic organ prolapse and stress urinary incontinence?

In Williams Obstetrics, the authors state: “We are of the view that episiotomy should be applied selectively for the appropriate indications. The final rule is that there is no substitute for surgical judgment and common sense.”²

Consider other metrics

Patients might be better served by measuring quality and safety metrics other than episiotomy. These might include, for example, measuring:

• the use of prophylactic oxytocin after the anterior shoulder is delivered in order to decrease the risk of postpartum hemorrhage, as advocated by the California Maternal Quality Care Collaborative³
• the number of patients admitted before active labor and those receiving an epidural before active labor (with the aim of decreasing the primary cesarean rate in the NTSV population)
• the number of patients in an advanced stage of labor whose labor pattern has become dysfunctional, in whom no interventions have been instituted to improve the labor pattern, and who subsequently deliver by primary cesarean.

Recommendation

I recommend that performing an episiotomy should be an individual clinical decision for the individual patient by the individual obstetrician, and not a national mandate. We can provide quality care to our patients by performing selective episiotomies when clinically necessary, and not avoid them to an extreme that harms our patients. In my opinion, using the episiotomy rate as a quality metric should be abandoned.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

Like most California institutions performing deliveries, St. Joseph Hospital in Orange, California, started releasing 2016 maternal quality metrics internally at first. Data for the first 9 months of 2016 were distributed in December 2016. These metrics depend on a denominator based on the number of deliveries attributed to each obstetrician.

• I was very pleased to see that I ranked first in the vaginal birth after cesarean (VBAC) rate at 36.8%.
• I also was pleased that I ranked the fourth lowest, at 15.9%, for my cesarean delivery rate in the low-risk, nulliparous term singleton vertex (NTSV) population.
• I was neither pleased nor displeased that I ranked number 29 of 31 physicians at 59.1% (39/66) for the episiotomy rate. The denominator range was 1 to 287. I knew I would hear about this! Sure enough, a medical director asked me how 2 of my metrics could be so good, yet the third be so abysmal.

After the release of the data and the somewhat humorous chastisement by the medical director, I decided to try complying with the new American College of Obstetricians and Gynecologists (ACOG) guidelines¹ again beginning in January 2017.

A little personal history

Allow me to date myself. I completed my residency in 1981 and was Board Certified in 1984. My wife refers to me as a “Dinosaur!” As an ObGyn in solo practice, I take my own call.

During my training, episiotomies were commonly performed but were not always necessary. We were taught to not perform an episiotomy if the patient could safely and easily deliver without one. However, if clinically indicated, an episiotomy should be performed. If a 3rd- or 4th-degree laceration occurred, we were taught to anatomically repair it. Nowadays in my practice, these lacerations are rare in conjunction with an episiotomy, and with a controlled delivery of the fetal head.

Our nursing staff will tell you that I resist change. However, I usually attempt and often do adapt the latest national guidelines into my practice. Although I did not agree when restrictive episiotomies became a national goal a few years ago, I tried to adhere to the new national episiotomy recommendations.¹ I am meticulous: a standard episiotomy repair that does not involve excessive bleeding usually takes 20 minutes to restore normal anatomy with a simple, straightforward, layered closure.

My episiotomy performance record

In 2015, I restricted my use of episiotomies. When I did not perform one, the patient usually experienced lacerations. These were labial or periurethral as well as complex 3-dimensional “Z” or “Y” shaped vaginal/perineal lacerations, not just the 1st- and 2nd-degree perineal lacerations to which the literature refers.

The problems associated with complex, geometric vaginal lacerations are multifactorial:

• Lacerations occur at multiple locations.
• Significant bleeding often occurs. Because the lacerations are in multiple locations, the bleeding cannot be addressed easily, quickly, or at once.
• Visualization is difficult because of the bleeding, thus further prolonging the repair.
• These lacerations are often deeper than an episiotomy would have been and are very friable as all the layers have been stretched to their breaking point before tearing.
• Sometimes the lacerations include avulsion of the hymen with extensive bleeding.
• Difficult-to-repair lacerations can tear upon suturing, requiring layer upon layer of sutures at the same site. Future scarring and vaginal stricture leading to sexual dysfunction are concerns.
• At times, the friability and bleeding is so brisk that once the bleeding is controlled and the episiotomy is partially repaired, I can see that it is has not been an anatomic repair. I then have to take it down and re-do the repair with an obscured field from bleeding again!
• Some repairs are so fragile that when I express retained blood from the uterus and upper vagina after completing the repair, the tissue tears, bleeds, and requires additional restoration.
• These tears usually require an hour to repair and achieve hemostasis. At times, an assistant and a retractor are necessary.

After 2015, when I spent the year complying with the new guidelines, I returned to my original protocol: I performed an episiotomy only when I thought the patient was going to experience a significant laceration. I did not perform an episiotomy if I thought the mother could deliver easily without one. That is how I attained the 59.1% episiotomy rate in 2016.

Another try

After the 2016 hospital data were released, I decided to comply with the new guidelines¹ again beginning in January 2017. Here I share the details of 3 deliveries that occurred in 2017:

1. A 30-year-old woman (G2P1) planned to have a repeat cesarean delivery. At 38 3/7 weeks’ gestation, she was admitted in active labor with the cervix dilated to 5 cm. She requested a VBAC. After successful vaginal delivery without episiotomy of a 7 lb 5 oz infant, there were bilateral periurethral and right labia minora abrasions/lacerations.
2. A 21-year-old woman (G1P0) at 40 4/7 weeks’ gestation was admitted in early labor. The cervix was 2-cm dilated and 70% effaced after spontaneous rupture of membranes. I exercised my clinical judgment and performed a midline episiotomy. A 9 lb 3 oz infant was delivered by vaginal delivery.
3. A 16-year-old woman (G1P0) at 41 weeks’ gestation was admitted for induction of labor with an unripe cervix. I was delayed, and the laborist performed a vaginal delivery after 1 attempt at vacuum extraction and no episiotomy. The 7 lb 3 oz baby had Apgar scores of 4 and 9 at 1 and 5 minutes, respectively. There was significant bleeding from bilateral vaginal lacerations with bilateral hymeneal avulsions.

What is the benefit?

Are we really benefitting our patients by restricting the use of episiotomy? Consider these questions:

• Should we delay the mother’s bonding with her baby for an hour’s complex repair versus 20 minutes for a simple, layered episiotomy repair?
• In a busy labor and delivery unit, should resources be tied up for this extra time? With all due respect to the national experts advocating this recommendation, are they in the trenches performing deliveries and spending hours repairing complex lacerations?
• Should we not use our clinical judgment instead of allowing the mother to experience an extensive vaginal/perineal laceration after a vaginal delivery of a 9- or 10-lb baby?
• Where are the long-term data showing that it is better for a woman to stretch and attenuate her perineal and vaginal muscles to the breaking point, and then tear?
• Do all the additional sutures lead to vaginal scarring, vaginal stricture, and sexual dysfunction in later years?
• Which protocol better enables the mother to maintain pelvic organ support and avoid pelvic organ prolapse and stress urinary incontinence?

In Williams Obstetrics, the authors state: “We are of the view that episiotomy should be applied selectively for the appropriate indications. The final rule is that there is no substitute for surgical judgment and common sense.”²

Consider other metrics

Patients might be better served by measuring quality and safety metrics other than episiotomy. These might include, for example, measuring:

• the use of prophylactic oxytocin after the anterior shoulder is delivered in order to decrease the risk of postpartum hemorrhage, as advocated by the California Maternal Quality Care Collaborative³
• the number of patients admitted before active labor and those receiving an epidural before active labor (with the aim of decreasing the primary cesarean rate in the NTSV population)
• the number of patients in an advanced stage of labor whose labor pattern has become dysfunctional, in whom no interventions have been instituted to improve the labor pattern, and who subsequently deliver by primary cesarean.

Recommendation

I recommend that performing an episiotomy should be an individual clinical decision for the individual patient by the individual obstetrician, and not a national mandate. We can provide quality care to our patients by performing selective episiotomies when clinically necessary, and not avoid them to an extreme that harms our patients. In my opinion, using the episiotomy rate as a quality metric should be abandoned.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

Like most California institutions performing deliveries, St. Joseph Hospital in Orange, California, started releasing 2016 maternal quality metrics internally at first. Data for the first 9 months of 2016 were distributed in December 2016. These metrics depend on a denominator based on the number of deliveries attributed to each obstetrician.

• I was very pleased to see that I ranked first in the vaginal birth after cesarean (VBAC) rate at 36.8%.
• I also was pleased that I ranked the fourth lowest, at 15.9%, for my cesarean delivery rate in the low-risk, nulliparous term singleton vertex (NTSV) population.
• I was neither pleased nor displeased that I ranked number 29 of 31 physicians at 59.1% (39/66) for the episiotomy rate. The denominator range was 1 to 287. I knew I would hear about this! Sure enough, a medical director asked me how 2 of my metrics could be so good, yet the third be so abysmal.

After the release of the data and the somewhat humorous chastisement by the medical director, I decided to try complying with the new American College of Obstetricians and Gynecologists (ACOG) guidelines¹ again beginning in January 2017.

A little personal history

Allow me to date myself. I completed my residency in 1981 and was Board Certified in 1984. My wife refers to me as a “Dinosaur!” As an ObGyn in solo practice, I take my own call.

During my training, episiotomies were commonly performed but were not always necessary. We were taught to not perform an episiotomy if the patient could safely and easily deliver without one. However, if clinically indicated, an episiotomy should be performed. If a 3rd- or 4th-degree laceration occurred, we were taught to anatomically repair it. Nowadays in my practice, these lacerations are rare in conjunction with an episiotomy, and with a controlled delivery of the fetal head.

Our nursing staff will tell you that I resist change. However, I usually attempt and often do adapt the latest national guidelines into my practice. Although I did not agree when restrictive episiotomies became a national goal a few years ago, I tried to adhere to the new national episiotomy recommendations.¹ I am meticulous: a standard episiotomy repair that does not involve excessive bleeding usually takes 20 minutes to restore normal anatomy with a simple, straightforward, layered closure.

My episiotomy performance record

In 2015, I restricted my use of episiotomies. When I did not perform one, the patient usually experienced lacerations. These were labial or periurethral as well as complex 3-dimensional “Z” or “Y” shaped vaginal/perineal lacerations, not just the 1st- and 2nd-degree perineal lacerations to which the literature refers.

The problems associated with complex, geometric vaginal lacerations are multifactorial:

• Lacerations occur at multiple locations.
• Significant bleeding often occurs. Because the lacerations are in multiple locations, the bleeding cannot be addressed easily, quickly, or at once.
• Visualization is difficult because of the bleeding, thus further prolonging the repair.
• These lacerations are often deeper than an episiotomy would have been and are very friable as all the layers have been stretched to their breaking point before tearing.
• Sometimes the lacerations include avulsion of the hymen with extensive bleeding.
• Difficult-to-repair lacerations can tear upon suturing, requiring layer upon layer of sutures at the same site. Future scarring and vaginal stricture leading to sexual dysfunction are concerns.
• At times, the friability and bleeding is so brisk that once the bleeding is controlled and the episiotomy is partially repaired, I can see that it is has not been an anatomic repair. I then have to take it down and re-do the repair with an obscured field from bleeding again!
• Some repairs are so fragile that when I express retained blood from the uterus and upper vagina after completing the repair, the tissue tears, bleeds, and requires additional restoration.
• These tears usually require an hour to repair and achieve hemostasis. At times, an assistant and a retractor are necessary.

After 2015, when I spent the year complying with the new guidelines, I returned to my original protocol: I performed an episiotomy only when I thought the patient was going to experience a significant laceration. I did not perform an episiotomy if I thought the mother could deliver easily without one. That is how I attained the 59.1% episiotomy rate in 2016.

Another try

After the 2016 hospital data were released, I decided to comply with the new guidelines¹ again beginning in January 2017. Here I share the details of 3 deliveries that occurred in 2017:

1. A 30-year-old woman (G2P1) planned to have a repeat cesarean delivery. At 38 3/7 weeks’ gestation, she was admitted in active labor with the cervix dilated to 5 cm. She requested a VBAC. After successful vaginal delivery without episiotomy of a 7 lb 5 oz infant, there were bilateral periurethral and right labia minora abrasions/lacerations.
2. A 21-year-old woman (G1P0) at 40 4/7 weeks’ gestation was admitted in early labor. The cervix was 2-cm dilated and 70% effaced after spontaneous rupture of membranes. I exercised my clinical judgment and performed a midline episiotomy. A 9 lb 3 oz infant was delivered by vaginal delivery.
3. A 16-year-old woman (G1P0) at 41 weeks’ gestation was admitted for induction of labor with an unripe cervix. I was delayed, and the laborist performed a vaginal delivery after 1 attempt at vacuum extraction and no episiotomy. The 7 lb 3 oz baby had Apgar scores of 4 and 9 at 1 and 5 minutes, respectively. There was significant bleeding from bilateral vaginal lacerations with bilateral hymeneal avulsions.

What is the benefit?

Are we really benefitting our patients by restricting the use of episiotomy? Consider these questions:

• Should we delay the mother’s bonding with her baby for an hour’s complex repair versus 20 minutes for a simple, layered episiotomy repair?
• In a busy labor and delivery unit, should resources be tied up for this extra time? With all due respect to the national experts advocating this recommendation, are they in the trenches performing deliveries and spending hours repairing complex lacerations?
• Should we not use our clinical judgment instead of allowing the mother to experience an extensive vaginal/perineal laceration after a vaginal delivery of a 9- or 10-lb baby?
• Where are the long-term data showing that it is better for a woman to stretch and attenuate her perineal and vaginal muscles to the breaking point, and then tear?
• Do all the additional sutures lead to vaginal scarring, vaginal stricture, and sexual dysfunction in later years?
• Which protocol better enables the mother to maintain pelvic organ support and avoid pelvic organ prolapse and stress urinary incontinence?

In Williams Obstetrics, the authors state: “We are of the view that episiotomy should be applied selectively for the appropriate indications. The final rule is that there is no substitute for surgical judgment and common sense.”²

Consider other metrics

Patients might be better served by measuring quality and safety metrics other than episiotomy. These might include, for example, measuring:

• the use of prophylactic oxytocin after the anterior shoulder is delivered in order to decrease the risk of postpartum hemorrhage, as advocated by the California Maternal Quality Care Collaborative³
• the number of patients admitted before active labor and those receiving an epidural before active labor (with the aim of decreasing the primary cesarean rate in the NTSV population)
• the number of patients in an advanced stage of labor whose labor pattern has become dysfunctional, in whom no interventions have been instituted to improve the labor pattern, and who subsequently deliver by primary cesarean.

Recommendation

I recommend that performing an episiotomy should be an individual clinical decision for the individual patient by the individual obstetrician, and not a national mandate. We can provide quality care to our patients by performing selective episiotomies when clinically necessary, and not avoid them to an extreme that harms our patients. In my opinion, using the episiotomy rate as a quality metric should be abandoned.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

NEW ORLEANS – U.S. clinicians prescribe opioid tablets to postsurgical patients too often and at too high a pill count, according to results from two independent studies that examined prescribing patterns and opioid use in patients following gynecologic surgery.

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

• Patients undergoing minimally invasive or outpatient surgery and with no history of chronic pain and low opioid need while hospitalized received the default dispense of 600 mg ibuprofen every 6 hours as needed for 7 days and 500 mg acetaminophen every 6 hours as needed for 7 days.
• Patients who underwent this surgery but required 5 or more opioid tablets while hospitalized or those with a history of chronic pain and opioid use received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply with 1 tablet taken every 6 hours as needed.
• Patients who underwent laparotomy and had no chronic pain and opioid history and low opioid use while hospitalized received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply.
• Patients who underwent laparotomy and showed a higher opioid need based on their use during the 24 hours before discharge received the ibuprofen and acetaminophen regimen plus 24 opioid tablets for 3 days so they could take 2 tablets every 6 hours as needed.

Dr. Mark and his associates collected data from 337 patients managed with these guidelines during June 2017–January 2018 and compared them with 626 patients who underwent gynecologic surgery at Roswell Park during July 2016–June 2017. The data showed the average number of opioid tablets dispensed per patient for all discharges fell from 31.7 before the new guideline to 3.5, an 89% reduction. For the subgroup of patients who had undergone a laparotomy, the average pill number fell from 43.6 to 11.6, a 72% drop. Among patients treated with minimally invasive or outpatient surgery, average tablets dispensed fell from 28.1 before to 0.9 after, a 97% reduction. The reduction among opioid-naive patients was 90%, and it was 83% among patients who used opioids prior to their surgery.

Dr. Mark, Dr. Weston, and Dr. Dowdy had no disclosures.

mzoler@mdedge.com

SOURCE: Mark J et al. SGO 2018, Abstract 7. Weston E et al. SGO 2018, Abstract 8.

NEW ORLEANS – U.S. clinicians prescribe opioid tablets to postsurgical patients too often and at too high a pill count, according to results from two independent studies that examined prescribing patterns and opioid use in patients following gynecologic surgery.

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

• Patients undergoing minimally invasive or outpatient surgery and with no history of chronic pain and low opioid need while hospitalized received the default dispense of 600 mg ibuprofen every 6 hours as needed for 7 days and 500 mg acetaminophen every 6 hours as needed for 7 days.
• Patients who underwent this surgery but required 5 or more opioid tablets while hospitalized or those with a history of chronic pain and opioid use received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply with 1 tablet taken every 6 hours as needed.
• Patients who underwent laparotomy and had no chronic pain and opioid history and low opioid use while hospitalized received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply.
• Patients who underwent laparotomy and showed a higher opioid need based on their use during the 24 hours before discharge received the ibuprofen and acetaminophen regimen plus 24 opioid tablets for 3 days so they could take 2 tablets every 6 hours as needed.

Dr. Mark and his associates collected data from 337 patients managed with these guidelines during June 2017–January 2018 and compared them with 626 patients who underwent gynecologic surgery at Roswell Park during July 2016–June 2017. The data showed the average number of opioid tablets dispensed per patient for all discharges fell from 31.7 before the new guideline to 3.5, an 89% reduction. For the subgroup of patients who had undergone a laparotomy, the average pill number fell from 43.6 to 11.6, a 72% drop. Among patients treated with minimally invasive or outpatient surgery, average tablets dispensed fell from 28.1 before to 0.9 after, a 97% reduction. The reduction among opioid-naive patients was 90%, and it was 83% among patients who used opioids prior to their surgery.

Dr. Mark, Dr. Weston, and Dr. Dowdy had no disclosures.

mzoler@mdedge.com

SOURCE: Mark J et al. SGO 2018, Abstract 7. Weston E et al. SGO 2018, Abstract 8.

NEW ORLEANS – U.S. clinicians prescribe opioid tablets to postsurgical patients too often and at too high a pill count, according to results from two independent studies that examined prescribing patterns and opioid use in patients following gynecologic surgery.

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

• Patients undergoing minimally invasive or outpatient surgery and with no history of chronic pain and low opioid need while hospitalized received the default dispense of 600 mg ibuprofen every 6 hours as needed for 7 days and 500 mg acetaminophen every 6 hours as needed for 7 days.
• Patients who underwent this surgery but required 5 or more opioid tablets while hospitalized or those with a history of chronic pain and opioid use received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply with 1 tablet taken every 6 hours as needed.
• Patients who underwent laparotomy and had no chronic pain and opioid history and low opioid use while hospitalized received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply.
• Patients who underwent laparotomy and showed a higher opioid need based on their use during the 24 hours before discharge received the ibuprofen and acetaminophen regimen plus 24 opioid tablets for 3 days so they could take 2 tablets every 6 hours as needed.

Dr. Mark and his associates collected data from 337 patients managed with these guidelines during June 2017–January 2018 and compared them with 626 patients who underwent gynecologic surgery at Roswell Park during July 2016–June 2017. The data showed the average number of opioid tablets dispensed per patient for all discharges fell from 31.7 before the new guideline to 3.5, an 89% reduction. For the subgroup of patients who had undergone a laparotomy, the average pill number fell from 43.6 to 11.6, a 72% drop. Among patients treated with minimally invasive or outpatient surgery, average tablets dispensed fell from 28.1 before to 0.9 after, a 97% reduction. The reduction among opioid-naive patients was 90%, and it was 83% among patients who used opioids prior to their surgery.

Dr. Mark, Dr. Weston, and Dr. Dowdy had no disclosures.

mzoler@mdedge.com

SOURCE: Mark J et al. SGO 2018, Abstract 7. Weston E et al. SGO 2018, Abstract 8.

Recent data suggest the longer a patient with polyarticular forms of juvenile idiopathic arthritis stays on anti–tumor necrosis factor therapy to maintain a clinical inactive disease state, the higher the likelihood of experiencing disease flare after discontinuing anti-TNF therapy.

Daniel J. Lovell, MD, MPH, of the Cincinnati Children’s Hospital Medical Center, and his coauthors prospectively evaluated 137 patients with clinical inactive PF-JIA who were receiving anti-TNF therapy at 16 academic pediatric centers. Of these, 7 patients dropped from the study and 24 patients did not maintain clinical inactive disease (CID) for 6 months.

“These data certainly do not support the existence of a protective effect of longer duration of CID before considering stopping anti-TNF therapy,” the authors wrote in their study. “In fact, the data suggest that CID, even in those who did demonstrate CID consistently for the first 6 months of the study, continued to be an unstable clinical state and prolonged observation of CID resulted in a significantly greater risk for flare.”

Dr. Lovell and his colleagues noted their results suggest a “window of opportunity” where treating JIA early with “aggressive therapy” to reach CID sooner will help improve outcomes and long-term control of the disease.

The study was sponsored by a grant from the National Institutes of Health.

SOURCE: Lovell D et al. Arthritis Rheumatol. 2018 Mar 31. doi: 10.1002/art.40509.

Recent data suggest the longer a patient with polyarticular forms of juvenile idiopathic arthritis stays on anti–tumor necrosis factor therapy to maintain a clinical inactive disease state, the higher the likelihood of experiencing disease flare after discontinuing anti-TNF therapy.

Daniel J. Lovell, MD, MPH, of the Cincinnati Children’s Hospital Medical Center, and his coauthors prospectively evaluated 137 patients with clinical inactive PF-JIA who were receiving anti-TNF therapy at 16 academic pediatric centers. Of these, 7 patients dropped from the study and 24 patients did not maintain clinical inactive disease (CID) for 6 months.

“These data certainly do not support the existence of a protective effect of longer duration of CID before considering stopping anti-TNF therapy,” the authors wrote in their study. “In fact, the data suggest that CID, even in those who did demonstrate CID consistently for the first 6 months of the study, continued to be an unstable clinical state and prolonged observation of CID resulted in a significantly greater risk for flare.”

Dr. Lovell and his colleagues noted their results suggest a “window of opportunity” where treating JIA early with “aggressive therapy” to reach CID sooner will help improve outcomes and long-term control of the disease.

The study was sponsored by a grant from the National Institutes of Health.

SOURCE: Lovell D et al. Arthritis Rheumatol. 2018 Mar 31. doi: 10.1002/art.40509.

Recent data suggest the longer a patient with polyarticular forms of juvenile idiopathic arthritis stays on anti–tumor necrosis factor therapy to maintain a clinical inactive disease state, the higher the likelihood of experiencing disease flare after discontinuing anti-TNF therapy.

Daniel J. Lovell, MD, MPH, of the Cincinnati Children’s Hospital Medical Center, and his coauthors prospectively evaluated 137 patients with clinical inactive PF-JIA who were receiving anti-TNF therapy at 16 academic pediatric centers. Of these, 7 patients dropped from the study and 24 patients did not maintain clinical inactive disease (CID) for 6 months.

“These data certainly do not support the existence of a protective effect of longer duration of CID before considering stopping anti-TNF therapy,” the authors wrote in their study. “In fact, the data suggest that CID, even in those who did demonstrate CID consistently for the first 6 months of the study, continued to be an unstable clinical state and prolonged observation of CID resulted in a significantly greater risk for flare.”

Dr. Lovell and his colleagues noted their results suggest a “window of opportunity” where treating JIA early with “aggressive therapy” to reach CID sooner will help improve outcomes and long-term control of the disease.

The study was sponsored by a grant from the National Institutes of Health.

SOURCE: Lovell D et al. Arthritis Rheumatol. 2018 Mar 31. doi: 10.1002/art.40509.

Background: Patients with saddle PEs can differ in terms of their clinical presentation and may present as hemodynamically stable or unstable. There have been few studies to quantify the presentation, management, and outcome of patients who present with saddle PEs.

Study design: Retrospective cohort study.

Setting: Quaternary care hospital in Minnesota.

Synopsis: Using a localized database, 187 consecutive patients with saddle PEs were matched with 187 nonsaddle PEs using age and the simplified Pulmonary Embolism Severity Index (sPESI). Saddle PE patients had no significant in-hospital mortality differences versus nonsaddle PEs. However, they were more likely to present with massive and submassive hemodynamics (80% vs. 52%; P less than .05), RV dilatation (84% vs. 67%; P less than .001), and troponin elevation (71% vs. 40%; P less than .001). Patients with saddle PEs were more likely to receive thrombolytics, inferior vena cava filter placement, and require mechanical ventilation. They also had increased risk of decompensation after 6 hours (12 patients vs. 6 patients). Limitations of this study include some selection bias and use of a single-center study. Regardless, hospitalists should consider close monitoring for patients with saddle PEs upon admission, independent of hemodynamics given risk of decompensation regardless of presenting vitals.

Bottom line: Saddle PEs have an increased risk of late decompensation, clot burden, and presentation with massive and submassive hemodynamics but not an increased risk of mortality when compared with nonsaddle PEs.

Citation: Alkinj B et al. Saddle vs. nonsaddle pulmonary embolism: Clinical presentation, hemodynamics, management, and outcomes. Mayo Clin Proc. 2017 Oct;92(10):1511-8.

Dr. O’Donnell is assistant professor of medicine in the division of hospital medicine, Emory University, Atlanta.

Background: Patients with saddle PEs can differ in terms of their clinical presentation and may present as hemodynamically stable or unstable. There have been few studies to quantify the presentation, management, and outcome of patients who present with saddle PEs.

Study design: Retrospective cohort study.

Setting: Quaternary care hospital in Minnesota.

Synopsis: Using a localized database, 187 consecutive patients with saddle PEs were matched with 187 nonsaddle PEs using age and the simplified Pulmonary Embolism Severity Index (sPESI). Saddle PE patients had no significant in-hospital mortality differences versus nonsaddle PEs. However, they were more likely to present with massive and submassive hemodynamics (80% vs. 52%; P less than .05), RV dilatation (84% vs. 67%; P less than .001), and troponin elevation (71% vs. 40%; P less than .001). Patients with saddle PEs were more likely to receive thrombolytics, inferior vena cava filter placement, and require mechanical ventilation. They also had increased risk of decompensation after 6 hours (12 patients vs. 6 patients). Limitations of this study include some selection bias and use of a single-center study. Regardless, hospitalists should consider close monitoring for patients with saddle PEs upon admission, independent of hemodynamics given risk of decompensation regardless of presenting vitals.

Bottom line: Saddle PEs have an increased risk of late decompensation, clot burden, and presentation with massive and submassive hemodynamics but not an increased risk of mortality when compared with nonsaddle PEs.

Citation: Alkinj B et al. Saddle vs. nonsaddle pulmonary embolism: Clinical presentation, hemodynamics, management, and outcomes. Mayo Clin Proc. 2017 Oct;92(10):1511-8.

Dr. O’Donnell is assistant professor of medicine in the division of hospital medicine, Emory University, Atlanta.

Background: Patients with saddle PEs can differ in terms of their clinical presentation and may present as hemodynamically stable or unstable. There have been few studies to quantify the presentation, management, and outcome of patients who present with saddle PEs.

Study design: Retrospective cohort study.

Setting: Quaternary care hospital in Minnesota.

Synopsis: Using a localized database, 187 consecutive patients with saddle PEs were matched with 187 nonsaddle PEs using age and the simplified Pulmonary Embolism Severity Index (sPESI). Saddle PE patients had no significant in-hospital mortality differences versus nonsaddle PEs. However, they were more likely to present with massive and submassive hemodynamics (80% vs. 52%; P less than .05), RV dilatation (84% vs. 67%; P less than .001), and troponin elevation (71% vs. 40%; P less than .001). Patients with saddle PEs were more likely to receive thrombolytics, inferior vena cava filter placement, and require mechanical ventilation. They also had increased risk of decompensation after 6 hours (12 patients vs. 6 patients). Limitations of this study include some selection bias and use of a single-center study. Regardless, hospitalists should consider close monitoring for patients with saddle PEs upon admission, independent of hemodynamics given risk of decompensation regardless of presenting vitals.

Bottom line: Saddle PEs have an increased risk of late decompensation, clot burden, and presentation with massive and submassive hemodynamics but not an increased risk of mortality when compared with nonsaddle PEs.

Citation: Alkinj B et al. Saddle vs. nonsaddle pulmonary embolism: Clinical presentation, hemodynamics, management, and outcomes. Mayo Clin Proc. 2017 Oct;92(10):1511-8.

Dr. O’Donnell is assistant professor of medicine in the division of hospital medicine, Emory University, Atlanta.

Duvelisib, a dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, is under priority review by the Food and Drug Administration.

The biopharmaceutical company Verastem is seeking full approval for duvelisib for the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed/refractory follicular lymphoma. The FDA has set Oct. 5, 2018, as the target action date, according to Verastem.

mschneider@mdedge.com

Duvelisib, a dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, is under priority review by the Food and Drug Administration.

The biopharmaceutical company Verastem is seeking full approval for duvelisib for the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed/refractory follicular lymphoma. The FDA has set Oct. 5, 2018, as the target action date, according to Verastem.

mschneider@mdedge.com

Duvelisib, a dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, is under priority review by the Food and Drug Administration.

The biopharmaceutical company Verastem is seeking full approval for duvelisib for the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed/refractory follicular lymphoma. The FDA has set Oct. 5, 2018, as the target action date, according to Verastem.

mschneider@mdedge.com

Avène Mineral Light Mattifying Sunscreen Lotion

Pierre Fabre Dermo-Cosmetique introduces the Avène Mineral Light Mattifying Sunscreen Lotion with SPF 50+. This sunscreen offers broad-spectrum sun protection without irritation while delivering oil control and providing a natural mattifying finish for oily and acne-prone skin. This product absorbs quickly into the skin and can be worn under makeup. Avène Mineral Light Mattifying Sunscreen Lotion should be applied to the face 15 minutes prior to sun exposure and reapplied after 80 minutes of swimming or sweating, immediately after towel drying, or every 2 hours. For more information, visit www.aveneusa.com.

Ducray Anacaps Activ+ Dietary Supplement

Pierre Fabre Dermo-Cosmetique introduces Ducray Anacaps Activ+ Dietary Supplement, a once-daily capsule that contains zinc, molybdenum, iron, and selenium. This supplement targets factors that trigger sudden hair loss, including seasonal changes, stress, and diet. It also targets chronic hair loss with genetic, hormonal, and vascular causes. This formula provides essential nutrients needed to promote healthy hair growth from within, preserve hair density, and maintain the strength and vitality of hair. This supplement also is used for weak, devitalized nails and has a vegan formula with good digestive tolerance. For more information, visit www.ducray.com/en-us/.

Luzu

Ortho Dermatologics receives US Food and Drug Administration approval of the Supplemental New Drug Application to expand the use of Luzu (luliconazole) Cream 1% to pediatric patients. This new indication is for the topical treatment of interdigital tinea pedis and tinea cruris in patients 12 years of age and older and for tinea corporis in patients 2 years of age and older. Luzu is a topical azole antifungal agent with a 1-week, once-daily treatment regimen with results available 3 weeks post-treatment. Luzu previously was approved for use in adult patients. For more information, visit www.luzurx.com/HCP.

Xeljanz and Xeljanz XR

Pfizer Inc announces US Food and Drug Administration approval of twice-daily Xeljanz 5 mg and once-daily Xeljanz XR extended release 11 mg (tofacitinib) for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs. Xeljanz and Xeljanz XR are Janus kinase inhibitors that previously were approved for the treatment of rheumatoid arthritis. For more information, visit www.xeljanz.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@mdedge.com.

Avène Mineral Light Mattifying Sunscreen Lotion

Pierre Fabre Dermo-Cosmetique introduces the Avène Mineral Light Mattifying Sunscreen Lotion with SPF 50+. This sunscreen offers broad-spectrum sun protection without irritation while delivering oil control and providing a natural mattifying finish for oily and acne-prone skin. This product absorbs quickly into the skin and can be worn under makeup. Avène Mineral Light Mattifying Sunscreen Lotion should be applied to the face 15 minutes prior to sun exposure and reapplied after 80 minutes of swimming or sweating, immediately after towel drying, or every 2 hours. For more information, visit www.aveneusa.com.

Ducray Anacaps Activ+ Dietary Supplement

Pierre Fabre Dermo-Cosmetique introduces Ducray Anacaps Activ+ Dietary Supplement, a once-daily capsule that contains zinc, molybdenum, iron, and selenium. This supplement targets factors that trigger sudden hair loss, including seasonal changes, stress, and diet. It also targets chronic hair loss with genetic, hormonal, and vascular causes. This formula provides essential nutrients needed to promote healthy hair growth from within, preserve hair density, and maintain the strength and vitality of hair. This supplement also is used for weak, devitalized nails and has a vegan formula with good digestive tolerance. For more information, visit www.ducray.com/en-us/.

Luzu

Ortho Dermatologics receives US Food and Drug Administration approval of the Supplemental New Drug Application to expand the use of Luzu (luliconazole) Cream 1% to pediatric patients. This new indication is for the topical treatment of interdigital tinea pedis and tinea cruris in patients 12 years of age and older and for tinea corporis in patients 2 years of age and older. Luzu is a topical azole antifungal agent with a 1-week, once-daily treatment regimen with results available 3 weeks post-treatment. Luzu previously was approved for use in adult patients. For more information, visit www.luzurx.com/HCP.

Xeljanz and Xeljanz XR

Pfizer Inc announces US Food and Drug Administration approval of twice-daily Xeljanz 5 mg and once-daily Xeljanz XR extended release 11 mg (tofacitinib) for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs. Xeljanz and Xeljanz XR are Janus kinase inhibitors that previously were approved for the treatment of rheumatoid arthritis. For more information, visit www.xeljanz.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@mdedge.com.

Avène Mineral Light Mattifying Sunscreen Lotion

Pierre Fabre Dermo-Cosmetique introduces the Avène Mineral Light Mattifying Sunscreen Lotion with SPF 50+. This sunscreen offers broad-spectrum sun protection without irritation while delivering oil control and providing a natural mattifying finish for oily and acne-prone skin. This product absorbs quickly into the skin and can be worn under makeup. Avène Mineral Light Mattifying Sunscreen Lotion should be applied to the face 15 minutes prior to sun exposure and reapplied after 80 minutes of swimming or sweating, immediately after towel drying, or every 2 hours. For more information, visit www.aveneusa.com.

Ducray Anacaps Activ+ Dietary Supplement

Pierre Fabre Dermo-Cosmetique introduces Ducray Anacaps Activ+ Dietary Supplement, a once-daily capsule that contains zinc, molybdenum, iron, and selenium. This supplement targets factors that trigger sudden hair loss, including seasonal changes, stress, and diet. It also targets chronic hair loss with genetic, hormonal, and vascular causes. This formula provides essential nutrients needed to promote healthy hair growth from within, preserve hair density, and maintain the strength and vitality of hair. This supplement also is used for weak, devitalized nails and has a vegan formula with good digestive tolerance. For more information, visit www.ducray.com/en-us/.

Luzu

Ortho Dermatologics receives US Food and Drug Administration approval of the Supplemental New Drug Application to expand the use of Luzu (luliconazole) Cream 1% to pediatric patients. This new indication is for the topical treatment of interdigital tinea pedis and tinea cruris in patients 12 years of age and older and for tinea corporis in patients 2 years of age and older. Luzu is a topical azole antifungal agent with a 1-week, once-daily treatment regimen with results available 3 weeks post-treatment. Luzu previously was approved for use in adult patients. For more information, visit www.luzurx.com/HCP.

Xeljanz and Xeljanz XR

Pfizer Inc announces US Food and Drug Administration approval of twice-daily Xeljanz 5 mg and once-daily Xeljanz XR extended release 11 mg (tofacitinib) for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs. Xeljanz and Xeljanz XR are Janus kinase inhibitors that previously were approved for the treatment of rheumatoid arthritis. For more information, visit www.xeljanz.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@mdedge.com.

Preemptive HLA-A*31:01 genetic screening may significantly decrease the incidence of carbamazepine-induced cutaneous adverse reactions in Japanese patients, according to a report published online ahead of print April 2 in JAMA Neurology. According to the researchers, their finding suggests that such screening may be warranted in routine clinical practice.

Carbamazepine, which is widely used to treat seizures, neuropathic pain, and other disorders, is a common cause of cutaneous adverse drug reactions worldwide. The allele HLA-A*31:01 has been associated with carbamazepine-induced cutaneous drug reactions in Japanese and European populations. The clinical utility of HLA-A*31:01 screening, however, has not been evaluated.

Genetic Screening Informed Treatment

To assess the use of HLA-A*31:01 genetic screening to identify individuals at risk of carbamazepine-induced cutaneous drug reactions, researchers from the Genotype-Based Carbamazepine Therapy Study Group conducted a cohort study in 36 hospitals in Japan from January 2012 to November 2014. The investigators enrolled 1,202 patients who were eligible to receive carbamazepine during the study period. Preemptive HLA-A*31:01 screening was performed for 1,187 study participants. Patients who did not start treatment with carbamazepine or alternative drugs were excluded. Participants were interviewed once weekly for eight weeks to monitor the development of cutaneous adverse drug reactions.

Neuropsychiatrists were asked to prescribe carbamazepine for patients who tested negative for HLA-A*31:01 and alternative drugs for those who tested positive for the allele. The study’s main outcome was the incidence of carbamazepine-induced cutaneous adverse drug reactions.

Of the 1,130 patients who were prescribed carbamazepine or alternative drugs, the mean age was 37.4; 614 (54.3%) were men, and 198 (17.5%) were positive for HLA-A*31:01. Dermatologists identified 23 patients (2.0%) who had carbamazepine-induced cutaneous adverse drug reactions, of whom four patients required hospitalization. Drug-induced hypersensitivity syndrome was observed for three patients, maculopapular eruption for nine patients, erythema multiforme for five patients, and an undetermined type of cutaneous adverse drug reaction for six patients. No patient developed Stevens-Johnson syndrome or toxic epidermal necrolysis.

Comparison with a historical control indicated that the preemptive use of HLA-A*31:01 screening was associated with a 40% reduction in the incidence of carbamazepine-induced cutaneous adverse drug reactions.

Two Alleles

The researchers noted that the clinical utility of the HLA-B*15:02 genetic test for reducing carbamazepine-induced cutaneous drug reactions has already been established by preemptive screening. However, the frequency of the HLA-B*15:02 allele is low in Korean, Japanese, African, and European populations.

In contrast, the frequency of the HLA-A*31:01 allele is 7% to 9% in Japanese, 5% in Korean, 2% in Chinese, 2% to 3% in European, and 1% in African populations. Moreover, HLA-A*31:01 has been associated with a full spectrum of carbamazepine-induced cutaneous adverse drug reactions. Therefore, “HLA-A*31:01 genetic screening prior to prescribing carbamazepine would be useful for preventing many types of carbamazepine-induced cutaneous adverse drug reactions in a range of patient populations,” the researchers concluded.

A First Step in Precision Neurology?

The present study “provides initial data that preemptive strategies may allow for a more consistent approach to safely administer this commonly used medication,” said Yijing He, MD, PhD; Lucia Seminario-Vidal, MD, PhD; and Howard L. McLeod, PharmD, in an accompanying editorial. A substantial decrease in the incidence and severity of carbamazepine-associated cutaneous adverse drug reactions was documented. While the study did not have the statistical power to definitively demonstrate complete avoidance of the high-morbidity and -mortality forms of severe cutaneous adverse drug reactions (ie, Stevens-Johnson syndrome and toxic epidermal necrolysis), it had statistical power to detect an important reduction in mild or moderately severe forms of cutaneous adverse drug reactions.

“However, 23 patients experienced a carbamazepine-associated cutaneous adverse drug reaction,” and four patients required hospitalization, the editorialists noted. “Therefore, the use of HLA-A*31:01 testing will not eliminate the risk of carbamazepine-associated events, nor will it decrease the need for neurologists to provide skin-focused monitoring as part of their management of cases involving carbamazepine-treated patients.”

This research, the editorialists said, indicates that there is still more to discover. “To date, a small number of heroes has relentlessly pursued mechanistic and preventive research on drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis. However, the field needs to build on these efforts with a more systematic approach that will aid more rapid progress and provide more consistent influence across the globe.” Much still needs to be learned about the basic mechanisms, clinical confounders, biomarkers, and epidemiologic aspects of the various drug reactions that become Stevens-Johnson syndrome and toxic epidermal necrolysis. Attributing this clinical, immunologic, and therapeutic problem to various idiosyncratic reactions does not serve patients well, said the editorialists.

A key first step, the editorialists said, is to “apply existing preemptive strategies, including genomic analysis. Whether this is initially implemented broadly or in regions with higher probability of the risk alleles is less important than learning how to change a culture that tolerates adverse drug events and inventing informatics tools to make proactive approaches less of a burden. Although we will not get it completely right the first time, we need to start the iterative process to eradicate severe cutaneous adverse drug reactions.”

—Glenn S. Williams

Suggested Reading

Mushiroda T, Takahashi Y, Onuma T, et al. Association of HLA-A*31:01 screening with the incidence of carbamazepine-induced cutaneous adverse reactions in a Japanese population. JAMA Neurol. 2018 Apr 2 [Epub ahead of print].

He Y, Seminario-Vidal S, McLeod HL. Avoidance of severe cutaneous adverse drug events as a first step in precision neurology. JAMA Neurol. Apr 2 [Epub ahead of print].

Preemptive HLA-A*31:01 genetic screening may significantly decrease the incidence of carbamazepine-induced cutaneous adverse reactions in Japanese patients, according to a report published online ahead of print April 2 in JAMA Neurology. According to the researchers, their finding suggests that such screening may be warranted in routine clinical practice.

Carbamazepine, which is widely used to treat seizures, neuropathic pain, and other disorders, is a common cause of cutaneous adverse drug reactions worldwide. The allele HLA-A*31:01 has been associated with carbamazepine-induced cutaneous drug reactions in Japanese and European populations. The clinical utility of HLA-A*31:01 screening, however, has not been evaluated.

Genetic Screening Informed Treatment

To assess the use of HLA-A*31:01 genetic screening to identify individuals at risk of carbamazepine-induced cutaneous drug reactions, researchers from the Genotype-Based Carbamazepine Therapy Study Group conducted a cohort study in 36 hospitals in Japan from January 2012 to November 2014. The investigators enrolled 1,202 patients who were eligible to receive carbamazepine during the study period. Preemptive HLA-A*31:01 screening was performed for 1,187 study participants. Patients who did not start treatment with carbamazepine or alternative drugs were excluded. Participants were interviewed once weekly for eight weeks to monitor the development of cutaneous adverse drug reactions.

Neuropsychiatrists were asked to prescribe carbamazepine for patients who tested negative for HLA-A*31:01 and alternative drugs for those who tested positive for the allele. The study’s main outcome was the incidence of carbamazepine-induced cutaneous adverse drug reactions.

Of the 1,130 patients who were prescribed carbamazepine or alternative drugs, the mean age was 37.4; 614 (54.3%) were men, and 198 (17.5%) were positive for HLA-A*31:01. Dermatologists identified 23 patients (2.0%) who had carbamazepine-induced cutaneous adverse drug reactions, of whom four patients required hospitalization. Drug-induced hypersensitivity syndrome was observed for three patients, maculopapular eruption for nine patients, erythema multiforme for five patients, and an undetermined type of cutaneous adverse drug reaction for six patients. No patient developed Stevens-Johnson syndrome or toxic epidermal necrolysis.

Comparison with a historical control indicated that the preemptive use of HLA-A*31:01 screening was associated with a 40% reduction in the incidence of carbamazepine-induced cutaneous adverse drug reactions.

Two Alleles

The researchers noted that the clinical utility of the HLA-B*15:02 genetic test for reducing carbamazepine-induced cutaneous drug reactions has already been established by preemptive screening. However, the frequency of the HLA-B*15:02 allele is low in Korean, Japanese, African, and European populations.

In contrast, the frequency of the HLA-A*31:01 allele is 7% to 9% in Japanese, 5% in Korean, 2% in Chinese, 2% to 3% in European, and 1% in African populations. Moreover, HLA-A*31:01 has been associated with a full spectrum of carbamazepine-induced cutaneous adverse drug reactions. Therefore, “HLA-A*31:01 genetic screening prior to prescribing carbamazepine would be useful for preventing many types of carbamazepine-induced cutaneous adverse drug reactions in a range of patient populations,” the researchers concluded.

A First Step in Precision Neurology?

The present study “provides initial data that preemptive strategies may allow for a more consistent approach to safely administer this commonly used medication,” said Yijing He, MD, PhD; Lucia Seminario-Vidal, MD, PhD; and Howard L. McLeod, PharmD, in an accompanying editorial. A substantial decrease in the incidence and severity of carbamazepine-associated cutaneous adverse drug reactions was documented. While the study did not have the statistical power to definitively demonstrate complete avoidance of the high-morbidity and -mortality forms of severe cutaneous adverse drug reactions (ie, Stevens-Johnson syndrome and toxic epidermal necrolysis), it had statistical power to detect an important reduction in mild or moderately severe forms of cutaneous adverse drug reactions.

“However, 23 patients experienced a carbamazepine-associated cutaneous adverse drug reaction,” and four patients required hospitalization, the editorialists noted. “Therefore, the use of HLA-A*31:01 testing will not eliminate the risk of carbamazepine-associated events, nor will it decrease the need for neurologists to provide skin-focused monitoring as part of their management of cases involving carbamazepine-treated patients.”

This research, the editorialists said, indicates that there is still more to discover. “To date, a small number of heroes has relentlessly pursued mechanistic and preventive research on drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis. However, the field needs to build on these efforts with a more systematic approach that will aid more rapid progress and provide more consistent influence across the globe.” Much still needs to be learned about the basic mechanisms, clinical confounders, biomarkers, and epidemiologic aspects of the various drug reactions that become Stevens-Johnson syndrome and toxic epidermal necrolysis. Attributing this clinical, immunologic, and therapeutic problem to various idiosyncratic reactions does not serve patients well, said the editorialists.

A key first step, the editorialists said, is to “apply existing preemptive strategies, including genomic analysis. Whether this is initially implemented broadly or in regions with higher probability of the risk alleles is less important than learning how to change a culture that tolerates adverse drug events and inventing informatics tools to make proactive approaches less of a burden. Although we will not get it completely right the first time, we need to start the iterative process to eradicate severe cutaneous adverse drug reactions.”

—Glenn S. Williams

Suggested Reading

Mushiroda T, Takahashi Y, Onuma T, et al. Association of HLA-A*31:01 screening with the incidence of carbamazepine-induced cutaneous adverse reactions in a Japanese population. JAMA Neurol. 2018 Apr 2 [Epub ahead of print].

He Y, Seminario-Vidal S, McLeod HL. Avoidance of severe cutaneous adverse drug events as a first step in precision neurology. JAMA Neurol. Apr 2 [Epub ahead of print].

Preemptive HLA-A*31:01 genetic screening may significantly decrease the incidence of carbamazepine-induced cutaneous adverse reactions in Japanese patients, according to a report published online ahead of print April 2 in JAMA Neurology. According to the researchers, their finding suggests that such screening may be warranted in routine clinical practice.

Carbamazepine, which is widely used to treat seizures, neuropathic pain, and other disorders, is a common cause of cutaneous adverse drug reactions worldwide. The allele HLA-A*31:01 has been associated with carbamazepine-induced cutaneous drug reactions in Japanese and European populations. The clinical utility of HLA-A*31:01 screening, however, has not been evaluated.

Genetic Screening Informed Treatment

To assess the use of HLA-A*31:01 genetic screening to identify individuals at risk of carbamazepine-induced cutaneous drug reactions, researchers from the Genotype-Based Carbamazepine Therapy Study Group conducted a cohort study in 36 hospitals in Japan from January 2012 to November 2014. The investigators enrolled 1,202 patients who were eligible to receive carbamazepine during the study period. Preemptive HLA-A*31:01 screening was performed for 1,187 study participants. Patients who did not start treatment with carbamazepine or alternative drugs were excluded. Participants were interviewed once weekly for eight weeks to monitor the development of cutaneous adverse drug reactions.

Neuropsychiatrists were asked to prescribe carbamazepine for patients who tested negative for HLA-A*31:01 and alternative drugs for those who tested positive for the allele. The study’s main outcome was the incidence of carbamazepine-induced cutaneous adverse drug reactions.

Of the 1,130 patients who were prescribed carbamazepine or alternative drugs, the mean age was 37.4; 614 (54.3%) were men, and 198 (17.5%) were positive for HLA-A*31:01. Dermatologists identified 23 patients (2.0%) who had carbamazepine-induced cutaneous adverse drug reactions, of whom four patients required hospitalization. Drug-induced hypersensitivity syndrome was observed for three patients, maculopapular eruption for nine patients, erythema multiforme for five patients, and an undetermined type of cutaneous adverse drug reaction for six patients. No patient developed Stevens-Johnson syndrome or toxic epidermal necrolysis.

Comparison with a historical control indicated that the preemptive use of HLA-A*31:01 screening was associated with a 40% reduction in the incidence of carbamazepine-induced cutaneous adverse drug reactions.

Two Alleles

The researchers noted that the clinical utility of the HLA-B*15:02 genetic test for reducing carbamazepine-induced cutaneous drug reactions has already been established by preemptive screening. However, the frequency of the HLA-B*15:02 allele is low in Korean, Japanese, African, and European populations.

In contrast, the frequency of the HLA-A*31:01 allele is 7% to 9% in Japanese, 5% in Korean, 2% in Chinese, 2% to 3% in European, and 1% in African populations. Moreover, HLA-A*31:01 has been associated with a full spectrum of carbamazepine-induced cutaneous adverse drug reactions. Therefore, “HLA-A*31:01 genetic screening prior to prescribing carbamazepine would be useful for preventing many types of carbamazepine-induced cutaneous adverse drug reactions in a range of patient populations,” the researchers concluded.

A First Step in Precision Neurology?

The present study “provides initial data that preemptive strategies may allow for a more consistent approach to safely administer this commonly used medication,” said Yijing He, MD, PhD; Lucia Seminario-Vidal, MD, PhD; and Howard L. McLeod, PharmD, in an accompanying editorial. A substantial decrease in the incidence and severity of carbamazepine-associated cutaneous adverse drug reactions was documented. While the study did not have the statistical power to definitively demonstrate complete avoidance of the high-morbidity and -mortality forms of severe cutaneous adverse drug reactions (ie, Stevens-Johnson syndrome and toxic epidermal necrolysis), it had statistical power to detect an important reduction in mild or moderately severe forms of cutaneous adverse drug reactions.

“However, 23 patients experienced a carbamazepine-associated cutaneous adverse drug reaction,” and four patients required hospitalization, the editorialists noted. “Therefore, the use of HLA-A*31:01 testing will not eliminate the risk of carbamazepine-associated events, nor will it decrease the need for neurologists to provide skin-focused monitoring as part of their management of cases involving carbamazepine-treated patients.”

This research, the editorialists said, indicates that there is still more to discover. “To date, a small number of heroes has relentlessly pursued mechanistic and preventive research on drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis. However, the field needs to build on these efforts with a more systematic approach that will aid more rapid progress and provide more consistent influence across the globe.” Much still needs to be learned about the basic mechanisms, clinical confounders, biomarkers, and epidemiologic aspects of the various drug reactions that become Stevens-Johnson syndrome and toxic epidermal necrolysis. Attributing this clinical, immunologic, and therapeutic problem to various idiosyncratic reactions does not serve patients well, said the editorialists.

A key first step, the editorialists said, is to “apply existing preemptive strategies, including genomic analysis. Whether this is initially implemented broadly or in regions with higher probability of the risk alleles is less important than learning how to change a culture that tolerates adverse drug events and inventing informatics tools to make proactive approaches less of a burden. Although we will not get it completely right the first time, we need to start the iterative process to eradicate severe cutaneous adverse drug reactions.”

—Glenn S. Williams

Suggested Reading

Mushiroda T, Takahashi Y, Onuma T, et al. Association of HLA-A*31:01 screening with the incidence of carbamazepine-induced cutaneous adverse reactions in a Japanese population. JAMA Neurol. 2018 Apr 2 [Epub ahead of print].

He Y, Seminario-Vidal S, McLeod HL. Avoidance of severe cutaneous adverse drug events as a first step in precision neurology. JAMA Neurol. Apr 2 [Epub ahead of print].