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COVID-19 impacts women’s contraception choices
The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.
Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.
“What is really striking is the very large increase in use of the IUD,” she noted. However, the increased use of IUDs has raised concerns about coercive tactics being used to push for IUD use in communities of color.
“The focus we should have is on reproductive autonomy and not on unintended pregnancy, a metric that is classist and racist and may value the reproduction of some groups over others,” Dr. Espey said. Previous studies have suggested that providers are biased in how they promote long-acting reversible contraception (LARC), and reports from patients suggest that women and people of color particularly may feel marginalized, not heard, and coerced, she noted.
Help patients feel empowered
Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.
The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.
A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.
ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.
ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.
“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
Consider MEC categories for contraception
When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.
Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.
“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”
For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.
Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.
Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m2.
Annovera offers more options
The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.
During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.
Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”
As for the off-label use by women with a BMI greater than 29 kg/m2, it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
IUDs appropriate for younger women
When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.
Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”
“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.
Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.
The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.
Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.
“What is really striking is the very large increase in use of the IUD,” she noted. However, the increased use of IUDs has raised concerns about coercive tactics being used to push for IUD use in communities of color.
“The focus we should have is on reproductive autonomy and not on unintended pregnancy, a metric that is classist and racist and may value the reproduction of some groups over others,” Dr. Espey said. Previous studies have suggested that providers are biased in how they promote long-acting reversible contraception (LARC), and reports from patients suggest that women and people of color particularly may feel marginalized, not heard, and coerced, she noted.
Help patients feel empowered
Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.
The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.
A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.
ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.
ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.
“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
Consider MEC categories for contraception
When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.
Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.
“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”
For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.
Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.
Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m2.
Annovera offers more options
The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.
During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.
Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”
As for the off-label use by women with a BMI greater than 29 kg/m2, it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
IUDs appropriate for younger women
When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.
Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”
“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.
Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.
The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.
Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.
“What is really striking is the very large increase in use of the IUD,” she noted. However, the increased use of IUDs has raised concerns about coercive tactics being used to push for IUD use in communities of color.
“The focus we should have is on reproductive autonomy and not on unintended pregnancy, a metric that is classist and racist and may value the reproduction of some groups over others,” Dr. Espey said. Previous studies have suggested that providers are biased in how they promote long-acting reversible contraception (LARC), and reports from patients suggest that women and people of color particularly may feel marginalized, not heard, and coerced, she noted.
Help patients feel empowered
Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.
The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.
A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.
ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.
ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.
“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
Consider MEC categories for contraception
When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.
Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.
“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”
For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.
Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.
Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m2.
Annovera offers more options
The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.
During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.
Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”
As for the off-label use by women with a BMI greater than 29 kg/m2, it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
IUDs appropriate for younger women
When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.
Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”
“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.
Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.
EXPERT ANALYSIS FROM ACOG 2020
Pembrolizumab ‘preferred choice’ in MSI-H/dMMR metastatic CRC
At a median follow-up of 32.4 months, PFS was 16.5 months for patients who received pembrolizumab versus 8.2 months for the chemotherapy group.
“In the past, no medical treatment has shown such difference in terms of improvement of PFS in metastatic colorectal cancer,” commented lead author Thierry André, MD, of Hôpital Saint Antoine, Paris, France, when presenting this study earlier this year at the annual meeting of the American Society of Clinical Oncology.
“I think this is setting a new standard of care,” said Michael J. Overman, MD, of the University of Texas MD Anderson Cancer Center, Houston, who was the invited discussant at the ASCO meeting. However, he also pointed out that, despite the higher overall response rate (43.8% vs. 33.1% with chemotherapy), the rate of progressive disease was higher in the pembrolizumab arm than in the chemotherapy arm (29.4% vs. 12.3% for patients who received chemotherapy).
The study has now been published in the New England Journal of Medicine.
Pembrolizumab is the “preferred choice” for patients with MSI-H/dMMR colorectal cancer because of “the durability of response, better safety profile, and improved quality of life associated with immunotherapy as compared with chemotherapy,” Axel Grothey, MD, GI cancer research, West Cancer Center and Research Institute, Germantown, Tenn., wrote in an accompanying editorial.
He noted that, in colorectal cancer, only 4%-5% of metastatic cancers show the MSI-H/dMMR phenotype; the prevalence is greater in BRAF V600E–mutated cancers, in cancers originating on the right side, and among female patients.
Immune checkpoint inhibitors have already demonstrated “convincing activity” in MSI-H/dMMR colorectal cancers, and pembrolizumab as well as nivolumab (Opdivo), with or without ipilimumab (Yervoy), are approved for use as salvage therapy in colorectal cancer, he noted.
These results for use as a first-line therapy in his patient population have been “long awaited,” he commented.
Study details
The KEYNOTE-177 trial included 307 patients with confirmed, untreated MSI-H/dMMR metastatic colorectal cancer who were randomly assigned to receive pembrolizumab 200 mg every 3 weeks for up to 35 cycles (n = 153) or the investigators’ choice of chemotherapy (n = 154). Chemotherapy regimens included modified FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) alone or in combination with either bevacizumab or cetuximab, or FOLFIRI (leucovorin, fluorouracil, irinotecan) alone or in combination with either bevacizumab or cetuximab. Patients in the chemotherapy group could cross over to pembrolizumab therapy after disease progression.
The study’s two primary endpoints were PFS and overall survival.
At the second interim analysis, at a median follow-up (from randomization to data cutoff) of 32.4 months, pembrolizumab proved superior to chemotherapy with regard to PFS (hazard ratio, 0.60; P = .0002).
At 12 months and at 24 months, the estimated percentages of those alive without disease progression were 55.3% and 48.3%, respectively (95% confidence interval, 39.9-56.2) in the pembrolizumab group and 37.3% and 18.6%, respectively, in the chemotherapy group.
The mean PFS after 24 months of follow-up was 13.7 months for patients who received pembrolizumab versus 10.8 months for those who received chemotherapy. PFS was consistently longer with pembrolizumab across key prespecified subgroups. Complete responses were achieved in 11% of patients treated with pembrolizumab and in 4% of those treated with chemotherapy. At 24 months, 83% of patients in the pembrolizumab group had ongoing responses, compared with 35% in the chemotherapy group.
Overall survival data continue to evolve, the authors commented, noting that 56 patients in the pembrolizumab group and 69 in the chemotherapy group have died. The independent data-monitoring committee has recommended that the trial continue without any changes to the final analysis for assessment of overall survival until 190 overall deaths have occurred or until 12 months after the second interim analysis.
Crossover will be a factor when overall survival is assessed, the authors noted. At the time of data cutoff, 56 of 154 patients (36%) who received chemotherapy had crossed over to the pembrolizumab group after their disease had progressed. In addition, 35 patients in the chemotherapy group received anti–programmed death-1 or PD-ligand 1 therapies outside the trial. This extrapolates to a crossover rate of 59% in the intention-to-treat population.
Treatment-related adverse events of grade 3 or higher were more common in the chemotherapy group (66% vs. 22%). Immune-mediated adverse events and infusion reactions were more common with pembrolizumab than with chemotherapy (31% and 13%, respectively). Adverse events that were common with chemotherapy included gastrointestinal events, fatigue, neutropenia, and peripheral sensory neuropathy.
Preferred choice
In the accompanying editorial, Dr. Grothey pointed out that the results of this trial “deserve some scrutiny,” because disease progression was higher in the pembrolizumab group. This is mirrored by early poorer performance among patients treated with pembrolizumab versus chemotherapy until about 6.5 months after onset of therapy. After that, the “pembrolizumab group showed protracted improvement – a phenomenon seen in various other trials with PD-1 antibodies in gastrointestinal cancers.
“It appears that a subgroup not yet clearly defined within the MSI-H–dMMR population does not have a response to immune checkpoint inhibitors,” Dr. Grothey wrote.
The study was funded by Merck. Dr. André has received honoraria from Amgen, GlaxoSmithKline, and Pierre Fabre Pharmaceuticals; consulting fees and travel support from Bristol-Myers Squibb; advisory board fees and honoraria from F. Hoffmann–La Roche; advisory board fees from Gritstone Oncology, Halliodx, and Tesaro; grant support, paid to Hôpitaux de Paris; advisory board fees, honoraria, and travel support from Merck Sharp and Dohme; consulting fees and honoraria from Servier; and honoraria and travel support from Ventana Medical Systems. Dr. Grothey has received grants and nonfinancial support from Bayer; grants from Boston Biomedicals; grants from OBI Pharmaceuticals, Array/Pfizer, Natera, Merck, and Bristol-Myers Squibb; and grants and nonfinancial support from Roche/ Genentech outside the submitted work.
A version of this article originally appeared on Medscape.com.
At a median follow-up of 32.4 months, PFS was 16.5 months for patients who received pembrolizumab versus 8.2 months for the chemotherapy group.
“In the past, no medical treatment has shown such difference in terms of improvement of PFS in metastatic colorectal cancer,” commented lead author Thierry André, MD, of Hôpital Saint Antoine, Paris, France, when presenting this study earlier this year at the annual meeting of the American Society of Clinical Oncology.
“I think this is setting a new standard of care,” said Michael J. Overman, MD, of the University of Texas MD Anderson Cancer Center, Houston, who was the invited discussant at the ASCO meeting. However, he also pointed out that, despite the higher overall response rate (43.8% vs. 33.1% with chemotherapy), the rate of progressive disease was higher in the pembrolizumab arm than in the chemotherapy arm (29.4% vs. 12.3% for patients who received chemotherapy).
The study has now been published in the New England Journal of Medicine.
Pembrolizumab is the “preferred choice” for patients with MSI-H/dMMR colorectal cancer because of “the durability of response, better safety profile, and improved quality of life associated with immunotherapy as compared with chemotherapy,” Axel Grothey, MD, GI cancer research, West Cancer Center and Research Institute, Germantown, Tenn., wrote in an accompanying editorial.
He noted that, in colorectal cancer, only 4%-5% of metastatic cancers show the MSI-H/dMMR phenotype; the prevalence is greater in BRAF V600E–mutated cancers, in cancers originating on the right side, and among female patients.
Immune checkpoint inhibitors have already demonstrated “convincing activity” in MSI-H/dMMR colorectal cancers, and pembrolizumab as well as nivolumab (Opdivo), with or without ipilimumab (Yervoy), are approved for use as salvage therapy in colorectal cancer, he noted.
These results for use as a first-line therapy in his patient population have been “long awaited,” he commented.
Study details
The KEYNOTE-177 trial included 307 patients with confirmed, untreated MSI-H/dMMR metastatic colorectal cancer who were randomly assigned to receive pembrolizumab 200 mg every 3 weeks for up to 35 cycles (n = 153) or the investigators’ choice of chemotherapy (n = 154). Chemotherapy regimens included modified FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) alone or in combination with either bevacizumab or cetuximab, or FOLFIRI (leucovorin, fluorouracil, irinotecan) alone or in combination with either bevacizumab or cetuximab. Patients in the chemotherapy group could cross over to pembrolizumab therapy after disease progression.
The study’s two primary endpoints were PFS and overall survival.
At the second interim analysis, at a median follow-up (from randomization to data cutoff) of 32.4 months, pembrolizumab proved superior to chemotherapy with regard to PFS (hazard ratio, 0.60; P = .0002).
At 12 months and at 24 months, the estimated percentages of those alive without disease progression were 55.3% and 48.3%, respectively (95% confidence interval, 39.9-56.2) in the pembrolizumab group and 37.3% and 18.6%, respectively, in the chemotherapy group.
The mean PFS after 24 months of follow-up was 13.7 months for patients who received pembrolizumab versus 10.8 months for those who received chemotherapy. PFS was consistently longer with pembrolizumab across key prespecified subgroups. Complete responses were achieved in 11% of patients treated with pembrolizumab and in 4% of those treated with chemotherapy. At 24 months, 83% of patients in the pembrolizumab group had ongoing responses, compared with 35% in the chemotherapy group.
Overall survival data continue to evolve, the authors commented, noting that 56 patients in the pembrolizumab group and 69 in the chemotherapy group have died. The independent data-monitoring committee has recommended that the trial continue without any changes to the final analysis for assessment of overall survival until 190 overall deaths have occurred or until 12 months after the second interim analysis.
Crossover will be a factor when overall survival is assessed, the authors noted. At the time of data cutoff, 56 of 154 patients (36%) who received chemotherapy had crossed over to the pembrolizumab group after their disease had progressed. In addition, 35 patients in the chemotherapy group received anti–programmed death-1 or PD-ligand 1 therapies outside the trial. This extrapolates to a crossover rate of 59% in the intention-to-treat population.
Treatment-related adverse events of grade 3 or higher were more common in the chemotherapy group (66% vs. 22%). Immune-mediated adverse events and infusion reactions were more common with pembrolizumab than with chemotherapy (31% and 13%, respectively). Adverse events that were common with chemotherapy included gastrointestinal events, fatigue, neutropenia, and peripheral sensory neuropathy.
Preferred choice
In the accompanying editorial, Dr. Grothey pointed out that the results of this trial “deserve some scrutiny,” because disease progression was higher in the pembrolizumab group. This is mirrored by early poorer performance among patients treated with pembrolizumab versus chemotherapy until about 6.5 months after onset of therapy. After that, the “pembrolizumab group showed protracted improvement – a phenomenon seen in various other trials with PD-1 antibodies in gastrointestinal cancers.
“It appears that a subgroup not yet clearly defined within the MSI-H–dMMR population does not have a response to immune checkpoint inhibitors,” Dr. Grothey wrote.
The study was funded by Merck. Dr. André has received honoraria from Amgen, GlaxoSmithKline, and Pierre Fabre Pharmaceuticals; consulting fees and travel support from Bristol-Myers Squibb; advisory board fees and honoraria from F. Hoffmann–La Roche; advisory board fees from Gritstone Oncology, Halliodx, and Tesaro; grant support, paid to Hôpitaux de Paris; advisory board fees, honoraria, and travel support from Merck Sharp and Dohme; consulting fees and honoraria from Servier; and honoraria and travel support from Ventana Medical Systems. Dr. Grothey has received grants and nonfinancial support from Bayer; grants from Boston Biomedicals; grants from OBI Pharmaceuticals, Array/Pfizer, Natera, Merck, and Bristol-Myers Squibb; and grants and nonfinancial support from Roche/ Genentech outside the submitted work.
A version of this article originally appeared on Medscape.com.
At a median follow-up of 32.4 months, PFS was 16.5 months for patients who received pembrolizumab versus 8.2 months for the chemotherapy group.
“In the past, no medical treatment has shown such difference in terms of improvement of PFS in metastatic colorectal cancer,” commented lead author Thierry André, MD, of Hôpital Saint Antoine, Paris, France, when presenting this study earlier this year at the annual meeting of the American Society of Clinical Oncology.
“I think this is setting a new standard of care,” said Michael J. Overman, MD, of the University of Texas MD Anderson Cancer Center, Houston, who was the invited discussant at the ASCO meeting. However, he also pointed out that, despite the higher overall response rate (43.8% vs. 33.1% with chemotherapy), the rate of progressive disease was higher in the pembrolizumab arm than in the chemotherapy arm (29.4% vs. 12.3% for patients who received chemotherapy).
The study has now been published in the New England Journal of Medicine.
Pembrolizumab is the “preferred choice” for patients with MSI-H/dMMR colorectal cancer because of “the durability of response, better safety profile, and improved quality of life associated with immunotherapy as compared with chemotherapy,” Axel Grothey, MD, GI cancer research, West Cancer Center and Research Institute, Germantown, Tenn., wrote in an accompanying editorial.
He noted that, in colorectal cancer, only 4%-5% of metastatic cancers show the MSI-H/dMMR phenotype; the prevalence is greater in BRAF V600E–mutated cancers, in cancers originating on the right side, and among female patients.
Immune checkpoint inhibitors have already demonstrated “convincing activity” in MSI-H/dMMR colorectal cancers, and pembrolizumab as well as nivolumab (Opdivo), with or without ipilimumab (Yervoy), are approved for use as salvage therapy in colorectal cancer, he noted.
These results for use as a first-line therapy in his patient population have been “long awaited,” he commented.
Study details
The KEYNOTE-177 trial included 307 patients with confirmed, untreated MSI-H/dMMR metastatic colorectal cancer who were randomly assigned to receive pembrolizumab 200 mg every 3 weeks for up to 35 cycles (n = 153) or the investigators’ choice of chemotherapy (n = 154). Chemotherapy regimens included modified FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) alone or in combination with either bevacizumab or cetuximab, or FOLFIRI (leucovorin, fluorouracil, irinotecan) alone or in combination with either bevacizumab or cetuximab. Patients in the chemotherapy group could cross over to pembrolizumab therapy after disease progression.
The study’s two primary endpoints were PFS and overall survival.
At the second interim analysis, at a median follow-up (from randomization to data cutoff) of 32.4 months, pembrolizumab proved superior to chemotherapy with regard to PFS (hazard ratio, 0.60; P = .0002).
At 12 months and at 24 months, the estimated percentages of those alive without disease progression were 55.3% and 48.3%, respectively (95% confidence interval, 39.9-56.2) in the pembrolizumab group and 37.3% and 18.6%, respectively, in the chemotherapy group.
The mean PFS after 24 months of follow-up was 13.7 months for patients who received pembrolizumab versus 10.8 months for those who received chemotherapy. PFS was consistently longer with pembrolizumab across key prespecified subgroups. Complete responses were achieved in 11% of patients treated with pembrolizumab and in 4% of those treated with chemotherapy. At 24 months, 83% of patients in the pembrolizumab group had ongoing responses, compared with 35% in the chemotherapy group.
Overall survival data continue to evolve, the authors commented, noting that 56 patients in the pembrolizumab group and 69 in the chemotherapy group have died. The independent data-monitoring committee has recommended that the trial continue without any changes to the final analysis for assessment of overall survival until 190 overall deaths have occurred or until 12 months after the second interim analysis.
Crossover will be a factor when overall survival is assessed, the authors noted. At the time of data cutoff, 56 of 154 patients (36%) who received chemotherapy had crossed over to the pembrolizumab group after their disease had progressed. In addition, 35 patients in the chemotherapy group received anti–programmed death-1 or PD-ligand 1 therapies outside the trial. This extrapolates to a crossover rate of 59% in the intention-to-treat population.
Treatment-related adverse events of grade 3 or higher were more common in the chemotherapy group (66% vs. 22%). Immune-mediated adverse events and infusion reactions were more common with pembrolizumab than with chemotherapy (31% and 13%, respectively). Adverse events that were common with chemotherapy included gastrointestinal events, fatigue, neutropenia, and peripheral sensory neuropathy.
Preferred choice
In the accompanying editorial, Dr. Grothey pointed out that the results of this trial “deserve some scrutiny,” because disease progression was higher in the pembrolizumab group. This is mirrored by early poorer performance among patients treated with pembrolizumab versus chemotherapy until about 6.5 months after onset of therapy. After that, the “pembrolizumab group showed protracted improvement – a phenomenon seen in various other trials with PD-1 antibodies in gastrointestinal cancers.
“It appears that a subgroup not yet clearly defined within the MSI-H–dMMR population does not have a response to immune checkpoint inhibitors,” Dr. Grothey wrote.
The study was funded by Merck. Dr. André has received honoraria from Amgen, GlaxoSmithKline, and Pierre Fabre Pharmaceuticals; consulting fees and travel support from Bristol-Myers Squibb; advisory board fees and honoraria from F. Hoffmann–La Roche; advisory board fees from Gritstone Oncology, Halliodx, and Tesaro; grant support, paid to Hôpitaux de Paris; advisory board fees, honoraria, and travel support from Merck Sharp and Dohme; consulting fees and honoraria from Servier; and honoraria and travel support from Ventana Medical Systems. Dr. Grothey has received grants and nonfinancial support from Bayer; grants from Boston Biomedicals; grants from OBI Pharmaceuticals, Array/Pfizer, Natera, Merck, and Bristol-Myers Squibb; and grants and nonfinancial support from Roche/ Genentech outside the submitted work.
A version of this article originally appeared on Medscape.com.
Menstrual cup use increases risk of IUD expulsion
Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.
Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.
Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.
“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.
The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.
At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
Patient behavior persists despite advisory
Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).
The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).
In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).
Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.
Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
More data to come from further analysis
During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.
“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”
When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.
Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.
The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.
The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.
Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.
Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.
Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.
“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.
The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.
At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
Patient behavior persists despite advisory
Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).
The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).
In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).
Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.
Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
More data to come from further analysis
During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.
“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”
When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.
Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.
The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.
The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.
Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.
Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.
Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.
“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.
The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.
At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
Patient behavior persists despite advisory
Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).
The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).
In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).
Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.
Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
More data to come from further analysis
During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.
“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”
When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.
Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.
The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.
The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.
FROM ACOG 2020
An alternative path to recertification
Recertification will include physicians who were initially board certified with UCNS in the subspecialties of autonomic disorders, behavioral neurology and neuropsychiatry, clinical neuromuscular pathology, geriatric neurology, headache medicine, neurocritical care, neuroimaging, and neuro-oncology.
In 2020, UCNS transitioned to a new continuous-certification (C-cert) model that requires its diplomates to pay an annual fee of $175 and complete a 25-question online quiz based on preselected journal articles with an 80% passing grade. In a press release outlining the details of the new C-cert program, UCNS said that diplomates began the transition last year by “attesting they have participated in subspecialty-specific continuing medical education (CME) requirements from the time their most recent certificate was issued through 2019.” Diplomates have a 2-year window, which began in 2019, to meet these transitional CME requirements and complete an attestation statement before their certification lapses. “Diplomates with a status of ‘meeting requirements’ will be issued a replacement certificate that shows their original certification date and will reflect there is no expiration date after they pay the first annual C-cert fee in 2020,” UCNS said in the press release.
“It is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,” Paul G. Mathew, MD, assistant professor of neurology at Harvard Medical School in Boston and Director of Legislative Affairs at NBPAS, said in an interview. “A one-size-fits-all approach for learning with preselected articles is not ideal, and physicians should be able to choose CME and other learning activities that best suit their individual interests and practice.”
The added requirements and fees have caused some UCNS diplomates to consider letting their certification lapse, Dr. Mathew said, but the NBPAS decision offers them a new path to recertification. “Many physicians who would have otherwise let their certification lapse and would no longer be considered board certified in headache medicine and other UCNS subspecialties will now have the option to recertify with NBPAS,” he said.
NBPAS was formed in 2014 in response to controversial American Board of Medical Specialties Maintenance of Certification (MOC) programs. NBPAS recertifies diplomates of all specialties and subspecialties offered by the ABMS and its member boards, including board certification in neurology and neurologic subspecialties offered by the American Board of Psychiatry and Neurology.
Board recertification with NBPAS requires an unrestricted license to practice medicine in the United States, an initial certification with ABPN, the American Osteopathic Association, and/or UCNS, a medical staff appointment/membership in good standing, active hospital privileges based on specialty, and 50 hours of relevant CME credits every 2 years.
“Although MOC compliance is not required for licensure, the vast majority of insurance carriers in the United States require to some extent that their physicians be MOC compliant. As such, the ABMS has a monopoly in that a physician cannot practice medicine without complying with MOC,” Dr. Mathew said. “That’s very gradually changing.”
So far, 13 states have passed legislation limiting ABMS MOC compliance as a requirement for credentialing or licensure, and 136 healthcare institutions have recognized NBPAS as a pathway for physician credentialing, according to an NBPAS press release.
Changing the rules
Alan Rapoport, MD, was asked to comment on the recertification situtaion. Dr. Rapoport is clinical professor of neurology at UCLA and the Editor in Chief of Neurology Reviews. “As Dr. Mathew aptly states, it is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,”
For context, Dr. Rapoport explained what has happened to him and about 200 neurologists and a few other specialists who took the first UCNS certifying exam in Headache Medicine. “I sat for the first exam in a testing center in 2006, after paying a large fee. I passed and was granted a certificate for a 10-year certification in Headache Medicine. Prior to the expiration of that certificate, I was told I had to pay about $1,800 and take a similar examination to certify for another 10 years. I was not sure I needed to do that, but I did so anyway and passed and was granted a new, dated certificate for another 10 years of certification in Headache Medicine. Shortly after that I began to get notices from UCNS saying that they were changing their certification process and I would soon have to read their designated articles, take an examination on that literature, pay $175 for this privilege of C-Cert yearly, all in spite of the fact that I had a valid certificate for 10 years of certification.”
After complaints from Dr. Rapoport and many others, “UCNS said we would only have to do this when we had 5 years left on our certification. When they advertised this new C-Cert plan on the AAN Headache Listserv, even though advertising was against the rules of the Listserv, I complained about it saying we had paid for a 10-year certification. Their response was to abruptly take me off the Listserv. Then they temporarily shut it down when others agreed with what I had written.”
Dr. Rapoport has the certificate that proves that he has 6 years left on his certification, but UCNS will not recognize this, he said. “I believe that to be unfair, unethical, and probably illegal, as do many senior Headache specialists in the country who have the same issue. The attorney for the UCNS, who is also the attorney for the AAN, has disregarded our objections to this move.”
Now the NBPAS will be recertifying Headache Medicine doctors and those of other specialties who are in a similar situation and do not want to pay for the privilege of taking exams yearly when they have already been certified. “I expect many specialists will switch to this new way of certifying,” Dr. Rapoport said.
“I believe the UCNS has cheapened the value of their certifications by not honoring them,” Dr. Rapoort said.
Dr. Mathew reports that he collects no salary for his role with NBPAS, but receives reimbursement for travel expenses, and occasionally receives honoraria for speaking on behalf of NBPAS.
Recertification will include physicians who were initially board certified with UCNS in the subspecialties of autonomic disorders, behavioral neurology and neuropsychiatry, clinical neuromuscular pathology, geriatric neurology, headache medicine, neurocritical care, neuroimaging, and neuro-oncology.
In 2020, UCNS transitioned to a new continuous-certification (C-cert) model that requires its diplomates to pay an annual fee of $175 and complete a 25-question online quiz based on preselected journal articles with an 80% passing grade. In a press release outlining the details of the new C-cert program, UCNS said that diplomates began the transition last year by “attesting they have participated in subspecialty-specific continuing medical education (CME) requirements from the time their most recent certificate was issued through 2019.” Diplomates have a 2-year window, which began in 2019, to meet these transitional CME requirements and complete an attestation statement before their certification lapses. “Diplomates with a status of ‘meeting requirements’ will be issued a replacement certificate that shows their original certification date and will reflect there is no expiration date after they pay the first annual C-cert fee in 2020,” UCNS said in the press release.
“It is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,” Paul G. Mathew, MD, assistant professor of neurology at Harvard Medical School in Boston and Director of Legislative Affairs at NBPAS, said in an interview. “A one-size-fits-all approach for learning with preselected articles is not ideal, and physicians should be able to choose CME and other learning activities that best suit their individual interests and practice.”
The added requirements and fees have caused some UCNS diplomates to consider letting their certification lapse, Dr. Mathew said, but the NBPAS decision offers them a new path to recertification. “Many physicians who would have otherwise let their certification lapse and would no longer be considered board certified in headache medicine and other UCNS subspecialties will now have the option to recertify with NBPAS,” he said.
NBPAS was formed in 2014 in response to controversial American Board of Medical Specialties Maintenance of Certification (MOC) programs. NBPAS recertifies diplomates of all specialties and subspecialties offered by the ABMS and its member boards, including board certification in neurology and neurologic subspecialties offered by the American Board of Psychiatry and Neurology.
Board recertification with NBPAS requires an unrestricted license to practice medicine in the United States, an initial certification with ABPN, the American Osteopathic Association, and/or UCNS, a medical staff appointment/membership in good standing, active hospital privileges based on specialty, and 50 hours of relevant CME credits every 2 years.
“Although MOC compliance is not required for licensure, the vast majority of insurance carriers in the United States require to some extent that their physicians be MOC compliant. As such, the ABMS has a monopoly in that a physician cannot practice medicine without complying with MOC,” Dr. Mathew said. “That’s very gradually changing.”
So far, 13 states have passed legislation limiting ABMS MOC compliance as a requirement for credentialing or licensure, and 136 healthcare institutions have recognized NBPAS as a pathway for physician credentialing, according to an NBPAS press release.
Changing the rules
Alan Rapoport, MD, was asked to comment on the recertification situtaion. Dr. Rapoport is clinical professor of neurology at UCLA and the Editor in Chief of Neurology Reviews. “As Dr. Mathew aptly states, it is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,”
For context, Dr. Rapoport explained what has happened to him and about 200 neurologists and a few other specialists who took the first UCNS certifying exam in Headache Medicine. “I sat for the first exam in a testing center in 2006, after paying a large fee. I passed and was granted a certificate for a 10-year certification in Headache Medicine. Prior to the expiration of that certificate, I was told I had to pay about $1,800 and take a similar examination to certify for another 10 years. I was not sure I needed to do that, but I did so anyway and passed and was granted a new, dated certificate for another 10 years of certification in Headache Medicine. Shortly after that I began to get notices from UCNS saying that they were changing their certification process and I would soon have to read their designated articles, take an examination on that literature, pay $175 for this privilege of C-Cert yearly, all in spite of the fact that I had a valid certificate for 10 years of certification.”
After complaints from Dr. Rapoport and many others, “UCNS said we would only have to do this when we had 5 years left on our certification. When they advertised this new C-Cert plan on the AAN Headache Listserv, even though advertising was against the rules of the Listserv, I complained about it saying we had paid for a 10-year certification. Their response was to abruptly take me off the Listserv. Then they temporarily shut it down when others agreed with what I had written.”
Dr. Rapoport has the certificate that proves that he has 6 years left on his certification, but UCNS will not recognize this, he said. “I believe that to be unfair, unethical, and probably illegal, as do many senior Headache specialists in the country who have the same issue. The attorney for the UCNS, who is also the attorney for the AAN, has disregarded our objections to this move.”
Now the NBPAS will be recertifying Headache Medicine doctors and those of other specialties who are in a similar situation and do not want to pay for the privilege of taking exams yearly when they have already been certified. “I expect many specialists will switch to this new way of certifying,” Dr. Rapoport said.
“I believe the UCNS has cheapened the value of their certifications by not honoring them,” Dr. Rapoort said.
Dr. Mathew reports that he collects no salary for his role with NBPAS, but receives reimbursement for travel expenses, and occasionally receives honoraria for speaking on behalf of NBPAS.
Recertification will include physicians who were initially board certified with UCNS in the subspecialties of autonomic disorders, behavioral neurology and neuropsychiatry, clinical neuromuscular pathology, geriatric neurology, headache medicine, neurocritical care, neuroimaging, and neuro-oncology.
In 2020, UCNS transitioned to a new continuous-certification (C-cert) model that requires its diplomates to pay an annual fee of $175 and complete a 25-question online quiz based on preselected journal articles with an 80% passing grade. In a press release outlining the details of the new C-cert program, UCNS said that diplomates began the transition last year by “attesting they have participated in subspecialty-specific continuing medical education (CME) requirements from the time their most recent certificate was issued through 2019.” Diplomates have a 2-year window, which began in 2019, to meet these transitional CME requirements and complete an attestation statement before their certification lapses. “Diplomates with a status of ‘meeting requirements’ will be issued a replacement certificate that shows their original certification date and will reflect there is no expiration date after they pay the first annual C-cert fee in 2020,” UCNS said in the press release.
“It is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,” Paul G. Mathew, MD, assistant professor of neurology at Harvard Medical School in Boston and Director of Legislative Affairs at NBPAS, said in an interview. “A one-size-fits-all approach for learning with preselected articles is not ideal, and physicians should be able to choose CME and other learning activities that best suit their individual interests and practice.”
The added requirements and fees have caused some UCNS diplomates to consider letting their certification lapse, Dr. Mathew said, but the NBPAS decision offers them a new path to recertification. “Many physicians who would have otherwise let their certification lapse and would no longer be considered board certified in headache medicine and other UCNS subspecialties will now have the option to recertify with NBPAS,” he said.
NBPAS was formed in 2014 in response to controversial American Board of Medical Specialties Maintenance of Certification (MOC) programs. NBPAS recertifies diplomates of all specialties and subspecialties offered by the ABMS and its member boards, including board certification in neurology and neurologic subspecialties offered by the American Board of Psychiatry and Neurology.
Board recertification with NBPAS requires an unrestricted license to practice medicine in the United States, an initial certification with ABPN, the American Osteopathic Association, and/or UCNS, a medical staff appointment/membership in good standing, active hospital privileges based on specialty, and 50 hours of relevant CME credits every 2 years.
“Although MOC compliance is not required for licensure, the vast majority of insurance carriers in the United States require to some extent that their physicians be MOC compliant. As such, the ABMS has a monopoly in that a physician cannot practice medicine without complying with MOC,” Dr. Mathew said. “That’s very gradually changing.”
So far, 13 states have passed legislation limiting ABMS MOC compliance as a requirement for credentialing or licensure, and 136 healthcare institutions have recognized NBPAS as a pathway for physician credentialing, according to an NBPAS press release.
Changing the rules
Alan Rapoport, MD, was asked to comment on the recertification situtaion. Dr. Rapoport is clinical professor of neurology at UCLA and the Editor in Chief of Neurology Reviews. “As Dr. Mathew aptly states, it is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,”
For context, Dr. Rapoport explained what has happened to him and about 200 neurologists and a few other specialists who took the first UCNS certifying exam in Headache Medicine. “I sat for the first exam in a testing center in 2006, after paying a large fee. I passed and was granted a certificate for a 10-year certification in Headache Medicine. Prior to the expiration of that certificate, I was told I had to pay about $1,800 and take a similar examination to certify for another 10 years. I was not sure I needed to do that, but I did so anyway and passed and was granted a new, dated certificate for another 10 years of certification in Headache Medicine. Shortly after that I began to get notices from UCNS saying that they were changing their certification process and I would soon have to read their designated articles, take an examination on that literature, pay $175 for this privilege of C-Cert yearly, all in spite of the fact that I had a valid certificate for 10 years of certification.”
After complaints from Dr. Rapoport and many others, “UCNS said we would only have to do this when we had 5 years left on our certification. When they advertised this new C-Cert plan on the AAN Headache Listserv, even though advertising was against the rules of the Listserv, I complained about it saying we had paid for a 10-year certification. Their response was to abruptly take me off the Listserv. Then they temporarily shut it down when others agreed with what I had written.”
Dr. Rapoport has the certificate that proves that he has 6 years left on his certification, but UCNS will not recognize this, he said. “I believe that to be unfair, unethical, and probably illegal, as do many senior Headache specialists in the country who have the same issue. The attorney for the UCNS, who is also the attorney for the AAN, has disregarded our objections to this move.”
Now the NBPAS will be recertifying Headache Medicine doctors and those of other specialties who are in a similar situation and do not want to pay for the privilege of taking exams yearly when they have already been certified. “I expect many specialists will switch to this new way of certifying,” Dr. Rapoport said.
“I believe the UCNS has cheapened the value of their certifications by not honoring them,” Dr. Rapoort said.
Dr. Mathew reports that he collects no salary for his role with NBPAS, but receives reimbursement for travel expenses, and occasionally receives honoraria for speaking on behalf of NBPAS.
Read This Rorschach Chest
ANSWER
The correct answer is Grover disease (choice “c”).
DISCUSSION
Grover disease—also known as transient acantholytic dermatosis—was first described in 1975 by Ralph Grover, MD, and is now recognized as a relatively common condition, especially in White men older than 40. Its appearance on darker skin is unusual. The morphologic presentation seen in this case is fairly typical, though most patients complain more about itching than this patient did.
The actual cause of Grover disease is unknown. Heat, sweat, and sunlight are suspected triggers. Its appearance can be associated with certain medications, recent treatment with ionizing radiation, or end-stage renal failure.
Biopsy is the key to diagnosis of Grover disease, especially in the context of the clinical presentation. This method also serves to rule out the other items in the differential.
Tinea corporis (choice “a”) was ruled out by the KOH as well as the rash’s appearance. Darier disease (choice “b”)—otherwise known as keratosis follicularis—is an inherited dermatosis that presents with multiple findings on skin, nails, and mucous membranes; however, the papulosquamous rash would be far more coarse than what manifests in Grover disease, and it would have manifested at a much earlier age. While folliculitis (choice “d”) was a possibility in this patient, the biopsy ruled it out.
TREATMENT
Grover disease is notoriously difficult to treat. Although it is described as a “transient” dermatosis, it can last months to years despite all therapeutic efforts.
This patient was treated with a stronger topical steroid (0.05% betamethasone cream) twice a day and minocycline (100 mg/d) for 2 months. These cleared his rash.
ANSWER
The correct answer is Grover disease (choice “c”).
DISCUSSION
Grover disease—also known as transient acantholytic dermatosis—was first described in 1975 by Ralph Grover, MD, and is now recognized as a relatively common condition, especially in White men older than 40. Its appearance on darker skin is unusual. The morphologic presentation seen in this case is fairly typical, though most patients complain more about itching than this patient did.
The actual cause of Grover disease is unknown. Heat, sweat, and sunlight are suspected triggers. Its appearance can be associated with certain medications, recent treatment with ionizing radiation, or end-stage renal failure.
Biopsy is the key to diagnosis of Grover disease, especially in the context of the clinical presentation. This method also serves to rule out the other items in the differential.
Tinea corporis (choice “a”) was ruled out by the KOH as well as the rash’s appearance. Darier disease (choice “b”)—otherwise known as keratosis follicularis—is an inherited dermatosis that presents with multiple findings on skin, nails, and mucous membranes; however, the papulosquamous rash would be far more coarse than what manifests in Grover disease, and it would have manifested at a much earlier age. While folliculitis (choice “d”) was a possibility in this patient, the biopsy ruled it out.
TREATMENT
Grover disease is notoriously difficult to treat. Although it is described as a “transient” dermatosis, it can last months to years despite all therapeutic efforts.
This patient was treated with a stronger topical steroid (0.05% betamethasone cream) twice a day and minocycline (100 mg/d) for 2 months. These cleared his rash.
ANSWER
The correct answer is Grover disease (choice “c”).
DISCUSSION
Grover disease—also known as transient acantholytic dermatosis—was first described in 1975 by Ralph Grover, MD, and is now recognized as a relatively common condition, especially in White men older than 40. Its appearance on darker skin is unusual. The morphologic presentation seen in this case is fairly typical, though most patients complain more about itching than this patient did.
The actual cause of Grover disease is unknown. Heat, sweat, and sunlight are suspected triggers. Its appearance can be associated with certain medications, recent treatment with ionizing radiation, or end-stage renal failure.
Biopsy is the key to diagnosis of Grover disease, especially in the context of the clinical presentation. This method also serves to rule out the other items in the differential.
Tinea corporis (choice “a”) was ruled out by the KOH as well as the rash’s appearance. Darier disease (choice “b”)—otherwise known as keratosis follicularis—is an inherited dermatosis that presents with multiple findings on skin, nails, and mucous membranes; however, the papulosquamous rash would be far more coarse than what manifests in Grover disease, and it would have manifested at a much earlier age. While folliculitis (choice “d”) was a possibility in this patient, the biopsy ruled it out.
TREATMENT
Grover disease is notoriously difficult to treat. Although it is described as a “transient” dermatosis, it can last months to years despite all therapeutic efforts.
This patient was treated with a stronger topical steroid (0.05% betamethasone cream) twice a day and minocycline (100 mg/d) for 2 months. These cleared his rash.
Several months ago, an asymptomatic rash manifested on the 63-year-old man’s chest. His primary care provider diagnosed this as eczema, though the patient has no history of atopic conditions. Initial treatment included 0.025% triamcinolone cream, which was later switched to 0.1%. This improved the appearance but failed to clear the condition, prompting a referral to dermatology.
The patient is in otherwise good health. He has no history of seasonal allergies, asthma, urticaria, or eczema. He takes no medications that could have caused the rash. There is no family history of atopy or any other skin disease.
The florid, papulovesicular rash covers his chest, from the upper sternum to the mid-abdomen. Palpation reveals a rough texture to the condition that is faintly erythematous. The rash also affects small areas of his triceps, but the rest of his skin—including back, legs, and buttocks—are clear. His hair and nails appear normal.
A KOH prep shows fungal elements, but the lab results are negative. Longitudinal shave biopsy shows subcorneal separation along with acantholysis (destruction of connections between keratinocytes).
Several strategies can prevent pandemic-related weight gain
If you have been faithfully following the COVID-19 stay-at-home restrictive orders, you may have become a victim of “COVID-15,” the additional, unexpected, unwanted 10- to 15-pound weight gain that is making your clothes not fit so well any more.
A change in routine; being home in comfy, stretchable clothing in front of the TV; and having unhealthy, processed foods ready to grab have set us up to lose the battle with COVID-15. We are set up to gain the weight because of excessive or unhealthful eating, taking an extra daily shot of alcohol, and being inactive, bored, depressed, anxious, and isolated from coworkers and family. Beware – weight gain can be “catching”; we tend to adopt the same poor eating habits and eat the same junk foods as those around us.
Since psychiatry can be a sedentary profession, I’ve (R.W.C.) kept myself very active and physically fit. Prior to the pandemic, I played tennis and ran every day. I was obese only once in my life. I had not realized that I had gained a lot of weight.
Thankfully, a physician called me “obese.” Initially, I was angry at the doctor, however, I realized that he did me the biggest favor of my life. I changed my diet and eating habits, and for the past 20 years, kept my weight between 135-140 pounds and my BMI at 23 consistently – until the pandemic stress caused me to fall into the same bad eating habits that have caused many others to gain the COVID-15.
I was surprised to see that when I weighed myself, and I had gained 12 pounds! I immediately modified my diet and increased my physical activity. I have now lost the extra 12 pounds and will offer suggestions that may help you and your patients exceed your prepandemic physical condition.
Possible solutions
1. Keep a food journal. Write down what you eat, the amount of food you eat, the time you are eating, and your mood at that moment. Keeping a small notebook to record what and when you eat is important because upon review, it will make you face reality and be accountable for what you put in your mouth. Until you review your journal, you may have underestimated the amount, as well as the kinds, of food and drinks you actually consume. A food journal can show your areas of struggle and unhealthy eating habits and help you make necessary changes in your habits and diet to eventually lose weight. You will be less likely to eat junk food or have an extra serving of food. If you do not want to use paper and pencil, you can download an app on your phone, such as myplate tracker to keep track of your food and calorie intake. Do your journaling immediately after you eat and include snacks; do not wait until night time to record your food and journal. Include your mood or how you felt during your meal or snack (for example, were you bored, sad, or anxious) since this information will indicate why you may be overeating.
2. Develop healthful eating habits. Eat a maximum of three meals and three snacks per day but eat only when you are hungry (that is, when your stomach growls or you feel light headed). Limiting yourself to eating only when you are hungry will help eliminate emotional eating to fill a loss in your life or to deal with feelings of stress, anxiety, sadness, or isolation, which have been exacerbated by the pandemic. Buy eat only healthful foods and not items with empty calories, such as chips, cake, and items with sugar. When you are eating, devote yourself to that activity only, eat slowly, and savor each bite. Do not watch television during your meal time.
3. Record the amount and type of exercise you engage in each day and determine the number of calories burned. Walk, run, or bicycle outside, or exercise inside with stretching, weights, or an exercycle. You may use a website, such as diet tool on WebMD.com to calculate daily calories burned. To lose weight, calories burned during a day must exceed caloric intake. You may want to invest in a Fitbit or an Apple Watch and use the health section to determine your caloric intake versus output. Analyzing your caloric data will provide a concrete measure of your progress.
4. Do not overconsume calories or underconsume protein. Protein plays a key role in the creation and maintenance of every cell of your body, and because the body does not store protein, it is important to consume it every day. To meet basic protein requirements, the DRI (Dietary Reference Intake) recommends 0.36 grams of protein per pound (0.8 grams per kg) of body weight. This amounts to: 56 grams per day for the average sedentary man, and 46 grams per day for the average sedentary woman. There is also an app entitled the Protein Tracker that can simplify your calculations.
5. Drink water. It is important to be hydrated to regulate body temperature, keep joints lubricated, prevent infections, deliver nutrients to cells, and keep organs functioning properly. Being well hydrated also improves sleep, cognition, and mood. Your daily water intake by ounce should be equal to your weight in pounds multiplied by two-thirds (or 67%) to determine the amount of water to drink daily. For example, if you weigh 175 pounds, you would multiply 175 by two-thirds and learn that you should be drinking about 117 ounces of water every day. You can also meet some of your daily water requirements by consuming fruits and vegetables, such as tomatoes, watermelon, lettuce, etc.
Also, drink 2 cups (16 oz.) of water before every meal: Often when you feel hungry, it is because your body simply needs water. Science has proven that drinking 2 cups of water before every meal helps you to eat less during meal time and lose weight. If you do this three times daily – at breakfast, lunch, and dinner – you have already consumed 48 ounces of water.
6. Keep track of your progress. In addition to keeping and analyzing your food journal, weigh yourself once or twice a week. Do not weigh yourself every day; you will not see any results on a day-to-day basis, but once a week gives your body time to regulate and show progress. Always calibrate/zero your scale before each use, and weigh yourself at the same time of the day (preferably after you first wake up in the morning) while wearing the same type of clothing. Keep a record of your weight in your journal to track your progress. Do not panic if the scale indicates you gained 1, 2, or 3 pounds, your weight can fluctuate because of glycogen storage, sodium retention, human bias, reporting or recall errors, and home scales can have a plus or minus 3 pound margin of error. Look at your weight trend over time. You may prefer buying a scale that indicates both weight and body mass index.
7. Celebrate and reward yourself with nonfood items. A healthful fitness and diet regime requires energy and dedication, so if you are able to follow a healthful routine, reward yourself with nonfood rewards for your good choices and new habits as an incentive to maintain your healthful behavior.
8. Don’t buy it if you can’t stop eating it. The biggest decision you make is when you decide what you are going to buy. Don’t lie to yourself in the store that you will only eat one at a time. Only buy what you can afford to binge eat if you can’t stop yourself from eating any particular type of food.
9. Have someone hide the food you can’t resist. You can’t eat what you can’t find. If you can’t avoid having irresistible food around, ask another adult to hide the food from you.
10. Learn what harm foods can cause in your body. Read about the effects of high blood sugar and high blood pressure can cause in your body. Find out which foods boost your immune system. Demonize the bad foods in your mind. Make up your mind before you go into the store that you are going to read food labels and find the best quality food with the lowest amount of sugar or saturated fat. Appreciate the flavor of vegetables and fruit.
11. Treat sugar as if it were an addictive drug. You can’t have just one. If you reduce your craving for sugar by slowly reducing your intake of sugar, you will find that you don’t crave sugar any more. This won’t be easy, but once it is done, you will be preventing many of the ravages that sugar takes on your body over time. But you can’t have one piece of pie because the craving will come back. At some point, it may be more likely that you find that piece of pie too sweet.
Here are a few other ideas: Buy a gift for yourself or new clothes, makeup, a plant or flowers, running shoes, exercise clothes, fitness tracker, water bottle, book, movie or network subscription. Improve your home décor. Or treat yourself to online lessons for painting, music, and so on. Or you might adopt a dog, donate food to a shelter or food bank; or organize and declutter your home since staying busy will give you a reason not to eat. In nice weather, enjoy the outdoors by going for a walk, run, bikeride or by gardening.
We are all worried about getting COVID-19. Preventing COVID-15 will go a long way toward boosting our immune systems to help protect us from the coronavirus.
Dr. Cohen is board-certified in psychiatry and has had a private practice in Philadelphia for more than 35 years. His areas of specialty include sports psychiatry, agoraphobia, depression, and substance abuse. In addition, Dr. Cohen is a former professor of psychiatry, family medicine, and otolaryngology at Thomas Jefferson University in Philadelphia. He has no conflicts of interest. Ms. Cohen holds an MBA from Temple University in Philadelphia with a focus on health care administration. Previously, Ms. Cohen was an associate administrator at Hahnemann University Hospital and an executive at the Health Services Council, both in Philadelphia. She currently writes biographical summaries of notable 18th- and 19th-century women. Ms. Cohen has no conflicts of interest.
If you have been faithfully following the COVID-19 stay-at-home restrictive orders, you may have become a victim of “COVID-15,” the additional, unexpected, unwanted 10- to 15-pound weight gain that is making your clothes not fit so well any more.
A change in routine; being home in comfy, stretchable clothing in front of the TV; and having unhealthy, processed foods ready to grab have set us up to lose the battle with COVID-15. We are set up to gain the weight because of excessive or unhealthful eating, taking an extra daily shot of alcohol, and being inactive, bored, depressed, anxious, and isolated from coworkers and family. Beware – weight gain can be “catching”; we tend to adopt the same poor eating habits and eat the same junk foods as those around us.
Since psychiatry can be a sedentary profession, I’ve (R.W.C.) kept myself very active and physically fit. Prior to the pandemic, I played tennis and ran every day. I was obese only once in my life. I had not realized that I had gained a lot of weight.
Thankfully, a physician called me “obese.” Initially, I was angry at the doctor, however, I realized that he did me the biggest favor of my life. I changed my diet and eating habits, and for the past 20 years, kept my weight between 135-140 pounds and my BMI at 23 consistently – until the pandemic stress caused me to fall into the same bad eating habits that have caused many others to gain the COVID-15.
I was surprised to see that when I weighed myself, and I had gained 12 pounds! I immediately modified my diet and increased my physical activity. I have now lost the extra 12 pounds and will offer suggestions that may help you and your patients exceed your prepandemic physical condition.
Possible solutions
1. Keep a food journal. Write down what you eat, the amount of food you eat, the time you are eating, and your mood at that moment. Keeping a small notebook to record what and when you eat is important because upon review, it will make you face reality and be accountable for what you put in your mouth. Until you review your journal, you may have underestimated the amount, as well as the kinds, of food and drinks you actually consume. A food journal can show your areas of struggle and unhealthy eating habits and help you make necessary changes in your habits and diet to eventually lose weight. You will be less likely to eat junk food or have an extra serving of food. If you do not want to use paper and pencil, you can download an app on your phone, such as myplate tracker to keep track of your food and calorie intake. Do your journaling immediately after you eat and include snacks; do not wait until night time to record your food and journal. Include your mood or how you felt during your meal or snack (for example, were you bored, sad, or anxious) since this information will indicate why you may be overeating.
2. Develop healthful eating habits. Eat a maximum of three meals and three snacks per day but eat only when you are hungry (that is, when your stomach growls or you feel light headed). Limiting yourself to eating only when you are hungry will help eliminate emotional eating to fill a loss in your life or to deal with feelings of stress, anxiety, sadness, or isolation, which have been exacerbated by the pandemic. Buy eat only healthful foods and not items with empty calories, such as chips, cake, and items with sugar. When you are eating, devote yourself to that activity only, eat slowly, and savor each bite. Do not watch television during your meal time.
3. Record the amount and type of exercise you engage in each day and determine the number of calories burned. Walk, run, or bicycle outside, or exercise inside with stretching, weights, or an exercycle. You may use a website, such as diet tool on WebMD.com to calculate daily calories burned. To lose weight, calories burned during a day must exceed caloric intake. You may want to invest in a Fitbit or an Apple Watch and use the health section to determine your caloric intake versus output. Analyzing your caloric data will provide a concrete measure of your progress.
4. Do not overconsume calories or underconsume protein. Protein plays a key role in the creation and maintenance of every cell of your body, and because the body does not store protein, it is important to consume it every day. To meet basic protein requirements, the DRI (Dietary Reference Intake) recommends 0.36 grams of protein per pound (0.8 grams per kg) of body weight. This amounts to: 56 grams per day for the average sedentary man, and 46 grams per day for the average sedentary woman. There is also an app entitled the Protein Tracker that can simplify your calculations.
5. Drink water. It is important to be hydrated to regulate body temperature, keep joints lubricated, prevent infections, deliver nutrients to cells, and keep organs functioning properly. Being well hydrated also improves sleep, cognition, and mood. Your daily water intake by ounce should be equal to your weight in pounds multiplied by two-thirds (or 67%) to determine the amount of water to drink daily. For example, if you weigh 175 pounds, you would multiply 175 by two-thirds and learn that you should be drinking about 117 ounces of water every day. You can also meet some of your daily water requirements by consuming fruits and vegetables, such as tomatoes, watermelon, lettuce, etc.
Also, drink 2 cups (16 oz.) of water before every meal: Often when you feel hungry, it is because your body simply needs water. Science has proven that drinking 2 cups of water before every meal helps you to eat less during meal time and lose weight. If you do this three times daily – at breakfast, lunch, and dinner – you have already consumed 48 ounces of water.
6. Keep track of your progress. In addition to keeping and analyzing your food journal, weigh yourself once or twice a week. Do not weigh yourself every day; you will not see any results on a day-to-day basis, but once a week gives your body time to regulate and show progress. Always calibrate/zero your scale before each use, and weigh yourself at the same time of the day (preferably after you first wake up in the morning) while wearing the same type of clothing. Keep a record of your weight in your journal to track your progress. Do not panic if the scale indicates you gained 1, 2, or 3 pounds, your weight can fluctuate because of glycogen storage, sodium retention, human bias, reporting or recall errors, and home scales can have a plus or minus 3 pound margin of error. Look at your weight trend over time. You may prefer buying a scale that indicates both weight and body mass index.
7. Celebrate and reward yourself with nonfood items. A healthful fitness and diet regime requires energy and dedication, so if you are able to follow a healthful routine, reward yourself with nonfood rewards for your good choices and new habits as an incentive to maintain your healthful behavior.
8. Don’t buy it if you can’t stop eating it. The biggest decision you make is when you decide what you are going to buy. Don’t lie to yourself in the store that you will only eat one at a time. Only buy what you can afford to binge eat if you can’t stop yourself from eating any particular type of food.
9. Have someone hide the food you can’t resist. You can’t eat what you can’t find. If you can’t avoid having irresistible food around, ask another adult to hide the food from you.
10. Learn what harm foods can cause in your body. Read about the effects of high blood sugar and high blood pressure can cause in your body. Find out which foods boost your immune system. Demonize the bad foods in your mind. Make up your mind before you go into the store that you are going to read food labels and find the best quality food with the lowest amount of sugar or saturated fat. Appreciate the flavor of vegetables and fruit.
11. Treat sugar as if it were an addictive drug. You can’t have just one. If you reduce your craving for sugar by slowly reducing your intake of sugar, you will find that you don’t crave sugar any more. This won’t be easy, but once it is done, you will be preventing many of the ravages that sugar takes on your body over time. But you can’t have one piece of pie because the craving will come back. At some point, it may be more likely that you find that piece of pie too sweet.
Here are a few other ideas: Buy a gift for yourself or new clothes, makeup, a plant or flowers, running shoes, exercise clothes, fitness tracker, water bottle, book, movie or network subscription. Improve your home décor. Or treat yourself to online lessons for painting, music, and so on. Or you might adopt a dog, donate food to a shelter or food bank; or organize and declutter your home since staying busy will give you a reason not to eat. In nice weather, enjoy the outdoors by going for a walk, run, bikeride or by gardening.
We are all worried about getting COVID-19. Preventing COVID-15 will go a long way toward boosting our immune systems to help protect us from the coronavirus.
Dr. Cohen is board-certified in psychiatry and has had a private practice in Philadelphia for more than 35 years. His areas of specialty include sports psychiatry, agoraphobia, depression, and substance abuse. In addition, Dr. Cohen is a former professor of psychiatry, family medicine, and otolaryngology at Thomas Jefferson University in Philadelphia. He has no conflicts of interest. Ms. Cohen holds an MBA from Temple University in Philadelphia with a focus on health care administration. Previously, Ms. Cohen was an associate administrator at Hahnemann University Hospital and an executive at the Health Services Council, both in Philadelphia. She currently writes biographical summaries of notable 18th- and 19th-century women. Ms. Cohen has no conflicts of interest.
If you have been faithfully following the COVID-19 stay-at-home restrictive orders, you may have become a victim of “COVID-15,” the additional, unexpected, unwanted 10- to 15-pound weight gain that is making your clothes not fit so well any more.
A change in routine; being home in comfy, stretchable clothing in front of the TV; and having unhealthy, processed foods ready to grab have set us up to lose the battle with COVID-15. We are set up to gain the weight because of excessive or unhealthful eating, taking an extra daily shot of alcohol, and being inactive, bored, depressed, anxious, and isolated from coworkers and family. Beware – weight gain can be “catching”; we tend to adopt the same poor eating habits and eat the same junk foods as those around us.
Since psychiatry can be a sedentary profession, I’ve (R.W.C.) kept myself very active and physically fit. Prior to the pandemic, I played tennis and ran every day. I was obese only once in my life. I had not realized that I had gained a lot of weight.
Thankfully, a physician called me “obese.” Initially, I was angry at the doctor, however, I realized that he did me the biggest favor of my life. I changed my diet and eating habits, and for the past 20 years, kept my weight between 135-140 pounds and my BMI at 23 consistently – until the pandemic stress caused me to fall into the same bad eating habits that have caused many others to gain the COVID-15.
I was surprised to see that when I weighed myself, and I had gained 12 pounds! I immediately modified my diet and increased my physical activity. I have now lost the extra 12 pounds and will offer suggestions that may help you and your patients exceed your prepandemic physical condition.
Possible solutions
1. Keep a food journal. Write down what you eat, the amount of food you eat, the time you are eating, and your mood at that moment. Keeping a small notebook to record what and when you eat is important because upon review, it will make you face reality and be accountable for what you put in your mouth. Until you review your journal, you may have underestimated the amount, as well as the kinds, of food and drinks you actually consume. A food journal can show your areas of struggle and unhealthy eating habits and help you make necessary changes in your habits and diet to eventually lose weight. You will be less likely to eat junk food or have an extra serving of food. If you do not want to use paper and pencil, you can download an app on your phone, such as myplate tracker to keep track of your food and calorie intake. Do your journaling immediately after you eat and include snacks; do not wait until night time to record your food and journal. Include your mood or how you felt during your meal or snack (for example, were you bored, sad, or anxious) since this information will indicate why you may be overeating.
2. Develop healthful eating habits. Eat a maximum of three meals and three snacks per day but eat only when you are hungry (that is, when your stomach growls or you feel light headed). Limiting yourself to eating only when you are hungry will help eliminate emotional eating to fill a loss in your life or to deal with feelings of stress, anxiety, sadness, or isolation, which have been exacerbated by the pandemic. Buy eat only healthful foods and not items with empty calories, such as chips, cake, and items with sugar. When you are eating, devote yourself to that activity only, eat slowly, and savor each bite. Do not watch television during your meal time.
3. Record the amount and type of exercise you engage in each day and determine the number of calories burned. Walk, run, or bicycle outside, or exercise inside with stretching, weights, or an exercycle. You may use a website, such as diet tool on WebMD.com to calculate daily calories burned. To lose weight, calories burned during a day must exceed caloric intake. You may want to invest in a Fitbit or an Apple Watch and use the health section to determine your caloric intake versus output. Analyzing your caloric data will provide a concrete measure of your progress.
4. Do not overconsume calories or underconsume protein. Protein plays a key role in the creation and maintenance of every cell of your body, and because the body does not store protein, it is important to consume it every day. To meet basic protein requirements, the DRI (Dietary Reference Intake) recommends 0.36 grams of protein per pound (0.8 grams per kg) of body weight. This amounts to: 56 grams per day for the average sedentary man, and 46 grams per day for the average sedentary woman. There is also an app entitled the Protein Tracker that can simplify your calculations.
5. Drink water. It is important to be hydrated to regulate body temperature, keep joints lubricated, prevent infections, deliver nutrients to cells, and keep organs functioning properly. Being well hydrated also improves sleep, cognition, and mood. Your daily water intake by ounce should be equal to your weight in pounds multiplied by two-thirds (or 67%) to determine the amount of water to drink daily. For example, if you weigh 175 pounds, you would multiply 175 by two-thirds and learn that you should be drinking about 117 ounces of water every day. You can also meet some of your daily water requirements by consuming fruits and vegetables, such as tomatoes, watermelon, lettuce, etc.
Also, drink 2 cups (16 oz.) of water before every meal: Often when you feel hungry, it is because your body simply needs water. Science has proven that drinking 2 cups of water before every meal helps you to eat less during meal time and lose weight. If you do this three times daily – at breakfast, lunch, and dinner – you have already consumed 48 ounces of water.
6. Keep track of your progress. In addition to keeping and analyzing your food journal, weigh yourself once or twice a week. Do not weigh yourself every day; you will not see any results on a day-to-day basis, but once a week gives your body time to regulate and show progress. Always calibrate/zero your scale before each use, and weigh yourself at the same time of the day (preferably after you first wake up in the morning) while wearing the same type of clothing. Keep a record of your weight in your journal to track your progress. Do not panic if the scale indicates you gained 1, 2, or 3 pounds, your weight can fluctuate because of glycogen storage, sodium retention, human bias, reporting or recall errors, and home scales can have a plus or minus 3 pound margin of error. Look at your weight trend over time. You may prefer buying a scale that indicates both weight and body mass index.
7. Celebrate and reward yourself with nonfood items. A healthful fitness and diet regime requires energy and dedication, so if you are able to follow a healthful routine, reward yourself with nonfood rewards for your good choices and new habits as an incentive to maintain your healthful behavior.
8. Don’t buy it if you can’t stop eating it. The biggest decision you make is when you decide what you are going to buy. Don’t lie to yourself in the store that you will only eat one at a time. Only buy what you can afford to binge eat if you can’t stop yourself from eating any particular type of food.
9. Have someone hide the food you can’t resist. You can’t eat what you can’t find. If you can’t avoid having irresistible food around, ask another adult to hide the food from you.
10. Learn what harm foods can cause in your body. Read about the effects of high blood sugar and high blood pressure can cause in your body. Find out which foods boost your immune system. Demonize the bad foods in your mind. Make up your mind before you go into the store that you are going to read food labels and find the best quality food with the lowest amount of sugar or saturated fat. Appreciate the flavor of vegetables and fruit.
11. Treat sugar as if it were an addictive drug. You can’t have just one. If you reduce your craving for sugar by slowly reducing your intake of sugar, you will find that you don’t crave sugar any more. This won’t be easy, but once it is done, you will be preventing many of the ravages that sugar takes on your body over time. But you can’t have one piece of pie because the craving will come back. At some point, it may be more likely that you find that piece of pie too sweet.
Here are a few other ideas: Buy a gift for yourself or new clothes, makeup, a plant or flowers, running shoes, exercise clothes, fitness tracker, water bottle, book, movie or network subscription. Improve your home décor. Or treat yourself to online lessons for painting, music, and so on. Or you might adopt a dog, donate food to a shelter or food bank; or organize and declutter your home since staying busy will give you a reason not to eat. In nice weather, enjoy the outdoors by going for a walk, run, bikeride or by gardening.
We are all worried about getting COVID-19. Preventing COVID-15 will go a long way toward boosting our immune systems to help protect us from the coronavirus.
Dr. Cohen is board-certified in psychiatry and has had a private practice in Philadelphia for more than 35 years. His areas of specialty include sports psychiatry, agoraphobia, depression, and substance abuse. In addition, Dr. Cohen is a former professor of psychiatry, family medicine, and otolaryngology at Thomas Jefferson University in Philadelphia. He has no conflicts of interest. Ms. Cohen holds an MBA from Temple University in Philadelphia with a focus on health care administration. Previously, Ms. Cohen was an associate administrator at Hahnemann University Hospital and an executive at the Health Services Council, both in Philadelphia. She currently writes biographical summaries of notable 18th- and 19th-century women. Ms. Cohen has no conflicts of interest.
Best of 2020: The MS Report
Best of 2020: The MS Report is a supplement to Neurology Reviews.
In this supplement, Neurology Reviews collects the top MS research from 2020. Coverage includes MS highlights from the ACTRIMS, AAN, CMSC, and ECTRIMS annual meetings.
Best of 2020: The MS Report is a supplement to Neurology Reviews.
In this supplement, Neurology Reviews collects the top MS research from 2020. Coverage includes MS highlights from the ACTRIMS, AAN, CMSC, and ECTRIMS annual meetings.
Best of 2020: The MS Report is a supplement to Neurology Reviews.
In this supplement, Neurology Reviews collects the top MS research from 2020. Coverage includes MS highlights from the ACTRIMS, AAN, CMSC, and ECTRIMS annual meetings.
Two consecutive negative FUBC results clear S. aureus bacteremia
reported Caitlin Cardenas-Comfort, MD, of the section of pediatric infectious diseases at Baylor College of Medicine, Houston, and colleagues.
In a retrospective cohort study of 122 pediatric patients with documented Staphylococcus aureus bacteremia (SAB) that were hospitalized at one of three hospitals in the Texas Children’s Hospital network in Houston, Dr. Cardenas-Comfort and colleagues sought to determine whether specific recommendations can be made on the number of follow-up blood cultures (FUBC) needed to document clearance of SAB. Patients included in the study were under 18 years of age and had confirmed diagnosis of SAB between Jan. 1, and Dec. 31, 2018.
Most cases of bacteremia resolve in under 48 hours
In the majority of cases, patients had bacteremia for less than 48 hours and few to no complications. Only 16% of patients experienced bacteremia lasting 3 or more days, and they had either central line-associated bloodstream infection, endocarditis, or osteomyelitis. In such cases, “patients with endovascular and closed-space infections are at an increased risk of persistent bacteremia,” warranting more conservative monitoring and follow-up, cautioned the researchers.
Although Dr. Cardenas-Comfort and colleagues did note an association between the duration of bacteremia and a diagnosis of infectious disease, increased risk for persistent SAB did not appear to be tied to an underlying medical condition, including immunosuppression.
Fewer than 5% of patients with SAB had intermittent positive cultures and fewer than 1% had repeat positive cultures following two negative FUBC results. For those patients with intermittent positive cultures, the risk of being diagnosed with endocarditis or osteomyelitis is more than double. The authors suggested that “source control could be a critical variable” increasing the risk for intermittent positive cultures, noting that surgical debridement occurred more than 24 hours following initial blood draw for every patient in the osteomyelitis group. In contrast, of those who had consistently negative FUBC results, only 2 of 33 (6%) had debridement in the same period, and only 6 of 33 (18%) required more than one debridement.
Children are less likely to have intermittent positive cultures
Dr. Cardenas-Comfort and colleagues also observed that intermittent positive cultures may appear less frequently in children than adults, consistent with a recent study of adults in which intermittent cultures were found in 13% of 1.071 SAB cases. In just 4% of the cases in that study, more than 2 days of negative blood cultures preceded a repeat positive culture.
The researchers noted several study limitations in their own research. Because more than half (61%) of patients had two or less FUBCs collected, and 21% one or less, they acknowledged that their conclusions are based on the presumption that the 61% of patients would not have any further positive cultures if they had been drawn. Relying on provider documentation also suggested that cases of bacteremia without an identified source also likely were overrepresented. The retrospective nature of the study only allowed for limited collection of standardized follow-up metrics with the limited patient sample available. Patient characteristics also may have affected the quality of study results because a large number of patients had underlying medical conditions or were premature infants.
Look for ongoing hemodynamic instability before third FUBC
Dr. Cardenas-Comfort and colleagues only recommend a third FUBC in cases where patients demonstrate ongoing hemodynamic instability. Applying this to their study population, in retrospect, the authors noted that unnecessary FUBCs could have been prevented in 26% of patients included in the study. They further recommend a thorough clinical evaluation for any patients with SAB lasting 3 or more days with an unidentified infection source. Further research could be beneficial in evaluating cost savings that come from eliminating unnecessary cultures. Additionally, performing a powered analysis would help to determine the probability of an increase in complications based on implementation of these recommendations.
In a separate interview, Tina Q. Tan, MD, infectious disease specialist at Ann & Robert H. Lurie Children’s Hospital of Chicago noted: “This study provides some importance evidence-based guidance on deciding how many blood cultures are needed to demonstrate clearance of S. aureus bacteremia, even in children who have intermittent positive cultures after having negative FUBCs. The recommendation that additional blood cultures to document sterility are not needed after 2 FUBC results are negative in well-appearing children is one that has the potential to decrease cost and unnecessary discomfort in patients. The recommendation currently is for well-appearing children; children who are ill appearing may require further blood cultures to document sterility. Even though this is a single-center study with a relatively small number of patients (n = 122), the information provided is a very useful guide to all clinicians who deal with this issue. Further studies are needed to determine the impact on cost reduction by the elimination of unnecessary blood cultures and whether the rate of complications would increase as a result of not obtaining further cultures in well-appearing children who have two negative follow up blood cultures.”
Dr. Cardenas-Comfort and colleagues as well as Dr. Tan had no conflicts of interest and no relevant financial disclosures. There was no external funding for the study.
SOURCE: Cardenas-Comfort C et al. Pediatrics. 2020. doi: 10.1542/peds.2020-1821.
reported Caitlin Cardenas-Comfort, MD, of the section of pediatric infectious diseases at Baylor College of Medicine, Houston, and colleagues.
In a retrospective cohort study of 122 pediatric patients with documented Staphylococcus aureus bacteremia (SAB) that were hospitalized at one of three hospitals in the Texas Children’s Hospital network in Houston, Dr. Cardenas-Comfort and colleagues sought to determine whether specific recommendations can be made on the number of follow-up blood cultures (FUBC) needed to document clearance of SAB. Patients included in the study were under 18 years of age and had confirmed diagnosis of SAB between Jan. 1, and Dec. 31, 2018.
Most cases of bacteremia resolve in under 48 hours
In the majority of cases, patients had bacteremia for less than 48 hours and few to no complications. Only 16% of patients experienced bacteremia lasting 3 or more days, and they had either central line-associated bloodstream infection, endocarditis, or osteomyelitis. In such cases, “patients with endovascular and closed-space infections are at an increased risk of persistent bacteremia,” warranting more conservative monitoring and follow-up, cautioned the researchers.
Although Dr. Cardenas-Comfort and colleagues did note an association between the duration of bacteremia and a diagnosis of infectious disease, increased risk for persistent SAB did not appear to be tied to an underlying medical condition, including immunosuppression.
Fewer than 5% of patients with SAB had intermittent positive cultures and fewer than 1% had repeat positive cultures following two negative FUBC results. For those patients with intermittent positive cultures, the risk of being diagnosed with endocarditis or osteomyelitis is more than double. The authors suggested that “source control could be a critical variable” increasing the risk for intermittent positive cultures, noting that surgical debridement occurred more than 24 hours following initial blood draw for every patient in the osteomyelitis group. In contrast, of those who had consistently negative FUBC results, only 2 of 33 (6%) had debridement in the same period, and only 6 of 33 (18%) required more than one debridement.
Children are less likely to have intermittent positive cultures
Dr. Cardenas-Comfort and colleagues also observed that intermittent positive cultures may appear less frequently in children than adults, consistent with a recent study of adults in which intermittent cultures were found in 13% of 1.071 SAB cases. In just 4% of the cases in that study, more than 2 days of negative blood cultures preceded a repeat positive culture.
The researchers noted several study limitations in their own research. Because more than half (61%) of patients had two or less FUBCs collected, and 21% one or less, they acknowledged that their conclusions are based on the presumption that the 61% of patients would not have any further positive cultures if they had been drawn. Relying on provider documentation also suggested that cases of bacteremia without an identified source also likely were overrepresented. The retrospective nature of the study only allowed for limited collection of standardized follow-up metrics with the limited patient sample available. Patient characteristics also may have affected the quality of study results because a large number of patients had underlying medical conditions or were premature infants.
Look for ongoing hemodynamic instability before third FUBC
Dr. Cardenas-Comfort and colleagues only recommend a third FUBC in cases where patients demonstrate ongoing hemodynamic instability. Applying this to their study population, in retrospect, the authors noted that unnecessary FUBCs could have been prevented in 26% of patients included in the study. They further recommend a thorough clinical evaluation for any patients with SAB lasting 3 or more days with an unidentified infection source. Further research could be beneficial in evaluating cost savings that come from eliminating unnecessary cultures. Additionally, performing a powered analysis would help to determine the probability of an increase in complications based on implementation of these recommendations.
In a separate interview, Tina Q. Tan, MD, infectious disease specialist at Ann & Robert H. Lurie Children’s Hospital of Chicago noted: “This study provides some importance evidence-based guidance on deciding how many blood cultures are needed to demonstrate clearance of S. aureus bacteremia, even in children who have intermittent positive cultures after having negative FUBCs. The recommendation that additional blood cultures to document sterility are not needed after 2 FUBC results are negative in well-appearing children is one that has the potential to decrease cost and unnecessary discomfort in patients. The recommendation currently is for well-appearing children; children who are ill appearing may require further blood cultures to document sterility. Even though this is a single-center study with a relatively small number of patients (n = 122), the information provided is a very useful guide to all clinicians who deal with this issue. Further studies are needed to determine the impact on cost reduction by the elimination of unnecessary blood cultures and whether the rate of complications would increase as a result of not obtaining further cultures in well-appearing children who have two negative follow up blood cultures.”
Dr. Cardenas-Comfort and colleagues as well as Dr. Tan had no conflicts of interest and no relevant financial disclosures. There was no external funding for the study.
SOURCE: Cardenas-Comfort C et al. Pediatrics. 2020. doi: 10.1542/peds.2020-1821.
reported Caitlin Cardenas-Comfort, MD, of the section of pediatric infectious diseases at Baylor College of Medicine, Houston, and colleagues.
In a retrospective cohort study of 122 pediatric patients with documented Staphylococcus aureus bacteremia (SAB) that were hospitalized at one of three hospitals in the Texas Children’s Hospital network in Houston, Dr. Cardenas-Comfort and colleagues sought to determine whether specific recommendations can be made on the number of follow-up blood cultures (FUBC) needed to document clearance of SAB. Patients included in the study were under 18 years of age and had confirmed diagnosis of SAB between Jan. 1, and Dec. 31, 2018.
Most cases of bacteremia resolve in under 48 hours
In the majority of cases, patients had bacteremia for less than 48 hours and few to no complications. Only 16% of patients experienced bacteremia lasting 3 or more days, and they had either central line-associated bloodstream infection, endocarditis, or osteomyelitis. In such cases, “patients with endovascular and closed-space infections are at an increased risk of persistent bacteremia,” warranting more conservative monitoring and follow-up, cautioned the researchers.
Although Dr. Cardenas-Comfort and colleagues did note an association between the duration of bacteremia and a diagnosis of infectious disease, increased risk for persistent SAB did not appear to be tied to an underlying medical condition, including immunosuppression.
Fewer than 5% of patients with SAB had intermittent positive cultures and fewer than 1% had repeat positive cultures following two negative FUBC results. For those patients with intermittent positive cultures, the risk of being diagnosed with endocarditis or osteomyelitis is more than double. The authors suggested that “source control could be a critical variable” increasing the risk for intermittent positive cultures, noting that surgical debridement occurred more than 24 hours following initial blood draw for every patient in the osteomyelitis group. In contrast, of those who had consistently negative FUBC results, only 2 of 33 (6%) had debridement in the same period, and only 6 of 33 (18%) required more than one debridement.
Children are less likely to have intermittent positive cultures
Dr. Cardenas-Comfort and colleagues also observed that intermittent positive cultures may appear less frequently in children than adults, consistent with a recent study of adults in which intermittent cultures were found in 13% of 1.071 SAB cases. In just 4% of the cases in that study, more than 2 days of negative blood cultures preceded a repeat positive culture.
The researchers noted several study limitations in their own research. Because more than half (61%) of patients had two or less FUBCs collected, and 21% one or less, they acknowledged that their conclusions are based on the presumption that the 61% of patients would not have any further positive cultures if they had been drawn. Relying on provider documentation also suggested that cases of bacteremia without an identified source also likely were overrepresented. The retrospective nature of the study only allowed for limited collection of standardized follow-up metrics with the limited patient sample available. Patient characteristics also may have affected the quality of study results because a large number of patients had underlying medical conditions or were premature infants.
Look for ongoing hemodynamic instability before third FUBC
Dr. Cardenas-Comfort and colleagues only recommend a third FUBC in cases where patients demonstrate ongoing hemodynamic instability. Applying this to their study population, in retrospect, the authors noted that unnecessary FUBCs could have been prevented in 26% of patients included in the study. They further recommend a thorough clinical evaluation for any patients with SAB lasting 3 or more days with an unidentified infection source. Further research could be beneficial in evaluating cost savings that come from eliminating unnecessary cultures. Additionally, performing a powered analysis would help to determine the probability of an increase in complications based on implementation of these recommendations.
In a separate interview, Tina Q. Tan, MD, infectious disease specialist at Ann & Robert H. Lurie Children’s Hospital of Chicago noted: “This study provides some importance evidence-based guidance on deciding how many blood cultures are needed to demonstrate clearance of S. aureus bacteremia, even in children who have intermittent positive cultures after having negative FUBCs. The recommendation that additional blood cultures to document sterility are not needed after 2 FUBC results are negative in well-appearing children is one that has the potential to decrease cost and unnecessary discomfort in patients. The recommendation currently is for well-appearing children; children who are ill appearing may require further blood cultures to document sterility. Even though this is a single-center study with a relatively small number of patients (n = 122), the information provided is a very useful guide to all clinicians who deal with this issue. Further studies are needed to determine the impact on cost reduction by the elimination of unnecessary blood cultures and whether the rate of complications would increase as a result of not obtaining further cultures in well-appearing children who have two negative follow up blood cultures.”
Dr. Cardenas-Comfort and colleagues as well as Dr. Tan had no conflicts of interest and no relevant financial disclosures. There was no external funding for the study.
SOURCE: Cardenas-Comfort C et al. Pediatrics. 2020. doi: 10.1542/peds.2020-1821.
FROM PEDIATRICS
Cervical cancer recurrence patterns differ after laparoscopic and open hysterectomy
When cervical cancer recurs after radical hysterectomy, the likelihood of recurrence at certain sites and the timing of recurrence may be associated with the surgical approach, according to a retrospective study.
according to a propensity-matched analysis of data from 105 patients with recurrence.
And recurrence in the pelvic cavity and peritoneal carcinomatosis were more common after laparoscopic hysterectomy than after open surgery. Overall survival was similar between the groups, however.
The different patterns of recurrence may relate to dissemination of the disease during colpotomy, but the reasons are unknown, study author Giorgio Bogani, MD, PhD, said at the meeting sponsored by AAGL.
To examine patterns of recurrence after laparoscopic and open abdominal radical hysterectomy for cervical cancer, Dr. Bogani of the department of gynecologic surgery at the National Cancer Institute in Milan and colleagues analyzed data from patients with cervical cancer who developed recurrence after surgery at two oncologic referral centers between 1990 and 2018 (Int J Gynecol Cancer. 2020 Jul. doi: 10.1136/ijgc-2020-001381).
The investigators applied a propensity-matching algorithm to reduce possible confounding factors. They matched 35 patients who had recurrence after laparoscopic hysterectomy to 70 patients who had recurrence after open surgery. The groups had similar baseline characteristics.
As in the Laparoscopic Approach to Cervical Cancer (LACC) trial, patients who had minimally invasive surgery were more likely to have a worse disease-free survival, compared with patients who had open surgery, Dr. Bogani said. Patients who underwent laparoscopic radical hysterectomy had a median progression-free survival of 8 months, whereas patients who underwent open abdominal procedures had a median progression-free survival of 15.8 months.
Although vaginal, lymphatic, and distant recurrences were similar between the groups, a greater percentage of patients in the laparoscopic hysterectomy group had recurrence in the pelvic cavity (74% vs. 34%) and peritoneal carcinomatosis (17% vs. 1.5%).
The LACC trial, which found significantly lower disease-free and overall survival with laparoscopic hysterectomy, sent a “shockwave through the gynecologic oncology community” when it was published in 2018, said Masoud Azodi, MD, in a discussion following Dr. Bogani’s presentation.
Researchers have raised questions about that trial’s design and validity, noted Dr. Azodi, director of minimally invasive and robotic surgery at Yale University in New Haven, Conn.
It could be that local recurrences are attributable to surgical technique, rather than to the minimally invasive approach in itself, Dr. Azodi said. Prior studies of laparoscopic hysterectomy for cervical cancer had indicated better surgical outcomes and equivalent oncologic results, relative to open surgery.
Before the LACC trial, Dr. Bogani used the minimally invasive approach for almost all surgeries. Since then, he has performed open surgeries. If he were to use a minimally invasive approach now, it would be in the context of a clinical trial, Dr. Bogani said.
Dr. Bogani and Dr. Azodi had no relevant financial disclosures.
SOURCE: Bogani G et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.069.
When cervical cancer recurs after radical hysterectomy, the likelihood of recurrence at certain sites and the timing of recurrence may be associated with the surgical approach, according to a retrospective study.
according to a propensity-matched analysis of data from 105 patients with recurrence.
And recurrence in the pelvic cavity and peritoneal carcinomatosis were more common after laparoscopic hysterectomy than after open surgery. Overall survival was similar between the groups, however.
The different patterns of recurrence may relate to dissemination of the disease during colpotomy, but the reasons are unknown, study author Giorgio Bogani, MD, PhD, said at the meeting sponsored by AAGL.
To examine patterns of recurrence after laparoscopic and open abdominal radical hysterectomy for cervical cancer, Dr. Bogani of the department of gynecologic surgery at the National Cancer Institute in Milan and colleagues analyzed data from patients with cervical cancer who developed recurrence after surgery at two oncologic referral centers between 1990 and 2018 (Int J Gynecol Cancer. 2020 Jul. doi: 10.1136/ijgc-2020-001381).
The investigators applied a propensity-matching algorithm to reduce possible confounding factors. They matched 35 patients who had recurrence after laparoscopic hysterectomy to 70 patients who had recurrence after open surgery. The groups had similar baseline characteristics.
As in the Laparoscopic Approach to Cervical Cancer (LACC) trial, patients who had minimally invasive surgery were more likely to have a worse disease-free survival, compared with patients who had open surgery, Dr. Bogani said. Patients who underwent laparoscopic radical hysterectomy had a median progression-free survival of 8 months, whereas patients who underwent open abdominal procedures had a median progression-free survival of 15.8 months.
Although vaginal, lymphatic, and distant recurrences were similar between the groups, a greater percentage of patients in the laparoscopic hysterectomy group had recurrence in the pelvic cavity (74% vs. 34%) and peritoneal carcinomatosis (17% vs. 1.5%).
The LACC trial, which found significantly lower disease-free and overall survival with laparoscopic hysterectomy, sent a “shockwave through the gynecologic oncology community” when it was published in 2018, said Masoud Azodi, MD, in a discussion following Dr. Bogani’s presentation.
Researchers have raised questions about that trial’s design and validity, noted Dr. Azodi, director of minimally invasive and robotic surgery at Yale University in New Haven, Conn.
It could be that local recurrences are attributable to surgical technique, rather than to the minimally invasive approach in itself, Dr. Azodi said. Prior studies of laparoscopic hysterectomy for cervical cancer had indicated better surgical outcomes and equivalent oncologic results, relative to open surgery.
Before the LACC trial, Dr. Bogani used the minimally invasive approach for almost all surgeries. Since then, he has performed open surgeries. If he were to use a minimally invasive approach now, it would be in the context of a clinical trial, Dr. Bogani said.
Dr. Bogani and Dr. Azodi had no relevant financial disclosures.
SOURCE: Bogani G et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.069.
When cervical cancer recurs after radical hysterectomy, the likelihood of recurrence at certain sites and the timing of recurrence may be associated with the surgical approach, according to a retrospective study.
according to a propensity-matched analysis of data from 105 patients with recurrence.
And recurrence in the pelvic cavity and peritoneal carcinomatosis were more common after laparoscopic hysterectomy than after open surgery. Overall survival was similar between the groups, however.
The different patterns of recurrence may relate to dissemination of the disease during colpotomy, but the reasons are unknown, study author Giorgio Bogani, MD, PhD, said at the meeting sponsored by AAGL.
To examine patterns of recurrence after laparoscopic and open abdominal radical hysterectomy for cervical cancer, Dr. Bogani of the department of gynecologic surgery at the National Cancer Institute in Milan and colleagues analyzed data from patients with cervical cancer who developed recurrence after surgery at two oncologic referral centers between 1990 and 2018 (Int J Gynecol Cancer. 2020 Jul. doi: 10.1136/ijgc-2020-001381).
The investigators applied a propensity-matching algorithm to reduce possible confounding factors. They matched 35 patients who had recurrence after laparoscopic hysterectomy to 70 patients who had recurrence after open surgery. The groups had similar baseline characteristics.
As in the Laparoscopic Approach to Cervical Cancer (LACC) trial, patients who had minimally invasive surgery were more likely to have a worse disease-free survival, compared with patients who had open surgery, Dr. Bogani said. Patients who underwent laparoscopic radical hysterectomy had a median progression-free survival of 8 months, whereas patients who underwent open abdominal procedures had a median progression-free survival of 15.8 months.
Although vaginal, lymphatic, and distant recurrences were similar between the groups, a greater percentage of patients in the laparoscopic hysterectomy group had recurrence in the pelvic cavity (74% vs. 34%) and peritoneal carcinomatosis (17% vs. 1.5%).
The LACC trial, which found significantly lower disease-free and overall survival with laparoscopic hysterectomy, sent a “shockwave through the gynecologic oncology community” when it was published in 2018, said Masoud Azodi, MD, in a discussion following Dr. Bogani’s presentation.
Researchers have raised questions about that trial’s design and validity, noted Dr. Azodi, director of minimally invasive and robotic surgery at Yale University in New Haven, Conn.
It could be that local recurrences are attributable to surgical technique, rather than to the minimally invasive approach in itself, Dr. Azodi said. Prior studies of laparoscopic hysterectomy for cervical cancer had indicated better surgical outcomes and equivalent oncologic results, relative to open surgery.
Before the LACC trial, Dr. Bogani used the minimally invasive approach for almost all surgeries. Since then, he has performed open surgeries. If he were to use a minimally invasive approach now, it would be in the context of a clinical trial, Dr. Bogani said.
Dr. Bogani and Dr. Azodi had no relevant financial disclosures.
SOURCE: Bogani G et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.069.
FROM AAGL GLOBAL CONGRESS
Diabetic retinopathy may predict greater risk of COVID-19 severity
Risk of intubation for COVID-19 in very sick hospitalized patients was increased over fivefold in those with diabetic retinopathy, compared with those without, in a small single-center study from the United Kingdom.
Importantly, the risk of intubation was independent of conventional risk factors for poor COVID-19 outcomes.
“People with preexisting diabetes-related vascular damage, such as retinopathy, might be predisposed to a more severe form of COVID-19 requiring ventilation in the intensive therapy unit,” said lead investigator Janaka Karalliedde, MBBS, PhD.
Dr. Karalliedde and colleagues note that this is “the first description of diabetic retinopathy as a potential risk factor for poor COVID-19 outcomes.”
“For this reason, looking for the presence or history of retinopathy or other vascular complications of diabetes may help health care professionals identify patients at high risk of severe COVID-19,” added Dr. Karalliedde, of Guy’s and St Thomas’ NHS Foundation Trust, London.
The study was published online in Diabetes Research and Clinical Practice.
Preexisting diabetic retinopathy and COVID-19 outcomes
The prevalence of diabetic retinopathy is thought to be around 55% in people with type 1 diabetes and 30% in people with type 2 diabetes, on average.
Dr. Karalliedde is part of a research group at King’s College London that has been focused on how vascular disease may predispose to more severe COVID-19.
“COVID-19 affects the blood vessels all over the body,” he said, so they wondered whether having preexisting retinopathy “would predispose to a severe manifestation of COVID-19.”
The observational study included 187 patients with diabetes (179 patients with type 2 diabetes and 8 patients with type 1 diabetes) hospitalized with COVID-19 at Guy’s and St Thomas’ NHS Foundation Trust between March 12 and April 7 (the peak of the first wave of the pandemic in the United Kingdom).
“It was an ethnically diverse population who were very sick and provides a clinical observation of real life,” Dr. Karalliedde said.
Nearly half of patients were African Caribbean (44%), 39% were White, and 17% were of other ethnicities, including 8% who were Asian. The mean age of the cohort was 68 years (range, 22-97 years), and 60% were men.
Diabetic retinopathy was reported in 67 (36%) patients, of whom 80% had background retinopathy and 20% had more advanced retinopathy.
They then looked at whether the presence of retinopathy was associated with a more severe manifestation of COVID-19 as defined by the need for tracheal intubation.
Of the 187 patients, 26% were intubated and 45% of these patients had diabetic retinopathy.
The analysis showed those with diabetic retinopathy had an over-fivefold increased risk for intubation (odds ratio, 5.81; 95% confidence interval, 1.37-24.66).
Of the entire cohort, 32% of patients died, although no association was observed between retinopathy and mortality.
“A greater number of diabetes patients with COVID-19 ended up on the intensive therapy unit. Upon multivariate analysis, we found retinopathy was independently associated with ending up on the intensive therapy unit,” stressed Dr. Karalliedde.
However, they noted that, “due to the cross-sectional design of our study, we cannot prove causality [between retinopathy and intubation]. Further studies are required to understand the mechanisms that explain the associations between retinopathy and other indices of microangiopathy with severe COVID-19.”
A version of this article originally appeared on Medscape.com.
Risk of intubation for COVID-19 in very sick hospitalized patients was increased over fivefold in those with diabetic retinopathy, compared with those without, in a small single-center study from the United Kingdom.
Importantly, the risk of intubation was independent of conventional risk factors for poor COVID-19 outcomes.
“People with preexisting diabetes-related vascular damage, such as retinopathy, might be predisposed to a more severe form of COVID-19 requiring ventilation in the intensive therapy unit,” said lead investigator Janaka Karalliedde, MBBS, PhD.
Dr. Karalliedde and colleagues note that this is “the first description of diabetic retinopathy as a potential risk factor for poor COVID-19 outcomes.”
“For this reason, looking for the presence or history of retinopathy or other vascular complications of diabetes may help health care professionals identify patients at high risk of severe COVID-19,” added Dr. Karalliedde, of Guy’s and St Thomas’ NHS Foundation Trust, London.
The study was published online in Diabetes Research and Clinical Practice.
Preexisting diabetic retinopathy and COVID-19 outcomes
The prevalence of diabetic retinopathy is thought to be around 55% in people with type 1 diabetes and 30% in people with type 2 diabetes, on average.
Dr. Karalliedde is part of a research group at King’s College London that has been focused on how vascular disease may predispose to more severe COVID-19.
“COVID-19 affects the blood vessels all over the body,” he said, so they wondered whether having preexisting retinopathy “would predispose to a severe manifestation of COVID-19.”
The observational study included 187 patients with diabetes (179 patients with type 2 diabetes and 8 patients with type 1 diabetes) hospitalized with COVID-19 at Guy’s and St Thomas’ NHS Foundation Trust between March 12 and April 7 (the peak of the first wave of the pandemic in the United Kingdom).
“It was an ethnically diverse population who were very sick and provides a clinical observation of real life,” Dr. Karalliedde said.
Nearly half of patients were African Caribbean (44%), 39% were White, and 17% were of other ethnicities, including 8% who were Asian. The mean age of the cohort was 68 years (range, 22-97 years), and 60% were men.
Diabetic retinopathy was reported in 67 (36%) patients, of whom 80% had background retinopathy and 20% had more advanced retinopathy.
They then looked at whether the presence of retinopathy was associated with a more severe manifestation of COVID-19 as defined by the need for tracheal intubation.
Of the 187 patients, 26% were intubated and 45% of these patients had diabetic retinopathy.
The analysis showed those with diabetic retinopathy had an over-fivefold increased risk for intubation (odds ratio, 5.81; 95% confidence interval, 1.37-24.66).
Of the entire cohort, 32% of patients died, although no association was observed between retinopathy and mortality.
“A greater number of diabetes patients with COVID-19 ended up on the intensive therapy unit. Upon multivariate analysis, we found retinopathy was independently associated with ending up on the intensive therapy unit,” stressed Dr. Karalliedde.
However, they noted that, “due to the cross-sectional design of our study, we cannot prove causality [between retinopathy and intubation]. Further studies are required to understand the mechanisms that explain the associations between retinopathy and other indices of microangiopathy with severe COVID-19.”
A version of this article originally appeared on Medscape.com.
Risk of intubation for COVID-19 in very sick hospitalized patients was increased over fivefold in those with diabetic retinopathy, compared with those without, in a small single-center study from the United Kingdom.
Importantly, the risk of intubation was independent of conventional risk factors for poor COVID-19 outcomes.
“People with preexisting diabetes-related vascular damage, such as retinopathy, might be predisposed to a more severe form of COVID-19 requiring ventilation in the intensive therapy unit,” said lead investigator Janaka Karalliedde, MBBS, PhD.
Dr. Karalliedde and colleagues note that this is “the first description of diabetic retinopathy as a potential risk factor for poor COVID-19 outcomes.”
“For this reason, looking for the presence or history of retinopathy or other vascular complications of diabetes may help health care professionals identify patients at high risk of severe COVID-19,” added Dr. Karalliedde, of Guy’s and St Thomas’ NHS Foundation Trust, London.
The study was published online in Diabetes Research and Clinical Practice.
Preexisting diabetic retinopathy and COVID-19 outcomes
The prevalence of diabetic retinopathy is thought to be around 55% in people with type 1 diabetes and 30% in people with type 2 diabetes, on average.
Dr. Karalliedde is part of a research group at King’s College London that has been focused on how vascular disease may predispose to more severe COVID-19.
“COVID-19 affects the blood vessels all over the body,” he said, so they wondered whether having preexisting retinopathy “would predispose to a severe manifestation of COVID-19.”
The observational study included 187 patients with diabetes (179 patients with type 2 diabetes and 8 patients with type 1 diabetes) hospitalized with COVID-19 at Guy’s and St Thomas’ NHS Foundation Trust between March 12 and April 7 (the peak of the first wave of the pandemic in the United Kingdom).
“It was an ethnically diverse population who were very sick and provides a clinical observation of real life,” Dr. Karalliedde said.
Nearly half of patients were African Caribbean (44%), 39% were White, and 17% were of other ethnicities, including 8% who were Asian. The mean age of the cohort was 68 years (range, 22-97 years), and 60% were men.
Diabetic retinopathy was reported in 67 (36%) patients, of whom 80% had background retinopathy and 20% had more advanced retinopathy.
They then looked at whether the presence of retinopathy was associated with a more severe manifestation of COVID-19 as defined by the need for tracheal intubation.
Of the 187 patients, 26% were intubated and 45% of these patients had diabetic retinopathy.
The analysis showed those with diabetic retinopathy had an over-fivefold increased risk for intubation (odds ratio, 5.81; 95% confidence interval, 1.37-24.66).
Of the entire cohort, 32% of patients died, although no association was observed between retinopathy and mortality.
“A greater number of diabetes patients with COVID-19 ended up on the intensive therapy unit. Upon multivariate analysis, we found retinopathy was independently associated with ending up on the intensive therapy unit,” stressed Dr. Karalliedde.
However, they noted that, “due to the cross-sectional design of our study, we cannot prove causality [between retinopathy and intubation]. Further studies are required to understand the mechanisms that explain the associations between retinopathy and other indices of microangiopathy with severe COVID-19.”
A version of this article originally appeared on Medscape.com.