Extracapsular spread predicts survival in SLN+ melanoma

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CHICAGO – Extracapsular extension, or extracapsular spread (ECS), has been recognized as a risk factor in melanoma patients with macrometastatic (N+) disease, but a study from the United Kingdom has found it may also be an important indicator of progression-free and overall survival in patients who have sentinel node positive (SLN+) micrometastatic disease, a researcher reported at the Society of Surgical Oncology Annual Cancer Symposium.

“There is limited published data on ECS in micrometastatic disease, although there is progression-free survival data published in the literature,” Michelle Lo, MBCHB, MRCS, of Norfolk and Norwich University Hospitals, in Norwich, England, said in presenting the results. “The goal of the study was to determine the incidence of ECS in the micrometastatic group and to determine the prognostic significance of this.”

The study found that the incidence of ECS in the N+ group was significantly higher than the SLN+ group, 52.4% vs. 16.2% (P less than .0001). ECS proved to be a significant prognostic indicator of disease-specific survival and overall survival for both N+ and SLN+ disease. “There was no statistical difference in Breslow thickness between the two groups regardless of ECS,” she said.

Both the N+ and SLN+ groups with ECS had more lymph nodes than the ECS-absent subgroups, Dr. Lo said. However, in the ECS-absent subgroups, N+ patients had twice the number of lymph nodes than SLN+ patients. “This would suggest that ECS is a high-risk phenotype from the outset of metastases rather than something that’s developed over time,” she said. “Our data is in line with international staging data.”

 

 


The ECS-absent SLN– disease group had the most favorable survival outcomes, while those with ECS-present N+ disease had the worst outcomes. The prognosis of ECS-present, SLN+ patients was statistically similar to the ECS-absent, N+ group, she said.

In patients with SLN+ disease, Breslow thickness and N-stage were independent prognostic indicators for progression-free survival (hazard ratio 2.4, P less than .0001) and disease-free survival (HR 2.3, P less than .0001), Dr. Lo noted that median progression-free survival in SLN+ and N+ disease was 20 and 10 months, respectively. “Within our cohort of patients with ECS present in the micrometastatic group, their disease progressed within 3 years,” she said.

A multivariate analysis showed the survival data from this study was consistent with American Joint Committee on Cancer staging criteria, Dr. Lo said. “ECS is well recognized in the macrometastatic group, but we demonstrated from our data that the incidence of ECS in the micrometastatic group is one in six. It’s an independent risk factor for disease progression and an independent risk factor for worst disease-specific and overall survival, and it upstages micrometastatic disease.” ECS upstages stage III disease in a fashion similar to that of ulceration in primary melanoma, she said.

“In the absence of data to suggest otherwise, we would still recommend completion lymph node dissection in our micrometastatic group where ECS is present, and we would advocate that ECS should be included as an independent staging variable in the future,” Dr. Lo said.

Dr. Lo and her coauthors reported having no financial disclosures.

SOURCE: Lo M, et al. SSO 2018 Abstract 70.

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CHICAGO – Extracapsular extension, or extracapsular spread (ECS), has been recognized as a risk factor in melanoma patients with macrometastatic (N+) disease, but a study from the United Kingdom has found it may also be an important indicator of progression-free and overall survival in patients who have sentinel node positive (SLN+) micrometastatic disease, a researcher reported at the Society of Surgical Oncology Annual Cancer Symposium.

“There is limited published data on ECS in micrometastatic disease, although there is progression-free survival data published in the literature,” Michelle Lo, MBCHB, MRCS, of Norfolk and Norwich University Hospitals, in Norwich, England, said in presenting the results. “The goal of the study was to determine the incidence of ECS in the micrometastatic group and to determine the prognostic significance of this.”

The study found that the incidence of ECS in the N+ group was significantly higher than the SLN+ group, 52.4% vs. 16.2% (P less than .0001). ECS proved to be a significant prognostic indicator of disease-specific survival and overall survival for both N+ and SLN+ disease. “There was no statistical difference in Breslow thickness between the two groups regardless of ECS,” she said.

Both the N+ and SLN+ groups with ECS had more lymph nodes than the ECS-absent subgroups, Dr. Lo said. However, in the ECS-absent subgroups, N+ patients had twice the number of lymph nodes than SLN+ patients. “This would suggest that ECS is a high-risk phenotype from the outset of metastases rather than something that’s developed over time,” she said. “Our data is in line with international staging data.”

 

 


The ECS-absent SLN– disease group had the most favorable survival outcomes, while those with ECS-present N+ disease had the worst outcomes. The prognosis of ECS-present, SLN+ patients was statistically similar to the ECS-absent, N+ group, she said.

In patients with SLN+ disease, Breslow thickness and N-stage were independent prognostic indicators for progression-free survival (hazard ratio 2.4, P less than .0001) and disease-free survival (HR 2.3, P less than .0001), Dr. Lo noted that median progression-free survival in SLN+ and N+ disease was 20 and 10 months, respectively. “Within our cohort of patients with ECS present in the micrometastatic group, their disease progressed within 3 years,” she said.

A multivariate analysis showed the survival data from this study was consistent with American Joint Committee on Cancer staging criteria, Dr. Lo said. “ECS is well recognized in the macrometastatic group, but we demonstrated from our data that the incidence of ECS in the micrometastatic group is one in six. It’s an independent risk factor for disease progression and an independent risk factor for worst disease-specific and overall survival, and it upstages micrometastatic disease.” ECS upstages stage III disease in a fashion similar to that of ulceration in primary melanoma, she said.

“In the absence of data to suggest otherwise, we would still recommend completion lymph node dissection in our micrometastatic group where ECS is present, and we would advocate that ECS should be included as an independent staging variable in the future,” Dr. Lo said.

Dr. Lo and her coauthors reported having no financial disclosures.

SOURCE: Lo M, et al. SSO 2018 Abstract 70.

 

CHICAGO – Extracapsular extension, or extracapsular spread (ECS), has been recognized as a risk factor in melanoma patients with macrometastatic (N+) disease, but a study from the United Kingdom has found it may also be an important indicator of progression-free and overall survival in patients who have sentinel node positive (SLN+) micrometastatic disease, a researcher reported at the Society of Surgical Oncology Annual Cancer Symposium.

“There is limited published data on ECS in micrometastatic disease, although there is progression-free survival data published in the literature,” Michelle Lo, MBCHB, MRCS, of Norfolk and Norwich University Hospitals, in Norwich, England, said in presenting the results. “The goal of the study was to determine the incidence of ECS in the micrometastatic group and to determine the prognostic significance of this.”

The study found that the incidence of ECS in the N+ group was significantly higher than the SLN+ group, 52.4% vs. 16.2% (P less than .0001). ECS proved to be a significant prognostic indicator of disease-specific survival and overall survival for both N+ and SLN+ disease. “There was no statistical difference in Breslow thickness between the two groups regardless of ECS,” she said.

Both the N+ and SLN+ groups with ECS had more lymph nodes than the ECS-absent subgroups, Dr. Lo said. However, in the ECS-absent subgroups, N+ patients had twice the number of lymph nodes than SLN+ patients. “This would suggest that ECS is a high-risk phenotype from the outset of metastases rather than something that’s developed over time,” she said. “Our data is in line with international staging data.”

 

 


The ECS-absent SLN– disease group had the most favorable survival outcomes, while those with ECS-present N+ disease had the worst outcomes. The prognosis of ECS-present, SLN+ patients was statistically similar to the ECS-absent, N+ group, she said.

In patients with SLN+ disease, Breslow thickness and N-stage were independent prognostic indicators for progression-free survival (hazard ratio 2.4, P less than .0001) and disease-free survival (HR 2.3, P less than .0001), Dr. Lo noted that median progression-free survival in SLN+ and N+ disease was 20 and 10 months, respectively. “Within our cohort of patients with ECS present in the micrometastatic group, their disease progressed within 3 years,” she said.

A multivariate analysis showed the survival data from this study was consistent with American Joint Committee on Cancer staging criteria, Dr. Lo said. “ECS is well recognized in the macrometastatic group, but we demonstrated from our data that the incidence of ECS in the micrometastatic group is one in six. It’s an independent risk factor for disease progression and an independent risk factor for worst disease-specific and overall survival, and it upstages micrometastatic disease.” ECS upstages stage III disease in a fashion similar to that of ulceration in primary melanoma, she said.

“In the absence of data to suggest otherwise, we would still recommend completion lymph node dissection in our micrometastatic group where ECS is present, and we would advocate that ECS should be included as an independent staging variable in the future,” Dr. Lo said.

Dr. Lo and her coauthors reported having no financial disclosures.

SOURCE: Lo M, et al. SSO 2018 Abstract 70.

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Key clinical point: Extracapsular spread (ECS) may be a reliable biomarker of survival in stage III melanoma.

Major finding: ECS status was an indicator of progression-free survival (hazard ratio 2.4; P less than .0001) in micrometastatic disease.

Study details: Retrospective cohort study of 515 patients who had micro- or macrometastatic lymphadenopathy at two U.K. centers from 2000 to 2017.

Disclosures: Dr. Lo and coauthors reported having no financial disclosures.

Source: Lo M et al. SSO 2018 Abstract 70.

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Most physicians support Medicaid work requirements

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Almost 75% of physicians support the new federal policy that permits states to attach work requirements to Medicaid participation, according to a survey by physician recruitment firm Merritt Hawkins.

“Many physicians have been frustrated for years because Medicaid often pays less than their costs of providing care. Physicians have to limit the number of Medicaid patients they treat for that reason and want to focus on those who need care the most,” Travis Singleton, executive vice president of Merritt Hawkins, said in a statement.

Almost 57% of the 667 physicians who completed the survey said that they felt very favorably about the new regulation, and nearly 18% said that they felt somewhat favorably. On the negative side, just over 9% of physicians said that they felt very unfavorably about the work requirement policy and slightly more than 8% reported feeling somewhat unfavorably. Another 8% said that they felt neither favorable nor unfavorable, Merritt Hawkins reported.

Kentucky, Indiana, and Arkansas currently are in the process of putting the work requirements into place. Kentucky’s policy will require able-bodied Medicaid applicants aged 19-64 years to do 80 hours of community engagement a month by working, going to school, training for a job, or volunteering, the company said.

The survey, which was conducted by email in early March, had a margin of error of less than 1%.

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Almost 75% of physicians support the new federal policy that permits states to attach work requirements to Medicaid participation, according to a survey by physician recruitment firm Merritt Hawkins.

“Many physicians have been frustrated for years because Medicaid often pays less than their costs of providing care. Physicians have to limit the number of Medicaid patients they treat for that reason and want to focus on those who need care the most,” Travis Singleton, executive vice president of Merritt Hawkins, said in a statement.

Almost 57% of the 667 physicians who completed the survey said that they felt very favorably about the new regulation, and nearly 18% said that they felt somewhat favorably. On the negative side, just over 9% of physicians said that they felt very unfavorably about the work requirement policy and slightly more than 8% reported feeling somewhat unfavorably. Another 8% said that they felt neither favorable nor unfavorable, Merritt Hawkins reported.

Kentucky, Indiana, and Arkansas currently are in the process of putting the work requirements into place. Kentucky’s policy will require able-bodied Medicaid applicants aged 19-64 years to do 80 hours of community engagement a month by working, going to school, training for a job, or volunteering, the company said.

The survey, which was conducted by email in early March, had a margin of error of less than 1%.

 

Almost 75% of physicians support the new federal policy that permits states to attach work requirements to Medicaid participation, according to a survey by physician recruitment firm Merritt Hawkins.

“Many physicians have been frustrated for years because Medicaid often pays less than their costs of providing care. Physicians have to limit the number of Medicaid patients they treat for that reason and want to focus on those who need care the most,” Travis Singleton, executive vice president of Merritt Hawkins, said in a statement.

Almost 57% of the 667 physicians who completed the survey said that they felt very favorably about the new regulation, and nearly 18% said that they felt somewhat favorably. On the negative side, just over 9% of physicians said that they felt very unfavorably about the work requirement policy and slightly more than 8% reported feeling somewhat unfavorably. Another 8% said that they felt neither favorable nor unfavorable, Merritt Hawkins reported.

Kentucky, Indiana, and Arkansas currently are in the process of putting the work requirements into place. Kentucky’s policy will require able-bodied Medicaid applicants aged 19-64 years to do 80 hours of community engagement a month by working, going to school, training for a job, or volunteering, the company said.

The survey, which was conducted by email in early March, had a margin of error of less than 1%.

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Updates in MS: Highlights From the ECTRIMS and ACTRIMS Annual Meetings

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Eating disorders put teens at risk for depression, bullying

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

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

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

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

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

Lisa Quarfoth/Thinkstock


“At every time point, adolescent girls reported greater bullying by peers, depressive symptoms, and disordered eating behavior than adolescent boys, except in grade 7 when there were no sex differences in disordered eating behavior,” the researchers noted.

The results were consistent with data from previous cross-sectional studies with regard to the stronger associations in girls vs. boys, the researchers said. However, contrary to previous research, they found no mediating effect of depression on the association between peer bullying and disordered eating behavior, and no longitudinal associations between peer bullying and depression.

 

 


The findings were limited by several factors, including the inability to analyze different types of eating disorders and the use of self-reports to assess bullying, the researchers said. However, the results support the value of targeting disordered eating behavior to help reduce the risk of other mental health problems, they noted.

“Interventions for disordered eating behavior should ideally target negative attitudes, promote healthy weight control behavior, and contain an element of self-compassion, which can reduce symptoms of disordered eating and other psychopathologic symptoms,” they wrote.

The researchers had no financial conflicts to disclose. The study was supported in part by the Ontario Mental Health Foundation, the Canadian Institute of Health Research, and the Social Sciences and Humanities Research Council of Canada.

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

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

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

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

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

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

Lisa Quarfoth/Thinkstock


“At every time point, adolescent girls reported greater bullying by peers, depressive symptoms, and disordered eating behavior than adolescent boys, except in grade 7 when there were no sex differences in disordered eating behavior,” the researchers noted.

The results were consistent with data from previous cross-sectional studies with regard to the stronger associations in girls vs. boys, the researchers said. However, contrary to previous research, they found no mediating effect of depression on the association between peer bullying and disordered eating behavior, and no longitudinal associations between peer bullying and depression.

 

 


The findings were limited by several factors, including the inability to analyze different types of eating disorders and the use of self-reports to assess bullying, the researchers said. However, the results support the value of targeting disordered eating behavior to help reduce the risk of other mental health problems, they noted.

“Interventions for disordered eating behavior should ideally target negative attitudes, promote healthy weight control behavior, and contain an element of self-compassion, which can reduce symptoms of disordered eating and other psychopathologic symptoms,” they wrote.

The researchers had no financial conflicts to disclose. The study was supported in part by the Ontario Mental Health Foundation, the Canadian Institute of Health Research, and the Social Sciences and Humanities Research Council of Canada.

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

 

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

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

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

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

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

Lisa Quarfoth/Thinkstock


“At every time point, adolescent girls reported greater bullying by peers, depressive symptoms, and disordered eating behavior than adolescent boys, except in grade 7 when there were no sex differences in disordered eating behavior,” the researchers noted.

The results were consistent with data from previous cross-sectional studies with regard to the stronger associations in girls vs. boys, the researchers said. However, contrary to previous research, they found no mediating effect of depression on the association between peer bullying and disordered eating behavior, and no longitudinal associations between peer bullying and depression.

 

 


The findings were limited by several factors, including the inability to analyze different types of eating disorders and the use of self-reports to assess bullying, the researchers said. However, the results support the value of targeting disordered eating behavior to help reduce the risk of other mental health problems, they noted.

“Interventions for disordered eating behavior should ideally target negative attitudes, promote healthy weight control behavior, and contain an element of self-compassion, which can reduce symptoms of disordered eating and other psychopathologic symptoms,” they wrote.

The researchers had no financial conflicts to disclose. The study was supported in part by the Ontario Mental Health Foundation, the Canadian Institute of Health Research, and the Social Sciences and Humanities Research Council of Canada.

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

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Key clinical point: Teens who demonstrate disordered eating behavior may be at increased risk for depression and peer bullying.

Major finding: Disordered eating was longitudinally linked to depression and peer bullying (P less than .02).

Study details: A 5-year longitudinal study of 612 adolescents.

Disclosures: The researchers had no financial conflicts to disclose. The study was supported in part by the Ontario Mental Health Foundation, the Canadian Institute of Health Research, and the Social Sciences and Humanities Research Council of Canada.

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

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New study establishes IBD severity index

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

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

Dr. Corey A. Siegel

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

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

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

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

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

 

 


The exercise first had participants decide which hypothetical patient profiles met their evaluation criteria; it then showed them two final profiles and asked which was the more severe case. Survey length depended on the consistency of participants’ responses, with those lacking consistency being given more tasks to complete, Dr. Siegel and his colleagues reported.

Respondents completed the exercise three times: first independently without discussion, then after discussion in a group setting with an automated response system, and finally, independently following group discussion.

Disease severity indexes were created on a 100-point scale, and average part-worth utility scores were used to determine minimum and maximum scores for each attribute, with zero representing the absence of a symptom.

Crohn’s disease severity was largely dependent on factors related to intestinal damage, whereas ulcerative colitis disease severity was associated with symptoms and effects on daily life.
 

 


This analysis “helps redefine overall disease severity for IBD,” the authors wrote. Once validated, the indexes will offer “both further research opportunities and a practical tool by which to classify overall disease severity of patients and offer appropriate treatment without relying on present symptoms alone,” they added.

Dr. Siegel and his colleagues noted that future studies should focus on prospective validation of the disease indexes in different patient populations, as well as conducting a conjoint analysis with patients.

“We expect this work to begin to address a change in how we think about patients with IBD and how to identify those at the higher end of the risk spectrum so that appropriate intensive treatment can be initiated and optimized in an efficient, precise, and cost-effective manner,” they concluded.

The study was funded by AbbVie and Tillotts Pharma. The authors disclosed financial relationships with numerous additional pharmaceutical companies.
 
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Experts have established a severity index for inflammatory bowel disease (IBD), according to results of an analysis published in the journal Gut (doi: 10.1136/gutjnl-2016-312648).

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

Dr. Corey A. Siegel

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

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

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

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

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

 

 


The exercise first had participants decide which hypothetical patient profiles met their evaluation criteria; it then showed them two final profiles and asked which was the more severe case. Survey length depended on the consistency of participants’ responses, with those lacking consistency being given more tasks to complete, Dr. Siegel and his colleagues reported.

Respondents completed the exercise three times: first independently without discussion, then after discussion in a group setting with an automated response system, and finally, independently following group discussion.

Disease severity indexes were created on a 100-point scale, and average part-worth utility scores were used to determine minimum and maximum scores for each attribute, with zero representing the absence of a symptom.

Crohn’s disease severity was largely dependent on factors related to intestinal damage, whereas ulcerative colitis disease severity was associated with symptoms and effects on daily life.
 

 


This analysis “helps redefine overall disease severity for IBD,” the authors wrote. Once validated, the indexes will offer “both further research opportunities and a practical tool by which to classify overall disease severity of patients and offer appropriate treatment without relying on present symptoms alone,” they added.

Dr. Siegel and his colleagues noted that future studies should focus on prospective validation of the disease indexes in different patient populations, as well as conducting a conjoint analysis with patients.

“We expect this work to begin to address a change in how we think about patients with IBD and how to identify those at the higher end of the risk spectrum so that appropriate intensive treatment can be initiated and optimized in an efficient, precise, and cost-effective manner,” they concluded.

The study was funded by AbbVie and Tillotts Pharma. The authors disclosed financial relationships with numerous additional pharmaceutical companies.
 

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

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

Dr. Corey A. Siegel

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

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

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

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

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

 

 


The exercise first had participants decide which hypothetical patient profiles met their evaluation criteria; it then showed them two final profiles and asked which was the more severe case. Survey length depended on the consistency of participants’ responses, with those lacking consistency being given more tasks to complete, Dr. Siegel and his colleagues reported.

Respondents completed the exercise three times: first independently without discussion, then after discussion in a group setting with an automated response system, and finally, independently following group discussion.

Disease severity indexes were created on a 100-point scale, and average part-worth utility scores were used to determine minimum and maximum scores for each attribute, with zero representing the absence of a symptom.

Crohn’s disease severity was largely dependent on factors related to intestinal damage, whereas ulcerative colitis disease severity was associated with symptoms and effects on daily life.
 

 


This analysis “helps redefine overall disease severity for IBD,” the authors wrote. Once validated, the indexes will offer “both further research opportunities and a practical tool by which to classify overall disease severity of patients and offer appropriate treatment without relying on present symptoms alone,” they added.

Dr. Siegel and his colleagues noted that future studies should focus on prospective validation of the disease indexes in different patient populations, as well as conducting a conjoint analysis with patients.

“We expect this work to begin to address a change in how we think about patients with IBD and how to identify those at the higher end of the risk spectrum so that appropriate intensive treatment can be initiated and optimized in an efficient, precise, and cost-effective manner,” they concluded.

The study was funded by AbbVie and Tillotts Pharma. The authors disclosed financial relationships with numerous additional pharmaceutical companies.
 
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Does measuring episiotomy rates really benefit the quality of care our patients receive?

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Are these the right metrics to evaluate our obstetric practice?

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

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

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

A little personal history

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

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

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

My episiotomy performance record

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

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

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

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

Another try

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

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

What is the benefit?

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

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

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

Consider other metrics

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

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

Recommendation

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

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References
  1. CambriaAmerican College of Obstetricians and Gynecologists’ Committee on Practice Bulletins—Obstetrics. Practice Bulletin No. 165: Prevention and management of obstetric lacerations at vaginal delivery. Obstet Gynecol. 2016;128(1):e1Times New Roman MT Std–e15.
  2. Vaginal delivery. In: Cunnigham FG, Leveno KJ, Bloom SL, et al, eds. Williams Obstetrics. 24th ed. New York, NY: McGraw-Hill Medical; 2014:550.
  3. CMQCC: California Maternal Quality Care Collaborative website. https://www.cmqcc.org/. Accessed March 12, 2018.
Author and Disclosure Information

Dr. Kanofsky is in private ObGyn practice in Orange, California. He is a member of the Perinatal Safety Work Group and the Perinatal Collaborative Committee at St. Joseph Hospital, Orange, and is Chairman, Division of Gynecology, Department of Surgery, at CHOC Children’s Hospital of Orange County.

The author reports that he is a consultant to the St. Joseph Hospital Clinical Information Systems Project.

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Dr. Kanofsky is in private ObGyn practice in Orange, California. He is a member of the Perinatal Safety Work Group and the Perinatal Collaborative Committee at St. Joseph Hospital, Orange, and is Chairman, Division of Gynecology, Department of Surgery, at CHOC Children’s Hospital of Orange County.

The author reports that he is a consultant to the St. Joseph Hospital Clinical Information Systems Project.

Author and Disclosure Information

Dr. Kanofsky is in private ObGyn practice in Orange, California. He is a member of the Perinatal Safety Work Group and the Perinatal Collaborative Committee at St. Joseph Hospital, Orange, and is Chairman, Division of Gynecology, Department of Surgery, at CHOC Children’s Hospital of Orange County.

The author reports that he is a consultant to the St. Joseph Hospital Clinical Information Systems Project.

Are these the right metrics to evaluate our obstetric practice?
Are these the right metrics to evaluate our obstetric practice?

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

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

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

A little personal history

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

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

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

My episiotomy performance record

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

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

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

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

Another try

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

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

What is the benefit?

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

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

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

Consider other metrics

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

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

Recommendation

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

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

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

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

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

A little personal history

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

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

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

My episiotomy performance record

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

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

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

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

Another try

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

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

What is the benefit?

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

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

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

Consider other metrics

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

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

Recommendation

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

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References
  1. CambriaAmerican College of Obstetricians and Gynecologists’ Committee on Practice Bulletins—Obstetrics. Practice Bulletin No. 165: Prevention and management of obstetric lacerations at vaginal delivery. Obstet Gynecol. 2016;128(1):e1Times New Roman MT Std–e15.
  2. Vaginal delivery. In: Cunnigham FG, Leveno KJ, Bloom SL, et al, eds. Williams Obstetrics. 24th ed. New York, NY: McGraw-Hill Medical; 2014:550.
  3. CMQCC: California Maternal Quality Care Collaborative website. https://www.cmqcc.org/. Accessed March 12, 2018.
References
  1. CambriaAmerican College of Obstetricians and Gynecologists’ Committee on Practice Bulletins—Obstetrics. Practice Bulletin No. 165: Prevention and management of obstetric lacerations at vaginal delivery. Obstet Gynecol. 2016;128(1):e1Times New Roman MT Std–e15.
  2. Vaginal delivery. In: Cunnigham FG, Leveno KJ, Bloom SL, et al, eds. Williams Obstetrics. 24th ed. New York, NY: McGraw-Hill Medical; 2014:550.
  3. CMQCC: California Maternal Quality Care Collaborative website. https://www.cmqcc.org/. Accessed March 12, 2018.
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VIDEO: Interventions target opioid overprescribing after gynecologic surgery

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

Mitchel L. Zoler/MDedge News
Dr. Jaron E. Mark
One of the studies also implemented an “ultrarestrictive” postsurgical opioid prescribing protocol for 337 patients at one U.S. center that did not allow the routine prescription at hospital dismissal of opioids to minimally invasive or outpatient surgery patients with no history of chronic pain. This approach cut opioid prescribing by 97%, compared with the historic rate from the preceding year while resulting in 96% of the patients reporting satisfaction with their treatment, Jaron E. Mark, MD, said at the annual meeting of the Society of Gynecologic Oncology.

In addition, “setting preoperative expectations about pain management led to increased compliance at discharge,” said Dr. Mark, a gynecologic oncologist at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y.

Findings from the second study, of 122 women who underwent gynecologic surgery at Women and Infants Hospital in Providence, R.I., showed that 32% did not use any opioids for pain following hospital discharge, and that opioid use during hospitalization was a significant predictor of postdischarge opioid needs. This finding provided a way to devise a new prescribing guide for postsurgical patients based on their opioid use while hospitalized, said Erica Weston, MD, a gynecologic oncologist at Johns Hopkins University, Baltimore.

Mitchel L. Zoler/MDedge News
Dr. Erica Weston
The findings from both studies show that “if we educate patients, fewer opioids are needed for pain control” after gynecologic surgery, commented Sean C. Dowdy, MD, a professor of ob.gyn. and chair of gynecologic surgery at the Mayo Clinic in Rochester, Minn. “A large proportion of both minimally invasive surgery and laparotomy patients require no opioids after their hospital dismissal,” he noted as designated discussant for the two reports.

“No question, we are overprescribing,” Dr. Dowdy said, and described a program he and his colleagues at Mayo recently put in place that capped routine opioid pill prescriptions following various surgeries based on historic patient needs. For example, most laparotomy patients receive a prescription for 10 opioid doses on discharge. Based on the first 6 months of this program, it’s on track to cut the annual number of opioid tablets prescribed to postsurgical patients at Mayo by 35,000 for all gynecologic surgeries and by 1.5 million tablets for all Mayo surgical subspecialties, he said.

Mitchel L. Zoler/MDedge News
Dr. Sean C. Dowdy
But while he highlighted the need for widespread action to reduce the clear overprescribing that occurs, he also cautioned against underprescribing. “The goal is not less opioid prescribing, but more appropriate prescribing,” Dr. Dowdy declared.
 

 


The study reported by Dr. Mark ran after the Roswell Park gynecologic oncology department implemented new guidelines for dispensing pain control medications following surgery. The guidelines called for comprehensive teaching for patients about pain expectations and pain management both before and after surgery and also established four dispensing categories:
  • Patients undergoing minimally invasive or outpatient surgery and with no history of chronic pain and low opioid need while hospitalized received the default dispense of 600 mg ibuprofen every 6 hours as needed for 7 days and 500 mg acetaminophen every 6 hours as needed for 7 days.
  • Patients who underwent this surgery but required 5 or more opioid tablets while hospitalized or those with a history of chronic pain and opioid use received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply with 1 tablet taken every 6 hours as needed.
  • Patients who underwent laparotomy and had no chronic pain and opioid history and low opioid use while hospitalized received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply.
  • Patients who underwent laparotomy and showed a higher opioid need based on their use during the 24 hours before discharge received the ibuprofen and acetaminophen regimen plus 24 opioid tablets for 3 days so they could take 2 tablets every 6 hours as needed.

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

 

 


Under the new program, patients requested an opioid refill 14% of the time after laparotomy and 8% of the time after minimally invasive surgery, rates that did not significantly differ from the prior era. Average postoperative pain scores were identical among patients treated under the new dispensing guidelines and those treated during the prior years, and 96% of patients said they were satisfied with the care they received during the new, restricted dispensing period, Dr. Mark reported.

The single-center experience reviewed by Dr. Weston tracked opioid use by 122 women who underwent a minimally invasive hysterectomy at Women and Infants both as inpatients and out to both 1-2 weeks and 4-6 weeks following discharge. The patients were an average age of 61 years, and included 16% who reported chronic pain and 5% with a history of chronic opioid use.

During the inpatient phase, median opioid use was three doses, with 25% of the patients using no opioids. During the first 1-2 weeks following discharge, median opioid use was nine tablets, with 37% of the patients using no opioids. By the 4- to 6-week follow-up (which collected data from 114 of the patients), median opioid use was a cumulative 11 tablets with 67% of the patients reporting no opioid use during the time between their first and second follow-up visit. During the total postdischarge period, 90% of the patients used 30 or fewer opioid tablets.

A multivariate analysis of the findings showed that opioid use while in hospital was the only significant predictor of opioid use after discharge. Age of 65 years or older showed a nonsignificant trend toward less postdischarge opioid use.

Based on these data Dr. Weston and her associates proposed a formula for estimating a patient’s opioid needs at discharge: Gynecologic surgery patients who needed no opioid medication as inpatients could receive 1-5 opioid tablets at discharge, patients who used opioids at or below the median level should receive 10-15 tablets at discharge, and those who used more than the median number of opioid tablets as inpatients should receive 25-30 tablets at discharge. For patients who undergo surgery as outpatients and have no record of pain medication needs, Dr. Weston recommended discharging them with a prescription for 25-30 tablets, possibly reducing this to 10-15 tablets for patients aged 65 years or older.

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

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

Body

 

The important and thought provoking reports by Dr. Mark and by Dr. Weston and their associates present innovative ways for clinicians to address the opioid crisis by prescribing fewer narcotics to postsurgical patients when they leave the hospital. Their work suggests that doing this can have little or no negative impact on patient satisfaction with their care. Their findings give us important documentation for prescribing fewer opioid tablets, while still giving patients adequate pain relief.

Dr. Brent Smith
Clinicians are often concerned about providing patients with inadequate pain medication following surgery and the possibility that patients will have to request a refill of their opioid prescription. The results from both of these studies indicate that the narcotic needs of patients while they are hospitalized provide an effective way to predict of the amount of pain medication they will need once they are discharged.

Their findings also provide clear documentation that, in current practice, without guidance like this opioids are often overprescribed, not out of negligence but because clinicians are simply not sure what a patient will need once they go home following gynecologic surgery. By reviewing the pain medication a patient needed in hospital we can better estimate what patients will need when they go home, and we can better avoid giving patients more opioid tablets than they will really need.

Brent Smith, MD , is a gynecologic oncologist at Ohio State University, Columbus. He had no disclosures. Dr. Smith made these comments in a video interview.

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The important and thought provoking reports by Dr. Mark and by Dr. Weston and their associates present innovative ways for clinicians to address the opioid crisis by prescribing fewer narcotics to postsurgical patients when they leave the hospital. Their work suggests that doing this can have little or no negative impact on patient satisfaction with their care. Their findings give us important documentation for prescribing fewer opioid tablets, while still giving patients adequate pain relief.

Dr. Brent Smith
Clinicians are often concerned about providing patients with inadequate pain medication following surgery and the possibility that patients will have to request a refill of their opioid prescription. The results from both of these studies indicate that the narcotic needs of patients while they are hospitalized provide an effective way to predict of the amount of pain medication they will need once they are discharged.

Their findings also provide clear documentation that, in current practice, without guidance like this opioids are often overprescribed, not out of negligence but because clinicians are simply not sure what a patient will need once they go home following gynecologic surgery. By reviewing the pain medication a patient needed in hospital we can better estimate what patients will need when they go home, and we can better avoid giving patients more opioid tablets than they will really need.

Brent Smith, MD , is a gynecologic oncologist at Ohio State University, Columbus. He had no disclosures. Dr. Smith made these comments in a video interview.

Body

 

The important and thought provoking reports by Dr. Mark and by Dr. Weston and their associates present innovative ways for clinicians to address the opioid crisis by prescribing fewer narcotics to postsurgical patients when they leave the hospital. Their work suggests that doing this can have little or no negative impact on patient satisfaction with their care. Their findings give us important documentation for prescribing fewer opioid tablets, while still giving patients adequate pain relief.

Dr. Brent Smith
Clinicians are often concerned about providing patients with inadequate pain medication following surgery and the possibility that patients will have to request a refill of their opioid prescription. The results from both of these studies indicate that the narcotic needs of patients while they are hospitalized provide an effective way to predict of the amount of pain medication they will need once they are discharged.

Their findings also provide clear documentation that, in current practice, without guidance like this opioids are often overprescribed, not out of negligence but because clinicians are simply not sure what a patient will need once they go home following gynecologic surgery. By reviewing the pain medication a patient needed in hospital we can better estimate what patients will need when they go home, and we can better avoid giving patients more opioid tablets than they will really need.

Brent Smith, MD , is a gynecologic oncologist at Ohio State University, Columbus. He had no disclosures. Dr. Smith made these comments in a video interview.

Title
Inpatient opioid needs can guide discharge prescribing
Inpatient opioid needs can guide discharge prescribing
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

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

Mitchel L. Zoler/MDedge News
Dr. Jaron E. Mark
One of the studies also implemented an “ultrarestrictive” postsurgical opioid prescribing protocol for 337 patients at one U.S. center that did not allow the routine prescription at hospital dismissal of opioids to minimally invasive or outpatient surgery patients with no history of chronic pain. This approach cut opioid prescribing by 97%, compared with the historic rate from the preceding year while resulting in 96% of the patients reporting satisfaction with their treatment, Jaron E. Mark, MD, said at the annual meeting of the Society of Gynecologic Oncology.

In addition, “setting preoperative expectations about pain management led to increased compliance at discharge,” said Dr. Mark, a gynecologic oncologist at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y.

Findings from the second study, of 122 women who underwent gynecologic surgery at Women and Infants Hospital in Providence, R.I., showed that 32% did not use any opioids for pain following hospital discharge, and that opioid use during hospitalization was a significant predictor of postdischarge opioid needs. This finding provided a way to devise a new prescribing guide for postsurgical patients based on their opioid use while hospitalized, said Erica Weston, MD, a gynecologic oncologist at Johns Hopkins University, Baltimore.

Mitchel L. Zoler/MDedge News
Dr. Erica Weston
The findings from both studies show that “if we educate patients, fewer opioids are needed for pain control” after gynecologic surgery, commented Sean C. Dowdy, MD, a professor of ob.gyn. and chair of gynecologic surgery at the Mayo Clinic in Rochester, Minn. “A large proportion of both minimally invasive surgery and laparotomy patients require no opioids after their hospital dismissal,” he noted as designated discussant for the two reports.

“No question, we are overprescribing,” Dr. Dowdy said, and described a program he and his colleagues at Mayo recently put in place that capped routine opioid pill prescriptions following various surgeries based on historic patient needs. For example, most laparotomy patients receive a prescription for 10 opioid doses on discharge. Based on the first 6 months of this program, it’s on track to cut the annual number of opioid tablets prescribed to postsurgical patients at Mayo by 35,000 for all gynecologic surgeries and by 1.5 million tablets for all Mayo surgical subspecialties, he said.

Mitchel L. Zoler/MDedge News
Dr. Sean C. Dowdy
But while he highlighted the need for widespread action to reduce the clear overprescribing that occurs, he also cautioned against underprescribing. “The goal is not less opioid prescribing, but more appropriate prescribing,” Dr. Dowdy declared.
 

 


The study reported by Dr. Mark ran after the Roswell Park gynecologic oncology department implemented new guidelines for dispensing pain control medications following surgery. The guidelines called for comprehensive teaching for patients about pain expectations and pain management both before and after surgery and also established four dispensing categories:
  • Patients undergoing minimally invasive or outpatient surgery and with no history of chronic pain and low opioid need while hospitalized received the default dispense of 600 mg ibuprofen every 6 hours as needed for 7 days and 500 mg acetaminophen every 6 hours as needed for 7 days.
  • Patients who underwent this surgery but required 5 or more opioid tablets while hospitalized or those with a history of chronic pain and opioid use received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply with 1 tablet taken every 6 hours as needed.
  • Patients who underwent laparotomy and had no chronic pain and opioid history and low opioid use while hospitalized received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply.
  • Patients who underwent laparotomy and showed a higher opioid need based on their use during the 24 hours before discharge received the ibuprofen and acetaminophen regimen plus 24 opioid tablets for 3 days so they could take 2 tablets every 6 hours as needed.

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

 

 


Under the new program, patients requested an opioid refill 14% of the time after laparotomy and 8% of the time after minimally invasive surgery, rates that did not significantly differ from the prior era. Average postoperative pain scores were identical among patients treated under the new dispensing guidelines and those treated during the prior years, and 96% of patients said they were satisfied with the care they received during the new, restricted dispensing period, Dr. Mark reported.

The single-center experience reviewed by Dr. Weston tracked opioid use by 122 women who underwent a minimally invasive hysterectomy at Women and Infants both as inpatients and out to both 1-2 weeks and 4-6 weeks following discharge. The patients were an average age of 61 years, and included 16% who reported chronic pain and 5% with a history of chronic opioid use.

During the inpatient phase, median opioid use was three doses, with 25% of the patients using no opioids. During the first 1-2 weeks following discharge, median opioid use was nine tablets, with 37% of the patients using no opioids. By the 4- to 6-week follow-up (which collected data from 114 of the patients), median opioid use was a cumulative 11 tablets with 67% of the patients reporting no opioid use during the time between their first and second follow-up visit. During the total postdischarge period, 90% of the patients used 30 or fewer opioid tablets.

A multivariate analysis of the findings showed that opioid use while in hospital was the only significant predictor of opioid use after discharge. Age of 65 years or older showed a nonsignificant trend toward less postdischarge opioid use.

Based on these data Dr. Weston and her associates proposed a formula for estimating a patient’s opioid needs at discharge: Gynecologic surgery patients who needed no opioid medication as inpatients could receive 1-5 opioid tablets at discharge, patients who used opioids at or below the median level should receive 10-15 tablets at discharge, and those who used more than the median number of opioid tablets as inpatients should receive 25-30 tablets at discharge. For patients who undergo surgery as outpatients and have no record of pain medication needs, Dr. Weston recommended discharging them with a prescription for 25-30 tablets, possibly reducing this to 10-15 tablets for patients aged 65 years or older.

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

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

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

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

Mitchel L. Zoler/MDedge News
Dr. Jaron E. Mark
One of the studies also implemented an “ultrarestrictive” postsurgical opioid prescribing protocol for 337 patients at one U.S. center that did not allow the routine prescription at hospital dismissal of opioids to minimally invasive or outpatient surgery patients with no history of chronic pain. This approach cut opioid prescribing by 97%, compared with the historic rate from the preceding year while resulting in 96% of the patients reporting satisfaction with their treatment, Jaron E. Mark, MD, said at the annual meeting of the Society of Gynecologic Oncology.

In addition, “setting preoperative expectations about pain management led to increased compliance at discharge,” said Dr. Mark, a gynecologic oncologist at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y.

Findings from the second study, of 122 women who underwent gynecologic surgery at Women and Infants Hospital in Providence, R.I., showed that 32% did not use any opioids for pain following hospital discharge, and that opioid use during hospitalization was a significant predictor of postdischarge opioid needs. This finding provided a way to devise a new prescribing guide for postsurgical patients based on their opioid use while hospitalized, said Erica Weston, MD, a gynecologic oncologist at Johns Hopkins University, Baltimore.

Mitchel L. Zoler/MDedge News
Dr. Erica Weston
The findings from both studies show that “if we educate patients, fewer opioids are needed for pain control” after gynecologic surgery, commented Sean C. Dowdy, MD, a professor of ob.gyn. and chair of gynecologic surgery at the Mayo Clinic in Rochester, Minn. “A large proportion of both minimally invasive surgery and laparotomy patients require no opioids after their hospital dismissal,” he noted as designated discussant for the two reports.

“No question, we are overprescribing,” Dr. Dowdy said, and described a program he and his colleagues at Mayo recently put in place that capped routine opioid pill prescriptions following various surgeries based on historic patient needs. For example, most laparotomy patients receive a prescription for 10 opioid doses on discharge. Based on the first 6 months of this program, it’s on track to cut the annual number of opioid tablets prescribed to postsurgical patients at Mayo by 35,000 for all gynecologic surgeries and by 1.5 million tablets for all Mayo surgical subspecialties, he said.

Mitchel L. Zoler/MDedge News
Dr. Sean C. Dowdy
But while he highlighted the need for widespread action to reduce the clear overprescribing that occurs, he also cautioned against underprescribing. “The goal is not less opioid prescribing, but more appropriate prescribing,” Dr. Dowdy declared.
 

 


The study reported by Dr. Mark ran after the Roswell Park gynecologic oncology department implemented new guidelines for dispensing pain control medications following surgery. The guidelines called for comprehensive teaching for patients about pain expectations and pain management both before and after surgery and also established four dispensing categories:
  • Patients undergoing minimally invasive or outpatient surgery and with no history of chronic pain and low opioid need while hospitalized received the default dispense of 600 mg ibuprofen every 6 hours as needed for 7 days and 500 mg acetaminophen every 6 hours as needed for 7 days.
  • Patients who underwent this surgery but required 5 or more opioid tablets while hospitalized or those with a history of chronic pain and opioid use received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply with 1 tablet taken every 6 hours as needed.
  • Patients who underwent laparotomy and had no chronic pain and opioid history and low opioid use while hospitalized received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply.
  • Patients who underwent laparotomy and showed a higher opioid need based on their use during the 24 hours before discharge received the ibuprofen and acetaminophen regimen plus 24 opioid tablets for 3 days so they could take 2 tablets every 6 hours as needed.

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

 

 


Under the new program, patients requested an opioid refill 14% of the time after laparotomy and 8% of the time after minimally invasive surgery, rates that did not significantly differ from the prior era. Average postoperative pain scores were identical among patients treated under the new dispensing guidelines and those treated during the prior years, and 96% of patients said they were satisfied with the care they received during the new, restricted dispensing period, Dr. Mark reported.

The single-center experience reviewed by Dr. Weston tracked opioid use by 122 women who underwent a minimally invasive hysterectomy at Women and Infants both as inpatients and out to both 1-2 weeks and 4-6 weeks following discharge. The patients were an average age of 61 years, and included 16% who reported chronic pain and 5% with a history of chronic opioid use.

During the inpatient phase, median opioid use was three doses, with 25% of the patients using no opioids. During the first 1-2 weeks following discharge, median opioid use was nine tablets, with 37% of the patients using no opioids. By the 4- to 6-week follow-up (which collected data from 114 of the patients), median opioid use was a cumulative 11 tablets with 67% of the patients reporting no opioid use during the time between their first and second follow-up visit. During the total postdischarge period, 90% of the patients used 30 or fewer opioid tablets.

A multivariate analysis of the findings showed that opioid use while in hospital was the only significant predictor of opioid use after discharge. Age of 65 years or older showed a nonsignificant trend toward less postdischarge opioid use.

Based on these data Dr. Weston and her associates proposed a formula for estimating a patient’s opioid needs at discharge: Gynecologic surgery patients who needed no opioid medication as inpatients could receive 1-5 opioid tablets at discharge, patients who used opioids at or below the median level should receive 10-15 tablets at discharge, and those who used more than the median number of opioid tablets as inpatients should receive 25-30 tablets at discharge. For patients who undergo surgery as outpatients and have no record of pain medication needs, Dr. Weston recommended discharging them with a prescription for 25-30 tablets, possibly reducing this to 10-15 tablets for patients aged 65 years or older.

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

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

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Key clinical point: Patients who underwent gynecologic surgery received adequate pain relief when receiving fewer opioid tablets.

Major finding: A protocol that restricted opioid dispensing successfully cut the discharge allotment of opioid tablets by 89%.

Study details: A single-center review of 337 patients, and a second single-center experience with 122 patients.

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

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

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Longer poly-JIA inactivity not necessarily better before stopping anti-TNF therapy

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

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

Dr. Daniel J. Lovell
“CID was an unstable state and 18.5% of the patients were unable to maintain CID for 6 continuous months of observation, even while continuing to receive the anti-TNF agent and stable doses of all background medications,” Dr. Lovell and his colleagues wrote in their study, published in Arthritis & Rheumatology.

Among the 106 patients who continued anti-TNF therapy for 6 months and maintained CID, the investigators then stopped anti-TNF therapy and examined patients for disease flare at 1-month, 2-month, 3-month, 4-month, 6-month, and 8-month follow-up. A total of 42% of these patients were also taking background medication such as methotrexate. Investigators found 39 patients (37%) who showed signs of disease flare within 8 months of discontinuing anti-TNF therapy. A number of factors proved to be significantly associated with disease flare, including age at disease onset (hazard ratio, 0.92; 95% confidence interval, 0.85-0.99; P = .03), age at disease diagnosis (HR, 0.91; 95% CI, 0.84-0.99; P = .02), disease duration at enrollment (HR, 1.12; 95% CI, 1.04-1.21; P less than .01) and time from onset until first CID (HR, 1.10; 95% CI, 1.01-1.20; P = .04). Flare occurred at a mean 7.01 months (standard error of the mean, 0.32) and median 8.26 months (95% CI, 7.80-8.66).



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

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

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

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

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

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

Dr. Daniel J. Lovell
“CID was an unstable state and 18.5% of the patients were unable to maintain CID for 6 continuous months of observation, even while continuing to receive the anti-TNF agent and stable doses of all background medications,” Dr. Lovell and his colleagues wrote in their study, published in Arthritis & Rheumatology.

Among the 106 patients who continued anti-TNF therapy for 6 months and maintained CID, the investigators then stopped anti-TNF therapy and examined patients for disease flare at 1-month, 2-month, 3-month, 4-month, 6-month, and 8-month follow-up. A total of 42% of these patients were also taking background medication such as methotrexate. Investigators found 39 patients (37%) who showed signs of disease flare within 8 months of discontinuing anti-TNF therapy. A number of factors proved to be significantly associated with disease flare, including age at disease onset (hazard ratio, 0.92; 95% confidence interval, 0.85-0.99; P = .03), age at disease diagnosis (HR, 0.91; 95% CI, 0.84-0.99; P = .02), disease duration at enrollment (HR, 1.12; 95% CI, 1.04-1.21; P less than .01) and time from onset until first CID (HR, 1.10; 95% CI, 1.01-1.20; P = .04). Flare occurred at a mean 7.01 months (standard error of the mean, 0.32) and median 8.26 months (95% CI, 7.80-8.66).



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

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

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

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

 

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

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

Dr. Daniel J. Lovell
“CID was an unstable state and 18.5% of the patients were unable to maintain CID for 6 continuous months of observation, even while continuing to receive the anti-TNF agent and stable doses of all background medications,” Dr. Lovell and his colleagues wrote in their study, published in Arthritis & Rheumatology.

Among the 106 patients who continued anti-TNF therapy for 6 months and maintained CID, the investigators then stopped anti-TNF therapy and examined patients for disease flare at 1-month, 2-month, 3-month, 4-month, 6-month, and 8-month follow-up. A total of 42% of these patients were also taking background medication such as methotrexate. Investigators found 39 patients (37%) who showed signs of disease flare within 8 months of discontinuing anti-TNF therapy. A number of factors proved to be significantly associated with disease flare, including age at disease onset (hazard ratio, 0.92; 95% confidence interval, 0.85-0.99; P = .03), age at disease diagnosis (HR, 0.91; 95% CI, 0.84-0.99; P = .02), disease duration at enrollment (HR, 1.12; 95% CI, 1.04-1.21; P less than .01) and time from onset until first CID (HR, 1.10; 95% CI, 1.01-1.20; P = .04). Flare occurred at a mean 7.01 months (standard error of the mean, 0.32) and median 8.26 months (95% CI, 7.80-8.66).



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

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

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

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

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FROM ARTHRITIS & RHEUMATOLOGY

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Key clinical point: Discontinuing anti–tumor necrosis factor therapy caused disease flare within 8 months in over one-third of children with clinically inactive polyarticular forms of juvenile idiopathic arthritis.

Major finding: Halting anti-TNF therapy caused disease flare in 39 patients (37%) with previous clinically inactive polyarticular forms of JIA.

Story details: A two-phase prospective study of 137 patients with PF-JIA in CID across 16 centers over a 16-month period.

Disclosures: This study was sponsored by a grant from the National Institutes of Health.

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

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Patients presenting with saddle pulmonary emboli (PE) versus nonsaddle PE have no mortality difference but have an increased risk for decompensation

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

Study design: Retrospective cohort study.

Setting: Quaternary care hospital in Minnesota.

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

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

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

Dr. Christopher M. O'Donnell

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

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

Study design: Retrospective cohort study.

Setting: Quaternary care hospital in Minnesota.

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

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

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

Dr. Christopher M. O'Donnell

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

 

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

Study design: Retrospective cohort study.

Setting: Quaternary care hospital in Minnesota.

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

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

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

Dr. Christopher M. O'Donnell

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

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FDA grants priority review of follicular lymphoma drug

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

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

Duvelisib met its primary endpoint of improved progression-free survival versus ofatumumab among patients with relapsed/refractory CLL/SLL in the phase 3 DUO study, showing a 48% reduction in risk of disease progression or death. In the phase 2 DYNAMO study among patients with indolent non-Hodgkin lymphoma who are refractory to both rituximab and chemotherapy or radioimmunotherapy, duvelisib achieved an objective response rate of 46% (P less than .0001), according to Verastem.

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

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

Duvelisib met its primary endpoint of improved progression-free survival versus ofatumumab among patients with relapsed/refractory CLL/SLL in the phase 3 DUO study, showing a 48% reduction in risk of disease progression or death. In the phase 2 DYNAMO study among patients with indolent non-Hodgkin lymphoma who are refractory to both rituximab and chemotherapy or radioimmunotherapy, duvelisib achieved an objective response rate of 46% (P less than .0001), according to Verastem.

 

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

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

Duvelisib met its primary endpoint of improved progression-free survival versus ofatumumab among patients with relapsed/refractory CLL/SLL in the phase 3 DUO study, showing a 48% reduction in risk of disease progression or death. In the phase 2 DYNAMO study among patients with indolent non-Hodgkin lymphoma who are refractory to both rituximab and chemotherapy or radioimmunotherapy, duvelisib achieved an objective response rate of 46% (P less than .0001), according to Verastem.

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