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Many women have unprotected sex in year after bariatric surgery
More than 40% of reproductive-age women reported having unprotected sex in the year after undergoing bariatric surgery, despite recommendations to avoid pregnancy for at least a year, a new study finds. Another 4% of women reported trying to conceive in the 12 months after surgery.
“We were surprised to find such a large percentage of women were not using contraception, and we were also surprised to find so many were actively trying to conceive,” the study’s lead author Marie N. Menke, MD, MPH, of the University of Pittsburgh, said in an interview. “Reproductive-age women who are considering bariatric surgery should be counseled that they should plan to use contraceptives after surgery for about 12-18 months.”
Pregnancy isn’t recommended over that period mainly because of the risks to the fetus, Dr. Menke said. “These risks are different from obesity in general. We don’t know exactly why surgery causes these risks, but ideally, patients would be weight-stable prior to conception.”
In 2013, the American Association of Clinical Endocrinologists, the Obesity Society, and the American Society for Metabolic & Bariatric Surgery provided a Grade D recommendation for a 12-18 month delay in conception (Obesity [Silver Spring] 2013;21[suppl 1]:S1-27). A recent study provided more insight into the potential risks of pregnancy soon after weight-loss procedures. It reported that, compared with those who gave birth more than 4 years later, women who gave birth within 2 years of bariatric surgery had higher risks of premature birth, admission to neonatal intensive care units, and small-for-gestational-age infants (JAMA Surg. 2017 Feb 1;152[2]:1-8).
The current prospective cohort study included women who underwent bariatric surgery for the first time during 2005-2009 at 10 U.S. hospitals. The women, all aged 18-44 years, answered questions for as long as 7 years, until January 2015 (Obstet Gynecol. 2017 Oct 6. doi: 10.1097/AOG.0000000000002323).
The analysis included 710 women who provided conception data. The median body mass index of the women was 46.3 kg/m2. Most patients underwent Roux-en-Y gastric bypass (73%), followed by laparoscopic adjustable gastric banding (23%).
Researchers found that 4.3% of the women tried to conceive in the first year after surgery (95% confidence interval, 2.4-6.3), and 13.1% did so in the second year (95% CI, 9.3-17.0; P less than .001).
During the first year after surgery, 12.7% of women had no intercourse (95% CI, 9.4-16.0), 40.5% had only protected intercourse (95% CI, 35.6-45.4), and 41.5% (95% CI, 36.4-46.6) had unprotected intercourse while not trying to conceive.
Why are the unprotected sex numbers so high? “We wonder if some women simply feel that they cannot get pregnant,” Dr. Menke said. “Our group has previously reported that 42% of women who had attempted to conceive prior to bariatric surgery had a history of infertility. Some of these women went on to deliver a live birth, but many did not.”
The study reports that 183 of the 710 women did ultimately conceive and that the number may be as high as 237 because data were missing for 54 women who may have not wanted to report a nonlive birth. Of the women who reported conceiving, 68.9% had live births, 1.1% had stillbirths, 1.1% had ectopic pregnancies, 21.9% miscarried and 7.1% had abortions.
“We’d really like this research to be a reason to consider presurgical contraceptive counseling as one of the steps prior to bariatric surgery,” Dr. Menke said. “This may include a referral by the bariatric surgeon to a physician would who provide counseling, prescribe, or both.”
The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Menke reported having no relevant disclosures. Her coauthors reported financial relationships with pharmaceutical and medical device companies with products to treat metabolic diseases.
More than 40% of reproductive-age women reported having unprotected sex in the year after undergoing bariatric surgery, despite recommendations to avoid pregnancy for at least a year, a new study finds. Another 4% of women reported trying to conceive in the 12 months after surgery.
“We were surprised to find such a large percentage of women were not using contraception, and we were also surprised to find so many were actively trying to conceive,” the study’s lead author Marie N. Menke, MD, MPH, of the University of Pittsburgh, said in an interview. “Reproductive-age women who are considering bariatric surgery should be counseled that they should plan to use contraceptives after surgery for about 12-18 months.”
Pregnancy isn’t recommended over that period mainly because of the risks to the fetus, Dr. Menke said. “These risks are different from obesity in general. We don’t know exactly why surgery causes these risks, but ideally, patients would be weight-stable prior to conception.”
In 2013, the American Association of Clinical Endocrinologists, the Obesity Society, and the American Society for Metabolic & Bariatric Surgery provided a Grade D recommendation for a 12-18 month delay in conception (Obesity [Silver Spring] 2013;21[suppl 1]:S1-27). A recent study provided more insight into the potential risks of pregnancy soon after weight-loss procedures. It reported that, compared with those who gave birth more than 4 years later, women who gave birth within 2 years of bariatric surgery had higher risks of premature birth, admission to neonatal intensive care units, and small-for-gestational-age infants (JAMA Surg. 2017 Feb 1;152[2]:1-8).
The current prospective cohort study included women who underwent bariatric surgery for the first time during 2005-2009 at 10 U.S. hospitals. The women, all aged 18-44 years, answered questions for as long as 7 years, until January 2015 (Obstet Gynecol. 2017 Oct 6. doi: 10.1097/AOG.0000000000002323).
The analysis included 710 women who provided conception data. The median body mass index of the women was 46.3 kg/m2. Most patients underwent Roux-en-Y gastric bypass (73%), followed by laparoscopic adjustable gastric banding (23%).
Researchers found that 4.3% of the women tried to conceive in the first year after surgery (95% confidence interval, 2.4-6.3), and 13.1% did so in the second year (95% CI, 9.3-17.0; P less than .001).
During the first year after surgery, 12.7% of women had no intercourse (95% CI, 9.4-16.0), 40.5% had only protected intercourse (95% CI, 35.6-45.4), and 41.5% (95% CI, 36.4-46.6) had unprotected intercourse while not trying to conceive.
Why are the unprotected sex numbers so high? “We wonder if some women simply feel that they cannot get pregnant,” Dr. Menke said. “Our group has previously reported that 42% of women who had attempted to conceive prior to bariatric surgery had a history of infertility. Some of these women went on to deliver a live birth, but many did not.”
The study reports that 183 of the 710 women did ultimately conceive and that the number may be as high as 237 because data were missing for 54 women who may have not wanted to report a nonlive birth. Of the women who reported conceiving, 68.9% had live births, 1.1% had stillbirths, 1.1% had ectopic pregnancies, 21.9% miscarried and 7.1% had abortions.
“We’d really like this research to be a reason to consider presurgical contraceptive counseling as one of the steps prior to bariatric surgery,” Dr. Menke said. “This may include a referral by the bariatric surgeon to a physician would who provide counseling, prescribe, or both.”
The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Menke reported having no relevant disclosures. Her coauthors reported financial relationships with pharmaceutical and medical device companies with products to treat metabolic diseases.
More than 40% of reproductive-age women reported having unprotected sex in the year after undergoing bariatric surgery, despite recommendations to avoid pregnancy for at least a year, a new study finds. Another 4% of women reported trying to conceive in the 12 months after surgery.
“We were surprised to find such a large percentage of women were not using contraception, and we were also surprised to find so many were actively trying to conceive,” the study’s lead author Marie N. Menke, MD, MPH, of the University of Pittsburgh, said in an interview. “Reproductive-age women who are considering bariatric surgery should be counseled that they should plan to use contraceptives after surgery for about 12-18 months.”
Pregnancy isn’t recommended over that period mainly because of the risks to the fetus, Dr. Menke said. “These risks are different from obesity in general. We don’t know exactly why surgery causes these risks, but ideally, patients would be weight-stable prior to conception.”
In 2013, the American Association of Clinical Endocrinologists, the Obesity Society, and the American Society for Metabolic & Bariatric Surgery provided a Grade D recommendation for a 12-18 month delay in conception (Obesity [Silver Spring] 2013;21[suppl 1]:S1-27). A recent study provided more insight into the potential risks of pregnancy soon after weight-loss procedures. It reported that, compared with those who gave birth more than 4 years later, women who gave birth within 2 years of bariatric surgery had higher risks of premature birth, admission to neonatal intensive care units, and small-for-gestational-age infants (JAMA Surg. 2017 Feb 1;152[2]:1-8).
The current prospective cohort study included women who underwent bariatric surgery for the first time during 2005-2009 at 10 U.S. hospitals. The women, all aged 18-44 years, answered questions for as long as 7 years, until January 2015 (Obstet Gynecol. 2017 Oct 6. doi: 10.1097/AOG.0000000000002323).
The analysis included 710 women who provided conception data. The median body mass index of the women was 46.3 kg/m2. Most patients underwent Roux-en-Y gastric bypass (73%), followed by laparoscopic adjustable gastric banding (23%).
Researchers found that 4.3% of the women tried to conceive in the first year after surgery (95% confidence interval, 2.4-6.3), and 13.1% did so in the second year (95% CI, 9.3-17.0; P less than .001).
During the first year after surgery, 12.7% of women had no intercourse (95% CI, 9.4-16.0), 40.5% had only protected intercourse (95% CI, 35.6-45.4), and 41.5% (95% CI, 36.4-46.6) had unprotected intercourse while not trying to conceive.
Why are the unprotected sex numbers so high? “We wonder if some women simply feel that they cannot get pregnant,” Dr. Menke said. “Our group has previously reported that 42% of women who had attempted to conceive prior to bariatric surgery had a history of infertility. Some of these women went on to deliver a live birth, but many did not.”
The study reports that 183 of the 710 women did ultimately conceive and that the number may be as high as 237 because data were missing for 54 women who may have not wanted to report a nonlive birth. Of the women who reported conceiving, 68.9% had live births, 1.1% had stillbirths, 1.1% had ectopic pregnancies, 21.9% miscarried and 7.1% had abortions.
“We’d really like this research to be a reason to consider presurgical contraceptive counseling as one of the steps prior to bariatric surgery,” Dr. Menke said. “This may include a referral by the bariatric surgeon to a physician would who provide counseling, prescribe, or both.”
The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Menke reported having no relevant disclosures. Her coauthors reported financial relationships with pharmaceutical and medical device companies with products to treat metabolic diseases.
FROM OBSTETRICS & GYNECOLOGY
Key clinical point:
Major finding: In the first year after surgery, 4.3% of women surveyed tried to conceive (95% CI, 2.4-6.3), and another 41.5% had unprotected intercourse (95% CI, 36.4-46.6).
Data source: Prospective cohort study of 710 women, aged 18-44 years, who underwent bariatric surgery for the first time during 2005-2009 at 10 U.S. hospitals.
Disclosures: The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Menke reported having no relevant disclosures. Her coauthors reported financial relationships with pharmaceutical and medical device companies with products to treat metabolic diseases.
System automates classification of RBCs
Scientists say they have developed an automated system that can identify shapes of red blood cells (RBCs).
The team found their system could classify sickled RBCs “with high accuracy,” which suggests it could be used to help monitor patients with sickle cell disease.
“We have developed the first deep learning tool that can automatically identify and classify red blood cell alteration, hence providing direct quantitative evidence of the severity of the disease,” said George Karniadakis, PhD, of Brown University in Providence, Rhode Island.
Dr Karniadakis and his colleagues described their tool in PLOS Computational Biology.
The researchers wanted to automate the process of identifying RBC shape. So they developed a computational framework that employs a machine-learning tool known as a deep convolutional neural network (CNN).
The framework uses 3 steps to classify the shapes of RBCs in microscopic images of blood.
First, it distinguishes RBCs from the background of each image and from each other. Then, for each cell detected, it zooms in or out until all cell images are a uniform size. Finally, it uses deep CNNs to categorize RBCs by shape.
The researchers validated their new tool using 7000 microscopy images from 8 patients with sickle cell disease. The method successfully classified RBC shape for both oxygenated and deoxygenated cells.
The researchers plan to further improve their deep CNN tool and test it in other diseases that alter the shape and size of RBCs, such as diabetes and HIV. They also plan to explore its usefulness in characterizing cancer cells.
Scientists say they have developed an automated system that can identify shapes of red blood cells (RBCs).
The team found their system could classify sickled RBCs “with high accuracy,” which suggests it could be used to help monitor patients with sickle cell disease.
“We have developed the first deep learning tool that can automatically identify and classify red blood cell alteration, hence providing direct quantitative evidence of the severity of the disease,” said George Karniadakis, PhD, of Brown University in Providence, Rhode Island.
Dr Karniadakis and his colleagues described their tool in PLOS Computational Biology.
The researchers wanted to automate the process of identifying RBC shape. So they developed a computational framework that employs a machine-learning tool known as a deep convolutional neural network (CNN).
The framework uses 3 steps to classify the shapes of RBCs in microscopic images of blood.
First, it distinguishes RBCs from the background of each image and from each other. Then, for each cell detected, it zooms in or out until all cell images are a uniform size. Finally, it uses deep CNNs to categorize RBCs by shape.
The researchers validated their new tool using 7000 microscopy images from 8 patients with sickle cell disease. The method successfully classified RBC shape for both oxygenated and deoxygenated cells.
The researchers plan to further improve their deep CNN tool and test it in other diseases that alter the shape and size of RBCs, such as diabetes and HIV. They also plan to explore its usefulness in characterizing cancer cells.
Scientists say they have developed an automated system that can identify shapes of red blood cells (RBCs).
The team found their system could classify sickled RBCs “with high accuracy,” which suggests it could be used to help monitor patients with sickle cell disease.
“We have developed the first deep learning tool that can automatically identify and classify red blood cell alteration, hence providing direct quantitative evidence of the severity of the disease,” said George Karniadakis, PhD, of Brown University in Providence, Rhode Island.
Dr Karniadakis and his colleagues described their tool in PLOS Computational Biology.
The researchers wanted to automate the process of identifying RBC shape. So they developed a computational framework that employs a machine-learning tool known as a deep convolutional neural network (CNN).
The framework uses 3 steps to classify the shapes of RBCs in microscopic images of blood.
First, it distinguishes RBCs from the background of each image and from each other. Then, for each cell detected, it zooms in or out until all cell images are a uniform size. Finally, it uses deep CNNs to categorize RBCs by shape.
The researchers validated their new tool using 7000 microscopy images from 8 patients with sickle cell disease. The method successfully classified RBC shape for both oxygenated and deoxygenated cells.
The researchers plan to further improve their deep CNN tool and test it in other diseases that alter the shape and size of RBCs, such as diabetes and HIV. They also plan to explore its usefulness in characterizing cancer cells.
Aptiom Receives FDA approval for Partial-Onset Seizures in Children
FDA has approved Aptiom (eslicarbazepine) for an expanded indication to treat partial-onset seizures in children.
Indications: Aptiom was previously approved form the treatment of partial onset seizures in adults. The new approval is for children ages 4 years to 17 years with the same disorder. It is a once daily immediate release anti-epilepsy drug that can be taken whole or crushed, with or without food. The approval is based in part on extrapolation of previous data to support its use in the pediatric population.
Dosage and administration. The recommended dosage of APTIOM is based on
body weight and is administered orally once daily. The package insert says to increase the dose in weekly intervals based on clinical response and tolerability to the recommended maintenance dosage. The initial pediatric dose is 200 mg/day for a patient 11 to 21 kg, with 200 mg/day as a maximum titration increment. Maximum dose for a child in this weight range in 400 to 600 mg/day.
Adverse effects. The most common reactions in adults include dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor. Adverse reactions are similar in pediatric patients.
Sunovion’s Aptiom (eslicarbazepine acetate) Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents 4 Years of Age and Older
http://www.sunovion.us/featured-news/press-releases/20170914a.pdf. Accessed October 16, 2017
FDA has approved Aptiom (eslicarbazepine) for an expanded indication to treat partial-onset seizures in children.
Indications: Aptiom was previously approved form the treatment of partial onset seizures in adults. The new approval is for children ages 4 years to 17 years with the same disorder. It is a once daily immediate release anti-epilepsy drug that can be taken whole or crushed, with or without food. The approval is based in part on extrapolation of previous data to support its use in the pediatric population.
Dosage and administration. The recommended dosage of APTIOM is based on
body weight and is administered orally once daily. The package insert says to increase the dose in weekly intervals based on clinical response and tolerability to the recommended maintenance dosage. The initial pediatric dose is 200 mg/day for a patient 11 to 21 kg, with 200 mg/day as a maximum titration increment. Maximum dose for a child in this weight range in 400 to 600 mg/day.
Adverse effects. The most common reactions in adults include dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor. Adverse reactions are similar in pediatric patients.
Sunovion’s Aptiom (eslicarbazepine acetate) Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents 4 Years of Age and Older
http://www.sunovion.us/featured-news/press-releases/20170914a.pdf. Accessed October 16, 2017
FDA has approved Aptiom (eslicarbazepine) for an expanded indication to treat partial-onset seizures in children.
Indications: Aptiom was previously approved form the treatment of partial onset seizures in adults. The new approval is for children ages 4 years to 17 years with the same disorder. It is a once daily immediate release anti-epilepsy drug that can be taken whole or crushed, with or without food. The approval is based in part on extrapolation of previous data to support its use in the pediatric population.
Dosage and administration. The recommended dosage of APTIOM is based on
body weight and is administered orally once daily. The package insert says to increase the dose in weekly intervals based on clinical response and tolerability to the recommended maintenance dosage. The initial pediatric dose is 200 mg/day for a patient 11 to 21 kg, with 200 mg/day as a maximum titration increment. Maximum dose for a child in this weight range in 400 to 600 mg/day.
Adverse effects. The most common reactions in adults include dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor. Adverse reactions are similar in pediatric patients.
Sunovion’s Aptiom (eslicarbazepine acetate) Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents 4 Years of Age and Older
http://www.sunovion.us/featured-news/press-releases/20170914a.pdf. Accessed October 16, 2017
Why is Psychogenic Nonepileptic Seizure Diagnosis Missed?
The diagnosis of psychogenic nonepileptic seizure (PNES) is often delayed—and a history of head trauma can contribute to that delay.
- 49 adult patients who were admitted to the epilepsy unit at the Jefferson Comprehensive Epilepsy Center for PNES were studied to determine how long it took for a correct diagnosis to be reached.
- Of the 49 patients, 39 were women, 10 were men; the study period was 2012 to 2016.
- On average, it took 3 years (median) to arrive at the correct diagnosis.
- A comparison of patients who received an early diagnosis to those whose diagnosis was delayed found that a history of head trauma was the only significant difference between the 2 groups.
- 2 of 19 patients had an early diagnosis (7%) and 11 of 28 patients experienced a delayed diagnosis, which was associated with head trauma (P=0.02).
Asadi-Pooya AA, Tinker J. Delay in diagnosis of psychogenic nonepileptic seizures in adults: A post hoc study [published online ahead of print Sept 15, 2017]. Epilepsy Behav. doi: 10.1016/j.yebeh.2017.08.005.
The diagnosis of psychogenic nonepileptic seizure (PNES) is often delayed—and a history of head trauma can contribute to that delay.
- 49 adult patients who were admitted to the epilepsy unit at the Jefferson Comprehensive Epilepsy Center for PNES were studied to determine how long it took for a correct diagnosis to be reached.
- Of the 49 patients, 39 were women, 10 were men; the study period was 2012 to 2016.
- On average, it took 3 years (median) to arrive at the correct diagnosis.
- A comparison of patients who received an early diagnosis to those whose diagnosis was delayed found that a history of head trauma was the only significant difference between the 2 groups.
- 2 of 19 patients had an early diagnosis (7%) and 11 of 28 patients experienced a delayed diagnosis, which was associated with head trauma (P=0.02).
Asadi-Pooya AA, Tinker J. Delay in diagnosis of psychogenic nonepileptic seizures in adults: A post hoc study [published online ahead of print Sept 15, 2017]. Epilepsy Behav. doi: 10.1016/j.yebeh.2017.08.005.
The diagnosis of psychogenic nonepileptic seizure (PNES) is often delayed—and a history of head trauma can contribute to that delay.
- 49 adult patients who were admitted to the epilepsy unit at the Jefferson Comprehensive Epilepsy Center for PNES were studied to determine how long it took for a correct diagnosis to be reached.
- Of the 49 patients, 39 were women, 10 were men; the study period was 2012 to 2016.
- On average, it took 3 years (median) to arrive at the correct diagnosis.
- A comparison of patients who received an early diagnosis to those whose diagnosis was delayed found that a history of head trauma was the only significant difference between the 2 groups.
- 2 of 19 patients had an early diagnosis (7%) and 11 of 28 patients experienced a delayed diagnosis, which was associated with head trauma (P=0.02).
Asadi-Pooya AA, Tinker J. Delay in diagnosis of psychogenic nonepileptic seizures in adults: A post hoc study [published online ahead of print Sept 15, 2017]. Epilepsy Behav. doi: 10.1016/j.yebeh.2017.08.005.
Federal Report Finds Increased Prevalence of Epilepsy
Three million adults and 470,000 children have epilepsy according to the latest statistics from the Centers for Disease Control and Prevention (CDC). These figures, based on the 2015 National Health Interview Survey, translate into 1.2% of the US population, an all-time high. Previous estimates, based on 2010 data, indicated that 2.3 million adults and 450,000 children had the disorder.
- The CDC report provides the first ever estimates of the prevalence of epilepsy state by state, with the agency reporting higher volumes in more densely populated states, as expected.
- The lowest prevalence of the neurological disease was noted in Wyoming, with 5900 active cases.
- California was estimated to have 427,700 cases of the disease.
- CDC believes increases from 2010 to 2015 are likely due to population growth.
- Among the limitations of the analysis is the fact that the estimates are based on self-reports, which are subject to bias.
- Underreporting by the public may reflect their reluctance to admit to a disorder because of its stigma and because they fear it could lead to driver’s license restrictions.
Zack MM, Kobau R. National and state estimates of the numbers of adults and children with active epilepsy — United States, 2015. MMWR; 2017;66(31):821-825.
Three million adults and 470,000 children have epilepsy according to the latest statistics from the Centers for Disease Control and Prevention (CDC). These figures, based on the 2015 National Health Interview Survey, translate into 1.2% of the US population, an all-time high. Previous estimates, based on 2010 data, indicated that 2.3 million adults and 450,000 children had the disorder.
- The CDC report provides the first ever estimates of the prevalence of epilepsy state by state, with the agency reporting higher volumes in more densely populated states, as expected.
- The lowest prevalence of the neurological disease was noted in Wyoming, with 5900 active cases.
- California was estimated to have 427,700 cases of the disease.
- CDC believes increases from 2010 to 2015 are likely due to population growth.
- Among the limitations of the analysis is the fact that the estimates are based on self-reports, which are subject to bias.
- Underreporting by the public may reflect their reluctance to admit to a disorder because of its stigma and because they fear it could lead to driver’s license restrictions.
Zack MM, Kobau R. National and state estimates of the numbers of adults and children with active epilepsy — United States, 2015. MMWR; 2017;66(31):821-825.
Three million adults and 470,000 children have epilepsy according to the latest statistics from the Centers for Disease Control and Prevention (CDC). These figures, based on the 2015 National Health Interview Survey, translate into 1.2% of the US population, an all-time high. Previous estimates, based on 2010 data, indicated that 2.3 million adults and 450,000 children had the disorder.
- The CDC report provides the first ever estimates of the prevalence of epilepsy state by state, with the agency reporting higher volumes in more densely populated states, as expected.
- The lowest prevalence of the neurological disease was noted in Wyoming, with 5900 active cases.
- California was estimated to have 427,700 cases of the disease.
- CDC believes increases from 2010 to 2015 are likely due to population growth.
- Among the limitations of the analysis is the fact that the estimates are based on self-reports, which are subject to bias.
- Underreporting by the public may reflect their reluctance to admit to a disorder because of its stigma and because they fear it could lead to driver’s license restrictions.
Zack MM, Kobau R. National and state estimates of the numbers of adults and children with active epilepsy — United States, 2015. MMWR; 2017;66(31):821-825.
Study: EHR malpractice claims rising
Malpractice claims involving the use of electronic health records (EHRs) are on the rise, according to data from The Doctors Company.
Cases in which EHRs were a factor grew from 2 claims during 2007-2010 to 161 claims from 2011 to December 2016, according an analysis published Oct. 16 by The Doctors Company, a national medical malpractice insurer.
The majority of EHR-related claims during 2014-2016 stemmed from incidents in a doctor’s office or a hospital clinic (35%), while the second most common location was a patient’s room. Malpractice claims involving EHRs were most commonly alleged against ob.gyns, followed by family physicians, and orthopedists. Diagnosis errors and improper medication management were the top most frequent allegations associated with EHR claims.
The analysis shows that while digitization of medicine has improved patient safety, it also has a dark side – as evidenced by the emergence of new kinds of errors, said Robert M. Wachter, MD, a professor at the University of California, San Francisco, and a member of the board of governors for The Doctors Company.
“This study makes an important contribution by chronicling actual errors, such as wrong medications selected from an autopick list, and helps point the way to changes ranging from physician education to EHR software design,” Dr. Wachter said in a statement.
agallegos@frontlinemedcom.com
On Twitter @legal_med
Malpractice claims involving the use of electronic health records (EHRs) are on the rise, according to data from The Doctors Company.
Cases in which EHRs were a factor grew from 2 claims during 2007-2010 to 161 claims from 2011 to December 2016, according an analysis published Oct. 16 by The Doctors Company, a national medical malpractice insurer.
The majority of EHR-related claims during 2014-2016 stemmed from incidents in a doctor’s office or a hospital clinic (35%), while the second most common location was a patient’s room. Malpractice claims involving EHRs were most commonly alleged against ob.gyns, followed by family physicians, and orthopedists. Diagnosis errors and improper medication management were the top most frequent allegations associated with EHR claims.
The analysis shows that while digitization of medicine has improved patient safety, it also has a dark side – as evidenced by the emergence of new kinds of errors, said Robert M. Wachter, MD, a professor at the University of California, San Francisco, and a member of the board of governors for The Doctors Company.
“This study makes an important contribution by chronicling actual errors, such as wrong medications selected from an autopick list, and helps point the way to changes ranging from physician education to EHR software design,” Dr. Wachter said in a statement.
agallegos@frontlinemedcom.com
On Twitter @legal_med
Malpractice claims involving the use of electronic health records (EHRs) are on the rise, according to data from The Doctors Company.
Cases in which EHRs were a factor grew from 2 claims during 2007-2010 to 161 claims from 2011 to December 2016, according an analysis published Oct. 16 by The Doctors Company, a national medical malpractice insurer.
The majority of EHR-related claims during 2014-2016 stemmed from incidents in a doctor’s office or a hospital clinic (35%), while the second most common location was a patient’s room. Malpractice claims involving EHRs were most commonly alleged against ob.gyns, followed by family physicians, and orthopedists. Diagnosis errors and improper medication management were the top most frequent allegations associated with EHR claims.
The analysis shows that while digitization of medicine has improved patient safety, it also has a dark side – as evidenced by the emergence of new kinds of errors, said Robert M. Wachter, MD, a professor at the University of California, San Francisco, and a member of the board of governors for The Doctors Company.
“This study makes an important contribution by chronicling actual errors, such as wrong medications selected from an autopick list, and helps point the way to changes ranging from physician education to EHR software design,” Dr. Wachter said in a statement.
agallegos@frontlinemedcom.com
On Twitter @legal_med
Key clinical point:
Major finding: Cases in which EHRs were a factor grew from 2 claims during 2007-2010 to 161 claims from 2011 to December 2016
Data source: Review of 163 claims from 2007 to 2016 in The Doctors Company database.
Disclosures: The study was funded by The Doctors Company.
DDSEP® 8 Quick quiz - October 2017 Question 2
Q2: Answer: E
This patient has elevated transaminases with normal alkaline phosphatase and total bilirubin levels. His AST is greater than his ALT. He does not meet criteria for having nonalcolholic steatohepatitis because of his history of drinking at least five drinks per day. Additionally, his AST:ALT ratio would be atypical for classic NASH presentation. This patient does not have chronic hepatitis B as his serologies reveal that he is hepatitis B immune. This patient’s labs are not suggestive of iron overload with a normal serum ferritin and normal iron saturation. Although this patient has emphysema diagnosed at a young age and an undetectable alpha-1-antitrypsin level, this patient’s liver enzyme elevations are not due to alpha-1-antitrypsin deficiency. Alpha-1-antitrypsin is a glycoprotein that functions as a serine protease inhibitor and is produced predominantly in hepatocytes and then secreted from the cell.
In alpha-1-antitrypsin mutations that affect the liver (most commonly the ZZ phenotype), there is an amino acid substitution that results in the production of an abnormal alpha-1-antitrypsin molecule that polymerizes within the hepatocyte preventing secretion from the cell and resulting in abnormal accumulation of the alpha-1-antitrypsin in hepatocytes with resulting hepatic damage over time. This patient, however, has the alpha-1-antitrypsin phenotype null/null, which results in the absence of alpha-1-antitrypsin production. As such, null/null individuals are at very high risk for emphysema due to the complete absence of the alpha-1-antitrypsin enzyme. However, since null/null individuals produce no alpha-1-antitrypsin at all, there is no abnormally polymerized alpha-1-antitrypsin protein build-up. Based upon the clinical history and laboratory data, this patient’s liver enzyme elevations are most likely due to alcohol abuse.
References
1. Fairbanks K.D., Tavill A.S. Liver disease in alpha-1-antitrypsin deficiency: A review. Am J Gastro. 2008;103:2136-41.
2. Silverman E.A., Sandhaus R.A. Alpha-1 antitrypsin deficiency. N Engl J Med. 2009;360;2749-5.
Q2: Answer: E
This patient has elevated transaminases with normal alkaline phosphatase and total bilirubin levels. His AST is greater than his ALT. He does not meet criteria for having nonalcolholic steatohepatitis because of his history of drinking at least five drinks per day. Additionally, his AST:ALT ratio would be atypical for classic NASH presentation. This patient does not have chronic hepatitis B as his serologies reveal that he is hepatitis B immune. This patient’s labs are not suggestive of iron overload with a normal serum ferritin and normal iron saturation. Although this patient has emphysema diagnosed at a young age and an undetectable alpha-1-antitrypsin level, this patient’s liver enzyme elevations are not due to alpha-1-antitrypsin deficiency. Alpha-1-antitrypsin is a glycoprotein that functions as a serine protease inhibitor and is produced predominantly in hepatocytes and then secreted from the cell.
In alpha-1-antitrypsin mutations that affect the liver (most commonly the ZZ phenotype), there is an amino acid substitution that results in the production of an abnormal alpha-1-antitrypsin molecule that polymerizes within the hepatocyte preventing secretion from the cell and resulting in abnormal accumulation of the alpha-1-antitrypsin in hepatocytes with resulting hepatic damage over time. This patient, however, has the alpha-1-antitrypsin phenotype null/null, which results in the absence of alpha-1-antitrypsin production. As such, null/null individuals are at very high risk for emphysema due to the complete absence of the alpha-1-antitrypsin enzyme. However, since null/null individuals produce no alpha-1-antitrypsin at all, there is no abnormally polymerized alpha-1-antitrypsin protein build-up. Based upon the clinical history and laboratory data, this patient’s liver enzyme elevations are most likely due to alcohol abuse.
References
1. Fairbanks K.D., Tavill A.S. Liver disease in alpha-1-antitrypsin deficiency: A review. Am J Gastro. 2008;103:2136-41.
2. Silverman E.A., Sandhaus R.A. Alpha-1 antitrypsin deficiency. N Engl J Med. 2009;360;2749-5.
Q2: Answer: E
This patient has elevated transaminases with normal alkaline phosphatase and total bilirubin levels. His AST is greater than his ALT. He does not meet criteria for having nonalcolholic steatohepatitis because of his history of drinking at least five drinks per day. Additionally, his AST:ALT ratio would be atypical for classic NASH presentation. This patient does not have chronic hepatitis B as his serologies reveal that he is hepatitis B immune. This patient’s labs are not suggestive of iron overload with a normal serum ferritin and normal iron saturation. Although this patient has emphysema diagnosed at a young age and an undetectable alpha-1-antitrypsin level, this patient’s liver enzyme elevations are not due to alpha-1-antitrypsin deficiency. Alpha-1-antitrypsin is a glycoprotein that functions as a serine protease inhibitor and is produced predominantly in hepatocytes and then secreted from the cell.
In alpha-1-antitrypsin mutations that affect the liver (most commonly the ZZ phenotype), there is an amino acid substitution that results in the production of an abnormal alpha-1-antitrypsin molecule that polymerizes within the hepatocyte preventing secretion from the cell and resulting in abnormal accumulation of the alpha-1-antitrypsin in hepatocytes with resulting hepatic damage over time. This patient, however, has the alpha-1-antitrypsin phenotype null/null, which results in the absence of alpha-1-antitrypsin production. As such, null/null individuals are at very high risk for emphysema due to the complete absence of the alpha-1-antitrypsin enzyme. However, since null/null individuals produce no alpha-1-antitrypsin at all, there is no abnormally polymerized alpha-1-antitrypsin protein build-up. Based upon the clinical history and laboratory data, this patient’s liver enzyme elevations are most likely due to alcohol abuse.
References
1. Fairbanks K.D., Tavill A.S. Liver disease in alpha-1-antitrypsin deficiency: A review. Am J Gastro. 2008;103:2136-41.
2. Silverman E.A., Sandhaus R.A. Alpha-1 antitrypsin deficiency. N Engl J Med. 2009;360;2749-5.
Q2. A 38-year-old man presents for evaluation of elevated liver enzymes. His past medical history is notable for being diagnosed with emphysema when he was 32 years old. He continues to smoke ½ pack of cigarettes per day and he drinks approximately five beers per day with binge drinking on weekends. He denies a history of drug use. His laboratory data are notable for the following: aspartate aminotransferase, 139 U/L; alanine aminotransferase, 76 U/L; total bilirubin, 0.8 mg/dL; alkaline phosphatase, 104 U/L; and serum albumin, 4.1 g/dL. Additional laboratory testing showed the following: HCV Ab, negative; HBsAg, negative; HBsAb, positive; HBc Total Ab, positive; alpha-1 antitrypsin phenotype, null/null; alpha-1 antitrypsin level, undetectable; antismooth muscle antibody, negative; antinuclear antibody, negative; ferritin, 114 mcg/L; iron saturation, 37%.
Hepatic ultrasound reveals an enlarged echogenic liver with patent portal and hepatic veins.
Use multimodal analgesia protocols after minimally invasive gynecologic surgery
Minimally invasive gynecologic surgeons can combat the opioid epidemic by devising creative, multimodal approaches to analgesia, according to the authors of an extensive narrative review.
Acetaminophen, NSAIDs, antiepileptics, and local anesthetic incision infiltration all significantly reduce postoperative pain, as does reducing laparoscopic trocar size to less than 10 mm and evacuating pneumoperitoneum at the end of a case, reported Marron Wong, MD, of Newton (Mass.)-Wellesley Hospital and her associates.
“In the midst of the opioid crisis currently affecting the United States, we believe that it is imperative for [minimally invasive gynecologic surgeons] to use these available tools,” Dr. Wong and her associates wrote in the Journal of Minimally Invasive Gynecology.
The experts reviewed studies identified through PubMed, EMBASE, and the Cochrane Database. They focused on randomized controlled trials and highlighted the role of multimodal approaches. “Reasonable evidence” supports the preemptive and postoperative use of NSAIDs and acetaminophen, as well as the preemptive use of gabapentin, pregabalin and dexamethasone, they concluded (J Minim Invasive Gynecol. 2017 Sep 27. doi: 10.1016/j.jmig.2017.09.016).
Preemptive liposomal bupivacaine also is promising, the reviewers said. In a randomized controlled trial, transverse abdominis plane (TAP) infiltration with liposomal bupivacaine was associated with significant and clinically meaningful reductions in pain, morphine use, and postoperative nausea and vomiting, compared with transverse abdominis plane infiltration with regular bupivacaine (Gynecol Oncol. 2015 Sep;138[3]:609-13).
“Local infiltration [also] has been shown to decrease pain as well as opioid intake,” the reviewers wrote. “Pre-closure infiltration has been shown to have more effect than pre-incisional dosing.” Bupivicaine has a longer duration of action (120-240 minutes) than lidocaine (30-60 minutes), which can be extended further by adding epinephrine, they noted.
The adverse effects of alpha-2 agonists (bradycardia and hypotension) and N-methyl-d-aspartate receptor antagonists (vivid dreams, hallucination, emergence confusion) limit their use, the reviewers found.
Another recent systematic review drew similar conclusions, recommending NSAIDs, acetaminophen, anti-epileptics, and dexamethasone for nonopioid pain management in benign minimally invasive hysterectomy (Am J Obstet Gynecol. 2017 Jun;216[6]:557-67). That review found no positive results for local anesthesia, suggesting that the benefits of local anesthesia are limited to minor procedures, Dr. Wong and her associates noted.
The authors reported having no financial disclosures.
Minimally invasive gynecologic surgeons can combat the opioid epidemic by devising creative, multimodal approaches to analgesia, according to the authors of an extensive narrative review.
Acetaminophen, NSAIDs, antiepileptics, and local anesthetic incision infiltration all significantly reduce postoperative pain, as does reducing laparoscopic trocar size to less than 10 mm and evacuating pneumoperitoneum at the end of a case, reported Marron Wong, MD, of Newton (Mass.)-Wellesley Hospital and her associates.
“In the midst of the opioid crisis currently affecting the United States, we believe that it is imperative for [minimally invasive gynecologic surgeons] to use these available tools,” Dr. Wong and her associates wrote in the Journal of Minimally Invasive Gynecology.
The experts reviewed studies identified through PubMed, EMBASE, and the Cochrane Database. They focused on randomized controlled trials and highlighted the role of multimodal approaches. “Reasonable evidence” supports the preemptive and postoperative use of NSAIDs and acetaminophen, as well as the preemptive use of gabapentin, pregabalin and dexamethasone, they concluded (J Minim Invasive Gynecol. 2017 Sep 27. doi: 10.1016/j.jmig.2017.09.016).
Preemptive liposomal bupivacaine also is promising, the reviewers said. In a randomized controlled trial, transverse abdominis plane (TAP) infiltration with liposomal bupivacaine was associated with significant and clinically meaningful reductions in pain, morphine use, and postoperative nausea and vomiting, compared with transverse abdominis plane infiltration with regular bupivacaine (Gynecol Oncol. 2015 Sep;138[3]:609-13).
“Local infiltration [also] has been shown to decrease pain as well as opioid intake,” the reviewers wrote. “Pre-closure infiltration has been shown to have more effect than pre-incisional dosing.” Bupivicaine has a longer duration of action (120-240 minutes) than lidocaine (30-60 minutes), which can be extended further by adding epinephrine, they noted.
The adverse effects of alpha-2 agonists (bradycardia and hypotension) and N-methyl-d-aspartate receptor antagonists (vivid dreams, hallucination, emergence confusion) limit their use, the reviewers found.
Another recent systematic review drew similar conclusions, recommending NSAIDs, acetaminophen, anti-epileptics, and dexamethasone for nonopioid pain management in benign minimally invasive hysterectomy (Am J Obstet Gynecol. 2017 Jun;216[6]:557-67). That review found no positive results for local anesthesia, suggesting that the benefits of local anesthesia are limited to minor procedures, Dr. Wong and her associates noted.
The authors reported having no financial disclosures.
Minimally invasive gynecologic surgeons can combat the opioid epidemic by devising creative, multimodal approaches to analgesia, according to the authors of an extensive narrative review.
Acetaminophen, NSAIDs, antiepileptics, and local anesthetic incision infiltration all significantly reduce postoperative pain, as does reducing laparoscopic trocar size to less than 10 mm and evacuating pneumoperitoneum at the end of a case, reported Marron Wong, MD, of Newton (Mass.)-Wellesley Hospital and her associates.
“In the midst of the opioid crisis currently affecting the United States, we believe that it is imperative for [minimally invasive gynecologic surgeons] to use these available tools,” Dr. Wong and her associates wrote in the Journal of Minimally Invasive Gynecology.
The experts reviewed studies identified through PubMed, EMBASE, and the Cochrane Database. They focused on randomized controlled trials and highlighted the role of multimodal approaches. “Reasonable evidence” supports the preemptive and postoperative use of NSAIDs and acetaminophen, as well as the preemptive use of gabapentin, pregabalin and dexamethasone, they concluded (J Minim Invasive Gynecol. 2017 Sep 27. doi: 10.1016/j.jmig.2017.09.016).
Preemptive liposomal bupivacaine also is promising, the reviewers said. In a randomized controlled trial, transverse abdominis plane (TAP) infiltration with liposomal bupivacaine was associated with significant and clinically meaningful reductions in pain, morphine use, and postoperative nausea and vomiting, compared with transverse abdominis plane infiltration with regular bupivacaine (Gynecol Oncol. 2015 Sep;138[3]:609-13).
“Local infiltration [also] has been shown to decrease pain as well as opioid intake,” the reviewers wrote. “Pre-closure infiltration has been shown to have more effect than pre-incisional dosing.” Bupivicaine has a longer duration of action (120-240 minutes) than lidocaine (30-60 minutes), which can be extended further by adding epinephrine, they noted.
The adverse effects of alpha-2 agonists (bradycardia and hypotension) and N-methyl-d-aspartate receptor antagonists (vivid dreams, hallucination, emergence confusion) limit their use, the reviewers found.
Another recent systematic review drew similar conclusions, recommending NSAIDs, acetaminophen, anti-epileptics, and dexamethasone for nonopioid pain management in benign minimally invasive hysterectomy (Am J Obstet Gynecol. 2017 Jun;216[6]:557-67). That review found no positive results for local anesthesia, suggesting that the benefits of local anesthesia are limited to minor procedures, Dr. Wong and her associates noted.
The authors reported having no financial disclosures.
FROM THE JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY
Key clinical point:
Major finding: Medical options include acetaminophen, NSAIDs, antiepileptics, and local anesthetic incision infiltration. Surgical measures include reducing laparoscopic trocar size to less than 10 mm and evacuating pneumoperitoneum at the end of a case.
Data source: An extensive narrative review, primarily of randomized controlled trials.
Disclosures: The authors reported having no financial disclosures.
ACR: Use comparative effectiveness research for clinical decisions, not payers’ cost decisions
The goal of comparative effectiveness research should be to find the best products to meet a clinical situation instead of a tool to be used by payers to make cost-based coverage decisions, the American College of Rheumatology recently said.
The ACR’s Committee on Rheumatologic Care recently updated its position statement on CER, noting that high-quality comparative effectiveness research and cost-effectiveness analysis “can and should inform individual provider and patient decisions about the relative value of diagnostic and therapeutic options.”
One concern that Dr. Fahey noted, specific to the rheumatology space, is that there currently are few CER data to draw upon, which as a result, makes it harder to have meaningful conversations about clinical value.
“Quite frankly right now, a lot of times those decisions are already heavily influenced by the payer’s formulary structure and what is on their preferred tier and what is on their second, third, or fourth tier,” he said. “We just don’t have enough comparative effectiveness data yet to be a huge influence. The formulary and step edits for each individual payer are still based extremely heavily on their cost and rebates. This is why, circling back to the whole question to begin with ... when we updated the position statement, we sort of reinforced our concern that this should be made to guide clinical decisions and not payer-type coverage decisions.”
He noted that the ACR does have registries that are building real-world data about the various products, but there is still a ways to go to have an effective database that would be usable for quality CER information.
“We are hopeful that, over time, especially with things like registries, the ACR has a registry that compiles real-world data from our members about our patients, that we will be able to come up with a more real-world comparison between different medications,” Dr. Fahey said. “The concern is that the payers will use the results of comparative effectiveness research to make very black-and-white decisions about their formulary and about treatment options and things like that.”
The position statement says that the ACR is doing its part to help collect information. In 2014, it launched the Rheumatology Informatics System for Effectiveness (RISE), which “allows rheumatologists throughout the country to seamlessly and effortlessly transfer anonymous patient outcome data to a national registry.” According to the position statement, “thus far, RISE has collected more than one million patient encounters, positioning RISE to become the premier source for real-world CER data in rheumatology.”
“It would be fantastic if we already had the data about which medication provided the best value,” Dr. Fahey said. “Our drugs are extremely expensive, at least our biologic drugs, and we understand that the goal is to provide both good quality care but cost efficient care.”
The goal of comparative effectiveness research should be to find the best products to meet a clinical situation instead of a tool to be used by payers to make cost-based coverage decisions, the American College of Rheumatology recently said.
The ACR’s Committee on Rheumatologic Care recently updated its position statement on CER, noting that high-quality comparative effectiveness research and cost-effectiveness analysis “can and should inform individual provider and patient decisions about the relative value of diagnostic and therapeutic options.”
One concern that Dr. Fahey noted, specific to the rheumatology space, is that there currently are few CER data to draw upon, which as a result, makes it harder to have meaningful conversations about clinical value.
“Quite frankly right now, a lot of times those decisions are already heavily influenced by the payer’s formulary structure and what is on their preferred tier and what is on their second, third, or fourth tier,” he said. “We just don’t have enough comparative effectiveness data yet to be a huge influence. The formulary and step edits for each individual payer are still based extremely heavily on their cost and rebates. This is why, circling back to the whole question to begin with ... when we updated the position statement, we sort of reinforced our concern that this should be made to guide clinical decisions and not payer-type coverage decisions.”
He noted that the ACR does have registries that are building real-world data about the various products, but there is still a ways to go to have an effective database that would be usable for quality CER information.
“We are hopeful that, over time, especially with things like registries, the ACR has a registry that compiles real-world data from our members about our patients, that we will be able to come up with a more real-world comparison between different medications,” Dr. Fahey said. “The concern is that the payers will use the results of comparative effectiveness research to make very black-and-white decisions about their formulary and about treatment options and things like that.”
The position statement says that the ACR is doing its part to help collect information. In 2014, it launched the Rheumatology Informatics System for Effectiveness (RISE), which “allows rheumatologists throughout the country to seamlessly and effortlessly transfer anonymous patient outcome data to a national registry.” According to the position statement, “thus far, RISE has collected more than one million patient encounters, positioning RISE to become the premier source for real-world CER data in rheumatology.”
“It would be fantastic if we already had the data about which medication provided the best value,” Dr. Fahey said. “Our drugs are extremely expensive, at least our biologic drugs, and we understand that the goal is to provide both good quality care but cost efficient care.”
The goal of comparative effectiveness research should be to find the best products to meet a clinical situation instead of a tool to be used by payers to make cost-based coverage decisions, the American College of Rheumatology recently said.
The ACR’s Committee on Rheumatologic Care recently updated its position statement on CER, noting that high-quality comparative effectiveness research and cost-effectiveness analysis “can and should inform individual provider and patient decisions about the relative value of diagnostic and therapeutic options.”
One concern that Dr. Fahey noted, specific to the rheumatology space, is that there currently are few CER data to draw upon, which as a result, makes it harder to have meaningful conversations about clinical value.
“Quite frankly right now, a lot of times those decisions are already heavily influenced by the payer’s formulary structure and what is on their preferred tier and what is on their second, third, or fourth tier,” he said. “We just don’t have enough comparative effectiveness data yet to be a huge influence. The formulary and step edits for each individual payer are still based extremely heavily on their cost and rebates. This is why, circling back to the whole question to begin with ... when we updated the position statement, we sort of reinforced our concern that this should be made to guide clinical decisions and not payer-type coverage decisions.”
He noted that the ACR does have registries that are building real-world data about the various products, but there is still a ways to go to have an effective database that would be usable for quality CER information.
“We are hopeful that, over time, especially with things like registries, the ACR has a registry that compiles real-world data from our members about our patients, that we will be able to come up with a more real-world comparison between different medications,” Dr. Fahey said. “The concern is that the payers will use the results of comparative effectiveness research to make very black-and-white decisions about their formulary and about treatment options and things like that.”
The position statement says that the ACR is doing its part to help collect information. In 2014, it launched the Rheumatology Informatics System for Effectiveness (RISE), which “allows rheumatologists throughout the country to seamlessly and effortlessly transfer anonymous patient outcome data to a national registry.” According to the position statement, “thus far, RISE has collected more than one million patient encounters, positioning RISE to become the premier source for real-world CER data in rheumatology.”
“It would be fantastic if we already had the data about which medication provided the best value,” Dr. Fahey said. “Our drugs are extremely expensive, at least our biologic drugs, and we understand that the goal is to provide both good quality care but cost efficient care.”
Use MADRS to dose ketamine for refractory depression
NEW ORLEANS – Ketamine infusions are becoming more and more routine for refractory depression, but the literature is just not clear about the optimal treatment regimen.
Studies have run the gamut from daily, to weekly, to monthly infusions, with scant information on how to predict who will respond and how to maintain response.
“Almost everybody feels significantly better an hour after the infusion. The question is how long will they continue to feel better, and how to find the ones who will stay well. That’s what we’ve tried to answer here,” said principal investigator and psychiatrist Ranjith Chandrasena, MD, the research center’s scientific director.
Ketamine is dosed at 0.5 mg/kg IV over 45 minutes, delivered in an ambulatory care center under the supervision of a respiratory therapist and a physician assistant, with vital signs monitored every 10 minutes. Patients are cleared ahead of time for anesthesia, since ketamine at higher doses is an anesthetic.
In the induction phase, patients are offered up to three ketamine infusions weekly; if MADRS scores don’t remain below 16 points a month after the last induction dose, ketamine is judged to be ineffective, and the patient is taken off the protocol. A score below 16 “pretty much translates to normal functioning,” Dr. Chandrasena said.
Patients who remain below 16 points a month after their last induction dose are moved onto maintenance and qualify for repeat infusions when their MADRS creeps above 16 points, so long as it’s stayed below 16 for a month or more in the interim. The majority of patients on maintenance go 6 or more weeks between infusions. MADRS scores are assessed weekly over the phone.
For patients on maintenance, scores have dropped from a mean of 28.72 points at baseline to 10.73 points, an impressive improvement in patients with long-standing depression who have failed multiple treatments.
Global Assessment of Functioning scores have improved as well, from a baseline of under 40 points to over 60 points, with improvements in social functioning and the ability to work. A few patients had made serious suicide attempts before starting ketamine; with treatment, “there has been success in keeping patients out of the hospital, with no suicide attempts reported,” Dr. Chandrasena said.
Ketamine’s been well tolerated at the center; no one has been discontinued because of side effects, and only one person has had noticeable hallucinations. “People are telling us that it’s a very pleasant experience,” he said.
But to cut costs and reduce the addiction risk, the investigators are considering nasal esketamine instead of IV ketamine, and rapastinel, an N-methyl-d-aspartate receptor antagonist that doesn’t have the dissociative effects of ketamine. Patients also are being taught how to recognize the signs of relapse, to see whether the medication reduces the need for weekly phone assessments.
“We would like someone to replicate our study. If the results are promising, that would be the time to do a double-blind placebo-controlled trial using this” protocol, Dr. Chandrasena said.
Almost two-thirds of the subjects were women, about a third were men, and a few were transgendered. Ages ranged from 19 to above 70 years, with most patients 30-70 years old.
There was no industry funding for the work, and the investigators had no disclosures.
NEW ORLEANS – Ketamine infusions are becoming more and more routine for refractory depression, but the literature is just not clear about the optimal treatment regimen.
Studies have run the gamut from daily, to weekly, to monthly infusions, with scant information on how to predict who will respond and how to maintain response.
“Almost everybody feels significantly better an hour after the infusion. The question is how long will they continue to feel better, and how to find the ones who will stay well. That’s what we’ve tried to answer here,” said principal investigator and psychiatrist Ranjith Chandrasena, MD, the research center’s scientific director.
Ketamine is dosed at 0.5 mg/kg IV over 45 minutes, delivered in an ambulatory care center under the supervision of a respiratory therapist and a physician assistant, with vital signs monitored every 10 minutes. Patients are cleared ahead of time for anesthesia, since ketamine at higher doses is an anesthetic.
In the induction phase, patients are offered up to three ketamine infusions weekly; if MADRS scores don’t remain below 16 points a month after the last induction dose, ketamine is judged to be ineffective, and the patient is taken off the protocol. A score below 16 “pretty much translates to normal functioning,” Dr. Chandrasena said.
Patients who remain below 16 points a month after their last induction dose are moved onto maintenance and qualify for repeat infusions when their MADRS creeps above 16 points, so long as it’s stayed below 16 for a month or more in the interim. The majority of patients on maintenance go 6 or more weeks between infusions. MADRS scores are assessed weekly over the phone.
For patients on maintenance, scores have dropped from a mean of 28.72 points at baseline to 10.73 points, an impressive improvement in patients with long-standing depression who have failed multiple treatments.
Global Assessment of Functioning scores have improved as well, from a baseline of under 40 points to over 60 points, with improvements in social functioning and the ability to work. A few patients had made serious suicide attempts before starting ketamine; with treatment, “there has been success in keeping patients out of the hospital, with no suicide attempts reported,” Dr. Chandrasena said.
Ketamine’s been well tolerated at the center; no one has been discontinued because of side effects, and only one person has had noticeable hallucinations. “People are telling us that it’s a very pleasant experience,” he said.
But to cut costs and reduce the addiction risk, the investigators are considering nasal esketamine instead of IV ketamine, and rapastinel, an N-methyl-d-aspartate receptor antagonist that doesn’t have the dissociative effects of ketamine. Patients also are being taught how to recognize the signs of relapse, to see whether the medication reduces the need for weekly phone assessments.
“We would like someone to replicate our study. If the results are promising, that would be the time to do a double-blind placebo-controlled trial using this” protocol, Dr. Chandrasena said.
Almost two-thirds of the subjects were women, about a third were men, and a few were transgendered. Ages ranged from 19 to above 70 years, with most patients 30-70 years old.
There was no industry funding for the work, and the investigators had no disclosures.
NEW ORLEANS – Ketamine infusions are becoming more and more routine for refractory depression, but the literature is just not clear about the optimal treatment regimen.
Studies have run the gamut from daily, to weekly, to monthly infusions, with scant information on how to predict who will respond and how to maintain response.
“Almost everybody feels significantly better an hour after the infusion. The question is how long will they continue to feel better, and how to find the ones who will stay well. That’s what we’ve tried to answer here,” said principal investigator and psychiatrist Ranjith Chandrasena, MD, the research center’s scientific director.
Ketamine is dosed at 0.5 mg/kg IV over 45 minutes, delivered in an ambulatory care center under the supervision of a respiratory therapist and a physician assistant, with vital signs monitored every 10 minutes. Patients are cleared ahead of time for anesthesia, since ketamine at higher doses is an anesthetic.
In the induction phase, patients are offered up to three ketamine infusions weekly; if MADRS scores don’t remain below 16 points a month after the last induction dose, ketamine is judged to be ineffective, and the patient is taken off the protocol. A score below 16 “pretty much translates to normal functioning,” Dr. Chandrasena said.
Patients who remain below 16 points a month after their last induction dose are moved onto maintenance and qualify for repeat infusions when their MADRS creeps above 16 points, so long as it’s stayed below 16 for a month or more in the interim. The majority of patients on maintenance go 6 or more weeks between infusions. MADRS scores are assessed weekly over the phone.
For patients on maintenance, scores have dropped from a mean of 28.72 points at baseline to 10.73 points, an impressive improvement in patients with long-standing depression who have failed multiple treatments.
Global Assessment of Functioning scores have improved as well, from a baseline of under 40 points to over 60 points, with improvements in social functioning and the ability to work. A few patients had made serious suicide attempts before starting ketamine; with treatment, “there has been success in keeping patients out of the hospital, with no suicide attempts reported,” Dr. Chandrasena said.
Ketamine’s been well tolerated at the center; no one has been discontinued because of side effects, and only one person has had noticeable hallucinations. “People are telling us that it’s a very pleasant experience,” he said.
But to cut costs and reduce the addiction risk, the investigators are considering nasal esketamine instead of IV ketamine, and rapastinel, an N-methyl-d-aspartate receptor antagonist that doesn’t have the dissociative effects of ketamine. Patients also are being taught how to recognize the signs of relapse, to see whether the medication reduces the need for weekly phone assessments.
“We would like someone to replicate our study. If the results are promising, that would be the time to do a double-blind placebo-controlled trial using this” protocol, Dr. Chandrasena said.
Almost two-thirds of the subjects were women, about a third were men, and a few were transgendered. Ages ranged from 19 to above 70 years, with most patients 30-70 years old.
There was no industry funding for the work, and the investigators had no disclosures.
AT IPS 2017
Key clinical point:
Major finding: Score-based dosing has led to marked improvements in 19 of 44 patients (43%), with remissions sustained for up to 74 weeks and counting.
Data source: Pilot study of 44 patients with refractory depression.
Disclosures: There was no industry funding for the work, and the investigators had no disclosures.