Ob.Gyn. News welcomes Angela Martin, MD, to the editorial advisory board.

Dr. Martin is an assistant professor of gynecology and obstetrics in the division of maternal-fetal medicine at the University of Kansas Medical Center in Kansas City, where she is the director of ultrasound training for the residency program. She also serves on the Pharmacy and Therapeutics Committee at the university.

Dr. Martin has been a primary author or coauthor of many articles published and accepted in refereed medical publications on topics including influenza infection during pregnancy, maternal and fetal risk associated with assisted reproductive technology, hepatitis B in pregnancy, umbilical cord blood banking, pregnancy and obesity, and cell-free fetal DNA. She currently is involved in research on resident operative delivery training, chorionic villus sampling, and preterm birth.

Graduating summa cum laude from Drake University in Des Moines, Iowa, with a bachelor of science degree in biology and a minor in psychology, Dr. Martin received her doctorate of medicine at the University of Missouri, Columbia. She completed her postgraduate training at Emory University in Atlanta with an internship and residency in the department of gynecology and obstetrics, followed by a fellowship in the maternal-fetal medicine division.

Dr. Martin has won numerous honors and awards, including Outstanding Research Proposal by a fellow at Emory University, Excellence in Teaching awards for a fellow for several consecutive years at the university, and a National Faculty Award from the American College of Obstetricians and Gynecologists.*

*This article was updated 2/7/2020.

Ob.Gyn. News welcomes Angela Martin, MD, to the editorial advisory board.

Dr. Martin is an assistant professor of gynecology and obstetrics in the division of maternal-fetal medicine at the University of Kansas Medical Center in Kansas City, where she is the director of ultrasound training for the residency program. She also serves on the Pharmacy and Therapeutics Committee at the university.

Dr. Martin has been a primary author or coauthor of many articles published and accepted in refereed medical publications on topics including influenza infection during pregnancy, maternal and fetal risk associated with assisted reproductive technology, hepatitis B in pregnancy, umbilical cord blood banking, pregnancy and obesity, and cell-free fetal DNA. She currently is involved in research on resident operative delivery training, chorionic villus sampling, and preterm birth.

Graduating summa cum laude from Drake University in Des Moines, Iowa, with a bachelor of science degree in biology and a minor in psychology, Dr. Martin received her doctorate of medicine at the University of Missouri, Columbia. She completed her postgraduate training at Emory University in Atlanta with an internship and residency in the department of gynecology and obstetrics, followed by a fellowship in the maternal-fetal medicine division.

Dr. Martin has won numerous honors and awards, including Outstanding Research Proposal by a fellow at Emory University, Excellence in Teaching awards for a fellow for several consecutive years at the university, and a National Faculty Award from the American College of Obstetricians and Gynecologists.*

*This article was updated 2/7/2020.

Ob.Gyn. News welcomes Angela Martin, MD, to the editorial advisory board.

Dr. Martin is an assistant professor of gynecology and obstetrics in the division of maternal-fetal medicine at the University of Kansas Medical Center in Kansas City, where she is the director of ultrasound training for the residency program. She also serves on the Pharmacy and Therapeutics Committee at the university.

Dr. Martin has been a primary author or coauthor of many articles published and accepted in refereed medical publications on topics including influenza infection during pregnancy, maternal and fetal risk associated with assisted reproductive technology, hepatitis B in pregnancy, umbilical cord blood banking, pregnancy and obesity, and cell-free fetal DNA. She currently is involved in research on resident operative delivery training, chorionic villus sampling, and preterm birth.

Graduating summa cum laude from Drake University in Des Moines, Iowa, with a bachelor of science degree in biology and a minor in psychology, Dr. Martin received her doctorate of medicine at the University of Missouri, Columbia. She completed her postgraduate training at Emory University in Atlanta with an internship and residency in the department of gynecology and obstetrics, followed by a fellowship in the maternal-fetal medicine division.

Dr. Martin has won numerous honors and awards, including Outstanding Research Proposal by a fellow at Emory University, Excellence in Teaching awards for a fellow for several consecutive years at the university, and a National Faculty Award from the American College of Obstetricians and Gynecologists.*

*This article was updated 2/7/2020.

PRACTICE CHANGER

Keep patients on antidepressant therapy for anxiety disorders for a year or longer before considering a taper.¹

STRENGTH OF RECOMMENDATION

A: Based on a systematic review/meta-analysis of several good-quality randomized controlled trials.

A 42-year-old woman with generalized anxiety disorder (GAD) and panic attacks has been treated with sertraline (100 mg/d) for the past 8 months. She has also engaged in cognitive behavioral therapy (CBT) for 6 months. Her Generalized Anxiety Disorder-7 score has decreased from 19 prior to treatment to 5 at present. Now she would like to stop her antidepressant medication because she feels better. Would you recommend that she discontinue her medication at this point?

Anxiety disorders are common and often chronic and can cause significant morbidity and impairment.^2,3 Firstline treatments for anxiety disorders include CBT and antidepressants, particularly selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors.^4-6

There is limited evidence regarding duration of antidepressant therapy for anxiety disorders. Previous studies have shown a high risk for relapse after discontinuation of antidepressants.⁶ A review of current practice patterns regarding pharmacologic treatment of depression and anxiety indicates an uptick in longer term antidepressant use for up to 2 years.7 However, long-term studies to guide treatment decisions are lacking.

STUDY SUMMARY

Clear benefit of continuing treatment

This systematic review and meta-analysis evaluated studies that looked at relapse rates and time to relapse in patients treated for anxiety disorders.¹ The authors used PubMed, Cochrane, and Embase to identify studies involving patients treated for a variety of psychiatric disorders, including GAD, posttraumatic stress disorder (PTSD), panic disorder (PD), obsessive compulsive disorder (OCD), and social phobia. Eligible studies enrolled patients with anxiety disorders who had a positive response to an antidepressant and then randomized them in a double-blind fashion to either discontinuation of antidepressants and commencement of placebo (stopping group) or continuation of antidepressants (continuation group) for a duration of 8 to 52 weeks. The primary outcomes were relapse rate and time to relapse.

Twenty-eight studies met the inclusion criteria for the meta-analysis, with a total of 5233 patients (2625 patients in the continuation group and 2608 patients in the stopping group). A breakdown of the trials by indication included OCD (7), PD (6), GAD (6), social phobia (5), and PTSD (4). The authors graded the overall risk for bias to be low but noted that attrition bias was present in most studies.

Continue to: Results

Results. Relapse was more likely in the stopping group (odds ratio [OR], 3.11; n = 28 studies). Heterogeneity for relapse rate was low (I² = 8.07%). Subgroup analyses by type of antidepressant, mode of discontinuation, and exclusion of patient comorbidities yielded similar results. Relapse prevalence was 16.4% in the continuation group and 36.4% in the stopping group. Additionally, time to relapse was shorter when antidepressants were discontinued (hazard ratio [HR], 3.63; n = 11 studies). Again, the heterogeneity for relapse rate was low (I2 = 0%). The original publications did not consistently report medication tolerance or withdrawal symptoms, preventing analysis of these. Dropout rates were higher in the stopping group (OR, 1.31; n = 27 studies).

WHAT’S NEW

No more guessing about how long to treat

Previously, there was limited evidence to guide decisions about the duration of antidepressant treatment for anxiety disorders. This study provides evidence that stopping antidepressants before completing 1 year of treatment increases the risk for relapse.

CAVEATS

In a word: Bias

While the authors used standard and appropriate methodologies for this type of study, some significant threats to validity remained. All but 2 studies in the analysis were industry funded. Publication bias is another potential issue, even though the authors identified and included 6 unpublished studies, 4 of which had negative results.

Additionally, the authors graded 11 of 28 trials as having a high likelihood of selective reporting bias, meaning that important portions of the original studies’ results may not have been published. Most studies were at high risk for attrition bias, resulting in loss of information when patients dropped out of the study. While this happened more often in the stopping groups, it is still possible that there are unidentified harms or unexpected outcomes in the medication groups.

While PTSD and OCD are no longer considered anxiety disorders, subgroup analyses found no difference in relapse rates between these diagnoses and the others included in the studies. Finally, a treatment duration longer than 52 weeks has not been studied, so the optimal treatment duration is unknown.

Continue to: CHALLENGES TO IMPLEMENTATION

Patient resistance to continuing treatment

Some patients may want to discontinue antidepressant treatment if their anxiety symptoms improve before completing 1 year. It may be difficult to convince them that continuing treatment will prevent relapse of their condition. Providing patients with information about the increased relapse rate associated with stopping their antidepressant early (with an estimated number needed to treat of 5) may help patients make a more informed decision.

ACKNOWLEDGMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[7]:409-410).

PRACTICE CHANGER

Keep patients on antidepressant therapy for anxiety disorders for a year or longer before considering a taper.¹

STRENGTH OF RECOMMENDATION

A: Based on a systematic review/meta-analysis of several good-quality randomized controlled trials.

A 42-year-old woman with generalized anxiety disorder (GAD) and panic attacks has been treated with sertraline (100 mg/d) for the past 8 months. She has also engaged in cognitive behavioral therapy (CBT) for 6 months. Her Generalized Anxiety Disorder-7 score has decreased from 19 prior to treatment to 5 at present. Now she would like to stop her antidepressant medication because she feels better. Would you recommend that she discontinue her medication at this point?

Anxiety disorders are common and often chronic and can cause significant morbidity and impairment.^2,3 Firstline treatments for anxiety disorders include CBT and antidepressants, particularly selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors.^4-6

There is limited evidence regarding duration of antidepressant therapy for anxiety disorders. Previous studies have shown a high risk for relapse after discontinuation of antidepressants.⁶ A review of current practice patterns regarding pharmacologic treatment of depression and anxiety indicates an uptick in longer term antidepressant use for up to 2 years.7 However, long-term studies to guide treatment decisions are lacking.

STUDY SUMMARY

Clear benefit of continuing treatment

This systematic review and meta-analysis evaluated studies that looked at relapse rates and time to relapse in patients treated for anxiety disorders.¹ The authors used PubMed, Cochrane, and Embase to identify studies involving patients treated for a variety of psychiatric disorders, including GAD, posttraumatic stress disorder (PTSD), panic disorder (PD), obsessive compulsive disorder (OCD), and social phobia. Eligible studies enrolled patients with anxiety disorders who had a positive response to an antidepressant and then randomized them in a double-blind fashion to either discontinuation of antidepressants and commencement of placebo (stopping group) or continuation of antidepressants (continuation group) for a duration of 8 to 52 weeks. The primary outcomes were relapse rate and time to relapse.

Twenty-eight studies met the inclusion criteria for the meta-analysis, with a total of 5233 patients (2625 patients in the continuation group and 2608 patients in the stopping group). A breakdown of the trials by indication included OCD (7), PD (6), GAD (6), social phobia (5), and PTSD (4). The authors graded the overall risk for bias to be low but noted that attrition bias was present in most studies.

Continue to: Results

Results. Relapse was more likely in the stopping group (odds ratio [OR], 3.11; n = 28 studies). Heterogeneity for relapse rate was low (I² = 8.07%). Subgroup analyses by type of antidepressant, mode of discontinuation, and exclusion of patient comorbidities yielded similar results. Relapse prevalence was 16.4% in the continuation group and 36.4% in the stopping group. Additionally, time to relapse was shorter when antidepressants were discontinued (hazard ratio [HR], 3.63; n = 11 studies). Again, the heterogeneity for relapse rate was low (I2 = 0%). The original publications did not consistently report medication tolerance or withdrawal symptoms, preventing analysis of these. Dropout rates were higher in the stopping group (OR, 1.31; n = 27 studies).

WHAT’S NEW

No more guessing about how long to treat

Previously, there was limited evidence to guide decisions about the duration of antidepressant treatment for anxiety disorders. This study provides evidence that stopping antidepressants before completing 1 year of treatment increases the risk for relapse.

CAVEATS

In a word: Bias

While the authors used standard and appropriate methodologies for this type of study, some significant threats to validity remained. All but 2 studies in the analysis were industry funded. Publication bias is another potential issue, even though the authors identified and included 6 unpublished studies, 4 of which had negative results.

Additionally, the authors graded 11 of 28 trials as having a high likelihood of selective reporting bias, meaning that important portions of the original studies’ results may not have been published. Most studies were at high risk for attrition bias, resulting in loss of information when patients dropped out of the study. While this happened more often in the stopping groups, it is still possible that there are unidentified harms or unexpected outcomes in the medication groups.

While PTSD and OCD are no longer considered anxiety disorders, subgroup analyses found no difference in relapse rates between these diagnoses and the others included in the studies. Finally, a treatment duration longer than 52 weeks has not been studied, so the optimal treatment duration is unknown.

Continue to: CHALLENGES TO IMPLEMENTATION

Patient resistance to continuing treatment

Some patients may want to discontinue antidepressant treatment if their anxiety symptoms improve before completing 1 year. It may be difficult to convince them that continuing treatment will prevent relapse of their condition. Providing patients with information about the increased relapse rate associated with stopping their antidepressant early (with an estimated number needed to treat of 5) may help patients make a more informed decision.

ACKNOWLEDGMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[7]:409-410).

PRACTICE CHANGER

Keep patients on antidepressant therapy for anxiety disorders for a year or longer before considering a taper.¹

STRENGTH OF RECOMMENDATION

A: Based on a systematic review/meta-analysis of several good-quality randomized controlled trials.

A 42-year-old woman with generalized anxiety disorder (GAD) and panic attacks has been treated with sertraline (100 mg/d) for the past 8 months. She has also engaged in cognitive behavioral therapy (CBT) for 6 months. Her Generalized Anxiety Disorder-7 score has decreased from 19 prior to treatment to 5 at present. Now she would like to stop her antidepressant medication because she feels better. Would you recommend that she discontinue her medication at this point?

Anxiety disorders are common and often chronic and can cause significant morbidity and impairment.^2,3 Firstline treatments for anxiety disorders include CBT and antidepressants, particularly selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors.^4-6

There is limited evidence regarding duration of antidepressant therapy for anxiety disorders. Previous studies have shown a high risk for relapse after discontinuation of antidepressants.⁶ A review of current practice patterns regarding pharmacologic treatment of depression and anxiety indicates an uptick in longer term antidepressant use for up to 2 years.7 However, long-term studies to guide treatment decisions are lacking.

STUDY SUMMARY

Clear benefit of continuing treatment

This systematic review and meta-analysis evaluated studies that looked at relapse rates and time to relapse in patients treated for anxiety disorders.¹ The authors used PubMed, Cochrane, and Embase to identify studies involving patients treated for a variety of psychiatric disorders, including GAD, posttraumatic stress disorder (PTSD), panic disorder (PD), obsessive compulsive disorder (OCD), and social phobia. Eligible studies enrolled patients with anxiety disorders who had a positive response to an antidepressant and then randomized them in a double-blind fashion to either discontinuation of antidepressants and commencement of placebo (stopping group) or continuation of antidepressants (continuation group) for a duration of 8 to 52 weeks. The primary outcomes were relapse rate and time to relapse.

Twenty-eight studies met the inclusion criteria for the meta-analysis, with a total of 5233 patients (2625 patients in the continuation group and 2608 patients in the stopping group). A breakdown of the trials by indication included OCD (7), PD (6), GAD (6), social phobia (5), and PTSD (4). The authors graded the overall risk for bias to be low but noted that attrition bias was present in most studies.

Continue to: Results

Results. Relapse was more likely in the stopping group (odds ratio [OR], 3.11; n = 28 studies). Heterogeneity for relapse rate was low (I² = 8.07%). Subgroup analyses by type of antidepressant, mode of discontinuation, and exclusion of patient comorbidities yielded similar results. Relapse prevalence was 16.4% in the continuation group and 36.4% in the stopping group. Additionally, time to relapse was shorter when antidepressants were discontinued (hazard ratio [HR], 3.63; n = 11 studies). Again, the heterogeneity for relapse rate was low (I2 = 0%). The original publications did not consistently report medication tolerance or withdrawal symptoms, preventing analysis of these. Dropout rates were higher in the stopping group (OR, 1.31; n = 27 studies).

WHAT’S NEW

No more guessing about how long to treat

Previously, there was limited evidence to guide decisions about the duration of antidepressant treatment for anxiety disorders. This study provides evidence that stopping antidepressants before completing 1 year of treatment increases the risk for relapse.

CAVEATS

In a word: Bias

While the authors used standard and appropriate methodologies for this type of study, some significant threats to validity remained. All but 2 studies in the analysis were industry funded. Publication bias is another potential issue, even though the authors identified and included 6 unpublished studies, 4 of which had negative results.

Additionally, the authors graded 11 of 28 trials as having a high likelihood of selective reporting bias, meaning that important portions of the original studies’ results may not have been published. Most studies were at high risk for attrition bias, resulting in loss of information when patients dropped out of the study. While this happened more often in the stopping groups, it is still possible that there are unidentified harms or unexpected outcomes in the medication groups.

While PTSD and OCD are no longer considered anxiety disorders, subgroup analyses found no difference in relapse rates between these diagnoses and the others included in the studies. Finally, a treatment duration longer than 52 weeks has not been studied, so the optimal treatment duration is unknown.

Continue to: CHALLENGES TO IMPLEMENTATION

Patient resistance to continuing treatment

Some patients may want to discontinue antidepressant treatment if their anxiety symptoms improve before completing 1 year. It may be difficult to convince them that continuing treatment will prevent relapse of their condition. Providing patients with information about the increased relapse rate associated with stopping their antidepressant early (with an estimated number needed to treat of 5) may help patients make a more informed decision.

ACKNOWLEDGMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[7]:409-410).

CHICAGO – Pediatric thyroid nodule cytopathology classified according to the Bethesda system and tracked over a 16-year period at a single center showed a higher rate of malignancy than that reported in adults.

Especially for nodules that fall into indeterminate categories, “the rate of malignancy in thyroid nodules is higher [in pediatric patients] than that reported in adults,” said Wen Jiang, MD, of the University of California San Diego and Rady Children’s Hospital, also in San Diego.

Current pediatric guidelines recommend that thyroid fine-needle aspiration (FNA) be performed only under ultrasound guidance, noted Dr. Jiang, a pediatric otolaryngologist, at the annual meeting of the American Thyroid Association. In addition, the Bethesda thyroid cytopathology system should be used to report FNA cytology results, and when cytopathology of FNA for a thyroid nodule is indeterminate, thyroid lobectomy is preferred over repeat FNA for most children with thyroid nodules.

To assess how well pediatric patients fared using the Bethesda system for thyroid cytopathology, Dr. Jiang and colleagues performed a retrospective review of children with thyroid nodules who received FNA at Rady Children’s Hospital during 2002-2018. The investigators used the Bethesda system to classify FNA results.

In addition to collecting the initial cytologic findings and demographic data, Dr. Jiang and colleagues also tracked repeat cytology and histopathology, as well as any radiographic and clinical follow-up data that were available.

A total of 203 cytologic samples were available from 171 patients. In all, 50 patients (29.2%) had malignancy. The mean age was about 15 years (range, 6-18 years), and the ratio of 140 female to 31 male participants was 4.5:1.

All but 21 of the samples were performed under ultrasound guidance. The nondiagnostic rate for ultrasound-guided samples was 11.5%, and for those obtained without use of ultrasound – which occurred in older cases – the nondiagnostic rate was 38.5%. “Ultrasound guidance improves the diagnostic rate,” said Dr. Jiang, adding that incorporation of on-site adequacy testing also “significantly decreased the nondiagnostic rate over the study period.”

The Bethesda system has the following six diagnostic categories, with each accompanied by follow-up recommendations in the adult population.

• Category I is nondiagnostic, and a repeat ultrasound-guided FNA is recommended for adults in this category.
• Category II is benign. Patients with these nodules should receive clinical follow-up and repeat ultrasound examination.
• Category III nodules may show atypia of undetermined significance or be judged a follicular lesion of undetermined significance. Here, adult management options include repeat FNA, molecular testing, or thyroid lobectomy.
• Category IV nodules may be assessed as follicular neoplasm or as suspicious for follicular neoplasm. Molecular testing or lobectomy are the adult management options.
• Category V describes nodules suspicious for malignancy. Either lobectomy or total thyroidectomy are options for adult management.
• Category VI is reserved for clearly malignant nodules. Again, lobectomy or total thyroidectomy are the adult management options.

In terms of the real-world outcomes in this cohort of pediatric patients with nodules, 14.8% of the 29 nodules with Bethesda category I – nondiagnostic – status were later found to be malignant, a higher rate than the 5%-10% expected in adults. Of 106 Bethesda category II – benign – nodules, 4% were malignant. In adults, 0%-3% of category II nodules turn out to be malignant.

Cytopathology from FNA of 22 nodules fell into the Bethesda category III, and 25% were malignant, which was within the expected range of 10%-30% for adults. “Bethesda class II accurately identified benign nodules with low risk of subsequent malignancy,” said Dr. Jiang.

Fourteen nodules were Bethesda category IV, and of those, 42.9% were malignant, again slightly higher than the 25%-40% expected in adults.

Just six nodules had FNA results falling into Bethesda category V, of which 83.3% were malignant, a higher rate than the 50%-75% expected for adult category V cytopathology results. All category V nodules were papillary thyroid carcinoma.

All 26 Bethesda category VI nodules were malignant; in adult category VI nodules, 97%-99% are expected to be malignant. All but four of the cases were found to be papillary thyroid carcinoma.

Dr. Jiang explained that at Rady Children’s Hospital, all FNA cytology slides received a second-opinion assessment by pathologists at the University of California San Diego. Of all the samples assessed in the study, there was disagreement about one slide, with a difference of one Bethesda category. “Malignant class cytology is quite reliable,” she said, adding the caveat that “second-opinion confirmation adds additional confidence to the cytologic diagnosis.”

She emphasized again that the initiation of on-site testing for sample adequacy significantly decreased the nondiagnostic rate seen over the course of the study.

Dr. Jiang reported no relevant conflicts of interest and no outside sources of funding.

[email protected]

SOURCE: Jiang W et al. ATA 2019, Oral Abstract 34.

CHICAGO – Pediatric thyroid nodule cytopathology classified according to the Bethesda system and tracked over a 16-year period at a single center showed a higher rate of malignancy than that reported in adults.

Especially for nodules that fall into indeterminate categories, “the rate of malignancy in thyroid nodules is higher [in pediatric patients] than that reported in adults,” said Wen Jiang, MD, of the University of California San Diego and Rady Children’s Hospital, also in San Diego.

Current pediatric guidelines recommend that thyroid fine-needle aspiration (FNA) be performed only under ultrasound guidance, noted Dr. Jiang, a pediatric otolaryngologist, at the annual meeting of the American Thyroid Association. In addition, the Bethesda thyroid cytopathology system should be used to report FNA cytology results, and when cytopathology of FNA for a thyroid nodule is indeterminate, thyroid lobectomy is preferred over repeat FNA for most children with thyroid nodules.

To assess how well pediatric patients fared using the Bethesda system for thyroid cytopathology, Dr. Jiang and colleagues performed a retrospective review of children with thyroid nodules who received FNA at Rady Children’s Hospital during 2002-2018. The investigators used the Bethesda system to classify FNA results.

In addition to collecting the initial cytologic findings and demographic data, Dr. Jiang and colleagues also tracked repeat cytology and histopathology, as well as any radiographic and clinical follow-up data that were available.

A total of 203 cytologic samples were available from 171 patients. In all, 50 patients (29.2%) had malignancy. The mean age was about 15 years (range, 6-18 years), and the ratio of 140 female to 31 male participants was 4.5:1.

All but 21 of the samples were performed under ultrasound guidance. The nondiagnostic rate for ultrasound-guided samples was 11.5%, and for those obtained without use of ultrasound – which occurred in older cases – the nondiagnostic rate was 38.5%. “Ultrasound guidance improves the diagnostic rate,” said Dr. Jiang, adding that incorporation of on-site adequacy testing also “significantly decreased the nondiagnostic rate over the study period.”

The Bethesda system has the following six diagnostic categories, with each accompanied by follow-up recommendations in the adult population.

• Category I is nondiagnostic, and a repeat ultrasound-guided FNA is recommended for adults in this category.
• Category II is benign. Patients with these nodules should receive clinical follow-up and repeat ultrasound examination.
• Category III nodules may show atypia of undetermined significance or be judged a follicular lesion of undetermined significance. Here, adult management options include repeat FNA, molecular testing, or thyroid lobectomy.
• Category IV nodules may be assessed as follicular neoplasm or as suspicious for follicular neoplasm. Molecular testing or lobectomy are the adult management options.
• Category V describes nodules suspicious for malignancy. Either lobectomy or total thyroidectomy are options for adult management.
• Category VI is reserved for clearly malignant nodules. Again, lobectomy or total thyroidectomy are the adult management options.

In terms of the real-world outcomes in this cohort of pediatric patients with nodules, 14.8% of the 29 nodules with Bethesda category I – nondiagnostic – status were later found to be malignant, a higher rate than the 5%-10% expected in adults. Of 106 Bethesda category II – benign – nodules, 4% were malignant. In adults, 0%-3% of category II nodules turn out to be malignant.

Cytopathology from FNA of 22 nodules fell into the Bethesda category III, and 25% were malignant, which was within the expected range of 10%-30% for adults. “Bethesda class II accurately identified benign nodules with low risk of subsequent malignancy,” said Dr. Jiang.

Fourteen nodules were Bethesda category IV, and of those, 42.9% were malignant, again slightly higher than the 25%-40% expected in adults.

Just six nodules had FNA results falling into Bethesda category V, of which 83.3% were malignant, a higher rate than the 50%-75% expected for adult category V cytopathology results. All category V nodules were papillary thyroid carcinoma.

All 26 Bethesda category VI nodules were malignant; in adult category VI nodules, 97%-99% are expected to be malignant. All but four of the cases were found to be papillary thyroid carcinoma.

Dr. Jiang explained that at Rady Children’s Hospital, all FNA cytology slides received a second-opinion assessment by pathologists at the University of California San Diego. Of all the samples assessed in the study, there was disagreement about one slide, with a difference of one Bethesda category. “Malignant class cytology is quite reliable,” she said, adding the caveat that “second-opinion confirmation adds additional confidence to the cytologic diagnosis.”

She emphasized again that the initiation of on-site testing for sample adequacy significantly decreased the nondiagnostic rate seen over the course of the study.

Dr. Jiang reported no relevant conflicts of interest and no outside sources of funding.

[email protected]

SOURCE: Jiang W et al. ATA 2019, Oral Abstract 34.

CHICAGO – Pediatric thyroid nodule cytopathology classified according to the Bethesda system and tracked over a 16-year period at a single center showed a higher rate of malignancy than that reported in adults.

Especially for nodules that fall into indeterminate categories, “the rate of malignancy in thyroid nodules is higher [in pediatric patients] than that reported in adults,” said Wen Jiang, MD, of the University of California San Diego and Rady Children’s Hospital, also in San Diego.

Current pediatric guidelines recommend that thyroid fine-needle aspiration (FNA) be performed only under ultrasound guidance, noted Dr. Jiang, a pediatric otolaryngologist, at the annual meeting of the American Thyroid Association. In addition, the Bethesda thyroid cytopathology system should be used to report FNA cytology results, and when cytopathology of FNA for a thyroid nodule is indeterminate, thyroid lobectomy is preferred over repeat FNA for most children with thyroid nodules.

To assess how well pediatric patients fared using the Bethesda system for thyroid cytopathology, Dr. Jiang and colleagues performed a retrospective review of children with thyroid nodules who received FNA at Rady Children’s Hospital during 2002-2018. The investigators used the Bethesda system to classify FNA results.

In addition to collecting the initial cytologic findings and demographic data, Dr. Jiang and colleagues also tracked repeat cytology and histopathology, as well as any radiographic and clinical follow-up data that were available.

A total of 203 cytologic samples were available from 171 patients. In all, 50 patients (29.2%) had malignancy. The mean age was about 15 years (range, 6-18 years), and the ratio of 140 female to 31 male participants was 4.5:1.

All but 21 of the samples were performed under ultrasound guidance. The nondiagnostic rate for ultrasound-guided samples was 11.5%, and for those obtained without use of ultrasound – which occurred in older cases – the nondiagnostic rate was 38.5%. “Ultrasound guidance improves the diagnostic rate,” said Dr. Jiang, adding that incorporation of on-site adequacy testing also “significantly decreased the nondiagnostic rate over the study period.”

The Bethesda system has the following six diagnostic categories, with each accompanied by follow-up recommendations in the adult population.

• Category I is nondiagnostic, and a repeat ultrasound-guided FNA is recommended for adults in this category.
• Category II is benign. Patients with these nodules should receive clinical follow-up and repeat ultrasound examination.
• Category III nodules may show atypia of undetermined significance or be judged a follicular lesion of undetermined significance. Here, adult management options include repeat FNA, molecular testing, or thyroid lobectomy.
• Category IV nodules may be assessed as follicular neoplasm or as suspicious for follicular neoplasm. Molecular testing or lobectomy are the adult management options.
• Category V describes nodules suspicious for malignancy. Either lobectomy or total thyroidectomy are options for adult management.
• Category VI is reserved for clearly malignant nodules. Again, lobectomy or total thyroidectomy are the adult management options.

In terms of the real-world outcomes in this cohort of pediatric patients with nodules, 14.8% of the 29 nodules with Bethesda category I – nondiagnostic – status were later found to be malignant, a higher rate than the 5%-10% expected in adults. Of 106 Bethesda category II – benign – nodules, 4% were malignant. In adults, 0%-3% of category II nodules turn out to be malignant.

Cytopathology from FNA of 22 nodules fell into the Bethesda category III, and 25% were malignant, which was within the expected range of 10%-30% for adults. “Bethesda class II accurately identified benign nodules with low risk of subsequent malignancy,” said Dr. Jiang.

Fourteen nodules were Bethesda category IV, and of those, 42.9% were malignant, again slightly higher than the 25%-40% expected in adults.

Just six nodules had FNA results falling into Bethesda category V, of which 83.3% were malignant, a higher rate than the 50%-75% expected for adult category V cytopathology results. All category V nodules were papillary thyroid carcinoma.

All 26 Bethesda category VI nodules were malignant; in adult category VI nodules, 97%-99% are expected to be malignant. All but four of the cases were found to be papillary thyroid carcinoma.

Dr. Jiang explained that at Rady Children’s Hospital, all FNA cytology slides received a second-opinion assessment by pathologists at the University of California San Diego. Of all the samples assessed in the study, there was disagreement about one slide, with a difference of one Bethesda category. “Malignant class cytology is quite reliable,” she said, adding the caveat that “second-opinion confirmation adds additional confidence to the cytologic diagnosis.”

She emphasized again that the initiation of on-site testing for sample adequacy significantly decreased the nondiagnostic rate seen over the course of the study.

Dr. Jiang reported no relevant conflicts of interest and no outside sources of funding.

[email protected]

SOURCE: Jiang W et al. ATA 2019, Oral Abstract 34.

After only 8 weeks, the 2019-2020 influenza season already has made itself noteworthy.

For the week ending Nov. 23, there were five states, along with Puerto Rico, at the highest level of the Centers for Disease Control and Prevention’s 1-10 scale of flu activity. That’s more than any year since 2012, including the pandemic season of 2017-2018, according to CDC data, and may suggest either an early peak or the beginning of a particularly bad winter.

“Nationally, ILI [influenza-like illness] activity has been at or above baseline for 3 weeks; however, the amount of influenza activity across the country varies with the south and parts of the west seeing elevated activity while other parts of the country are still seeing low activity,” the CDC’s influenza division said in its weekly FluView report.

The five highest-activity states – Alabama, Georgia, Louisiana, Mississippi, and Texas – are all at level 10, and they join two others – South Carolina and Tennessee, which are at level 8 – in the “high” range from 8-10 on the ILI activity scale; Puerto Rico also is at level 10. ILI is defined as “fever (temperature of 100° F [37.8° C] or greater) and a cough and/or a sore throat without a known cause other than influenza,” the CDC said.

The activity scale is based on the percentage of outpatient visits for ILI in each state, which is reported to the CDC’s Outpatient Influenza-like Illness Surveillance Network (ILINet) each week. The national rate for the week ending Nov. 23 was 2.9%, which is above the new-for-this-season baseline rate of 2.4%. For the three previous flu seasons, the national baseline was 2.2%, having been raised from its previous level of 2.1% in 2015-2016, CDC data show.

The peak month of flu activity occurs most often in February – 15 times from 1982-1983 to 2017-2018 – but there were seven peaks in December and six each in January and March over that time period, along with one peak each in October and November, the CDC said. The October peak occurred during the H1N1 pandemic year of 2009, when the national outpatient ILI rate climbed to just over 7.7%.
 

[email protected]

After only 8 weeks, the 2019-2020 influenza season already has made itself noteworthy.

For the week ending Nov. 23, there were five states, along with Puerto Rico, at the highest level of the Centers for Disease Control and Prevention’s 1-10 scale of flu activity. That’s more than any year since 2012, including the pandemic season of 2017-2018, according to CDC data, and may suggest either an early peak or the beginning of a particularly bad winter.

“Nationally, ILI [influenza-like illness] activity has been at or above baseline for 3 weeks; however, the amount of influenza activity across the country varies with the south and parts of the west seeing elevated activity while other parts of the country are still seeing low activity,” the CDC’s influenza division said in its weekly FluView report.

The five highest-activity states – Alabama, Georgia, Louisiana, Mississippi, and Texas – are all at level 10, and they join two others – South Carolina and Tennessee, which are at level 8 – in the “high” range from 8-10 on the ILI activity scale; Puerto Rico also is at level 10. ILI is defined as “fever (temperature of 100° F [37.8° C] or greater) and a cough and/or a sore throat without a known cause other than influenza,” the CDC said.

The activity scale is based on the percentage of outpatient visits for ILI in each state, which is reported to the CDC’s Outpatient Influenza-like Illness Surveillance Network (ILINet) each week. The national rate for the week ending Nov. 23 was 2.9%, which is above the new-for-this-season baseline rate of 2.4%. For the three previous flu seasons, the national baseline was 2.2%, having been raised from its previous level of 2.1% in 2015-2016, CDC data show.

The peak month of flu activity occurs most often in February – 15 times from 1982-1983 to 2017-2018 – but there were seven peaks in December and six each in January and March over that time period, along with one peak each in October and November, the CDC said. The October peak occurred during the H1N1 pandemic year of 2009, when the national outpatient ILI rate climbed to just over 7.7%.
 

[email protected]

After only 8 weeks, the 2019-2020 influenza season already has made itself noteworthy.

For the week ending Nov. 23, there were five states, along with Puerto Rico, at the highest level of the Centers for Disease Control and Prevention’s 1-10 scale of flu activity. That’s more than any year since 2012, including the pandemic season of 2017-2018, according to CDC data, and may suggest either an early peak or the beginning of a particularly bad winter.

“Nationally, ILI [influenza-like illness] activity has been at or above baseline for 3 weeks; however, the amount of influenza activity across the country varies with the south and parts of the west seeing elevated activity while other parts of the country are still seeing low activity,” the CDC’s influenza division said in its weekly FluView report.

The five highest-activity states – Alabama, Georgia, Louisiana, Mississippi, and Texas – are all at level 10, and they join two others – South Carolina and Tennessee, which are at level 8 – in the “high” range from 8-10 on the ILI activity scale; Puerto Rico also is at level 10. ILI is defined as “fever (temperature of 100° F [37.8° C] or greater) and a cough and/or a sore throat without a known cause other than influenza,” the CDC said.

The activity scale is based on the percentage of outpatient visits for ILI in each state, which is reported to the CDC’s Outpatient Influenza-like Illness Surveillance Network (ILINet) each week. The national rate for the week ending Nov. 23 was 2.9%, which is above the new-for-this-season baseline rate of 2.4%. For the three previous flu seasons, the national baseline was 2.2%, having been raised from its previous level of 2.1% in 2015-2016, CDC data show.

The peak month of flu activity occurs most often in February – 15 times from 1982-1983 to 2017-2018 – but there were seven peaks in December and six each in January and March over that time period, along with one peak each in October and November, the CDC said. The October peak occurred during the H1N1 pandemic year of 2009, when the national outpatient ILI rate climbed to just over 7.7%.
 

[email protected]

SAN ANTONIO – Three-quarters of gastroenterologists who participated in an American College of Gastroenterology–sponsored national survey indicated they have experienced endoscopy-related musculoskeletal injuries, Swati Pawa, MD, reported at the annual meeting of the American College of Gastroenterology.

Moreover, most respondents said they received zero training in ergonomic strategies for endoscopy-related injury (ERI) prevention during their fellowship training. And there’s been none since. Eighty-one percent of respondents indicated they would welcome such training, added Dr. Pawa, a gastroenterologist at Wake Forest University, Winston-Salem, N.C.

The survey results expose a glaring unmet need in clinical practice, she said: “There have been no published guidelines from any of the major professional GI societies to date addressing how to prevent endoscopy-related injuries.”

The 38-item survey was created by the ACG Women in GI Committee and sponsored by the ACG governing board.

Among the key findings was the identification of sex differences in the types of ERIs reported, which suggests different contributory mechanisms. For example, female gastroenterologists were more likely than were their male colleagues to have experienced ERIs involving the upper back, by a margin of 49% to 36%. Upper extremity pain was more common among the women, too, with 63% reporting hand or finger pain, compared with 53% of men. Twenty-four percent of women reported carpal tunnel syndrome and an equal percentage developed tendonitis, compared with 18% and 17% of men, respectively.

Seventy-one percent of women attributed their ERI to torquing with their right hand, as did 63% of men. Women also more frequently cited having to deal with a nonadjustable bed or monitor as contributing to injury. In contrast, roughly twice as many men as women attributed their ERI to wearing a lead apron or use of the elevator on the duodenoscope.

Equally common causes of ERIs in men and women included standing in awkward positions while supporting an endoscope, standing for a long time, and adjusting tip angulation with the left hand.

Male and female gastroenterologists differed in their practice patterns. The men had been performing endoscopy for a mean of 23 years, compared with 13 years for the women. Fifty-six percent of the men were in private practice, compared with 35% of the women. In contrast, 43% of the women worked in academic settings versus 28% of the men. Thirty percent of the male gastroenterologists characterized themselves as interventional specialists, a rate more than twice that in women, who more commonly specialized in inflammatory bowel disease.

The survey was sent to nearly 16,000 ACG members. It generated a 14% response rate. Roughly two-thirds of responses were provided by male gastroenterologists.

Dr. Pawa and her coinvestigators are now drilling down through the survey data in an effort to identify an appropriate endoscopy workload limit that’s associated with reduced ERI risk.

One audience member commented, “The incidence of ERI in your survey is much higher than most of us would expect.” He speculated that response bias might be at work, with gastroenterologists who have personally experienced an ERI being perhaps more highly motivated to be among the 14% who completed the 38-question survey. Dr. Pawa replied that the survey figures are in line with other, smaller studies.

She reported having no financial conflicts regarding her study.

[email protected]

Visit https://www.ddwnews.org/news/aga-session-offers-ergonomics-tips-for-endoscopy/ for ergonomics tips for endoscopy presented during Digestive Disease Week® 2019. 

SAN ANTONIO – Three-quarters of gastroenterologists who participated in an American College of Gastroenterology–sponsored national survey indicated they have experienced endoscopy-related musculoskeletal injuries, Swati Pawa, MD, reported at the annual meeting of the American College of Gastroenterology.

Moreover, most respondents said they received zero training in ergonomic strategies for endoscopy-related injury (ERI) prevention during their fellowship training. And there’s been none since. Eighty-one percent of respondents indicated they would welcome such training, added Dr. Pawa, a gastroenterologist at Wake Forest University, Winston-Salem, N.C.

The survey results expose a glaring unmet need in clinical practice, she said: “There have been no published guidelines from any of the major professional GI societies to date addressing how to prevent endoscopy-related injuries.”

The 38-item survey was created by the ACG Women in GI Committee and sponsored by the ACG governing board.

Among the key findings was the identification of sex differences in the types of ERIs reported, which suggests different contributory mechanisms. For example, female gastroenterologists were more likely than were their male colleagues to have experienced ERIs involving the upper back, by a margin of 49% to 36%. Upper extremity pain was more common among the women, too, with 63% reporting hand or finger pain, compared with 53% of men. Twenty-four percent of women reported carpal tunnel syndrome and an equal percentage developed tendonitis, compared with 18% and 17% of men, respectively.

Seventy-one percent of women attributed their ERI to torquing with their right hand, as did 63% of men. Women also more frequently cited having to deal with a nonadjustable bed or monitor as contributing to injury. In contrast, roughly twice as many men as women attributed their ERI to wearing a lead apron or use of the elevator on the duodenoscope.

Equally common causes of ERIs in men and women included standing in awkward positions while supporting an endoscope, standing for a long time, and adjusting tip angulation with the left hand.

Male and female gastroenterologists differed in their practice patterns. The men had been performing endoscopy for a mean of 23 years, compared with 13 years for the women. Fifty-six percent of the men were in private practice, compared with 35% of the women. In contrast, 43% of the women worked in academic settings versus 28% of the men. Thirty percent of the male gastroenterologists characterized themselves as interventional specialists, a rate more than twice that in women, who more commonly specialized in inflammatory bowel disease.

The survey was sent to nearly 16,000 ACG members. It generated a 14% response rate. Roughly two-thirds of responses were provided by male gastroenterologists.

Dr. Pawa and her coinvestigators are now drilling down through the survey data in an effort to identify an appropriate endoscopy workload limit that’s associated with reduced ERI risk.

One audience member commented, “The incidence of ERI in your survey is much higher than most of us would expect.” He speculated that response bias might be at work, with gastroenterologists who have personally experienced an ERI being perhaps more highly motivated to be among the 14% who completed the 38-question survey. Dr. Pawa replied that the survey figures are in line with other, smaller studies.

She reported having no financial conflicts regarding her study.

[email protected]

Visit https://www.ddwnews.org/news/aga-session-offers-ergonomics-tips-for-endoscopy/ for ergonomics tips for endoscopy presented during Digestive Disease Week® 2019. 

SAN ANTONIO – Three-quarters of gastroenterologists who participated in an American College of Gastroenterology–sponsored national survey indicated they have experienced endoscopy-related musculoskeletal injuries, Swati Pawa, MD, reported at the annual meeting of the American College of Gastroenterology.

Moreover, most respondents said they received zero training in ergonomic strategies for endoscopy-related injury (ERI) prevention during their fellowship training. And there’s been none since. Eighty-one percent of respondents indicated they would welcome such training, added Dr. Pawa, a gastroenterologist at Wake Forest University, Winston-Salem, N.C.

The survey results expose a glaring unmet need in clinical practice, she said: “There have been no published guidelines from any of the major professional GI societies to date addressing how to prevent endoscopy-related injuries.”

The 38-item survey was created by the ACG Women in GI Committee and sponsored by the ACG governing board.

Among the key findings was the identification of sex differences in the types of ERIs reported, which suggests different contributory mechanisms. For example, female gastroenterologists were more likely than were their male colleagues to have experienced ERIs involving the upper back, by a margin of 49% to 36%. Upper extremity pain was more common among the women, too, with 63% reporting hand or finger pain, compared with 53% of men. Twenty-four percent of women reported carpal tunnel syndrome and an equal percentage developed tendonitis, compared with 18% and 17% of men, respectively.

Seventy-one percent of women attributed their ERI to torquing with their right hand, as did 63% of men. Women also more frequently cited having to deal with a nonadjustable bed or monitor as contributing to injury. In contrast, roughly twice as many men as women attributed their ERI to wearing a lead apron or use of the elevator on the duodenoscope.

Equally common causes of ERIs in men and women included standing in awkward positions while supporting an endoscope, standing for a long time, and adjusting tip angulation with the left hand.

Male and female gastroenterologists differed in their practice patterns. The men had been performing endoscopy for a mean of 23 years, compared with 13 years for the women. Fifty-six percent of the men were in private practice, compared with 35% of the women. In contrast, 43% of the women worked in academic settings versus 28% of the men. Thirty percent of the male gastroenterologists characterized themselves as interventional specialists, a rate more than twice that in women, who more commonly specialized in inflammatory bowel disease.

The survey was sent to nearly 16,000 ACG members. It generated a 14% response rate. Roughly two-thirds of responses were provided by male gastroenterologists.

Dr. Pawa and her coinvestigators are now drilling down through the survey data in an effort to identify an appropriate endoscopy workload limit that’s associated with reduced ERI risk.

One audience member commented, “The incidence of ERI in your survey is much higher than most of us would expect.” He speculated that response bias might be at work, with gastroenterologists who have personally experienced an ERI being perhaps more highly motivated to be among the 14% who completed the 38-question survey. Dr. Pawa replied that the survey figures are in line with other, smaller studies.

She reported having no financial conflicts regarding her study.

[email protected]

Visit https://www.ddwnews.org/news/aga-session-offers-ergonomics-tips-for-endoscopy/ for ergonomics tips for endoscopy presented during Digestive Disease Week® 2019. 

In the United States, endoscopists who participate in advanced endoscopy fellowship programs use rectal NSAIDs more often than pancreatic duct stent placement to prevent post-ERCP pancreatitis (PEP), according to research published online in Gastrointestinal Endoscopy. In addition, methods for PEP prophylaxis in clinical practice are not implemented to the extent that the current evidence warrants.

“Future studies should not only further clarify the optimal PEP prophylaxis strategy, but should also focus on strategies to improve the implementation of evidence-based PEP prophylaxis techniques,” wrote Patrick Avila, MD, MPH, gastroenterologist at the University of California, San Francisco, and colleagues.
 

A survey of American endoscopists

Approximately 4% of patients who undergo biliopancreatic endoscopy develop PEP, which has a mortality rate of 3%. The American Society for Gastrointestinal Endoscopy (ASGE) recommends prophylactic pancreatic duct stent placement and rectal NSAIDs to reduce the incidence and severity of PEP in patients at high risk. The ASGE further suggests that rectal indomethacin may decrease the risk and severity of PEP in patients at average risk.

The European Society for Gastrointestinal Endoscopy (ESGE) recommends rectal indomethacin for all patients undergoing ERCP (endoscopic retrograde cholangiopancreatography). Several surveys of European endoscopists, however, indicate that relatively few respondents have adopted the recommended prophylactic techniques. The literature does not contain information about practice patterns among American endoscopists, and Dr. Avila and colleagues decided to investigate this question.

The researchers developed a 16-question online survey to assess current practice patterns with regard to PEP prophylaxis. They defined ERCPs that entailed a high risk for PEP as any that involved pancreatic or precut sphincterotomy, traumatic biliary sphincterotomy, balloon dilation of the biliary sphincter, injection of the pancreatic duct, extensive pancreatic duct instrumentation, difficult cannulation, suspected sphincter of Oddi dysfunction, previous PEP, or a female patient. Dr. Avila and colleagues distributed the survey to 233 advanced endoscopists involved in advanced endoscopy fellowship training programs.
 

Respondents had years of experience

Sixty-two endoscopists (26.7%) completed the survey. Respondents’ mean age was 47 years, and most respondents (74.6%) had been performing ERCP for more than 5 years. Almost all respondents (95%) worked at a tertiary referral center, and all worked with fellows.

All respondents reported having used pancreatic duct stent placement to prevent PEP. Most responders (72%) used pancreatic duct stent placement only in patients at high risk of PEP, and 64% reported using pancreatic duct stent placement in 25% or less of the ERCPs that they had performed. Four respondents (6.8%) used pancreatic duct stent placement for PEP in more than half of ERCPs. Among endoscopists who rarely use pancreatic duct stent placement for PEP, the major reasons cited included concern about increased risk of PEP with failed pancreatic duct insertion, the belief that stents do not provide additional benefit beyond pharmacologic prophylaxis, and difficulties in following up patients to ensure stent passage.

About 98% of respondents reported using rectal NSAIDs for PEP. Thirty-four respondents (59.7%) used this treatment only for patients at high risk, and 23 respondents (40.1%) used it for patients at average risk. Among respondents who used rectal NSAIDs to prevent PEP, 67.8% used the treatment in half or more of ERCPs. The NSAID of choice was indomethacin for all respondents. One respondent reported never using rectal NSAIDs for PEP because of doubts about its efficacy, in addition to cost and availability.

In addition, 49 respondents (83.0%) reported using rapid intravenous fluids to prevent PEP. None reported using octreotide or antibiotics to prevent PEP.
 

Results may reflect recall bias

The survey reveals “a significant divergence from the scientific evidence in how PEP techniques are used in routine clinical practice,” wrote Dr. Avila and colleagues. Several studies, including a randomized controlled trial, support the use of rectal NSAIDs as prophylaxis as patients at average risk of PEP, but less than half of respondents reported using it. The ASGE guidelines state that this treatment is “reasonable,” but do not advocate for it. “If appropriate, adopting a stronger stance in our practice guidelines may lead to further widespread use of rectal NSAIDs in this group of patients,” wrote Dr. Avila and colleagues.

Pancreatic duct stent placement is a difficult procedure to perform. The success rate in one British study was 51%, and a study of expert pancreaticobiliary endoscopists found a failure rate of 7%. It therefore may not be surprising that pancreatic duct stent placement was used less often than rectal NSAIDs among respondents, according to the authors.

Dr. Avila and colleagues acknowledged that the survey’s low response rate could have introduced nonresponse bias into the findings. They also stated that the study may have been affected by selection and recall biases. The results thus may not be generalizable to other practice settings, they concluded.

The authors did not report any study funding or disclosures.

[email protected]

SOURCE: Avila P et al. Gastrointest Endosc. 2019 Nov 16. doi: 10.1016/j.gie.2019.11.013.

AGA offers resources to help your patients understand ECRP and scope safety. Learn more at https://www.gastro.org/news/help-your-patients-understand-ercp-and-scope-safety.  

In the United States, endoscopists who participate in advanced endoscopy fellowship programs use rectal NSAIDs more often than pancreatic duct stent placement to prevent post-ERCP pancreatitis (PEP), according to research published online in Gastrointestinal Endoscopy. In addition, methods for PEP prophylaxis in clinical practice are not implemented to the extent that the current evidence warrants.

“Future studies should not only further clarify the optimal PEP prophylaxis strategy, but should also focus on strategies to improve the implementation of evidence-based PEP prophylaxis techniques,” wrote Patrick Avila, MD, MPH, gastroenterologist at the University of California, San Francisco, and colleagues.
 

A survey of American endoscopists

Approximately 4% of patients who undergo biliopancreatic endoscopy develop PEP, which has a mortality rate of 3%. The American Society for Gastrointestinal Endoscopy (ASGE) recommends prophylactic pancreatic duct stent placement and rectal NSAIDs to reduce the incidence and severity of PEP in patients at high risk. The ASGE further suggests that rectal indomethacin may decrease the risk and severity of PEP in patients at average risk.

The European Society for Gastrointestinal Endoscopy (ESGE) recommends rectal indomethacin for all patients undergoing ERCP (endoscopic retrograde cholangiopancreatography). Several surveys of European endoscopists, however, indicate that relatively few respondents have adopted the recommended prophylactic techniques. The literature does not contain information about practice patterns among American endoscopists, and Dr. Avila and colleagues decided to investigate this question.

The researchers developed a 16-question online survey to assess current practice patterns with regard to PEP prophylaxis. They defined ERCPs that entailed a high risk for PEP as any that involved pancreatic or precut sphincterotomy, traumatic biliary sphincterotomy, balloon dilation of the biliary sphincter, injection of the pancreatic duct, extensive pancreatic duct instrumentation, difficult cannulation, suspected sphincter of Oddi dysfunction, previous PEP, or a female patient. Dr. Avila and colleagues distributed the survey to 233 advanced endoscopists involved in advanced endoscopy fellowship training programs.
 

Respondents had years of experience

Sixty-two endoscopists (26.7%) completed the survey. Respondents’ mean age was 47 years, and most respondents (74.6%) had been performing ERCP for more than 5 years. Almost all respondents (95%) worked at a tertiary referral center, and all worked with fellows.

All respondents reported having used pancreatic duct stent placement to prevent PEP. Most responders (72%) used pancreatic duct stent placement only in patients at high risk of PEP, and 64% reported using pancreatic duct stent placement in 25% or less of the ERCPs that they had performed. Four respondents (6.8%) used pancreatic duct stent placement for PEP in more than half of ERCPs. Among endoscopists who rarely use pancreatic duct stent placement for PEP, the major reasons cited included concern about increased risk of PEP with failed pancreatic duct insertion, the belief that stents do not provide additional benefit beyond pharmacologic prophylaxis, and difficulties in following up patients to ensure stent passage.

About 98% of respondents reported using rectal NSAIDs for PEP. Thirty-four respondents (59.7%) used this treatment only for patients at high risk, and 23 respondents (40.1%) used it for patients at average risk. Among respondents who used rectal NSAIDs to prevent PEP, 67.8% used the treatment in half or more of ERCPs. The NSAID of choice was indomethacin for all respondents. One respondent reported never using rectal NSAIDs for PEP because of doubts about its efficacy, in addition to cost and availability.

In addition, 49 respondents (83.0%) reported using rapid intravenous fluids to prevent PEP. None reported using octreotide or antibiotics to prevent PEP.
 

Results may reflect recall bias

The survey reveals “a significant divergence from the scientific evidence in how PEP techniques are used in routine clinical practice,” wrote Dr. Avila and colleagues. Several studies, including a randomized controlled trial, support the use of rectal NSAIDs as prophylaxis as patients at average risk of PEP, but less than half of respondents reported using it. The ASGE guidelines state that this treatment is “reasonable,” but do not advocate for it. “If appropriate, adopting a stronger stance in our practice guidelines may lead to further widespread use of rectal NSAIDs in this group of patients,” wrote Dr. Avila and colleagues.

Pancreatic duct stent placement is a difficult procedure to perform. The success rate in one British study was 51%, and a study of expert pancreaticobiliary endoscopists found a failure rate of 7%. It therefore may not be surprising that pancreatic duct stent placement was used less often than rectal NSAIDs among respondents, according to the authors.

Dr. Avila and colleagues acknowledged that the survey’s low response rate could have introduced nonresponse bias into the findings. They also stated that the study may have been affected by selection and recall biases. The results thus may not be generalizable to other practice settings, they concluded.

The authors did not report any study funding or disclosures.

[email protected]

SOURCE: Avila P et al. Gastrointest Endosc. 2019 Nov 16. doi: 10.1016/j.gie.2019.11.013.

AGA offers resources to help your patients understand ECRP and scope safety. Learn more at https://www.gastro.org/news/help-your-patients-understand-ercp-and-scope-safety.  

In the United States, endoscopists who participate in advanced endoscopy fellowship programs use rectal NSAIDs more often than pancreatic duct stent placement to prevent post-ERCP pancreatitis (PEP), according to research published online in Gastrointestinal Endoscopy. In addition, methods for PEP prophylaxis in clinical practice are not implemented to the extent that the current evidence warrants.

“Future studies should not only further clarify the optimal PEP prophylaxis strategy, but should also focus on strategies to improve the implementation of evidence-based PEP prophylaxis techniques,” wrote Patrick Avila, MD, MPH, gastroenterologist at the University of California, San Francisco, and colleagues.
 

A survey of American endoscopists

Approximately 4% of patients who undergo biliopancreatic endoscopy develop PEP, which has a mortality rate of 3%. The American Society for Gastrointestinal Endoscopy (ASGE) recommends prophylactic pancreatic duct stent placement and rectal NSAIDs to reduce the incidence and severity of PEP in patients at high risk. The ASGE further suggests that rectal indomethacin may decrease the risk and severity of PEP in patients at average risk.

The European Society for Gastrointestinal Endoscopy (ESGE) recommends rectal indomethacin for all patients undergoing ERCP (endoscopic retrograde cholangiopancreatography). Several surveys of European endoscopists, however, indicate that relatively few respondents have adopted the recommended prophylactic techniques. The literature does not contain information about practice patterns among American endoscopists, and Dr. Avila and colleagues decided to investigate this question.

The researchers developed a 16-question online survey to assess current practice patterns with regard to PEP prophylaxis. They defined ERCPs that entailed a high risk for PEP as any that involved pancreatic or precut sphincterotomy, traumatic biliary sphincterotomy, balloon dilation of the biliary sphincter, injection of the pancreatic duct, extensive pancreatic duct instrumentation, difficult cannulation, suspected sphincter of Oddi dysfunction, previous PEP, or a female patient. Dr. Avila and colleagues distributed the survey to 233 advanced endoscopists involved in advanced endoscopy fellowship training programs.
 

Respondents had years of experience

Sixty-two endoscopists (26.7%) completed the survey. Respondents’ mean age was 47 years, and most respondents (74.6%) had been performing ERCP for more than 5 years. Almost all respondents (95%) worked at a tertiary referral center, and all worked with fellows.

All respondents reported having used pancreatic duct stent placement to prevent PEP. Most responders (72%) used pancreatic duct stent placement only in patients at high risk of PEP, and 64% reported using pancreatic duct stent placement in 25% or less of the ERCPs that they had performed. Four respondents (6.8%) used pancreatic duct stent placement for PEP in more than half of ERCPs. Among endoscopists who rarely use pancreatic duct stent placement for PEP, the major reasons cited included concern about increased risk of PEP with failed pancreatic duct insertion, the belief that stents do not provide additional benefit beyond pharmacologic prophylaxis, and difficulties in following up patients to ensure stent passage.

About 98% of respondents reported using rectal NSAIDs for PEP. Thirty-four respondents (59.7%) used this treatment only for patients at high risk, and 23 respondents (40.1%) used it for patients at average risk. Among respondents who used rectal NSAIDs to prevent PEP, 67.8% used the treatment in half or more of ERCPs. The NSAID of choice was indomethacin for all respondents. One respondent reported never using rectal NSAIDs for PEP because of doubts about its efficacy, in addition to cost and availability.

In addition, 49 respondents (83.0%) reported using rapid intravenous fluids to prevent PEP. None reported using octreotide or antibiotics to prevent PEP.
 

Results may reflect recall bias

The survey reveals “a significant divergence from the scientific evidence in how PEP techniques are used in routine clinical practice,” wrote Dr. Avila and colleagues. Several studies, including a randomized controlled trial, support the use of rectal NSAIDs as prophylaxis as patients at average risk of PEP, but less than half of respondents reported using it. The ASGE guidelines state that this treatment is “reasonable,” but do not advocate for it. “If appropriate, adopting a stronger stance in our practice guidelines may lead to further widespread use of rectal NSAIDs in this group of patients,” wrote Dr. Avila and colleagues.

Pancreatic duct stent placement is a difficult procedure to perform. The success rate in one British study was 51%, and a study of expert pancreaticobiliary endoscopists found a failure rate of 7%. It therefore may not be surprising that pancreatic duct stent placement was used less often than rectal NSAIDs among respondents, according to the authors.

Dr. Avila and colleagues acknowledged that the survey’s low response rate could have introduced nonresponse bias into the findings. They also stated that the study may have been affected by selection and recall biases. The results thus may not be generalizable to other practice settings, they concluded.

The authors did not report any study funding or disclosures.

[email protected]

SOURCE: Avila P et al. Gastrointest Endosc. 2019 Nov 16. doi: 10.1016/j.gie.2019.11.013.

AGA offers resources to help your patients understand ECRP and scope safety. Learn more at https://www.gastro.org/news/help-your-patients-understand-ercp-and-scope-safety.  

A new study has found that keloid formation may be driven by Th2 pathogenesis and, as such, Th2-targeting dupilumab may be useful in treating chronic keloids.

“This preliminary report demonstrates a novel use of dupilumab for chronic keloids, showing major reductions in skin fibrosis and keloidal scarring,” wrote Aisleen Diaz, from the department of dermatology and laboratory of inflammatory skin diseases at the Icahn School of Medicine at Mount Sinai, New York, and coauthors. The study was published as a letter to the editor in the Journal of the European Academy of Dermatology and Venereology.

The authors described a 53-year-old black male patient with severe atopic dermatitis and two keloids who, after 7 months of treatment with dupilumab for AD, had significant improvements in AD – as well as shrinkage of the larger keloid and “complete disappearance” of the smaller keloid.

As a follow-up, the researchers used real-time polymerase chain reaction testing to monitor Th2 gene expression in lesional and nonlesional keloid skin from three black patients (mean age, 47.3 years) with severe keloids and no AD. Five healthy black controls (mean age, 39.8 years) were also included for comparison. In addition, 6-mm whole-skin biopsy specimens were obtained from all patients.

Interleukin-4 receptors, directly targeted by dupilumab, were highly up-regulated in keloid lesions, compared with controls (P less than .1). The Th2 cytokine IL-13 was significantly increased in lesional and nonlesional keloids, compared with controls (P less than .05), and the TH2 cytokine CCL18 was also highly increased in keloids, chiefly in nonlesional skin (P less than .05).

With regard to genes involved in cartilage and bone development that have been recognized as highly expressed in keloids – such as cadherin 11 and fibrillin 2 – all were increased in keloid lesions, compared with both controls and to nonlesional skin (P less than .05), the researchers reported.

“Dupilumab and other Th2-targeting agents may provide treatment options for patients with severe keloids, warranting further studies,” they commented, adding that the patient they described was the first report of a keloid improving with dupilumab, which “blocks type 2 driven inflammation via IL-4/IL-13 signaling.”

Four authors, including Ms. Diaz, had no disclosures. Two authors reported numerous disclosures, including receiving grants, research funds, and personal and consulting fees, from various pharmaceutical companies, including dupilumab manufacturers Regeneron and/or Sanofi.

SOURCE: Diaz A et al. J Eur Acad Dermatol Venereol. 2019 Nov 20. doi: 10.1111/jdv.16097.

A new study has found that keloid formation may be driven by Th2 pathogenesis and, as such, Th2-targeting dupilumab may be useful in treating chronic keloids.

“This preliminary report demonstrates a novel use of dupilumab for chronic keloids, showing major reductions in skin fibrosis and keloidal scarring,” wrote Aisleen Diaz, from the department of dermatology and laboratory of inflammatory skin diseases at the Icahn School of Medicine at Mount Sinai, New York, and coauthors. The study was published as a letter to the editor in the Journal of the European Academy of Dermatology and Venereology.

The authors described a 53-year-old black male patient with severe atopic dermatitis and two keloids who, after 7 months of treatment with dupilumab for AD, had significant improvements in AD – as well as shrinkage of the larger keloid and “complete disappearance” of the smaller keloid.

As a follow-up, the researchers used real-time polymerase chain reaction testing to monitor Th2 gene expression in lesional and nonlesional keloid skin from three black patients (mean age, 47.3 years) with severe keloids and no AD. Five healthy black controls (mean age, 39.8 years) were also included for comparison. In addition, 6-mm whole-skin biopsy specimens were obtained from all patients.

Interleukin-4 receptors, directly targeted by dupilumab, were highly up-regulated in keloid lesions, compared with controls (P less than .1). The Th2 cytokine IL-13 was significantly increased in lesional and nonlesional keloids, compared with controls (P less than .05), and the TH2 cytokine CCL18 was also highly increased in keloids, chiefly in nonlesional skin (P less than .05).

With regard to genes involved in cartilage and bone development that have been recognized as highly expressed in keloids – such as cadherin 11 and fibrillin 2 – all were increased in keloid lesions, compared with both controls and to nonlesional skin (P less than .05), the researchers reported.

“Dupilumab and other Th2-targeting agents may provide treatment options for patients with severe keloids, warranting further studies,” they commented, adding that the patient they described was the first report of a keloid improving with dupilumab, which “blocks type 2 driven inflammation via IL-4/IL-13 signaling.”

Four authors, including Ms. Diaz, had no disclosures. Two authors reported numerous disclosures, including receiving grants, research funds, and personal and consulting fees, from various pharmaceutical companies, including dupilumab manufacturers Regeneron and/or Sanofi.

SOURCE: Diaz A et al. J Eur Acad Dermatol Venereol. 2019 Nov 20. doi: 10.1111/jdv.16097.

A new study has found that keloid formation may be driven by Th2 pathogenesis and, as such, Th2-targeting dupilumab may be useful in treating chronic keloids.

“This preliminary report demonstrates a novel use of dupilumab for chronic keloids, showing major reductions in skin fibrosis and keloidal scarring,” wrote Aisleen Diaz, from the department of dermatology and laboratory of inflammatory skin diseases at the Icahn School of Medicine at Mount Sinai, New York, and coauthors. The study was published as a letter to the editor in the Journal of the European Academy of Dermatology and Venereology.

The authors described a 53-year-old black male patient with severe atopic dermatitis and two keloids who, after 7 months of treatment with dupilumab for AD, had significant improvements in AD – as well as shrinkage of the larger keloid and “complete disappearance” of the smaller keloid.

As a follow-up, the researchers used real-time polymerase chain reaction testing to monitor Th2 gene expression in lesional and nonlesional keloid skin from three black patients (mean age, 47.3 years) with severe keloids and no AD. Five healthy black controls (mean age, 39.8 years) were also included for comparison. In addition, 6-mm whole-skin biopsy specimens were obtained from all patients.

Interleukin-4 receptors, directly targeted by dupilumab, were highly up-regulated in keloid lesions, compared with controls (P less than .1). The Th2 cytokine IL-13 was significantly increased in lesional and nonlesional keloids, compared with controls (P less than .05), and the TH2 cytokine CCL18 was also highly increased in keloids, chiefly in nonlesional skin (P less than .05).

With regard to genes involved in cartilage and bone development that have been recognized as highly expressed in keloids – such as cadherin 11 and fibrillin 2 – all were increased in keloid lesions, compared with both controls and to nonlesional skin (P less than .05), the researchers reported.

“Dupilumab and other Th2-targeting agents may provide treatment options for patients with severe keloids, warranting further studies,” they commented, adding that the patient they described was the first report of a keloid improving with dupilumab, which “blocks type 2 driven inflammation via IL-4/IL-13 signaling.”

Four authors, including Ms. Diaz, had no disclosures. Two authors reported numerous disclosures, including receiving grants, research funds, and personal and consulting fees, from various pharmaceutical companies, including dupilumab manufacturers Regeneron and/or Sanofi.

SOURCE: Diaz A et al. J Eur Acad Dermatol Venereol. 2019 Nov 20. doi: 10.1111/jdv.16097.

A new study has found that a simple screening tool can identify patients at risk of postoperative delirium (POD) after orthopedic surgery, and a prevention program can help improve staff education and outcomes.

Spotmatik/Thinkstock

“In an aging society, it is very important to develop and implement a strategy for POD prevention to ensure that aging patients are treated as safely and effectively as possible,” wrote Jung-Yeon Choi of Seoul (South Korea) National University Bundang Hospital and coauthors. The study was published in BMC Geriatrics.

To determine how to better identify and treat high-risk patients for POD after orthopedic surgery, the researchers led a retrospective cohort study that included an intervention group of participants who were aged at least 65 years (n = 275) and a control group from a year prior (n = 274). Patients in the intervention group had their risk of delirium assessed and categorized using a simple screening tool, and those deemed at risk were entered into a multicomponent delirium prevention program.

Of the 275 patients in the intervention group, 144 required screening for delirium. Ninety-nine were classified as low risk, 29 were classified as high risk, and 16 missed the screening. Fifty-three additional patients were classified as high risk because they were aged 80 years or older. During the study, 17 participants experienced POD, 16 of whom were classified as high risk. In regard to estimating POD risk, the sensitivity and specificity of the delirium screening tool were 94.1% and 72.7%, respectively. Incidence rates of POD were 10.2% in the control group and 6.2% in the intervention group.

The authors noted their study’s limitations, including its design as a retrospective review of medical records rather than a prospective randomized controlled trial. In addition, because it was conducted in just one teaching hospital, they deemed it “not possible to determine the generalizability and long-term effect of our findings.”

The authors reported no conflicts of interest.

SOURCE: Choi JY et al. BMC Geriatr. 2019 Oct 26. doi: 10.1186/s12877-019-1303-z.

A new study has found that a simple screening tool can identify patients at risk of postoperative delirium (POD) after orthopedic surgery, and a prevention program can help improve staff education and outcomes.

Spotmatik/Thinkstock

“In an aging society, it is very important to develop and implement a strategy for POD prevention to ensure that aging patients are treated as safely and effectively as possible,” wrote Jung-Yeon Choi of Seoul (South Korea) National University Bundang Hospital and coauthors. The study was published in BMC Geriatrics.

To determine how to better identify and treat high-risk patients for POD after orthopedic surgery, the researchers led a retrospective cohort study that included an intervention group of participants who were aged at least 65 years (n = 275) and a control group from a year prior (n = 274). Patients in the intervention group had their risk of delirium assessed and categorized using a simple screening tool, and those deemed at risk were entered into a multicomponent delirium prevention program.

Of the 275 patients in the intervention group, 144 required screening for delirium. Ninety-nine were classified as low risk, 29 were classified as high risk, and 16 missed the screening. Fifty-three additional patients were classified as high risk because they were aged 80 years or older. During the study, 17 participants experienced POD, 16 of whom were classified as high risk. In regard to estimating POD risk, the sensitivity and specificity of the delirium screening tool were 94.1% and 72.7%, respectively. Incidence rates of POD were 10.2% in the control group and 6.2% in the intervention group.

The authors noted their study’s limitations, including its design as a retrospective review of medical records rather than a prospective randomized controlled trial. In addition, because it was conducted in just one teaching hospital, they deemed it “not possible to determine the generalizability and long-term effect of our findings.”

The authors reported no conflicts of interest.

SOURCE: Choi JY et al. BMC Geriatr. 2019 Oct 26. doi: 10.1186/s12877-019-1303-z.

A new study has found that a simple screening tool can identify patients at risk of postoperative delirium (POD) after orthopedic surgery, and a prevention program can help improve staff education and outcomes.

Spotmatik/Thinkstock

“In an aging society, it is very important to develop and implement a strategy for POD prevention to ensure that aging patients are treated as safely and effectively as possible,” wrote Jung-Yeon Choi of Seoul (South Korea) National University Bundang Hospital and coauthors. The study was published in BMC Geriatrics.

To determine how to better identify and treat high-risk patients for POD after orthopedic surgery, the researchers led a retrospective cohort study that included an intervention group of participants who were aged at least 65 years (n = 275) and a control group from a year prior (n = 274). Patients in the intervention group had their risk of delirium assessed and categorized using a simple screening tool, and those deemed at risk were entered into a multicomponent delirium prevention program.

Of the 275 patients in the intervention group, 144 required screening for delirium. Ninety-nine were classified as low risk, 29 were classified as high risk, and 16 missed the screening. Fifty-three additional patients were classified as high risk because they were aged 80 years or older. During the study, 17 participants experienced POD, 16 of whom were classified as high risk. In regard to estimating POD risk, the sensitivity and specificity of the delirium screening tool were 94.1% and 72.7%, respectively. Incidence rates of POD were 10.2% in the control group and 6.2% in the intervention group.

The authors noted their study’s limitations, including its design as a retrospective review of medical records rather than a prospective randomized controlled trial. In addition, because it was conducted in just one teaching hospital, they deemed it “not possible to determine the generalizability and long-term effect of our findings.”

The authors reported no conflicts of interest.

SOURCE: Choi JY et al. BMC Geriatr. 2019 Oct 26. doi: 10.1186/s12877-019-1303-z.

As many hospitalists know, a frequently deployed approach to quality improvement (QI) is the Plan-Do-Study-Act (PDSA) cycle method. But it comes with challenges, according to a recent paper in BMJ Quality & Safety.

“There is little evidence on the fidelity of PDSA cycles used by frontline teams, nor how to support and improve the method’s use,” according to the authors. They used document analysis and interviews to review 421 PDSA cycles, tracking fidelity over three annual rounds of projects.

The researchers found that modest, statistically significant improvements in PDSA fidelity occurred, but overall fidelity was low.

“Challenges to achieving greater fidelity reflected problems with understanding the PDSA methodology, intention to use and application in practice,” the authors reported. “These problems were exacerbated by assumptions made in the original QI training and support strategies: that PDSA was easy to understand, that teams would be motivated and willing to use PDSA, and that PDSA is easy to apply.”

The study describes several strategies to help improve PDSA cycle fidelity: different project selection process, redesign of training, increased hands-on support, and investment in training quality improvement support staff. “The findings suggest achieving high PDSA fidelity requires a gradual and negotiated process to explore different perspectives and encourage new ways of working,” the authors concluded.

Reference

1. McNicholas C et al. Evolving quality improvement support strategies to improve Plan-Do-Study–Act cycle fidelity: A retrospective mixed-methods study. BMJ Qual Saf. 2019 Mar 18. doi: 10.1136/bmjqs-2017-007605.

As many hospitalists know, a frequently deployed approach to quality improvement (QI) is the Plan-Do-Study-Act (PDSA) cycle method. But it comes with challenges, according to a recent paper in BMJ Quality & Safety.

“There is little evidence on the fidelity of PDSA cycles used by frontline teams, nor how to support and improve the method’s use,” according to the authors. They used document analysis and interviews to review 421 PDSA cycles, tracking fidelity over three annual rounds of projects.

The researchers found that modest, statistically significant improvements in PDSA fidelity occurred, but overall fidelity was low.

“Challenges to achieving greater fidelity reflected problems with understanding the PDSA methodology, intention to use and application in practice,” the authors reported. “These problems were exacerbated by assumptions made in the original QI training and support strategies: that PDSA was easy to understand, that teams would be motivated and willing to use PDSA, and that PDSA is easy to apply.”

The study describes several strategies to help improve PDSA cycle fidelity: different project selection process, redesign of training, increased hands-on support, and investment in training quality improvement support staff. “The findings suggest achieving high PDSA fidelity requires a gradual and negotiated process to explore different perspectives and encourage new ways of working,” the authors concluded.

Reference

1. McNicholas C et al. Evolving quality improvement support strategies to improve Plan-Do-Study–Act cycle fidelity: A retrospective mixed-methods study. BMJ Qual Saf. 2019 Mar 18. doi: 10.1136/bmjqs-2017-007605.

As many hospitalists know, a frequently deployed approach to quality improvement (QI) is the Plan-Do-Study-Act (PDSA) cycle method. But it comes with challenges, according to a recent paper in BMJ Quality & Safety.

“There is little evidence on the fidelity of PDSA cycles used by frontline teams, nor how to support and improve the method’s use,” according to the authors. They used document analysis and interviews to review 421 PDSA cycles, tracking fidelity over three annual rounds of projects.

The researchers found that modest, statistically significant improvements in PDSA fidelity occurred, but overall fidelity was low.

“Challenges to achieving greater fidelity reflected problems with understanding the PDSA methodology, intention to use and application in practice,” the authors reported. “These problems were exacerbated by assumptions made in the original QI training and support strategies: that PDSA was easy to understand, that teams would be motivated and willing to use PDSA, and that PDSA is easy to apply.”

The study describes several strategies to help improve PDSA cycle fidelity: different project selection process, redesign of training, increased hands-on support, and investment in training quality improvement support staff. “The findings suggest achieving high PDSA fidelity requires a gradual and negotiated process to explore different perspectives and encourage new ways of working,” the authors concluded.

Reference

1. McNicholas C et al. Evolving quality improvement support strategies to improve Plan-Do-Study–Act cycle fidelity: A retrospective mixed-methods study. BMJ Qual Saf. 2019 Mar 18. doi: 10.1136/bmjqs-2017-007605.

Sequential chemoradiotherapy (CRT) and immunotherapy is safe, well tolerated, and efficacious among patients with locally advanced cervical cancer being treated with curative intent, a multicenter phase 1 trial suggests.

Less than 10% of patients treated with this sequence experienced a grade 3 toxicity. Meanwhile, more than 80% were alive and free of disease progression at 1 year.

“Despite standard CRT, most women with lymph node–positive cervical cancer experience disease recurrence,” note the investigators, led by Jyoti S. Mayadev, MD, associate professor in the department of radiation medicine and applied sciences, University of California, San Diego, in La Jolla. “Our study is potentially transformative in the standard treatment schema of locally advanced cervical cancer, with the prospect for immuno-oncology to add durable survival in patients with node-positive disease, a current unmet oncologic need.”

The investigators enrolled in the trial 32 women from Gynecology Oncology Cooperative Group member institutions who had stage IB2 to IVA cervical cancer with positive pelvic and/or para-aortic lymph nodes. Treatment consisted of six weekly doses of cisplatin, 40 mg/m², concurrent with extended-field, 3-dimensional conformal radiotherapy, followed by the immune checkpoint inhibitor ipilimumab (Yervoy) every 21 days for four cycles.

Results reported in JAMA Oncology showed that all 32 patients completed CRT and 21 patients went on to receive ipilimumab. Among the latter, 86% completed all four planned cycles and the rest completed two cycles.

In the group receiving sequential CRT and ipilimumab, 9.5% experienced grade 3 toxicity (lipase increase in one case and dermatitis in another case). Both toxicities were self-limited.

With a 14.8-month median follow-up, the patients treated with CRT-ipilimumab had a 12-month overall survival rate of 90%, and a 12-month progression-free survival rate of 81% (median durations were not reached). Neither human papillomavirus genotype nor HLA subtype was associated with these outcomes.

Translational analyses showed that patients experienced an increase in peripheral blood T cells expressing programmed cell death 1 (PD-1) after CRT that was then sustained with ipilimumab therapy. “[T]he use of an immune checkpoint inhibitor could stimulate the antitumor activity of tumor-specific cytotoxic T cells and augment radiation-induced neoantigen load,” the investigators proposed.

“To our knowledge, this phase 1 study is the first to show tolerability with a signal of efficacy of an immune check-point inhibitor ... as a part of the definitive treatment of locally advanced cervical cancer,” they concluded. “Our findings show promise for the use of immunotherapy in the definitive setting of locally advanced, node-positive cervical cancer; patients with this cancer historically have a poor prognosis with standard therapy alone.”

Dr. Mayadev disclosed receiving a grant from the National Cancer Institute during the conduct of the study, personal fees from AstraZeneca, grants from NRG Oncology, and personal fees and nonfinancial support from the Gynecology Oncology Group Foundation outside the submitted work; receiving compensation for serving on the advisory board of Varian Medical Systems in 2018; and being a speaker for Samsung Medical Systems in 2017. The study was supported by the National Cancer Institute and by institutional funds.

SOURCE: Mayadev JS et al. JAMA Oncol. 2019 Nov 27. doi: 10.1001/jamaoncol.2019.3857.

Sequential chemoradiotherapy (CRT) and immunotherapy is safe, well tolerated, and efficacious among patients with locally advanced cervical cancer being treated with curative intent, a multicenter phase 1 trial suggests.

Less than 10% of patients treated with this sequence experienced a grade 3 toxicity. Meanwhile, more than 80% were alive and free of disease progression at 1 year.

“Despite standard CRT, most women with lymph node–positive cervical cancer experience disease recurrence,” note the investigators, led by Jyoti S. Mayadev, MD, associate professor in the department of radiation medicine and applied sciences, University of California, San Diego, in La Jolla. “Our study is potentially transformative in the standard treatment schema of locally advanced cervical cancer, with the prospect for immuno-oncology to add durable survival in patients with node-positive disease, a current unmet oncologic need.”

The investigators enrolled in the trial 32 women from Gynecology Oncology Cooperative Group member institutions who had stage IB2 to IVA cervical cancer with positive pelvic and/or para-aortic lymph nodes. Treatment consisted of six weekly doses of cisplatin, 40 mg/m², concurrent with extended-field, 3-dimensional conformal radiotherapy, followed by the immune checkpoint inhibitor ipilimumab (Yervoy) every 21 days for four cycles.

Results reported in JAMA Oncology showed that all 32 patients completed CRT and 21 patients went on to receive ipilimumab. Among the latter, 86% completed all four planned cycles and the rest completed two cycles.

In the group receiving sequential CRT and ipilimumab, 9.5% experienced grade 3 toxicity (lipase increase in one case and dermatitis in another case). Both toxicities were self-limited.

With a 14.8-month median follow-up, the patients treated with CRT-ipilimumab had a 12-month overall survival rate of 90%, and a 12-month progression-free survival rate of 81% (median durations were not reached). Neither human papillomavirus genotype nor HLA subtype was associated with these outcomes.

Translational analyses showed that patients experienced an increase in peripheral blood T cells expressing programmed cell death 1 (PD-1) after CRT that was then sustained with ipilimumab therapy. “[T]he use of an immune checkpoint inhibitor could stimulate the antitumor activity of tumor-specific cytotoxic T cells and augment radiation-induced neoantigen load,” the investigators proposed.

“To our knowledge, this phase 1 study is the first to show tolerability with a signal of efficacy of an immune check-point inhibitor ... as a part of the definitive treatment of locally advanced cervical cancer,” they concluded. “Our findings show promise for the use of immunotherapy in the definitive setting of locally advanced, node-positive cervical cancer; patients with this cancer historically have a poor prognosis with standard therapy alone.”

Dr. Mayadev disclosed receiving a grant from the National Cancer Institute during the conduct of the study, personal fees from AstraZeneca, grants from NRG Oncology, and personal fees and nonfinancial support from the Gynecology Oncology Group Foundation outside the submitted work; receiving compensation for serving on the advisory board of Varian Medical Systems in 2018; and being a speaker for Samsung Medical Systems in 2017. The study was supported by the National Cancer Institute and by institutional funds.

SOURCE: Mayadev JS et al. JAMA Oncol. 2019 Nov 27. doi: 10.1001/jamaoncol.2019.3857.

Sequential chemoradiotherapy (CRT) and immunotherapy is safe, well tolerated, and efficacious among patients with locally advanced cervical cancer being treated with curative intent, a multicenter phase 1 trial suggests.

Less than 10% of patients treated with this sequence experienced a grade 3 toxicity. Meanwhile, more than 80% were alive and free of disease progression at 1 year.

“Despite standard CRT, most women with lymph node–positive cervical cancer experience disease recurrence,” note the investigators, led by Jyoti S. Mayadev, MD, associate professor in the department of radiation medicine and applied sciences, University of California, San Diego, in La Jolla. “Our study is potentially transformative in the standard treatment schema of locally advanced cervical cancer, with the prospect for immuno-oncology to add durable survival in patients with node-positive disease, a current unmet oncologic need.”

The investigators enrolled in the trial 32 women from Gynecology Oncology Cooperative Group member institutions who had stage IB2 to IVA cervical cancer with positive pelvic and/or para-aortic lymph nodes. Treatment consisted of six weekly doses of cisplatin, 40 mg/m², concurrent with extended-field, 3-dimensional conformal radiotherapy, followed by the immune checkpoint inhibitor ipilimumab (Yervoy) every 21 days for four cycles.

Results reported in JAMA Oncology showed that all 32 patients completed CRT and 21 patients went on to receive ipilimumab. Among the latter, 86% completed all four planned cycles and the rest completed two cycles.

In the group receiving sequential CRT and ipilimumab, 9.5% experienced grade 3 toxicity (lipase increase in one case and dermatitis in another case). Both toxicities were self-limited.

With a 14.8-month median follow-up, the patients treated with CRT-ipilimumab had a 12-month overall survival rate of 90%, and a 12-month progression-free survival rate of 81% (median durations were not reached). Neither human papillomavirus genotype nor HLA subtype was associated with these outcomes.

Translational analyses showed that patients experienced an increase in peripheral blood T cells expressing programmed cell death 1 (PD-1) after CRT that was then sustained with ipilimumab therapy. “[T]he use of an immune checkpoint inhibitor could stimulate the antitumor activity of tumor-specific cytotoxic T cells and augment radiation-induced neoantigen load,” the investigators proposed.

“To our knowledge, this phase 1 study is the first to show tolerability with a signal of efficacy of an immune check-point inhibitor ... as a part of the definitive treatment of locally advanced cervical cancer,” they concluded. “Our findings show promise for the use of immunotherapy in the definitive setting of locally advanced, node-positive cervical cancer; patients with this cancer historically have a poor prognosis with standard therapy alone.”

Dr. Mayadev disclosed receiving a grant from the National Cancer Institute during the conduct of the study, personal fees from AstraZeneca, grants from NRG Oncology, and personal fees and nonfinancial support from the Gynecology Oncology Group Foundation outside the submitted work; receiving compensation for serving on the advisory board of Varian Medical Systems in 2018; and being a speaker for Samsung Medical Systems in 2017. The study was supported by the National Cancer Institute and by institutional funds.

SOURCE: Mayadev JS et al. JAMA Oncol. 2019 Nov 27. doi: 10.1001/jamaoncol.2019.3857.