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FDA approves marketing for retinal imaging device that uses artificial intelligence
The Food and Drug Administration has permitted the marketing of IDx-DR, a retinal imaging device that uses artificial intelligence (AI) to detect greater than a mild level of diabetic retinopathy in adult patients with diabetes. It also is the first authorized device that provides a screening tool without the need of an eye care specialist, making it ideal for health care providers who do not specialize in eye care.
“Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy.” About 50% of people with diabetes do not have the recommended annual retinopathy screening exam, Malvina Eydelman, MD, director of the division of ophthalmic, and ear, nose, and throat devices at the FDA’s Center for Devices and Radiological Health noted in a press release.
The software behind IDx-DR utilizes an artificial intelligence program to analyze retinal images captured by a retinal camera, the Topcon NW400. After one or more images are taken, they are uploaded to a Cloud server, on which IDx-DR software is installed, where they can be analyzed using an algorithm. In cases in which the images are of sufficient quality, the software provides the doctor with one of two results: “More than mild diabetic retinopathy detected: refer to an eye care professional” or “Negative for more than mild diabetic retinopathy; rescreen in 12 months.”
If a positive result is detected, patients should see an eye care specialist for further diagnostic evaluation and treatment as soon as possible.
The FDA reviewed data obtained from a clinical study prior to approving IDx-DR for marketing. The study looked at retinal images from 900 patients at 10 primary care sites. The aim of the study was to determine how often IDx-DR was correct in identifying mild diabetic retinopathy. The device was accurate nearly 90% of the time, correctly identifying mild diabetic retinopathy 87.4% of the time. It was also able to identify correctly patients who did not have mild diabetic retinopathy 89.5% of the time.
IDx-DR was approved via the FDA’s De Novo premarket review pathway, which offers a way to approve novel, low to moderate risk devices for which there are no similar devices previously approved. It also was granted a Breakthrough Device designation, because of its effectiveness in treating or diagnosing a irreversibly debilitating disease or condition.
Michael Abramoff, MD, PhD, and founder and president of IDx, said in an interview: “The FDA’s authorization to market IDx-DR is a historic moment that will launch a transformation in the way U.S. health care is delivered. Autonomous AI systems have massive potential to improve health care productivity, lower health care costs, and improve accessibility and quality. As the first of its kind to be authorized for commercialization, IDx-DR provides a roadmap for the safe and responsible use of AI in medicine.”
IDx-DR is intended to identify mild diabetic retinopathy and should not be used to detect rapidly progressive cases of diabetic retinopathy, particularly in pregnant women in which the disease can progress quickly. Patients with a history of laser treatment, surgery, or injections in the eye and other types of retinopathy, including radiation retinopathy, should not use IDx-DR.
For more information on other uses of AI in the treatment of diabetic disorders, click here.
The Food and Drug Administration has permitted the marketing of IDx-DR, a retinal imaging device that uses artificial intelligence (AI) to detect greater than a mild level of diabetic retinopathy in adult patients with diabetes. It also is the first authorized device that provides a screening tool without the need of an eye care specialist, making it ideal for health care providers who do not specialize in eye care.
“Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy.” About 50% of people with diabetes do not have the recommended annual retinopathy screening exam, Malvina Eydelman, MD, director of the division of ophthalmic, and ear, nose, and throat devices at the FDA’s Center for Devices and Radiological Health noted in a press release.
The software behind IDx-DR utilizes an artificial intelligence program to analyze retinal images captured by a retinal camera, the Topcon NW400. After one or more images are taken, they are uploaded to a Cloud server, on which IDx-DR software is installed, where they can be analyzed using an algorithm. In cases in which the images are of sufficient quality, the software provides the doctor with one of two results: “More than mild diabetic retinopathy detected: refer to an eye care professional” or “Negative for more than mild diabetic retinopathy; rescreen in 12 months.”
If a positive result is detected, patients should see an eye care specialist for further diagnostic evaluation and treatment as soon as possible.
The FDA reviewed data obtained from a clinical study prior to approving IDx-DR for marketing. The study looked at retinal images from 900 patients at 10 primary care sites. The aim of the study was to determine how often IDx-DR was correct in identifying mild diabetic retinopathy. The device was accurate nearly 90% of the time, correctly identifying mild diabetic retinopathy 87.4% of the time. It was also able to identify correctly patients who did not have mild diabetic retinopathy 89.5% of the time.
IDx-DR was approved via the FDA’s De Novo premarket review pathway, which offers a way to approve novel, low to moderate risk devices for which there are no similar devices previously approved. It also was granted a Breakthrough Device designation, because of its effectiveness in treating or diagnosing a irreversibly debilitating disease or condition.
Michael Abramoff, MD, PhD, and founder and president of IDx, said in an interview: “The FDA’s authorization to market IDx-DR is a historic moment that will launch a transformation in the way U.S. health care is delivered. Autonomous AI systems have massive potential to improve health care productivity, lower health care costs, and improve accessibility and quality. As the first of its kind to be authorized for commercialization, IDx-DR provides a roadmap for the safe and responsible use of AI in medicine.”
IDx-DR is intended to identify mild diabetic retinopathy and should not be used to detect rapidly progressive cases of diabetic retinopathy, particularly in pregnant women in which the disease can progress quickly. Patients with a history of laser treatment, surgery, or injections in the eye and other types of retinopathy, including radiation retinopathy, should not use IDx-DR.
For more information on other uses of AI in the treatment of diabetic disorders, click here.
The Food and Drug Administration has permitted the marketing of IDx-DR, a retinal imaging device that uses artificial intelligence (AI) to detect greater than a mild level of diabetic retinopathy in adult patients with diabetes. It also is the first authorized device that provides a screening tool without the need of an eye care specialist, making it ideal for health care providers who do not specialize in eye care.
“Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy.” About 50% of people with diabetes do not have the recommended annual retinopathy screening exam, Malvina Eydelman, MD, director of the division of ophthalmic, and ear, nose, and throat devices at the FDA’s Center for Devices and Radiological Health noted in a press release.
The software behind IDx-DR utilizes an artificial intelligence program to analyze retinal images captured by a retinal camera, the Topcon NW400. After one or more images are taken, they are uploaded to a Cloud server, on which IDx-DR software is installed, where they can be analyzed using an algorithm. In cases in which the images are of sufficient quality, the software provides the doctor with one of two results: “More than mild diabetic retinopathy detected: refer to an eye care professional” or “Negative for more than mild diabetic retinopathy; rescreen in 12 months.”
If a positive result is detected, patients should see an eye care specialist for further diagnostic evaluation and treatment as soon as possible.
The FDA reviewed data obtained from a clinical study prior to approving IDx-DR for marketing. The study looked at retinal images from 900 patients at 10 primary care sites. The aim of the study was to determine how often IDx-DR was correct in identifying mild diabetic retinopathy. The device was accurate nearly 90% of the time, correctly identifying mild diabetic retinopathy 87.4% of the time. It was also able to identify correctly patients who did not have mild diabetic retinopathy 89.5% of the time.
IDx-DR was approved via the FDA’s De Novo premarket review pathway, which offers a way to approve novel, low to moderate risk devices for which there are no similar devices previously approved. It also was granted a Breakthrough Device designation, because of its effectiveness in treating or diagnosing a irreversibly debilitating disease or condition.
Michael Abramoff, MD, PhD, and founder and president of IDx, said in an interview: “The FDA’s authorization to market IDx-DR is a historic moment that will launch a transformation in the way U.S. health care is delivered. Autonomous AI systems have massive potential to improve health care productivity, lower health care costs, and improve accessibility and quality. As the first of its kind to be authorized for commercialization, IDx-DR provides a roadmap for the safe and responsible use of AI in medicine.”
IDx-DR is intended to identify mild diabetic retinopathy and should not be used to detect rapidly progressive cases of diabetic retinopathy, particularly in pregnant women in which the disease can progress quickly. Patients with a history of laser treatment, surgery, or injections in the eye and other types of retinopathy, including radiation retinopathy, should not use IDx-DR.
For more information on other uses of AI in the treatment of diabetic disorders, click here.
Make the Diagnosis - May 2018
Generally, school-aged children are most often affected. Infections are more likely in late winter and early spring. The virus is spread via respiratory secretions, blood products, and transmission from mother to fetus. The cutaneous findings occur about 10 days after exposure to the virus. By that time, the risk of being contagious is low.
Healthy individuals have no sequelae from fifth disease and require no treatment. However, in patients with hemoglobinopathies, such as sickle cell disease, an aplastic crisis can be triggered. In patients with deficient immune systems, parvovirus B19 may cause infection and anemia, requiring hospitalization. Pregnant women exposed to parvovirus B19 are at risk for hydrops fetalis and rarely, fetal malformations or fetal demise. Other uncommon associations include hepatitis, vasculitides, and neurologic disease.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to dermnews@mdedge.com. This case and photo were submitted by Dr. Bilu Martin.
Generally, school-aged children are most often affected. Infections are more likely in late winter and early spring. The virus is spread via respiratory secretions, blood products, and transmission from mother to fetus. The cutaneous findings occur about 10 days after exposure to the virus. By that time, the risk of being contagious is low.
Healthy individuals have no sequelae from fifth disease and require no treatment. However, in patients with hemoglobinopathies, such as sickle cell disease, an aplastic crisis can be triggered. In patients with deficient immune systems, parvovirus B19 may cause infection and anemia, requiring hospitalization. Pregnant women exposed to parvovirus B19 are at risk for hydrops fetalis and rarely, fetal malformations or fetal demise. Other uncommon associations include hepatitis, vasculitides, and neurologic disease.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to dermnews@mdedge.com. This case and photo were submitted by Dr. Bilu Martin.
Generally, school-aged children are most often affected. Infections are more likely in late winter and early spring. The virus is spread via respiratory secretions, blood products, and transmission from mother to fetus. The cutaneous findings occur about 10 days after exposure to the virus. By that time, the risk of being contagious is low.
Healthy individuals have no sequelae from fifth disease and require no treatment. However, in patients with hemoglobinopathies, such as sickle cell disease, an aplastic crisis can be triggered. In patients with deficient immune systems, parvovirus B19 may cause infection and anemia, requiring hospitalization. Pregnant women exposed to parvovirus B19 are at risk for hydrops fetalis and rarely, fetal malformations or fetal demise. Other uncommon associations include hepatitis, vasculitides, and neurologic disease.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to dermnews@mdedge.com. This case and photo were submitted by Dr. Bilu Martin.
Residual single-site ovarian cancer surpasses multisite outcomes
NEW ORLEANS – When complete resection of advanced-stage, epithelial ovarian cancer is not possible, surgical resection that leaves a small volume of residual tumor at a single site produces significantly better outcomes than leaving minimal residual cancer at multiple sites, according to a review of 510 patients at two U.S. centers.
“In the past, we separated these patients based on whether they had a complete resection, R0 disease, or had 1 cm or less of residual disease” regardless of the number of sites with this small amount of residual tumor. The third category was patients with more than 1 cm of residual tumor at one or more sites, explained Dr. Manning-Geist in an interview. “What we did was break down the patients with 1 cm or less of residual tumor into those with one site or multiple sites. This is the first reported study to use number of sites” as a clinical characteristic for analysis in this context.
The message from the findings is that, while the goal of debulking surgery in patients with advanced epithelial ovarian cancer is complete tumor resection, if that can’t be achieved, the next goal is to leave residual tumor at just a single site, she concluded. A question that remains is whether primary debulking surgery is preferable to neoadjuvant treatment followed by interval debulking surgery. In the results Dr. Manning-Geist presented, patients who underwent primary debulking had better outcomes than those with neoadjuvant therapy followed by interval debulking, but these two subgroups also had different clinical characteristics.
The study used data from 510 patients with stage IIIC or IV epithelial ovarian cancer treated at either Brigham and Women’s or Massachusetts General Hospital during 2010-2015. The study cohort included 240 patients who underwent primary debulking surgery and 270 who first received neoadjuvant chemotherapy and then underwent interval debulking surgery. The patients who received neoadjuvant therapy were, on average, older (65 years vs. 63 years), had a higher prevalence of stage IV disease (44% vs. 16%), and had a higher prevalence of tumors with serous histology (93% vs. 77%), compared with patients who underwent primary debulking.
Complete tumor resections occurred in 39% of the primary debulking patients and in 64% of those who received neoadjuvant therapy; residual disease of 1 cm or less at one site occurred in 17% and 13%, respectively; minimal residual disease at multiple sites remained in 28% and 17% respectively; and the remaining patients had residual disease of more than 1 cm in at least one site, 16% and 6% respectively.
For this analysis, Dr. Manning-Geist and her associates considered residual disease at any of seven possible sites: diaphragm, upper abdomen, bowel mesentary, bowel serosa, abdominal peritoneum, pelvis, and nodal. Even if multiple individual metastases remained within one of these sites after surgery, it was categorized as a single site of residual disease.
Among patients who underwent primary debulking surgery, progression-free survival persisted for a median of 23 months among patients with full resection, 19 months in patients with a single site with minimal residual disease, 13 months among those with multiple sites of residual disease, and 10 months in patients with more than 1 cm of residual tumor. Median overall survival in these four subgroups was not yet reached, 64 months, 50 months, and 49 months, respectively.
Among patients who received neoadjuvant chemotherapy and then underwent interval debulking surgery, median durations of progression-free survival were 14 months, 12 months, 10 months, and 6 months, respectively. Median overall survival rates were 58 months, 37 months, 26 months, and 33 months, respectively. Within each of these four analyses, the differences in both survival and progression-free survival across the four subgroups was statistically significant, with a P less than .001 for each analysis.
In multivariate analyses, among patients who underwent primary debulking surgery, the significant linkages with worsening progression-free and overall survival were age, cancer stage, and amount and site number of residual disease. Among patients who received neoadjuvant chemotherapy followed by interval debulking residual disease diameter and site number of residual tumor was the only significant determinant for both progression-free and overall survival, Dr. Manning-Geist reported.
Dr. Manning-Geist had no disclosures.
SOURCE: Manning-Geist B et al. SGO 2018, Abstract 43.
NEW ORLEANS – When complete resection of advanced-stage, epithelial ovarian cancer is not possible, surgical resection that leaves a small volume of residual tumor at a single site produces significantly better outcomes than leaving minimal residual cancer at multiple sites, according to a review of 510 patients at two U.S. centers.
“In the past, we separated these patients based on whether they had a complete resection, R0 disease, or had 1 cm or less of residual disease” regardless of the number of sites with this small amount of residual tumor. The third category was patients with more than 1 cm of residual tumor at one or more sites, explained Dr. Manning-Geist in an interview. “What we did was break down the patients with 1 cm or less of residual tumor into those with one site or multiple sites. This is the first reported study to use number of sites” as a clinical characteristic for analysis in this context.
The message from the findings is that, while the goal of debulking surgery in patients with advanced epithelial ovarian cancer is complete tumor resection, if that can’t be achieved, the next goal is to leave residual tumor at just a single site, she concluded. A question that remains is whether primary debulking surgery is preferable to neoadjuvant treatment followed by interval debulking surgery. In the results Dr. Manning-Geist presented, patients who underwent primary debulking had better outcomes than those with neoadjuvant therapy followed by interval debulking, but these two subgroups also had different clinical characteristics.
The study used data from 510 patients with stage IIIC or IV epithelial ovarian cancer treated at either Brigham and Women’s or Massachusetts General Hospital during 2010-2015. The study cohort included 240 patients who underwent primary debulking surgery and 270 who first received neoadjuvant chemotherapy and then underwent interval debulking surgery. The patients who received neoadjuvant therapy were, on average, older (65 years vs. 63 years), had a higher prevalence of stage IV disease (44% vs. 16%), and had a higher prevalence of tumors with serous histology (93% vs. 77%), compared with patients who underwent primary debulking.
Complete tumor resections occurred in 39% of the primary debulking patients and in 64% of those who received neoadjuvant therapy; residual disease of 1 cm or less at one site occurred in 17% and 13%, respectively; minimal residual disease at multiple sites remained in 28% and 17% respectively; and the remaining patients had residual disease of more than 1 cm in at least one site, 16% and 6% respectively.
For this analysis, Dr. Manning-Geist and her associates considered residual disease at any of seven possible sites: diaphragm, upper abdomen, bowel mesentary, bowel serosa, abdominal peritoneum, pelvis, and nodal. Even if multiple individual metastases remained within one of these sites after surgery, it was categorized as a single site of residual disease.
Among patients who underwent primary debulking surgery, progression-free survival persisted for a median of 23 months among patients with full resection, 19 months in patients with a single site with minimal residual disease, 13 months among those with multiple sites of residual disease, and 10 months in patients with more than 1 cm of residual tumor. Median overall survival in these four subgroups was not yet reached, 64 months, 50 months, and 49 months, respectively.
Among patients who received neoadjuvant chemotherapy and then underwent interval debulking surgery, median durations of progression-free survival were 14 months, 12 months, 10 months, and 6 months, respectively. Median overall survival rates were 58 months, 37 months, 26 months, and 33 months, respectively. Within each of these four analyses, the differences in both survival and progression-free survival across the four subgroups was statistically significant, with a P less than .001 for each analysis.
In multivariate analyses, among patients who underwent primary debulking surgery, the significant linkages with worsening progression-free and overall survival were age, cancer stage, and amount and site number of residual disease. Among patients who received neoadjuvant chemotherapy followed by interval debulking residual disease diameter and site number of residual tumor was the only significant determinant for both progression-free and overall survival, Dr. Manning-Geist reported.
Dr. Manning-Geist had no disclosures.
SOURCE: Manning-Geist B et al. SGO 2018, Abstract 43.
NEW ORLEANS – When complete resection of advanced-stage, epithelial ovarian cancer is not possible, surgical resection that leaves a small volume of residual tumor at a single site produces significantly better outcomes than leaving minimal residual cancer at multiple sites, according to a review of 510 patients at two U.S. centers.
“In the past, we separated these patients based on whether they had a complete resection, R0 disease, or had 1 cm or less of residual disease” regardless of the number of sites with this small amount of residual tumor. The third category was patients with more than 1 cm of residual tumor at one or more sites, explained Dr. Manning-Geist in an interview. “What we did was break down the patients with 1 cm or less of residual tumor into those with one site or multiple sites. This is the first reported study to use number of sites” as a clinical characteristic for analysis in this context.
The message from the findings is that, while the goal of debulking surgery in patients with advanced epithelial ovarian cancer is complete tumor resection, if that can’t be achieved, the next goal is to leave residual tumor at just a single site, she concluded. A question that remains is whether primary debulking surgery is preferable to neoadjuvant treatment followed by interval debulking surgery. In the results Dr. Manning-Geist presented, patients who underwent primary debulking had better outcomes than those with neoadjuvant therapy followed by interval debulking, but these two subgroups also had different clinical characteristics.
The study used data from 510 patients with stage IIIC or IV epithelial ovarian cancer treated at either Brigham and Women’s or Massachusetts General Hospital during 2010-2015. The study cohort included 240 patients who underwent primary debulking surgery and 270 who first received neoadjuvant chemotherapy and then underwent interval debulking surgery. The patients who received neoadjuvant therapy were, on average, older (65 years vs. 63 years), had a higher prevalence of stage IV disease (44% vs. 16%), and had a higher prevalence of tumors with serous histology (93% vs. 77%), compared with patients who underwent primary debulking.
Complete tumor resections occurred in 39% of the primary debulking patients and in 64% of those who received neoadjuvant therapy; residual disease of 1 cm or less at one site occurred in 17% and 13%, respectively; minimal residual disease at multiple sites remained in 28% and 17% respectively; and the remaining patients had residual disease of more than 1 cm in at least one site, 16% and 6% respectively.
For this analysis, Dr. Manning-Geist and her associates considered residual disease at any of seven possible sites: diaphragm, upper abdomen, bowel mesentary, bowel serosa, abdominal peritoneum, pelvis, and nodal. Even if multiple individual metastases remained within one of these sites after surgery, it was categorized as a single site of residual disease.
Among patients who underwent primary debulking surgery, progression-free survival persisted for a median of 23 months among patients with full resection, 19 months in patients with a single site with minimal residual disease, 13 months among those with multiple sites of residual disease, and 10 months in patients with more than 1 cm of residual tumor. Median overall survival in these four subgroups was not yet reached, 64 months, 50 months, and 49 months, respectively.
Among patients who received neoadjuvant chemotherapy and then underwent interval debulking surgery, median durations of progression-free survival were 14 months, 12 months, 10 months, and 6 months, respectively. Median overall survival rates were 58 months, 37 months, 26 months, and 33 months, respectively. Within each of these four analyses, the differences in both survival and progression-free survival across the four subgroups was statistically significant, with a P less than .001 for each analysis.
In multivariate analyses, among patients who underwent primary debulking surgery, the significant linkages with worsening progression-free and overall survival were age, cancer stage, and amount and site number of residual disease. Among patients who received neoadjuvant chemotherapy followed by interval debulking residual disease diameter and site number of residual tumor was the only significant determinant for both progression-free and overall survival, Dr. Manning-Geist reported.
Dr. Manning-Geist had no disclosures.
SOURCE: Manning-Geist B et al. SGO 2018, Abstract 43.
REPORTING FROM SGO 2018
Key clinical point:
Major finding: Median overall survival after primary debulking was 64 months with single-site residual disease and 50 months with multisite disease.
Study details: Retrospective review of 510 patients from two U.S. centers.
Disclosures: Dr. Manning-Geist had no disclosures.
Source: Manning-Geist BL et al. SGO 2018, Abstract 43.
Extracapsular spread predicts survival in SLN+ melanoma
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.
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.
REPORTING FROM SSO 2018
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.
Most physicians support Medicaid work requirements
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.
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.
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.
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.
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.
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.
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%.
Updates in MS: Highlights From the ECTRIMS and ACTRIMS Annual Meetings
Eating disorders put teens at risk for depression, bullying
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.
“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.
, 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.
“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.
, 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.
“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.
, 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.
FROM JAMA PSYCHIATRY
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.
New study establishes IBD severity index
Experts have established a severity index for inflammatory bowel disease (IBD), according to results of an analysis published in the journal Gut (doi: 10.1136/gutjnl-2016-312648).
The index, conceived by a panel of IBD specialists from the International Organization for the Study of Inflammatory Bowel Diseases, is a step toward the standardization of disease severity definitions in ulcerative colitis and Crohn’s disease.
The panel determined 16 severity attributes for Crohn’s disease and 13 for ulcerative colitis. The analysis found that, in Crohn’s disease, mucosal lesions, fistulas, and abscesses were the greatest contributors to disease severity at 15.8%, 10.9%, and 9.7%, respectively. In ulcerative colitis, 18.1% of disease severity was attributed to mucosal lesions, 14% to impact on daily activities, and 11.2% to C-reactive protein, wrote Corey A. Siegel, MD, MS, of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his coauthors.
Investigators used a PubMed literature search to identify three broad elements of disease severity: impact of disease symptoms on daily activities, inflammatory burden, and disease course.
A panel of 16 experts then conducted a series of votes to determine which attributes within each domain would be used to assess disease severity. Two sets of attributes were defined as disease markers in Crohn’s disease and ulcerative colitis.
A type of conjoint analysis called adaptive choice-based conjoint was then performed to ascertain how different clinical factors influenced specialists’ decision making and impressions of disease severity.
A series of questions was asked, with each response determining subsequent questions, until “ample consistency” was found in their choices.
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.
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.
SOURCE: Siegel CA et al. Gut. 2018 Feb;67(2):244-54.
AGA patient education materials can help your IBD patients better understand and manage their disease. Learn more at www.gastro.org/IBD
Experts have established a severity index for inflammatory bowel disease (IBD), according to results of an analysis published in the journal Gut (doi: 10.1136/gutjnl-2016-312648).
The index, conceived by a panel of IBD specialists from the International Organization for the Study of Inflammatory Bowel Diseases, is a step toward the standardization of disease severity definitions in ulcerative colitis and Crohn’s disease.
The panel determined 16 severity attributes for Crohn’s disease and 13 for ulcerative colitis. The analysis found that, in Crohn’s disease, mucosal lesions, fistulas, and abscesses were the greatest contributors to disease severity at 15.8%, 10.9%, and 9.7%, respectively. In ulcerative colitis, 18.1% of disease severity was attributed to mucosal lesions, 14% to impact on daily activities, and 11.2% to C-reactive protein, wrote Corey A. Siegel, MD, MS, of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his coauthors.
Investigators used a PubMed literature search to identify three broad elements of disease severity: impact of disease symptoms on daily activities, inflammatory burden, and disease course.
A panel of 16 experts then conducted a series of votes to determine which attributes within each domain would be used to assess disease severity. Two sets of attributes were defined as disease markers in Crohn’s disease and ulcerative colitis.
A type of conjoint analysis called adaptive choice-based conjoint was then performed to ascertain how different clinical factors influenced specialists’ decision making and impressions of disease severity.
A series of questions was asked, with each response determining subsequent questions, until “ample consistency” was found in their choices.
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.
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.
SOURCE: Siegel CA et al. Gut. 2018 Feb;67(2):244-54.
AGA patient education materials can help your IBD patients better understand and manage their disease. Learn more at www.gastro.org/IBD
Experts have established a severity index for inflammatory bowel disease (IBD), according to results of an analysis published in the journal Gut (doi: 10.1136/gutjnl-2016-312648).
The index, conceived by a panel of IBD specialists from the International Organization for the Study of Inflammatory Bowel Diseases, is a step toward the standardization of disease severity definitions in ulcerative colitis and Crohn’s disease.
The panel determined 16 severity attributes for Crohn’s disease and 13 for ulcerative colitis. The analysis found that, in Crohn’s disease, mucosal lesions, fistulas, and abscesses were the greatest contributors to disease severity at 15.8%, 10.9%, and 9.7%, respectively. In ulcerative colitis, 18.1% of disease severity was attributed to mucosal lesions, 14% to impact on daily activities, and 11.2% to C-reactive protein, wrote Corey A. Siegel, MD, MS, of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his coauthors.
Investigators used a PubMed literature search to identify three broad elements of disease severity: impact of disease symptoms on daily activities, inflammatory burden, and disease course.
A panel of 16 experts then conducted a series of votes to determine which attributes within each domain would be used to assess disease severity. Two sets of attributes were defined as disease markers in Crohn’s disease and ulcerative colitis.
A type of conjoint analysis called adaptive choice-based conjoint was then performed to ascertain how different clinical factors influenced specialists’ decision making and impressions of disease severity.
A series of questions was asked, with each response determining subsequent questions, until “ample consistency” was found in their choices.
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.
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.
SOURCE: Siegel CA et al. Gut. 2018 Feb;67(2):244-54.
AGA patient education materials can help your IBD patients better understand and manage their disease. Learn more at www.gastro.org/IBD
FROM GUT
Does measuring episiotomy rates really benefit the quality of care our patients receive?
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:
- 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.
- 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.
- A 16-year-old woman (G1P0) at 41 weeks’ gestation was admitted for induction of labor with an unripe cervix. I was delayed, and the laborist performed a vaginal delivery after 1 attempt at vacuum extraction and no episiotomy. The 7 lb 3 oz baby had Apgar scores of 4 and 9 at 1 and 5 minutes, respectively. There was significant bleeding from bilateral vaginal lacerations with bilateral hymeneal avulsions.
What is the benefit?
Are we really benefitting our patients by restricting the use of episiotomy? Consider these questions:
- Should we delay the mother’s bonding with her baby for an hour’s complex repair versus 20 minutes for a simple, layered episiotomy repair?
- In a busy labor and delivery unit, should resources be tied up for this extra time? With all due respect to the national experts advocating this recommendation, are they in the trenches performing deliveries and spending hours repairing complex lacerations?
- Should we not use our clinical judgment instead of allowing the mother to experience an extensive vaginal/perineal laceration after a vaginal delivery of a 9- or 10-lb baby?
- Where are the long-term data showing that it is better for a woman to stretch and attenuate her perineal and vaginal muscles to the breaking point, and then tear?
- Do all the additional sutures lead to vaginal scarring, vaginal stricture, and sexual dysfunction in later years?
- Which protocol better enables the mother to maintain pelvic organ support and avoid pelvic organ prolapse and stress urinary incontinence?
In Williams Obstetrics, the authors state: “We are of the view that episiotomy should be applied selectively for the appropriate indications. The final rule is that there is no substitute for surgical judgment and common sense.”2
Consider other metrics
Patients might be better served by measuring quality and safety metrics other than episiotomy. These might include, for example, measuring:
- the use of prophylactic oxytocin after the anterior shoulder is delivered in order to decrease the risk of postpartum hemorrhage, as advocated by the California Maternal Quality Care Collaborative3
- the number of patients admitted before active labor and those receiving an epidural before active labor (with the aim of decreasing the primary cesarean rate in the NTSV population)
- the number of patients in an advanced stage of labor whose labor pattern has become dysfunctional, in whom no interventions have been instituted to improve the labor pattern, and who subsequently deliver by primary cesarean.
Recommendation
I recommend that performing an episiotomy should be an individual clinical decision for the individual patient by the individual obstetrician, and not a national mandate. We can provide quality care to our patients by performing selective episiotomies when clinically necessary, and not avoid them to an extreme that harms our patients. In my opinion, using the episiotomy rate as a quality metric should be abandoned.
Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.
- 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.
- Vaginal delivery. In: Cunnigham FG, Leveno KJ, Bloom SL, et al, eds. Williams Obstetrics. 24th ed. New York, NY: McGraw-Hill Medical; 2014:550.
- CMQCC: California Maternal Quality Care Collaborative website. https://www.cmqcc.org/. Accessed March 12, 2018.
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.
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.
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.
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:
- 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.
- 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.
- A 16-year-old woman (G1P0) at 41 weeks’ gestation was admitted for induction of labor with an unripe cervix. I was delayed, and the laborist performed a vaginal delivery after 1 attempt at vacuum extraction and no episiotomy. The 7 lb 3 oz baby had Apgar scores of 4 and 9 at 1 and 5 minutes, respectively. There was significant bleeding from bilateral vaginal lacerations with bilateral hymeneal avulsions.
What is the benefit?
Are we really benefitting our patients by restricting the use of episiotomy? Consider these questions:
- Should we delay the mother’s bonding with her baby for an hour’s complex repair versus 20 minutes for a simple, layered episiotomy repair?
- In a busy labor and delivery unit, should resources be tied up for this extra time? With all due respect to the national experts advocating this recommendation, are they in the trenches performing deliveries and spending hours repairing complex lacerations?
- Should we not use our clinical judgment instead of allowing the mother to experience an extensive vaginal/perineal laceration after a vaginal delivery of a 9- or 10-lb baby?
- Where are the long-term data showing that it is better for a woman to stretch and attenuate her perineal and vaginal muscles to the breaking point, and then tear?
- Do all the additional sutures lead to vaginal scarring, vaginal stricture, and sexual dysfunction in later years?
- Which protocol better enables the mother to maintain pelvic organ support and avoid pelvic organ prolapse and stress urinary incontinence?
In Williams Obstetrics, the authors state: “We are of the view that episiotomy should be applied selectively for the appropriate indications. The final rule is that there is no substitute for surgical judgment and common sense.”2
Consider other metrics
Patients might be better served by measuring quality and safety metrics other than episiotomy. These might include, for example, measuring:
- the use of prophylactic oxytocin after the anterior shoulder is delivered in order to decrease the risk of postpartum hemorrhage, as advocated by the California Maternal Quality Care Collaborative3
- the number of patients admitted before active labor and those receiving an epidural before active labor (with the aim of decreasing the primary cesarean rate in the NTSV population)
- the number of patients in an advanced stage of labor whose labor pattern has become dysfunctional, in whom no interventions have been instituted to improve the labor pattern, and who subsequently deliver by primary cesarean.
Recommendation
I recommend that performing an episiotomy should be an individual clinical decision for the individual patient by the individual obstetrician, and not a national mandate. We can provide quality care to our patients by performing selective episiotomies when clinically necessary, and not avoid them to an extreme that harms our patients. In my opinion, using the episiotomy rate as a quality metric should be abandoned.
Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.
Like most California institutions performing deliveries, St. Joseph Hospital in Orange, California, started releasing 2016 maternal quality metrics internally at first. Data for the first 9 months of 2016 were distributed in December 2016. These metrics depend on a denominator based on the number of deliveries attributed to each obstetrician.
- I was very pleased to see that I ranked first in the vaginal birth after cesarean (VBAC) rate at 36.8%.
- I also was pleased that I ranked the fourth lowest, at 15.9%, for my cesarean delivery rate in the low-risk, nulliparous term singleton vertex (NTSV) population.
- I was neither pleased nor displeased that I ranked number 29 of 31 physicians at 59.1% (39/66) for the episiotomy rate. The denominator range was 1 to 287. I knew I would hear about this! Sure enough, a medical director asked me how 2 of my metrics could be so good, yet the third be so abysmal.
After the release of the data and the somewhat humorous chastisement by the medical director, I decided to try complying with the new American College of Obstetricians and Gynecologists (ACOG) guidelines1 again beginning in January 2017.
A little personal history
Allow me to date myself. I completed my residency in 1981 and was Board Certified in 1984. My wife refers to me as a “Dinosaur!” As an ObGyn in solo practice, I take my own call.
During my training, episiotomies were commonly performed but were not always necessary. We were taught to not perform an episiotomy if the patient could safely and easily deliver without one. However, if clinically indicated, an episiotomy should be performed. If a 3rd- or 4th-degree laceration occurred, we were taught to anatomically repair it. Nowadays in my practice, these lacerations are rare in conjunction with an episiotomy, and with a controlled delivery of the fetal head.
Our nursing staff will tell you that I resist change. However, I usually attempt and often do adapt the latest national guidelines into my practice. Although I did not agree when restrictive episiotomies became a national goal a few years ago, I tried to adhere to the new national episiotomy recommendations.1 I am meticulous: a standard episiotomy repair that does not involve excessive bleeding usually takes 20 minutes to restore normal anatomy with a simple, straightforward, layered closure.
My episiotomy performance record
In 2015, I restricted my use of episiotomies. When I did not perform one, the patient usually experienced lacerations. These were labial or periurethral as well as complex 3-dimensional “Z” or “Y” shaped vaginal/perineal lacerations, not just the 1st- and 2nd-degree perineal lacerations to which the literature refers.
The problems associated with complex, geometric vaginal lacerations are multifactorial:
- Lacerations occur at multiple locations.
- Significant bleeding often occurs. Because the lacerations are in multiple locations, the bleeding cannot be addressed easily, quickly, or at once.
- Visualization is difficult because of the bleeding, thus further prolonging the repair.
- These lacerations are often deeper than an episiotomy would have been and are very friable as all the layers have been stretched to their breaking point before tearing.
- Sometimes the lacerations include avulsion of the hymen with extensive bleeding.
- Difficult-to-repair lacerations can tear upon suturing, requiring layer upon layer of sutures at the same site. Future scarring and vaginal stricture leading to sexual dysfunction are concerns.
- At times, the friability and bleeding is so brisk that once the bleeding is controlled and the episiotomy is partially repaired, I can see that it is has not been an anatomic repair. I then have to take it down and re-do the repair with an obscured field from bleeding again!
- Some repairs are so fragile that when I express retained blood from the uterus and upper vagina after completing the repair, the tissue tears, bleeds, and requires additional restoration.
- These tears usually require an hour to repair and achieve hemostasis. At times, an assistant and a retractor are necessary.
After 2015, when I spent the year complying with the new guidelines, I returned to my original protocol: I performed an episiotomy only when I thought the patient was going to experience a significant laceration. I did not perform an episiotomy if I thought the mother could deliver easily without one. That is how I attained the 59.1% episiotomy rate in 2016.
Another try
After the 2016 hospital data were released, I decided to comply with the new guidelines1 again beginning in January 2017. Here I share the details of 3 deliveries that occurred in 2017:
- 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.
- 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.
- A 16-year-old woman (G1P0) at 41 weeks’ gestation was admitted for induction of labor with an unripe cervix. I was delayed, and the laborist performed a vaginal delivery after 1 attempt at vacuum extraction and no episiotomy. The 7 lb 3 oz baby had Apgar scores of 4 and 9 at 1 and 5 minutes, respectively. There was significant bleeding from bilateral vaginal lacerations with bilateral hymeneal avulsions.
What is the benefit?
Are we really benefitting our patients by restricting the use of episiotomy? Consider these questions:
- Should we delay the mother’s bonding with her baby for an hour’s complex repair versus 20 minutes for a simple, layered episiotomy repair?
- In a busy labor and delivery unit, should resources be tied up for this extra time? With all due respect to the national experts advocating this recommendation, are they in the trenches performing deliveries and spending hours repairing complex lacerations?
- Should we not use our clinical judgment instead of allowing the mother to experience an extensive vaginal/perineal laceration after a vaginal delivery of a 9- or 10-lb baby?
- Where are the long-term data showing that it is better for a woman to stretch and attenuate her perineal and vaginal muscles to the breaking point, and then tear?
- Do all the additional sutures lead to vaginal scarring, vaginal stricture, and sexual dysfunction in later years?
- Which protocol better enables the mother to maintain pelvic organ support and avoid pelvic organ prolapse and stress urinary incontinence?
In Williams Obstetrics, the authors state: “We are of the view that episiotomy should be applied selectively for the appropriate indications. The final rule is that there is no substitute for surgical judgment and common sense.”2
Consider other metrics
Patients might be better served by measuring quality and safety metrics other than episiotomy. These might include, for example, measuring:
- the use of prophylactic oxytocin after the anterior shoulder is delivered in order to decrease the risk of postpartum hemorrhage, as advocated by the California Maternal Quality Care Collaborative3
- the number of patients admitted before active labor and those receiving an epidural before active labor (with the aim of decreasing the primary cesarean rate in the NTSV population)
- the number of patients in an advanced stage of labor whose labor pattern has become dysfunctional, in whom no interventions have been instituted to improve the labor pattern, and who subsequently deliver by primary cesarean.
Recommendation
I recommend that performing an episiotomy should be an individual clinical decision for the individual patient by the individual obstetrician, and not a national mandate. We can provide quality care to our patients by performing selective episiotomies when clinically necessary, and not avoid them to an extreme that harms our patients. In my opinion, using the episiotomy rate as a quality metric should be abandoned.
Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.
- 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.
- Vaginal delivery. In: Cunnigham FG, Leveno KJ, Bloom SL, et al, eds. Williams Obstetrics. 24th ed. New York, NY: McGraw-Hill Medical; 2014:550.
- CMQCC: California Maternal Quality Care Collaborative website. https://www.cmqcc.org/. Accessed March 12, 2018.
- 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.
- Vaginal delivery. In: Cunnigham FG, Leveno KJ, Bloom SL, et al, eds. Williams Obstetrics. 24th ed. New York, NY: McGraw-Hill Medical; 2014:550.
- CMQCC: California Maternal Quality Care Collaborative website. https://www.cmqcc.org/. Accessed March 12, 2018.
VIDEO: Interventions target opioid overprescribing after gynecologic surgery
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NEW ORLEANS – U.S. clinicians prescribe opioid tablets to postsurgical patients too often and at too high a pill count, according to results from two independent studies that examined prescribing patterns and opioid use in patients following gynecologic surgery.
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.
“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.
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 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.
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.
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.
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.
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.
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.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NEW ORLEANS – U.S. clinicians prescribe opioid tablets to postsurgical patients too often and at too high a pill count, according to results from two independent studies that examined prescribing patterns and opioid use in patients following gynecologic surgery.
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.
“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.
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
NEW ORLEANS – U.S. clinicians prescribe opioid tablets to postsurgical patients too often and at too high a pill count, according to results from two independent studies that examined prescribing patterns and opioid use in patients following gynecologic surgery.
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.
“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.
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.
REPORTING FROM SGO 2018
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.