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Why are boosters being given after 8 months? Experts weigh in
Following the White House administration’s announcement to start booster COVID-19 vaccinations for American adults in September, experts weighed in on the evidence for choosing an 8-month cutoff, how breakthrough infections figure in, and why calling one mRNA vaccine better than the other could be misleading.
Timing came up more than once at the Aug. 18 White House briefing announcing the booster plans. Reporters asked about the start time of Sept. 20 and people waiting at least 8 months after their second mRNA vaccine dose to get a booster.
Anthony Fauci, MD, chief medical adviser to the president and director of the National Institute of Allergy and Infectious Diseases, explained that late September gives the United States time to set up the logistics.
Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, added that 8 months is in part based on data from Israel and other countries on the waning of vaccine effectiveness over time.
“It is possible that 8 [months] is associated with the amount of time that we’ve been able to follow large groups of people, especially those who are 65 and older,” Julie Swann, PhD, said during a subsequent media briefing sponsored by Newswise on Aug. 18. “I know that Pfizer has said that they think a booster sometime between 6 and 12 months would be reasonable.”
Dr. Swann supported the administration’s booster shots plan. She said it is important “that we continue to get people the full amount of protection if it’s recommended by CDC and ACIP [Advisory Committee on Immunization Practices] that would come from a booster shot.” Dr. Swann is department head and A. Doug Allison Distinguished Professor at North Carolina State University and an adjunct professor in the joint department of biomedical engineering at the University of North Carolina at Chapel Hill.
Rising importance of breakthrough cases
Also on Aug. 18, news emerged that breakthrough cases are on the rise in seven U.S. states, likely because of the Delta variant.
These SARS-CoV-2 infections among the fully vaccinated account for 20% of cases in six of the seven states cited in a New York Times report, for example. Researchers also suggested that hospitalization and deaths associated with breakthrough cases could be higher than previously appreciated.
“It is expected that over time we will see more cases of Delta variant infections among vaccinated people. This points toward the need for booster vaccines and/or eventual modifications to the vaccine to capture new variants in the future,” Juan Wisnivesky, MD, DrPH, chief of the division of general internal medicine at Mount Sinai Health System in New York City, said during the briefing.
Vaccine comparisons unfair?
Following the release of a Mayo Clinic study reporting lower effectiveness of the Pfizer mRNA vaccine at 42% versus 76% for the Moderna product, some people started asking if one vaccine was better than the other.
“To begin with, the vaccines are not being compared side-by-side,” Dr. Wisnivesky said. “So we only know the effectiveness of each vaccine versus placebo, but we don’t know one versus the other.”
He added that different study designs, different populations, and other factors make direct comparisons difficult.
More evidence will be needed, Dr. Wisnivesky said, before public health officials can recommend that someone who received one mRNA vaccine switch to another for their booster shot.
Layering protections
Continuing to recommend masks is essential, Dr. Swann added. “With this Delta variant, it does appear that the possibility of reinfection or of a disease case breaking through vaccination can occur. So that makes it even more important to consider using nonpharmaceutical interventions while we continue to vaccinate people.”
Wearing or not wearing a mask is one of the behaviors that drive the transmission of disease, Dr. Swann said.
“What we saw across the board is that many people really wanted to go back to normal as much as they could. And we went back to normal a little bit too soon, especially given this new version of the virus that was circulating,” she said.
In poll, most favor boosters
A recent poll conducted by Medscape indicates that a majority of vaccinated physicians and nurses are ready and willing to take a COVID-19 booster vaccine. For example, 93% of 943 doctors and 87% of 1,680 nurses who responded want booster shots, either immediately or when they are authorized and recommended.
Among 510 WebMD readers responding to a similar poll, 82% indicated they wanted a booster shot.
A challenging task lies ahead
According to CDC data, as of Aug. 18, 2021, almost 169 million Americans are fully vaccinated, including the one-shot Johnson & Johnson adenovirus vaccine.
“I think it will be a challenge to get everyone who is fully vaccinated to come in for that booster,” Dr. Swann said.
Logistically speaking, Dr. Swann explained that many sites that were open for initial vaccinations, including drive-up locations and 24/7 vaccination sites, are no longer operating.
“We might see that rollout look a little bit differently. You might be able to go to your pharmacy or go to your primary care physician,” she said.
“But we may not see as many weekend events so it is going to be easier to get some people a booster than others.
“One interesting thing will also be whether a booster is effective in actually preventing you from giving a disease to someone else,” Dr. Swann said. “That could make a difference as well, because that might play into whether companies, hospitals, universities, or others require a booster.”
A version of this article first appeared on Medscape.com.
Following the White House administration’s announcement to start booster COVID-19 vaccinations for American adults in September, experts weighed in on the evidence for choosing an 8-month cutoff, how breakthrough infections figure in, and why calling one mRNA vaccine better than the other could be misleading.
Timing came up more than once at the Aug. 18 White House briefing announcing the booster plans. Reporters asked about the start time of Sept. 20 and people waiting at least 8 months after their second mRNA vaccine dose to get a booster.
Anthony Fauci, MD, chief medical adviser to the president and director of the National Institute of Allergy and Infectious Diseases, explained that late September gives the United States time to set up the logistics.
Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, added that 8 months is in part based on data from Israel and other countries on the waning of vaccine effectiveness over time.
“It is possible that 8 [months] is associated with the amount of time that we’ve been able to follow large groups of people, especially those who are 65 and older,” Julie Swann, PhD, said during a subsequent media briefing sponsored by Newswise on Aug. 18. “I know that Pfizer has said that they think a booster sometime between 6 and 12 months would be reasonable.”
Dr. Swann supported the administration’s booster shots plan. She said it is important “that we continue to get people the full amount of protection if it’s recommended by CDC and ACIP [Advisory Committee on Immunization Practices] that would come from a booster shot.” Dr. Swann is department head and A. Doug Allison Distinguished Professor at North Carolina State University and an adjunct professor in the joint department of biomedical engineering at the University of North Carolina at Chapel Hill.
Rising importance of breakthrough cases
Also on Aug. 18, news emerged that breakthrough cases are on the rise in seven U.S. states, likely because of the Delta variant.
These SARS-CoV-2 infections among the fully vaccinated account for 20% of cases in six of the seven states cited in a New York Times report, for example. Researchers also suggested that hospitalization and deaths associated with breakthrough cases could be higher than previously appreciated.
“It is expected that over time we will see more cases of Delta variant infections among vaccinated people. This points toward the need for booster vaccines and/or eventual modifications to the vaccine to capture new variants in the future,” Juan Wisnivesky, MD, DrPH, chief of the division of general internal medicine at Mount Sinai Health System in New York City, said during the briefing.
Vaccine comparisons unfair?
Following the release of a Mayo Clinic study reporting lower effectiveness of the Pfizer mRNA vaccine at 42% versus 76% for the Moderna product, some people started asking if one vaccine was better than the other.
“To begin with, the vaccines are not being compared side-by-side,” Dr. Wisnivesky said. “So we only know the effectiveness of each vaccine versus placebo, but we don’t know one versus the other.”
He added that different study designs, different populations, and other factors make direct comparisons difficult.
More evidence will be needed, Dr. Wisnivesky said, before public health officials can recommend that someone who received one mRNA vaccine switch to another for their booster shot.
Layering protections
Continuing to recommend masks is essential, Dr. Swann added. “With this Delta variant, it does appear that the possibility of reinfection or of a disease case breaking through vaccination can occur. So that makes it even more important to consider using nonpharmaceutical interventions while we continue to vaccinate people.”
Wearing or not wearing a mask is one of the behaviors that drive the transmission of disease, Dr. Swann said.
“What we saw across the board is that many people really wanted to go back to normal as much as they could. And we went back to normal a little bit too soon, especially given this new version of the virus that was circulating,” she said.
In poll, most favor boosters
A recent poll conducted by Medscape indicates that a majority of vaccinated physicians and nurses are ready and willing to take a COVID-19 booster vaccine. For example, 93% of 943 doctors and 87% of 1,680 nurses who responded want booster shots, either immediately or when they are authorized and recommended.
Among 510 WebMD readers responding to a similar poll, 82% indicated they wanted a booster shot.
A challenging task lies ahead
According to CDC data, as of Aug. 18, 2021, almost 169 million Americans are fully vaccinated, including the one-shot Johnson & Johnson adenovirus vaccine.
“I think it will be a challenge to get everyone who is fully vaccinated to come in for that booster,” Dr. Swann said.
Logistically speaking, Dr. Swann explained that many sites that were open for initial vaccinations, including drive-up locations and 24/7 vaccination sites, are no longer operating.
“We might see that rollout look a little bit differently. You might be able to go to your pharmacy or go to your primary care physician,” she said.
“But we may not see as many weekend events so it is going to be easier to get some people a booster than others.
“One interesting thing will also be whether a booster is effective in actually preventing you from giving a disease to someone else,” Dr. Swann said. “That could make a difference as well, because that might play into whether companies, hospitals, universities, or others require a booster.”
A version of this article first appeared on Medscape.com.
Following the White House administration’s announcement to start booster COVID-19 vaccinations for American adults in September, experts weighed in on the evidence for choosing an 8-month cutoff, how breakthrough infections figure in, and why calling one mRNA vaccine better than the other could be misleading.
Timing came up more than once at the Aug. 18 White House briefing announcing the booster plans. Reporters asked about the start time of Sept. 20 and people waiting at least 8 months after their second mRNA vaccine dose to get a booster.
Anthony Fauci, MD, chief medical adviser to the president and director of the National Institute of Allergy and Infectious Diseases, explained that late September gives the United States time to set up the logistics.
Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, added that 8 months is in part based on data from Israel and other countries on the waning of vaccine effectiveness over time.
“It is possible that 8 [months] is associated with the amount of time that we’ve been able to follow large groups of people, especially those who are 65 and older,” Julie Swann, PhD, said during a subsequent media briefing sponsored by Newswise on Aug. 18. “I know that Pfizer has said that they think a booster sometime between 6 and 12 months would be reasonable.”
Dr. Swann supported the administration’s booster shots plan. She said it is important “that we continue to get people the full amount of protection if it’s recommended by CDC and ACIP [Advisory Committee on Immunization Practices] that would come from a booster shot.” Dr. Swann is department head and A. Doug Allison Distinguished Professor at North Carolina State University and an adjunct professor in the joint department of biomedical engineering at the University of North Carolina at Chapel Hill.
Rising importance of breakthrough cases
Also on Aug. 18, news emerged that breakthrough cases are on the rise in seven U.S. states, likely because of the Delta variant.
These SARS-CoV-2 infections among the fully vaccinated account for 20% of cases in six of the seven states cited in a New York Times report, for example. Researchers also suggested that hospitalization and deaths associated with breakthrough cases could be higher than previously appreciated.
“It is expected that over time we will see more cases of Delta variant infections among vaccinated people. This points toward the need for booster vaccines and/or eventual modifications to the vaccine to capture new variants in the future,” Juan Wisnivesky, MD, DrPH, chief of the division of general internal medicine at Mount Sinai Health System in New York City, said during the briefing.
Vaccine comparisons unfair?
Following the release of a Mayo Clinic study reporting lower effectiveness of the Pfizer mRNA vaccine at 42% versus 76% for the Moderna product, some people started asking if one vaccine was better than the other.
“To begin with, the vaccines are not being compared side-by-side,” Dr. Wisnivesky said. “So we only know the effectiveness of each vaccine versus placebo, but we don’t know one versus the other.”
He added that different study designs, different populations, and other factors make direct comparisons difficult.
More evidence will be needed, Dr. Wisnivesky said, before public health officials can recommend that someone who received one mRNA vaccine switch to another for their booster shot.
Layering protections
Continuing to recommend masks is essential, Dr. Swann added. “With this Delta variant, it does appear that the possibility of reinfection or of a disease case breaking through vaccination can occur. So that makes it even more important to consider using nonpharmaceutical interventions while we continue to vaccinate people.”
Wearing or not wearing a mask is one of the behaviors that drive the transmission of disease, Dr. Swann said.
“What we saw across the board is that many people really wanted to go back to normal as much as they could. And we went back to normal a little bit too soon, especially given this new version of the virus that was circulating,” she said.
In poll, most favor boosters
A recent poll conducted by Medscape indicates that a majority of vaccinated physicians and nurses are ready and willing to take a COVID-19 booster vaccine. For example, 93% of 943 doctors and 87% of 1,680 nurses who responded want booster shots, either immediately or when they are authorized and recommended.
Among 510 WebMD readers responding to a similar poll, 82% indicated they wanted a booster shot.
A challenging task lies ahead
According to CDC data, as of Aug. 18, 2021, almost 169 million Americans are fully vaccinated, including the one-shot Johnson & Johnson adenovirus vaccine.
“I think it will be a challenge to get everyone who is fully vaccinated to come in for that booster,” Dr. Swann said.
Logistically speaking, Dr. Swann explained that many sites that were open for initial vaccinations, including drive-up locations and 24/7 vaccination sites, are no longer operating.
“We might see that rollout look a little bit differently. You might be able to go to your pharmacy or go to your primary care physician,” she said.
“But we may not see as many weekend events so it is going to be easier to get some people a booster than others.
“One interesting thing will also be whether a booster is effective in actually preventing you from giving a disease to someone else,” Dr. Swann said. “That could make a difference as well, because that might play into whether companies, hospitals, universities, or others require a booster.”
A version of this article first appeared on Medscape.com.
An ethics challenge in hospital medicine
Editor’s note: In this article, we present an archetypal ethics challenge in hospital medicine. The authors, members of the SHM’s Ethics Special Interest Group and clinical ethics consultants at their respective hospitals, will comment on the questions and practical approaches for hospitalists.
Ms. S, an 82-year-old woman with severe dementia, was initially hospitalized in the ICU with acute on chronic respiratory failure. Prior to admission, Ms. S lived with her daughter, who is her primary caregiver. Ms. S is able to say her daughter’s name, and answer “yes” and “no” to simple questions. She is bed bound, incontinent of urine and feces, and dependent on her daughter for all ADLs.
This admission, Ms. S has been re-intubated 4 times for recurrent respiratory failure. The nursing staff are distressed that she is suffering physically. Her daughter requests to continue all intensive, life-prolonging treatment including mechanical ventilation and artificial nutrition.
During sign out, your colleague remarks that his grandmother was in a similar situation and that his family chose to pursue comfort care. He questions whether Ms. S has any quality of life and asks if you think further intensive care is futile.
On your first day caring for Ms. S, you contact her primary care provider. Her PCP reports that Ms. S and her daughter completed an advance directive (AD) 10 years ago which documents a preference for all life prolonging treatment.
Question #1: What are the ethical challenges?
Dr. Chase: In caring for Ms. S, we face a common ethical challenge: how to respect the patient’s prior preferences (autonomy) when the currently requested treatments have diminishing benefits (beneficence) and escalating harms (non-maleficence). Life-prolonging care can have diminishing returns at the end of life. Ms. S’s loss of decision-making capacity adds a layer of complexity. Her AD was completed when she was able to consider decisions about her care, and she might make different decisions in her current state of health. Shared decision-making with a surrogate can be complicated by a surrogate’s anxiety with making life-altering decisions or their desire to avoid guilt or loneliness. Health care professionals face the limits of scientific knowledge in delivering accurate prognostic estimates, probabilities of recovery, and likelihood of benefit from interventions. In addition to the guideposts of ethical principles, some hospitals have policies which advise clinicians to avoid non-beneficial care.
Such situations are emotionally intense and can trigger distress among patients, families, caregivers and health care professionals. Conscious and unconscious bias about a patient’s perceived quality of life undermines equity and can play a role in our recommendations for patients of advanced age, with cognitive impairment, and those who live with a disability.
Question #2: How might you meet the patient’s medical needs in line with her goals?
Dr. Khawaja: In order to provide care consistent with the patient’s goals, the first step is to clarify these goals with Ms. S’s surrogate decision-maker, her daughter. In a previously autonomous but presently incapacitated patient, the previously expressed preferences in the form of a written AD should be respected. However, the AD is only a set of preferences completed at a particular time, not medical orders. The clinician and surrogate must consider how to apply the AD to the current clinical circumstances. The clinician should verify that the clinical circumstances specified in the AD have been met and evaluate if the patient’s preferences have changed since she originally completed the AD.
Surrogates are asked to use a Substituted Judgement Standard (i.e., what would the patient choose in this situation if known). This may differ from what the surrogate wants. If not known, surrogates are asked to use the Best Interest Standard (i.e., what would bring the most net benefit to the patient by weighing benefits and risks of treatment options). I often ask the surrogate, “Tell us about your loved one.” Or, “Knowing your loved one, what do you think would be the most important for her right now?”1
I would also caution against bias in judging quality of life in patients with dementia, and using the term “futility,” as these concepts are inherently subjective. In general, when a colleague raises the issue of futility, I begin by asking, “…futile to achieve what goal?” That can help clarify some of the disagreement as some goals can be accomplished while others cannot.
Finally, I work to include other members of our team in these discussions. The distress of nurses, social workers, and others are important to acknowledge, validate, and involve in the problem-solving process.
Question #3: If you were Ms. S’s hospitalist, what would you do?
Dr. Khawaja: As the hospitalist caring for Ms. S, I would use the “four boxes” model as a helpful, clinically relevant and systematic approach to managing ethical concerns.2
This “four boxes” model gives us a practical framework to address these ethical principles by asking questions in four domains.
Medical indications: What is the nature of her current illness, and is it reversible or not? What is the probability of success of treatment options like mechanical ventilation? Are there adverse effects of treatment?
Patient preferences: Since Ms. S lacks capacity, does her daughter understand the benefits and burdens of treatment? What are the goals of treatment? Prolonging life? Minimizing discomfort? Spending time with loved ones? What burdens would the patient be willing to endure to reach her goals?
Quality of life: What would the patient’s quality of life be with and without the treatments?
Contextual features: My priorities would be building a relationship of trust with Ms. S’s daughter – by educating her about her mother’s clinical status, addressing her concerns and questions, and supporting her as we work through patient-centered decisions about what is best for her mother. Honest communication is a must, even if it means acknowledging uncertainties about the course of disease and prognosis.
These are not easy decisions for surrogates to make. They should be given time to process information and to make what they believe are the best decisions for their loved ones. It is critical for clinicians to provide honest and complete clinical information and to avoid value judgments, bias, or unreasonable time pressure. While one-on-one conversations are central, I find that multidisciplinary meetings allow all stakeholders to ask and answer vital questions and ideally to reach consensus in treatment planning.
Dr. Chase: In caring for Ms. S, I would use a structured approach to discussions with her daughter, such as the “SPIKES” protocol.3 Using open ended questions, I would ask about the patient’s and her daughter’s goals, values, and fears and provide support about the responsibility for shared-decision making and the difficulty of uncertainty. Reflecting statements can help in confirming understanding and showing attention (e.g. “I hear that avoiding discomfort would be important to your mother.”)
I find it helpful to emphasize my commitment to honesty and non-abandonment (a common fear among patients and families). By offering to provide recommendations about both disease-directed and palliative, comfort-focused interventions, the patient’s daughter has an opportunity to engage voluntarily in discussion. When asked about care that may have marginal benefit, I suggest time-limited trials.4 I do not offer non-beneficial treatments and if asked about such treatments, I note the underlying motive and why the treatment is not feasible (“I see that you are hoping that your mother will live longer, but I am concerned that tube feeding will not help because…”), offer preferable alternatives, and leave space for questions and emotions. It is important not to force a premature resolution of the situation through unilateral or coercive decisions5 (i.e., going off service does not mean I have to wrap up the existential crisis which is occurring.) A broader challenge is the grief and other emotions which accompany illness and death. I can neither prevent death nor grief, but I can offer my professional guidance and provide a supportive space for the patient and family to experience this transition. By acknowledging this, I center myself with the patient and family and we can work together toward a common goal of providing compassionate and ethical care.
Dr. Chase is associate professor, Department of Family and Community Medicine, University of California San Francisco; and co-chair, Ethics Committee, San Francisco General Hospital. Dr. Khawaja is assistant professor, Department of Internal Medicine, Baylor College of Medicine, Houston, and a member of the Ethics Committee of the Society of General Internal Medicine.
References
1. Sulmasy DP, Snyder L. Substituted interests and best judgments: an integrated model of surrogate decision making. JAMA. 2010 Nov 3;304(17):1946-7. doi: 10.1001/jama.2010.159.
2. Jonsen AR, Siegler M, Winslade WJ. Clinical ethics: A practical approach to ethical decisions in clinical medicine. 6th ed. New York: McGraw Hill Medical; 2006.
3. Baile WF, et al. SPIKES-A six-step protocol for delivering bad news: application to the patient with cancer. Oncologist. 2000;5(4):302–311. doi: 10.1634/theoncologist.5-4-302.
4. Chang DW, et al. Evaluation of time-limited trials among critically ill patients with advanced medical illnesses and reduction of nonbeneficial ICU treatments. JAMA Intern Med. 2021;181(6):786–794. doi: 10.1001/jamainternmed.2021.1000.
5. Sedig, L. What’s the role of autonomy in patient-and family-centered care when patients and family members don’t agree? AMA J Ethics. 2016;18(1):12-17. doi: 10.1001/journalofethics.2017.18.1.ecas2-1601.
Editor’s note: In this article, we present an archetypal ethics challenge in hospital medicine. The authors, members of the SHM’s Ethics Special Interest Group and clinical ethics consultants at their respective hospitals, will comment on the questions and practical approaches for hospitalists.
Ms. S, an 82-year-old woman with severe dementia, was initially hospitalized in the ICU with acute on chronic respiratory failure. Prior to admission, Ms. S lived with her daughter, who is her primary caregiver. Ms. S is able to say her daughter’s name, and answer “yes” and “no” to simple questions. She is bed bound, incontinent of urine and feces, and dependent on her daughter for all ADLs.
This admission, Ms. S has been re-intubated 4 times for recurrent respiratory failure. The nursing staff are distressed that she is suffering physically. Her daughter requests to continue all intensive, life-prolonging treatment including mechanical ventilation and artificial nutrition.
During sign out, your colleague remarks that his grandmother was in a similar situation and that his family chose to pursue comfort care. He questions whether Ms. S has any quality of life and asks if you think further intensive care is futile.
On your first day caring for Ms. S, you contact her primary care provider. Her PCP reports that Ms. S and her daughter completed an advance directive (AD) 10 years ago which documents a preference for all life prolonging treatment.
Question #1: What are the ethical challenges?
Dr. Chase: In caring for Ms. S, we face a common ethical challenge: how to respect the patient’s prior preferences (autonomy) when the currently requested treatments have diminishing benefits (beneficence) and escalating harms (non-maleficence). Life-prolonging care can have diminishing returns at the end of life. Ms. S’s loss of decision-making capacity adds a layer of complexity. Her AD was completed when she was able to consider decisions about her care, and she might make different decisions in her current state of health. Shared decision-making with a surrogate can be complicated by a surrogate’s anxiety with making life-altering decisions or their desire to avoid guilt or loneliness. Health care professionals face the limits of scientific knowledge in delivering accurate prognostic estimates, probabilities of recovery, and likelihood of benefit from interventions. In addition to the guideposts of ethical principles, some hospitals have policies which advise clinicians to avoid non-beneficial care.
Such situations are emotionally intense and can trigger distress among patients, families, caregivers and health care professionals. Conscious and unconscious bias about a patient’s perceived quality of life undermines equity and can play a role in our recommendations for patients of advanced age, with cognitive impairment, and those who live with a disability.
Question #2: How might you meet the patient’s medical needs in line with her goals?
Dr. Khawaja: In order to provide care consistent with the patient’s goals, the first step is to clarify these goals with Ms. S’s surrogate decision-maker, her daughter. In a previously autonomous but presently incapacitated patient, the previously expressed preferences in the form of a written AD should be respected. However, the AD is only a set of preferences completed at a particular time, not medical orders. The clinician and surrogate must consider how to apply the AD to the current clinical circumstances. The clinician should verify that the clinical circumstances specified in the AD have been met and evaluate if the patient’s preferences have changed since she originally completed the AD.
Surrogates are asked to use a Substituted Judgement Standard (i.e., what would the patient choose in this situation if known). This may differ from what the surrogate wants. If not known, surrogates are asked to use the Best Interest Standard (i.e., what would bring the most net benefit to the patient by weighing benefits and risks of treatment options). I often ask the surrogate, “Tell us about your loved one.” Or, “Knowing your loved one, what do you think would be the most important for her right now?”1
I would also caution against bias in judging quality of life in patients with dementia, and using the term “futility,” as these concepts are inherently subjective. In general, when a colleague raises the issue of futility, I begin by asking, “…futile to achieve what goal?” That can help clarify some of the disagreement as some goals can be accomplished while others cannot.
Finally, I work to include other members of our team in these discussions. The distress of nurses, social workers, and others are important to acknowledge, validate, and involve in the problem-solving process.
Question #3: If you were Ms. S’s hospitalist, what would you do?
Dr. Khawaja: As the hospitalist caring for Ms. S, I would use the “four boxes” model as a helpful, clinically relevant and systematic approach to managing ethical concerns.2
This “four boxes” model gives us a practical framework to address these ethical principles by asking questions in four domains.
Medical indications: What is the nature of her current illness, and is it reversible or not? What is the probability of success of treatment options like mechanical ventilation? Are there adverse effects of treatment?
Patient preferences: Since Ms. S lacks capacity, does her daughter understand the benefits and burdens of treatment? What are the goals of treatment? Prolonging life? Minimizing discomfort? Spending time with loved ones? What burdens would the patient be willing to endure to reach her goals?
Quality of life: What would the patient’s quality of life be with and without the treatments?
Contextual features: My priorities would be building a relationship of trust with Ms. S’s daughter – by educating her about her mother’s clinical status, addressing her concerns and questions, and supporting her as we work through patient-centered decisions about what is best for her mother. Honest communication is a must, even if it means acknowledging uncertainties about the course of disease and prognosis.
These are not easy decisions for surrogates to make. They should be given time to process information and to make what they believe are the best decisions for their loved ones. It is critical for clinicians to provide honest and complete clinical information and to avoid value judgments, bias, or unreasonable time pressure. While one-on-one conversations are central, I find that multidisciplinary meetings allow all stakeholders to ask and answer vital questions and ideally to reach consensus in treatment planning.
Dr. Chase: In caring for Ms. S, I would use a structured approach to discussions with her daughter, such as the “SPIKES” protocol.3 Using open ended questions, I would ask about the patient’s and her daughter’s goals, values, and fears and provide support about the responsibility for shared-decision making and the difficulty of uncertainty. Reflecting statements can help in confirming understanding and showing attention (e.g. “I hear that avoiding discomfort would be important to your mother.”)
I find it helpful to emphasize my commitment to honesty and non-abandonment (a common fear among patients and families). By offering to provide recommendations about both disease-directed and palliative, comfort-focused interventions, the patient’s daughter has an opportunity to engage voluntarily in discussion. When asked about care that may have marginal benefit, I suggest time-limited trials.4 I do not offer non-beneficial treatments and if asked about such treatments, I note the underlying motive and why the treatment is not feasible (“I see that you are hoping that your mother will live longer, but I am concerned that tube feeding will not help because…”), offer preferable alternatives, and leave space for questions and emotions. It is important not to force a premature resolution of the situation through unilateral or coercive decisions5 (i.e., going off service does not mean I have to wrap up the existential crisis which is occurring.) A broader challenge is the grief and other emotions which accompany illness and death. I can neither prevent death nor grief, but I can offer my professional guidance and provide a supportive space for the patient and family to experience this transition. By acknowledging this, I center myself with the patient and family and we can work together toward a common goal of providing compassionate and ethical care.
Dr. Chase is associate professor, Department of Family and Community Medicine, University of California San Francisco; and co-chair, Ethics Committee, San Francisco General Hospital. Dr. Khawaja is assistant professor, Department of Internal Medicine, Baylor College of Medicine, Houston, and a member of the Ethics Committee of the Society of General Internal Medicine.
References
1. Sulmasy DP, Snyder L. Substituted interests and best judgments: an integrated model of surrogate decision making. JAMA. 2010 Nov 3;304(17):1946-7. doi: 10.1001/jama.2010.159.
2. Jonsen AR, Siegler M, Winslade WJ. Clinical ethics: A practical approach to ethical decisions in clinical medicine. 6th ed. New York: McGraw Hill Medical; 2006.
3. Baile WF, et al. SPIKES-A six-step protocol for delivering bad news: application to the patient with cancer. Oncologist. 2000;5(4):302–311. doi: 10.1634/theoncologist.5-4-302.
4. Chang DW, et al. Evaluation of time-limited trials among critically ill patients with advanced medical illnesses and reduction of nonbeneficial ICU treatments. JAMA Intern Med. 2021;181(6):786–794. doi: 10.1001/jamainternmed.2021.1000.
5. Sedig, L. What’s the role of autonomy in patient-and family-centered care when patients and family members don’t agree? AMA J Ethics. 2016;18(1):12-17. doi: 10.1001/journalofethics.2017.18.1.ecas2-1601.
Editor’s note: In this article, we present an archetypal ethics challenge in hospital medicine. The authors, members of the SHM’s Ethics Special Interest Group and clinical ethics consultants at their respective hospitals, will comment on the questions and practical approaches for hospitalists.
Ms. S, an 82-year-old woman with severe dementia, was initially hospitalized in the ICU with acute on chronic respiratory failure. Prior to admission, Ms. S lived with her daughter, who is her primary caregiver. Ms. S is able to say her daughter’s name, and answer “yes” and “no” to simple questions. She is bed bound, incontinent of urine and feces, and dependent on her daughter for all ADLs.
This admission, Ms. S has been re-intubated 4 times for recurrent respiratory failure. The nursing staff are distressed that she is suffering physically. Her daughter requests to continue all intensive, life-prolonging treatment including mechanical ventilation and artificial nutrition.
During sign out, your colleague remarks that his grandmother was in a similar situation and that his family chose to pursue comfort care. He questions whether Ms. S has any quality of life and asks if you think further intensive care is futile.
On your first day caring for Ms. S, you contact her primary care provider. Her PCP reports that Ms. S and her daughter completed an advance directive (AD) 10 years ago which documents a preference for all life prolonging treatment.
Question #1: What are the ethical challenges?
Dr. Chase: In caring for Ms. S, we face a common ethical challenge: how to respect the patient’s prior preferences (autonomy) when the currently requested treatments have diminishing benefits (beneficence) and escalating harms (non-maleficence). Life-prolonging care can have diminishing returns at the end of life. Ms. S’s loss of decision-making capacity adds a layer of complexity. Her AD was completed when she was able to consider decisions about her care, and she might make different decisions in her current state of health. Shared decision-making with a surrogate can be complicated by a surrogate’s anxiety with making life-altering decisions or their desire to avoid guilt or loneliness. Health care professionals face the limits of scientific knowledge in delivering accurate prognostic estimates, probabilities of recovery, and likelihood of benefit from interventions. In addition to the guideposts of ethical principles, some hospitals have policies which advise clinicians to avoid non-beneficial care.
Such situations are emotionally intense and can trigger distress among patients, families, caregivers and health care professionals. Conscious and unconscious bias about a patient’s perceived quality of life undermines equity and can play a role in our recommendations for patients of advanced age, with cognitive impairment, and those who live with a disability.
Question #2: How might you meet the patient’s medical needs in line with her goals?
Dr. Khawaja: In order to provide care consistent with the patient’s goals, the first step is to clarify these goals with Ms. S’s surrogate decision-maker, her daughter. In a previously autonomous but presently incapacitated patient, the previously expressed preferences in the form of a written AD should be respected. However, the AD is only a set of preferences completed at a particular time, not medical orders. The clinician and surrogate must consider how to apply the AD to the current clinical circumstances. The clinician should verify that the clinical circumstances specified in the AD have been met and evaluate if the patient’s preferences have changed since she originally completed the AD.
Surrogates are asked to use a Substituted Judgement Standard (i.e., what would the patient choose in this situation if known). This may differ from what the surrogate wants. If not known, surrogates are asked to use the Best Interest Standard (i.e., what would bring the most net benefit to the patient by weighing benefits and risks of treatment options). I often ask the surrogate, “Tell us about your loved one.” Or, “Knowing your loved one, what do you think would be the most important for her right now?”1
I would also caution against bias in judging quality of life in patients with dementia, and using the term “futility,” as these concepts are inherently subjective. In general, when a colleague raises the issue of futility, I begin by asking, “…futile to achieve what goal?” That can help clarify some of the disagreement as some goals can be accomplished while others cannot.
Finally, I work to include other members of our team in these discussions. The distress of nurses, social workers, and others are important to acknowledge, validate, and involve in the problem-solving process.
Question #3: If you were Ms. S’s hospitalist, what would you do?
Dr. Khawaja: As the hospitalist caring for Ms. S, I would use the “four boxes” model as a helpful, clinically relevant and systematic approach to managing ethical concerns.2
This “four boxes” model gives us a practical framework to address these ethical principles by asking questions in four domains.
Medical indications: What is the nature of her current illness, and is it reversible or not? What is the probability of success of treatment options like mechanical ventilation? Are there adverse effects of treatment?
Patient preferences: Since Ms. S lacks capacity, does her daughter understand the benefits and burdens of treatment? What are the goals of treatment? Prolonging life? Minimizing discomfort? Spending time with loved ones? What burdens would the patient be willing to endure to reach her goals?
Quality of life: What would the patient’s quality of life be with and without the treatments?
Contextual features: My priorities would be building a relationship of trust with Ms. S’s daughter – by educating her about her mother’s clinical status, addressing her concerns and questions, and supporting her as we work through patient-centered decisions about what is best for her mother. Honest communication is a must, even if it means acknowledging uncertainties about the course of disease and prognosis.
These are not easy decisions for surrogates to make. They should be given time to process information and to make what they believe are the best decisions for their loved ones. It is critical for clinicians to provide honest and complete clinical information and to avoid value judgments, bias, or unreasonable time pressure. While one-on-one conversations are central, I find that multidisciplinary meetings allow all stakeholders to ask and answer vital questions and ideally to reach consensus in treatment planning.
Dr. Chase: In caring for Ms. S, I would use a structured approach to discussions with her daughter, such as the “SPIKES” protocol.3 Using open ended questions, I would ask about the patient’s and her daughter’s goals, values, and fears and provide support about the responsibility for shared-decision making and the difficulty of uncertainty. Reflecting statements can help in confirming understanding and showing attention (e.g. “I hear that avoiding discomfort would be important to your mother.”)
I find it helpful to emphasize my commitment to honesty and non-abandonment (a common fear among patients and families). By offering to provide recommendations about both disease-directed and palliative, comfort-focused interventions, the patient’s daughter has an opportunity to engage voluntarily in discussion. When asked about care that may have marginal benefit, I suggest time-limited trials.4 I do not offer non-beneficial treatments and if asked about such treatments, I note the underlying motive and why the treatment is not feasible (“I see that you are hoping that your mother will live longer, but I am concerned that tube feeding will not help because…”), offer preferable alternatives, and leave space for questions and emotions. It is important not to force a premature resolution of the situation through unilateral or coercive decisions5 (i.e., going off service does not mean I have to wrap up the existential crisis which is occurring.) A broader challenge is the grief and other emotions which accompany illness and death. I can neither prevent death nor grief, but I can offer my professional guidance and provide a supportive space for the patient and family to experience this transition. By acknowledging this, I center myself with the patient and family and we can work together toward a common goal of providing compassionate and ethical care.
Dr. Chase is associate professor, Department of Family and Community Medicine, University of California San Francisco; and co-chair, Ethics Committee, San Francisco General Hospital. Dr. Khawaja is assistant professor, Department of Internal Medicine, Baylor College of Medicine, Houston, and a member of the Ethics Committee of the Society of General Internal Medicine.
References
1. Sulmasy DP, Snyder L. Substituted interests and best judgments: an integrated model of surrogate decision making. JAMA. 2010 Nov 3;304(17):1946-7. doi: 10.1001/jama.2010.159.
2. Jonsen AR, Siegler M, Winslade WJ. Clinical ethics: A practical approach to ethical decisions in clinical medicine. 6th ed. New York: McGraw Hill Medical; 2006.
3. Baile WF, et al. SPIKES-A six-step protocol for delivering bad news: application to the patient with cancer. Oncologist. 2000;5(4):302–311. doi: 10.1634/theoncologist.5-4-302.
4. Chang DW, et al. Evaluation of time-limited trials among critically ill patients with advanced medical illnesses and reduction of nonbeneficial ICU treatments. JAMA Intern Med. 2021;181(6):786–794. doi: 10.1001/jamainternmed.2021.1000.
5. Sedig, L. What’s the role of autonomy in patient-and family-centered care when patients and family members don’t agree? AMA J Ethics. 2016;18(1):12-17. doi: 10.1001/journalofethics.2017.18.1.ecas2-1601.
Diet, exercise in older adults with knee OA have long-term payoff
Older patients with knee osteoarthritis (OA) who underwent lengthy diet and exercise interventions reported less pain and maintained some weight loss years after the program ended, according to a new study published in Arthritis Care & Research.
“These data imply that clinicians who treat people with knee osteoarthritis have a variety of nonpharmacologic options that preserve clinically important effects 3.5 years after the treatments end,” wrote lead author Stephen P. Messier, PhD, professor and director of the J.B. Snow Biomechanics Laboratory at Wake Forest University, Winston-Salem, N.C.
The study involved patients with overweight or obesity aged 55 years or older who were previously enrolled in the 1.5-year Intensive Diet and Exercise for Arthritis (IDEA) trial.
“You have to remember, this is 3.5 years after the IDEA trial ended,” Dr. Messier said in an interview. “There was no contact with them for that entire time; you’d expect, based on the literature, that they’d revert back to where they were before they entered the trial. And certainly, there was some regression, there was some weight regain, but the important part of the study is that, even after 3.5 years, and even with some weight regain, there were some clinically important effects that lasted.”
“What we feel now is that if we can somehow prepare people better for that time after they finish a weight loss intervention, from a psychological standpoint, it will make a real difference,” he added. “We are very good at helping people have the confidence to lose weight. But having the confidence to lose weight is totally different than having confidence to maintain weight loss. If we can give folks an intervention that has a psychological component, hopefully we can increase their confidence to maintain the weight loss that they attained.”
Study details
Of the 184 participants who were contacted for a follow-up visit, 94 consented to participate, 67% of whom were females and 88% of whom were White. A total of 27 participants had completed the diet and exercise intervention, and another 35 completed the diet-only and 32 exercise-only interventions.
In the 3.5-year period between the IDEA trial’s end and follow-up, body weight increased by 5.9 kg in the diet and exercise group (P < .0001) and by 3.1 kg in the diet-only group (P = .0006) but decreased in the exercise-only group by 1.0 kg (P = .25). However, from baseline to 5-year follow-up, all groups saw a reduction in body weight. Mean weight loss was –3.7 kg for the diet and exercise group (P = .0007), –5.8 kg for the diet group (P < .0001), and –2.9 kg for the exercise group (P = .003). Body mass index also decreased in all groups: by –1.2 kg/m2 in the diet and exercise group (P = .001), by –2.0 kg/m2 in the diet group (P < .0001), and by –1.0 kg/m2 in the exercise group (P = .004).
Pain – as measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score – was reduced in all groups across 5-year follow-up: –1.2 (P = .03) for the diet and exercise group, –1.5 (P = .001) for the diet-only group, and –1.6 (P = .0008) for the exercise-only group. WOMAC function also significantly improved relative to baseline by 6.2 (P = .0001) in the diet and exercise group, by 6.1 (P < .0001) in the diet group, and by 3.7 (P = .01) in the exercise-only group.
Finding time to advise on weight loss, exercise
“If exercise and weight loss were easy, this country wouldn’t be in the state we’re in,” Tuhina Neogi, MD, PhD, of Boston University said in an interview. “Shared decision-making and personalized medicine are important; unfortunately, for the majority of physicians – particularly primary care physicians, where a good deal of OA management is undertaken – they don’t have a lot of time in their 20 minutes with a patient who has OA to counsel individuals toward a healthy weight and physical activity program when they’re also addressing common comorbidities seen in OA such as diabetes and heart disease.
“But as we know,” she added, “when you do address weight loss and physical activity, it has wide-ranging health benefits. This study provides support for utilizing formal diet and exercise programs to achieve important and durable benefits for people with OA.”
Dr. Neogi did note one of the study’s acknowledged limitations: Only slightly more than half of the contacted participants returned for follow-up. Though the authors stated that the individuals who returned were representative of both the pool of potential participants and the IDEA cohort as a whole, “we don’t want to make too many inferences when you don’t have the whole study population available,” she said. “The people who have agreed to come back 3.5 years later for follow-up testing, maybe they are a little more health conscious, more resilient. Those people might be systematically different than the people who [did not return], even though most of the factors were not statistically different between the groups.
“Whatever positive attributes they may have, though, we need to understand more about them,” she added. “We need to know how they maintained the benefits they had 3.5 years prior. That kind of understanding is important to inform long-term strategies in OA management.”
Dr. Messier highlighted a related, ongoing study he’s leading in which more than 800 overweight patients in North Carolina who suffer from knee pain are being led through diet and exercise interventions in a community setting. The goal is to replicate the IDEA results outside of a clinical trial setting and show skeptical physicians that diet and exercise can be enacted and maintained in this subset of patients.
“I think we know how effective weight loss is, especially when combined with exercise, in reducing pain, improving function, improving quality of life in these patients,” he said. “The next step is to allow them to maintain those benefits for a long period of time after the intervention ends.”
The study was supported by grants from the National Institutes of Health and by General Nutrition Centers. Its authors reported no potential conflicts of interest.
Older patients with knee osteoarthritis (OA) who underwent lengthy diet and exercise interventions reported less pain and maintained some weight loss years after the program ended, according to a new study published in Arthritis Care & Research.
“These data imply that clinicians who treat people with knee osteoarthritis have a variety of nonpharmacologic options that preserve clinically important effects 3.5 years after the treatments end,” wrote lead author Stephen P. Messier, PhD, professor and director of the J.B. Snow Biomechanics Laboratory at Wake Forest University, Winston-Salem, N.C.
The study involved patients with overweight or obesity aged 55 years or older who were previously enrolled in the 1.5-year Intensive Diet and Exercise for Arthritis (IDEA) trial.
“You have to remember, this is 3.5 years after the IDEA trial ended,” Dr. Messier said in an interview. “There was no contact with them for that entire time; you’d expect, based on the literature, that they’d revert back to where they were before they entered the trial. And certainly, there was some regression, there was some weight regain, but the important part of the study is that, even after 3.5 years, and even with some weight regain, there were some clinically important effects that lasted.”
“What we feel now is that if we can somehow prepare people better for that time after they finish a weight loss intervention, from a psychological standpoint, it will make a real difference,” he added. “We are very good at helping people have the confidence to lose weight. But having the confidence to lose weight is totally different than having confidence to maintain weight loss. If we can give folks an intervention that has a psychological component, hopefully we can increase their confidence to maintain the weight loss that they attained.”
Study details
Of the 184 participants who were contacted for a follow-up visit, 94 consented to participate, 67% of whom were females and 88% of whom were White. A total of 27 participants had completed the diet and exercise intervention, and another 35 completed the diet-only and 32 exercise-only interventions.
In the 3.5-year period between the IDEA trial’s end and follow-up, body weight increased by 5.9 kg in the diet and exercise group (P < .0001) and by 3.1 kg in the diet-only group (P = .0006) but decreased in the exercise-only group by 1.0 kg (P = .25). However, from baseline to 5-year follow-up, all groups saw a reduction in body weight. Mean weight loss was –3.7 kg for the diet and exercise group (P = .0007), –5.8 kg for the diet group (P < .0001), and –2.9 kg for the exercise group (P = .003). Body mass index also decreased in all groups: by –1.2 kg/m2 in the diet and exercise group (P = .001), by –2.0 kg/m2 in the diet group (P < .0001), and by –1.0 kg/m2 in the exercise group (P = .004).
Pain – as measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score – was reduced in all groups across 5-year follow-up: –1.2 (P = .03) for the diet and exercise group, –1.5 (P = .001) for the diet-only group, and –1.6 (P = .0008) for the exercise-only group. WOMAC function also significantly improved relative to baseline by 6.2 (P = .0001) in the diet and exercise group, by 6.1 (P < .0001) in the diet group, and by 3.7 (P = .01) in the exercise-only group.
Finding time to advise on weight loss, exercise
“If exercise and weight loss were easy, this country wouldn’t be in the state we’re in,” Tuhina Neogi, MD, PhD, of Boston University said in an interview. “Shared decision-making and personalized medicine are important; unfortunately, for the majority of physicians – particularly primary care physicians, where a good deal of OA management is undertaken – they don’t have a lot of time in their 20 minutes with a patient who has OA to counsel individuals toward a healthy weight and physical activity program when they’re also addressing common comorbidities seen in OA such as diabetes and heart disease.
“But as we know,” she added, “when you do address weight loss and physical activity, it has wide-ranging health benefits. This study provides support for utilizing formal diet and exercise programs to achieve important and durable benefits for people with OA.”
Dr. Neogi did note one of the study’s acknowledged limitations: Only slightly more than half of the contacted participants returned for follow-up. Though the authors stated that the individuals who returned were representative of both the pool of potential participants and the IDEA cohort as a whole, “we don’t want to make too many inferences when you don’t have the whole study population available,” she said. “The people who have agreed to come back 3.5 years later for follow-up testing, maybe they are a little more health conscious, more resilient. Those people might be systematically different than the people who [did not return], even though most of the factors were not statistically different between the groups.
“Whatever positive attributes they may have, though, we need to understand more about them,” she added. “We need to know how they maintained the benefits they had 3.5 years prior. That kind of understanding is important to inform long-term strategies in OA management.”
Dr. Messier highlighted a related, ongoing study he’s leading in which more than 800 overweight patients in North Carolina who suffer from knee pain are being led through diet and exercise interventions in a community setting. The goal is to replicate the IDEA results outside of a clinical trial setting and show skeptical physicians that diet and exercise can be enacted and maintained in this subset of patients.
“I think we know how effective weight loss is, especially when combined with exercise, in reducing pain, improving function, improving quality of life in these patients,” he said. “The next step is to allow them to maintain those benefits for a long period of time after the intervention ends.”
The study was supported by grants from the National Institutes of Health and by General Nutrition Centers. Its authors reported no potential conflicts of interest.
Older patients with knee osteoarthritis (OA) who underwent lengthy diet and exercise interventions reported less pain and maintained some weight loss years after the program ended, according to a new study published in Arthritis Care & Research.
“These data imply that clinicians who treat people with knee osteoarthritis have a variety of nonpharmacologic options that preserve clinically important effects 3.5 years after the treatments end,” wrote lead author Stephen P. Messier, PhD, professor and director of the J.B. Snow Biomechanics Laboratory at Wake Forest University, Winston-Salem, N.C.
The study involved patients with overweight or obesity aged 55 years or older who were previously enrolled in the 1.5-year Intensive Diet and Exercise for Arthritis (IDEA) trial.
“You have to remember, this is 3.5 years after the IDEA trial ended,” Dr. Messier said in an interview. “There was no contact with them for that entire time; you’d expect, based on the literature, that they’d revert back to where they were before they entered the trial. And certainly, there was some regression, there was some weight regain, but the important part of the study is that, even after 3.5 years, and even with some weight regain, there were some clinically important effects that lasted.”
“What we feel now is that if we can somehow prepare people better for that time after they finish a weight loss intervention, from a psychological standpoint, it will make a real difference,” he added. “We are very good at helping people have the confidence to lose weight. But having the confidence to lose weight is totally different than having confidence to maintain weight loss. If we can give folks an intervention that has a psychological component, hopefully we can increase their confidence to maintain the weight loss that they attained.”
Study details
Of the 184 participants who were contacted for a follow-up visit, 94 consented to participate, 67% of whom were females and 88% of whom were White. A total of 27 participants had completed the diet and exercise intervention, and another 35 completed the diet-only and 32 exercise-only interventions.
In the 3.5-year period between the IDEA trial’s end and follow-up, body weight increased by 5.9 kg in the diet and exercise group (P < .0001) and by 3.1 kg in the diet-only group (P = .0006) but decreased in the exercise-only group by 1.0 kg (P = .25). However, from baseline to 5-year follow-up, all groups saw a reduction in body weight. Mean weight loss was –3.7 kg for the diet and exercise group (P = .0007), –5.8 kg for the diet group (P < .0001), and –2.9 kg for the exercise group (P = .003). Body mass index also decreased in all groups: by –1.2 kg/m2 in the diet and exercise group (P = .001), by –2.0 kg/m2 in the diet group (P < .0001), and by –1.0 kg/m2 in the exercise group (P = .004).
Pain – as measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score – was reduced in all groups across 5-year follow-up: –1.2 (P = .03) for the diet and exercise group, –1.5 (P = .001) for the diet-only group, and –1.6 (P = .0008) for the exercise-only group. WOMAC function also significantly improved relative to baseline by 6.2 (P = .0001) in the diet and exercise group, by 6.1 (P < .0001) in the diet group, and by 3.7 (P = .01) in the exercise-only group.
Finding time to advise on weight loss, exercise
“If exercise and weight loss were easy, this country wouldn’t be in the state we’re in,” Tuhina Neogi, MD, PhD, of Boston University said in an interview. “Shared decision-making and personalized medicine are important; unfortunately, for the majority of physicians – particularly primary care physicians, where a good deal of OA management is undertaken – they don’t have a lot of time in their 20 minutes with a patient who has OA to counsel individuals toward a healthy weight and physical activity program when they’re also addressing common comorbidities seen in OA such as diabetes and heart disease.
“But as we know,” she added, “when you do address weight loss and physical activity, it has wide-ranging health benefits. This study provides support for utilizing formal diet and exercise programs to achieve important and durable benefits for people with OA.”
Dr. Neogi did note one of the study’s acknowledged limitations: Only slightly more than half of the contacted participants returned for follow-up. Though the authors stated that the individuals who returned were representative of both the pool of potential participants and the IDEA cohort as a whole, “we don’t want to make too many inferences when you don’t have the whole study population available,” she said. “The people who have agreed to come back 3.5 years later for follow-up testing, maybe they are a little more health conscious, more resilient. Those people might be systematically different than the people who [did not return], even though most of the factors were not statistically different between the groups.
“Whatever positive attributes they may have, though, we need to understand more about them,” she added. “We need to know how they maintained the benefits they had 3.5 years prior. That kind of understanding is important to inform long-term strategies in OA management.”
Dr. Messier highlighted a related, ongoing study he’s leading in which more than 800 overweight patients in North Carolina who suffer from knee pain are being led through diet and exercise interventions in a community setting. The goal is to replicate the IDEA results outside of a clinical trial setting and show skeptical physicians that diet and exercise can be enacted and maintained in this subset of patients.
“I think we know how effective weight loss is, especially when combined with exercise, in reducing pain, improving function, improving quality of life in these patients,” he said. “The next step is to allow them to maintain those benefits for a long period of time after the intervention ends.”
The study was supported by grants from the National Institutes of Health and by General Nutrition Centers. Its authors reported no potential conflicts of interest.
FROM ARTHRITIS CARE & RESEARCH
Medicinal liquor and edited mosquitoes
Drink to your health?
Whether you drink or not, most of us can agree that liquor is not the first thing that comes to mind when looking to make health improvements. But researchers have found a small exception in something traditional.
We’ve added buckwheat to pancakes, bread, and other baked goodies we made during the height of quarantine, but it’s also used to create a traditional liquor in some East Asian countries, where it is used medicinally.
Investigators have found that extracts in the Tartary buckwheat used to make the liquor induce autophagy, a process cells go through to remove proteins that are damaged or not needed anymore – sort of like a cellular spring cleaning.
To test this, the researchers treated liver and skin cells with Tartary buckwheat extract and looked to see how the cells responded with fluorescent markers. The results were clear.
“Treating cells with the extract stimulated the formation of autophagosomes, specialized cellular structures that carry out autophagy, and altered the location of proteins involved in regulating autophagy,” said senior author Takeshi Noda of Osaka (Japan) University.
Looking deeper, the researchers found that quercetin, a component of the buckwheat extract, had the same autophagic effect. And both the buckwheat and the quercetin gave the green light for liver cells to induce aggrephagy, the process of cleaning up protein aggregates.
Those protein aggregates in liver cells are closely linked to alcoholic liver disease, suggesting that quercetin could be a game changer in its treatment. In other words, liquor could help fix the problem that liquor started. Go figure.
From hospital bills to X-rated
Ralph Puglisi was an accounting manager for the University Medical Service Association (UMSA), a nonprofit that supports the massive University of South Florida health system. The association took in over $300 million in revenue in the 2019-2020 fiscal year, which is a rather large sum of money, but we’ll glide over the ethics of a “nonprofit” making a few hundred million for now.
Mr. Puglisi was in very close proximity to the money, generated from patient care, and he pled guilty to stealing it using UMSA credit cards. Now, that wouldn’t be LOTME worthy on its own, but what elevates this above garden-variety embezzlement is how the intrepid Mr. Puglisi chose to spend the millions he stole from the university health system: Adult entertainment.
And before you ask, he didn’t spend $11.5 million on something most people so inclined can find for free with judicious Google searches. What Mr. Puglisi actually did was invest in a website providing adult content through individual user profiles, one of which is believed to belong to his stepson’s fiancée, which brings a whole new level of sleaze to this enterprise. Over the course of 2 years, he visited her profile 2,800 times, an amount some might view as excessive.
While the vast majority of the embezzled money went to the adult website, Mr. Puglisi also used thousands of UMSA dollars to pay for travel, household improvements, rent, the works. Almost $44,000 was spent at a resort sometimes known as the happiest place on earth.
Then there’s Mr. Puglisi’s wife. Oh yes, this guy is married. He poured over $600,000 into a company he and his wife owned, which is a lot, but how much do you think went to the woman he married? Probably quite a bit. Go ahead, try to think of a number. It’s not like it was his money.
Did you guess $100 went into his wife’s PayPal account? No? Clearly you don’t understand the criminal mind. His stepson’s fiancée got millions, and his wife got a hundred. Now there are some priorities.
Step 1: Sit at desk. Step 2: Get in shape
Being a physician is not really a desk job, but doctors must spend a fair share of their time sitting, yes? Dealing with recalcitrant EHRs or talking on the phone to insurers or PBMs? If you are one of these physicians, or if you have patients who spend a lot of time sitting at their desks and might need to get a bit of exercise, then we’ve got a multitasking tip for you.
It came to us via one of our favorite websites, Sad and Useless. It’s the site that declares itself “the most depressive humor site on the Internet” and they’re offering up the “12 Best Exercises To Do At Your Desk.” It may not sound like much, but we think that the gang at Dunder-Mifflin would approve. And besides, who couldn’t stand to burn a few calories without having to leave the chair?
We won’t spoil your fun by going through all 12 – each one comes with step-by-step instructions and a helpful illustration or GIF – but here are just a few:
- Bending over backwards: “Agree to do something you don’t want to do. Spend twice as long as expected doing that thing. Hate yourself.”
- Fake laughter: “Hear a joke that isn’t even remotely funny. Open your mouth and make laughing sounds.”
- Bang your head: Feel the “pointlessness of your job overwhelm you” and then “bring your head forcefully down to your desk.”
Now, we here at LOTME are, of course [Bang!], highly skilled, professional wordsmithing humorists [Bang!], so when we tell you that this is a great workout [Bang!] … that this is a great workout [Bang!] … it’s great … uggh.
Wooooo. Feel the burn.
One order of mosquitoes, extra Crispr
What would it be like to have a barbecue in your backyard on a humid summer night and not get eaten alive by mosquitoes? If you’re like us, you probably thought you’d never see that day.
Mosquitoes cause itchy bites, but, more importantly, they can carry dengue, malaria, yellow fever, and Zika virus. New research shows that protection from these diseases may be possible with use of the Crispr-Cas9 gene-editing tool, which could make humans invisible to mosquitoes by taking away their light-sensing abilities and, thus, their ability to find us.
“The better we understand how they sense the human, the better we can control the mosquito in an eco-friendly manner,” Yinpeng Zhan, a postdoctoral researcher at the University of California, Santa Barbara, and the study’s lead author, told the New York Times.
After studying the mosquitoes and figuring out their hunting patterns, the researchers found that mosquitoes are attracted to dark spots more than white spots and used this to their advantage. After knocking out two of the proteins that mosquitoes need for vision – via Crispr – the little suckers could not distinguish the difference between the white and dark spots.
We’re sure mosquitoes don’t mean any harm – they’re just trying to survive and reproduce like any other species – but thanks to this new tool, gone might be the days of having to douse yourself in bug spray that smells like a mix of chemicals and melon.
Drink to your health?
Whether you drink or not, most of us can agree that liquor is not the first thing that comes to mind when looking to make health improvements. But researchers have found a small exception in something traditional.
We’ve added buckwheat to pancakes, bread, and other baked goodies we made during the height of quarantine, but it’s also used to create a traditional liquor in some East Asian countries, where it is used medicinally.
Investigators have found that extracts in the Tartary buckwheat used to make the liquor induce autophagy, a process cells go through to remove proteins that are damaged or not needed anymore – sort of like a cellular spring cleaning.
To test this, the researchers treated liver and skin cells with Tartary buckwheat extract and looked to see how the cells responded with fluorescent markers. The results were clear.
“Treating cells with the extract stimulated the formation of autophagosomes, specialized cellular structures that carry out autophagy, and altered the location of proteins involved in regulating autophagy,” said senior author Takeshi Noda of Osaka (Japan) University.
Looking deeper, the researchers found that quercetin, a component of the buckwheat extract, had the same autophagic effect. And both the buckwheat and the quercetin gave the green light for liver cells to induce aggrephagy, the process of cleaning up protein aggregates.
Those protein aggregates in liver cells are closely linked to alcoholic liver disease, suggesting that quercetin could be a game changer in its treatment. In other words, liquor could help fix the problem that liquor started. Go figure.
From hospital bills to X-rated
Ralph Puglisi was an accounting manager for the University Medical Service Association (UMSA), a nonprofit that supports the massive University of South Florida health system. The association took in over $300 million in revenue in the 2019-2020 fiscal year, which is a rather large sum of money, but we’ll glide over the ethics of a “nonprofit” making a few hundred million for now.
Mr. Puglisi was in very close proximity to the money, generated from patient care, and he pled guilty to stealing it using UMSA credit cards. Now, that wouldn’t be LOTME worthy on its own, but what elevates this above garden-variety embezzlement is how the intrepid Mr. Puglisi chose to spend the millions he stole from the university health system: Adult entertainment.
And before you ask, he didn’t spend $11.5 million on something most people so inclined can find for free with judicious Google searches. What Mr. Puglisi actually did was invest in a website providing adult content through individual user profiles, one of which is believed to belong to his stepson’s fiancée, which brings a whole new level of sleaze to this enterprise. Over the course of 2 years, he visited her profile 2,800 times, an amount some might view as excessive.
While the vast majority of the embezzled money went to the adult website, Mr. Puglisi also used thousands of UMSA dollars to pay for travel, household improvements, rent, the works. Almost $44,000 was spent at a resort sometimes known as the happiest place on earth.
Then there’s Mr. Puglisi’s wife. Oh yes, this guy is married. He poured over $600,000 into a company he and his wife owned, which is a lot, but how much do you think went to the woman he married? Probably quite a bit. Go ahead, try to think of a number. It’s not like it was his money.
Did you guess $100 went into his wife’s PayPal account? No? Clearly you don’t understand the criminal mind. His stepson’s fiancée got millions, and his wife got a hundred. Now there are some priorities.
Step 1: Sit at desk. Step 2: Get in shape
Being a physician is not really a desk job, but doctors must spend a fair share of their time sitting, yes? Dealing with recalcitrant EHRs or talking on the phone to insurers or PBMs? If you are one of these physicians, or if you have patients who spend a lot of time sitting at their desks and might need to get a bit of exercise, then we’ve got a multitasking tip for you.
It came to us via one of our favorite websites, Sad and Useless. It’s the site that declares itself “the most depressive humor site on the Internet” and they’re offering up the “12 Best Exercises To Do At Your Desk.” It may not sound like much, but we think that the gang at Dunder-Mifflin would approve. And besides, who couldn’t stand to burn a few calories without having to leave the chair?
We won’t spoil your fun by going through all 12 – each one comes with step-by-step instructions and a helpful illustration or GIF – but here are just a few:
- Bending over backwards: “Agree to do something you don’t want to do. Spend twice as long as expected doing that thing. Hate yourself.”
- Fake laughter: “Hear a joke that isn’t even remotely funny. Open your mouth and make laughing sounds.”
- Bang your head: Feel the “pointlessness of your job overwhelm you” and then “bring your head forcefully down to your desk.”
Now, we here at LOTME are, of course [Bang!], highly skilled, professional wordsmithing humorists [Bang!], so when we tell you that this is a great workout [Bang!] … that this is a great workout [Bang!] … it’s great … uggh.
Wooooo. Feel the burn.
One order of mosquitoes, extra Crispr
What would it be like to have a barbecue in your backyard on a humid summer night and not get eaten alive by mosquitoes? If you’re like us, you probably thought you’d never see that day.
Mosquitoes cause itchy bites, but, more importantly, they can carry dengue, malaria, yellow fever, and Zika virus. New research shows that protection from these diseases may be possible with use of the Crispr-Cas9 gene-editing tool, which could make humans invisible to mosquitoes by taking away their light-sensing abilities and, thus, their ability to find us.
“The better we understand how they sense the human, the better we can control the mosquito in an eco-friendly manner,” Yinpeng Zhan, a postdoctoral researcher at the University of California, Santa Barbara, and the study’s lead author, told the New York Times.
After studying the mosquitoes and figuring out their hunting patterns, the researchers found that mosquitoes are attracted to dark spots more than white spots and used this to their advantage. After knocking out two of the proteins that mosquitoes need for vision – via Crispr – the little suckers could not distinguish the difference between the white and dark spots.
We’re sure mosquitoes don’t mean any harm – they’re just trying to survive and reproduce like any other species – but thanks to this new tool, gone might be the days of having to douse yourself in bug spray that smells like a mix of chemicals and melon.
Drink to your health?
Whether you drink or not, most of us can agree that liquor is not the first thing that comes to mind when looking to make health improvements. But researchers have found a small exception in something traditional.
We’ve added buckwheat to pancakes, bread, and other baked goodies we made during the height of quarantine, but it’s also used to create a traditional liquor in some East Asian countries, where it is used medicinally.
Investigators have found that extracts in the Tartary buckwheat used to make the liquor induce autophagy, a process cells go through to remove proteins that are damaged or not needed anymore – sort of like a cellular spring cleaning.
To test this, the researchers treated liver and skin cells with Tartary buckwheat extract and looked to see how the cells responded with fluorescent markers. The results were clear.
“Treating cells with the extract stimulated the formation of autophagosomes, specialized cellular structures that carry out autophagy, and altered the location of proteins involved in regulating autophagy,” said senior author Takeshi Noda of Osaka (Japan) University.
Looking deeper, the researchers found that quercetin, a component of the buckwheat extract, had the same autophagic effect. And both the buckwheat and the quercetin gave the green light for liver cells to induce aggrephagy, the process of cleaning up protein aggregates.
Those protein aggregates in liver cells are closely linked to alcoholic liver disease, suggesting that quercetin could be a game changer in its treatment. In other words, liquor could help fix the problem that liquor started. Go figure.
From hospital bills to X-rated
Ralph Puglisi was an accounting manager for the University Medical Service Association (UMSA), a nonprofit that supports the massive University of South Florida health system. The association took in over $300 million in revenue in the 2019-2020 fiscal year, which is a rather large sum of money, but we’ll glide over the ethics of a “nonprofit” making a few hundred million for now.
Mr. Puglisi was in very close proximity to the money, generated from patient care, and he pled guilty to stealing it using UMSA credit cards. Now, that wouldn’t be LOTME worthy on its own, but what elevates this above garden-variety embezzlement is how the intrepid Mr. Puglisi chose to spend the millions he stole from the university health system: Adult entertainment.
And before you ask, he didn’t spend $11.5 million on something most people so inclined can find for free with judicious Google searches. What Mr. Puglisi actually did was invest in a website providing adult content through individual user profiles, one of which is believed to belong to his stepson’s fiancée, which brings a whole new level of sleaze to this enterprise. Over the course of 2 years, he visited her profile 2,800 times, an amount some might view as excessive.
While the vast majority of the embezzled money went to the adult website, Mr. Puglisi also used thousands of UMSA dollars to pay for travel, household improvements, rent, the works. Almost $44,000 was spent at a resort sometimes known as the happiest place on earth.
Then there’s Mr. Puglisi’s wife. Oh yes, this guy is married. He poured over $600,000 into a company he and his wife owned, which is a lot, but how much do you think went to the woman he married? Probably quite a bit. Go ahead, try to think of a number. It’s not like it was his money.
Did you guess $100 went into his wife’s PayPal account? No? Clearly you don’t understand the criminal mind. His stepson’s fiancée got millions, and his wife got a hundred. Now there are some priorities.
Step 1: Sit at desk. Step 2: Get in shape
Being a physician is not really a desk job, but doctors must spend a fair share of their time sitting, yes? Dealing with recalcitrant EHRs or talking on the phone to insurers or PBMs? If you are one of these physicians, or if you have patients who spend a lot of time sitting at their desks and might need to get a bit of exercise, then we’ve got a multitasking tip for you.
It came to us via one of our favorite websites, Sad and Useless. It’s the site that declares itself “the most depressive humor site on the Internet” and they’re offering up the “12 Best Exercises To Do At Your Desk.” It may not sound like much, but we think that the gang at Dunder-Mifflin would approve. And besides, who couldn’t stand to burn a few calories without having to leave the chair?
We won’t spoil your fun by going through all 12 – each one comes with step-by-step instructions and a helpful illustration or GIF – but here are just a few:
- Bending over backwards: “Agree to do something you don’t want to do. Spend twice as long as expected doing that thing. Hate yourself.”
- Fake laughter: “Hear a joke that isn’t even remotely funny. Open your mouth and make laughing sounds.”
- Bang your head: Feel the “pointlessness of your job overwhelm you” and then “bring your head forcefully down to your desk.”
Now, we here at LOTME are, of course [Bang!], highly skilled, professional wordsmithing humorists [Bang!], so when we tell you that this is a great workout [Bang!] … that this is a great workout [Bang!] … it’s great … uggh.
Wooooo. Feel the burn.
One order of mosquitoes, extra Crispr
What would it be like to have a barbecue in your backyard on a humid summer night and not get eaten alive by mosquitoes? If you’re like us, you probably thought you’d never see that day.
Mosquitoes cause itchy bites, but, more importantly, they can carry dengue, malaria, yellow fever, and Zika virus. New research shows that protection from these diseases may be possible with use of the Crispr-Cas9 gene-editing tool, which could make humans invisible to mosquitoes by taking away their light-sensing abilities and, thus, their ability to find us.
“The better we understand how they sense the human, the better we can control the mosquito in an eco-friendly manner,” Yinpeng Zhan, a postdoctoral researcher at the University of California, Santa Barbara, and the study’s lead author, told the New York Times.
After studying the mosquitoes and figuring out their hunting patterns, the researchers found that mosquitoes are attracted to dark spots more than white spots and used this to their advantage. After knocking out two of the proteins that mosquitoes need for vision – via Crispr – the little suckers could not distinguish the difference between the white and dark spots.
We’re sure mosquitoes don’t mean any harm – they’re just trying to survive and reproduce like any other species – but thanks to this new tool, gone might be the days of having to douse yourself in bug spray that smells like a mix of chemicals and melon.
Annular lesions
This patient was given a diagnosis of disseminated granuloma annulare (DGA). While granuloma annulare usually manifests as a single lesion with a raised erythematous border (often with central pallor or hypopigmentation) it can also manifest as multiple large annular lesions on the extremities and occasionally the trunk, as was seen with this case of DGA.
Although the etiology of DGA is unknown, infections including HIV and hepatitis have been reported as possible triggers. Laboratory testing should be considered if the history or physical examination raises suspicion for either condition. Diabetes has also been associated with the disseminated form and the literature suggests a connection with autoimmune diseases of the liver and thyroid.1
Watchful waiting is usually the best treatment for localized disease, which can spontaneously regress within a year and is usually asymptomatic. Intralesional steroid injections into the raised annulus are more effective than topical steroids, as the effects of the topical steroids are sometimes augmented by occlusion.
Multiple treatments have been proposed for DGA, including UVA treatments, systemic retinoids, doxycycline, and hydroxychloroquine.1 Unfortunately, the disseminated form can persist for many years—even with treatment.
Due to the extent of the lesions, the patient in this case was not interested in intralesional steroid injections, and she had already tried topical steroids. She was prescribed topical tacrolimus to reduce the highly visible nature of her lesions.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
Beretta-Piccoli BT, Mainetti C, Peeters MA, et al. Cutaneous granulomatosis: a comprehensive review. Clin Rev Allergy Immunol. 2018;54:131-146. doi: 10.1007/s12016-017-8666-8
This patient was given a diagnosis of disseminated granuloma annulare (DGA). While granuloma annulare usually manifests as a single lesion with a raised erythematous border (often with central pallor or hypopigmentation) it can also manifest as multiple large annular lesions on the extremities and occasionally the trunk, as was seen with this case of DGA.
Although the etiology of DGA is unknown, infections including HIV and hepatitis have been reported as possible triggers. Laboratory testing should be considered if the history or physical examination raises suspicion for either condition. Diabetes has also been associated with the disseminated form and the literature suggests a connection with autoimmune diseases of the liver and thyroid.1
Watchful waiting is usually the best treatment for localized disease, which can spontaneously regress within a year and is usually asymptomatic. Intralesional steroid injections into the raised annulus are more effective than topical steroids, as the effects of the topical steroids are sometimes augmented by occlusion.
Multiple treatments have been proposed for DGA, including UVA treatments, systemic retinoids, doxycycline, and hydroxychloroquine.1 Unfortunately, the disseminated form can persist for many years—even with treatment.
Due to the extent of the lesions, the patient in this case was not interested in intralesional steroid injections, and she had already tried topical steroids. She was prescribed topical tacrolimus to reduce the highly visible nature of her lesions.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
This patient was given a diagnosis of disseminated granuloma annulare (DGA). While granuloma annulare usually manifests as a single lesion with a raised erythematous border (often with central pallor or hypopigmentation) it can also manifest as multiple large annular lesions on the extremities and occasionally the trunk, as was seen with this case of DGA.
Although the etiology of DGA is unknown, infections including HIV and hepatitis have been reported as possible triggers. Laboratory testing should be considered if the history or physical examination raises suspicion for either condition. Diabetes has also been associated with the disseminated form and the literature suggests a connection with autoimmune diseases of the liver and thyroid.1
Watchful waiting is usually the best treatment for localized disease, which can spontaneously regress within a year and is usually asymptomatic. Intralesional steroid injections into the raised annulus are more effective than topical steroids, as the effects of the topical steroids are sometimes augmented by occlusion.
Multiple treatments have been proposed for DGA, including UVA treatments, systemic retinoids, doxycycline, and hydroxychloroquine.1 Unfortunately, the disseminated form can persist for many years—even with treatment.
Due to the extent of the lesions, the patient in this case was not interested in intralesional steroid injections, and she had already tried topical steroids. She was prescribed topical tacrolimus to reduce the highly visible nature of her lesions.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
Beretta-Piccoli BT, Mainetti C, Peeters MA, et al. Cutaneous granulomatosis: a comprehensive review. Clin Rev Allergy Immunol. 2018;54:131-146. doi: 10.1007/s12016-017-8666-8
Beretta-Piccoli BT, Mainetti C, Peeters MA, et al. Cutaneous granulomatosis: a comprehensive review. Clin Rev Allergy Immunol. 2018;54:131-146. doi: 10.1007/s12016-017-8666-8
The hateful patient
A 64-year-old White woman with very few medical problems complains of bug bites. She had seen no bugs and had no visible bites. There is no rash. “So what bit me?” she asked, pulling her mask down for emphasis. How should I know? I thought, but didn’t say. She and I have been through this many times.
Before I could respond, she filled the pause with her usual complaints including how hard it is to get an appointment with me and how every appointment with me is a waste of her time. Ignoring the contradistinction of her charges, I took some satisfaction realizing she has just given me a topic to write about: The hateful patient.
They are frustrating, troublesome, rude, sometimes racist, misogynistic, depressing, hopeless, and disheartening. They call you, email you, and come to see you just to annoy you (so it seems). And they’re everywhere. According to one study, nearly one in six are “difficult patients.” It feels like more lately because the vaccine has brought haters back into clinic, just to get us.
But hateful patients aren’t new. In 1978, James E. Groves, MD, a Harvard psychiatrist, wrote a now-classic New England Journal of Medicine article about them called: Taking Care of the Hateful Patient. Even Osler, back in 1889, covered these patients in his lecture to University of Pennsylvania students, advising us to “deal gently with this deliciously credulous old human nature in which we work ... restrain your indignation.” But like much of Osler’s advice, it is easier said than done.
Dr. Groves is more helpful, and presents a model to understand them. Difficult patients, as we’d now call them, fall into four stereotypes: dependent clingers, entitled demanders, manipulative help-rejectors, and self-destructive deniers. It’s Dr. Groves’s bottom line I found insightful. He says that, when patients create negative feelings in us, we’re more likely to make errors. He then gives sound advice: Set firm boundaries and learn to counter the countertransference these patients provoke. Don’t disavow or discharge, Dr. Groves advises, redirect these emotions to motivate you to dig deeper. There you’ll find clinical data that will facilitate understanding and enable better patient management. Yes, easier said.
In addition to Dr. Groves’s analysis of how we harm these patients, I’d add that these disagreeable, malingering patients also harm us doctors. The hangover from a difficult patient encounter can linger for several appointments later or, worse, carryover to home. And now with patient emails proliferating, demanding patients behave as if we have an inexhaustible ability to engage them. We don’t. Many physicians are struggling to care at all; their low empathy battery warnings are blinking red, less than 1% remaining.
What is toxic to us doctors is the maelstrom of cognitive dissonance these patients create in us. Have you ever felt relief to learn a difficult patient has “finally” died? How could we think such a thing?! Didn’t we choose medicine instead of Wall Street because we care about people? But manipulative patients can make us care less. We even use secret language with each other to protect ourselves from them, those GOMERs (get out of my emergency room), bouncebacks, patients with status dramaticus, and those ornery FTDs (failure to die). Save yourself, we say to each other, this patient will kill you.
Caring for my somatizing 64-year-old patient has been difficult, but writing this has helped me reframe our interaction. Unsurprisingly, at the end of her failed visit she asked when she could see me again. “I need to schedule now because I have to find a neighbor to watch my dogs. It takes two buses to come here and I can’t take them with me.” Ah, there’s the clinical data Dr. Groves said I’d find – she’s not here to hurt me, she’s here because I’m all she’s got. At least for this difficult patient, I have a plan. At the bottom of my note I type “RTC 3 mo.”
Dr. Benabio is director of healthcare transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
A 64-year-old White woman with very few medical problems complains of bug bites. She had seen no bugs and had no visible bites. There is no rash. “So what bit me?” she asked, pulling her mask down for emphasis. How should I know? I thought, but didn’t say. She and I have been through this many times.
Before I could respond, she filled the pause with her usual complaints including how hard it is to get an appointment with me and how every appointment with me is a waste of her time. Ignoring the contradistinction of her charges, I took some satisfaction realizing she has just given me a topic to write about: The hateful patient.
They are frustrating, troublesome, rude, sometimes racist, misogynistic, depressing, hopeless, and disheartening. They call you, email you, and come to see you just to annoy you (so it seems). And they’re everywhere. According to one study, nearly one in six are “difficult patients.” It feels like more lately because the vaccine has brought haters back into clinic, just to get us.
But hateful patients aren’t new. In 1978, James E. Groves, MD, a Harvard psychiatrist, wrote a now-classic New England Journal of Medicine article about them called: Taking Care of the Hateful Patient. Even Osler, back in 1889, covered these patients in his lecture to University of Pennsylvania students, advising us to “deal gently with this deliciously credulous old human nature in which we work ... restrain your indignation.” But like much of Osler’s advice, it is easier said than done.
Dr. Groves is more helpful, and presents a model to understand them. Difficult patients, as we’d now call them, fall into four stereotypes: dependent clingers, entitled demanders, manipulative help-rejectors, and self-destructive deniers. It’s Dr. Groves’s bottom line I found insightful. He says that, when patients create negative feelings in us, we’re more likely to make errors. He then gives sound advice: Set firm boundaries and learn to counter the countertransference these patients provoke. Don’t disavow or discharge, Dr. Groves advises, redirect these emotions to motivate you to dig deeper. There you’ll find clinical data that will facilitate understanding and enable better patient management. Yes, easier said.
In addition to Dr. Groves’s analysis of how we harm these patients, I’d add that these disagreeable, malingering patients also harm us doctors. The hangover from a difficult patient encounter can linger for several appointments later or, worse, carryover to home. And now with patient emails proliferating, demanding patients behave as if we have an inexhaustible ability to engage them. We don’t. Many physicians are struggling to care at all; their low empathy battery warnings are blinking red, less than 1% remaining.
What is toxic to us doctors is the maelstrom of cognitive dissonance these patients create in us. Have you ever felt relief to learn a difficult patient has “finally” died? How could we think such a thing?! Didn’t we choose medicine instead of Wall Street because we care about people? But manipulative patients can make us care less. We even use secret language with each other to protect ourselves from them, those GOMERs (get out of my emergency room), bouncebacks, patients with status dramaticus, and those ornery FTDs (failure to die). Save yourself, we say to each other, this patient will kill you.
Caring for my somatizing 64-year-old patient has been difficult, but writing this has helped me reframe our interaction. Unsurprisingly, at the end of her failed visit she asked when she could see me again. “I need to schedule now because I have to find a neighbor to watch my dogs. It takes two buses to come here and I can’t take them with me.” Ah, there’s the clinical data Dr. Groves said I’d find – she’s not here to hurt me, she’s here because I’m all she’s got. At least for this difficult patient, I have a plan. At the bottom of my note I type “RTC 3 mo.”
Dr. Benabio is director of healthcare transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
A 64-year-old White woman with very few medical problems complains of bug bites. She had seen no bugs and had no visible bites. There is no rash. “So what bit me?” she asked, pulling her mask down for emphasis. How should I know? I thought, but didn’t say. She and I have been through this many times.
Before I could respond, she filled the pause with her usual complaints including how hard it is to get an appointment with me and how every appointment with me is a waste of her time. Ignoring the contradistinction of her charges, I took some satisfaction realizing she has just given me a topic to write about: The hateful patient.
They are frustrating, troublesome, rude, sometimes racist, misogynistic, depressing, hopeless, and disheartening. They call you, email you, and come to see you just to annoy you (so it seems). And they’re everywhere. According to one study, nearly one in six are “difficult patients.” It feels like more lately because the vaccine has brought haters back into clinic, just to get us.
But hateful patients aren’t new. In 1978, James E. Groves, MD, a Harvard psychiatrist, wrote a now-classic New England Journal of Medicine article about them called: Taking Care of the Hateful Patient. Even Osler, back in 1889, covered these patients in his lecture to University of Pennsylvania students, advising us to “deal gently with this deliciously credulous old human nature in which we work ... restrain your indignation.” But like much of Osler’s advice, it is easier said than done.
Dr. Groves is more helpful, and presents a model to understand them. Difficult patients, as we’d now call them, fall into four stereotypes: dependent clingers, entitled demanders, manipulative help-rejectors, and self-destructive deniers. It’s Dr. Groves’s bottom line I found insightful. He says that, when patients create negative feelings in us, we’re more likely to make errors. He then gives sound advice: Set firm boundaries and learn to counter the countertransference these patients provoke. Don’t disavow or discharge, Dr. Groves advises, redirect these emotions to motivate you to dig deeper. There you’ll find clinical data that will facilitate understanding and enable better patient management. Yes, easier said.
In addition to Dr. Groves’s analysis of how we harm these patients, I’d add that these disagreeable, malingering patients also harm us doctors. The hangover from a difficult patient encounter can linger for several appointments later or, worse, carryover to home. And now with patient emails proliferating, demanding patients behave as if we have an inexhaustible ability to engage them. We don’t. Many physicians are struggling to care at all; their low empathy battery warnings are blinking red, less than 1% remaining.
What is toxic to us doctors is the maelstrom of cognitive dissonance these patients create in us. Have you ever felt relief to learn a difficult patient has “finally” died? How could we think such a thing?! Didn’t we choose medicine instead of Wall Street because we care about people? But manipulative patients can make us care less. We even use secret language with each other to protect ourselves from them, those GOMERs (get out of my emergency room), bouncebacks, patients with status dramaticus, and those ornery FTDs (failure to die). Save yourself, we say to each other, this patient will kill you.
Caring for my somatizing 64-year-old patient has been difficult, but writing this has helped me reframe our interaction. Unsurprisingly, at the end of her failed visit she asked when she could see me again. “I need to schedule now because I have to find a neighbor to watch my dogs. It takes two buses to come here and I can’t take them with me.” Ah, there’s the clinical data Dr. Groves said I’d find – she’s not here to hurt me, she’s here because I’m all she’s got. At least for this difficult patient, I have a plan. At the bottom of my note I type “RTC 3 mo.”
Dr. Benabio is director of healthcare transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
Microbiome: Gut dysbiosis linked to development of alopecia areata
presented at the annual meeting of the Society for Investigative Dermatology.
There have been reports of gut microbiome dysbiosis associated with autoimmune diseases such as rheumatoid arthritis, diabetes, and celiac disease. “It is now clear that these events not just shape the immune response in the gut, but also distant sites and immune-privileged organs,” Tanya Sezin, a doctor of natural science from the University of Lübeck (Germany) and Columbia University, New York, said in her presentation.
Whether the gut microbiome may also play a role as an environmental factor in alopecia areata, another T-cell–mediated autoimmune disease for which there are few available treatment options, is being evaluated at the Christiano Laboratory at Columbia University, Dr. Sezin noted. “Much of the difficulty underlying the lack of an effective treatment has been the incomplete understanding of the pathogenesis of AA.”
She also referred to several case reports describing hair growth in patients who received fecal microbiota transplantation (FMT), including a 20-year-old with alopecia universalis, who experienced hair growth after receiving FMT for Crohn’s disease.
Dr. Sezin and colleagues at the lab first performed a study in mice to test whether the gut microbiome was involved in the pathogenesis of AA. Mice given an antibiotic cocktail of ampicillin, neomycin, and vancomycin prior to or at the time of a skin graft taken from a mouse model of AA to induce AA were protected from hair loss, while mice given the antibiotic cocktail after skin grafting were not protected from hair loss.
“16S rRNA sequencing analysis of the gut microbiota revealed a significant shift in gut microbiome composition in animals treated with antibiotics and protected from hair loss, as reflected by significant changes in alpha and beta diversity,” Dr. Sezin explained. “In AA mice, we also observed differential abundance of families from the Bacteroidetes and Firmicutes phyla.” Specifically, Lactobacillus murinus and Muribaculum intestinale were overrepresented in mice with AA.
The investigators then performed 16S rRNA sequencing on 26 patients with AA, who stopped treatment for 30 days beforehand, and 9 participants who did not have AA as controls. “Though we did not observe difference in alpha and beta diversity, we see changes in the relative abundance of several families belonging to the Firmicutes phyla,” in patients with AA, Dr. Sezin said.
In another cohort of 30 patients with AA and 20 participants without AA, who stopped treatment before the study, Dr. Sezin and colleagues found “differences in the relative abundance of members of the Firmicutes and Bacteroides phyla,” including Bacteroides caccae, Prevotella copri, Syntrophomonas wolfei, Blautia wexlerae, and Eubacterium eligens, she said. “Consistent with our findings, there are previous reports in the literature showing gut dysbiosis in several other autoimmune diseases associated with differential regulation of some of the top species we have identified.”
Dr. Sezin said her group is recruiting patients for a clinical trial evaluating FMT in patients with AA. “We plan to study the association between changes in the gut microbiome and immune cell composition in AA patients undergoing FMT,” she said. “Additionally, functional studies in mice are also currently [being conducted] to further pinpoint the contribution of gut microbiome to the pathogenesis of AA.”
When asked during the discussion session if there was any relationship between the skin microbiome and AA, Dr. Sezin said there was no connection found in mice studies, which she and her colleagues are investigating further. “In the human samples, we are currently recruiting more patients and healthy controls to try to get a better understanding of whether we see differences in the skin microbiome,” she added.
Dr. Sezin explained that how the gut microbiota “is really remediated in alopecia areata” is not well understood. “We think that it is possible that we see intestinal permeability in the gut due to the gut dysbiosis that we see in alopecia areata patients, and this might lead to systemic distribution of bacteria, which might cross-react or present cross reactivity with the antigens” identified in AA, which is also being investigated, she said.
FMT not a ‘simple fix’ for AA
Leslie Castelo-Soccio, MD, PhD, a dermatologist at the Children’s Hospital of Philadelphia, who was not involved with the research, said in an interview that the findings presented by Dr. Sezin show how AA shares similarities with other autoimmune diseases. “It does highlight how important the gut microbiome is to human disease, and that differences in relative abundance of bacteria play one part as a trigger in a genetically susceptible person.”
However, while some autoimmune diseases have a big difference in alpha and beta diversity, for example, “this has not been seen in people with alopecia areata,” Dr. Castelo-Soccio pointed out. “The differences are more subtle in terms of amounts of certain bacteria,” she said, noting that, in this study, the biggest differences were seen in the studies of mice.
Dr. Castelo-Soccio also said there may be also be differences in the gut microbiome in children and adults. “The gut microbiome shifts in very early childhood from a very diverse microbiome to a more ‘adult microbiome’ around age 4, which is the age we see the first peak of many autoimmune diseases, including alopecia areata. I think microbiome work in humans needs to focus on this transition point.”
As for the clinical trial at Columbia that is evaluating FMT in patients with AA, Dr. Castelo-Soccio said she is excited. “There is much to learn about fecal transplant for all diseases and about the role of the gut microbiome and environment. Most of what we know for fecal transplant centers on its use for Clostridium difficile infections.”
Patients and their families have been asking about the potential for FMT in alopecia area, Dr. Castelo-Soccio said, but some believe it is a “simple fix” when the reality is much more complex.
“When I speak to patients and families about this, I explain that currently the ‘active ingredient’ in fecal transplants is not definitively established. In any one donor, the community of bacteria is highly variable and can be from batch to batch. While the short-term risks are relatively low – cramping, diarrhea, discomfort, mode of delivery – there are reports of transmission of infectious bacteria from donors like [Escherichia] coli, which have led to severe infections.”
Long-term safety and durability of effects are also unclear, “so we do not know if a patient receiving one [FMT] will need many in the future. We do not know how changing the microbiome could affect the transplant recipient in terms of noninfectious diseases/disorders. We are learning about the role of microbiome in obesity, insulin resistance, mood disorders. We could be ‘fixing’ one trigger of alopecia but setting up [the] patient for other noninfectious conditions,” Dr. Castelo-Soccio said.
Dr. Sezin and Dr. Castelo-Soccio reported no relevant financial disclosures.
presented at the annual meeting of the Society for Investigative Dermatology.
There have been reports of gut microbiome dysbiosis associated with autoimmune diseases such as rheumatoid arthritis, diabetes, and celiac disease. “It is now clear that these events not just shape the immune response in the gut, but also distant sites and immune-privileged organs,” Tanya Sezin, a doctor of natural science from the University of Lübeck (Germany) and Columbia University, New York, said in her presentation.
Whether the gut microbiome may also play a role as an environmental factor in alopecia areata, another T-cell–mediated autoimmune disease for which there are few available treatment options, is being evaluated at the Christiano Laboratory at Columbia University, Dr. Sezin noted. “Much of the difficulty underlying the lack of an effective treatment has been the incomplete understanding of the pathogenesis of AA.”
She also referred to several case reports describing hair growth in patients who received fecal microbiota transplantation (FMT), including a 20-year-old with alopecia universalis, who experienced hair growth after receiving FMT for Crohn’s disease.
Dr. Sezin and colleagues at the lab first performed a study in mice to test whether the gut microbiome was involved in the pathogenesis of AA. Mice given an antibiotic cocktail of ampicillin, neomycin, and vancomycin prior to or at the time of a skin graft taken from a mouse model of AA to induce AA were protected from hair loss, while mice given the antibiotic cocktail after skin grafting were not protected from hair loss.
“16S rRNA sequencing analysis of the gut microbiota revealed a significant shift in gut microbiome composition in animals treated with antibiotics and protected from hair loss, as reflected by significant changes in alpha and beta diversity,” Dr. Sezin explained. “In AA mice, we also observed differential abundance of families from the Bacteroidetes and Firmicutes phyla.” Specifically, Lactobacillus murinus and Muribaculum intestinale were overrepresented in mice with AA.
The investigators then performed 16S rRNA sequencing on 26 patients with AA, who stopped treatment for 30 days beforehand, and 9 participants who did not have AA as controls. “Though we did not observe difference in alpha and beta diversity, we see changes in the relative abundance of several families belonging to the Firmicutes phyla,” in patients with AA, Dr. Sezin said.
In another cohort of 30 patients with AA and 20 participants without AA, who stopped treatment before the study, Dr. Sezin and colleagues found “differences in the relative abundance of members of the Firmicutes and Bacteroides phyla,” including Bacteroides caccae, Prevotella copri, Syntrophomonas wolfei, Blautia wexlerae, and Eubacterium eligens, she said. “Consistent with our findings, there are previous reports in the literature showing gut dysbiosis in several other autoimmune diseases associated with differential regulation of some of the top species we have identified.”
Dr. Sezin said her group is recruiting patients for a clinical trial evaluating FMT in patients with AA. “We plan to study the association between changes in the gut microbiome and immune cell composition in AA patients undergoing FMT,” she said. “Additionally, functional studies in mice are also currently [being conducted] to further pinpoint the contribution of gut microbiome to the pathogenesis of AA.”
When asked during the discussion session if there was any relationship between the skin microbiome and AA, Dr. Sezin said there was no connection found in mice studies, which she and her colleagues are investigating further. “In the human samples, we are currently recruiting more patients and healthy controls to try to get a better understanding of whether we see differences in the skin microbiome,” she added.
Dr. Sezin explained that how the gut microbiota “is really remediated in alopecia areata” is not well understood. “We think that it is possible that we see intestinal permeability in the gut due to the gut dysbiosis that we see in alopecia areata patients, and this might lead to systemic distribution of bacteria, which might cross-react or present cross reactivity with the antigens” identified in AA, which is also being investigated, she said.
FMT not a ‘simple fix’ for AA
Leslie Castelo-Soccio, MD, PhD, a dermatologist at the Children’s Hospital of Philadelphia, who was not involved with the research, said in an interview that the findings presented by Dr. Sezin show how AA shares similarities with other autoimmune diseases. “It does highlight how important the gut microbiome is to human disease, and that differences in relative abundance of bacteria play one part as a trigger in a genetically susceptible person.”
However, while some autoimmune diseases have a big difference in alpha and beta diversity, for example, “this has not been seen in people with alopecia areata,” Dr. Castelo-Soccio pointed out. “The differences are more subtle in terms of amounts of certain bacteria,” she said, noting that, in this study, the biggest differences were seen in the studies of mice.
Dr. Castelo-Soccio also said there may be also be differences in the gut microbiome in children and adults. “The gut microbiome shifts in very early childhood from a very diverse microbiome to a more ‘adult microbiome’ around age 4, which is the age we see the first peak of many autoimmune diseases, including alopecia areata. I think microbiome work in humans needs to focus on this transition point.”
As for the clinical trial at Columbia that is evaluating FMT in patients with AA, Dr. Castelo-Soccio said she is excited. “There is much to learn about fecal transplant for all diseases and about the role of the gut microbiome and environment. Most of what we know for fecal transplant centers on its use for Clostridium difficile infections.”
Patients and their families have been asking about the potential for FMT in alopecia area, Dr. Castelo-Soccio said, but some believe it is a “simple fix” when the reality is much more complex.
“When I speak to patients and families about this, I explain that currently the ‘active ingredient’ in fecal transplants is not definitively established. In any one donor, the community of bacteria is highly variable and can be from batch to batch. While the short-term risks are relatively low – cramping, diarrhea, discomfort, mode of delivery – there are reports of transmission of infectious bacteria from donors like [Escherichia] coli, which have led to severe infections.”
Long-term safety and durability of effects are also unclear, “so we do not know if a patient receiving one [FMT] will need many in the future. We do not know how changing the microbiome could affect the transplant recipient in terms of noninfectious diseases/disorders. We are learning about the role of microbiome in obesity, insulin resistance, mood disorders. We could be ‘fixing’ one trigger of alopecia but setting up [the] patient for other noninfectious conditions,” Dr. Castelo-Soccio said.
Dr. Sezin and Dr. Castelo-Soccio reported no relevant financial disclosures.
presented at the annual meeting of the Society for Investigative Dermatology.
There have been reports of gut microbiome dysbiosis associated with autoimmune diseases such as rheumatoid arthritis, diabetes, and celiac disease. “It is now clear that these events not just shape the immune response in the gut, but also distant sites and immune-privileged organs,” Tanya Sezin, a doctor of natural science from the University of Lübeck (Germany) and Columbia University, New York, said in her presentation.
Whether the gut microbiome may also play a role as an environmental factor in alopecia areata, another T-cell–mediated autoimmune disease for which there are few available treatment options, is being evaluated at the Christiano Laboratory at Columbia University, Dr. Sezin noted. “Much of the difficulty underlying the lack of an effective treatment has been the incomplete understanding of the pathogenesis of AA.”
She also referred to several case reports describing hair growth in patients who received fecal microbiota transplantation (FMT), including a 20-year-old with alopecia universalis, who experienced hair growth after receiving FMT for Crohn’s disease.
Dr. Sezin and colleagues at the lab first performed a study in mice to test whether the gut microbiome was involved in the pathogenesis of AA. Mice given an antibiotic cocktail of ampicillin, neomycin, and vancomycin prior to or at the time of a skin graft taken from a mouse model of AA to induce AA were protected from hair loss, while mice given the antibiotic cocktail after skin grafting were not protected from hair loss.
“16S rRNA sequencing analysis of the gut microbiota revealed a significant shift in gut microbiome composition in animals treated with antibiotics and protected from hair loss, as reflected by significant changes in alpha and beta diversity,” Dr. Sezin explained. “In AA mice, we also observed differential abundance of families from the Bacteroidetes and Firmicutes phyla.” Specifically, Lactobacillus murinus and Muribaculum intestinale were overrepresented in mice with AA.
The investigators then performed 16S rRNA sequencing on 26 patients with AA, who stopped treatment for 30 days beforehand, and 9 participants who did not have AA as controls. “Though we did not observe difference in alpha and beta diversity, we see changes in the relative abundance of several families belonging to the Firmicutes phyla,” in patients with AA, Dr. Sezin said.
In another cohort of 30 patients with AA and 20 participants without AA, who stopped treatment before the study, Dr. Sezin and colleagues found “differences in the relative abundance of members of the Firmicutes and Bacteroides phyla,” including Bacteroides caccae, Prevotella copri, Syntrophomonas wolfei, Blautia wexlerae, and Eubacterium eligens, she said. “Consistent with our findings, there are previous reports in the literature showing gut dysbiosis in several other autoimmune diseases associated with differential regulation of some of the top species we have identified.”
Dr. Sezin said her group is recruiting patients for a clinical trial evaluating FMT in patients with AA. “We plan to study the association between changes in the gut microbiome and immune cell composition in AA patients undergoing FMT,” she said. “Additionally, functional studies in mice are also currently [being conducted] to further pinpoint the contribution of gut microbiome to the pathogenesis of AA.”
When asked during the discussion session if there was any relationship between the skin microbiome and AA, Dr. Sezin said there was no connection found in mice studies, which she and her colleagues are investigating further. “In the human samples, we are currently recruiting more patients and healthy controls to try to get a better understanding of whether we see differences in the skin microbiome,” she added.
Dr. Sezin explained that how the gut microbiota “is really remediated in alopecia areata” is not well understood. “We think that it is possible that we see intestinal permeability in the gut due to the gut dysbiosis that we see in alopecia areata patients, and this might lead to systemic distribution of bacteria, which might cross-react or present cross reactivity with the antigens” identified in AA, which is also being investigated, she said.
FMT not a ‘simple fix’ for AA
Leslie Castelo-Soccio, MD, PhD, a dermatologist at the Children’s Hospital of Philadelphia, who was not involved with the research, said in an interview that the findings presented by Dr. Sezin show how AA shares similarities with other autoimmune diseases. “It does highlight how important the gut microbiome is to human disease, and that differences in relative abundance of bacteria play one part as a trigger in a genetically susceptible person.”
However, while some autoimmune diseases have a big difference in alpha and beta diversity, for example, “this has not been seen in people with alopecia areata,” Dr. Castelo-Soccio pointed out. “The differences are more subtle in terms of amounts of certain bacteria,” she said, noting that, in this study, the biggest differences were seen in the studies of mice.
Dr. Castelo-Soccio also said there may be also be differences in the gut microbiome in children and adults. “The gut microbiome shifts in very early childhood from a very diverse microbiome to a more ‘adult microbiome’ around age 4, which is the age we see the first peak of many autoimmune diseases, including alopecia areata. I think microbiome work in humans needs to focus on this transition point.”
As for the clinical trial at Columbia that is evaluating FMT in patients with AA, Dr. Castelo-Soccio said she is excited. “There is much to learn about fecal transplant for all diseases and about the role of the gut microbiome and environment. Most of what we know for fecal transplant centers on its use for Clostridium difficile infections.”
Patients and their families have been asking about the potential for FMT in alopecia area, Dr. Castelo-Soccio said, but some believe it is a “simple fix” when the reality is much more complex.
“When I speak to patients and families about this, I explain that currently the ‘active ingredient’ in fecal transplants is not definitively established. In any one donor, the community of bacteria is highly variable and can be from batch to batch. While the short-term risks are relatively low – cramping, diarrhea, discomfort, mode of delivery – there are reports of transmission of infectious bacteria from donors like [Escherichia] coli, which have led to severe infections.”
Long-term safety and durability of effects are also unclear, “so we do not know if a patient receiving one [FMT] will need many in the future. We do not know how changing the microbiome could affect the transplant recipient in terms of noninfectious diseases/disorders. We are learning about the role of microbiome in obesity, insulin resistance, mood disorders. We could be ‘fixing’ one trigger of alopecia but setting up [the] patient for other noninfectious conditions,” Dr. Castelo-Soccio said.
Dr. Sezin and Dr. Castelo-Soccio reported no relevant financial disclosures.
FROM SID 2021
Increased stroke risk linked with excess sitting in those under 60
While the risk of stroke increased more than fourfold among sedentary people under the age of 60, no significant increase in risk was observed among older individuals, according to the study based on self-reported data from more than 140,000 people. This highlights the need for relevant public health messaging directed at younger people, reported lead author, Raed A. Joundi, MD, DPhil, a stroke fellow at the University of Calgary (Alta.), and colleagues, in the paper published in Stroke.
“Sedentary time has increased over the past 2 decades in the United States and Canada, particularly in the young, raising the importance of characterizing its effect on long-term health , ” the investigators wrote. “A better understanding of the risk of sedentary time specific to stroke may be important for public health campaigns to reduce sedentary behavior.” Dr. Joundi and colleagues reviewed data from the Canadian Community Health Survey, including 143,180 healthy individuals without baseline history of cancer, heart disease, or stroke. Those under the age of 40 years were also excluded from the analysis.
Excess sedentary leisure time was defined as 8 or more hours of sedentary leisure time per day, whereas low physical activity was defined as less than 3.5 metabolic equivalent hours per week. The analysis also included a range of demographic and medical covariates, such as age, sex, marital status, smoking status, presence of hypertension, and others.
After a median follow-up of 9.4 years, 2,965 stroke events occurred, with a median time from survey response of 5.6 years. Risk of stroke among individuals aged younger than 60 years who engaged in low physical activity and excess sedentary leisure time was increased 4.5-fold, compared with individuals with low physical activity who were sedentary less than 4 hours per day (fully adjusted hazard ratio, 4.50; 95% confidence interval, 1.64-12.3).
Findings highlight benefits of physical activity
Similar risk elevations were not observed among individuals aged 60-79 years, or those older than 80. And among people younger than 60, high physical activity appeared to eliminate the additional risk imposed by excess sedentary leisure time.
“Sedentary time is associated with higher risk of stroke in inactive individuals, but not an active individual, ” Dr. Joundi said in an interview. “So it suggests that there’s two ways to lower risk: One would be to lower your sedentary time, and the other would be to engage in physical activity.”
These interpretations are speculative, Dr. Joundi cautioned, as the study was not interventional. Even so, he said that the findings “bring the spotlight back on physical activity,” thereby aligning with previous research.
“The more you exercise, the more that relationship between sedentary time and poor health outcomes is blunted, and in fact, can be completely negated with enough physical activity,” he said.
How exactly physical activity offers such protection remains unclear, Dr. Joundi added. He speculated that regularity of exercise may be key, with each session counteracting the adverse effects of prolonged sedentary time, which may include reduced blood flow, increased insulin resistance, and inflammatory changes that can affect blood vessels.
“This study is particularly a message for younger individuals,” Dr. Joundi said, suggesting that the findings may alter behavior, as many people have witnessed, or are aware of, the long-term impacts of stroke.
“There’s a sort of social or cognitive aversion to stroke, I think, in the general population, because of how disabling it can be, and how it can lower your quality of life,” he said.
Subtle lifestyle changes may be enough.
For those aiming to lower their risk of stroke, Dr. Joundi suggested that subtle lifestyle changes may be enough.
“Ultimately, what we saw is that even minimal amounts of physical activity – walking 3 hours a week, for example – could blunt the impact of sedentary time,” he said. “Doing what you can, even if it’s a small amount, tends to be quite meaningful over a long period of time.”
Daniel T. Lackland, DrPH, professor of epidemiology in the department of neurology at the Medical University of South Carolina, Charleston, offered a similar takeaway, noting that small efforts can lead to great benefits.
“Less intense activity is still better than being sedentary,” he said in an interview. “For many people, if you do get up and you just walk around, move your arms around – do any kind of movement – that’s better than being sedentary.”
Dr. Lackland applauded the practicality of studying sedentary leisure time, versus overall leisure time, as many people can’t control their work environment.
“You can’t do very much about how you work your job,” Dr. Lackland said. “Sometimes we have to sit, and I guess there are things you can do – you can put a treadmill instead of a chair and that kind of thing – but more often than not, you don’t really have that choice to do something. With leisure time, though, you’re in full control. And so what do you do with your leisure time? Do you sit and watch TV, or do you engage in some type of activity? Not necessarily aerobic activity, but some type of activity that would not let you be sedentary. You want to be active as much as you possibly can.”
Dr. Joundi disclosed grant support from the Canadian Institutes of Health Research. The other investigators and Dr. Lackland reported no relevant disclosures.
While the risk of stroke increased more than fourfold among sedentary people under the age of 60, no significant increase in risk was observed among older individuals, according to the study based on self-reported data from more than 140,000 people. This highlights the need for relevant public health messaging directed at younger people, reported lead author, Raed A. Joundi, MD, DPhil, a stroke fellow at the University of Calgary (Alta.), and colleagues, in the paper published in Stroke.
“Sedentary time has increased over the past 2 decades in the United States and Canada, particularly in the young, raising the importance of characterizing its effect on long-term health , ” the investigators wrote. “A better understanding of the risk of sedentary time specific to stroke may be important for public health campaigns to reduce sedentary behavior.” Dr. Joundi and colleagues reviewed data from the Canadian Community Health Survey, including 143,180 healthy individuals without baseline history of cancer, heart disease, or stroke. Those under the age of 40 years were also excluded from the analysis.
Excess sedentary leisure time was defined as 8 or more hours of sedentary leisure time per day, whereas low physical activity was defined as less than 3.5 metabolic equivalent hours per week. The analysis also included a range of demographic and medical covariates, such as age, sex, marital status, smoking status, presence of hypertension, and others.
After a median follow-up of 9.4 years, 2,965 stroke events occurred, with a median time from survey response of 5.6 years. Risk of stroke among individuals aged younger than 60 years who engaged in low physical activity and excess sedentary leisure time was increased 4.5-fold, compared with individuals with low physical activity who were sedentary less than 4 hours per day (fully adjusted hazard ratio, 4.50; 95% confidence interval, 1.64-12.3).
Findings highlight benefits of physical activity
Similar risk elevations were not observed among individuals aged 60-79 years, or those older than 80. And among people younger than 60, high physical activity appeared to eliminate the additional risk imposed by excess sedentary leisure time.
“Sedentary time is associated with higher risk of stroke in inactive individuals, but not an active individual, ” Dr. Joundi said in an interview. “So it suggests that there’s two ways to lower risk: One would be to lower your sedentary time, and the other would be to engage in physical activity.”
These interpretations are speculative, Dr. Joundi cautioned, as the study was not interventional. Even so, he said that the findings “bring the spotlight back on physical activity,” thereby aligning with previous research.
“The more you exercise, the more that relationship between sedentary time and poor health outcomes is blunted, and in fact, can be completely negated with enough physical activity,” he said.
How exactly physical activity offers such protection remains unclear, Dr. Joundi added. He speculated that regularity of exercise may be key, with each session counteracting the adverse effects of prolonged sedentary time, which may include reduced blood flow, increased insulin resistance, and inflammatory changes that can affect blood vessels.
“This study is particularly a message for younger individuals,” Dr. Joundi said, suggesting that the findings may alter behavior, as many people have witnessed, or are aware of, the long-term impacts of stroke.
“There’s a sort of social or cognitive aversion to stroke, I think, in the general population, because of how disabling it can be, and how it can lower your quality of life,” he said.
Subtle lifestyle changes may be enough.
For those aiming to lower their risk of stroke, Dr. Joundi suggested that subtle lifestyle changes may be enough.
“Ultimately, what we saw is that even minimal amounts of physical activity – walking 3 hours a week, for example – could blunt the impact of sedentary time,” he said. “Doing what you can, even if it’s a small amount, tends to be quite meaningful over a long period of time.”
Daniel T. Lackland, DrPH, professor of epidemiology in the department of neurology at the Medical University of South Carolina, Charleston, offered a similar takeaway, noting that small efforts can lead to great benefits.
“Less intense activity is still better than being sedentary,” he said in an interview. “For many people, if you do get up and you just walk around, move your arms around – do any kind of movement – that’s better than being sedentary.”
Dr. Lackland applauded the practicality of studying sedentary leisure time, versus overall leisure time, as many people can’t control their work environment.
“You can’t do very much about how you work your job,” Dr. Lackland said. “Sometimes we have to sit, and I guess there are things you can do – you can put a treadmill instead of a chair and that kind of thing – but more often than not, you don’t really have that choice to do something. With leisure time, though, you’re in full control. And so what do you do with your leisure time? Do you sit and watch TV, or do you engage in some type of activity? Not necessarily aerobic activity, but some type of activity that would not let you be sedentary. You want to be active as much as you possibly can.”
Dr. Joundi disclosed grant support from the Canadian Institutes of Health Research. The other investigators and Dr. Lackland reported no relevant disclosures.
While the risk of stroke increased more than fourfold among sedentary people under the age of 60, no significant increase in risk was observed among older individuals, according to the study based on self-reported data from more than 140,000 people. This highlights the need for relevant public health messaging directed at younger people, reported lead author, Raed A. Joundi, MD, DPhil, a stroke fellow at the University of Calgary (Alta.), and colleagues, in the paper published in Stroke.
“Sedentary time has increased over the past 2 decades in the United States and Canada, particularly in the young, raising the importance of characterizing its effect on long-term health , ” the investigators wrote. “A better understanding of the risk of sedentary time specific to stroke may be important for public health campaigns to reduce sedentary behavior.” Dr. Joundi and colleagues reviewed data from the Canadian Community Health Survey, including 143,180 healthy individuals without baseline history of cancer, heart disease, or stroke. Those under the age of 40 years were also excluded from the analysis.
Excess sedentary leisure time was defined as 8 or more hours of sedentary leisure time per day, whereas low physical activity was defined as less than 3.5 metabolic equivalent hours per week. The analysis also included a range of demographic and medical covariates, such as age, sex, marital status, smoking status, presence of hypertension, and others.
After a median follow-up of 9.4 years, 2,965 stroke events occurred, with a median time from survey response of 5.6 years. Risk of stroke among individuals aged younger than 60 years who engaged in low physical activity and excess sedentary leisure time was increased 4.5-fold, compared with individuals with low physical activity who were sedentary less than 4 hours per day (fully adjusted hazard ratio, 4.50; 95% confidence interval, 1.64-12.3).
Findings highlight benefits of physical activity
Similar risk elevations were not observed among individuals aged 60-79 years, or those older than 80. And among people younger than 60, high physical activity appeared to eliminate the additional risk imposed by excess sedentary leisure time.
“Sedentary time is associated with higher risk of stroke in inactive individuals, but not an active individual, ” Dr. Joundi said in an interview. “So it suggests that there’s two ways to lower risk: One would be to lower your sedentary time, and the other would be to engage in physical activity.”
These interpretations are speculative, Dr. Joundi cautioned, as the study was not interventional. Even so, he said that the findings “bring the spotlight back on physical activity,” thereby aligning with previous research.
“The more you exercise, the more that relationship between sedentary time and poor health outcomes is blunted, and in fact, can be completely negated with enough physical activity,” he said.
How exactly physical activity offers such protection remains unclear, Dr. Joundi added. He speculated that regularity of exercise may be key, with each session counteracting the adverse effects of prolonged sedentary time, which may include reduced blood flow, increased insulin resistance, and inflammatory changes that can affect blood vessels.
“This study is particularly a message for younger individuals,” Dr. Joundi said, suggesting that the findings may alter behavior, as many people have witnessed, or are aware of, the long-term impacts of stroke.
“There’s a sort of social or cognitive aversion to stroke, I think, in the general population, because of how disabling it can be, and how it can lower your quality of life,” he said.
Subtle lifestyle changes may be enough.
For those aiming to lower their risk of stroke, Dr. Joundi suggested that subtle lifestyle changes may be enough.
“Ultimately, what we saw is that even minimal amounts of physical activity – walking 3 hours a week, for example – could blunt the impact of sedentary time,” he said. “Doing what you can, even if it’s a small amount, tends to be quite meaningful over a long period of time.”
Daniel T. Lackland, DrPH, professor of epidemiology in the department of neurology at the Medical University of South Carolina, Charleston, offered a similar takeaway, noting that small efforts can lead to great benefits.
“Less intense activity is still better than being sedentary,” he said in an interview. “For many people, if you do get up and you just walk around, move your arms around – do any kind of movement – that’s better than being sedentary.”
Dr. Lackland applauded the practicality of studying sedentary leisure time, versus overall leisure time, as many people can’t control their work environment.
“You can’t do very much about how you work your job,” Dr. Lackland said. “Sometimes we have to sit, and I guess there are things you can do – you can put a treadmill instead of a chair and that kind of thing – but more often than not, you don’t really have that choice to do something. With leisure time, though, you’re in full control. And so what do you do with your leisure time? Do you sit and watch TV, or do you engage in some type of activity? Not necessarily aerobic activity, but some type of activity that would not let you be sedentary. You want to be active as much as you possibly can.”
Dr. Joundi disclosed grant support from the Canadian Institutes of Health Research. The other investigators and Dr. Lackland reported no relevant disclosures.
FROM STROKE
FDA OKs stimulation device for anxiety in depression
The U.S. Food and Drug Administration has expanded the indication for the noninvasive BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) System to include treatment of comorbid anxiety symptoms in adult patients with depression, the company has announced.
As reported by this news organization, the neurostimulation system has previously received FDA approval for treatment-resistant major depression, obsessive-compulsive disorder, and smoking addiction.
In the August 18 announcement, BrainsWay reported that it has also received 510(k) clearance from the FDA to market its TMS system for the reduction of anxious depression symptoms.
“This clearance is confirmation of what many have believed anecdotally for years – that Deep TMS is a unique form of therapy that can address comorbid anxiety symptoms using the same depression treatment protocol,” Aron Tendler, MD, chief medical officer at BrainsWay, said in a press release.
‘Consistent, robust’ effect
, which included both randomized controlled trials and open-label studies.
“The data demonstrated a treatment effect that was consistent, robust, and clinically meaningful for decreasing anxiety symptoms in adult patients suffering from major depressive disorder [MDD],” the company said in its release.
Data from three of the randomized trials showed an effect size of 0.3 when compared with a sham device and an effect size of 0.9 when compared with medication. The overall, weighted, pooled effect size was 0.55.
The company noted that in more than 70 published studies with about 16,000 total participants, effect sizes have ranged from 0.2-0.37 for drug-based anxiety treatments.
“The expanded FDA labeling now allows BrainsWay to market its Deep TMS System for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from [MDD] and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode,” the company said.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has expanded the indication for the noninvasive BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) System to include treatment of comorbid anxiety symptoms in adult patients with depression, the company has announced.
As reported by this news organization, the neurostimulation system has previously received FDA approval for treatment-resistant major depression, obsessive-compulsive disorder, and smoking addiction.
In the August 18 announcement, BrainsWay reported that it has also received 510(k) clearance from the FDA to market its TMS system for the reduction of anxious depression symptoms.
“This clearance is confirmation of what many have believed anecdotally for years – that Deep TMS is a unique form of therapy that can address comorbid anxiety symptoms using the same depression treatment protocol,” Aron Tendler, MD, chief medical officer at BrainsWay, said in a press release.
‘Consistent, robust’ effect
, which included both randomized controlled trials and open-label studies.
“The data demonstrated a treatment effect that was consistent, robust, and clinically meaningful for decreasing anxiety symptoms in adult patients suffering from major depressive disorder [MDD],” the company said in its release.
Data from three of the randomized trials showed an effect size of 0.3 when compared with a sham device and an effect size of 0.9 when compared with medication. The overall, weighted, pooled effect size was 0.55.
The company noted that in more than 70 published studies with about 16,000 total participants, effect sizes have ranged from 0.2-0.37 for drug-based anxiety treatments.
“The expanded FDA labeling now allows BrainsWay to market its Deep TMS System for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from [MDD] and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode,” the company said.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has expanded the indication for the noninvasive BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) System to include treatment of comorbid anxiety symptoms in adult patients with depression, the company has announced.
As reported by this news organization, the neurostimulation system has previously received FDA approval for treatment-resistant major depression, obsessive-compulsive disorder, and smoking addiction.
In the August 18 announcement, BrainsWay reported that it has also received 510(k) clearance from the FDA to market its TMS system for the reduction of anxious depression symptoms.
“This clearance is confirmation of what many have believed anecdotally for years – that Deep TMS is a unique form of therapy that can address comorbid anxiety symptoms using the same depression treatment protocol,” Aron Tendler, MD, chief medical officer at BrainsWay, said in a press release.
‘Consistent, robust’ effect
, which included both randomized controlled trials and open-label studies.
“The data demonstrated a treatment effect that was consistent, robust, and clinically meaningful for decreasing anxiety symptoms in adult patients suffering from major depressive disorder [MDD],” the company said in its release.
Data from three of the randomized trials showed an effect size of 0.3 when compared with a sham device and an effect size of 0.9 when compared with medication. The overall, weighted, pooled effect size was 0.55.
The company noted that in more than 70 published studies with about 16,000 total participants, effect sizes have ranged from 0.2-0.37 for drug-based anxiety treatments.
“The expanded FDA labeling now allows BrainsWay to market its Deep TMS System for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from [MDD] and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode,” the company said.
A version of this article first appeared on Medscape.com.
COVID-19 booster shots to start in September: Officials
at a press briefing August 18.
Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.
“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”
The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.
“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”
Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.
At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.
“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
Data driving the plan
CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.
Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.
Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.
Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
Immunologic facts
Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.
“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”
A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
Booster details
“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.
The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
Big picture
Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”
Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”
Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”
A version of this article first appeared on WebMD.com.
at a press briefing August 18.
Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.
“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”
The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.
“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”
Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.
At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.
“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
Data driving the plan
CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.
Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.
Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.
Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
Immunologic facts
Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.
“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”
A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
Booster details
“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.
The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
Big picture
Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”
Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”
Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”
A version of this article first appeared on WebMD.com.
at a press briefing August 18.
Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.
“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”
The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.
“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”
Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.
At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.
“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
Data driving the plan
CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.
Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.
Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.
Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
Immunologic facts
Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.
“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”
A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
Booster details
“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.
The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
Big picture
Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”
Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”
Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”
A version of this article first appeared on WebMD.com.