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Letter counters study that focuses on low-risk home births
A research letter published recently in the American Journal of Obstetrics and Gynecology argues that the methodology of a recent paper on the safety of planned home births presented a biased analysis.
The paper that Amos Grünebaum, MD, and colleagues with the department of obstetrics and gynecology at Lenox Hill Hospital in Hempstead, N.J., referred to is a study in Obstetrics & Gynecology which concluded that planned home births in Washington state are low risk.
In that paper, Elizabeth Nethery, RM, MS, MSM, a midwife and PhD candidate at the University of British Columbia, Vancouver, calculated the outcomes from 2015 to 2020 for “all births attended by members of a statewide midwifery professional association that were within professional association guidelines and met eligibility criteria for planned birth center birth.”
Ms. Nethery’s team concluded: “Rates of adverse outcomes for this cohort in a U.S. state with well-established and integrated community midwifery were low overall. Birth outcomes were similar for births planned at home or at a state-licensed, freestanding birth center.”
This news organization was among the publications that reported the results of that study.
But it’s the exclusion criteria in that study, primarily, that Dr. Grünebaum and colleagues take issue with.
Births excluded from the main analysis of the study by Ms. Nethery and coauthors involved “multifetal pregnancy, prior cesarean delivery, onset of labor at more than 42 0/7 weeks of gestation or preterm (less than 37 weeks), preexisting hypertension or diabetes, known amniotic fluid abnormality, gestational hypertension or preeclampsia, or malpresentation.”
Those are conditions that fall outside guidelines for planned home births. But both Ms. Nethery and Dr. Grünebaum said that sometimes these high-risk conditions are present in home births.
Different conclusion for home birth safety
Dr. Grünebaum and colleagues’ analysis of the risk profiles and outcomes for U.S. planned home births for the years 2016-2020 came to a different conclusion about the safety of home births.
They used a retrospective population-based cohort study that used the Centers for Disease Control and Prevention WONDER natality online database. They included planned home births and compared the outcomes with and without certain risk factors, including some high-risk factors such as twin deliveries, breech births, and previous cesarean.
Dr. Grünebaum’s analysis concluded that “it is an immutable truth that planned home births in the United States result in avoidable risks of increased adverse neonatal outcomes.”
Ms. Nethery said though the high-risk conditions were excluded from their main analysis, they are mentioned in the paper and detailed in the supplement.
She acknowledged in the paper that some midwives practice outside the guidelines and that was the case in 7% of births or for 800 people in the Washington state study. But she told this publication it’s a small number and high-risk births should be handled in a hospital so the team focused its research on low-risk births.
“People plan home births who are outside the guidelines everywhere in the world. There are a lot of reasons why people do it,” she said. Among them are not feeling safe in the hospital, being rejected by an obstetrician for a desired procedure, or, in some cases, because they are misinformed.
She said midwives are sometimes faced with a difficult choice, when a patient wants, for instance, a vaginal birth after cesarean (VBAC), one of the conditions not recommended for home births.
The midwife is left with the choice of saying she will not do a VBAC in the home, or she can explain to the patient why it is not recommended and explain all the reasons it is not recommended, such as an elevated risk of rupture, but honor the patient’s choice.
“Do you tell the person: ‘Sorry, go have the cesarean anyway or do you do your best to support this person?’ Birthing people have the right to autonomy of choice,” Ms. Nethery said.
Dr. Grünebaum and colleagues said: “The recent study by Nethery et al. concluded that planned home births in the state of Washington have good neonatal outcomes by focusing on results of low-risk patients.”
Dr. Grünebaum said in an interview: “It’s like reporting on smoking and lung cancer and saying I’m only going to report on patients who have smoked for less than 5 years. You need to take the whole picture into consideration.”
Ms. Nethery gave this explanation for excluding the high-risk patients: “If you are studying a drug, you exclude people from your study who got the drug even though they had risk factors that were ‘contraindications’ to that drug. Likely there was a reason they got the drug – in consultation with their doctor, the patient and the doctor decided that the potential benefit outweighed the risk – but they are not relevant to understanding how that drug impacts people who were ‘eligible’ for the drug in the first place.”
“That is part of the reason we excluded ‘high-risk’ people from our study,” she said. “The other reason is that that is what is commonly done in most research on this topic – we focus on ‘low-risk’ people who are within standards and eligibility criteria.”
She gave examples such as a 2019 meta-analysis and a 2011 Birthplace in England national prospective cohort study, both of which excluded high-risk home births.
“Third, we wanted to compare apples to apples (for our analysis of home vs. hospital) – and licensed birth centers in Washington state have restrictions based on risk,” Ms. Nethery said.
Dr. Grünebaum said his team supports the right of all women to give birth where they wish. “But you cannot choose unless you are given the right information.”
Dr. Grünebaum also said planned home births in the United States cannot be compared with home births delivered by midwives in other countries. Different from the United States, he said, in countries such as Canada, Germany, and England, midwives are well integrated in the medical system and they are typically affiliated with hospitals and they belong to organizations which support very strong guidelines.
He added that, while Washington state has its own set of guidelines, there are no national guidelines for home births and practice varies greatly by state.
The authors concluded: “It is the professional responsibility of all health care providers, obstetricians, and midwives to present unbiased information. Focusing the reporting of outcomes on low-risk deliveries underreports true adverse outcomes in U.S. home births and provides biased information to patients considering planned home births. It is an immutable truth that planned home births in the United States result in avoidable risks of increased adverse neonatal outcomes.”
Angela Martin, MD, assistant professor of maternal-fetal medicine and medical director of the labor and delivery department at University of Kansas Medical Center, Kansas City, who was not part of either study, said she did not believe it was a problem that Ms. Nethery’s study excluded the high-risk conditions in the main analysis because it was disclosed.
“The authors were clear that they excluded high-risk conditions,” she said. “Therefore, the study should not be extrapolated to women with these conditions.”
“I believe her results do make that case for low-risk women in Washington state,” Dr. Martin said. “Again, it is important that findings are not extrapolated to women outside of those included in the study.”
She said there are several things that make Washington unusual in midwifery care. Consequently, the results should not be seen as representative of the United States.
“It is one of the most integrated states for midwife care in the country,” Dr. Martin said. “Washington has licensure available for midwives, which is not true of all states. It also has a robust state professional association that publishes guidelines for midwives to follow. And midwives in Washington have a wide formulary. For example, they can administer antibiotics, carry and administer hemorrhage medications, they can carry oxygen, and they are allowed to suture.”
Iris Krishna, MD, MPH, director of perinatal quality, Emory Perinatal Center and assistant professor in the division of maternal-fetal medicine at Emory University, Atlanta, said in an interview that the arguments by Ms. Nethery and Dr. Grünebaum illustrate the controversy over home births.
Dr. Krishna, who was not part of either study, said physicians and midwives should counsel patients contemplating a planned community birth that available data is not generalizable to all birth settings or all patients.
“Women should be counseled that delivery in a hospital setting or accredited birth center is safer than home birth,” she said. “Ultimately, each woman has the right to make a medically informed decision about delivery after adequate counseling on the risks and benefits of community birth.”
Dr. Grünebaum and colleagues reported no relevant financial relationships. Ms. Nethery, Dr. Martin, and Dr. Krishna also reported no relevant financial relationships.
A research letter published recently in the American Journal of Obstetrics and Gynecology argues that the methodology of a recent paper on the safety of planned home births presented a biased analysis.
The paper that Amos Grünebaum, MD, and colleagues with the department of obstetrics and gynecology at Lenox Hill Hospital in Hempstead, N.J., referred to is a study in Obstetrics & Gynecology which concluded that planned home births in Washington state are low risk.
In that paper, Elizabeth Nethery, RM, MS, MSM, a midwife and PhD candidate at the University of British Columbia, Vancouver, calculated the outcomes from 2015 to 2020 for “all births attended by members of a statewide midwifery professional association that were within professional association guidelines and met eligibility criteria for planned birth center birth.”
Ms. Nethery’s team concluded: “Rates of adverse outcomes for this cohort in a U.S. state with well-established and integrated community midwifery were low overall. Birth outcomes were similar for births planned at home or at a state-licensed, freestanding birth center.”
This news organization was among the publications that reported the results of that study.
But it’s the exclusion criteria in that study, primarily, that Dr. Grünebaum and colleagues take issue with.
Births excluded from the main analysis of the study by Ms. Nethery and coauthors involved “multifetal pregnancy, prior cesarean delivery, onset of labor at more than 42 0/7 weeks of gestation or preterm (less than 37 weeks), preexisting hypertension or diabetes, known amniotic fluid abnormality, gestational hypertension or preeclampsia, or malpresentation.”
Those are conditions that fall outside guidelines for planned home births. But both Ms. Nethery and Dr. Grünebaum said that sometimes these high-risk conditions are present in home births.
Different conclusion for home birth safety
Dr. Grünebaum and colleagues’ analysis of the risk profiles and outcomes for U.S. planned home births for the years 2016-2020 came to a different conclusion about the safety of home births.
They used a retrospective population-based cohort study that used the Centers for Disease Control and Prevention WONDER natality online database. They included planned home births and compared the outcomes with and without certain risk factors, including some high-risk factors such as twin deliveries, breech births, and previous cesarean.
Dr. Grünebaum’s analysis concluded that “it is an immutable truth that planned home births in the United States result in avoidable risks of increased adverse neonatal outcomes.”
Ms. Nethery said though the high-risk conditions were excluded from their main analysis, they are mentioned in the paper and detailed in the supplement.
She acknowledged in the paper that some midwives practice outside the guidelines and that was the case in 7% of births or for 800 people in the Washington state study. But she told this publication it’s a small number and high-risk births should be handled in a hospital so the team focused its research on low-risk births.
“People plan home births who are outside the guidelines everywhere in the world. There are a lot of reasons why people do it,” she said. Among them are not feeling safe in the hospital, being rejected by an obstetrician for a desired procedure, or, in some cases, because they are misinformed.
She said midwives are sometimes faced with a difficult choice, when a patient wants, for instance, a vaginal birth after cesarean (VBAC), one of the conditions not recommended for home births.
The midwife is left with the choice of saying she will not do a VBAC in the home, or she can explain to the patient why it is not recommended and explain all the reasons it is not recommended, such as an elevated risk of rupture, but honor the patient’s choice.
“Do you tell the person: ‘Sorry, go have the cesarean anyway or do you do your best to support this person?’ Birthing people have the right to autonomy of choice,” Ms. Nethery said.
Dr. Grünebaum and colleagues said: “The recent study by Nethery et al. concluded that planned home births in the state of Washington have good neonatal outcomes by focusing on results of low-risk patients.”
Dr. Grünebaum said in an interview: “It’s like reporting on smoking and lung cancer and saying I’m only going to report on patients who have smoked for less than 5 years. You need to take the whole picture into consideration.”
Ms. Nethery gave this explanation for excluding the high-risk patients: “If you are studying a drug, you exclude people from your study who got the drug even though they had risk factors that were ‘contraindications’ to that drug. Likely there was a reason they got the drug – in consultation with their doctor, the patient and the doctor decided that the potential benefit outweighed the risk – but they are not relevant to understanding how that drug impacts people who were ‘eligible’ for the drug in the first place.”
“That is part of the reason we excluded ‘high-risk’ people from our study,” she said. “The other reason is that that is what is commonly done in most research on this topic – we focus on ‘low-risk’ people who are within standards and eligibility criteria.”
She gave examples such as a 2019 meta-analysis and a 2011 Birthplace in England national prospective cohort study, both of which excluded high-risk home births.
“Third, we wanted to compare apples to apples (for our analysis of home vs. hospital) – and licensed birth centers in Washington state have restrictions based on risk,” Ms. Nethery said.
Dr. Grünebaum said his team supports the right of all women to give birth where they wish. “But you cannot choose unless you are given the right information.”
Dr. Grünebaum also said planned home births in the United States cannot be compared with home births delivered by midwives in other countries. Different from the United States, he said, in countries such as Canada, Germany, and England, midwives are well integrated in the medical system and they are typically affiliated with hospitals and they belong to organizations which support very strong guidelines.
He added that, while Washington state has its own set of guidelines, there are no national guidelines for home births and practice varies greatly by state.
The authors concluded: “It is the professional responsibility of all health care providers, obstetricians, and midwives to present unbiased information. Focusing the reporting of outcomes on low-risk deliveries underreports true adverse outcomes in U.S. home births and provides biased information to patients considering planned home births. It is an immutable truth that planned home births in the United States result in avoidable risks of increased adverse neonatal outcomes.”
Angela Martin, MD, assistant professor of maternal-fetal medicine and medical director of the labor and delivery department at University of Kansas Medical Center, Kansas City, who was not part of either study, said she did not believe it was a problem that Ms. Nethery’s study excluded the high-risk conditions in the main analysis because it was disclosed.
“The authors were clear that they excluded high-risk conditions,” she said. “Therefore, the study should not be extrapolated to women with these conditions.”
“I believe her results do make that case for low-risk women in Washington state,” Dr. Martin said. “Again, it is important that findings are not extrapolated to women outside of those included in the study.”
She said there are several things that make Washington unusual in midwifery care. Consequently, the results should not be seen as representative of the United States.
“It is one of the most integrated states for midwife care in the country,” Dr. Martin said. “Washington has licensure available for midwives, which is not true of all states. It also has a robust state professional association that publishes guidelines for midwives to follow. And midwives in Washington have a wide formulary. For example, they can administer antibiotics, carry and administer hemorrhage medications, they can carry oxygen, and they are allowed to suture.”
Iris Krishna, MD, MPH, director of perinatal quality, Emory Perinatal Center and assistant professor in the division of maternal-fetal medicine at Emory University, Atlanta, said in an interview that the arguments by Ms. Nethery and Dr. Grünebaum illustrate the controversy over home births.
Dr. Krishna, who was not part of either study, said physicians and midwives should counsel patients contemplating a planned community birth that available data is not generalizable to all birth settings or all patients.
“Women should be counseled that delivery in a hospital setting or accredited birth center is safer than home birth,” she said. “Ultimately, each woman has the right to make a medically informed decision about delivery after adequate counseling on the risks and benefits of community birth.”
Dr. Grünebaum and colleagues reported no relevant financial relationships. Ms. Nethery, Dr. Martin, and Dr. Krishna also reported no relevant financial relationships.
A research letter published recently in the American Journal of Obstetrics and Gynecology argues that the methodology of a recent paper on the safety of planned home births presented a biased analysis.
The paper that Amos Grünebaum, MD, and colleagues with the department of obstetrics and gynecology at Lenox Hill Hospital in Hempstead, N.J., referred to is a study in Obstetrics & Gynecology which concluded that planned home births in Washington state are low risk.
In that paper, Elizabeth Nethery, RM, MS, MSM, a midwife and PhD candidate at the University of British Columbia, Vancouver, calculated the outcomes from 2015 to 2020 for “all births attended by members of a statewide midwifery professional association that were within professional association guidelines and met eligibility criteria for planned birth center birth.”
Ms. Nethery’s team concluded: “Rates of adverse outcomes for this cohort in a U.S. state with well-established and integrated community midwifery were low overall. Birth outcomes were similar for births planned at home or at a state-licensed, freestanding birth center.”
This news organization was among the publications that reported the results of that study.
But it’s the exclusion criteria in that study, primarily, that Dr. Grünebaum and colleagues take issue with.
Births excluded from the main analysis of the study by Ms. Nethery and coauthors involved “multifetal pregnancy, prior cesarean delivery, onset of labor at more than 42 0/7 weeks of gestation or preterm (less than 37 weeks), preexisting hypertension or diabetes, known amniotic fluid abnormality, gestational hypertension or preeclampsia, or malpresentation.”
Those are conditions that fall outside guidelines for planned home births. But both Ms. Nethery and Dr. Grünebaum said that sometimes these high-risk conditions are present in home births.
Different conclusion for home birth safety
Dr. Grünebaum and colleagues’ analysis of the risk profiles and outcomes for U.S. planned home births for the years 2016-2020 came to a different conclusion about the safety of home births.
They used a retrospective population-based cohort study that used the Centers for Disease Control and Prevention WONDER natality online database. They included planned home births and compared the outcomes with and without certain risk factors, including some high-risk factors such as twin deliveries, breech births, and previous cesarean.
Dr. Grünebaum’s analysis concluded that “it is an immutable truth that planned home births in the United States result in avoidable risks of increased adverse neonatal outcomes.”
Ms. Nethery said though the high-risk conditions were excluded from their main analysis, they are mentioned in the paper and detailed in the supplement.
She acknowledged in the paper that some midwives practice outside the guidelines and that was the case in 7% of births or for 800 people in the Washington state study. But she told this publication it’s a small number and high-risk births should be handled in a hospital so the team focused its research on low-risk births.
“People plan home births who are outside the guidelines everywhere in the world. There are a lot of reasons why people do it,” she said. Among them are not feeling safe in the hospital, being rejected by an obstetrician for a desired procedure, or, in some cases, because they are misinformed.
She said midwives are sometimes faced with a difficult choice, when a patient wants, for instance, a vaginal birth after cesarean (VBAC), one of the conditions not recommended for home births.
The midwife is left with the choice of saying she will not do a VBAC in the home, or she can explain to the patient why it is not recommended and explain all the reasons it is not recommended, such as an elevated risk of rupture, but honor the patient’s choice.
“Do you tell the person: ‘Sorry, go have the cesarean anyway or do you do your best to support this person?’ Birthing people have the right to autonomy of choice,” Ms. Nethery said.
Dr. Grünebaum and colleagues said: “The recent study by Nethery et al. concluded that planned home births in the state of Washington have good neonatal outcomes by focusing on results of low-risk patients.”
Dr. Grünebaum said in an interview: “It’s like reporting on smoking and lung cancer and saying I’m only going to report on patients who have smoked for less than 5 years. You need to take the whole picture into consideration.”
Ms. Nethery gave this explanation for excluding the high-risk patients: “If you are studying a drug, you exclude people from your study who got the drug even though they had risk factors that were ‘contraindications’ to that drug. Likely there was a reason they got the drug – in consultation with their doctor, the patient and the doctor decided that the potential benefit outweighed the risk – but they are not relevant to understanding how that drug impacts people who were ‘eligible’ for the drug in the first place.”
“That is part of the reason we excluded ‘high-risk’ people from our study,” she said. “The other reason is that that is what is commonly done in most research on this topic – we focus on ‘low-risk’ people who are within standards and eligibility criteria.”
She gave examples such as a 2019 meta-analysis and a 2011 Birthplace in England national prospective cohort study, both of which excluded high-risk home births.
“Third, we wanted to compare apples to apples (for our analysis of home vs. hospital) – and licensed birth centers in Washington state have restrictions based on risk,” Ms. Nethery said.
Dr. Grünebaum said his team supports the right of all women to give birth where they wish. “But you cannot choose unless you are given the right information.”
Dr. Grünebaum also said planned home births in the United States cannot be compared with home births delivered by midwives in other countries. Different from the United States, he said, in countries such as Canada, Germany, and England, midwives are well integrated in the medical system and they are typically affiliated with hospitals and they belong to organizations which support very strong guidelines.
He added that, while Washington state has its own set of guidelines, there are no national guidelines for home births and practice varies greatly by state.
The authors concluded: “It is the professional responsibility of all health care providers, obstetricians, and midwives to present unbiased information. Focusing the reporting of outcomes on low-risk deliveries underreports true adverse outcomes in U.S. home births and provides biased information to patients considering planned home births. It is an immutable truth that planned home births in the United States result in avoidable risks of increased adverse neonatal outcomes.”
Angela Martin, MD, assistant professor of maternal-fetal medicine and medical director of the labor and delivery department at University of Kansas Medical Center, Kansas City, who was not part of either study, said she did not believe it was a problem that Ms. Nethery’s study excluded the high-risk conditions in the main analysis because it was disclosed.
“The authors were clear that they excluded high-risk conditions,” she said. “Therefore, the study should not be extrapolated to women with these conditions.”
“I believe her results do make that case for low-risk women in Washington state,” Dr. Martin said. “Again, it is important that findings are not extrapolated to women outside of those included in the study.”
She said there are several things that make Washington unusual in midwifery care. Consequently, the results should not be seen as representative of the United States.
“It is one of the most integrated states for midwife care in the country,” Dr. Martin said. “Washington has licensure available for midwives, which is not true of all states. It also has a robust state professional association that publishes guidelines for midwives to follow. And midwives in Washington have a wide formulary. For example, they can administer antibiotics, carry and administer hemorrhage medications, they can carry oxygen, and they are allowed to suture.”
Iris Krishna, MD, MPH, director of perinatal quality, Emory Perinatal Center and assistant professor in the division of maternal-fetal medicine at Emory University, Atlanta, said in an interview that the arguments by Ms. Nethery and Dr. Grünebaum illustrate the controversy over home births.
Dr. Krishna, who was not part of either study, said physicians and midwives should counsel patients contemplating a planned community birth that available data is not generalizable to all birth settings or all patients.
“Women should be counseled that delivery in a hospital setting or accredited birth center is safer than home birth,” she said. “Ultimately, each woman has the right to make a medically informed decision about delivery after adequate counseling on the risks and benefits of community birth.”
Dr. Grünebaum and colleagues reported no relevant financial relationships. Ms. Nethery, Dr. Martin, and Dr. Krishna also reported no relevant financial relationships.
FROM THE AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY
Dust mite immunotherapy may help some with eczema
, but improvement in the primary outcome was not significant, new data show.
Results of the small, randomized, double-blind, placebo-controlled trial were published recently in The Journal of Allergy and Clinical Immunology: In Practice.
Lead author Sarah Sella Langer, MD, of the department of medicine, Ribeirão Preto (Brazil) Medical School, University of São Paulo, and colleagues said their results suggest HDM SLIT is safe and effective as an add-on treatment.
The dust mite extract therapy had no major side effects after 18 months of treatment, the authors reported.
The researchers included data from 66 patients who completed the study. The participants were at least 3 years old, registered at least 15 on the SCORing Atopic Dermatitis (SCORAD) measure, and had a skin prick test and/or immunoglobulin E (IgE) test for sensitization to dust mites.
Patients were grouped by age (younger than 12 years or 12 years and older) to receive HDM SLIT (n = 35) or placebo (n = 31) 3 days a week for the study period – between May 2018 and June 2020 – at the Clinical Research Unit of Ribeirão Preto Medical School Hospital.
At baseline, the mean SCORAD was 46.9 (range, 17-87).
After 18 months, 74.2% and 58% of patients in HDM SLIT and placebo groups, respectively, showed at least a15-point decrease in SCORAD (relative risk, 1.28; 95% confidence interval, 0.89-1.83). However, those primary outcome results did not reach statistical significance.
On the other hand, some secondary outcomes did show significant results.
At 95% CI, the researchers reported significant objective-SCORAD decreases of 56.8% and 34.9% in HDM SLIT and placebo groups (average difference, 21.3). Significantly more patients had a score of 0 or 1 on the 5-point Investigator’s Global Assessment scale in the intervention group than in the placebo group (14/35 vs. 5/31; RR, 2.63).
There were no significant changes in the Eczema Area and Severity Index, the visual analogue scale for symptoms, the pruritus scale, or the Dermatology Life Quality Index.
Patients in the trial, most of whom had moderate to severe disease, continued to be treated with usual, individualized therapy for AD, in accordance with current guidelines and experts’ recommendations.
Tina Sindher, MD, an allergist with the Sean N. Parker Center for Allergy and Asthma Research at Stanford (Calif.) University, , told this news organization that the results are not robust enough to recommend the immunotherapy widely.
She pointed out that even in the placebo group, more than half the patients met the primary endpoint.
However, she did say HDM SLIT could be considered as an add-on treatment for the right patients, especially since risk for an allergic reaction or other adverse condition is small. The most common adverse effects were headache and abdominal pain, and they were reported in both the treatment and placebo groups.
With AD, she said, “there is no one drug that’s right for everyone,” because genetics and environment make the kind of symptoms and severity and duration different for each patient.
It all comes down to risk and benefits, she said.
She said if she had a patient with an environmental allergy who’s trying to manage nasal congestion and also happened to have eczema, “I think they’re a great candidate for sublingual dust mite therapy because then not only am I treating their nasal congestions, their other symptoms, it may also help their eczema,” Dr. Sindher said.
Without those concurrent conditions, she said, the benefits of dust mite immunotherapy would not outweigh the risks or the potential burden on the patient of having to take the SLIT.
She said she would present the choice to the patient, and if other treatments haven’t been successful and the patient wants to try it, she would be open to a trial period.
The study was supported by the Brazilian National Council for Scientific and Technological Development, the Institute of Investigation in Immunology, the National Institutes of Science and Technology, the Brazilian National Council for Scientific and Technological Development, and the São Paulo Research Foundation. The mite extract for immunotherapy was provided by the laboratory IPI-ASAC Brasil/ASAC Pharma Brasil. Dr. Langer received a doctoral scholarship from the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). Dr. Sindher reported no relevant financial relationships.
Commentary by Lawrence F. Eichenfield, MD
Environmental triggers of atopic dermatitis (AD) may be difficult to assess, especially as children with AD commonly develop “overlap” conditions of allergic rhinitis, food allergy, and asthma. The place of immunotherapy in treatment of AD has been controversial over the years, with mixed results from studies on its effect on eczema in different subpopulations. However, a holistic view of allergy care makes consideration of environmental allergies reasonable. The study by Dr. Langer and colleagues was a well-designed double-blind placebo-controlled trial of house dust mite sublingual immunotherapy in mite-sensitized AD patients aged 3 and older with at least mild AD, though the mean eczema severity was severe. After 18 months, there was an impressive 74% decrease in eczema score (SCORAD), but also a 58% decrease in the placebo group. While the primary outcome measure wasn’t statistically significant, some secondary ones were. I agree with the commentary in the article that the data doesn’t support immunotherapy being advised to everyone, while its use as an add-on treatment for certain patients in whom the eczema may overlap with other allergic manifestations is reasonable. For several years at Rady Children’s Hospital, San Diego, we have run a multidisciplinary atopic dermatitis program where patients are comanaged by dermatology and allergy. We have learned to appreciate that a broad perspective on managing comorbid conditions in children with AD really helps the patients and families to understand the many effects of inflammatory and allergic conditions, with improved outcomes and quality of life.
Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.
A version of this article first appeared on Medscape.com.
This article was updated 6/18/22.
, but improvement in the primary outcome was not significant, new data show.
Results of the small, randomized, double-blind, placebo-controlled trial were published recently in The Journal of Allergy and Clinical Immunology: In Practice.
Lead author Sarah Sella Langer, MD, of the department of medicine, Ribeirão Preto (Brazil) Medical School, University of São Paulo, and colleagues said their results suggest HDM SLIT is safe and effective as an add-on treatment.
The dust mite extract therapy had no major side effects after 18 months of treatment, the authors reported.
The researchers included data from 66 patients who completed the study. The participants were at least 3 years old, registered at least 15 on the SCORing Atopic Dermatitis (SCORAD) measure, and had a skin prick test and/or immunoglobulin E (IgE) test for sensitization to dust mites.
Patients were grouped by age (younger than 12 years or 12 years and older) to receive HDM SLIT (n = 35) or placebo (n = 31) 3 days a week for the study period – between May 2018 and June 2020 – at the Clinical Research Unit of Ribeirão Preto Medical School Hospital.
At baseline, the mean SCORAD was 46.9 (range, 17-87).
After 18 months, 74.2% and 58% of patients in HDM SLIT and placebo groups, respectively, showed at least a15-point decrease in SCORAD (relative risk, 1.28; 95% confidence interval, 0.89-1.83). However, those primary outcome results did not reach statistical significance.
On the other hand, some secondary outcomes did show significant results.
At 95% CI, the researchers reported significant objective-SCORAD decreases of 56.8% and 34.9% in HDM SLIT and placebo groups (average difference, 21.3). Significantly more patients had a score of 0 or 1 on the 5-point Investigator’s Global Assessment scale in the intervention group than in the placebo group (14/35 vs. 5/31; RR, 2.63).
There were no significant changes in the Eczema Area and Severity Index, the visual analogue scale for symptoms, the pruritus scale, or the Dermatology Life Quality Index.
Patients in the trial, most of whom had moderate to severe disease, continued to be treated with usual, individualized therapy for AD, in accordance with current guidelines and experts’ recommendations.
Tina Sindher, MD, an allergist with the Sean N. Parker Center for Allergy and Asthma Research at Stanford (Calif.) University, , told this news organization that the results are not robust enough to recommend the immunotherapy widely.
She pointed out that even in the placebo group, more than half the patients met the primary endpoint.
However, she did say HDM SLIT could be considered as an add-on treatment for the right patients, especially since risk for an allergic reaction or other adverse condition is small. The most common adverse effects were headache and abdominal pain, and they were reported in both the treatment and placebo groups.
With AD, she said, “there is no one drug that’s right for everyone,” because genetics and environment make the kind of symptoms and severity and duration different for each patient.
It all comes down to risk and benefits, she said.
She said if she had a patient with an environmental allergy who’s trying to manage nasal congestion and also happened to have eczema, “I think they’re a great candidate for sublingual dust mite therapy because then not only am I treating their nasal congestions, their other symptoms, it may also help their eczema,” Dr. Sindher said.
Without those concurrent conditions, she said, the benefits of dust mite immunotherapy would not outweigh the risks or the potential burden on the patient of having to take the SLIT.
She said she would present the choice to the patient, and if other treatments haven’t been successful and the patient wants to try it, she would be open to a trial period.
The study was supported by the Brazilian National Council for Scientific and Technological Development, the Institute of Investigation in Immunology, the National Institutes of Science and Technology, the Brazilian National Council for Scientific and Technological Development, and the São Paulo Research Foundation. The mite extract for immunotherapy was provided by the laboratory IPI-ASAC Brasil/ASAC Pharma Brasil. Dr. Langer received a doctoral scholarship from the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). Dr. Sindher reported no relevant financial relationships.
Commentary by Lawrence F. Eichenfield, MD
Environmental triggers of atopic dermatitis (AD) may be difficult to assess, especially as children with AD commonly develop “overlap” conditions of allergic rhinitis, food allergy, and asthma. The place of immunotherapy in treatment of AD has been controversial over the years, with mixed results from studies on its effect on eczema in different subpopulations. However, a holistic view of allergy care makes consideration of environmental allergies reasonable. The study by Dr. Langer and colleagues was a well-designed double-blind placebo-controlled trial of house dust mite sublingual immunotherapy in mite-sensitized AD patients aged 3 and older with at least mild AD, though the mean eczema severity was severe. After 18 months, there was an impressive 74% decrease in eczema score (SCORAD), but also a 58% decrease in the placebo group. While the primary outcome measure wasn’t statistically significant, some secondary ones were. I agree with the commentary in the article that the data doesn’t support immunotherapy being advised to everyone, while its use as an add-on treatment for certain patients in whom the eczema may overlap with other allergic manifestations is reasonable. For several years at Rady Children’s Hospital, San Diego, we have run a multidisciplinary atopic dermatitis program where patients are comanaged by dermatology and allergy. We have learned to appreciate that a broad perspective on managing comorbid conditions in children with AD really helps the patients and families to understand the many effects of inflammatory and allergic conditions, with improved outcomes and quality of life.
Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.
A version of this article first appeared on Medscape.com.
This article was updated 6/18/22.
, but improvement in the primary outcome was not significant, new data show.
Results of the small, randomized, double-blind, placebo-controlled trial were published recently in The Journal of Allergy and Clinical Immunology: In Practice.
Lead author Sarah Sella Langer, MD, of the department of medicine, Ribeirão Preto (Brazil) Medical School, University of São Paulo, and colleagues said their results suggest HDM SLIT is safe and effective as an add-on treatment.
The dust mite extract therapy had no major side effects after 18 months of treatment, the authors reported.
The researchers included data from 66 patients who completed the study. The participants were at least 3 years old, registered at least 15 on the SCORing Atopic Dermatitis (SCORAD) measure, and had a skin prick test and/or immunoglobulin E (IgE) test for sensitization to dust mites.
Patients were grouped by age (younger than 12 years or 12 years and older) to receive HDM SLIT (n = 35) or placebo (n = 31) 3 days a week for the study period – between May 2018 and June 2020 – at the Clinical Research Unit of Ribeirão Preto Medical School Hospital.
At baseline, the mean SCORAD was 46.9 (range, 17-87).
After 18 months, 74.2% and 58% of patients in HDM SLIT and placebo groups, respectively, showed at least a15-point decrease in SCORAD (relative risk, 1.28; 95% confidence interval, 0.89-1.83). However, those primary outcome results did not reach statistical significance.
On the other hand, some secondary outcomes did show significant results.
At 95% CI, the researchers reported significant objective-SCORAD decreases of 56.8% and 34.9% in HDM SLIT and placebo groups (average difference, 21.3). Significantly more patients had a score of 0 or 1 on the 5-point Investigator’s Global Assessment scale in the intervention group than in the placebo group (14/35 vs. 5/31; RR, 2.63).
There were no significant changes in the Eczema Area and Severity Index, the visual analogue scale for symptoms, the pruritus scale, or the Dermatology Life Quality Index.
Patients in the trial, most of whom had moderate to severe disease, continued to be treated with usual, individualized therapy for AD, in accordance with current guidelines and experts’ recommendations.
Tina Sindher, MD, an allergist with the Sean N. Parker Center for Allergy and Asthma Research at Stanford (Calif.) University, , told this news organization that the results are not robust enough to recommend the immunotherapy widely.
She pointed out that even in the placebo group, more than half the patients met the primary endpoint.
However, she did say HDM SLIT could be considered as an add-on treatment for the right patients, especially since risk for an allergic reaction or other adverse condition is small. The most common adverse effects were headache and abdominal pain, and they were reported in both the treatment and placebo groups.
With AD, she said, “there is no one drug that’s right for everyone,” because genetics and environment make the kind of symptoms and severity and duration different for each patient.
It all comes down to risk and benefits, she said.
She said if she had a patient with an environmental allergy who’s trying to manage nasal congestion and also happened to have eczema, “I think they’re a great candidate for sublingual dust mite therapy because then not only am I treating their nasal congestions, their other symptoms, it may also help their eczema,” Dr. Sindher said.
Without those concurrent conditions, she said, the benefits of dust mite immunotherapy would not outweigh the risks or the potential burden on the patient of having to take the SLIT.
She said she would present the choice to the patient, and if other treatments haven’t been successful and the patient wants to try it, she would be open to a trial period.
The study was supported by the Brazilian National Council for Scientific and Technological Development, the Institute of Investigation in Immunology, the National Institutes of Science and Technology, the Brazilian National Council for Scientific and Technological Development, and the São Paulo Research Foundation. The mite extract for immunotherapy was provided by the laboratory IPI-ASAC Brasil/ASAC Pharma Brasil. Dr. Langer received a doctoral scholarship from the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). Dr. Sindher reported no relevant financial relationships.
Commentary by Lawrence F. Eichenfield, MD
Environmental triggers of atopic dermatitis (AD) may be difficult to assess, especially as children with AD commonly develop “overlap” conditions of allergic rhinitis, food allergy, and asthma. The place of immunotherapy in treatment of AD has been controversial over the years, with mixed results from studies on its effect on eczema in different subpopulations. However, a holistic view of allergy care makes consideration of environmental allergies reasonable. The study by Dr. Langer and colleagues was a well-designed double-blind placebo-controlled trial of house dust mite sublingual immunotherapy in mite-sensitized AD patients aged 3 and older with at least mild AD, though the mean eczema severity was severe. After 18 months, there was an impressive 74% decrease in eczema score (SCORAD), but also a 58% decrease in the placebo group. While the primary outcome measure wasn’t statistically significant, some secondary ones were. I agree with the commentary in the article that the data doesn’t support immunotherapy being advised to everyone, while its use as an add-on treatment for certain patients in whom the eczema may overlap with other allergic manifestations is reasonable. For several years at Rady Children’s Hospital, San Diego, we have run a multidisciplinary atopic dermatitis program where patients are comanaged by dermatology and allergy. We have learned to appreciate that a broad perspective on managing comorbid conditions in children with AD really helps the patients and families to understand the many effects of inflammatory and allergic conditions, with improved outcomes and quality of life.
Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.
A version of this article first appeared on Medscape.com.
This article was updated 6/18/22.
Ten changes that could keep clinicians in the workforce in a pandemic
Indeed, a recent poll of 1,000 health care workers conducted Sept. 2-8 by Morning Consult, showed that 18% of medical workers polled quit their jobs during the pandemic. Additionally, 31% said they had at least thought about leaving their work.
“As physicians, educators, peers and friends of COVID-19 responders, we are gravely concerned about our colleagues’ exhaustion, burnout, and disillusionment,” wrote lead author Eileen Barrett, MD, and coauthors of the new action plan, which was published in the Annals of Internal Medicine.
The 10-point, one-page checklist includes providing “practical support in the areas that clinicians identify as causing emotional stress or moral injury,” such as managing anger and grief when patients have chosen not to be vaccinated or confronting misinformation.
“Those are the things that are making people’s mental health worse” psychiatrist Jessi Gold, MD, MS, said in an interview. “I don’t think I’ve seen that mentioned other places.”
Among the other action items are:
- Reduce administrative tasks that are not “mission critical,” such as mandatory training that has no evidence of improving patient outcomes and meetings that could be skipped.
- Offer free and confidential resources to support clinicians’ mental health, such as easy access to crisis hotlines and peer support groups.
- Maintain transparency about personal protective equipment and contingency plans when there are shortages to restore trust.
- Encourage clinicians to use vacation time; leaders should model this.
- Implement suicide prevention strategies, including wellness check-ins for clinicians in hard-hit areas.
The action plan was based on the authors’ own experiences and the stories of colleagues and information in literature. It includes 10 changes health care leaders could make to help retain providers who may be on the brink of leaving their jobs or leaving medicine
Action items intended to be easily achievable, low cost
Dr. Barrett, who is a hospitalist in Albuquerque, said the goal was to present easily achievable and low-cost action items that clinicians and health care leaders could use as a starting point when change seems insurmountable and evidence on what works is slow to come.
She said one of the things that spurred her to coauthor the list was becoming aware of other clinicians’ “secret shame” in thinking about leaving medicine.
“Maybe a person who is not being listened to could take this journal article and say ‘we don’t know where to start. It looks like we can start here,’ ” said Dr. Barrett, who is also an associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.
She noted that some of the good ideas floated around did not make the list, because they required daunting budget commitments and too much time to put into place.
Numerous other proposed solutions were of the wrong tone, according to Dr. Barrett.
“It’s not just about a hug or a piece of pizza,” she said.
Dr. Gold, who is an assistant professor at Washington University, St. Louis, and specializes in the mental health of health care workers, noted that, even though the list was pared to 10 action items, it is still hard for health care organizations to prioritize mental health.
“Many hospitals are still struggling with the active bleed of the pandemic and financially recovering,” she said. “If you’re dealing with a full ER and people are still dying of COVID and you don’t have the resources to support them, it’s really hard to then find magic money to deal with mental health. I’d love for that to be true.”
Every organization, however, can start with removing questions about mental and physical health diagnoses from credentialing and employment applications, which is one of the items on the list, she said.
“It’s the lowest-bar thing that you can fix for making people in crisis not fear getting help,” she said. That change must come on a state-by-state and individual hospital level.
Favorable reactions to list
Dr. Barrett, who also serves on the editorial advisory board of Internal Medicine News, said the reactions to the checklist have been “overwhelmingly favorable and appreciative.”
Eric J. Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News, tweeted about this list: “For COVID-19, more than ever before, it’s vital to keep clinicians in the U.S. health care workforce. These are 10 steps that will help.” The tweet was retweeted more than 100 times.
Lotte Dyrbye, MD, MHPE, a primary care physician and codirector of the program on physician well-being at the Mayo Clinic in Rochester, Minn., said in an interview that managing the anger around patients who choose to be unvaccinated is critical and something that has gotten little notice since the vaccines became available.
“Physicians and nurses are working extremely hard and seeing a lot of suffering and are taking care of patients very sick with COVID-19, knowing they had access to the vaccine. That is causing anger and frustration. We haven’t prepared health care workers to deal with that,” she said.
Outside expert: Not all items may be easy to implement
Dr. Dyrbye said that, though she found adding time to address COVID misinformation questions in appointments is very important, it may be wishful thinking.
The authors suggested training other members of the care team to answer those questions to free up time, but she said, for patients who have been swayed by misinformation, hearing information from someone other than the physician they have a relationship with won’t be convincing.
According to Dr. Dyrbye, the items on the list are not easy to implement, but the action plan is worthwhile to consider adopting as a multipronged approach.
“Most of these things are hard and we need to be in it for the long run,” she said.
The need is clear for efforts to address the mental health of not just experienced clinicians but those in training as well, she noted.
Related research
A study that was also recently published in the Annals of Internal Medicine suggested that making a few simple changes can help improve the mental health of residents. The research, which included nearly 17,000 first-year residents who started training between 2007 and 2019, addressed indicators of mental health in light of interventions such as limiting residents’ work hours and providing more services.
The investigators found that, though depression remains high among residents, depressive symptoms among first-year residents dropped 24.4% from 2007 to 2019 in parallel with four main factors: an increase in mental health services; restrictions on work hours for residents; more sleep hours; and higher-quality feedback from faculty.
Dr. Barrett said she hopes her colleagues and health care workers everywhere will find some solace in seeing that the new checklist she coauthored was published in a prominent journal.
The message Dr. Barrett said she hopes they see is: “Someone is validating it is not in their head. They are validating we can do better. They are validating that we must.”
Dr. Barrett and coauthors had no conflicts of interest. Dr. Gold and Dr. Dyrbye also disclosed having no relevant financial relationships.
Indeed, a recent poll of 1,000 health care workers conducted Sept. 2-8 by Morning Consult, showed that 18% of medical workers polled quit their jobs during the pandemic. Additionally, 31% said they had at least thought about leaving their work.
“As physicians, educators, peers and friends of COVID-19 responders, we are gravely concerned about our colleagues’ exhaustion, burnout, and disillusionment,” wrote lead author Eileen Barrett, MD, and coauthors of the new action plan, which was published in the Annals of Internal Medicine.
The 10-point, one-page checklist includes providing “practical support in the areas that clinicians identify as causing emotional stress or moral injury,” such as managing anger and grief when patients have chosen not to be vaccinated or confronting misinformation.
“Those are the things that are making people’s mental health worse” psychiatrist Jessi Gold, MD, MS, said in an interview. “I don’t think I’ve seen that mentioned other places.”
Among the other action items are:
- Reduce administrative tasks that are not “mission critical,” such as mandatory training that has no evidence of improving patient outcomes and meetings that could be skipped.
- Offer free and confidential resources to support clinicians’ mental health, such as easy access to crisis hotlines and peer support groups.
- Maintain transparency about personal protective equipment and contingency plans when there are shortages to restore trust.
- Encourage clinicians to use vacation time; leaders should model this.
- Implement suicide prevention strategies, including wellness check-ins for clinicians in hard-hit areas.
The action plan was based on the authors’ own experiences and the stories of colleagues and information in literature. It includes 10 changes health care leaders could make to help retain providers who may be on the brink of leaving their jobs or leaving medicine
Action items intended to be easily achievable, low cost
Dr. Barrett, who is a hospitalist in Albuquerque, said the goal was to present easily achievable and low-cost action items that clinicians and health care leaders could use as a starting point when change seems insurmountable and evidence on what works is slow to come.
She said one of the things that spurred her to coauthor the list was becoming aware of other clinicians’ “secret shame” in thinking about leaving medicine.
“Maybe a person who is not being listened to could take this journal article and say ‘we don’t know where to start. It looks like we can start here,’ ” said Dr. Barrett, who is also an associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.
She noted that some of the good ideas floated around did not make the list, because they required daunting budget commitments and too much time to put into place.
Numerous other proposed solutions were of the wrong tone, according to Dr. Barrett.
“It’s not just about a hug or a piece of pizza,” she said.
Dr. Gold, who is an assistant professor at Washington University, St. Louis, and specializes in the mental health of health care workers, noted that, even though the list was pared to 10 action items, it is still hard for health care organizations to prioritize mental health.
“Many hospitals are still struggling with the active bleed of the pandemic and financially recovering,” she said. “If you’re dealing with a full ER and people are still dying of COVID and you don’t have the resources to support them, it’s really hard to then find magic money to deal with mental health. I’d love for that to be true.”
Every organization, however, can start with removing questions about mental and physical health diagnoses from credentialing and employment applications, which is one of the items on the list, she said.
“It’s the lowest-bar thing that you can fix for making people in crisis not fear getting help,” she said. That change must come on a state-by-state and individual hospital level.
Favorable reactions to list
Dr. Barrett, who also serves on the editorial advisory board of Internal Medicine News, said the reactions to the checklist have been “overwhelmingly favorable and appreciative.”
Eric J. Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News, tweeted about this list: “For COVID-19, more than ever before, it’s vital to keep clinicians in the U.S. health care workforce. These are 10 steps that will help.” The tweet was retweeted more than 100 times.
Lotte Dyrbye, MD, MHPE, a primary care physician and codirector of the program on physician well-being at the Mayo Clinic in Rochester, Minn., said in an interview that managing the anger around patients who choose to be unvaccinated is critical and something that has gotten little notice since the vaccines became available.
“Physicians and nurses are working extremely hard and seeing a lot of suffering and are taking care of patients very sick with COVID-19, knowing they had access to the vaccine. That is causing anger and frustration. We haven’t prepared health care workers to deal with that,” she said.
Outside expert: Not all items may be easy to implement
Dr. Dyrbye said that, though she found adding time to address COVID misinformation questions in appointments is very important, it may be wishful thinking.
The authors suggested training other members of the care team to answer those questions to free up time, but she said, for patients who have been swayed by misinformation, hearing information from someone other than the physician they have a relationship with won’t be convincing.
According to Dr. Dyrbye, the items on the list are not easy to implement, but the action plan is worthwhile to consider adopting as a multipronged approach.
“Most of these things are hard and we need to be in it for the long run,” she said.
The need is clear for efforts to address the mental health of not just experienced clinicians but those in training as well, she noted.
Related research
A study that was also recently published in the Annals of Internal Medicine suggested that making a few simple changes can help improve the mental health of residents. The research, which included nearly 17,000 first-year residents who started training between 2007 and 2019, addressed indicators of mental health in light of interventions such as limiting residents’ work hours and providing more services.
The investigators found that, though depression remains high among residents, depressive symptoms among first-year residents dropped 24.4% from 2007 to 2019 in parallel with four main factors: an increase in mental health services; restrictions on work hours for residents; more sleep hours; and higher-quality feedback from faculty.
Dr. Barrett said she hopes her colleagues and health care workers everywhere will find some solace in seeing that the new checklist she coauthored was published in a prominent journal.
The message Dr. Barrett said she hopes they see is: “Someone is validating it is not in their head. They are validating we can do better. They are validating that we must.”
Dr. Barrett and coauthors had no conflicts of interest. Dr. Gold and Dr. Dyrbye also disclosed having no relevant financial relationships.
Indeed, a recent poll of 1,000 health care workers conducted Sept. 2-8 by Morning Consult, showed that 18% of medical workers polled quit their jobs during the pandemic. Additionally, 31% said they had at least thought about leaving their work.
“As physicians, educators, peers and friends of COVID-19 responders, we are gravely concerned about our colleagues’ exhaustion, burnout, and disillusionment,” wrote lead author Eileen Barrett, MD, and coauthors of the new action plan, which was published in the Annals of Internal Medicine.
The 10-point, one-page checklist includes providing “practical support in the areas that clinicians identify as causing emotional stress or moral injury,” such as managing anger and grief when patients have chosen not to be vaccinated or confronting misinformation.
“Those are the things that are making people’s mental health worse” psychiatrist Jessi Gold, MD, MS, said in an interview. “I don’t think I’ve seen that mentioned other places.”
Among the other action items are:
- Reduce administrative tasks that are not “mission critical,” such as mandatory training that has no evidence of improving patient outcomes and meetings that could be skipped.
- Offer free and confidential resources to support clinicians’ mental health, such as easy access to crisis hotlines and peer support groups.
- Maintain transparency about personal protective equipment and contingency plans when there are shortages to restore trust.
- Encourage clinicians to use vacation time; leaders should model this.
- Implement suicide prevention strategies, including wellness check-ins for clinicians in hard-hit areas.
The action plan was based on the authors’ own experiences and the stories of colleagues and information in literature. It includes 10 changes health care leaders could make to help retain providers who may be on the brink of leaving their jobs or leaving medicine
Action items intended to be easily achievable, low cost
Dr. Barrett, who is a hospitalist in Albuquerque, said the goal was to present easily achievable and low-cost action items that clinicians and health care leaders could use as a starting point when change seems insurmountable and evidence on what works is slow to come.
She said one of the things that spurred her to coauthor the list was becoming aware of other clinicians’ “secret shame” in thinking about leaving medicine.
“Maybe a person who is not being listened to could take this journal article and say ‘we don’t know where to start. It looks like we can start here,’ ” said Dr. Barrett, who is also an associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.
She noted that some of the good ideas floated around did not make the list, because they required daunting budget commitments and too much time to put into place.
Numerous other proposed solutions were of the wrong tone, according to Dr. Barrett.
“It’s not just about a hug or a piece of pizza,” she said.
Dr. Gold, who is an assistant professor at Washington University, St. Louis, and specializes in the mental health of health care workers, noted that, even though the list was pared to 10 action items, it is still hard for health care organizations to prioritize mental health.
“Many hospitals are still struggling with the active bleed of the pandemic and financially recovering,” she said. “If you’re dealing with a full ER and people are still dying of COVID and you don’t have the resources to support them, it’s really hard to then find magic money to deal with mental health. I’d love for that to be true.”
Every organization, however, can start with removing questions about mental and physical health diagnoses from credentialing and employment applications, which is one of the items on the list, she said.
“It’s the lowest-bar thing that you can fix for making people in crisis not fear getting help,” she said. That change must come on a state-by-state and individual hospital level.
Favorable reactions to list
Dr. Barrett, who also serves on the editorial advisory board of Internal Medicine News, said the reactions to the checklist have been “overwhelmingly favorable and appreciative.”
Eric J. Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News, tweeted about this list: “For COVID-19, more than ever before, it’s vital to keep clinicians in the U.S. health care workforce. These are 10 steps that will help.” The tweet was retweeted more than 100 times.
Lotte Dyrbye, MD, MHPE, a primary care physician and codirector of the program on physician well-being at the Mayo Clinic in Rochester, Minn., said in an interview that managing the anger around patients who choose to be unvaccinated is critical and something that has gotten little notice since the vaccines became available.
“Physicians and nurses are working extremely hard and seeing a lot of suffering and are taking care of patients very sick with COVID-19, knowing they had access to the vaccine. That is causing anger and frustration. We haven’t prepared health care workers to deal with that,” she said.
Outside expert: Not all items may be easy to implement
Dr. Dyrbye said that, though she found adding time to address COVID misinformation questions in appointments is very important, it may be wishful thinking.
The authors suggested training other members of the care team to answer those questions to free up time, but she said, for patients who have been swayed by misinformation, hearing information from someone other than the physician they have a relationship with won’t be convincing.
According to Dr. Dyrbye, the items on the list are not easy to implement, but the action plan is worthwhile to consider adopting as a multipronged approach.
“Most of these things are hard and we need to be in it for the long run,” she said.
The need is clear for efforts to address the mental health of not just experienced clinicians but those in training as well, she noted.
Related research
A study that was also recently published in the Annals of Internal Medicine suggested that making a few simple changes can help improve the mental health of residents. The research, which included nearly 17,000 first-year residents who started training between 2007 and 2019, addressed indicators of mental health in light of interventions such as limiting residents’ work hours and providing more services.
The investigators found that, though depression remains high among residents, depressive symptoms among first-year residents dropped 24.4% from 2007 to 2019 in parallel with four main factors: an increase in mental health services; restrictions on work hours for residents; more sleep hours; and higher-quality feedback from faculty.
Dr. Barrett said she hopes her colleagues and health care workers everywhere will find some solace in seeing that the new checklist she coauthored was published in a prominent journal.
The message Dr. Barrett said she hopes they see is: “Someone is validating it is not in their head. They are validating we can do better. They are validating that we must.”
Dr. Barrett and coauthors had no conflicts of interest. Dr. Gold and Dr. Dyrbye also disclosed having no relevant financial relationships.
FROM ANNALS OF INTERNAL MEDICINE
30% of docs say they don’t want own kids 5-11 to get COVID vaccine
A Medscape
Among physician respondents who have children in that age group, 30% said they would not want their children to be vaccinated; 9% were unsure. For nurses/advanced practice registered nurses (APRNs), more (45%) said they did not want their kids to get the COVID-19 vaccine; 13% were unsure. Among pharmacists, 31% said they would not get them vaccinated and 9% were unsure.
Clinicians were more likely to want vaccinations for their kids 5-11 than were 510 consumers polled by WebMD at the same time. Overall, 49% of the consumers who had kids that age did not want them to get the COVID-19 vaccine.
On November 2, Centers for Disease Control and Prevention (CDC) Director Rochelle P. Walensky, MD, MPH, endorsed the CDC Advisory Committee on Immunization Practices’ recommendation that children 5-11 be vaccinated with the Pfizer-BioNTech pediatric vaccine. That decision expanded vaccine recommendations to about 28 million children in the United States.
The CDC states that, in clinical trials, the Pfizer vaccine had more than 90% efficacy in preventing laboratory-confirmed COVID-19 infection in children 5 to 15 years old, and that the immune response in children ages 5-15 equaled the immune response in people 16 to 25 years old.
The Medscape poll, fielded from November 3 to November 11, included 325 physicians, 793 nurses/APRNs, and 151 pharmacists.
How safe is the vaccine?
Clinicians were asked how confident they were that the vaccine is safe for that age group, and 66% of physicians, 52% of nurses/APRNs, and 66% of pharmacists said they were somewhat or very confident.
Among consumers overall in the WebMD poll, 56% said they were confident or somewhat confident that the vaccine is safe in that age group.
Among adolescents and young adults, rare cases of myocarditis and pericarditis in adolescents and young adults have been reported. According to the CDC, “[I]n one study, the risk of myocarditis after the second dose of Pfizer-BioNTech in the week following vaccination was around 54 cases per million doses administered to males ages 12-17 years.”
Known and potential benefits of COVID-19 vaccination outweigh the risks, including the possible risk for myocarditis or pericarditis, the CDC states.
Across clinician types, women edged out their male counterparts on confidence in the vaccine’ s safety: 71% vs 65% among physicians, 55% vs 45% among nurses/APRNs, and 68% vs 60% among pharmacists.
Among both physicians and nurses, younger physicians (under 45) tended to have greater confidence in the vaccine’ s safety: 72% vs 64% (physicians), 54% vs 51% (nurses/APRNs), and 71% vs 59% (pharmacists).
The difference in confidence was clear between vaccinated and unvaccinated physicians. All of the unvaccinated physicians who responded to the poll said they had no confidence in the vaccine for kids. Among unvaccinated nurses/APRNs, 2% were somewhat confident in the vaccine for kids under 12.
Knowledge about smaller dosage
The clinicians were asked about whether they were aware, before reading the poll question, that the Pfizer vaccine for children and the proposed Moderna vaccine for children in this age group (5-11) would have a different dosage.
The dose for kids 5-11 is 10 micrograms rather than 30 micrograms for people at least 12 years old. Children 5-11 receive a second dose 21 days or more after their first shot. The formulation comes with an orange cap, and a smaller needle is used.
Knowledge on the lower dose was highest among pharmacists (91% said they knew), followed by physicians (84%) and nurses (79%).
The poll also asked whether the COVID-19 vaccine should be added to the list of childhood immunizations. Responses varied widely and uncertainty was evident.
Notably, female physicians were more likely to say it should be added to the list of immunizations than were their male counterparts: 46% vs 35% (physicians), 26% vs 22% (nurses/APRNs), and 33% vs 30% (pharmacists).
A version of this article first appeared on Medscape.com.
A Medscape
Among physician respondents who have children in that age group, 30% said they would not want their children to be vaccinated; 9% were unsure. For nurses/advanced practice registered nurses (APRNs), more (45%) said they did not want their kids to get the COVID-19 vaccine; 13% were unsure. Among pharmacists, 31% said they would not get them vaccinated and 9% were unsure.
Clinicians were more likely to want vaccinations for their kids 5-11 than were 510 consumers polled by WebMD at the same time. Overall, 49% of the consumers who had kids that age did not want them to get the COVID-19 vaccine.
On November 2, Centers for Disease Control and Prevention (CDC) Director Rochelle P. Walensky, MD, MPH, endorsed the CDC Advisory Committee on Immunization Practices’ recommendation that children 5-11 be vaccinated with the Pfizer-BioNTech pediatric vaccine. That decision expanded vaccine recommendations to about 28 million children in the United States.
The CDC states that, in clinical trials, the Pfizer vaccine had more than 90% efficacy in preventing laboratory-confirmed COVID-19 infection in children 5 to 15 years old, and that the immune response in children ages 5-15 equaled the immune response in people 16 to 25 years old.
The Medscape poll, fielded from November 3 to November 11, included 325 physicians, 793 nurses/APRNs, and 151 pharmacists.
How safe is the vaccine?
Clinicians were asked how confident they were that the vaccine is safe for that age group, and 66% of physicians, 52% of nurses/APRNs, and 66% of pharmacists said they were somewhat or very confident.
Among consumers overall in the WebMD poll, 56% said they were confident or somewhat confident that the vaccine is safe in that age group.
Among adolescents and young adults, rare cases of myocarditis and pericarditis in adolescents and young adults have been reported. According to the CDC, “[I]n one study, the risk of myocarditis after the second dose of Pfizer-BioNTech in the week following vaccination was around 54 cases per million doses administered to males ages 12-17 years.”
Known and potential benefits of COVID-19 vaccination outweigh the risks, including the possible risk for myocarditis or pericarditis, the CDC states.
Across clinician types, women edged out their male counterparts on confidence in the vaccine’ s safety: 71% vs 65% among physicians, 55% vs 45% among nurses/APRNs, and 68% vs 60% among pharmacists.
Among both physicians and nurses, younger physicians (under 45) tended to have greater confidence in the vaccine’ s safety: 72% vs 64% (physicians), 54% vs 51% (nurses/APRNs), and 71% vs 59% (pharmacists).
The difference in confidence was clear between vaccinated and unvaccinated physicians. All of the unvaccinated physicians who responded to the poll said they had no confidence in the vaccine for kids. Among unvaccinated nurses/APRNs, 2% were somewhat confident in the vaccine for kids under 12.
Knowledge about smaller dosage
The clinicians were asked about whether they were aware, before reading the poll question, that the Pfizer vaccine for children and the proposed Moderna vaccine for children in this age group (5-11) would have a different dosage.
The dose for kids 5-11 is 10 micrograms rather than 30 micrograms for people at least 12 years old. Children 5-11 receive a second dose 21 days or more after their first shot. The formulation comes with an orange cap, and a smaller needle is used.
Knowledge on the lower dose was highest among pharmacists (91% said they knew), followed by physicians (84%) and nurses (79%).
The poll also asked whether the COVID-19 vaccine should be added to the list of childhood immunizations. Responses varied widely and uncertainty was evident.
Notably, female physicians were more likely to say it should be added to the list of immunizations than were their male counterparts: 46% vs 35% (physicians), 26% vs 22% (nurses/APRNs), and 33% vs 30% (pharmacists).
A version of this article first appeared on Medscape.com.
A Medscape
Among physician respondents who have children in that age group, 30% said they would not want their children to be vaccinated; 9% were unsure. For nurses/advanced practice registered nurses (APRNs), more (45%) said they did not want their kids to get the COVID-19 vaccine; 13% were unsure. Among pharmacists, 31% said they would not get them vaccinated and 9% were unsure.
Clinicians were more likely to want vaccinations for their kids 5-11 than were 510 consumers polled by WebMD at the same time. Overall, 49% of the consumers who had kids that age did not want them to get the COVID-19 vaccine.
On November 2, Centers for Disease Control and Prevention (CDC) Director Rochelle P. Walensky, MD, MPH, endorsed the CDC Advisory Committee on Immunization Practices’ recommendation that children 5-11 be vaccinated with the Pfizer-BioNTech pediatric vaccine. That decision expanded vaccine recommendations to about 28 million children in the United States.
The CDC states that, in clinical trials, the Pfizer vaccine had more than 90% efficacy in preventing laboratory-confirmed COVID-19 infection in children 5 to 15 years old, and that the immune response in children ages 5-15 equaled the immune response in people 16 to 25 years old.
The Medscape poll, fielded from November 3 to November 11, included 325 physicians, 793 nurses/APRNs, and 151 pharmacists.
How safe is the vaccine?
Clinicians were asked how confident they were that the vaccine is safe for that age group, and 66% of physicians, 52% of nurses/APRNs, and 66% of pharmacists said they were somewhat or very confident.
Among consumers overall in the WebMD poll, 56% said they were confident or somewhat confident that the vaccine is safe in that age group.
Among adolescents and young adults, rare cases of myocarditis and pericarditis in adolescents and young adults have been reported. According to the CDC, “[I]n one study, the risk of myocarditis after the second dose of Pfizer-BioNTech in the week following vaccination was around 54 cases per million doses administered to males ages 12-17 years.”
Known and potential benefits of COVID-19 vaccination outweigh the risks, including the possible risk for myocarditis or pericarditis, the CDC states.
Across clinician types, women edged out their male counterparts on confidence in the vaccine’ s safety: 71% vs 65% among physicians, 55% vs 45% among nurses/APRNs, and 68% vs 60% among pharmacists.
Among both physicians and nurses, younger physicians (under 45) tended to have greater confidence in the vaccine’ s safety: 72% vs 64% (physicians), 54% vs 51% (nurses/APRNs), and 71% vs 59% (pharmacists).
The difference in confidence was clear between vaccinated and unvaccinated physicians. All of the unvaccinated physicians who responded to the poll said they had no confidence in the vaccine for kids. Among unvaccinated nurses/APRNs, 2% were somewhat confident in the vaccine for kids under 12.
Knowledge about smaller dosage
The clinicians were asked about whether they were aware, before reading the poll question, that the Pfizer vaccine for children and the proposed Moderna vaccine for children in this age group (5-11) would have a different dosage.
The dose for kids 5-11 is 10 micrograms rather than 30 micrograms for people at least 12 years old. Children 5-11 receive a second dose 21 days or more after their first shot. The formulation comes with an orange cap, and a smaller needle is used.
Knowledge on the lower dose was highest among pharmacists (91% said they knew), followed by physicians (84%) and nurses (79%).
The poll also asked whether the COVID-19 vaccine should be added to the list of childhood immunizations. Responses varied widely and uncertainty was evident.
Notably, female physicians were more likely to say it should be added to the list of immunizations than were their male counterparts: 46% vs 35% (physicians), 26% vs 22% (nurses/APRNs), and 33% vs 30% (pharmacists).
A version of this article first appeared on Medscape.com.
Short-acting opioids needed for withdrawal in U.S. hospitals, say experts
The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.
Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.
Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.
“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.
The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.
Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
Short-acting opioids may address limitations of other opioids
Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.
“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “
Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.
Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.
Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.
With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.
Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.
Barriers to short-acting opioid use
Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.
“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.
Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.
But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
When short-acting opioids are helpful, according to outside expert
Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.
One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.
“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.
The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.
She said she then found it easy to switch from those medications to buprenorphine and methadone.
Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.
It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.
But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
Take-home message
“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”
Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.
The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.
Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.
Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.
“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.
The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.
Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
Short-acting opioids may address limitations of other opioids
Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.
“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “
Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.
Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.
Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.
With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.
Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.
Barriers to short-acting opioid use
Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.
“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.
Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.
But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
When short-acting opioids are helpful, according to outside expert
Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.
One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.
“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.
The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.
She said she then found it easy to switch from those medications to buprenorphine and methadone.
Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.
It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.
But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
Take-home message
“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”
Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.
The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.
Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.
Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.
“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.
The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.
Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
Short-acting opioids may address limitations of other opioids
Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.
“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “
Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.
Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.
Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.
With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.
Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.
Barriers to short-acting opioid use
Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.
“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.
Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.
But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
When short-acting opioids are helpful, according to outside expert
Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.
One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.
“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.
The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.
She said she then found it easy to switch from those medications to buprenorphine and methadone.
Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.
It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.
But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
Take-home message
“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”
Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.
FROM ANNALS OF INTERNAL MEDICINE
Adding questions in primary care may help predict suicide risk
Craig J. Bryan, PsyD, ABPP, with the department of psychiatry and behavioral health at Ohio State University Wexner Medical Center, Columbus, led the study, published online on Nov. 8, 2021, in Annals of Family Medicine.
The authors cited the urgency highlighted by statistics showing that, from 1999 to 2017, the U.S. suicide rate increased by more than 33% and was particularly high among military personnel and veterans.
Primary care offices are seen as a prime target for prevention efforts as nearly one-half of people who die by suicide in the United States visit a primary care office in the months before their deaths.
A common approach to screening for suicide risk has been to use the Patient Health Questionnaire–9 (PHQ-9). The first two questions assess the frequency of depressed mood and anhedonia in the past 2 weeks. If patients screen positive on those two questions, they are given the remaining seven questions.
A single item – question 9 – asks about how often a patient has “thoughts that you would be better off dead, or of hurting yourself in some way” during the past 2 weeks.
Yet, more that 95% of patients who screen positive on the PHQ-9 suicide risk question do not attempt or die by suicide, the authors noted.
Two methods tested for improving screening
Dr. Bryan and colleagues wanted to assess whether suicide risk screening could be improved in primary care and evaluated two methods.
One was to see whether using any of the other PHQ-9 items could be better than just using item 9 alone to identify the patients who were most likely to attempt suicide in the near future. Researchers found that method was not significantly beneficial. The second was to evaluate the performance of the 16 items on the Suicide Cognitions Scale (SCS), a questionnaire that asks patients to rate the extent to which they agree or disagree with statements that are commonly endorsed by suicidal people.
Patients who were eligible for medical treatment from the Department of Defense medical system were recruited from six large and small military primary care clinics across the United States from July 2015 to August 2018.
Patients answered questions on the PHQ-9 and 16 items from the SCS during routine primary care visits. Evaluators, who were blind to screening results, assessed postbaseline suicide attempts, interrupted attempts and aborted attempts by interviewing patients.
The study included 2,744 primary care patients, ranging from 18 to 89 years of age, with an average age of 40.
Adding at least one question may help
Researchers found that the accuracy of suicide risk screening using the PHQ-9 can be significantly improved by adding one or more questions from the SCS. Three items from SCS contributed most to meaningful improvements in identifying patients who went on to exhibit suicidal behaviors within 30-90 days of screening.
One question was item 16: “I don’t deserve to live another moment.”
Two SCS items improved specificity and positive predictive value without reducing sensitivity, the authors wrote. They are: “It is unbearable when I get this upset” (item 8) and “I can’t imagine anyone being able to withstand this kind of pain” (item 13).
“For example,” the authors wrote, “only 4.1% of patients who screened positive on the PHQ-9 suicide risk item 9 engaged in suicidal behavior within the next 30 days, but when the PHQ-9 suicide risk item 9 was combined with SCS item 13 (the best-performing SCS item), this percentage nearly doubled, to 7.6% of patients.”
Adding one of these SCS items to the PHQ-9 “could provide a simple, accessible, and low-cost method for more accurately identifying primary care patients who require more immediate clinical intervention,” the authors wrote.
Outside expert perspective
Meredith Williamson, PhD, a mental health diagnosis and psychotherapy expert and clinical assistant professor at Texas A&M University, Bryan, said that, though the SCS questions are valuable, neither they nor the PHQ-9 question get to the direct question of whether the person is likely to act on their thoughts and attempt or complete suicide.
“Someone with depression may have thought of wishing they were dead or wishing they weren’t here but that doesn’t always mean they necessarily want to kill themselves,” she said in an interview. “It’s our responsibility as providers to really clarify the meaning of that item.”
Dr. Williamson noted the PHQ-9 is a very accessible method to screen for depression in primary care settings and is a way to catch large numbers of people screening positive, but its shortcomings are well known and additional information is needed.
She said that, in her practice, if a patient screens positive on PHQ-9, clinicians ask more about their intentions, how frequently they occur and whether patients have developed a plan for killing themselves.
The challenge is that “we have yet to predict who is and who is not going to kill themselves.”
Dr. Williamson said she finds the Columbia-Suicide Severity Rating Scale a valuable tool used in research settings that looks at prior attempts and current desire to engage in an attempt in more detail.
“It doesn’t stop people from killing themselves, but helps to better understand their suicidal behavior,” she explained.
This project was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Defense Medical Research and Development Program. Dr. Williamson has no relevant financial disclosures. Dr. Bryan is a paid consultant to Oui Therapeutics and Neurostat Analytical Solutions. He is a principal of Anduril, which conducts training workshops and provides mental health consultation focused on suicide prevention and PTSD.
Craig J. Bryan, PsyD, ABPP, with the department of psychiatry and behavioral health at Ohio State University Wexner Medical Center, Columbus, led the study, published online on Nov. 8, 2021, in Annals of Family Medicine.
The authors cited the urgency highlighted by statistics showing that, from 1999 to 2017, the U.S. suicide rate increased by more than 33% and was particularly high among military personnel and veterans.
Primary care offices are seen as a prime target for prevention efforts as nearly one-half of people who die by suicide in the United States visit a primary care office in the months before their deaths.
A common approach to screening for suicide risk has been to use the Patient Health Questionnaire–9 (PHQ-9). The first two questions assess the frequency of depressed mood and anhedonia in the past 2 weeks. If patients screen positive on those two questions, they are given the remaining seven questions.
A single item – question 9 – asks about how often a patient has “thoughts that you would be better off dead, or of hurting yourself in some way” during the past 2 weeks.
Yet, more that 95% of patients who screen positive on the PHQ-9 suicide risk question do not attempt or die by suicide, the authors noted.
Two methods tested for improving screening
Dr. Bryan and colleagues wanted to assess whether suicide risk screening could be improved in primary care and evaluated two methods.
One was to see whether using any of the other PHQ-9 items could be better than just using item 9 alone to identify the patients who were most likely to attempt suicide in the near future. Researchers found that method was not significantly beneficial. The second was to evaluate the performance of the 16 items on the Suicide Cognitions Scale (SCS), a questionnaire that asks patients to rate the extent to which they agree or disagree with statements that are commonly endorsed by suicidal people.
Patients who were eligible for medical treatment from the Department of Defense medical system were recruited from six large and small military primary care clinics across the United States from July 2015 to August 2018.
Patients answered questions on the PHQ-9 and 16 items from the SCS during routine primary care visits. Evaluators, who were blind to screening results, assessed postbaseline suicide attempts, interrupted attempts and aborted attempts by interviewing patients.
The study included 2,744 primary care patients, ranging from 18 to 89 years of age, with an average age of 40.
Adding at least one question may help
Researchers found that the accuracy of suicide risk screening using the PHQ-9 can be significantly improved by adding one or more questions from the SCS. Three items from SCS contributed most to meaningful improvements in identifying patients who went on to exhibit suicidal behaviors within 30-90 days of screening.
One question was item 16: “I don’t deserve to live another moment.”
Two SCS items improved specificity and positive predictive value without reducing sensitivity, the authors wrote. They are: “It is unbearable when I get this upset” (item 8) and “I can’t imagine anyone being able to withstand this kind of pain” (item 13).
“For example,” the authors wrote, “only 4.1% of patients who screened positive on the PHQ-9 suicide risk item 9 engaged in suicidal behavior within the next 30 days, but when the PHQ-9 suicide risk item 9 was combined with SCS item 13 (the best-performing SCS item), this percentage nearly doubled, to 7.6% of patients.”
Adding one of these SCS items to the PHQ-9 “could provide a simple, accessible, and low-cost method for more accurately identifying primary care patients who require more immediate clinical intervention,” the authors wrote.
Outside expert perspective
Meredith Williamson, PhD, a mental health diagnosis and psychotherapy expert and clinical assistant professor at Texas A&M University, Bryan, said that, though the SCS questions are valuable, neither they nor the PHQ-9 question get to the direct question of whether the person is likely to act on their thoughts and attempt or complete suicide.
“Someone with depression may have thought of wishing they were dead or wishing they weren’t here but that doesn’t always mean they necessarily want to kill themselves,” she said in an interview. “It’s our responsibility as providers to really clarify the meaning of that item.”
Dr. Williamson noted the PHQ-9 is a very accessible method to screen for depression in primary care settings and is a way to catch large numbers of people screening positive, but its shortcomings are well known and additional information is needed.
She said that, in her practice, if a patient screens positive on PHQ-9, clinicians ask more about their intentions, how frequently they occur and whether patients have developed a plan for killing themselves.
The challenge is that “we have yet to predict who is and who is not going to kill themselves.”
Dr. Williamson said she finds the Columbia-Suicide Severity Rating Scale a valuable tool used in research settings that looks at prior attempts and current desire to engage in an attempt in more detail.
“It doesn’t stop people from killing themselves, but helps to better understand their suicidal behavior,” she explained.
This project was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Defense Medical Research and Development Program. Dr. Williamson has no relevant financial disclosures. Dr. Bryan is a paid consultant to Oui Therapeutics and Neurostat Analytical Solutions. He is a principal of Anduril, which conducts training workshops and provides mental health consultation focused on suicide prevention and PTSD.
Craig J. Bryan, PsyD, ABPP, with the department of psychiatry and behavioral health at Ohio State University Wexner Medical Center, Columbus, led the study, published online on Nov. 8, 2021, in Annals of Family Medicine.
The authors cited the urgency highlighted by statistics showing that, from 1999 to 2017, the U.S. suicide rate increased by more than 33% and was particularly high among military personnel and veterans.
Primary care offices are seen as a prime target for prevention efforts as nearly one-half of people who die by suicide in the United States visit a primary care office in the months before their deaths.
A common approach to screening for suicide risk has been to use the Patient Health Questionnaire–9 (PHQ-9). The first two questions assess the frequency of depressed mood and anhedonia in the past 2 weeks. If patients screen positive on those two questions, they are given the remaining seven questions.
A single item – question 9 – asks about how often a patient has “thoughts that you would be better off dead, or of hurting yourself in some way” during the past 2 weeks.
Yet, more that 95% of patients who screen positive on the PHQ-9 suicide risk question do not attempt or die by suicide, the authors noted.
Two methods tested for improving screening
Dr. Bryan and colleagues wanted to assess whether suicide risk screening could be improved in primary care and evaluated two methods.
One was to see whether using any of the other PHQ-9 items could be better than just using item 9 alone to identify the patients who were most likely to attempt suicide in the near future. Researchers found that method was not significantly beneficial. The second was to evaluate the performance of the 16 items on the Suicide Cognitions Scale (SCS), a questionnaire that asks patients to rate the extent to which they agree or disagree with statements that are commonly endorsed by suicidal people.
Patients who were eligible for medical treatment from the Department of Defense medical system were recruited from six large and small military primary care clinics across the United States from July 2015 to August 2018.
Patients answered questions on the PHQ-9 and 16 items from the SCS during routine primary care visits. Evaluators, who were blind to screening results, assessed postbaseline suicide attempts, interrupted attempts and aborted attempts by interviewing patients.
The study included 2,744 primary care patients, ranging from 18 to 89 years of age, with an average age of 40.
Adding at least one question may help
Researchers found that the accuracy of suicide risk screening using the PHQ-9 can be significantly improved by adding one or more questions from the SCS. Three items from SCS contributed most to meaningful improvements in identifying patients who went on to exhibit suicidal behaviors within 30-90 days of screening.
One question was item 16: “I don’t deserve to live another moment.”
Two SCS items improved specificity and positive predictive value without reducing sensitivity, the authors wrote. They are: “It is unbearable when I get this upset” (item 8) and “I can’t imagine anyone being able to withstand this kind of pain” (item 13).
“For example,” the authors wrote, “only 4.1% of patients who screened positive on the PHQ-9 suicide risk item 9 engaged in suicidal behavior within the next 30 days, but when the PHQ-9 suicide risk item 9 was combined with SCS item 13 (the best-performing SCS item), this percentage nearly doubled, to 7.6% of patients.”
Adding one of these SCS items to the PHQ-9 “could provide a simple, accessible, and low-cost method for more accurately identifying primary care patients who require more immediate clinical intervention,” the authors wrote.
Outside expert perspective
Meredith Williamson, PhD, a mental health diagnosis and psychotherapy expert and clinical assistant professor at Texas A&M University, Bryan, said that, though the SCS questions are valuable, neither they nor the PHQ-9 question get to the direct question of whether the person is likely to act on their thoughts and attempt or complete suicide.
“Someone with depression may have thought of wishing they were dead or wishing they weren’t here but that doesn’t always mean they necessarily want to kill themselves,” she said in an interview. “It’s our responsibility as providers to really clarify the meaning of that item.”
Dr. Williamson noted the PHQ-9 is a very accessible method to screen for depression in primary care settings and is a way to catch large numbers of people screening positive, but its shortcomings are well known and additional information is needed.
She said that, in her practice, if a patient screens positive on PHQ-9, clinicians ask more about their intentions, how frequently they occur and whether patients have developed a plan for killing themselves.
The challenge is that “we have yet to predict who is and who is not going to kill themselves.”
Dr. Williamson said she finds the Columbia-Suicide Severity Rating Scale a valuable tool used in research settings that looks at prior attempts and current desire to engage in an attempt in more detail.
“It doesn’t stop people from killing themselves, but helps to better understand their suicidal behavior,” she explained.
This project was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Defense Medical Research and Development Program. Dr. Williamson has no relevant financial disclosures. Dr. Bryan is a paid consultant to Oui Therapeutics and Neurostat Analytical Solutions. He is a principal of Anduril, which conducts training workshops and provides mental health consultation focused on suicide prevention and PTSD.
FROM ANNALS OF FAMILY MEDICINE
Enriched infant formula offers no academic benefit later: Study
Infants who are given nutrient- or supplement-enriched formula milk do not later have higher academic scores as adolescents than those fed with standard formula, a study published online in the BMJ suggests.
One goal of modifying infant formula has been to make long-term cognitive outcomes similar to those for breast-fed infants, the authors noted. Rates for breastfeeding beyond 6 weeks are low in many parts of the world and more than 60% of babies worldwide under the age of 6 months are given formula to replace or supplement breast milk, the paper states.
So far, research has been inconclusive on benefits, though enhancements continue to be added and claims have been made as to their benefits on cognition in advertising. Long-term trials are difficult as researchers move on and participants are lost to follow-up.
In a new study, however, researchers led by Maximiliane L. Verfürden, MsC, with the University College of London’s Great Ormond Street Institute of Child Health, linked data from seven dormant, randomized, controlled infant formula trials to participants’ performance later as adolescents in the United Kingdom on mandatory national school math and English exams at ages 11 and 16 and found no difference in scores.
They followed 1,763 adolescents who had been participants in the formula trials, which were conducted between 1993 and 2001, and were able to link 91.2% (1,607) to academic records.
They found “no benefit of the infant formula modifications on cognitive outcomes.”
Three types of formula studied
In this study, the researchers discuss three widely available types of modified infant formulas that have been promoted as benefiting cognitive development: formula enriched with nutrients; formula supplemented with long-chain polyunsaturated fatty acids (LCPUFAs); and follow-on formula fortified with iron.
In one supplement group the academic results were worse than for those given standard formula. At age 11, children who had been given the LCPUFA-enhanced formula scored lower in both English and math.
“Given the potential associations between the source of LCPUFAs and adverse cognitive outcomes, long-term follow-up of trials testing infant formulas from other sources of LCPUFAs is recommended,” the authors wrote.
Nutrients can harm, editorialist says
Charlotte Wright, BM BCH, MSc, a pediatrician and epidemiologist with the Glasgow Royal Hospital for Children in Glasgow, who was not part of the study, coauthored an editorial that accompanied the article in the BMJ.
Dr. Wright and nutritionist Ada L. Gargia, PhD, at the University of Glasgow, wrote that nutrients in some formula enhancements can harm and that infant milk trials often have been poorly conducted.
The editorialists point to a large systematic review of formula milk trials published this year in the BMJ by Helfer et al. that found that most were funded by industry.
“Helfer and colleagues’ review found that 80% of studies were at high risk of bias, mainly because of selective reporting, with 92% of abstracts mentioning positive findings, despite only 42% of trials finding statistically significant differences in a stated primary outcome,” they wrote.
Dr. Wright, who runs a specialist feeding clinic for children, said in an interview that the study is valuable in that it has follow-up “to an age when adult cognition can be robustly assessed.”
She noted that the authors say additives that have been shown to be harmful are still routinely added.
“There is now evidence that adding LCPUFAs results in lower cognition and that giving extra iron to healthy children increases their risk of infection and may even slow their growth,” she said.
But advertisements to the contrary are quickly found in an Internet search, she said, even if no specific claims are made for them.
She gave an example of an advertisement for a commonly used enhanced formula, which reads: “Our formulation contains our highest levels of DHA (Omega 3 LCPs) and is enriched with iron to support normal cognitive development.”
The formula studies were done more than 20 years ago, but Dr. Wright said that does not downplay their relevance.
The basic formulation of the formulas hasn’t changed much, she said, and the additives are still present.
This work was supported by the Economic and Social Research Council UCL, Bloomsbury and East London Doctoral Training Partnership and a Great Ormond Street Hospital Charity Research grant. Full disclosures for all authors are available with the full text of the paper. Dr. Wright and Dr. Garcia declared no relevant financial relationships.
Infants who are given nutrient- or supplement-enriched formula milk do not later have higher academic scores as adolescents than those fed with standard formula, a study published online in the BMJ suggests.
One goal of modifying infant formula has been to make long-term cognitive outcomes similar to those for breast-fed infants, the authors noted. Rates for breastfeeding beyond 6 weeks are low in many parts of the world and more than 60% of babies worldwide under the age of 6 months are given formula to replace or supplement breast milk, the paper states.
So far, research has been inconclusive on benefits, though enhancements continue to be added and claims have been made as to their benefits on cognition in advertising. Long-term trials are difficult as researchers move on and participants are lost to follow-up.
In a new study, however, researchers led by Maximiliane L. Verfürden, MsC, with the University College of London’s Great Ormond Street Institute of Child Health, linked data from seven dormant, randomized, controlled infant formula trials to participants’ performance later as adolescents in the United Kingdom on mandatory national school math and English exams at ages 11 and 16 and found no difference in scores.
They followed 1,763 adolescents who had been participants in the formula trials, which were conducted between 1993 and 2001, and were able to link 91.2% (1,607) to academic records.
They found “no benefit of the infant formula modifications on cognitive outcomes.”
Three types of formula studied
In this study, the researchers discuss three widely available types of modified infant formulas that have been promoted as benefiting cognitive development: formula enriched with nutrients; formula supplemented with long-chain polyunsaturated fatty acids (LCPUFAs); and follow-on formula fortified with iron.
In one supplement group the academic results were worse than for those given standard formula. At age 11, children who had been given the LCPUFA-enhanced formula scored lower in both English and math.
“Given the potential associations between the source of LCPUFAs and adverse cognitive outcomes, long-term follow-up of trials testing infant formulas from other sources of LCPUFAs is recommended,” the authors wrote.
Nutrients can harm, editorialist says
Charlotte Wright, BM BCH, MSc, a pediatrician and epidemiologist with the Glasgow Royal Hospital for Children in Glasgow, who was not part of the study, coauthored an editorial that accompanied the article in the BMJ.
Dr. Wright and nutritionist Ada L. Gargia, PhD, at the University of Glasgow, wrote that nutrients in some formula enhancements can harm and that infant milk trials often have been poorly conducted.
The editorialists point to a large systematic review of formula milk trials published this year in the BMJ by Helfer et al. that found that most were funded by industry.
“Helfer and colleagues’ review found that 80% of studies were at high risk of bias, mainly because of selective reporting, with 92% of abstracts mentioning positive findings, despite only 42% of trials finding statistically significant differences in a stated primary outcome,” they wrote.
Dr. Wright, who runs a specialist feeding clinic for children, said in an interview that the study is valuable in that it has follow-up “to an age when adult cognition can be robustly assessed.”
She noted that the authors say additives that have been shown to be harmful are still routinely added.
“There is now evidence that adding LCPUFAs results in lower cognition and that giving extra iron to healthy children increases their risk of infection and may even slow their growth,” she said.
But advertisements to the contrary are quickly found in an Internet search, she said, even if no specific claims are made for them.
She gave an example of an advertisement for a commonly used enhanced formula, which reads: “Our formulation contains our highest levels of DHA (Omega 3 LCPs) and is enriched with iron to support normal cognitive development.”
The formula studies were done more than 20 years ago, but Dr. Wright said that does not downplay their relevance.
The basic formulation of the formulas hasn’t changed much, she said, and the additives are still present.
This work was supported by the Economic and Social Research Council UCL, Bloomsbury and East London Doctoral Training Partnership and a Great Ormond Street Hospital Charity Research grant. Full disclosures for all authors are available with the full text of the paper. Dr. Wright and Dr. Garcia declared no relevant financial relationships.
Infants who are given nutrient- or supplement-enriched formula milk do not later have higher academic scores as adolescents than those fed with standard formula, a study published online in the BMJ suggests.
One goal of modifying infant formula has been to make long-term cognitive outcomes similar to those for breast-fed infants, the authors noted. Rates for breastfeeding beyond 6 weeks are low in many parts of the world and more than 60% of babies worldwide under the age of 6 months are given formula to replace or supplement breast milk, the paper states.
So far, research has been inconclusive on benefits, though enhancements continue to be added and claims have been made as to their benefits on cognition in advertising. Long-term trials are difficult as researchers move on and participants are lost to follow-up.
In a new study, however, researchers led by Maximiliane L. Verfürden, MsC, with the University College of London’s Great Ormond Street Institute of Child Health, linked data from seven dormant, randomized, controlled infant formula trials to participants’ performance later as adolescents in the United Kingdom on mandatory national school math and English exams at ages 11 and 16 and found no difference in scores.
They followed 1,763 adolescents who had been participants in the formula trials, which were conducted between 1993 and 2001, and were able to link 91.2% (1,607) to academic records.
They found “no benefit of the infant formula modifications on cognitive outcomes.”
Three types of formula studied
In this study, the researchers discuss three widely available types of modified infant formulas that have been promoted as benefiting cognitive development: formula enriched with nutrients; formula supplemented with long-chain polyunsaturated fatty acids (LCPUFAs); and follow-on formula fortified with iron.
In one supplement group the academic results were worse than for those given standard formula. At age 11, children who had been given the LCPUFA-enhanced formula scored lower in both English and math.
“Given the potential associations between the source of LCPUFAs and adverse cognitive outcomes, long-term follow-up of trials testing infant formulas from other sources of LCPUFAs is recommended,” the authors wrote.
Nutrients can harm, editorialist says
Charlotte Wright, BM BCH, MSc, a pediatrician and epidemiologist with the Glasgow Royal Hospital for Children in Glasgow, who was not part of the study, coauthored an editorial that accompanied the article in the BMJ.
Dr. Wright and nutritionist Ada L. Gargia, PhD, at the University of Glasgow, wrote that nutrients in some formula enhancements can harm and that infant milk trials often have been poorly conducted.
The editorialists point to a large systematic review of formula milk trials published this year in the BMJ by Helfer et al. that found that most were funded by industry.
“Helfer and colleagues’ review found that 80% of studies were at high risk of bias, mainly because of selective reporting, with 92% of abstracts mentioning positive findings, despite only 42% of trials finding statistically significant differences in a stated primary outcome,” they wrote.
Dr. Wright, who runs a specialist feeding clinic for children, said in an interview that the study is valuable in that it has follow-up “to an age when adult cognition can be robustly assessed.”
She noted that the authors say additives that have been shown to be harmful are still routinely added.
“There is now evidence that adding LCPUFAs results in lower cognition and that giving extra iron to healthy children increases their risk of infection and may even slow their growth,” she said.
But advertisements to the contrary are quickly found in an Internet search, she said, even if no specific claims are made for them.
She gave an example of an advertisement for a commonly used enhanced formula, which reads: “Our formulation contains our highest levels of DHA (Omega 3 LCPs) and is enriched with iron to support normal cognitive development.”
The formula studies were done more than 20 years ago, but Dr. Wright said that does not downplay their relevance.
The basic formulation of the formulas hasn’t changed much, she said, and the additives are still present.
This work was supported by the Economic and Social Research Council UCL, Bloomsbury and East London Doctoral Training Partnership and a Great Ormond Street Hospital Charity Research grant. Full disclosures for all authors are available with the full text of the paper. Dr. Wright and Dr. Garcia declared no relevant financial relationships.
FROM THE BMJ
Early trials underway to test mushrooms as COVID treatment
The U.S. Food and Drug Administration (FDA) approved the MACH-19 trials (the acronym for Mushrooms and Chinese Herbs for COVID-19) after researchers applied for approval in April.
The first two phase 1 randomized, double-blind, placebo-controlled trials have begun at UCLA and the University of California San Diego to treat COVID-19 patients quarantining at home with mild to moderate symptoms. A third trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.
The researchers have also launched a fourth trial testing the mushrooms against placebo as an adjunct to a COVID booster shot. It looks at the effect in people who have comorbidities that would reduce their vaccine response. An article in JAMA described the trials.
The two mushroom varieties being tested — turkey tail and agarikon — are available as over-the-counter supplements, according to the report. They are a separate class from hallucinogenic or “magic” mushrooms being tested for other uses in medicine.
“They are not even as psychoactive as a cup of tea,” Gordon Saxe, MD, PhD, MPH, principal investigator for the MACH-19 trials, told this news organization.
For each of the MACH-19 treatment trials, researchers plan to recruit 66 people who are quarantined at home with mild to moderate COVID-19 symptoms. Participants will be randomly assigned either to receive the mushroom combination, the Chinese herbs, or a placebo for 2 weeks, according to the JAMA paper.
D. Craig Hopp, PhD, deputy director of the division of extramural research at the National Center for Complementary and Integrative Health (NCCIH), told JAMA in an interview that he was “mildly concerned” about using mushrooms to treat people with active SARS-CoV-2 infection.
“We know that a cytokine storm poses the greatest risk of COVID mortality, not the virus itself,” Dr. Hopp said. “The danger is that an immune-stimulating agent like mushrooms might supercharge an individual’s immune response, leading to a cytokine storm.”
Stephen Wilson, PhD, an immunologist who consulted on the trials when he was chief operating officer of the La Jolla Institute for Immunology, says in the JAMA article that a cytokine storm is unlikely for these patients because the mushroom components “don’t mimic inflammatory cytokines.” Dr. Wilson is now chief innovations officer at Statera Biopharma.
“We think the mushrooms increase the number of immunologic opportunities to better see and respond to a specific threat. In the doses used, the mushrooms perturb the immune system in a good way but fall far short of driving hyper or sustained inflammation,” Dr. Wilson said.
Dr. Saxe said the FDA process was extensive and rigorous and FDA investigators also asked about potential cytokine storms before approving the trials. Cytokine storm is not an issue with a healthy response, Dr. Saxe pointed out. It’s a response that’s not balanced or modulated.
“Mushrooms are immunomodulatory,” he said. “In some ways they very specifically enhance immunity. In other ways they calm down overimmunity.” Dr. Saxe noted that they did a sentinel study for the storm potential “and we didn’t see any evidence for it.”
“Not a crazy concept”
Dr. Saxe pointed out that one of the mushrooms in the combo they use — agarikon — was used to treat pulmonary infections 2,300 years ago.
“Hippocrates, the father of western medicine, used mushrooms,” he said. “Penicillin comes from fungi. It’s not a crazy concept. Most people who oppose this or are skeptics — to some extent, it’s a lack of information.”
Dr. Saxe explained that there are receptors on human cells that bind specific mushroom polysaccharides.
“There’s a hand-in-glove fit there,” Dr. Saxe said, and that’s one way mushrooms can modulate immune cell behavior, which could have an effect against SARS-CoV-2.
Daniel Kuritzkes, MD, chief of the division of infectious diseases at Brigham and Women’s Hospital in Boston, who was not part of the study, told this news organization that he wasn’t surprised the FDA approved moving forward with the trials.
“As long as you can demonstrate that there is a rationale for doing the trial and that you have some safety data or a plan to collect safety data, they are fairly liberal about doing early-phase studies. It would be a much different issue, I think, if they were proposing to do a study for actual licensing or approval of a drug,” Dr. Kuritzkes said.
As yet unanswered, he noted, is which component of the mushrooms or herbs is having the effect. It will be a challenge, he said, to know from one batch of the compound to the next that you have the same amount of material and that it’s going to have the same potency among lots.
Another challenge is how the mushrooms and herbs might interact with other therapies, Dr. Kuritzkes said.
He gave the example of St. John’s Wort, which has been problematic in HIV treatment.
“If someone is on certain HIV medicines and they also are taking St. John’s Wort, they basically are causing the liver to eat up the HIV drug and they don’t get adequate levels of the drug,” he said.
Though there are many challenges ahead, Dr. Kuritzkes acknowledged, but added that “this is a great starting point.”
He, too, pointed out that many traditional medicines were discovered from plants.
“The most famous of these is quinine, which came from cinchona bark that was used to treat malaria.” Dr. Kuritzkes said. Digitalis, often used to treat heart failure, comes from the fox glove plant, he added.
He said it’s important to remember that “people shouldn’t be seeking experimental therapies in place of proven therapies, they should be thinking of them in addition to proven therapies.»
A co-author reports an investment in the dietary supplement company Mycomedica Life Sciences, for which he also serves as an unpaid scientific adviser. Another co-author is a medical consultant for Evergreen Herbs and Medical Supplies. Dr. Hopp, Dr. Saxe, and Dr. Wilson have disclosed no relevant financial relationships. Dr. Kuritzkes consults for Merck, Gilead, and GlaxoSmithKline.
The U.S. Food and Drug Administration (FDA) approved the MACH-19 trials (the acronym for Mushrooms and Chinese Herbs for COVID-19) after researchers applied for approval in April.
The first two phase 1 randomized, double-blind, placebo-controlled trials have begun at UCLA and the University of California San Diego to treat COVID-19 patients quarantining at home with mild to moderate symptoms. A third trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.
The researchers have also launched a fourth trial testing the mushrooms against placebo as an adjunct to a COVID booster shot. It looks at the effect in people who have comorbidities that would reduce their vaccine response. An article in JAMA described the trials.
The two mushroom varieties being tested — turkey tail and agarikon — are available as over-the-counter supplements, according to the report. They are a separate class from hallucinogenic or “magic” mushrooms being tested for other uses in medicine.
“They are not even as psychoactive as a cup of tea,” Gordon Saxe, MD, PhD, MPH, principal investigator for the MACH-19 trials, told this news organization.
For each of the MACH-19 treatment trials, researchers plan to recruit 66 people who are quarantined at home with mild to moderate COVID-19 symptoms. Participants will be randomly assigned either to receive the mushroom combination, the Chinese herbs, or a placebo for 2 weeks, according to the JAMA paper.
D. Craig Hopp, PhD, deputy director of the division of extramural research at the National Center for Complementary and Integrative Health (NCCIH), told JAMA in an interview that he was “mildly concerned” about using mushrooms to treat people with active SARS-CoV-2 infection.
“We know that a cytokine storm poses the greatest risk of COVID mortality, not the virus itself,” Dr. Hopp said. “The danger is that an immune-stimulating agent like mushrooms might supercharge an individual’s immune response, leading to a cytokine storm.”
Stephen Wilson, PhD, an immunologist who consulted on the trials when he was chief operating officer of the La Jolla Institute for Immunology, says in the JAMA article that a cytokine storm is unlikely for these patients because the mushroom components “don’t mimic inflammatory cytokines.” Dr. Wilson is now chief innovations officer at Statera Biopharma.
“We think the mushrooms increase the number of immunologic opportunities to better see and respond to a specific threat. In the doses used, the mushrooms perturb the immune system in a good way but fall far short of driving hyper or sustained inflammation,” Dr. Wilson said.
Dr. Saxe said the FDA process was extensive and rigorous and FDA investigators also asked about potential cytokine storms before approving the trials. Cytokine storm is not an issue with a healthy response, Dr. Saxe pointed out. It’s a response that’s not balanced or modulated.
“Mushrooms are immunomodulatory,” he said. “In some ways they very specifically enhance immunity. In other ways they calm down overimmunity.” Dr. Saxe noted that they did a sentinel study for the storm potential “and we didn’t see any evidence for it.”
“Not a crazy concept”
Dr. Saxe pointed out that one of the mushrooms in the combo they use — agarikon — was used to treat pulmonary infections 2,300 years ago.
“Hippocrates, the father of western medicine, used mushrooms,” he said. “Penicillin comes from fungi. It’s not a crazy concept. Most people who oppose this or are skeptics — to some extent, it’s a lack of information.”
Dr. Saxe explained that there are receptors on human cells that bind specific mushroom polysaccharides.
“There’s a hand-in-glove fit there,” Dr. Saxe said, and that’s one way mushrooms can modulate immune cell behavior, which could have an effect against SARS-CoV-2.
Daniel Kuritzkes, MD, chief of the division of infectious diseases at Brigham and Women’s Hospital in Boston, who was not part of the study, told this news organization that he wasn’t surprised the FDA approved moving forward with the trials.
“As long as you can demonstrate that there is a rationale for doing the trial and that you have some safety data or a plan to collect safety data, they are fairly liberal about doing early-phase studies. It would be a much different issue, I think, if they were proposing to do a study for actual licensing or approval of a drug,” Dr. Kuritzkes said.
As yet unanswered, he noted, is which component of the mushrooms or herbs is having the effect. It will be a challenge, he said, to know from one batch of the compound to the next that you have the same amount of material and that it’s going to have the same potency among lots.
Another challenge is how the mushrooms and herbs might interact with other therapies, Dr. Kuritzkes said.
He gave the example of St. John’s Wort, which has been problematic in HIV treatment.
“If someone is on certain HIV medicines and they also are taking St. John’s Wort, they basically are causing the liver to eat up the HIV drug and they don’t get adequate levels of the drug,” he said.
Though there are many challenges ahead, Dr. Kuritzkes acknowledged, but added that “this is a great starting point.”
He, too, pointed out that many traditional medicines were discovered from plants.
“The most famous of these is quinine, which came from cinchona bark that was used to treat malaria.” Dr. Kuritzkes said. Digitalis, often used to treat heart failure, comes from the fox glove plant, he added.
He said it’s important to remember that “people shouldn’t be seeking experimental therapies in place of proven therapies, they should be thinking of them in addition to proven therapies.»
A co-author reports an investment in the dietary supplement company Mycomedica Life Sciences, for which he also serves as an unpaid scientific adviser. Another co-author is a medical consultant for Evergreen Herbs and Medical Supplies. Dr. Hopp, Dr. Saxe, and Dr. Wilson have disclosed no relevant financial relationships. Dr. Kuritzkes consults for Merck, Gilead, and GlaxoSmithKline.
The U.S. Food and Drug Administration (FDA) approved the MACH-19 trials (the acronym for Mushrooms and Chinese Herbs for COVID-19) after researchers applied for approval in April.
The first two phase 1 randomized, double-blind, placebo-controlled trials have begun at UCLA and the University of California San Diego to treat COVID-19 patients quarantining at home with mild to moderate symptoms. A third trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.
The researchers have also launched a fourth trial testing the mushrooms against placebo as an adjunct to a COVID booster shot. It looks at the effect in people who have comorbidities that would reduce their vaccine response. An article in JAMA described the trials.
The two mushroom varieties being tested — turkey tail and agarikon — are available as over-the-counter supplements, according to the report. They are a separate class from hallucinogenic or “magic” mushrooms being tested for other uses in medicine.
“They are not even as psychoactive as a cup of tea,” Gordon Saxe, MD, PhD, MPH, principal investigator for the MACH-19 trials, told this news organization.
For each of the MACH-19 treatment trials, researchers plan to recruit 66 people who are quarantined at home with mild to moderate COVID-19 symptoms. Participants will be randomly assigned either to receive the mushroom combination, the Chinese herbs, or a placebo for 2 weeks, according to the JAMA paper.
D. Craig Hopp, PhD, deputy director of the division of extramural research at the National Center for Complementary and Integrative Health (NCCIH), told JAMA in an interview that he was “mildly concerned” about using mushrooms to treat people with active SARS-CoV-2 infection.
“We know that a cytokine storm poses the greatest risk of COVID mortality, not the virus itself,” Dr. Hopp said. “The danger is that an immune-stimulating agent like mushrooms might supercharge an individual’s immune response, leading to a cytokine storm.”
Stephen Wilson, PhD, an immunologist who consulted on the trials when he was chief operating officer of the La Jolla Institute for Immunology, says in the JAMA article that a cytokine storm is unlikely for these patients because the mushroom components “don’t mimic inflammatory cytokines.” Dr. Wilson is now chief innovations officer at Statera Biopharma.
“We think the mushrooms increase the number of immunologic opportunities to better see and respond to a specific threat. In the doses used, the mushrooms perturb the immune system in a good way but fall far short of driving hyper or sustained inflammation,” Dr. Wilson said.
Dr. Saxe said the FDA process was extensive and rigorous and FDA investigators also asked about potential cytokine storms before approving the trials. Cytokine storm is not an issue with a healthy response, Dr. Saxe pointed out. It’s a response that’s not balanced or modulated.
“Mushrooms are immunomodulatory,” he said. “In some ways they very specifically enhance immunity. In other ways they calm down overimmunity.” Dr. Saxe noted that they did a sentinel study for the storm potential “and we didn’t see any evidence for it.”
“Not a crazy concept”
Dr. Saxe pointed out that one of the mushrooms in the combo they use — agarikon — was used to treat pulmonary infections 2,300 years ago.
“Hippocrates, the father of western medicine, used mushrooms,” he said. “Penicillin comes from fungi. It’s not a crazy concept. Most people who oppose this or are skeptics — to some extent, it’s a lack of information.”
Dr. Saxe explained that there are receptors on human cells that bind specific mushroom polysaccharides.
“There’s a hand-in-glove fit there,” Dr. Saxe said, and that’s one way mushrooms can modulate immune cell behavior, which could have an effect against SARS-CoV-2.
Daniel Kuritzkes, MD, chief of the division of infectious diseases at Brigham and Women’s Hospital in Boston, who was not part of the study, told this news organization that he wasn’t surprised the FDA approved moving forward with the trials.
“As long as you can demonstrate that there is a rationale for doing the trial and that you have some safety data or a plan to collect safety data, they are fairly liberal about doing early-phase studies. It would be a much different issue, I think, if they were proposing to do a study for actual licensing or approval of a drug,” Dr. Kuritzkes said.
As yet unanswered, he noted, is which component of the mushrooms or herbs is having the effect. It will be a challenge, he said, to know from one batch of the compound to the next that you have the same amount of material and that it’s going to have the same potency among lots.
Another challenge is how the mushrooms and herbs might interact with other therapies, Dr. Kuritzkes said.
He gave the example of St. John’s Wort, which has been problematic in HIV treatment.
“If someone is on certain HIV medicines and they also are taking St. John’s Wort, they basically are causing the liver to eat up the HIV drug and they don’t get adequate levels of the drug,” he said.
Though there are many challenges ahead, Dr. Kuritzkes acknowledged, but added that “this is a great starting point.”
He, too, pointed out that many traditional medicines were discovered from plants.
“The most famous of these is quinine, which came from cinchona bark that was used to treat malaria.” Dr. Kuritzkes said. Digitalis, often used to treat heart failure, comes from the fox glove plant, he added.
He said it’s important to remember that “people shouldn’t be seeking experimental therapies in place of proven therapies, they should be thinking of them in addition to proven therapies.»
A co-author reports an investment in the dietary supplement company Mycomedica Life Sciences, for which he also serves as an unpaid scientific adviser. Another co-author is a medical consultant for Evergreen Herbs and Medical Supplies. Dr. Hopp, Dr. Saxe, and Dr. Wilson have disclosed no relevant financial relationships. Dr. Kuritzkes consults for Merck, Gilead, and GlaxoSmithKline.
FROM JAMA
Universal depression screening in schools doubles odds for teen treatment
Universal screening for adolescent depression in schools, compared with the usual process of targeting students for referral after observing behaviors, resulted in significantly higher odds of identifying major depressive disorder (MDD) and of starting treatment for it, a study of more than 12,000 students suggests. Findings were published online in JAMA Network Open.
Deepa L. Sekhar, MD, MSc, with the department of pediatrics at Pennsylvania State College of Medicine in Hershey, Pa., and colleagues conducted a randomized clinical trial comparing the two screening methods from November 2018 to November 2020.
The trial included students in grades 9 through 12 enrolled at any of the 14 participating Pennsylvania public high schools. Researchers compared the two groups using mixed-effects logistic regression.
They found that adolescents in the universal screening intervention group had 5.92 times higher odds (95% confidence interval [CI], 5.07-6.93) of being identified with MDD symptoms, 3.30 times higher odds (95% CI, 2.49-4.38) of the Student Assistance Program (SAP) confirming follow-up needs, and 2.07 times higher odds (95% CI, 1.39-3.10) of starting MDD treatment.
The study comprised 12,909 students, with an average age of 16 years. Of those students, 2,687 (20.8%) were Hispanic; 2,891 (22.4%) were non-Hispanic Black, 5,842 (45.3%) were non-Hispanic White; and 1,489 (11.5%) were multiracial or of other race or ethnicity.
In the universal screening intervention (n = 6,473) all students completed the Patient Health Questionnaire–9 (PHQ-9). Students who screened positive proceeded to the Student Assistance Program. Students could receive a targeted referral to SAP if they had concerning behavior beyond the PHQ-9.
In the targeted screening group (n = 6,436), students with behaviors prompting concern for MDD were referred to the Student Assistance Program (SAP), mandated in all Pennsylvania schools. The SAP determined follow-up.
The U.S. Preventive Services Task Force (USPSTF) endorsed primary care screening in 2009 and again in 2016 for all adolescents 12-18 years old.
However, the study authors wrote, most U.S. adolescents (more than 60%) don’t have routine access to preventive health care, which limits primary care offices’ ability to properly address the growing numbers.
“[S]creening is inconsistent, with inequalities by race and ethnicity and region, and potential worsening with the COVID-19 pandemic,” they noted.
Depression rates see sharp increase
Meanwhile, the prevalence of adolescents reporting MDD symptoms has “nearly doubled in the last decade, increasing from 8.3% in 2008 to 14.4% in 2018.”
The American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry, and Children’s Hospital Association recently declared a national emergency in children’s mental health, citing COVID-19’s toll on top of existing challenges.
This study provides further evidence that universal screening is the better approach to identify and treat adolescent depression to save lives, Andres Pumariega, MD, a child and adolescent psychiatrist at University of Florida in Gainesville, told this news organization.
“If you catch these kids early, you can prevent suicide attempts and suicide. You can also prevent complicating costs of care,” he said.
He noted the universal screening removes the potential for bias.
“Relying purely on referral and clinical identification means a lot of kids in minority groups will not be identified and will not be treated accurately. Many clinicians have a problem identifying depression in diverse kids,” he said.
Pushback for universal screening likely
However, he said he has been part of such efforts to implement such programs in Mexico and the United States and said in the Unites States, the political climate will guarantee pushback from having schools more involved in health care and prevention. Recent controversy around COVID-19 vaccines for children illustrates the potential backlash, he said.
Parents often fight such programs as attempts to “label” their children, he said.
“If I have cancer, I sure want to be labeled. A label is used to get them help. We need to find ways to educate parents and support them in facing these issues,” he added.
One concern he has with this intervention is having the SAPs, composed largely of nonclinicians, be the triage point “instead of doing that objectively through objective criteria and by clinicians,” he said. “If we are to have a comprehensive health system where we can serve all kids and manage costs, schools need to be a major part of it.”
School settings offer the chance to see more children, collaborate with teachers and counselors, and integrate results with educational outcomes, he added.
In the study by Sekhar and colleagues, 7 of the 14 schools were classified as urban, with a median size of 370 students.
Researchers noted that the benefit of the universal screening is likely understated because of COVID-19–related school closures during the study period. The closures meant screening wasn’t completed for 7% of students.
The authors concluded that universal screening finds teens living with depression who otherwise would not be found. They said such a program likely works best in schools with strong SAP.
“Adolescents’ consistent contact with schools has been used to support physical health screenings that affect academic success,” the authors wrote. “Major depressive disorder similarly affects academic success, suggesting school-based screening may be especially beneficial.”
In the past 3 years, Dr. Sekhar reported receiving funding from Pfizer through the American Academy of Pediatrics, the Penn State Clinical and Translational Science Awards Program, and a Eugene Washington Patient-Centered Outcomes Research Institute Engagement Award. Full disclosures for coauthors are available in the journal article.
This work was supported in part by the Patient-Centered Outcomes Research Institute. The use of REDCap (Research Electronic Data Capture) in this project was supported by the National Institutes of Health.
Universal screening for adolescent depression in schools, compared with the usual process of targeting students for referral after observing behaviors, resulted in significantly higher odds of identifying major depressive disorder (MDD) and of starting treatment for it, a study of more than 12,000 students suggests. Findings were published online in JAMA Network Open.
Deepa L. Sekhar, MD, MSc, with the department of pediatrics at Pennsylvania State College of Medicine in Hershey, Pa., and colleagues conducted a randomized clinical trial comparing the two screening methods from November 2018 to November 2020.
The trial included students in grades 9 through 12 enrolled at any of the 14 participating Pennsylvania public high schools. Researchers compared the two groups using mixed-effects logistic regression.
They found that adolescents in the universal screening intervention group had 5.92 times higher odds (95% confidence interval [CI], 5.07-6.93) of being identified with MDD symptoms, 3.30 times higher odds (95% CI, 2.49-4.38) of the Student Assistance Program (SAP) confirming follow-up needs, and 2.07 times higher odds (95% CI, 1.39-3.10) of starting MDD treatment.
The study comprised 12,909 students, with an average age of 16 years. Of those students, 2,687 (20.8%) were Hispanic; 2,891 (22.4%) were non-Hispanic Black, 5,842 (45.3%) were non-Hispanic White; and 1,489 (11.5%) were multiracial or of other race or ethnicity.
In the universal screening intervention (n = 6,473) all students completed the Patient Health Questionnaire–9 (PHQ-9). Students who screened positive proceeded to the Student Assistance Program. Students could receive a targeted referral to SAP if they had concerning behavior beyond the PHQ-9.
In the targeted screening group (n = 6,436), students with behaviors prompting concern for MDD were referred to the Student Assistance Program (SAP), mandated in all Pennsylvania schools. The SAP determined follow-up.
The U.S. Preventive Services Task Force (USPSTF) endorsed primary care screening in 2009 and again in 2016 for all adolescents 12-18 years old.
However, the study authors wrote, most U.S. adolescents (more than 60%) don’t have routine access to preventive health care, which limits primary care offices’ ability to properly address the growing numbers.
“[S]creening is inconsistent, with inequalities by race and ethnicity and region, and potential worsening with the COVID-19 pandemic,” they noted.
Depression rates see sharp increase
Meanwhile, the prevalence of adolescents reporting MDD symptoms has “nearly doubled in the last decade, increasing from 8.3% in 2008 to 14.4% in 2018.”
The American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry, and Children’s Hospital Association recently declared a national emergency in children’s mental health, citing COVID-19’s toll on top of existing challenges.
This study provides further evidence that universal screening is the better approach to identify and treat adolescent depression to save lives, Andres Pumariega, MD, a child and adolescent psychiatrist at University of Florida in Gainesville, told this news organization.
“If you catch these kids early, you can prevent suicide attempts and suicide. You can also prevent complicating costs of care,” he said.
He noted the universal screening removes the potential for bias.
“Relying purely on referral and clinical identification means a lot of kids in minority groups will not be identified and will not be treated accurately. Many clinicians have a problem identifying depression in diverse kids,” he said.
Pushback for universal screening likely
However, he said he has been part of such efforts to implement such programs in Mexico and the United States and said in the Unites States, the political climate will guarantee pushback from having schools more involved in health care and prevention. Recent controversy around COVID-19 vaccines for children illustrates the potential backlash, he said.
Parents often fight such programs as attempts to “label” their children, he said.
“If I have cancer, I sure want to be labeled. A label is used to get them help. We need to find ways to educate parents and support them in facing these issues,” he added.
One concern he has with this intervention is having the SAPs, composed largely of nonclinicians, be the triage point “instead of doing that objectively through objective criteria and by clinicians,” he said. “If we are to have a comprehensive health system where we can serve all kids and manage costs, schools need to be a major part of it.”
School settings offer the chance to see more children, collaborate with teachers and counselors, and integrate results with educational outcomes, he added.
In the study by Sekhar and colleagues, 7 of the 14 schools were classified as urban, with a median size of 370 students.
Researchers noted that the benefit of the universal screening is likely understated because of COVID-19–related school closures during the study period. The closures meant screening wasn’t completed for 7% of students.
The authors concluded that universal screening finds teens living with depression who otherwise would not be found. They said such a program likely works best in schools with strong SAP.
“Adolescents’ consistent contact with schools has been used to support physical health screenings that affect academic success,” the authors wrote. “Major depressive disorder similarly affects academic success, suggesting school-based screening may be especially beneficial.”
In the past 3 years, Dr. Sekhar reported receiving funding from Pfizer through the American Academy of Pediatrics, the Penn State Clinical and Translational Science Awards Program, and a Eugene Washington Patient-Centered Outcomes Research Institute Engagement Award. Full disclosures for coauthors are available in the journal article.
This work was supported in part by the Patient-Centered Outcomes Research Institute. The use of REDCap (Research Electronic Data Capture) in this project was supported by the National Institutes of Health.
Universal screening for adolescent depression in schools, compared with the usual process of targeting students for referral after observing behaviors, resulted in significantly higher odds of identifying major depressive disorder (MDD) and of starting treatment for it, a study of more than 12,000 students suggests. Findings were published online in JAMA Network Open.
Deepa L. Sekhar, MD, MSc, with the department of pediatrics at Pennsylvania State College of Medicine in Hershey, Pa., and colleagues conducted a randomized clinical trial comparing the two screening methods from November 2018 to November 2020.
The trial included students in grades 9 through 12 enrolled at any of the 14 participating Pennsylvania public high schools. Researchers compared the two groups using mixed-effects logistic regression.
They found that adolescents in the universal screening intervention group had 5.92 times higher odds (95% confidence interval [CI], 5.07-6.93) of being identified with MDD symptoms, 3.30 times higher odds (95% CI, 2.49-4.38) of the Student Assistance Program (SAP) confirming follow-up needs, and 2.07 times higher odds (95% CI, 1.39-3.10) of starting MDD treatment.
The study comprised 12,909 students, with an average age of 16 years. Of those students, 2,687 (20.8%) were Hispanic; 2,891 (22.4%) were non-Hispanic Black, 5,842 (45.3%) were non-Hispanic White; and 1,489 (11.5%) were multiracial or of other race or ethnicity.
In the universal screening intervention (n = 6,473) all students completed the Patient Health Questionnaire–9 (PHQ-9). Students who screened positive proceeded to the Student Assistance Program. Students could receive a targeted referral to SAP if they had concerning behavior beyond the PHQ-9.
In the targeted screening group (n = 6,436), students with behaviors prompting concern for MDD were referred to the Student Assistance Program (SAP), mandated in all Pennsylvania schools. The SAP determined follow-up.
The U.S. Preventive Services Task Force (USPSTF) endorsed primary care screening in 2009 and again in 2016 for all adolescents 12-18 years old.
However, the study authors wrote, most U.S. adolescents (more than 60%) don’t have routine access to preventive health care, which limits primary care offices’ ability to properly address the growing numbers.
“[S]creening is inconsistent, with inequalities by race and ethnicity and region, and potential worsening with the COVID-19 pandemic,” they noted.
Depression rates see sharp increase
Meanwhile, the prevalence of adolescents reporting MDD symptoms has “nearly doubled in the last decade, increasing from 8.3% in 2008 to 14.4% in 2018.”
The American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry, and Children’s Hospital Association recently declared a national emergency in children’s mental health, citing COVID-19’s toll on top of existing challenges.
This study provides further evidence that universal screening is the better approach to identify and treat adolescent depression to save lives, Andres Pumariega, MD, a child and adolescent psychiatrist at University of Florida in Gainesville, told this news organization.
“If you catch these kids early, you can prevent suicide attempts and suicide. You can also prevent complicating costs of care,” he said.
He noted the universal screening removes the potential for bias.
“Relying purely on referral and clinical identification means a lot of kids in minority groups will not be identified and will not be treated accurately. Many clinicians have a problem identifying depression in diverse kids,” he said.
Pushback for universal screening likely
However, he said he has been part of such efforts to implement such programs in Mexico and the United States and said in the Unites States, the political climate will guarantee pushback from having schools more involved in health care and prevention. Recent controversy around COVID-19 vaccines for children illustrates the potential backlash, he said.
Parents often fight such programs as attempts to “label” their children, he said.
“If I have cancer, I sure want to be labeled. A label is used to get them help. We need to find ways to educate parents and support them in facing these issues,” he added.
One concern he has with this intervention is having the SAPs, composed largely of nonclinicians, be the triage point “instead of doing that objectively through objective criteria and by clinicians,” he said. “If we are to have a comprehensive health system where we can serve all kids and manage costs, schools need to be a major part of it.”
School settings offer the chance to see more children, collaborate with teachers and counselors, and integrate results with educational outcomes, he added.
In the study by Sekhar and colleagues, 7 of the 14 schools were classified as urban, with a median size of 370 students.
Researchers noted that the benefit of the universal screening is likely understated because of COVID-19–related school closures during the study period. The closures meant screening wasn’t completed for 7% of students.
The authors concluded that universal screening finds teens living with depression who otherwise would not be found. They said such a program likely works best in schools with strong SAP.
“Adolescents’ consistent contact with schools has been used to support physical health screenings that affect academic success,” the authors wrote. “Major depressive disorder similarly affects academic success, suggesting school-based screening may be especially beneficial.”
In the past 3 years, Dr. Sekhar reported receiving funding from Pfizer through the American Academy of Pediatrics, the Penn State Clinical and Translational Science Awards Program, and a Eugene Washington Patient-Centered Outcomes Research Institute Engagement Award. Full disclosures for coauthors are available in the journal article.
This work was supported in part by the Patient-Centered Outcomes Research Institute. The use of REDCap (Research Electronic Data Capture) in this project was supported by the National Institutes of Health.
JAMA NETWORK OPEN
COVID-19 has brought more complex, longer office visits
Evidence of this came from the latest Primary Care Collaborative (PCC) survey, which found that primary care clinicians are seeing more complex patients requiring longer appointments in the wake of COVID-19.
The PCC with the Larry A. Green Center regularly surveys primary care clinicians. This round of questions came August 14-17 and included 1,263 respondents from 49 states, the District of Columbia, and two territories.
More than 7 in 10 (71%) respondents said their patients are more complex and nearly the same percentage said appointments are taking more time.
Ann Greiner, president and CEO of the PCC, said in an interview that 55% of respondents reported that clinicians are struggling to keep up with pent-up demand after patients have delayed or canceled care. Sixty-five percent in the survey said they had seen a rise in children’s mental health issues, and 58% said they were unsure how to help their patients with long COVID.
In addition, primary care clinicians are having repeated conversations with patients on why they should get a vaccine and which one.
“I think that’s adding to the complexity. There is a lot going on here with patient trust,” Ms. Greiner said.
‘We’re going to be playing catch-up’
Jacqueline Fincher, MD, an internist in Thompson, Ga., said in an interview that appointments have gotten longer and more complex in the wake of the pandemic – “no question.”
The immediate past president of the American College of Physicians is seeing patients with chronic disease that has gone untreated for sometimes a year or more, she said.
“Their blood pressure was not under good control, they were under more stress, their sugars were up and weren’t being followed as closely for conditions such as congestive heart failure,” she said.
Dr. Fincher, who works in a rural practice 40 miles from Augusta, Ga., with her physician husband and two other physicians, said patients are ready to come back in, “but I don’t have enough slots for them.”
She said she prioritizes what to help patients with first and schedules the next tier for the next appointment, but added, “honestly, over the next 2 years we’re going to be playing catch-up.”
At the same time, the CDC has estimated that 45% of U.S. adults are at increased risk for complications from COVID-19 because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer. Rates ranged from 19.8% for people 18-29 years old to 80.7% for people over 80 years of age.
Long COVID could overwhelm existing health care capacity
Primary care physicians are also having to diagnose sometimes “invisible” symptoms after people have recovered from acute COVID-19 infection. Diagnosing takes intent listening to patients who describe symptoms that tests can’t confirm.
As this news organization has previously reported, half of COVID-19 survivors report postacute sequelae of COVID-19 (PASC) lasting longer than 6 months.
“These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries,” the authors wrote.
Anxiety, depression ‘have gone off the charts’
Danielle Loeb, MD, MPH, associate professor of internal medicine at the University of Colorado in Denver, who studies complexity in primary care, said in the wake of COVID-19, more patients have developed “new, serious anxiety.”
“That got extremely exacerbated during the pandemic. Anxiety and depression have gone off the charts,” said Dr. Loeb, who prefers the pronoun “they.”
Dr. Loeb cares for a large number of transgender patients. As offices reopen, some patients are having trouble reintegrating into the workplace and resuming social contacts. The primary care doctor says appointments can get longer because of the need to complete tasks, such as filling out forms for Family Medical Leave Act for those not yet ready to return to work.
COVID-19–related fears are keeping many patients from coming into the office, Dr. Loeb said, either from fear of exposure or because they have mental health issues that keep them from feeling safe leaving the house.
“That really affects my ability to care for them,” they said.
Loss of employment in the pandemic or fear of job loss and subsequent changing of insurance has complicated primary care in terms of treatment and administrative tasks, according to Dr. Loeb.
To help treat patients with acute mental health issues and manage other patients, Dr. Loeb’s practice has brought in a social worker and a therapist.
Team-based care is key in the survival of primary care practices, though providing that is difficult in the smaller clinics because of the critical mass of patients needed to make it viable, they said.
“It’s the only answer. It’s the only way you don’t drown,” Dr. Loeb added. “I’m not drowning, and I credit that to my clinic having the help to support the mental health piece of things.”
Rethinking workflow
Tricia McGinnis, MPP, MPH, executive vice president of the nonprofit Center for Health Care Strategies (CHCS) says complexity has forced rethinking workflow.
“A lot of the trends we’re seeing in primary care were there pre-COVID, but COVID has exacerbated those trends,” she said in an interview.
“The good news ... is that it was already becoming clear that primary care needed to provide basic mental health services and integrate with behavioral health. It had also become clear that effective primary care needed to address social issues that keep patients from accessing health care,” she said.
Expanding care teams, as Dr. Loeb mentioned, is a key strategy, according to Ms. McGinnis. Potential teams would include the clinical staff, but also social workers and community health workers – people who come from the community primary care is serving who can help build trust with patients and connect the patient to the primary care team.
“There’s a lot that needs to happen that the clinician doesn’t need to do,” she said.
Telehealth can be a big factor in coordinating the team, Ms. McGinnis added.
“It’s thinking less about who’s doing the work, but more about the work that needs to be done to keep people healthy. Then let’s think about the type of workers best suited to perform those tasks,” she said.
As for reimbursing more complex care, population-based, up-front capitated payments linked to high-quality care and better outcomes will need to replace fee-for-service models, according to Ms. McGinnis.
That will provide reliable incomes for primary care offices, but also flexibility in how each patient with different levels of complexity is managed, she said.
Ms. Greiner, Dr. Fincher, Dr. Loeb, and Ms. McGinnis have no relevant financial relationships.
Evidence of this came from the latest Primary Care Collaborative (PCC) survey, which found that primary care clinicians are seeing more complex patients requiring longer appointments in the wake of COVID-19.
The PCC with the Larry A. Green Center regularly surveys primary care clinicians. This round of questions came August 14-17 and included 1,263 respondents from 49 states, the District of Columbia, and two territories.
More than 7 in 10 (71%) respondents said their patients are more complex and nearly the same percentage said appointments are taking more time.
Ann Greiner, president and CEO of the PCC, said in an interview that 55% of respondents reported that clinicians are struggling to keep up with pent-up demand after patients have delayed or canceled care. Sixty-five percent in the survey said they had seen a rise in children’s mental health issues, and 58% said they were unsure how to help their patients with long COVID.
In addition, primary care clinicians are having repeated conversations with patients on why they should get a vaccine and which one.
“I think that’s adding to the complexity. There is a lot going on here with patient trust,” Ms. Greiner said.
‘We’re going to be playing catch-up’
Jacqueline Fincher, MD, an internist in Thompson, Ga., said in an interview that appointments have gotten longer and more complex in the wake of the pandemic – “no question.”
The immediate past president of the American College of Physicians is seeing patients with chronic disease that has gone untreated for sometimes a year or more, she said.
“Their blood pressure was not under good control, they were under more stress, their sugars were up and weren’t being followed as closely for conditions such as congestive heart failure,” she said.
Dr. Fincher, who works in a rural practice 40 miles from Augusta, Ga., with her physician husband and two other physicians, said patients are ready to come back in, “but I don’t have enough slots for them.”
She said she prioritizes what to help patients with first and schedules the next tier for the next appointment, but added, “honestly, over the next 2 years we’re going to be playing catch-up.”
At the same time, the CDC has estimated that 45% of U.S. adults are at increased risk for complications from COVID-19 because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer. Rates ranged from 19.8% for people 18-29 years old to 80.7% for people over 80 years of age.
Long COVID could overwhelm existing health care capacity
Primary care physicians are also having to diagnose sometimes “invisible” symptoms after people have recovered from acute COVID-19 infection. Diagnosing takes intent listening to patients who describe symptoms that tests can’t confirm.
As this news organization has previously reported, half of COVID-19 survivors report postacute sequelae of COVID-19 (PASC) lasting longer than 6 months.
“These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries,” the authors wrote.
Anxiety, depression ‘have gone off the charts’
Danielle Loeb, MD, MPH, associate professor of internal medicine at the University of Colorado in Denver, who studies complexity in primary care, said in the wake of COVID-19, more patients have developed “new, serious anxiety.”
“That got extremely exacerbated during the pandemic. Anxiety and depression have gone off the charts,” said Dr. Loeb, who prefers the pronoun “they.”
Dr. Loeb cares for a large number of transgender patients. As offices reopen, some patients are having trouble reintegrating into the workplace and resuming social contacts. The primary care doctor says appointments can get longer because of the need to complete tasks, such as filling out forms for Family Medical Leave Act for those not yet ready to return to work.
COVID-19–related fears are keeping many patients from coming into the office, Dr. Loeb said, either from fear of exposure or because they have mental health issues that keep them from feeling safe leaving the house.
“That really affects my ability to care for them,” they said.
Loss of employment in the pandemic or fear of job loss and subsequent changing of insurance has complicated primary care in terms of treatment and administrative tasks, according to Dr. Loeb.
To help treat patients with acute mental health issues and manage other patients, Dr. Loeb’s practice has brought in a social worker and a therapist.
Team-based care is key in the survival of primary care practices, though providing that is difficult in the smaller clinics because of the critical mass of patients needed to make it viable, they said.
“It’s the only answer. It’s the only way you don’t drown,” Dr. Loeb added. “I’m not drowning, and I credit that to my clinic having the help to support the mental health piece of things.”
Rethinking workflow
Tricia McGinnis, MPP, MPH, executive vice president of the nonprofit Center for Health Care Strategies (CHCS) says complexity has forced rethinking workflow.
“A lot of the trends we’re seeing in primary care were there pre-COVID, but COVID has exacerbated those trends,” she said in an interview.
“The good news ... is that it was already becoming clear that primary care needed to provide basic mental health services and integrate with behavioral health. It had also become clear that effective primary care needed to address social issues that keep patients from accessing health care,” she said.
Expanding care teams, as Dr. Loeb mentioned, is a key strategy, according to Ms. McGinnis. Potential teams would include the clinical staff, but also social workers and community health workers – people who come from the community primary care is serving who can help build trust with patients and connect the patient to the primary care team.
“There’s a lot that needs to happen that the clinician doesn’t need to do,” she said.
Telehealth can be a big factor in coordinating the team, Ms. McGinnis added.
“It’s thinking less about who’s doing the work, but more about the work that needs to be done to keep people healthy. Then let’s think about the type of workers best suited to perform those tasks,” she said.
As for reimbursing more complex care, population-based, up-front capitated payments linked to high-quality care and better outcomes will need to replace fee-for-service models, according to Ms. McGinnis.
That will provide reliable incomes for primary care offices, but also flexibility in how each patient with different levels of complexity is managed, she said.
Ms. Greiner, Dr. Fincher, Dr. Loeb, and Ms. McGinnis have no relevant financial relationships.
Evidence of this came from the latest Primary Care Collaborative (PCC) survey, which found that primary care clinicians are seeing more complex patients requiring longer appointments in the wake of COVID-19.
The PCC with the Larry A. Green Center regularly surveys primary care clinicians. This round of questions came August 14-17 and included 1,263 respondents from 49 states, the District of Columbia, and two territories.
More than 7 in 10 (71%) respondents said their patients are more complex and nearly the same percentage said appointments are taking more time.
Ann Greiner, president and CEO of the PCC, said in an interview that 55% of respondents reported that clinicians are struggling to keep up with pent-up demand after patients have delayed or canceled care. Sixty-five percent in the survey said they had seen a rise in children’s mental health issues, and 58% said they were unsure how to help their patients with long COVID.
In addition, primary care clinicians are having repeated conversations with patients on why they should get a vaccine and which one.
“I think that’s adding to the complexity. There is a lot going on here with patient trust,” Ms. Greiner said.
‘We’re going to be playing catch-up’
Jacqueline Fincher, MD, an internist in Thompson, Ga., said in an interview that appointments have gotten longer and more complex in the wake of the pandemic – “no question.”
The immediate past president of the American College of Physicians is seeing patients with chronic disease that has gone untreated for sometimes a year or more, she said.
“Their blood pressure was not under good control, they were under more stress, their sugars were up and weren’t being followed as closely for conditions such as congestive heart failure,” she said.
Dr. Fincher, who works in a rural practice 40 miles from Augusta, Ga., with her physician husband and two other physicians, said patients are ready to come back in, “but I don’t have enough slots for them.”
She said she prioritizes what to help patients with first and schedules the next tier for the next appointment, but added, “honestly, over the next 2 years we’re going to be playing catch-up.”
At the same time, the CDC has estimated that 45% of U.S. adults are at increased risk for complications from COVID-19 because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer. Rates ranged from 19.8% for people 18-29 years old to 80.7% for people over 80 years of age.
Long COVID could overwhelm existing health care capacity
Primary care physicians are also having to diagnose sometimes “invisible” symptoms after people have recovered from acute COVID-19 infection. Diagnosing takes intent listening to patients who describe symptoms that tests can’t confirm.
As this news organization has previously reported, half of COVID-19 survivors report postacute sequelae of COVID-19 (PASC) lasting longer than 6 months.
“These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries,” the authors wrote.
Anxiety, depression ‘have gone off the charts’
Danielle Loeb, MD, MPH, associate professor of internal medicine at the University of Colorado in Denver, who studies complexity in primary care, said in the wake of COVID-19, more patients have developed “new, serious anxiety.”
“That got extremely exacerbated during the pandemic. Anxiety and depression have gone off the charts,” said Dr. Loeb, who prefers the pronoun “they.”
Dr. Loeb cares for a large number of transgender patients. As offices reopen, some patients are having trouble reintegrating into the workplace and resuming social contacts. The primary care doctor says appointments can get longer because of the need to complete tasks, such as filling out forms for Family Medical Leave Act for those not yet ready to return to work.
COVID-19–related fears are keeping many patients from coming into the office, Dr. Loeb said, either from fear of exposure or because they have mental health issues that keep them from feeling safe leaving the house.
“That really affects my ability to care for them,” they said.
Loss of employment in the pandemic or fear of job loss and subsequent changing of insurance has complicated primary care in terms of treatment and administrative tasks, according to Dr. Loeb.
To help treat patients with acute mental health issues and manage other patients, Dr. Loeb’s practice has brought in a social worker and a therapist.
Team-based care is key in the survival of primary care practices, though providing that is difficult in the smaller clinics because of the critical mass of patients needed to make it viable, they said.
“It’s the only answer. It’s the only way you don’t drown,” Dr. Loeb added. “I’m not drowning, and I credit that to my clinic having the help to support the mental health piece of things.”
Rethinking workflow
Tricia McGinnis, MPP, MPH, executive vice president of the nonprofit Center for Health Care Strategies (CHCS) says complexity has forced rethinking workflow.
“A lot of the trends we’re seeing in primary care were there pre-COVID, but COVID has exacerbated those trends,” she said in an interview.
“The good news ... is that it was already becoming clear that primary care needed to provide basic mental health services and integrate with behavioral health. It had also become clear that effective primary care needed to address social issues that keep patients from accessing health care,” she said.
Expanding care teams, as Dr. Loeb mentioned, is a key strategy, according to Ms. McGinnis. Potential teams would include the clinical staff, but also social workers and community health workers – people who come from the community primary care is serving who can help build trust with patients and connect the patient to the primary care team.
“There’s a lot that needs to happen that the clinician doesn’t need to do,” she said.
Telehealth can be a big factor in coordinating the team, Ms. McGinnis added.
“It’s thinking less about who’s doing the work, but more about the work that needs to be done to keep people healthy. Then let’s think about the type of workers best suited to perform those tasks,” she said.
As for reimbursing more complex care, population-based, up-front capitated payments linked to high-quality care and better outcomes will need to replace fee-for-service models, according to Ms. McGinnis.
That will provide reliable incomes for primary care offices, but also flexibility in how each patient with different levels of complexity is managed, she said.
Ms. Greiner, Dr. Fincher, Dr. Loeb, and Ms. McGinnis have no relevant financial relationships.