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azzed
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bullturds
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cocaine
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cocainees
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crackwhore
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cum
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cumsluted
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cunthunterer
cunthunteres
cunthuntering
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cunthunters
cunting
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cuntlicked
cuntlicker
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dagos
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damn
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damneder
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dickbag
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dickbags
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dickdippered
dickdipperer
dickdipperes
dickdippering
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dicker
dickes
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dickfaceed
dickfaceer
dickfacees
dickfaceing
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dickflippered
dickflipperer
dickflipperes
dickflippering
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dickheaded
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dickheadser
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dingleed
dingleer
dinglees
dingleing
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dipship
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dipshipes
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dizzyed
dizzyer
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dizzying
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dizzys
doggiestyleed
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dopeyer
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drunker
drunkes
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dumass
dumassed
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dumasses
dumassing
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dumasss
dumbass
dumbassed
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dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
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dyke
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dykeer
dykees
dykeing
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erotic
eroticed
eroticer
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erotics
extacy
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extacying
extacyly
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extasy
extasyed
extasyer
extasyes
extasying
extasyly
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facked
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faged
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fagged
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faggoted
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fagoted
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faiged
faiger
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faigts
fannybandit
fannybandited
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fannybandits
farted
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fartknockered
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fartly
farts
felch
felched
felcher
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fellateer
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fellateing
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fellatio
fellatioed
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feltched
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floozy
floozyed
floozyer
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foad
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freexes
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friggaer
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fuckined
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fuckinged
fuckinger
fuckinges
fuckinging
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fuckings
fuckining
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COVID-19 death rate was twice as high in cancer patients in NYC study
COVID-19 patients with cancer had double the fatality rate of COVID-19 patients without cancer treated in an urban New York hospital system, according to data from a retrospective study.
Vikas Mehta, MD, of Montefiore Medical Center, New York, and colleagues reported these results in Cancer Discovery.
“As New York has emerged as the current epicenter of the pandemic, we sought to investigate the risk posed by COVID-19 to our cancer population,” the authors wrote.
They identified 218 cancer patients treated for COVID-19 in the Montefiore Health System between March 18 and April 8, 2020. Three-quarters of patients had solid tumors, and 25% had hematologic malignancies. Most patients were adults (98.6%), their median age was 69 years (range, 10-92 years), and 58% were men.
In all, 28% of the cancer patients (61/218) died from COVID-19, including 25% (41/164) of those with solid tumors and 37% (20/54) of those with hematologic malignancies.
Deaths by cancer type
Among the 164 patients with solid tumors, case fatality rates were as follows:
- Pancreatic – 67% (2/3)
- Lung – 55% (6/11)
- Colorectal – 38% (8/21)
- Upper gastrointestinal – 38% (3/8)
- Gynecologic – 38% (5/13)
- Skin – 33% (1/3)
- Hepatobiliary – 29% (2/7)
- Bone/soft tissue – 20% (1/5)
- Genitourinary – 15% (7/46)
- Breast – 14% (4/28)
- Neurologic – 13% (1/8)
- Head and neck – 13% (1/8).
None of the three patients with neuroendocrine tumors died.
Among the 54 patients with hematologic malignancies, case fatality rates were as follows:
- Chronic myeloid leukemia – 100% (1/1)
- Hodgkin lymphoma – 60% (3/5)
- Myelodysplastic syndromes – 60% (3/5)
- Multiple myeloma – 38% (5/13)
- Non-Hodgkin lymphoma – 33% (5/15)
- Chronic lymphocytic leukemia – 33% (1/3)
- Myeloproliferative neoplasms – 29% (2/7).
None of the four patients with acute lymphoblastic leukemia died, and there was one patient with acute myeloid leukemia who did not die.
Factors associated with increased mortality
The researchers compared the 218 cancer patients with COVID-19 with 1,090 age- and sex-matched noncancer patients with COVID-19 treated in the Montefiore Health System between March 18 and April 8, 2020.
Case fatality rates in cancer patients with COVID-19 were significantly increased in all age groups, but older age was associated with higher mortality.
“We observed case fatality rates were elevated in all age cohorts in cancer patients and achieved statistical significance in the age groups 45-64 and in patients older than 75 years of age,” the authors reported.
Other factors significantly associated with higher mortality in a multivariable analysis included the presence of multiple comorbidities; the need for ICU support; and increased levels of d-dimer, lactate, and lactate dehydrogenase.
Additional factors, such as socioeconomic and health disparities, may also be significant predictors of mortality, according to the authors. They noted that this cohort largely consisted of patients from a socioeconomically underprivileged community where mortality because of COVID-19 is reportedly higher.
Proactive strategies moving forward
“We have been addressing the significant burden of the COVID-19 pandemic on our vulnerable cancer patients through a variety of ways,” said study author Balazs Halmos, MD, of Montefiore Medical Center.
The center set up a separate infusion unit exclusively for COVID-positive patients and established separate inpatient areas. Dr. Halmos and colleagues are also providing telemedicine, virtual supportive care services, telephonic counseling, and bilingual peer-support programs.
“Many questions remain as we continue to establish new practices for our cancer patients,” Dr. Halmos said. “We will find answers to these questions as we continue to focus on adaptation and not acceptance in response to the COVID crisis. Our patients deserve nothing less.”
The Albert Einstein Cancer Center supported this study. The authors reported having no conflicts of interest.
SOURCE: Mehta V et al. Cancer Discov. 2020 May 1. doi: 10.1158/2159-8290.CD-20-0516.
COVID-19 patients with cancer had double the fatality rate of COVID-19 patients without cancer treated in an urban New York hospital system, according to data from a retrospective study.
Vikas Mehta, MD, of Montefiore Medical Center, New York, and colleagues reported these results in Cancer Discovery.
“As New York has emerged as the current epicenter of the pandemic, we sought to investigate the risk posed by COVID-19 to our cancer population,” the authors wrote.
They identified 218 cancer patients treated for COVID-19 in the Montefiore Health System between March 18 and April 8, 2020. Three-quarters of patients had solid tumors, and 25% had hematologic malignancies. Most patients were adults (98.6%), their median age was 69 years (range, 10-92 years), and 58% were men.
In all, 28% of the cancer patients (61/218) died from COVID-19, including 25% (41/164) of those with solid tumors and 37% (20/54) of those with hematologic malignancies.
Deaths by cancer type
Among the 164 patients with solid tumors, case fatality rates were as follows:
- Pancreatic – 67% (2/3)
- Lung – 55% (6/11)
- Colorectal – 38% (8/21)
- Upper gastrointestinal – 38% (3/8)
- Gynecologic – 38% (5/13)
- Skin – 33% (1/3)
- Hepatobiliary – 29% (2/7)
- Bone/soft tissue – 20% (1/5)
- Genitourinary – 15% (7/46)
- Breast – 14% (4/28)
- Neurologic – 13% (1/8)
- Head and neck – 13% (1/8).
None of the three patients with neuroendocrine tumors died.
Among the 54 patients with hematologic malignancies, case fatality rates were as follows:
- Chronic myeloid leukemia – 100% (1/1)
- Hodgkin lymphoma – 60% (3/5)
- Myelodysplastic syndromes – 60% (3/5)
- Multiple myeloma – 38% (5/13)
- Non-Hodgkin lymphoma – 33% (5/15)
- Chronic lymphocytic leukemia – 33% (1/3)
- Myeloproliferative neoplasms – 29% (2/7).
None of the four patients with acute lymphoblastic leukemia died, and there was one patient with acute myeloid leukemia who did not die.
Factors associated with increased mortality
The researchers compared the 218 cancer patients with COVID-19 with 1,090 age- and sex-matched noncancer patients with COVID-19 treated in the Montefiore Health System between March 18 and April 8, 2020.
Case fatality rates in cancer patients with COVID-19 were significantly increased in all age groups, but older age was associated with higher mortality.
“We observed case fatality rates were elevated in all age cohorts in cancer patients and achieved statistical significance in the age groups 45-64 and in patients older than 75 years of age,” the authors reported.
Other factors significantly associated with higher mortality in a multivariable analysis included the presence of multiple comorbidities; the need for ICU support; and increased levels of d-dimer, lactate, and lactate dehydrogenase.
Additional factors, such as socioeconomic and health disparities, may also be significant predictors of mortality, according to the authors. They noted that this cohort largely consisted of patients from a socioeconomically underprivileged community where mortality because of COVID-19 is reportedly higher.
Proactive strategies moving forward
“We have been addressing the significant burden of the COVID-19 pandemic on our vulnerable cancer patients through a variety of ways,” said study author Balazs Halmos, MD, of Montefiore Medical Center.
The center set up a separate infusion unit exclusively for COVID-positive patients and established separate inpatient areas. Dr. Halmos and colleagues are also providing telemedicine, virtual supportive care services, telephonic counseling, and bilingual peer-support programs.
“Many questions remain as we continue to establish new practices for our cancer patients,” Dr. Halmos said. “We will find answers to these questions as we continue to focus on adaptation and not acceptance in response to the COVID crisis. Our patients deserve nothing less.”
The Albert Einstein Cancer Center supported this study. The authors reported having no conflicts of interest.
SOURCE: Mehta V et al. Cancer Discov. 2020 May 1. doi: 10.1158/2159-8290.CD-20-0516.
COVID-19 patients with cancer had double the fatality rate of COVID-19 patients without cancer treated in an urban New York hospital system, according to data from a retrospective study.
Vikas Mehta, MD, of Montefiore Medical Center, New York, and colleagues reported these results in Cancer Discovery.
“As New York has emerged as the current epicenter of the pandemic, we sought to investigate the risk posed by COVID-19 to our cancer population,” the authors wrote.
They identified 218 cancer patients treated for COVID-19 in the Montefiore Health System between March 18 and April 8, 2020. Three-quarters of patients had solid tumors, and 25% had hematologic malignancies. Most patients were adults (98.6%), their median age was 69 years (range, 10-92 years), and 58% were men.
In all, 28% of the cancer patients (61/218) died from COVID-19, including 25% (41/164) of those with solid tumors and 37% (20/54) of those with hematologic malignancies.
Deaths by cancer type
Among the 164 patients with solid tumors, case fatality rates were as follows:
- Pancreatic – 67% (2/3)
- Lung – 55% (6/11)
- Colorectal – 38% (8/21)
- Upper gastrointestinal – 38% (3/8)
- Gynecologic – 38% (5/13)
- Skin – 33% (1/3)
- Hepatobiliary – 29% (2/7)
- Bone/soft tissue – 20% (1/5)
- Genitourinary – 15% (7/46)
- Breast – 14% (4/28)
- Neurologic – 13% (1/8)
- Head and neck – 13% (1/8).
None of the three patients with neuroendocrine tumors died.
Among the 54 patients with hematologic malignancies, case fatality rates were as follows:
- Chronic myeloid leukemia – 100% (1/1)
- Hodgkin lymphoma – 60% (3/5)
- Myelodysplastic syndromes – 60% (3/5)
- Multiple myeloma – 38% (5/13)
- Non-Hodgkin lymphoma – 33% (5/15)
- Chronic lymphocytic leukemia – 33% (1/3)
- Myeloproliferative neoplasms – 29% (2/7).
None of the four patients with acute lymphoblastic leukemia died, and there was one patient with acute myeloid leukemia who did not die.
Factors associated with increased mortality
The researchers compared the 218 cancer patients with COVID-19 with 1,090 age- and sex-matched noncancer patients with COVID-19 treated in the Montefiore Health System between March 18 and April 8, 2020.
Case fatality rates in cancer patients with COVID-19 were significantly increased in all age groups, but older age was associated with higher mortality.
“We observed case fatality rates were elevated in all age cohorts in cancer patients and achieved statistical significance in the age groups 45-64 and in patients older than 75 years of age,” the authors reported.
Other factors significantly associated with higher mortality in a multivariable analysis included the presence of multiple comorbidities; the need for ICU support; and increased levels of d-dimer, lactate, and lactate dehydrogenase.
Additional factors, such as socioeconomic and health disparities, may also be significant predictors of mortality, according to the authors. They noted that this cohort largely consisted of patients from a socioeconomically underprivileged community where mortality because of COVID-19 is reportedly higher.
Proactive strategies moving forward
“We have been addressing the significant burden of the COVID-19 pandemic on our vulnerable cancer patients through a variety of ways,” said study author Balazs Halmos, MD, of Montefiore Medical Center.
The center set up a separate infusion unit exclusively for COVID-positive patients and established separate inpatient areas. Dr. Halmos and colleagues are also providing telemedicine, virtual supportive care services, telephonic counseling, and bilingual peer-support programs.
“Many questions remain as we continue to establish new practices for our cancer patients,” Dr. Halmos said. “We will find answers to these questions as we continue to focus on adaptation and not acceptance in response to the COVID crisis. Our patients deserve nothing less.”
The Albert Einstein Cancer Center supported this study. The authors reported having no conflicts of interest.
SOURCE: Mehta V et al. Cancer Discov. 2020 May 1. doi: 10.1158/2159-8290.CD-20-0516.
FROM CANCER DISCOVERY
NSDUH data might underestimate substance use by pregnant women
New study suggests rate of alcohol use might be almost 19%
The use of alcohol, tobacco products, and drugs by pregnant women is a substantial problem that may be more prevalent than previously thought, according to researcher Kimberly Yonkers, MD.
Higher levels of substance use during pregnancy means more negative impacts on maternal and fetal, neonatal, and child health. However, one bit of good news is that pregnant women still are less likely than nonpregnant women to engage in such behavior, said Dr. Yonkers, director of psychological medicine and the Center for Wellbeing of Women and Mothers at Yale University, New Haven, Conn.
Dr. Yonkers said in a featured presentation at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
Tobacco predominates among substances of concern used by pregnant women, with 11.6% reporting past-month use in 2018, according to the National Survey on Drug Use and Health, Dr. Yonkers said. Alcohol was next, with 9.9% of pregnant women reporting use in the past month, followed by drugs at 5.4%, of which marijuana was the most common.
Those numbers may jump much higher when focusing on substance use that’s biologically verified, she added, referring to a recent three-center cross-sectional study she and her colleagues published in Addiction (2019 Jun 19. doi: 10.1111/add.14651). In that study, alcohol use was as high as 18.9% among pregnant women who either had positive urine or self-reported use. Similarly, rates of nicotine or nicotine byproduct detected were 27% at one center in the study, and tetrahydrocannabinol reached 29.4% at that same center.
“These numbers are impressive,” Dr. Yonkers told attendees at the meeting. “So what we may be seeing in terms of the National Survey on Drug Use and Health, as valuable as it is, is in all likelihood it underestimates the use of substances in pregnancy.”
Substance use goes down in pregnancy as some women become more mindful of perinatal health, though unfortunately, that abstinence is offset by a dramatic rise in substance use in the 6-12 months’ post partum, research suggests.
Interestingly, big differences are found in both abstinence and relapse rates, with some data sets showing that, while alcohol is stopped fairly early, cigarettes are stopped much later, if at all.
On the postpartum side of the equation, relapse rates look similar for cigarettes, alcohol, and marijuana, but for some reason, cocaine relapse rates are much lower “That’s kind of nice, and we’d like to be able to understand what it is about this whole process that enabled that relative period of wellness,” Dr. Yonkers said.
Opioid use disorder is rising among pregnant women, just like it is in the general population, and 50% – or possibly even as high as 80% – of babies born to these women will experience neonatal opioid withdrawal, Dr. Yonkers said.
Maternal mortality in the United States increased by 34% from 2008 to 2016; while that’s a sobering statistic, Dr. Yonkers said, opioid-related maternal mortality doubled over that same time period.
“We really have to be mindful that we’re not just talking about taking care of kids and offspring, but we have to take care of moms – it’s really critical,” she said.
With the increasing legalization of cannabis, it’s expected that a lot more cannabis-exposed pregnancies will be seen in clinical practice, and some studies are starting to show an increase in prevalence in the preconception, prenatal, and postpartum period.
While some people feel that cannabis is benign, more data are needed, according to Dr. Yonkers, who said that cannabis and its metabolites cross the blood/placenta and blood/milk barriers, and that cannabinoid receptors are “very important” to fertility, implantation, and fetal development. One study recently published linked cannabis use in pregnancy to significant increases in preterm birth rates (JAMA. 2019 Jun 18;322[2]:145-52).
“We don’t really have a context for this, so we don’t really know what’s going to have an impact, and what’s not,” Dr. Yonkers said.
While both standard and novel treatments could help in the quest to achieve and maintain well-being in this unique patient population, Dr. Yonkers said that health equity and universal approaches to care might be needed to more comprehensively address the problem, which means taking a close look at how much money women have, the resources available to them, and where they live.
In many communities, eliminating inequalities in care will be critical to successfully addressing substance use issues in pregnant women, agreed Maureen Sayres Van Niel, MD, a specialist in women’s psychiatry in Boston and president of the Women’s Caucus of the APA.
“What we see is such a disparity in the delivery of care to women who are poor and living in communities where the socioeconomic and financial problems are very severe,” Dr. Van Niel said in an interview. “Unless we address these disparities, women will not be getting the kind of health care that they really need to have in the perinatal period.”
Dr. Yonkers reported a disclosure related to UpToDate.
New study suggests rate of alcohol use might be almost 19%
New study suggests rate of alcohol use might be almost 19%
The use of alcohol, tobacco products, and drugs by pregnant women is a substantial problem that may be more prevalent than previously thought, according to researcher Kimberly Yonkers, MD.
Higher levels of substance use during pregnancy means more negative impacts on maternal and fetal, neonatal, and child health. However, one bit of good news is that pregnant women still are less likely than nonpregnant women to engage in such behavior, said Dr. Yonkers, director of psychological medicine and the Center for Wellbeing of Women and Mothers at Yale University, New Haven, Conn.
Dr. Yonkers said in a featured presentation at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
Tobacco predominates among substances of concern used by pregnant women, with 11.6% reporting past-month use in 2018, according to the National Survey on Drug Use and Health, Dr. Yonkers said. Alcohol was next, with 9.9% of pregnant women reporting use in the past month, followed by drugs at 5.4%, of which marijuana was the most common.
Those numbers may jump much higher when focusing on substance use that’s biologically verified, she added, referring to a recent three-center cross-sectional study she and her colleagues published in Addiction (2019 Jun 19. doi: 10.1111/add.14651). In that study, alcohol use was as high as 18.9% among pregnant women who either had positive urine or self-reported use. Similarly, rates of nicotine or nicotine byproduct detected were 27% at one center in the study, and tetrahydrocannabinol reached 29.4% at that same center.
“These numbers are impressive,” Dr. Yonkers told attendees at the meeting. “So what we may be seeing in terms of the National Survey on Drug Use and Health, as valuable as it is, is in all likelihood it underestimates the use of substances in pregnancy.”
Substance use goes down in pregnancy as some women become more mindful of perinatal health, though unfortunately, that abstinence is offset by a dramatic rise in substance use in the 6-12 months’ post partum, research suggests.
Interestingly, big differences are found in both abstinence and relapse rates, with some data sets showing that, while alcohol is stopped fairly early, cigarettes are stopped much later, if at all.
On the postpartum side of the equation, relapse rates look similar for cigarettes, alcohol, and marijuana, but for some reason, cocaine relapse rates are much lower “That’s kind of nice, and we’d like to be able to understand what it is about this whole process that enabled that relative period of wellness,” Dr. Yonkers said.
Opioid use disorder is rising among pregnant women, just like it is in the general population, and 50% – or possibly even as high as 80% – of babies born to these women will experience neonatal opioid withdrawal, Dr. Yonkers said.
Maternal mortality in the United States increased by 34% from 2008 to 2016; while that’s a sobering statistic, Dr. Yonkers said, opioid-related maternal mortality doubled over that same time period.
“We really have to be mindful that we’re not just talking about taking care of kids and offspring, but we have to take care of moms – it’s really critical,” she said.
With the increasing legalization of cannabis, it’s expected that a lot more cannabis-exposed pregnancies will be seen in clinical practice, and some studies are starting to show an increase in prevalence in the preconception, prenatal, and postpartum period.
While some people feel that cannabis is benign, more data are needed, according to Dr. Yonkers, who said that cannabis and its metabolites cross the blood/placenta and blood/milk barriers, and that cannabinoid receptors are “very important” to fertility, implantation, and fetal development. One study recently published linked cannabis use in pregnancy to significant increases in preterm birth rates (JAMA. 2019 Jun 18;322[2]:145-52).
“We don’t really have a context for this, so we don’t really know what’s going to have an impact, and what’s not,” Dr. Yonkers said.
While both standard and novel treatments could help in the quest to achieve and maintain well-being in this unique patient population, Dr. Yonkers said that health equity and universal approaches to care might be needed to more comprehensively address the problem, which means taking a close look at how much money women have, the resources available to them, and where they live.
In many communities, eliminating inequalities in care will be critical to successfully addressing substance use issues in pregnant women, agreed Maureen Sayres Van Niel, MD, a specialist in women’s psychiatry in Boston and president of the Women’s Caucus of the APA.
“What we see is such a disparity in the delivery of care to women who are poor and living in communities where the socioeconomic and financial problems are very severe,” Dr. Van Niel said in an interview. “Unless we address these disparities, women will not be getting the kind of health care that they really need to have in the perinatal period.”
Dr. Yonkers reported a disclosure related to UpToDate.
The use of alcohol, tobacco products, and drugs by pregnant women is a substantial problem that may be more prevalent than previously thought, according to researcher Kimberly Yonkers, MD.
Higher levels of substance use during pregnancy means more negative impacts on maternal and fetal, neonatal, and child health. However, one bit of good news is that pregnant women still are less likely than nonpregnant women to engage in such behavior, said Dr. Yonkers, director of psychological medicine and the Center for Wellbeing of Women and Mothers at Yale University, New Haven, Conn.
Dr. Yonkers said in a featured presentation at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
Tobacco predominates among substances of concern used by pregnant women, with 11.6% reporting past-month use in 2018, according to the National Survey on Drug Use and Health, Dr. Yonkers said. Alcohol was next, with 9.9% of pregnant women reporting use in the past month, followed by drugs at 5.4%, of which marijuana was the most common.
Those numbers may jump much higher when focusing on substance use that’s biologically verified, she added, referring to a recent three-center cross-sectional study she and her colleagues published in Addiction (2019 Jun 19. doi: 10.1111/add.14651). In that study, alcohol use was as high as 18.9% among pregnant women who either had positive urine or self-reported use. Similarly, rates of nicotine or nicotine byproduct detected were 27% at one center in the study, and tetrahydrocannabinol reached 29.4% at that same center.
“These numbers are impressive,” Dr. Yonkers told attendees at the meeting. “So what we may be seeing in terms of the National Survey on Drug Use and Health, as valuable as it is, is in all likelihood it underestimates the use of substances in pregnancy.”
Substance use goes down in pregnancy as some women become more mindful of perinatal health, though unfortunately, that abstinence is offset by a dramatic rise in substance use in the 6-12 months’ post partum, research suggests.
Interestingly, big differences are found in both abstinence and relapse rates, with some data sets showing that, while alcohol is stopped fairly early, cigarettes are stopped much later, if at all.
On the postpartum side of the equation, relapse rates look similar for cigarettes, alcohol, and marijuana, but for some reason, cocaine relapse rates are much lower “That’s kind of nice, and we’d like to be able to understand what it is about this whole process that enabled that relative period of wellness,” Dr. Yonkers said.
Opioid use disorder is rising among pregnant women, just like it is in the general population, and 50% – or possibly even as high as 80% – of babies born to these women will experience neonatal opioid withdrawal, Dr. Yonkers said.
Maternal mortality in the United States increased by 34% from 2008 to 2016; while that’s a sobering statistic, Dr. Yonkers said, opioid-related maternal mortality doubled over that same time period.
“We really have to be mindful that we’re not just talking about taking care of kids and offspring, but we have to take care of moms – it’s really critical,” she said.
With the increasing legalization of cannabis, it’s expected that a lot more cannabis-exposed pregnancies will be seen in clinical practice, and some studies are starting to show an increase in prevalence in the preconception, prenatal, and postpartum period.
While some people feel that cannabis is benign, more data are needed, according to Dr. Yonkers, who said that cannabis and its metabolites cross the blood/placenta and blood/milk barriers, and that cannabinoid receptors are “very important” to fertility, implantation, and fetal development. One study recently published linked cannabis use in pregnancy to significant increases in preterm birth rates (JAMA. 2019 Jun 18;322[2]:145-52).
“We don’t really have a context for this, so we don’t really know what’s going to have an impact, and what’s not,” Dr. Yonkers said.
While both standard and novel treatments could help in the quest to achieve and maintain well-being in this unique patient population, Dr. Yonkers said that health equity and universal approaches to care might be needed to more comprehensively address the problem, which means taking a close look at how much money women have, the resources available to them, and where they live.
In many communities, eliminating inequalities in care will be critical to successfully addressing substance use issues in pregnant women, agreed Maureen Sayres Van Niel, MD, a specialist in women’s psychiatry in Boston and president of the Women’s Caucus of the APA.
“What we see is such a disparity in the delivery of care to women who are poor and living in communities where the socioeconomic and financial problems are very severe,” Dr. Van Niel said in an interview. “Unless we address these disparities, women will not be getting the kind of health care that they really need to have in the perinatal period.”
Dr. Yonkers reported a disclosure related to UpToDate.
EXPERT ANALYSIS FROM APA 2020
Fountains of Wayne, and a hospitalist’s first day, remembered
Like many in the health care field, I have found it hard to watch the news over these past couple of months when it seems that almost every story is about COVID-19 or its repercussions. Luckily, I have two young daughters who “encourage” me to listen to the Frozen 2 soundtrack instead of putting on the evening news when I get home from work. Still, news manages to seep through my defenses. As I scrolled through some headlines recently, I learned of the death of musician Adam Schlesinger from COVID-19. He wasn’t a household name, but his death still hit me in unexpected ways.
I started internship in late June 2005, in a city (Portland, Ore.) about as different from my previous home (Dallas) as any two places can possibly be. I think the day before internship started still ranks as the most nervous of my life. I’m not sure how I slept at all that night, but somehow I did and arrived at the Portland Veterans Affairs Hospital the following morning to start my new career.
And then … nothing happened. Early on that first day, the electronic medical records crashed, and no patients were admitted during our time on “short call.” My upper level resident took care of the one or two established patients on the team (both discharged), so I ended the day with records that would not be broken during the remainder of my residency: 0 notes written, 0 patients seen. Perhaps the most successful first day that any intern, anywhere has ever had, although it prepared me quite poorly for all the subsequent days.
Since I had some time on my hands, I made the 20-minute walk to one of my new hometown’s record stores where Fountains of Wayne (FOW) was playing an acoustic in-store set. Their album from a few years prior, “Welcome Interstate Managers,” was in heavy rotation when I made the drive from Dallas to Portland. It was (and is) a great album for long drives – melodic, catchy, and (mostly) up-tempo. Adam and the band’s singer, Chris Collingwood, played several songs that night on the store’s stage. Then they headed out to the next city, and I headed back home and on to many far-busier days of residency.
We would cross paths again a decade later. I moved back to Texas and became a hospitalist. It turns out that, if you have enough hospitalists of a certain age and if enough of those hospitalists have unearned confidence in their musical ability, then a covers band will undoubtedly be formed. And so, it happened here in San Antonio. We were not selective in our song choices – we played songs from every decade of the last 50 years, bands as popular as the Beatles and as indie as the Rentals. And we played some FOW.
Our band (which will go nameless here so that our YouTube recordings are more difficult to find) played a grand total of one gig during our years of intermittent practicing. That one gig was my wedding rehearsal dinner and the penultimate song we played was “Stacy’s Mom,” which is notable for being both FOW’s biggest hit and a completely inappropriate song to play at a wedding rehearsal dinner. The crowd was probably around the same size as the one that had seen Adam and Chris play in Portland 10 years prior. I don’t think the applause we received was quite as genuine or deserved, though.
After Adam and Chris played their gig, there was an autograph session and I took home a signed poster. Last year, I decided to take it out of storage and hang it in my office. The date of the show and the first day of my physician career, a date now nearly 15 years ago, is written in psychedelic typography at the bottom. The store that I went to that day is no longer there, a victim of progress like so many other record stores across the country. Another location of the same store is still open in Portland. I hope that it and all the other small book and music stores across the country can survive this current crisis, but I know that many will not.
So, here’s to you Adam, and to all the others who have lost their lives to this terrible illness. As a small token of remembrance, I’ll be playing some Fountains of Wayne on the drive home tonight. It’s not quite the same as playing it on a cross-country drive, but hopefully, we will all be able to do that again soon.
Dr. Sehgal is a clinical associate professor of medicine in the division of general and hospital medicine at the South Texas Veterans Health Care System and UT-Health San Antonio. He is a member of the editorial advisory board for The Hospitalist.
Like many in the health care field, I have found it hard to watch the news over these past couple of months when it seems that almost every story is about COVID-19 or its repercussions. Luckily, I have two young daughters who “encourage” me to listen to the Frozen 2 soundtrack instead of putting on the evening news when I get home from work. Still, news manages to seep through my defenses. As I scrolled through some headlines recently, I learned of the death of musician Adam Schlesinger from COVID-19. He wasn’t a household name, but his death still hit me in unexpected ways.
I started internship in late June 2005, in a city (Portland, Ore.) about as different from my previous home (Dallas) as any two places can possibly be. I think the day before internship started still ranks as the most nervous of my life. I’m not sure how I slept at all that night, but somehow I did and arrived at the Portland Veterans Affairs Hospital the following morning to start my new career.
And then … nothing happened. Early on that first day, the electronic medical records crashed, and no patients were admitted during our time on “short call.” My upper level resident took care of the one or two established patients on the team (both discharged), so I ended the day with records that would not be broken during the remainder of my residency: 0 notes written, 0 patients seen. Perhaps the most successful first day that any intern, anywhere has ever had, although it prepared me quite poorly for all the subsequent days.
Since I had some time on my hands, I made the 20-minute walk to one of my new hometown’s record stores where Fountains of Wayne (FOW) was playing an acoustic in-store set. Their album from a few years prior, “Welcome Interstate Managers,” was in heavy rotation when I made the drive from Dallas to Portland. It was (and is) a great album for long drives – melodic, catchy, and (mostly) up-tempo. Adam and the band’s singer, Chris Collingwood, played several songs that night on the store’s stage. Then they headed out to the next city, and I headed back home and on to many far-busier days of residency.
We would cross paths again a decade later. I moved back to Texas and became a hospitalist. It turns out that, if you have enough hospitalists of a certain age and if enough of those hospitalists have unearned confidence in their musical ability, then a covers band will undoubtedly be formed. And so, it happened here in San Antonio. We were not selective in our song choices – we played songs from every decade of the last 50 years, bands as popular as the Beatles and as indie as the Rentals. And we played some FOW.
Our band (which will go nameless here so that our YouTube recordings are more difficult to find) played a grand total of one gig during our years of intermittent practicing. That one gig was my wedding rehearsal dinner and the penultimate song we played was “Stacy’s Mom,” which is notable for being both FOW’s biggest hit and a completely inappropriate song to play at a wedding rehearsal dinner. The crowd was probably around the same size as the one that had seen Adam and Chris play in Portland 10 years prior. I don’t think the applause we received was quite as genuine or deserved, though.
After Adam and Chris played their gig, there was an autograph session and I took home a signed poster. Last year, I decided to take it out of storage and hang it in my office. The date of the show and the first day of my physician career, a date now nearly 15 years ago, is written in psychedelic typography at the bottom. The store that I went to that day is no longer there, a victim of progress like so many other record stores across the country. Another location of the same store is still open in Portland. I hope that it and all the other small book and music stores across the country can survive this current crisis, but I know that many will not.
So, here’s to you Adam, and to all the others who have lost their lives to this terrible illness. As a small token of remembrance, I’ll be playing some Fountains of Wayne on the drive home tonight. It’s not quite the same as playing it on a cross-country drive, but hopefully, we will all be able to do that again soon.
Dr. Sehgal is a clinical associate professor of medicine in the division of general and hospital medicine at the South Texas Veterans Health Care System and UT-Health San Antonio. He is a member of the editorial advisory board for The Hospitalist.
Like many in the health care field, I have found it hard to watch the news over these past couple of months when it seems that almost every story is about COVID-19 or its repercussions. Luckily, I have two young daughters who “encourage” me to listen to the Frozen 2 soundtrack instead of putting on the evening news when I get home from work. Still, news manages to seep through my defenses. As I scrolled through some headlines recently, I learned of the death of musician Adam Schlesinger from COVID-19. He wasn’t a household name, but his death still hit me in unexpected ways.
I started internship in late June 2005, in a city (Portland, Ore.) about as different from my previous home (Dallas) as any two places can possibly be. I think the day before internship started still ranks as the most nervous of my life. I’m not sure how I slept at all that night, but somehow I did and arrived at the Portland Veterans Affairs Hospital the following morning to start my new career.
And then … nothing happened. Early on that first day, the electronic medical records crashed, and no patients were admitted during our time on “short call.” My upper level resident took care of the one or two established patients on the team (both discharged), so I ended the day with records that would not be broken during the remainder of my residency: 0 notes written, 0 patients seen. Perhaps the most successful first day that any intern, anywhere has ever had, although it prepared me quite poorly for all the subsequent days.
Since I had some time on my hands, I made the 20-minute walk to one of my new hometown’s record stores where Fountains of Wayne (FOW) was playing an acoustic in-store set. Their album from a few years prior, “Welcome Interstate Managers,” was in heavy rotation when I made the drive from Dallas to Portland. It was (and is) a great album for long drives – melodic, catchy, and (mostly) up-tempo. Adam and the band’s singer, Chris Collingwood, played several songs that night on the store’s stage. Then they headed out to the next city, and I headed back home and on to many far-busier days of residency.
We would cross paths again a decade later. I moved back to Texas and became a hospitalist. It turns out that, if you have enough hospitalists of a certain age and if enough of those hospitalists have unearned confidence in their musical ability, then a covers band will undoubtedly be formed. And so, it happened here in San Antonio. We were not selective in our song choices – we played songs from every decade of the last 50 years, bands as popular as the Beatles and as indie as the Rentals. And we played some FOW.
Our band (which will go nameless here so that our YouTube recordings are more difficult to find) played a grand total of one gig during our years of intermittent practicing. That one gig was my wedding rehearsal dinner and the penultimate song we played was “Stacy’s Mom,” which is notable for being both FOW’s biggest hit and a completely inappropriate song to play at a wedding rehearsal dinner. The crowd was probably around the same size as the one that had seen Adam and Chris play in Portland 10 years prior. I don’t think the applause we received was quite as genuine or deserved, though.
After Adam and Chris played their gig, there was an autograph session and I took home a signed poster. Last year, I decided to take it out of storage and hang it in my office. The date of the show and the first day of my physician career, a date now nearly 15 years ago, is written in psychedelic typography at the bottom. The store that I went to that day is no longer there, a victim of progress like so many other record stores across the country. Another location of the same store is still open in Portland. I hope that it and all the other small book and music stores across the country can survive this current crisis, but I know that many will not.
So, here’s to you Adam, and to all the others who have lost their lives to this terrible illness. As a small token of remembrance, I’ll be playing some Fountains of Wayne on the drive home tonight. It’s not quite the same as playing it on a cross-country drive, but hopefully, we will all be able to do that again soon.
Dr. Sehgal is a clinical associate professor of medicine in the division of general and hospital medicine at the South Texas Veterans Health Care System and UT-Health San Antonio. He is a member of the editorial advisory board for The Hospitalist.
Doctor with a mask: Enhancing communication and empathy
Delivering a goodbye monologue to an elderly patient, I said: “Tomorrow, my colleague Dr. XYZ, who is an excellent physician, will be here in my place, and I will leave a detailed sign out for them.” I was on the last day of a 7-day-long block on hospital medicine service. Typically, when I say goodbye, some patients respond “thank you, enjoy your time,” some don’t care, and some show disappointment at the transition. This patient became uneasy, choking back tears, and said: “But, I don’t want a new doctor. You know me well. ... They don’t even allow my family in the hospital.”
That expression of anxiety, of having to build rapport with a new provider, concerns about continuity of care, and missing support of family members were not alien to me. As I instinctively took a step toward him to offer a comforting hug, an unsolicited voice in my head said, “social distancing.” I steered back, handing him a box of tissues. I continued: “You have come a long way, and things are looking good from here,” providing more details before I left the room. There was a change in my practice that week. I didn’t shake hands with my patients; I didn’t sit on any unassigned chair; I had no family members in the room asking me questions or supporting my patients. I was trying to show empathy or a smile behind a mask and protective eyewear. The business card with photograph had become more critical than ever for patients to “see” their doctor.
Moving from room to room and examining patients, it felt like the coronavirus was changing the practice of medicine beyond concerns of virus transmission, losing a patient, or putting in extra hours. I realized I was missing so-called “nonverbal communication” amid social distancing: facial expressions, social touch, and the support of family or friends to motivate or destress patients. With no visitors and curbed health care staff entries into patient’s rooms, social distancing was amounting to social isolation. My protective gear and social distancing seemed to be reducing my perceived empathy with patients, and the ability to build a good patient-physician relationship.
Amid alarms, beeps, and buzzes, patients were not only missing their families but also the familiar faces of their physicians. I needed to raise my game while embracing the “new normal” of health care. Cut to the next 13 patients: I paid more attention to voice, tone, and posture. I called patient families from the bedside instead of the office. I translated my emotions with words, loud and clear, replacing “your renal function looks better” (said without a smile) with “I am happy to see your renal function better.”
Through years of practice, I felt prepared to deal with feelings of denial, grief, anxiety, and much more, but the emotions arising as a result of this pandemic were unique. “I knew my mother was old, and this day would come,” said one of the inconsolable family members of a critically ill patient. “However, I wished to be at her side that day, not like this.” I spend my days listening to patient and family concerns about unemployment with quarantine, fears of spreading the disease to loved ones, and the possibility of medications not working.
After a long day, I went back to that first elderly patient to see if he was comfortable with the transition of care. I did a video conference with his daughter, and repeated my goodbyes. The patient smiled and said: “Doc, you deserve a break.” That day I learned about the challenges of good clinical rounding in coronavirus times, and how to overcome them. For “millennial” physicians, it is our first pandemic, and we are learning from it every day.
Driving home through empty streets, I concluded that my answers to the clinical questions asked by patients and families lean heavily on ever-changing data, and the treatments offered have yet to prove their mettle. As a result, I will continue to focus as much on the time-tested fundamentals of clinical practice: communication and empathy. I cannot allow the social distancing and the mask to hide my compassion, or take away from patient satisfaction. Shifting gears, I turned on my car radio, using music to reset my mind before attending to my now-homeschooling kids.
Dr. Saigal is a hospitalist and clinical assistant professor of medicine in the division of hospital medicine at the Ohio State University Wexner Medical Center, Columbus.
References
1. Wong CK et al. Effect of facemasks on empathy and relational continuity: A randomised controlled trial in primary care. BMC Fam Pract. 2013;14:200.
2. Little P et al. Randomised controlled trial of a brief intervention targeting predominantly nonverbal communication in general practice consultations. Br J Gen Pract. 2015;65(635):e351-6.
3. Varghese A. A doctor’s touch. TEDGlobal 2011. 2011 Jul. https://www.ted.com/talks/abraham_verghese_a_doctor_s_touch?language=en
Delivering a goodbye monologue to an elderly patient, I said: “Tomorrow, my colleague Dr. XYZ, who is an excellent physician, will be here in my place, and I will leave a detailed sign out for them.” I was on the last day of a 7-day-long block on hospital medicine service. Typically, when I say goodbye, some patients respond “thank you, enjoy your time,” some don’t care, and some show disappointment at the transition. This patient became uneasy, choking back tears, and said: “But, I don’t want a new doctor. You know me well. ... They don’t even allow my family in the hospital.”
That expression of anxiety, of having to build rapport with a new provider, concerns about continuity of care, and missing support of family members were not alien to me. As I instinctively took a step toward him to offer a comforting hug, an unsolicited voice in my head said, “social distancing.” I steered back, handing him a box of tissues. I continued: “You have come a long way, and things are looking good from here,” providing more details before I left the room. There was a change in my practice that week. I didn’t shake hands with my patients; I didn’t sit on any unassigned chair; I had no family members in the room asking me questions or supporting my patients. I was trying to show empathy or a smile behind a mask and protective eyewear. The business card with photograph had become more critical than ever for patients to “see” their doctor.
Moving from room to room and examining patients, it felt like the coronavirus was changing the practice of medicine beyond concerns of virus transmission, losing a patient, or putting in extra hours. I realized I was missing so-called “nonverbal communication” amid social distancing: facial expressions, social touch, and the support of family or friends to motivate or destress patients. With no visitors and curbed health care staff entries into patient’s rooms, social distancing was amounting to social isolation. My protective gear and social distancing seemed to be reducing my perceived empathy with patients, and the ability to build a good patient-physician relationship.
Amid alarms, beeps, and buzzes, patients were not only missing their families but also the familiar faces of their physicians. I needed to raise my game while embracing the “new normal” of health care. Cut to the next 13 patients: I paid more attention to voice, tone, and posture. I called patient families from the bedside instead of the office. I translated my emotions with words, loud and clear, replacing “your renal function looks better” (said without a smile) with “I am happy to see your renal function better.”
Through years of practice, I felt prepared to deal with feelings of denial, grief, anxiety, and much more, but the emotions arising as a result of this pandemic were unique. “I knew my mother was old, and this day would come,” said one of the inconsolable family members of a critically ill patient. “However, I wished to be at her side that day, not like this.” I spend my days listening to patient and family concerns about unemployment with quarantine, fears of spreading the disease to loved ones, and the possibility of medications not working.
After a long day, I went back to that first elderly patient to see if he was comfortable with the transition of care. I did a video conference with his daughter, and repeated my goodbyes. The patient smiled and said: “Doc, you deserve a break.” That day I learned about the challenges of good clinical rounding in coronavirus times, and how to overcome them. For “millennial” physicians, it is our first pandemic, and we are learning from it every day.
Driving home through empty streets, I concluded that my answers to the clinical questions asked by patients and families lean heavily on ever-changing data, and the treatments offered have yet to prove their mettle. As a result, I will continue to focus as much on the time-tested fundamentals of clinical practice: communication and empathy. I cannot allow the social distancing and the mask to hide my compassion, or take away from patient satisfaction. Shifting gears, I turned on my car radio, using music to reset my mind before attending to my now-homeschooling kids.
Dr. Saigal is a hospitalist and clinical assistant professor of medicine in the division of hospital medicine at the Ohio State University Wexner Medical Center, Columbus.
References
1. Wong CK et al. Effect of facemasks on empathy and relational continuity: A randomised controlled trial in primary care. BMC Fam Pract. 2013;14:200.
2. Little P et al. Randomised controlled trial of a brief intervention targeting predominantly nonverbal communication in general practice consultations. Br J Gen Pract. 2015;65(635):e351-6.
3. Varghese A. A doctor’s touch. TEDGlobal 2011. 2011 Jul. https://www.ted.com/talks/abraham_verghese_a_doctor_s_touch?language=en
Delivering a goodbye monologue to an elderly patient, I said: “Tomorrow, my colleague Dr. XYZ, who is an excellent physician, will be here in my place, and I will leave a detailed sign out for them.” I was on the last day of a 7-day-long block on hospital medicine service. Typically, when I say goodbye, some patients respond “thank you, enjoy your time,” some don’t care, and some show disappointment at the transition. This patient became uneasy, choking back tears, and said: “But, I don’t want a new doctor. You know me well. ... They don’t even allow my family in the hospital.”
That expression of anxiety, of having to build rapport with a new provider, concerns about continuity of care, and missing support of family members were not alien to me. As I instinctively took a step toward him to offer a comforting hug, an unsolicited voice in my head said, “social distancing.” I steered back, handing him a box of tissues. I continued: “You have come a long way, and things are looking good from here,” providing more details before I left the room. There was a change in my practice that week. I didn’t shake hands with my patients; I didn’t sit on any unassigned chair; I had no family members in the room asking me questions or supporting my patients. I was trying to show empathy or a smile behind a mask and protective eyewear. The business card with photograph had become more critical than ever for patients to “see” their doctor.
Moving from room to room and examining patients, it felt like the coronavirus was changing the practice of medicine beyond concerns of virus transmission, losing a patient, or putting in extra hours. I realized I was missing so-called “nonverbal communication” amid social distancing: facial expressions, social touch, and the support of family or friends to motivate or destress patients. With no visitors and curbed health care staff entries into patient’s rooms, social distancing was amounting to social isolation. My protective gear and social distancing seemed to be reducing my perceived empathy with patients, and the ability to build a good patient-physician relationship.
Amid alarms, beeps, and buzzes, patients were not only missing their families but also the familiar faces of their physicians. I needed to raise my game while embracing the “new normal” of health care. Cut to the next 13 patients: I paid more attention to voice, tone, and posture. I called patient families from the bedside instead of the office. I translated my emotions with words, loud and clear, replacing “your renal function looks better” (said without a smile) with “I am happy to see your renal function better.”
Through years of practice, I felt prepared to deal with feelings of denial, grief, anxiety, and much more, but the emotions arising as a result of this pandemic were unique. “I knew my mother was old, and this day would come,” said one of the inconsolable family members of a critically ill patient. “However, I wished to be at her side that day, not like this.” I spend my days listening to patient and family concerns about unemployment with quarantine, fears of spreading the disease to loved ones, and the possibility of medications not working.
After a long day, I went back to that first elderly patient to see if he was comfortable with the transition of care. I did a video conference with his daughter, and repeated my goodbyes. The patient smiled and said: “Doc, you deserve a break.” That day I learned about the challenges of good clinical rounding in coronavirus times, and how to overcome them. For “millennial” physicians, it is our first pandemic, and we are learning from it every day.
Driving home through empty streets, I concluded that my answers to the clinical questions asked by patients and families lean heavily on ever-changing data, and the treatments offered have yet to prove their mettle. As a result, I will continue to focus as much on the time-tested fundamentals of clinical practice: communication and empathy. I cannot allow the social distancing and the mask to hide my compassion, or take away from patient satisfaction. Shifting gears, I turned on my car radio, using music to reset my mind before attending to my now-homeschooling kids.
Dr. Saigal is a hospitalist and clinical assistant professor of medicine in the division of hospital medicine at the Ohio State University Wexner Medical Center, Columbus.
References
1. Wong CK et al. Effect of facemasks on empathy and relational continuity: A randomised controlled trial in primary care. BMC Fam Pract. 2013;14:200.
2. Little P et al. Randomised controlled trial of a brief intervention targeting predominantly nonverbal communication in general practice consultations. Br J Gen Pract. 2015;65(635):e351-6.
3. Varghese A. A doctor’s touch. TEDGlobal 2011. 2011 Jul. https://www.ted.com/talks/abraham_verghese_a_doctor_s_touch?language=en
The American maternal mortality crisis: The role of racism and bias
April 11-17 marked the third annual national Black Maternal Health Week, an event launched in 2017 by the Atlanta-based Black Mamas Matter Alliance (BMMA), in part to “deepen the national conversation about black maternal health.”
Around the same time, emerging data showing higher mortality rates among black patients versus patients of other races with COVID-19 opened similar dialogue fraught with questions about what might explain the disturbing health disparities.
“It’s kind of surprising to me that people are shocked by these [COVID-19] disparities,” Rebekah Gee, MD, an ob.gyn. who is director of the Louisiana State University Health System in New Orleans and a driving force behind initiatives addressing racial disparities in maternal health, said in an interview. If this is it, great – and certainly every moment is a moment for learning – but these COVID-19 disparities should not be surprising to people who have been looking at data.”
Veronica Gillispie, MD, an ob.gyn. and medical director of the Louisiana Perinatal Quality Collaborative and Pregnancy-Associated Mortality Review, was similarly baffled that the news was treated as a revelation.
That news includes outcomes data from New York showing that in March there were 92.3 and 74.3 deaths per 100,000 black and Hispanic COVID-19 patients, respectively, compared with 45.2 per 100,000 white patients.
“Now there’s a task force and all these initiatives to look at why this is happening, and I think those of us who work in maternal mortality are all saying, ‘We know why it’s happening,’ ” she said. “It’s the same thing we’ve been telling people why it’s been happening in maternal mortality.
“It’s implicit bias and structural racism.”
Facing hard numbers, harder conversations
The U.S. maternal mortality rate in 2018 was 17 per 100,000 live births – the highest of any similarly wealthy industrialized nation, the Centers for Disease Control and Prevention’s National Center for Health Statistics (NCHS) reported in January. That’s a striking statistic in its own right. Perhaps more striking is the breakdown by race.
Hispanic women had the lowest maternal mortality rate at 12 per 100,000 live births, followed by non-Hispanic white women at 15.
The rate for non-Hispanic black women was 37 per 100,000 live births.
Numerous factors contribute to these disparities. Among those listed by the American College of Obstetricians and Gynecologists’ chief executive officer Maureen G. Phipps, MD, in a press statement on the NCHS data, are care access issues, lack of standardization of care, bias, and racism. All of these must be addressed if the disparities in maternal and other areas of care are to be eliminated, according to Dr. Phipps.
“The NCHS data confirmed what we have known from other data sources: The rate of maternal deaths for non-Hispanic black women is substantially higher than the rates for non-Hispanic white women,” she wrote. “Continued efforts to improve the standardization of data and review processes related to U.S. maternal mortality are a necessary step to achieving the goal of eliminating disparities and preventable maternal mortality.”
However, such efforts frequently encounter roadblocks constructed by the reluctance among “many academics, policy makers, scientists, elected officials, journalists, and others responsible for defining and responding to the public discourse” to identify racism as a root cause of health disparities, according to Zinzi D. Bailey, ScD, former director of research and evaluation for the New York City Department of Health and Mental Hygiene, and colleagues.
In the third of a three-part conceptual report in The Lancet, entitled America: Equity and Equality in Health, Dr. Bailey and colleagues argued that advancing health equity requires a focus on structural racism – which they defined as “the totality of ways in which societies foster racial discrimination via mutually reinforcing inequitable systems (e.g., in housing, education, employment, earning, benefits, credit, media, healthcare, and criminal justice, etc.) that in turn reinforce discriminatory beliefs, values, and distribution of resources.”
In their series, the authors peeled back layer upon layer of sociological and political contributors to structural racism throughout history, revealing how each laid a foundation for health inequity over time. They particularly home in on health care quality and access.
“Interpersonal racism, bias, and discrimination in healthcare settings can directly affect health through poor health care,” they wrote, noting that “almost 15 years ago, the Institute of Medicine report entitled Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care, documented systematic and pervasive bias in the treatment of people of color resulting in substandard care.”
That report concluded that “bias, stereotyping, prejudice, and clinical uncertainty on the part of healthcare providers” likely play a role in the continuation of health disparities. More recent data – including the NCHS maternal mortality data – show an ongoing crisis.
A study of 210 experienced primary care providers and 190 community members in the Denver area, for example, found substantial evidence of implicit bias against both Latino and African American patients. The authors defined implicit bias as “unintentional and even unconscious” negative evaluation of one group and its members relative to another that is expressed implicitly, such as through negative nonverbal behavior.
“Activated by situational cues (e.g., a person’s skin color), implicit bias can quickly and unknowingly exert its influence on perception, memory, and behavior,” they wrote.
In their study, Implicit Association Test and self-report measures of bias showed similar rates of implicit bias among the providers and community members, with only a slight weakening of ethnic/racial bias among providers after adjustment for background characteristics, which suggests “a wider societal problem,” they said.
A specific example of how implicit bias can manifest was described in a 2016 report addressing the well-documented under-treatment of pain among black versus white patients. Kelly M. Hoffman, PhD, and colleagues demonstrated that a substantial number of individuals with at least some medical training endorse false beliefs regarding biological differences between black and white patients. For example, 25% of 28 white residents surveyed agreed black individuals have thicker skin, and 4% believed black individuals have faster blood coagulation and less sensitivity in their nerve endings.
Those who more strongly endorsed such erroneous beliefs were more likely to underestimate and undertreat pain among black patients, the authors found.
Another study, which underscored the insidiousness of structural racism, was reported in Science. The authors identified significant racial bias in an algorithm widely used by health systems, insurers, and practitioners to allocate health care resources for patients with complex health needs. The algorithm, which affects millions of patients, uses predictions of future health care costs rather than future illness to determine who should receive extra medical care.
The problem is that unequal care access for black patients skews lower the foundational cost data used for making those predictions. Correcting the algorithm would increase the percentage of black patients receiving additional medical help from 17.7% to 46.5%, the authors concluded.
This evidence of persistent racism and bias in medicine, however, doesn’t mean progress is lacking.
ACOG has partnered with numerous other organizations to promote awareness and change, including through legislation. A recent win was the enactment of the Preventing Maternal Deaths Act of 2018, a bipartisan bill designed to promote and support maternal mortality review committees in every state. A major focus of BMMA’s Black Maternal Health Week was the Black Maternal Health Momnibus Act of 2020, a nine-bill package introduced in March to comprehensively address the crisis.
But efforts like these, whether they aim to elucidate the contributors to health disparities or to directly target structural and overt racism and root out implicit bias in medical care, are nothing new. As Dr. Bailey and colleagues noted, a challenge is getting the message across because efforts to avoid tough conversations around these topics are nothing new, either.
Dr. Gee attested to that during a maternal mortality panel discussion at the 2019 ACOG meeting where she spoke about the resistance she encountered in 2016 when she was appointed secretary of the Louisiana Health Department and worked to make racism and bias a foundational part of the discussion on improving maternal and fetal outcomes.
She established the first Office of Health Equity in the state – and the first in the nation to not only require measurement outcomes by race but also explicitly address racial bias at the outset. The goal wasn’t just to talk about it but to “plan for addressing equity in every single aspect of what we do with ... our case equity action teams.”
“At our first maternal mortality quality meetings we insisted on focusing on equity at the very outset, and we had people that left when we started talking about racism,” she said, noting that others said it was “too political” to discuss during an election year or that equity was something to address later.
“We said no. We insisted on it, and I think that was very important because all ships don’t rise with the tide, not with health disparities,” she said, recounting an earlier experience when she led the Louisiana Birth Outcomes Initiative: “I asked to have a brown-bag focused on racism at the department so we could talk about the impact of implicit bias on decision making, and I was told that I was a Yankee who didn’t understand the South and that racism didn’t really exist here, and what did I know about it – and I couldn’t have the brown-bag.”
That was in 2011.
Fast-forward to April 24, 2020. As Dr. Gee shared her perspective on addressing racism and bias in medicine, she was preparing for a call regarding the racial disparities in COVID-19 outcomes – the first health equity action sanctioned by Louisiana Governor John Bel Edwards (D).
“I think we really set the stage for these discussions,” she said.
Addressing equity to enact change
The efforts in Louisiana also set the stage for better maternal outcomes. At the 2019 ACOG meeting where she spoke as part of the President’s Panel, Dr. Gee said Louisiana had the highest maternal mortality rates in the nation. The NCHC data released in January, however, suggest that may no longer be the case.
Inconsistencies in how the latest and prior data were reported, including in how maternal mortality was defined, make direct comparison impossible. But in the latest report, Louisiana ranked seventh among states with available data.
“Ninety percent of the deliveries in the state happen at hospitals that we worked with,” Dr. Gee said, highlighting the reach of the efforts to improve outcomes there.
She also described a recent case involving an anemic patient whose bleeding risk was identified early thanks to the programs put in place. That enabled early preparation in the event of complications.
The patient experienced a massive hemorrhage, but the preparation, including having units of blood on hand in case of such an emergency, saved her life.
“So we clearly have not just data, but individual stories of people whose lives have been saved by this work,” she said.
More tangible data on maternal morbidity further show that the efforts in the state are making a difference, Dr. Gillispie said, citing preliminary outcomes data from the Pregnancy-Associated Mortality Review launched in 2018.
“We started with an initial goal of reducing severe maternal morbidity related to hypertension and hemorrhage by 20%, as well as reducing the black/white disparity gap by Mother’s Day 2020,” she said.
Final analyses have been delayed because of COVID-19, but early assessments showed a reduction in the disparity gap, she said, again highlighting the importance of focusing on equity.
“Definitely from the standpoint of the Quality Collaborative side ... we’ve been working with our facilities to make them aware of what implicit bias is, helping them to also do the Harvard Implicit Bias Test so they can figure out what their own biases are, start working to acknowledge them and address them, and start working to fight against letting that bias change how they treat individuals,” Dr. Gillispie said.
The work started through these initiatives will continue because there is much left to be done, she said.
Indeed, the surprised reactions in recent weeks to the reports of disparities in COVID-19 outcomes further underscore that reality, and the maternal mortality statistics – with use of the voices of those directly affected by structural and overt racism and bias in maternal care as a megaphone – speak for themselves.
Hearing implicit bias from patients’ perspective
Just ask Timoria McQueen Saba, a black woman who nearly died from a postpartum hemorrhage in 2010. At ACOG 2019, she spoke about how she had to switch ob.gyns. three times during her first pregnancy because she felt she had not received quality care – one doctor neglected to tell her she had placenta previa. She also experienced excessive wait times at prenatal appointments and had been on the receiving end of microaggressions and degrading questions such as “Are you still married?” and “Is your husband your baby’s father?” – and these are all things her white friends who recommended those physicians never experienced, she said.
“The health care system has just sometimes beaten people down so much, just like the world has – people of color, especially – to where you’re dismissed, your concerns are invalidated,” she said. “Some doctors don’t even think black people feel pain [or that] our pain is less.”
Mrs. Saba also spoke about how her health care “improved a billion percent” when her white husband accompanied her to appointments.
Just ask Charles S. Johnson IV, whose wife Kira Dixon Johnson died in 2016 during surgery for postpartum bleeding complications – after he and other family members spent 10 hours pleading for help for her.
Speaking at the ACOG panel discussion with Mrs. Saba, Mr. Johnson described “a clear disconnect” between the medical staff at the hospital and the way they viewed and valued Kira. He shared his frustration in wanting to advocate for his wife, but knowing that, as an African American male, he risked being seen as a threat and removed from the hospital if he didn’t stay calm, if he “tapped into those natural instincts as a man and a husband who wants to just protect his family.”
He fought back emotions, struggling to get the words out, saying that’s what haunts him and keeps him up at night – wondering if he should have “fought harder, grabbed the doctor by the collar, raised his voice, slammed on the counter.
“Maybe they would have done something,” he said.
Such experiences cross all socioeconomic boundaries. Ask U.S. Track and Field Olympic gold medalist Allyson Felix, who testified at a U.S. House Ways and Means Committee hearing on May 16, 2019 after developing severe preeclampsia that threatened her life and that of her baby. Ask tennis champion Serena Williams, who demanded assessment for pulmonary embolism following the birth of her child; she knew the signs, but her health care providers initially dismissed her concerns.
Their experiences aren’t just anecdotal. Data consistently show how racism and bias affect patient treatment and outcomes. Dr. Gee, for example, shared findings from a retrospective assessment of 47 confirmed pregnancy-related deaths in Louisiana between 2011 and 2016 that looked specifically at whether the deaths could potentially have been prevented if blood was given sooner, cardiomyopathy was recognized sooner, hypertension was treated on time, or other changes were made to care.
The answer was “Yes” in 9% of cases involving white patients – and in 59% of cases involving black patients (odds ratio, 14.6).
The study, reported in February in Obstetrics & Gynecology, showed that 27 of the deaths (58%) occurred at level III or IV birth facilities and that those deaths were not less likely than those at level I or II facilities to be categorized as preventable (OR, 2.0).
Findings from the Giving Voice to Mothers study, published in Reproductive Health in 2019, showed how mistreatment during childbirth might contribute to such outcomes.
In an online cross-sectional survey of more than 2,100 U.S. women, one in six reported at least one type of mistreatment, such as loss of autonomy, being yelled at or threatened, being ignored or having requests for help ignored, Saraswathi Vedam, SciD, of the Birth Place Lab at the University of British Columbia, Vancouver, and colleagues reported.
Race was among the factors associated with likelihood of mistreatment, and the rates of mistreatment for women of color were consistently higher – even when looking at interactions between race and other characteristics, such as socioeconomic status (SES). For example, 27.2% of women of color with low SES, compared with 18.7% of white women with low SES, reported mistreatment. Having a partner who was black, regardless of maternal race, was also associated with an increased rate of mistreatment, the authors found.
“I often get the question, ‘Do you think Kira would be alive if she was white,’ ” Mr. Johnson said. “The first way I respond to that question is [by saying that] the simple fact that you have to ask me is a problem.
“When this first happened, I was in so much pain that I couldn’t process the fact that something so egregious and outrageous happened to my wife because of the color of her skin, but as I began to process and really think about it and unpack this scenario, I have to be really frank ... do I think that she would have sat there for 10 hours while we begged and pleaded? Absolutely not.”
He stressed that his words aren’t “an indictment of the profession.”
“This is not an indictment saying that all people are racist or prejudiced,” he said. “But here’s the reality: If you are in this profession, if you are responsible for the well-being of patients and their families, and you are not able to see them in the same way that you see your mother, your wife, your sister, you have two options – you need to find something else to do or you need to take steps to get better.”
Fixing systems, finding solutions
Dr. Gee acknowledged the work that physicians need to do to help improve outcomes.
“The average time we give a patient to talk is 11 seconds before we interrupt them,” she said, as one example. “We have to recognize that.”
But efforts to improve outcomes shouldn’t just focus on changing physician behavior, she said.
“We really need to focus, as has the U.K. – very effectively – on using midwives, doulas, other health care professionals as complements to physicians to make sure that we have women-centered birth experiences.
“So, instead of just blaming the doctors, I think we need to change the system,” Dr. Gee emphasized.
The disruptions in health systems caused by COVID-19 present a unique opportunity to do that, she said. There is now an opportunity to build them back.
“We have a chance to build the systems back, and when we do so, we ought to build them back correcting for implicit bias and some of the systemic issues that lead to poor outcomes for people of color in our country,” she said.
Solutions proposed by Dr. Gee and others include more diversity in the workforce, more inclusion of patient advocates in maternal care, development of culturally appropriate literacy and numeracy communications, measurement by race (and action on the outcomes), standardization of care, and development of new ways to improve care access.
We will focus more specifically on these solutions in Part 2 of this article in our maternal mortality series. Previous articles in the series are available at mdedge.com/obgyn/maternal-mortality.
April 11-17 marked the third annual national Black Maternal Health Week, an event launched in 2017 by the Atlanta-based Black Mamas Matter Alliance (BMMA), in part to “deepen the national conversation about black maternal health.”
Around the same time, emerging data showing higher mortality rates among black patients versus patients of other races with COVID-19 opened similar dialogue fraught with questions about what might explain the disturbing health disparities.
“It’s kind of surprising to me that people are shocked by these [COVID-19] disparities,” Rebekah Gee, MD, an ob.gyn. who is director of the Louisiana State University Health System in New Orleans and a driving force behind initiatives addressing racial disparities in maternal health, said in an interview. If this is it, great – and certainly every moment is a moment for learning – but these COVID-19 disparities should not be surprising to people who have been looking at data.”
Veronica Gillispie, MD, an ob.gyn. and medical director of the Louisiana Perinatal Quality Collaborative and Pregnancy-Associated Mortality Review, was similarly baffled that the news was treated as a revelation.
That news includes outcomes data from New York showing that in March there were 92.3 and 74.3 deaths per 100,000 black and Hispanic COVID-19 patients, respectively, compared with 45.2 per 100,000 white patients.
“Now there’s a task force and all these initiatives to look at why this is happening, and I think those of us who work in maternal mortality are all saying, ‘We know why it’s happening,’ ” she said. “It’s the same thing we’ve been telling people why it’s been happening in maternal mortality.
“It’s implicit bias and structural racism.”
Facing hard numbers, harder conversations
The U.S. maternal mortality rate in 2018 was 17 per 100,000 live births – the highest of any similarly wealthy industrialized nation, the Centers for Disease Control and Prevention’s National Center for Health Statistics (NCHS) reported in January. That’s a striking statistic in its own right. Perhaps more striking is the breakdown by race.
Hispanic women had the lowest maternal mortality rate at 12 per 100,000 live births, followed by non-Hispanic white women at 15.
The rate for non-Hispanic black women was 37 per 100,000 live births.
Numerous factors contribute to these disparities. Among those listed by the American College of Obstetricians and Gynecologists’ chief executive officer Maureen G. Phipps, MD, in a press statement on the NCHS data, are care access issues, lack of standardization of care, bias, and racism. All of these must be addressed if the disparities in maternal and other areas of care are to be eliminated, according to Dr. Phipps.
“The NCHS data confirmed what we have known from other data sources: The rate of maternal deaths for non-Hispanic black women is substantially higher than the rates for non-Hispanic white women,” she wrote. “Continued efforts to improve the standardization of data and review processes related to U.S. maternal mortality are a necessary step to achieving the goal of eliminating disparities and preventable maternal mortality.”
However, such efforts frequently encounter roadblocks constructed by the reluctance among “many academics, policy makers, scientists, elected officials, journalists, and others responsible for defining and responding to the public discourse” to identify racism as a root cause of health disparities, according to Zinzi D. Bailey, ScD, former director of research and evaluation for the New York City Department of Health and Mental Hygiene, and colleagues.
In the third of a three-part conceptual report in The Lancet, entitled America: Equity and Equality in Health, Dr. Bailey and colleagues argued that advancing health equity requires a focus on structural racism – which they defined as “the totality of ways in which societies foster racial discrimination via mutually reinforcing inequitable systems (e.g., in housing, education, employment, earning, benefits, credit, media, healthcare, and criminal justice, etc.) that in turn reinforce discriminatory beliefs, values, and distribution of resources.”
In their series, the authors peeled back layer upon layer of sociological and political contributors to structural racism throughout history, revealing how each laid a foundation for health inequity over time. They particularly home in on health care quality and access.
“Interpersonal racism, bias, and discrimination in healthcare settings can directly affect health through poor health care,” they wrote, noting that “almost 15 years ago, the Institute of Medicine report entitled Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care, documented systematic and pervasive bias in the treatment of people of color resulting in substandard care.”
That report concluded that “bias, stereotyping, prejudice, and clinical uncertainty on the part of healthcare providers” likely play a role in the continuation of health disparities. More recent data – including the NCHS maternal mortality data – show an ongoing crisis.
A study of 210 experienced primary care providers and 190 community members in the Denver area, for example, found substantial evidence of implicit bias against both Latino and African American patients. The authors defined implicit bias as “unintentional and even unconscious” negative evaluation of one group and its members relative to another that is expressed implicitly, such as through negative nonverbal behavior.
“Activated by situational cues (e.g., a person’s skin color), implicit bias can quickly and unknowingly exert its influence on perception, memory, and behavior,” they wrote.
In their study, Implicit Association Test and self-report measures of bias showed similar rates of implicit bias among the providers and community members, with only a slight weakening of ethnic/racial bias among providers after adjustment for background characteristics, which suggests “a wider societal problem,” they said.
A specific example of how implicit bias can manifest was described in a 2016 report addressing the well-documented under-treatment of pain among black versus white patients. Kelly M. Hoffman, PhD, and colleagues demonstrated that a substantial number of individuals with at least some medical training endorse false beliefs regarding biological differences between black and white patients. For example, 25% of 28 white residents surveyed agreed black individuals have thicker skin, and 4% believed black individuals have faster blood coagulation and less sensitivity in their nerve endings.
Those who more strongly endorsed such erroneous beliefs were more likely to underestimate and undertreat pain among black patients, the authors found.
Another study, which underscored the insidiousness of structural racism, was reported in Science. The authors identified significant racial bias in an algorithm widely used by health systems, insurers, and practitioners to allocate health care resources for patients with complex health needs. The algorithm, which affects millions of patients, uses predictions of future health care costs rather than future illness to determine who should receive extra medical care.
The problem is that unequal care access for black patients skews lower the foundational cost data used for making those predictions. Correcting the algorithm would increase the percentage of black patients receiving additional medical help from 17.7% to 46.5%, the authors concluded.
This evidence of persistent racism and bias in medicine, however, doesn’t mean progress is lacking.
ACOG has partnered with numerous other organizations to promote awareness and change, including through legislation. A recent win was the enactment of the Preventing Maternal Deaths Act of 2018, a bipartisan bill designed to promote and support maternal mortality review committees in every state. A major focus of BMMA’s Black Maternal Health Week was the Black Maternal Health Momnibus Act of 2020, a nine-bill package introduced in March to comprehensively address the crisis.
But efforts like these, whether they aim to elucidate the contributors to health disparities or to directly target structural and overt racism and root out implicit bias in medical care, are nothing new. As Dr. Bailey and colleagues noted, a challenge is getting the message across because efforts to avoid tough conversations around these topics are nothing new, either.
Dr. Gee attested to that during a maternal mortality panel discussion at the 2019 ACOG meeting where she spoke about the resistance she encountered in 2016 when she was appointed secretary of the Louisiana Health Department and worked to make racism and bias a foundational part of the discussion on improving maternal and fetal outcomes.
She established the first Office of Health Equity in the state – and the first in the nation to not only require measurement outcomes by race but also explicitly address racial bias at the outset. The goal wasn’t just to talk about it but to “plan for addressing equity in every single aspect of what we do with ... our case equity action teams.”
“At our first maternal mortality quality meetings we insisted on focusing on equity at the very outset, and we had people that left when we started talking about racism,” she said, noting that others said it was “too political” to discuss during an election year or that equity was something to address later.
“We said no. We insisted on it, and I think that was very important because all ships don’t rise with the tide, not with health disparities,” she said, recounting an earlier experience when she led the Louisiana Birth Outcomes Initiative: “I asked to have a brown-bag focused on racism at the department so we could talk about the impact of implicit bias on decision making, and I was told that I was a Yankee who didn’t understand the South and that racism didn’t really exist here, and what did I know about it – and I couldn’t have the brown-bag.”
That was in 2011.
Fast-forward to April 24, 2020. As Dr. Gee shared her perspective on addressing racism and bias in medicine, she was preparing for a call regarding the racial disparities in COVID-19 outcomes – the first health equity action sanctioned by Louisiana Governor John Bel Edwards (D).
“I think we really set the stage for these discussions,” she said.
Addressing equity to enact change
The efforts in Louisiana also set the stage for better maternal outcomes. At the 2019 ACOG meeting where she spoke as part of the President’s Panel, Dr. Gee said Louisiana had the highest maternal mortality rates in the nation. The NCHC data released in January, however, suggest that may no longer be the case.
Inconsistencies in how the latest and prior data were reported, including in how maternal mortality was defined, make direct comparison impossible. But in the latest report, Louisiana ranked seventh among states with available data.
“Ninety percent of the deliveries in the state happen at hospitals that we worked with,” Dr. Gee said, highlighting the reach of the efforts to improve outcomes there.
She also described a recent case involving an anemic patient whose bleeding risk was identified early thanks to the programs put in place. That enabled early preparation in the event of complications.
The patient experienced a massive hemorrhage, but the preparation, including having units of blood on hand in case of such an emergency, saved her life.
“So we clearly have not just data, but individual stories of people whose lives have been saved by this work,” she said.
More tangible data on maternal morbidity further show that the efforts in the state are making a difference, Dr. Gillispie said, citing preliminary outcomes data from the Pregnancy-Associated Mortality Review launched in 2018.
“We started with an initial goal of reducing severe maternal morbidity related to hypertension and hemorrhage by 20%, as well as reducing the black/white disparity gap by Mother’s Day 2020,” she said.
Final analyses have been delayed because of COVID-19, but early assessments showed a reduction in the disparity gap, she said, again highlighting the importance of focusing on equity.
“Definitely from the standpoint of the Quality Collaborative side ... we’ve been working with our facilities to make them aware of what implicit bias is, helping them to also do the Harvard Implicit Bias Test so they can figure out what their own biases are, start working to acknowledge them and address them, and start working to fight against letting that bias change how they treat individuals,” Dr. Gillispie said.
The work started through these initiatives will continue because there is much left to be done, she said.
Indeed, the surprised reactions in recent weeks to the reports of disparities in COVID-19 outcomes further underscore that reality, and the maternal mortality statistics – with use of the voices of those directly affected by structural and overt racism and bias in maternal care as a megaphone – speak for themselves.
Hearing implicit bias from patients’ perspective
Just ask Timoria McQueen Saba, a black woman who nearly died from a postpartum hemorrhage in 2010. At ACOG 2019, she spoke about how she had to switch ob.gyns. three times during her first pregnancy because she felt she had not received quality care – one doctor neglected to tell her she had placenta previa. She also experienced excessive wait times at prenatal appointments and had been on the receiving end of microaggressions and degrading questions such as “Are you still married?” and “Is your husband your baby’s father?” – and these are all things her white friends who recommended those physicians never experienced, she said.
“The health care system has just sometimes beaten people down so much, just like the world has – people of color, especially – to where you’re dismissed, your concerns are invalidated,” she said. “Some doctors don’t even think black people feel pain [or that] our pain is less.”
Mrs. Saba also spoke about how her health care “improved a billion percent” when her white husband accompanied her to appointments.
Just ask Charles S. Johnson IV, whose wife Kira Dixon Johnson died in 2016 during surgery for postpartum bleeding complications – after he and other family members spent 10 hours pleading for help for her.
Speaking at the ACOG panel discussion with Mrs. Saba, Mr. Johnson described “a clear disconnect” between the medical staff at the hospital and the way they viewed and valued Kira. He shared his frustration in wanting to advocate for his wife, but knowing that, as an African American male, he risked being seen as a threat and removed from the hospital if he didn’t stay calm, if he “tapped into those natural instincts as a man and a husband who wants to just protect his family.”
He fought back emotions, struggling to get the words out, saying that’s what haunts him and keeps him up at night – wondering if he should have “fought harder, grabbed the doctor by the collar, raised his voice, slammed on the counter.
“Maybe they would have done something,” he said.
Such experiences cross all socioeconomic boundaries. Ask U.S. Track and Field Olympic gold medalist Allyson Felix, who testified at a U.S. House Ways and Means Committee hearing on May 16, 2019 after developing severe preeclampsia that threatened her life and that of her baby. Ask tennis champion Serena Williams, who demanded assessment for pulmonary embolism following the birth of her child; she knew the signs, but her health care providers initially dismissed her concerns.
Their experiences aren’t just anecdotal. Data consistently show how racism and bias affect patient treatment and outcomes. Dr. Gee, for example, shared findings from a retrospective assessment of 47 confirmed pregnancy-related deaths in Louisiana between 2011 and 2016 that looked specifically at whether the deaths could potentially have been prevented if blood was given sooner, cardiomyopathy was recognized sooner, hypertension was treated on time, or other changes were made to care.
The answer was “Yes” in 9% of cases involving white patients – and in 59% of cases involving black patients (odds ratio, 14.6).
The study, reported in February in Obstetrics & Gynecology, showed that 27 of the deaths (58%) occurred at level III or IV birth facilities and that those deaths were not less likely than those at level I or II facilities to be categorized as preventable (OR, 2.0).
Findings from the Giving Voice to Mothers study, published in Reproductive Health in 2019, showed how mistreatment during childbirth might contribute to such outcomes.
In an online cross-sectional survey of more than 2,100 U.S. women, one in six reported at least one type of mistreatment, such as loss of autonomy, being yelled at or threatened, being ignored or having requests for help ignored, Saraswathi Vedam, SciD, of the Birth Place Lab at the University of British Columbia, Vancouver, and colleagues reported.
Race was among the factors associated with likelihood of mistreatment, and the rates of mistreatment for women of color were consistently higher – even when looking at interactions between race and other characteristics, such as socioeconomic status (SES). For example, 27.2% of women of color with low SES, compared with 18.7% of white women with low SES, reported mistreatment. Having a partner who was black, regardless of maternal race, was also associated with an increased rate of mistreatment, the authors found.
“I often get the question, ‘Do you think Kira would be alive if she was white,’ ” Mr. Johnson said. “The first way I respond to that question is [by saying that] the simple fact that you have to ask me is a problem.
“When this first happened, I was in so much pain that I couldn’t process the fact that something so egregious and outrageous happened to my wife because of the color of her skin, but as I began to process and really think about it and unpack this scenario, I have to be really frank ... do I think that she would have sat there for 10 hours while we begged and pleaded? Absolutely not.”
He stressed that his words aren’t “an indictment of the profession.”
“This is not an indictment saying that all people are racist or prejudiced,” he said. “But here’s the reality: If you are in this profession, if you are responsible for the well-being of patients and their families, and you are not able to see them in the same way that you see your mother, your wife, your sister, you have two options – you need to find something else to do or you need to take steps to get better.”
Fixing systems, finding solutions
Dr. Gee acknowledged the work that physicians need to do to help improve outcomes.
“The average time we give a patient to talk is 11 seconds before we interrupt them,” she said, as one example. “We have to recognize that.”
But efforts to improve outcomes shouldn’t just focus on changing physician behavior, she said.
“We really need to focus, as has the U.K. – very effectively – on using midwives, doulas, other health care professionals as complements to physicians to make sure that we have women-centered birth experiences.
“So, instead of just blaming the doctors, I think we need to change the system,” Dr. Gee emphasized.
The disruptions in health systems caused by COVID-19 present a unique opportunity to do that, she said. There is now an opportunity to build them back.
“We have a chance to build the systems back, and when we do so, we ought to build them back correcting for implicit bias and some of the systemic issues that lead to poor outcomes for people of color in our country,” she said.
Solutions proposed by Dr. Gee and others include more diversity in the workforce, more inclusion of patient advocates in maternal care, development of culturally appropriate literacy and numeracy communications, measurement by race (and action on the outcomes), standardization of care, and development of new ways to improve care access.
We will focus more specifically on these solutions in Part 2 of this article in our maternal mortality series. Previous articles in the series are available at mdedge.com/obgyn/maternal-mortality.
April 11-17 marked the third annual national Black Maternal Health Week, an event launched in 2017 by the Atlanta-based Black Mamas Matter Alliance (BMMA), in part to “deepen the national conversation about black maternal health.”
Around the same time, emerging data showing higher mortality rates among black patients versus patients of other races with COVID-19 opened similar dialogue fraught with questions about what might explain the disturbing health disparities.
“It’s kind of surprising to me that people are shocked by these [COVID-19] disparities,” Rebekah Gee, MD, an ob.gyn. who is director of the Louisiana State University Health System in New Orleans and a driving force behind initiatives addressing racial disparities in maternal health, said in an interview. If this is it, great – and certainly every moment is a moment for learning – but these COVID-19 disparities should not be surprising to people who have been looking at data.”
Veronica Gillispie, MD, an ob.gyn. and medical director of the Louisiana Perinatal Quality Collaborative and Pregnancy-Associated Mortality Review, was similarly baffled that the news was treated as a revelation.
That news includes outcomes data from New York showing that in March there were 92.3 and 74.3 deaths per 100,000 black and Hispanic COVID-19 patients, respectively, compared with 45.2 per 100,000 white patients.
“Now there’s a task force and all these initiatives to look at why this is happening, and I think those of us who work in maternal mortality are all saying, ‘We know why it’s happening,’ ” she said. “It’s the same thing we’ve been telling people why it’s been happening in maternal mortality.
“It’s implicit bias and structural racism.”
Facing hard numbers, harder conversations
The U.S. maternal mortality rate in 2018 was 17 per 100,000 live births – the highest of any similarly wealthy industrialized nation, the Centers for Disease Control and Prevention’s National Center for Health Statistics (NCHS) reported in January. That’s a striking statistic in its own right. Perhaps more striking is the breakdown by race.
Hispanic women had the lowest maternal mortality rate at 12 per 100,000 live births, followed by non-Hispanic white women at 15.
The rate for non-Hispanic black women was 37 per 100,000 live births.
Numerous factors contribute to these disparities. Among those listed by the American College of Obstetricians and Gynecologists’ chief executive officer Maureen G. Phipps, MD, in a press statement on the NCHS data, are care access issues, lack of standardization of care, bias, and racism. All of these must be addressed if the disparities in maternal and other areas of care are to be eliminated, according to Dr. Phipps.
“The NCHS data confirmed what we have known from other data sources: The rate of maternal deaths for non-Hispanic black women is substantially higher than the rates for non-Hispanic white women,” she wrote. “Continued efforts to improve the standardization of data and review processes related to U.S. maternal mortality are a necessary step to achieving the goal of eliminating disparities and preventable maternal mortality.”
However, such efforts frequently encounter roadblocks constructed by the reluctance among “many academics, policy makers, scientists, elected officials, journalists, and others responsible for defining and responding to the public discourse” to identify racism as a root cause of health disparities, according to Zinzi D. Bailey, ScD, former director of research and evaluation for the New York City Department of Health and Mental Hygiene, and colleagues.
In the third of a three-part conceptual report in The Lancet, entitled America: Equity and Equality in Health, Dr. Bailey and colleagues argued that advancing health equity requires a focus on structural racism – which they defined as “the totality of ways in which societies foster racial discrimination via mutually reinforcing inequitable systems (e.g., in housing, education, employment, earning, benefits, credit, media, healthcare, and criminal justice, etc.) that in turn reinforce discriminatory beliefs, values, and distribution of resources.”
In their series, the authors peeled back layer upon layer of sociological and political contributors to structural racism throughout history, revealing how each laid a foundation for health inequity over time. They particularly home in on health care quality and access.
“Interpersonal racism, bias, and discrimination in healthcare settings can directly affect health through poor health care,” they wrote, noting that “almost 15 years ago, the Institute of Medicine report entitled Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care, documented systematic and pervasive bias in the treatment of people of color resulting in substandard care.”
That report concluded that “bias, stereotyping, prejudice, and clinical uncertainty on the part of healthcare providers” likely play a role in the continuation of health disparities. More recent data – including the NCHS maternal mortality data – show an ongoing crisis.
A study of 210 experienced primary care providers and 190 community members in the Denver area, for example, found substantial evidence of implicit bias against both Latino and African American patients. The authors defined implicit bias as “unintentional and even unconscious” negative evaluation of one group and its members relative to another that is expressed implicitly, such as through negative nonverbal behavior.
“Activated by situational cues (e.g., a person’s skin color), implicit bias can quickly and unknowingly exert its influence on perception, memory, and behavior,” they wrote.
In their study, Implicit Association Test and self-report measures of bias showed similar rates of implicit bias among the providers and community members, with only a slight weakening of ethnic/racial bias among providers after adjustment for background characteristics, which suggests “a wider societal problem,” they said.
A specific example of how implicit bias can manifest was described in a 2016 report addressing the well-documented under-treatment of pain among black versus white patients. Kelly M. Hoffman, PhD, and colleagues demonstrated that a substantial number of individuals with at least some medical training endorse false beliefs regarding biological differences between black and white patients. For example, 25% of 28 white residents surveyed agreed black individuals have thicker skin, and 4% believed black individuals have faster blood coagulation and less sensitivity in their nerve endings.
Those who more strongly endorsed such erroneous beliefs were more likely to underestimate and undertreat pain among black patients, the authors found.
Another study, which underscored the insidiousness of structural racism, was reported in Science. The authors identified significant racial bias in an algorithm widely used by health systems, insurers, and practitioners to allocate health care resources for patients with complex health needs. The algorithm, which affects millions of patients, uses predictions of future health care costs rather than future illness to determine who should receive extra medical care.
The problem is that unequal care access for black patients skews lower the foundational cost data used for making those predictions. Correcting the algorithm would increase the percentage of black patients receiving additional medical help from 17.7% to 46.5%, the authors concluded.
This evidence of persistent racism and bias in medicine, however, doesn’t mean progress is lacking.
ACOG has partnered with numerous other organizations to promote awareness and change, including through legislation. A recent win was the enactment of the Preventing Maternal Deaths Act of 2018, a bipartisan bill designed to promote and support maternal mortality review committees in every state. A major focus of BMMA’s Black Maternal Health Week was the Black Maternal Health Momnibus Act of 2020, a nine-bill package introduced in March to comprehensively address the crisis.
But efforts like these, whether they aim to elucidate the contributors to health disparities or to directly target structural and overt racism and root out implicit bias in medical care, are nothing new. As Dr. Bailey and colleagues noted, a challenge is getting the message across because efforts to avoid tough conversations around these topics are nothing new, either.
Dr. Gee attested to that during a maternal mortality panel discussion at the 2019 ACOG meeting where she spoke about the resistance she encountered in 2016 when she was appointed secretary of the Louisiana Health Department and worked to make racism and bias a foundational part of the discussion on improving maternal and fetal outcomes.
She established the first Office of Health Equity in the state – and the first in the nation to not only require measurement outcomes by race but also explicitly address racial bias at the outset. The goal wasn’t just to talk about it but to “plan for addressing equity in every single aspect of what we do with ... our case equity action teams.”
“At our first maternal mortality quality meetings we insisted on focusing on equity at the very outset, and we had people that left when we started talking about racism,” she said, noting that others said it was “too political” to discuss during an election year or that equity was something to address later.
“We said no. We insisted on it, and I think that was very important because all ships don’t rise with the tide, not with health disparities,” she said, recounting an earlier experience when she led the Louisiana Birth Outcomes Initiative: “I asked to have a brown-bag focused on racism at the department so we could talk about the impact of implicit bias on decision making, and I was told that I was a Yankee who didn’t understand the South and that racism didn’t really exist here, and what did I know about it – and I couldn’t have the brown-bag.”
That was in 2011.
Fast-forward to April 24, 2020. As Dr. Gee shared her perspective on addressing racism and bias in medicine, she was preparing for a call regarding the racial disparities in COVID-19 outcomes – the first health equity action sanctioned by Louisiana Governor John Bel Edwards (D).
“I think we really set the stage for these discussions,” she said.
Addressing equity to enact change
The efforts in Louisiana also set the stage for better maternal outcomes. At the 2019 ACOG meeting where she spoke as part of the President’s Panel, Dr. Gee said Louisiana had the highest maternal mortality rates in the nation. The NCHC data released in January, however, suggest that may no longer be the case.
Inconsistencies in how the latest and prior data were reported, including in how maternal mortality was defined, make direct comparison impossible. But in the latest report, Louisiana ranked seventh among states with available data.
“Ninety percent of the deliveries in the state happen at hospitals that we worked with,” Dr. Gee said, highlighting the reach of the efforts to improve outcomes there.
She also described a recent case involving an anemic patient whose bleeding risk was identified early thanks to the programs put in place. That enabled early preparation in the event of complications.
The patient experienced a massive hemorrhage, but the preparation, including having units of blood on hand in case of such an emergency, saved her life.
“So we clearly have not just data, but individual stories of people whose lives have been saved by this work,” she said.
More tangible data on maternal morbidity further show that the efforts in the state are making a difference, Dr. Gillispie said, citing preliminary outcomes data from the Pregnancy-Associated Mortality Review launched in 2018.
“We started with an initial goal of reducing severe maternal morbidity related to hypertension and hemorrhage by 20%, as well as reducing the black/white disparity gap by Mother’s Day 2020,” she said.
Final analyses have been delayed because of COVID-19, but early assessments showed a reduction in the disparity gap, she said, again highlighting the importance of focusing on equity.
“Definitely from the standpoint of the Quality Collaborative side ... we’ve been working with our facilities to make them aware of what implicit bias is, helping them to also do the Harvard Implicit Bias Test so they can figure out what their own biases are, start working to acknowledge them and address them, and start working to fight against letting that bias change how they treat individuals,” Dr. Gillispie said.
The work started through these initiatives will continue because there is much left to be done, she said.
Indeed, the surprised reactions in recent weeks to the reports of disparities in COVID-19 outcomes further underscore that reality, and the maternal mortality statistics – with use of the voices of those directly affected by structural and overt racism and bias in maternal care as a megaphone – speak for themselves.
Hearing implicit bias from patients’ perspective
Just ask Timoria McQueen Saba, a black woman who nearly died from a postpartum hemorrhage in 2010. At ACOG 2019, she spoke about how she had to switch ob.gyns. three times during her first pregnancy because she felt she had not received quality care – one doctor neglected to tell her she had placenta previa. She also experienced excessive wait times at prenatal appointments and had been on the receiving end of microaggressions and degrading questions such as “Are you still married?” and “Is your husband your baby’s father?” – and these are all things her white friends who recommended those physicians never experienced, she said.
“The health care system has just sometimes beaten people down so much, just like the world has – people of color, especially – to where you’re dismissed, your concerns are invalidated,” she said. “Some doctors don’t even think black people feel pain [or that] our pain is less.”
Mrs. Saba also spoke about how her health care “improved a billion percent” when her white husband accompanied her to appointments.
Just ask Charles S. Johnson IV, whose wife Kira Dixon Johnson died in 2016 during surgery for postpartum bleeding complications – after he and other family members spent 10 hours pleading for help for her.
Speaking at the ACOG panel discussion with Mrs. Saba, Mr. Johnson described “a clear disconnect” between the medical staff at the hospital and the way they viewed and valued Kira. He shared his frustration in wanting to advocate for his wife, but knowing that, as an African American male, he risked being seen as a threat and removed from the hospital if he didn’t stay calm, if he “tapped into those natural instincts as a man and a husband who wants to just protect his family.”
He fought back emotions, struggling to get the words out, saying that’s what haunts him and keeps him up at night – wondering if he should have “fought harder, grabbed the doctor by the collar, raised his voice, slammed on the counter.
“Maybe they would have done something,” he said.
Such experiences cross all socioeconomic boundaries. Ask U.S. Track and Field Olympic gold medalist Allyson Felix, who testified at a U.S. House Ways and Means Committee hearing on May 16, 2019 after developing severe preeclampsia that threatened her life and that of her baby. Ask tennis champion Serena Williams, who demanded assessment for pulmonary embolism following the birth of her child; she knew the signs, but her health care providers initially dismissed her concerns.
Their experiences aren’t just anecdotal. Data consistently show how racism and bias affect patient treatment and outcomes. Dr. Gee, for example, shared findings from a retrospective assessment of 47 confirmed pregnancy-related deaths in Louisiana between 2011 and 2016 that looked specifically at whether the deaths could potentially have been prevented if blood was given sooner, cardiomyopathy was recognized sooner, hypertension was treated on time, or other changes were made to care.
The answer was “Yes” in 9% of cases involving white patients – and in 59% of cases involving black patients (odds ratio, 14.6).
The study, reported in February in Obstetrics & Gynecology, showed that 27 of the deaths (58%) occurred at level III or IV birth facilities and that those deaths were not less likely than those at level I or II facilities to be categorized as preventable (OR, 2.0).
Findings from the Giving Voice to Mothers study, published in Reproductive Health in 2019, showed how mistreatment during childbirth might contribute to such outcomes.
In an online cross-sectional survey of more than 2,100 U.S. women, one in six reported at least one type of mistreatment, such as loss of autonomy, being yelled at or threatened, being ignored or having requests for help ignored, Saraswathi Vedam, SciD, of the Birth Place Lab at the University of British Columbia, Vancouver, and colleagues reported.
Race was among the factors associated with likelihood of mistreatment, and the rates of mistreatment for women of color were consistently higher – even when looking at interactions between race and other characteristics, such as socioeconomic status (SES). For example, 27.2% of women of color with low SES, compared with 18.7% of white women with low SES, reported mistreatment. Having a partner who was black, regardless of maternal race, was also associated with an increased rate of mistreatment, the authors found.
“I often get the question, ‘Do you think Kira would be alive if she was white,’ ” Mr. Johnson said. “The first way I respond to that question is [by saying that] the simple fact that you have to ask me is a problem.
“When this first happened, I was in so much pain that I couldn’t process the fact that something so egregious and outrageous happened to my wife because of the color of her skin, but as I began to process and really think about it and unpack this scenario, I have to be really frank ... do I think that she would have sat there for 10 hours while we begged and pleaded? Absolutely not.”
He stressed that his words aren’t “an indictment of the profession.”
“This is not an indictment saying that all people are racist or prejudiced,” he said. “But here’s the reality: If you are in this profession, if you are responsible for the well-being of patients and their families, and you are not able to see them in the same way that you see your mother, your wife, your sister, you have two options – you need to find something else to do or you need to take steps to get better.”
Fixing systems, finding solutions
Dr. Gee acknowledged the work that physicians need to do to help improve outcomes.
“The average time we give a patient to talk is 11 seconds before we interrupt them,” she said, as one example. “We have to recognize that.”
But efforts to improve outcomes shouldn’t just focus on changing physician behavior, she said.
“We really need to focus, as has the U.K. – very effectively – on using midwives, doulas, other health care professionals as complements to physicians to make sure that we have women-centered birth experiences.
“So, instead of just blaming the doctors, I think we need to change the system,” Dr. Gee emphasized.
The disruptions in health systems caused by COVID-19 present a unique opportunity to do that, she said. There is now an opportunity to build them back.
“We have a chance to build the systems back, and when we do so, we ought to build them back correcting for implicit bias and some of the systemic issues that lead to poor outcomes for people of color in our country,” she said.
Solutions proposed by Dr. Gee and others include more diversity in the workforce, more inclusion of patient advocates in maternal care, development of culturally appropriate literacy and numeracy communications, measurement by race (and action on the outcomes), standardization of care, and development of new ways to improve care access.
We will focus more specifically on these solutions in Part 2 of this article in our maternal mortality series. Previous articles in the series are available at mdedge.com/obgyn/maternal-mortality.
Case reports illustrate heterogeneity of skin manifestations in COVID patients
Two
infection.It is not yet clear from these or other case reports which, if any, skin eruptions accompanying COVID-19 infections are caused by the virus, but the authors of the editorial, led by Lauren M. Madigan, MD, of the department of dermatology at the University of Utah, Salt Lake City, urged dermatologists to lead efforts to find out.
“To fully characterize skin manifestations, it may be necessary for dermatologists to evaluate these patients directly; comprehensive evaluation could reveal important morphologic clues, such as the subtle purpuric nature of skin lesions or the characteristic mucosal or ophthalmologic features of COVID-19,” the authors of the editorial stated.
So far, the patterns of skin symptoms, which have been identified in up to 20% of COVID-19–infected patients in some series, have been heterogeneous as demonstrated in the two published case reports.
In one case, a papulosquamous and erythematous periumbilical patch that appeared on the trunk in an elderly patient 1 day after hospital admission for acute respiratory distress rapidly evolved into a digitate papulosquamous eruption involving the upper arms, shoulder, and back. It was described as “clinically reminiscent” of pityriasis rosea by the authors, from the divisions of dermatology and venereology, pathology, intensive care, and the virology laboratory, of the Hôpital Cochin, Paris.
In the other, pruritic erythematous macules, papules, and petechiae affecting the buttocks, popliteal fossae, anterior thighs, and lower abdomen appeared 3 days after the onset of fever in a 48-year-old man hospitalized in Madrid. A biopsy demonstrated a superficial perivascular lymphocytic infiltrate with red cell extravasation and focal papillary edema, “along with focal parakeratosis and isolated dyskeratotic cells,” according to the authors of this report, from the department of dermatology at Ramon y Cajal University, Madrid.
It was unclear whether COVID-19 directly caused either skin eruption. In the patient with the digitate papulosquamous eruption, no virus could be isolated from the skin. Based on high levels of proinflammatory cytokines, it was hypothesized that the rash might have been secondary to an immune response. The rash resolved within a week, but the patient subsequently died of the infection.
In the second case, the petechial lesions, which developed before any treatment was initiated, were said to resemble those associated with other viruses, such as parvovirus B19. This led the investigators to speculate that SARS-CoV-2 “could affect the skin in a similar way,” even though other potential etiologies could not be excluded. Treated with a topical steroid and an oral antihistamine, the skin lesions resolved after 5 days. This patient was discharged after recovering from the respiratory illness after 12 days.
Like previously reported cutaneous eruptions associated with COVID-19 infection, these cases “raise more questions than they provide answers,” wrote the authors of the editorial, but the limited information currently available was the basis for encouraging dermatologists to get involved.
To participate, dermatologists need not necessarily be affiliated with an academic center, according to one of the editorial coauthors, Kanade Shinkai, MD, PhD, professor of dermatology at the University of California, San Francisco. She noted that any health professional is invited to submit cases of COVID-19–associated dermatoses to a registry set up by the American Academy of Dermatology.
It is hoped that cases captured in this registry will create sufficient data to allow clinically relevant patterns and etiologies to be characterized.
The need for data is clear to those on the front lines. Kirsten Lo Sicco, MD, associate director of the skin and cancer unit at New York University, reported that her center is already set up to collect data systematically. “At NYU, we are currently working on standardizing laboratory and histopathology work up for COVID-19 patients who present with various skin eruptions.”
The goal, she added, is “to better determine COVID-19 pathophysiology, systemic associations, patient outcomes, and potential therapeutics.”
“Presumably, many of the eruptions seen in the setting of COVID-19 infection are related,” Dr. Lo Sicco explained in an interview. However, skin complications of infection “may overlap with or be a result of other etiologies as well.”
While better testing for COVID-19 and more lesion biopsies will play a critical role in differentiating etiologies, “we must not overcall COVID-19–related skin eruptions and potentially overlook other diagnoses,” Dr. Lo Sicco said.
In recounting some challenges from the NYU experience so far, Dr. Lo Sicco described the difficulty of differentiating COVID-19–related skin eruptions from skin eruptions caused by treatments, such as antibiotics and antivirals, when the presentation is delayed.
“This is where collaboration with our dermatopathologists becomes important. Drug eruptions, viral exanthems, urticarial eruptions, vasculopathy, and vasculitis can all be differentiated on dermpath,” she said.
One early obstacle to the skin biopsies essential for these types of studies was the limited supply of personal protective equipment at many centers, including hospitals in New York. Biopsies could not be safely performed if supplies of masks and gowns were limited.
Recent evidence suggests that some of the more common morphologies, such as purpuric eruptions, livedo reticularis, and retiform purpura, are linked to the vasculopathy associated with COVID-19 infection, according to Dr. Lo Sicco, but this invites a new set of questions.
One is whether vasculopathies can be prevented with prophylactic anticoagulation. Many hospitalized COVID-19 patients are already receiving therapeutic anticoagulation, but Dr. Lo Sicco questioned whether prophylactic anticoagulation might improve prognosis for outpatients, such as those discharged or those never hospitalized. This is a strategy now being investigated.
Ultimately, she agreed with the thrust of the JAMA Dermatology editorial.
“Dermatologists are vital to determine if various morphologies, such as urticarial, vesicular, purpuric, or papulosquamous lesions, have any specific systemic implications or relate to differences in patient outcomes,” she said.
These are exactly the types of issues being actively investigated at her center.
Neither the authors of the case reports nor of the editorial reported any conflicts of interest.
SOURCEs: Madigan LM et al. JAMA Dermatol. 2020 Apr 30. doi:10.1001/jamadermatol.2020.1438; Diaz-Guimaraens B et al. JAMA Dermatol. 2020 Apr 30. doi: 10.1001/jamadermatol.2020.1741; Sanchez A et al. JAMA Dermatol. 2020 Apr 30. doi: 10.1001/jamadermatol.2020.1704.
Two
infection.It is not yet clear from these or other case reports which, if any, skin eruptions accompanying COVID-19 infections are caused by the virus, but the authors of the editorial, led by Lauren M. Madigan, MD, of the department of dermatology at the University of Utah, Salt Lake City, urged dermatologists to lead efforts to find out.
“To fully characterize skin manifestations, it may be necessary for dermatologists to evaluate these patients directly; comprehensive evaluation could reveal important morphologic clues, such as the subtle purpuric nature of skin lesions or the characteristic mucosal or ophthalmologic features of COVID-19,” the authors of the editorial stated.
So far, the patterns of skin symptoms, which have been identified in up to 20% of COVID-19–infected patients in some series, have been heterogeneous as demonstrated in the two published case reports.
In one case, a papulosquamous and erythematous periumbilical patch that appeared on the trunk in an elderly patient 1 day after hospital admission for acute respiratory distress rapidly evolved into a digitate papulosquamous eruption involving the upper arms, shoulder, and back. It was described as “clinically reminiscent” of pityriasis rosea by the authors, from the divisions of dermatology and venereology, pathology, intensive care, and the virology laboratory, of the Hôpital Cochin, Paris.
In the other, pruritic erythematous macules, papules, and petechiae affecting the buttocks, popliteal fossae, anterior thighs, and lower abdomen appeared 3 days after the onset of fever in a 48-year-old man hospitalized in Madrid. A biopsy demonstrated a superficial perivascular lymphocytic infiltrate with red cell extravasation and focal papillary edema, “along with focal parakeratosis and isolated dyskeratotic cells,” according to the authors of this report, from the department of dermatology at Ramon y Cajal University, Madrid.
It was unclear whether COVID-19 directly caused either skin eruption. In the patient with the digitate papulosquamous eruption, no virus could be isolated from the skin. Based on high levels of proinflammatory cytokines, it was hypothesized that the rash might have been secondary to an immune response. The rash resolved within a week, but the patient subsequently died of the infection.
In the second case, the petechial lesions, which developed before any treatment was initiated, were said to resemble those associated with other viruses, such as parvovirus B19. This led the investigators to speculate that SARS-CoV-2 “could affect the skin in a similar way,” even though other potential etiologies could not be excluded. Treated with a topical steroid and an oral antihistamine, the skin lesions resolved after 5 days. This patient was discharged after recovering from the respiratory illness after 12 days.
Like previously reported cutaneous eruptions associated with COVID-19 infection, these cases “raise more questions than they provide answers,” wrote the authors of the editorial, but the limited information currently available was the basis for encouraging dermatologists to get involved.
To participate, dermatologists need not necessarily be affiliated with an academic center, according to one of the editorial coauthors, Kanade Shinkai, MD, PhD, professor of dermatology at the University of California, San Francisco. She noted that any health professional is invited to submit cases of COVID-19–associated dermatoses to a registry set up by the American Academy of Dermatology.
It is hoped that cases captured in this registry will create sufficient data to allow clinically relevant patterns and etiologies to be characterized.
The need for data is clear to those on the front lines. Kirsten Lo Sicco, MD, associate director of the skin and cancer unit at New York University, reported that her center is already set up to collect data systematically. “At NYU, we are currently working on standardizing laboratory and histopathology work up for COVID-19 patients who present with various skin eruptions.”
The goal, she added, is “to better determine COVID-19 pathophysiology, systemic associations, patient outcomes, and potential therapeutics.”
“Presumably, many of the eruptions seen in the setting of COVID-19 infection are related,” Dr. Lo Sicco explained in an interview. However, skin complications of infection “may overlap with or be a result of other etiologies as well.”
While better testing for COVID-19 and more lesion biopsies will play a critical role in differentiating etiologies, “we must not overcall COVID-19–related skin eruptions and potentially overlook other diagnoses,” Dr. Lo Sicco said.
In recounting some challenges from the NYU experience so far, Dr. Lo Sicco described the difficulty of differentiating COVID-19–related skin eruptions from skin eruptions caused by treatments, such as antibiotics and antivirals, when the presentation is delayed.
“This is where collaboration with our dermatopathologists becomes important. Drug eruptions, viral exanthems, urticarial eruptions, vasculopathy, and vasculitis can all be differentiated on dermpath,” she said.
One early obstacle to the skin biopsies essential for these types of studies was the limited supply of personal protective equipment at many centers, including hospitals in New York. Biopsies could not be safely performed if supplies of masks and gowns were limited.
Recent evidence suggests that some of the more common morphologies, such as purpuric eruptions, livedo reticularis, and retiform purpura, are linked to the vasculopathy associated with COVID-19 infection, according to Dr. Lo Sicco, but this invites a new set of questions.
One is whether vasculopathies can be prevented with prophylactic anticoagulation. Many hospitalized COVID-19 patients are already receiving therapeutic anticoagulation, but Dr. Lo Sicco questioned whether prophylactic anticoagulation might improve prognosis for outpatients, such as those discharged or those never hospitalized. This is a strategy now being investigated.
Ultimately, she agreed with the thrust of the JAMA Dermatology editorial.
“Dermatologists are vital to determine if various morphologies, such as urticarial, vesicular, purpuric, or papulosquamous lesions, have any specific systemic implications or relate to differences in patient outcomes,” she said.
These are exactly the types of issues being actively investigated at her center.
Neither the authors of the case reports nor of the editorial reported any conflicts of interest.
SOURCEs: Madigan LM et al. JAMA Dermatol. 2020 Apr 30. doi:10.1001/jamadermatol.2020.1438; Diaz-Guimaraens B et al. JAMA Dermatol. 2020 Apr 30. doi: 10.1001/jamadermatol.2020.1741; Sanchez A et al. JAMA Dermatol. 2020 Apr 30. doi: 10.1001/jamadermatol.2020.1704.
Two
infection.It is not yet clear from these or other case reports which, if any, skin eruptions accompanying COVID-19 infections are caused by the virus, but the authors of the editorial, led by Lauren M. Madigan, MD, of the department of dermatology at the University of Utah, Salt Lake City, urged dermatologists to lead efforts to find out.
“To fully characterize skin manifestations, it may be necessary for dermatologists to evaluate these patients directly; comprehensive evaluation could reveal important morphologic clues, such as the subtle purpuric nature of skin lesions or the characteristic mucosal or ophthalmologic features of COVID-19,” the authors of the editorial stated.
So far, the patterns of skin symptoms, which have been identified in up to 20% of COVID-19–infected patients in some series, have been heterogeneous as demonstrated in the two published case reports.
In one case, a papulosquamous and erythematous periumbilical patch that appeared on the trunk in an elderly patient 1 day after hospital admission for acute respiratory distress rapidly evolved into a digitate papulosquamous eruption involving the upper arms, shoulder, and back. It was described as “clinically reminiscent” of pityriasis rosea by the authors, from the divisions of dermatology and venereology, pathology, intensive care, and the virology laboratory, of the Hôpital Cochin, Paris.
In the other, pruritic erythematous macules, papules, and petechiae affecting the buttocks, popliteal fossae, anterior thighs, and lower abdomen appeared 3 days after the onset of fever in a 48-year-old man hospitalized in Madrid. A biopsy demonstrated a superficial perivascular lymphocytic infiltrate with red cell extravasation and focal papillary edema, “along with focal parakeratosis and isolated dyskeratotic cells,” according to the authors of this report, from the department of dermatology at Ramon y Cajal University, Madrid.
It was unclear whether COVID-19 directly caused either skin eruption. In the patient with the digitate papulosquamous eruption, no virus could be isolated from the skin. Based on high levels of proinflammatory cytokines, it was hypothesized that the rash might have been secondary to an immune response. The rash resolved within a week, but the patient subsequently died of the infection.
In the second case, the petechial lesions, which developed before any treatment was initiated, were said to resemble those associated with other viruses, such as parvovirus B19. This led the investigators to speculate that SARS-CoV-2 “could affect the skin in a similar way,” even though other potential etiologies could not be excluded. Treated with a topical steroid and an oral antihistamine, the skin lesions resolved after 5 days. This patient was discharged after recovering from the respiratory illness after 12 days.
Like previously reported cutaneous eruptions associated with COVID-19 infection, these cases “raise more questions than they provide answers,” wrote the authors of the editorial, but the limited information currently available was the basis for encouraging dermatologists to get involved.
To participate, dermatologists need not necessarily be affiliated with an academic center, according to one of the editorial coauthors, Kanade Shinkai, MD, PhD, professor of dermatology at the University of California, San Francisco. She noted that any health professional is invited to submit cases of COVID-19–associated dermatoses to a registry set up by the American Academy of Dermatology.
It is hoped that cases captured in this registry will create sufficient data to allow clinically relevant patterns and etiologies to be characterized.
The need for data is clear to those on the front lines. Kirsten Lo Sicco, MD, associate director of the skin and cancer unit at New York University, reported that her center is already set up to collect data systematically. “At NYU, we are currently working on standardizing laboratory and histopathology work up for COVID-19 patients who present with various skin eruptions.”
The goal, she added, is “to better determine COVID-19 pathophysiology, systemic associations, patient outcomes, and potential therapeutics.”
“Presumably, many of the eruptions seen in the setting of COVID-19 infection are related,” Dr. Lo Sicco explained in an interview. However, skin complications of infection “may overlap with or be a result of other etiologies as well.”
While better testing for COVID-19 and more lesion biopsies will play a critical role in differentiating etiologies, “we must not overcall COVID-19–related skin eruptions and potentially overlook other diagnoses,” Dr. Lo Sicco said.
In recounting some challenges from the NYU experience so far, Dr. Lo Sicco described the difficulty of differentiating COVID-19–related skin eruptions from skin eruptions caused by treatments, such as antibiotics and antivirals, when the presentation is delayed.
“This is where collaboration with our dermatopathologists becomes important. Drug eruptions, viral exanthems, urticarial eruptions, vasculopathy, and vasculitis can all be differentiated on dermpath,” she said.
One early obstacle to the skin biopsies essential for these types of studies was the limited supply of personal protective equipment at many centers, including hospitals in New York. Biopsies could not be safely performed if supplies of masks and gowns were limited.
Recent evidence suggests that some of the more common morphologies, such as purpuric eruptions, livedo reticularis, and retiform purpura, are linked to the vasculopathy associated with COVID-19 infection, according to Dr. Lo Sicco, but this invites a new set of questions.
One is whether vasculopathies can be prevented with prophylactic anticoagulation. Many hospitalized COVID-19 patients are already receiving therapeutic anticoagulation, but Dr. Lo Sicco questioned whether prophylactic anticoagulation might improve prognosis for outpatients, such as those discharged or those never hospitalized. This is a strategy now being investigated.
Ultimately, she agreed with the thrust of the JAMA Dermatology editorial.
“Dermatologists are vital to determine if various morphologies, such as urticarial, vesicular, purpuric, or papulosquamous lesions, have any specific systemic implications or relate to differences in patient outcomes,” she said.
These are exactly the types of issues being actively investigated at her center.
Neither the authors of the case reports nor of the editorial reported any conflicts of interest.
SOURCEs: Madigan LM et al. JAMA Dermatol. 2020 Apr 30. doi:10.1001/jamadermatol.2020.1438; Diaz-Guimaraens B et al. JAMA Dermatol. 2020 Apr 30. doi: 10.1001/jamadermatol.2020.1741; Sanchez A et al. JAMA Dermatol. 2020 Apr 30. doi: 10.1001/jamadermatol.2020.1704.
Three months of COVID-19 may mean 80,000 missed cancer diagnoses
a report by the IQVIA Institute for Human Data Science looking at trends in the United States.
, according toScreening and monitoring tests for breast, prostate, colorectal, cervical, and lung cancer were down 39%-90% in early April, compared with the baseline month of February, according to report authors Murray Aitken and Michael Kleinrock, both of IQVIA.
These findings are based on data from IQVIA’s medical claims database, which includes more than 205 million patients, over 1.7 billion claims, and 3 billion service records obtained annually.
The data suggest that, at current positivity rates, there could be 36,000 missed or delayed diagnoses of breast cancer during the 3-month period from early March through early June. Estimates for missed diagnoses of the four other cancers analyzed include 450 for lung cancer, 2,500 for cervical cancer, 18,800 for colorectal cancer, and 22,600 for prostate cancer.
The authors project a total of 22 million canceled or delayed tests for the five cancers over the 3-month period ending June 5, based on a comparison of claims data for early April with the February baseline. Catching up on this backlog will be problematic, according to the authors.
“Current excess health care capacity ... would require providers to shift priorities to make time and space in schedules and facilities as well as the cooperation of patients to return to health care providers,” the authors wrote. “Both of these could be further disrupted by economic factors or reintroduction of social distancing in a reemergence of the outbreak.”
The report was produced by the IQVIA Institute for Human Data Science without industry or government funding.
SOURCE: Murray A and Kleinrock M. Shifts in healthcare demand, delivery and care during the COVID-19 era. IQVIA Institute for Human Data Science. April 2020.
a report by the IQVIA Institute for Human Data Science looking at trends in the United States.
, according toScreening and monitoring tests for breast, prostate, colorectal, cervical, and lung cancer were down 39%-90% in early April, compared with the baseline month of February, according to report authors Murray Aitken and Michael Kleinrock, both of IQVIA.
These findings are based on data from IQVIA’s medical claims database, which includes more than 205 million patients, over 1.7 billion claims, and 3 billion service records obtained annually.
The data suggest that, at current positivity rates, there could be 36,000 missed or delayed diagnoses of breast cancer during the 3-month period from early March through early June. Estimates for missed diagnoses of the four other cancers analyzed include 450 for lung cancer, 2,500 for cervical cancer, 18,800 for colorectal cancer, and 22,600 for prostate cancer.
The authors project a total of 22 million canceled or delayed tests for the five cancers over the 3-month period ending June 5, based on a comparison of claims data for early April with the February baseline. Catching up on this backlog will be problematic, according to the authors.
“Current excess health care capacity ... would require providers to shift priorities to make time and space in schedules and facilities as well as the cooperation of patients to return to health care providers,” the authors wrote. “Both of these could be further disrupted by economic factors or reintroduction of social distancing in a reemergence of the outbreak.”
The report was produced by the IQVIA Institute for Human Data Science without industry or government funding.
SOURCE: Murray A and Kleinrock M. Shifts in healthcare demand, delivery and care during the COVID-19 era. IQVIA Institute for Human Data Science. April 2020.
a report by the IQVIA Institute for Human Data Science looking at trends in the United States.
, according toScreening and monitoring tests for breast, prostate, colorectal, cervical, and lung cancer were down 39%-90% in early April, compared with the baseline month of February, according to report authors Murray Aitken and Michael Kleinrock, both of IQVIA.
These findings are based on data from IQVIA’s medical claims database, which includes more than 205 million patients, over 1.7 billion claims, and 3 billion service records obtained annually.
The data suggest that, at current positivity rates, there could be 36,000 missed or delayed diagnoses of breast cancer during the 3-month period from early March through early June. Estimates for missed diagnoses of the four other cancers analyzed include 450 for lung cancer, 2,500 for cervical cancer, 18,800 for colorectal cancer, and 22,600 for prostate cancer.
The authors project a total of 22 million canceled or delayed tests for the five cancers over the 3-month period ending June 5, based on a comparison of claims data for early April with the February baseline. Catching up on this backlog will be problematic, according to the authors.
“Current excess health care capacity ... would require providers to shift priorities to make time and space in schedules and facilities as well as the cooperation of patients to return to health care providers,” the authors wrote. “Both of these could be further disrupted by economic factors or reintroduction of social distancing in a reemergence of the outbreak.”
The report was produced by the IQVIA Institute for Human Data Science without industry or government funding.
SOURCE: Murray A and Kleinrock M. Shifts in healthcare demand, delivery and care during the COVID-19 era. IQVIA Institute for Human Data Science. April 2020.
Cancer screening, monitoring down during pandemic
according to a report by the IQVIA Institute for Human Data Science.
There were 90% fewer colonoscopies ordered during the week ending April 10, compared with the weekly average for Feb. 1-28, based on claims data analyzed by IQVIA.
IQVIA’s medical claims database includes more than 205 million patients, over 1.7 billion claims, and 3 billion service records obtained annually.
The data also showed an 87% reduction in mammograms and an 83% reduction in Pap smears during the week ending April 10. Prostate-specific antigen tests for prostate cancer decreased by 60%, and CT scans for lung cancer decreased by 39%.
The smaller decrease in CT scans for lung cancer “may reflect the generally more serious nature of those tumors or be due to concerns about ruling out COVID-related issues in some patients,” according to report authors Murray Aitken and Michael Kleinrock, both of IQVIA.
The report also showed that overall patient interactions with oncologists were down by 20% through April 3, based on medical and pharmacy claims processed since February, but there was variation by tumor type.
The authors noted “little or no disruption” in oncologist visits in March for patients with aggressive tumors or those diagnosed at advanced stages, compared with February. However, for patients with skin cancer or prostate cancer, visit rates were down by 20%-50% in March.
“This may reflect that oncologists who are providing care across multiple tumor types are prioritizing their time and efforts to those patients with more advanced or aggressive tumors,” the authors wrote.
This report was produced by the IQVIA Institute for Human Data Science without industry or government funding.
SOURCE: Murray A and Kleinrock M. Shifts in healthcare demand, delivery and care during the COVID-19 era. IQVIA Institute for Human Data Science. April 2020.
according to a report by the IQVIA Institute for Human Data Science.
There were 90% fewer colonoscopies ordered during the week ending April 10, compared with the weekly average for Feb. 1-28, based on claims data analyzed by IQVIA.
IQVIA’s medical claims database includes more than 205 million patients, over 1.7 billion claims, and 3 billion service records obtained annually.
The data also showed an 87% reduction in mammograms and an 83% reduction in Pap smears during the week ending April 10. Prostate-specific antigen tests for prostate cancer decreased by 60%, and CT scans for lung cancer decreased by 39%.
The smaller decrease in CT scans for lung cancer “may reflect the generally more serious nature of those tumors or be due to concerns about ruling out COVID-related issues in some patients,” according to report authors Murray Aitken and Michael Kleinrock, both of IQVIA.
The report also showed that overall patient interactions with oncologists were down by 20% through April 3, based on medical and pharmacy claims processed since February, but there was variation by tumor type.
The authors noted “little or no disruption” in oncologist visits in March for patients with aggressive tumors or those diagnosed at advanced stages, compared with February. However, for patients with skin cancer or prostate cancer, visit rates were down by 20%-50% in March.
“This may reflect that oncologists who are providing care across multiple tumor types are prioritizing their time and efforts to those patients with more advanced or aggressive tumors,” the authors wrote.
This report was produced by the IQVIA Institute for Human Data Science without industry or government funding.
SOURCE: Murray A and Kleinrock M. Shifts in healthcare demand, delivery and care during the COVID-19 era. IQVIA Institute for Human Data Science. April 2020.
according to a report by the IQVIA Institute for Human Data Science.
There were 90% fewer colonoscopies ordered during the week ending April 10, compared with the weekly average for Feb. 1-28, based on claims data analyzed by IQVIA.
IQVIA’s medical claims database includes more than 205 million patients, over 1.7 billion claims, and 3 billion service records obtained annually.
The data also showed an 87% reduction in mammograms and an 83% reduction in Pap smears during the week ending April 10. Prostate-specific antigen tests for prostate cancer decreased by 60%, and CT scans for lung cancer decreased by 39%.
The smaller decrease in CT scans for lung cancer “may reflect the generally more serious nature of those tumors or be due to concerns about ruling out COVID-related issues in some patients,” according to report authors Murray Aitken and Michael Kleinrock, both of IQVIA.
The report also showed that overall patient interactions with oncologists were down by 20% through April 3, based on medical and pharmacy claims processed since February, but there was variation by tumor type.
The authors noted “little or no disruption” in oncologist visits in March for patients with aggressive tumors or those diagnosed at advanced stages, compared with February. However, for patients with skin cancer or prostate cancer, visit rates were down by 20%-50% in March.
“This may reflect that oncologists who are providing care across multiple tumor types are prioritizing their time and efforts to those patients with more advanced or aggressive tumors,” the authors wrote.
This report was produced by the IQVIA Institute for Human Data Science without industry or government funding.
SOURCE: Murray A and Kleinrock M. Shifts in healthcare demand, delivery and care during the COVID-19 era. IQVIA Institute for Human Data Science. April 2020.
FDA tightens requirements for COVID-19 antibody tests
The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.
The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.
When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.
“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.
The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.
In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.
“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”
At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.
In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.
To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.
Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.
“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”
The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.
The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.
When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.
“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.
The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.
In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.
“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”
At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.
In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.
To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.
Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.
“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”
The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.
The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.
When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.
“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.
The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.
In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.
“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”
At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.
In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.
To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.
Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.
“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”
Hydroxychloroquine-triggered QTc-interval prolongations mount in COVID-19 patients
The potential for serious arrhythmias from hydroxychloroquine treatment of COVID-19 patients received further documentation from a pair of studies released on May 1, casting further doubt on whether the uncertain benefit from this or related drugs to infected patients is worth the clear risks the agents pose.
A report from 90 confirmed COVID-19 patients treated with hydroxychloroquine at one Boston hospital during March-April 2020 identified a significantly prolonged, corrected QT (QTc) interval of at least 500 msec in 18 patients (20%), which included 10 patients whose QTc rose by at least 60 msec above baseline, and a total of 21 patients (23%) having a notable prolongation (JAMA Cardiol. 2020 May 4. doi: 10.1001/jamacardio.2020.1834). This series included one patient who developed torsades de pointes following treatment with hydroxychloroquine and azithromycin, “which to our knowledge has yet to be reported elsewhere in the literature,” the report said.
The second report, from a single center in Lyon, France, included 40 confirmed COVID-19 patients treated with hydroxychloroquine during 2 weeks in late March, and found that 37 (93%) had some increase in the QTc interval, including 14 patients (36%) with an increase of at least 60 msec, and 7 patients (18%) whose QTc rose to at least 500 msec (JAMA Cardiol. 2020 May. doi: 10.1001/jamacardio.2020.1787). However, none of the 40 patients in this series developed an identified ventricular arrhythmia. All patients in both studies received hydroxychloroquine for at least 1 day, and roughly half the patients in each series also received concurrent azithromycin, another drug that can prolong the QTc interval and that has been frequently used in combination with hydroxychloroquine as an unproven COVID-19 treatment cocktail.
These two reports, as well as prior report from Brazil on COVID-19 patients treated with chloroquine diphosphate (JAMA Netw Open. 2020;3[4]:e208857), “underscore the potential risk associated with widespread use of hydroxychloroquine and the combination of hydroxychloroquine and azithromycin in ambulatory patients with known or suspected COVID-19. Understanding whether this risk is worth taking in the absence of evidence of therapeutic efficacy creates a knowledge gap that needs to be addressed,” wrote Robert O. Bonow, MD, a professor of medicine at Northwestern University in Chicago, and coauthors in an editorial that accompanied the two reports (JAMA Cardiol. 2020 May 4;doi: 10.1001/jamacardio.2020.1782). The editorial cited two recently-begun prospective trials, ORCHID and RECOVERY, that are more systematically assessing the safety and efficacy of hydroxychloroquine treatment in COVID-19 patients.
The findings lend further support to a Safety Communication from the U.S. Food and Drug Administration on April 24 that reminded clinicians that the Emergency Use Authorization for hydroxychloroquine and chloroquine in COVID-19 patients that the FDA issued on March 28 applied to only certain hospitalized patients or those enrolled in clinical trials. The Safety Communication also said that agency was aware of reports of adverse arrhythmia events when COVID-19 patients received these drugs outside a hospital setting as well as uninfected people who had received one of these drugs for preventing infection.
In addition, leaders of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society on April 10 issued a summary of considerations when using hydroxychloroquine and azithromycin to treat COVID-19 patients, and noted that a way to minimized the risk from these drugs is to withhold them from patients with a QTc interval of 500 msec or greater at baseline (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). The summary also highlighted the need for regular ECG monitoring of COVID-19 patients who receive drugs that can prolong the QTc interval, and recommended withdrawing treatment from patients when their QTc exceeds the 500 msec threshold.
None of the authors of the two reports and editorial had relevant commercial disclosures.
The potential for serious arrhythmias from hydroxychloroquine treatment of COVID-19 patients received further documentation from a pair of studies released on May 1, casting further doubt on whether the uncertain benefit from this or related drugs to infected patients is worth the clear risks the agents pose.
A report from 90 confirmed COVID-19 patients treated with hydroxychloroquine at one Boston hospital during March-April 2020 identified a significantly prolonged, corrected QT (QTc) interval of at least 500 msec in 18 patients (20%), which included 10 patients whose QTc rose by at least 60 msec above baseline, and a total of 21 patients (23%) having a notable prolongation (JAMA Cardiol. 2020 May 4. doi: 10.1001/jamacardio.2020.1834). This series included one patient who developed torsades de pointes following treatment with hydroxychloroquine and azithromycin, “which to our knowledge has yet to be reported elsewhere in the literature,” the report said.
The second report, from a single center in Lyon, France, included 40 confirmed COVID-19 patients treated with hydroxychloroquine during 2 weeks in late March, and found that 37 (93%) had some increase in the QTc interval, including 14 patients (36%) with an increase of at least 60 msec, and 7 patients (18%) whose QTc rose to at least 500 msec (JAMA Cardiol. 2020 May. doi: 10.1001/jamacardio.2020.1787). However, none of the 40 patients in this series developed an identified ventricular arrhythmia. All patients in both studies received hydroxychloroquine for at least 1 day, and roughly half the patients in each series also received concurrent azithromycin, another drug that can prolong the QTc interval and that has been frequently used in combination with hydroxychloroquine as an unproven COVID-19 treatment cocktail.
These two reports, as well as prior report from Brazil on COVID-19 patients treated with chloroquine diphosphate (JAMA Netw Open. 2020;3[4]:e208857), “underscore the potential risk associated with widespread use of hydroxychloroquine and the combination of hydroxychloroquine and azithromycin in ambulatory patients with known or suspected COVID-19. Understanding whether this risk is worth taking in the absence of evidence of therapeutic efficacy creates a knowledge gap that needs to be addressed,” wrote Robert O. Bonow, MD, a professor of medicine at Northwestern University in Chicago, and coauthors in an editorial that accompanied the two reports (JAMA Cardiol. 2020 May 4;doi: 10.1001/jamacardio.2020.1782). The editorial cited two recently-begun prospective trials, ORCHID and RECOVERY, that are more systematically assessing the safety and efficacy of hydroxychloroquine treatment in COVID-19 patients.
The findings lend further support to a Safety Communication from the U.S. Food and Drug Administration on April 24 that reminded clinicians that the Emergency Use Authorization for hydroxychloroquine and chloroquine in COVID-19 patients that the FDA issued on March 28 applied to only certain hospitalized patients or those enrolled in clinical trials. The Safety Communication also said that agency was aware of reports of adverse arrhythmia events when COVID-19 patients received these drugs outside a hospital setting as well as uninfected people who had received one of these drugs for preventing infection.
In addition, leaders of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society on April 10 issued a summary of considerations when using hydroxychloroquine and azithromycin to treat COVID-19 patients, and noted that a way to minimized the risk from these drugs is to withhold them from patients with a QTc interval of 500 msec or greater at baseline (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). The summary also highlighted the need for regular ECG monitoring of COVID-19 patients who receive drugs that can prolong the QTc interval, and recommended withdrawing treatment from patients when their QTc exceeds the 500 msec threshold.
None of the authors of the two reports and editorial had relevant commercial disclosures.
The potential for serious arrhythmias from hydroxychloroquine treatment of COVID-19 patients received further documentation from a pair of studies released on May 1, casting further doubt on whether the uncertain benefit from this or related drugs to infected patients is worth the clear risks the agents pose.
A report from 90 confirmed COVID-19 patients treated with hydroxychloroquine at one Boston hospital during March-April 2020 identified a significantly prolonged, corrected QT (QTc) interval of at least 500 msec in 18 patients (20%), which included 10 patients whose QTc rose by at least 60 msec above baseline, and a total of 21 patients (23%) having a notable prolongation (JAMA Cardiol. 2020 May 4. doi: 10.1001/jamacardio.2020.1834). This series included one patient who developed torsades de pointes following treatment with hydroxychloroquine and azithromycin, “which to our knowledge has yet to be reported elsewhere in the literature,” the report said.
The second report, from a single center in Lyon, France, included 40 confirmed COVID-19 patients treated with hydroxychloroquine during 2 weeks in late March, and found that 37 (93%) had some increase in the QTc interval, including 14 patients (36%) with an increase of at least 60 msec, and 7 patients (18%) whose QTc rose to at least 500 msec (JAMA Cardiol. 2020 May. doi: 10.1001/jamacardio.2020.1787). However, none of the 40 patients in this series developed an identified ventricular arrhythmia. All patients in both studies received hydroxychloroquine for at least 1 day, and roughly half the patients in each series also received concurrent azithromycin, another drug that can prolong the QTc interval and that has been frequently used in combination with hydroxychloroquine as an unproven COVID-19 treatment cocktail.
These two reports, as well as prior report from Brazil on COVID-19 patients treated with chloroquine diphosphate (JAMA Netw Open. 2020;3[4]:e208857), “underscore the potential risk associated with widespread use of hydroxychloroquine and the combination of hydroxychloroquine and azithromycin in ambulatory patients with known or suspected COVID-19. Understanding whether this risk is worth taking in the absence of evidence of therapeutic efficacy creates a knowledge gap that needs to be addressed,” wrote Robert O. Bonow, MD, a professor of medicine at Northwestern University in Chicago, and coauthors in an editorial that accompanied the two reports (JAMA Cardiol. 2020 May 4;doi: 10.1001/jamacardio.2020.1782). The editorial cited two recently-begun prospective trials, ORCHID and RECOVERY, that are more systematically assessing the safety and efficacy of hydroxychloroquine treatment in COVID-19 patients.
The findings lend further support to a Safety Communication from the U.S. Food and Drug Administration on April 24 that reminded clinicians that the Emergency Use Authorization for hydroxychloroquine and chloroquine in COVID-19 patients that the FDA issued on March 28 applied to only certain hospitalized patients or those enrolled in clinical trials. The Safety Communication also said that agency was aware of reports of adverse arrhythmia events when COVID-19 patients received these drugs outside a hospital setting as well as uninfected people who had received one of these drugs for preventing infection.
In addition, leaders of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society on April 10 issued a summary of considerations when using hydroxychloroquine and azithromycin to treat COVID-19 patients, and noted that a way to minimized the risk from these drugs is to withhold them from patients with a QTc interval of 500 msec or greater at baseline (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). The summary also highlighted the need for regular ECG monitoring of COVID-19 patients who receive drugs that can prolong the QTc interval, and recommended withdrawing treatment from patients when their QTc exceeds the 500 msec threshold.
None of the authors of the two reports and editorial had relevant commercial disclosures.
FROM JAMA CARDIOLOGY