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My patient is having an affair and has an STI. I’m treating both partners. What would you do?
A psychiatrist was treating a couple individually, one of whom was HIV-positive. During a session, the infected partner revealed he was having sex with other men outside the relationship and not using safe sex practices.
“He was being treated for major depression and anxiety at the time,” explained the anonymous psychiatrist. “I strongly encouraged him to tell his partner, but he was scared of doing so. He stated that they had not been using safe sex practices between the two of them, but he was willing to start at that point.”
At a session with the HIV-negative partner, the psychiatrist inquired about the couple’s current sex practices. The HIV-negative partner reported no changes and said the two continued to have sex without condoms, said the psychiatrist, who shared the experience in Medscape’s Ethics 2020 Survey open-ended questions.
“My dilemma now was whether or not to inform him about his partner’s ‘extracurricular sex behavior,’ the psychiatrist said. “Since he was now at greater risk of contracting HIV, I felt compelled to do something to intervene.”
What would you do in this situation?
according to responses from the Ethics 2020 Report. When asked to share their toughest ethical dilemma, one internist for example, wrote, “I have couples as patients, and it is very challenging if they reveal infidelity or separate/divorce; I cannot reveal info to the spouse, but it makes me very uncomfortable caring for both.” Similarly, an obstetrician-gynecologist wrote about her experience counseling patients who reveal extramarital affairs.
“Women confide deeply with their gynecologist, and although I was not successful in rescuing 100% of them, the majority accepted my counseling and saved their marriages,” the anonymous ob/gyn wrote. “In every case in which my patient was willing to resume her marital relationship, I always ensured that she advised her spouse of the infidelity, and the couple was referred to a qualified provider for marriage counseling.”
When a sexually transmitted infection (STI) comes into play however, physicians describe a deeper level of internal conflict. A family physician wrote her top ethical dilemma was “Cheating spouses and STIs: how do you get the other spouse treated?” An ob-gyn stated that, “disclosure of STI status in couples when this may indicate infidelity,” was a frequent ethical issue in her specialty. Commenters on Medscape’s recent story, “The Secret I’ll Take to my Grave: Doc Reveals,” also raised the uncomfortable topic. One physician recalled a deaf female patient who requested in writing not to test for syphilis and not to discuss the issue with her husband. “Patient knew that she had syphilis, but she did not want her husband to know,” the physician wrote.
It’s not uncommon for physicians to encounter such scenarios when treating long-term couples, especially in the digital era, said Shannon Dowler, MD, chief medical officer for North Carolina Medicaid and a family physician at the Buncombe County STI Clinic.
“This is definitely something I think we see more of in our age of ‘hookup apps’ and easier access to casual sexual connections than we did before,” said Dr. Dowler, who serves on the CDC Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment.
The topic is particularly timely because of the pandemic’s impact on STI testing and the expected rise in sexually transmitted infection rates over the next year, Dr. Dowler notes.
“People weren’t necessarily coming in for routine screening or testing during the pandemic because they didn’t want to take a chance on being exposed to COVID,” she said. “But also, the reagent used for testing for certain types of transmitted infections was in short supply because they use that same reagent for the COVID test. We had shortages of STI testing in many parts of the country. I expect what we’re going to see over the next year are a lot of diagnoses that were missed during the pandemic and a lot of asymptomatic spread.”
What do the experts suggest?
Caring for spouses or two partners when an STI is discovered can be challenging for physicians, particularly in small towns where many people know each other, said Kenneth Goodman, PhD, founder and director of the Institute for Bioethics and Health Policy at the University of Miami.
“This can be a real challenge for family physicians and others in a small town,” he said. “If you discover one partner is positive for a sexually transmitted infection and the other is negative, then you’ve got a challenge to manage. The way to do that is to start with moral persuasion, namely you tell your patient, ‘You really need to disclose this. Because when he or she gets it, chances are, you’re going to be the prime suspect.’ “
Dr. Dowler, who practices in an STI clinic, said she once diagnosed a sexually transmitted infection in a patient who was married to one of Dowler’s coworkers. The patient would not allow the partner to be notified, she said. In this case, Dr. Dowler practiced expedited partner therapy (EPT), the clinical practice of treating sex partners of patients diagnosed with chlamydia or gonorrhea by giving the patient prescriptions or medications to take to the partner without having first examined the partner. The practice is legal to some extent in all states, Dr. Dowler said, but some states have different rules about how the practice can be utilized.
Physicians are obligated to report communicable diseases to their local health department, Dr. Goodman said. The health department would then do contract tracing and be responsible for conveying the STI diagnosis to any relevant parties. Even so, Dr. Goodman said physicians have a moral obligation to strongly encourage patients to divulge the infection to their partner.
“Doctors should work on being persuasive to change behavior,” he said. “Tell your patients to do the right thing and follow up with them. You should tell patients they have a responsibility to disclose a sexually transmitted infection to any of their partners and a responsibility not to have unprotected sex. Doctors can be very powerful advocates for that.”
Dr. Dowler said if she is treating two partners, and one is diagnosed with a sexually transmitted infection, she generally asks the patient for their consent to disclose the diagnosis to the partner. She ensures a witness, usually a nurse, is present when she asks. If consent is refused, Dr. Dowler guides her treatment to be as protective as possible, she said. A helpful resource for patients is Tellyourpartner.org, a website that sends an anonymous text or email about infection exposure and provides guidance on treatment locations and options.
Of course, if the sexually transmitted infection is HIV, another set of rules apply. As of 2021, 35 states have laws that criminalize HIV exposure. Laws vary, but many hold patients criminally liable if they knowingly expose another party to HIV. Many states and some cities also have ‘partner notification’ laws that require health providers to disclose an HIV diagnosis to the patient’s sex partners or to report the names of sex partners to the health department, if known.
However, case law on a physician’s duty to warn is mixed, and doctors’ responsibility for STI reporting and partner notification is determined by individual states. Making matters more complex is the fact that some states have recently changed their HIV control requirements, Dr. Dowler said. In North Carolina for example, patients living with HIV who have been virally suppressed for 6 months and who are adherent to medications, are no longer in violation of the control measure if they do not disclose their HIV diagnosis to sex partners or if they don’t wear a condom.
“This means physicians would not have to report a virally suppressed, adequately treated HIV-positive patient who is having unprotected sex or take measures to inform any known sex partners of the diagnosis,” she said. “The landscape is constantly changing so physicians have to be vigilant about their state public health statutes. It’s a tricky area. It takes an already complicated topic and makes it just a little more complicated.”
Consider drafting a policy
It’s a good idea to have a policy in place at your practice that addresses such ethical dilemmas before they occur, says Michael Heitt, PsyD, a clinical psychologist on the faculty of Loyola University Maryland in Baltimore, and a member of the Maryland Psychological Association’s Ethics Committee. Dr. Heitt developed a model of ethical reasoning called CLEAR Lenses, which stands for Clinical, Legal, Ethical, Administrative, and Risk management. The approach encourages clinicians to identify often competing factors in the decision-making process before choosing a course of action to take.
In the situation of an unfaithful spouse who contracted an STI for example, the physician should consider clinical issues such as the medical likelihood the unaware partner has the STI, and legal issues such as maintaining the confidentiality of all patient information and possible mandated reporting of STI data, Dr. Heitt said. The lenses overlap since confidentiality is also a key ethical issue, and other ethical issues involve the balance of helping the unaware spouse and not harming the infected spouse, he explained. Administrative issues might include how medical records are maintained and whether the physician documents information about patients’ family members in the medical record, while risk management elements may include informed consent, documentation, and consultation.
“So, if the physician has a policy about how such matters are dealt with, and patients are informed about this when they come to the practice, this can guide the physician much more easily through this sticky situation,” Dr. Heitt said. “Documentation of the decision-making process in the medical record demonstrates the physician’s thought process should it ever be challenged in the future, and consultation with peers (while disguising the identity of the patients, of course) sets a foundation of what a ‘reasonable standard’ might be in such situations.”
There is also the conflict-avoidant approach, Dr. Heitt said, in which the physician could perform “routine” STI testing if the unaware spouse was due for an appointment soon.
“But of course, this is far from avoiding any conflict; it just kicks the can down the road as there will surely be conflict — and plenty of confusion — if the wife tests positive for an STI,” he said. “In most situations, it is usually best to be brave, do the hard work upfront, and deal with the tough situation then, rather than trying to avoid the probable inevitable difficult conversation.”
As for the psychiatrist who was treating the cheating HIV-positive partner, the physician ultimately convinced both patients to come in for a couple’s session. The doctor allowed for a 2-hour timeframe to encourage discussion of any conflicts and unresolved issues, the psychiatrist said. After several more couple’s sessions, it was apparent the HIV-positive partner wanted out of the relationship, according to the psychiatrist’s account. The physician referred them to a couples’ therapist for ongoing treatment.
“During that same session, the HIV positive partner disclosed his recent behaviors and, as a result, they decided not to have further sexual contact until they could explore this further in therapy,” the psychiatrist wrote. “At last communication the couple decided to end the relationship, and the HIV negative partner remained negative.”
A version of this article first appeared on Medscape.com.
A psychiatrist was treating a couple individually, one of whom was HIV-positive. During a session, the infected partner revealed he was having sex with other men outside the relationship and not using safe sex practices.
“He was being treated for major depression and anxiety at the time,” explained the anonymous psychiatrist. “I strongly encouraged him to tell his partner, but he was scared of doing so. He stated that they had not been using safe sex practices between the two of them, but he was willing to start at that point.”
At a session with the HIV-negative partner, the psychiatrist inquired about the couple’s current sex practices. The HIV-negative partner reported no changes and said the two continued to have sex without condoms, said the psychiatrist, who shared the experience in Medscape’s Ethics 2020 Survey open-ended questions.
“My dilemma now was whether or not to inform him about his partner’s ‘extracurricular sex behavior,’ the psychiatrist said. “Since he was now at greater risk of contracting HIV, I felt compelled to do something to intervene.”
What would you do in this situation?
according to responses from the Ethics 2020 Report. When asked to share their toughest ethical dilemma, one internist for example, wrote, “I have couples as patients, and it is very challenging if they reveal infidelity or separate/divorce; I cannot reveal info to the spouse, but it makes me very uncomfortable caring for both.” Similarly, an obstetrician-gynecologist wrote about her experience counseling patients who reveal extramarital affairs.
“Women confide deeply with their gynecologist, and although I was not successful in rescuing 100% of them, the majority accepted my counseling and saved their marriages,” the anonymous ob/gyn wrote. “In every case in which my patient was willing to resume her marital relationship, I always ensured that she advised her spouse of the infidelity, and the couple was referred to a qualified provider for marriage counseling.”
When a sexually transmitted infection (STI) comes into play however, physicians describe a deeper level of internal conflict. A family physician wrote her top ethical dilemma was “Cheating spouses and STIs: how do you get the other spouse treated?” An ob-gyn stated that, “disclosure of STI status in couples when this may indicate infidelity,” was a frequent ethical issue in her specialty. Commenters on Medscape’s recent story, “The Secret I’ll Take to my Grave: Doc Reveals,” also raised the uncomfortable topic. One physician recalled a deaf female patient who requested in writing not to test for syphilis and not to discuss the issue with her husband. “Patient knew that she had syphilis, but she did not want her husband to know,” the physician wrote.
It’s not uncommon for physicians to encounter such scenarios when treating long-term couples, especially in the digital era, said Shannon Dowler, MD, chief medical officer for North Carolina Medicaid and a family physician at the Buncombe County STI Clinic.
“This is definitely something I think we see more of in our age of ‘hookup apps’ and easier access to casual sexual connections than we did before,” said Dr. Dowler, who serves on the CDC Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment.
The topic is particularly timely because of the pandemic’s impact on STI testing and the expected rise in sexually transmitted infection rates over the next year, Dr. Dowler notes.
“People weren’t necessarily coming in for routine screening or testing during the pandemic because they didn’t want to take a chance on being exposed to COVID,” she said. “But also, the reagent used for testing for certain types of transmitted infections was in short supply because they use that same reagent for the COVID test. We had shortages of STI testing in many parts of the country. I expect what we’re going to see over the next year are a lot of diagnoses that were missed during the pandemic and a lot of asymptomatic spread.”
What do the experts suggest?
Caring for spouses or two partners when an STI is discovered can be challenging for physicians, particularly in small towns where many people know each other, said Kenneth Goodman, PhD, founder and director of the Institute for Bioethics and Health Policy at the University of Miami.
“This can be a real challenge for family physicians and others in a small town,” he said. “If you discover one partner is positive for a sexually transmitted infection and the other is negative, then you’ve got a challenge to manage. The way to do that is to start with moral persuasion, namely you tell your patient, ‘You really need to disclose this. Because when he or she gets it, chances are, you’re going to be the prime suspect.’ “
Dr. Dowler, who practices in an STI clinic, said she once diagnosed a sexually transmitted infection in a patient who was married to one of Dowler’s coworkers. The patient would not allow the partner to be notified, she said. In this case, Dr. Dowler practiced expedited partner therapy (EPT), the clinical practice of treating sex partners of patients diagnosed with chlamydia or gonorrhea by giving the patient prescriptions or medications to take to the partner without having first examined the partner. The practice is legal to some extent in all states, Dr. Dowler said, but some states have different rules about how the practice can be utilized.
Physicians are obligated to report communicable diseases to their local health department, Dr. Goodman said. The health department would then do contract tracing and be responsible for conveying the STI diagnosis to any relevant parties. Even so, Dr. Goodman said physicians have a moral obligation to strongly encourage patients to divulge the infection to their partner.
“Doctors should work on being persuasive to change behavior,” he said. “Tell your patients to do the right thing and follow up with them. You should tell patients they have a responsibility to disclose a sexually transmitted infection to any of their partners and a responsibility not to have unprotected sex. Doctors can be very powerful advocates for that.”
Dr. Dowler said if she is treating two partners, and one is diagnosed with a sexually transmitted infection, she generally asks the patient for their consent to disclose the diagnosis to the partner. She ensures a witness, usually a nurse, is present when she asks. If consent is refused, Dr. Dowler guides her treatment to be as protective as possible, she said. A helpful resource for patients is Tellyourpartner.org, a website that sends an anonymous text or email about infection exposure and provides guidance on treatment locations and options.
Of course, if the sexually transmitted infection is HIV, another set of rules apply. As of 2021, 35 states have laws that criminalize HIV exposure. Laws vary, but many hold patients criminally liable if they knowingly expose another party to HIV. Many states and some cities also have ‘partner notification’ laws that require health providers to disclose an HIV diagnosis to the patient’s sex partners or to report the names of sex partners to the health department, if known.
However, case law on a physician’s duty to warn is mixed, and doctors’ responsibility for STI reporting and partner notification is determined by individual states. Making matters more complex is the fact that some states have recently changed their HIV control requirements, Dr. Dowler said. In North Carolina for example, patients living with HIV who have been virally suppressed for 6 months and who are adherent to medications, are no longer in violation of the control measure if they do not disclose their HIV diagnosis to sex partners or if they don’t wear a condom.
“This means physicians would not have to report a virally suppressed, adequately treated HIV-positive patient who is having unprotected sex or take measures to inform any known sex partners of the diagnosis,” she said. “The landscape is constantly changing so physicians have to be vigilant about their state public health statutes. It’s a tricky area. It takes an already complicated topic and makes it just a little more complicated.”
Consider drafting a policy
It’s a good idea to have a policy in place at your practice that addresses such ethical dilemmas before they occur, says Michael Heitt, PsyD, a clinical psychologist on the faculty of Loyola University Maryland in Baltimore, and a member of the Maryland Psychological Association’s Ethics Committee. Dr. Heitt developed a model of ethical reasoning called CLEAR Lenses, which stands for Clinical, Legal, Ethical, Administrative, and Risk management. The approach encourages clinicians to identify often competing factors in the decision-making process before choosing a course of action to take.
In the situation of an unfaithful spouse who contracted an STI for example, the physician should consider clinical issues such as the medical likelihood the unaware partner has the STI, and legal issues such as maintaining the confidentiality of all patient information and possible mandated reporting of STI data, Dr. Heitt said. The lenses overlap since confidentiality is also a key ethical issue, and other ethical issues involve the balance of helping the unaware spouse and not harming the infected spouse, he explained. Administrative issues might include how medical records are maintained and whether the physician documents information about patients’ family members in the medical record, while risk management elements may include informed consent, documentation, and consultation.
“So, if the physician has a policy about how such matters are dealt with, and patients are informed about this when they come to the practice, this can guide the physician much more easily through this sticky situation,” Dr. Heitt said. “Documentation of the decision-making process in the medical record demonstrates the physician’s thought process should it ever be challenged in the future, and consultation with peers (while disguising the identity of the patients, of course) sets a foundation of what a ‘reasonable standard’ might be in such situations.”
There is also the conflict-avoidant approach, Dr. Heitt said, in which the physician could perform “routine” STI testing if the unaware spouse was due for an appointment soon.
“But of course, this is far from avoiding any conflict; it just kicks the can down the road as there will surely be conflict — and plenty of confusion — if the wife tests positive for an STI,” he said. “In most situations, it is usually best to be brave, do the hard work upfront, and deal with the tough situation then, rather than trying to avoid the probable inevitable difficult conversation.”
As for the psychiatrist who was treating the cheating HIV-positive partner, the physician ultimately convinced both patients to come in for a couple’s session. The doctor allowed for a 2-hour timeframe to encourage discussion of any conflicts and unresolved issues, the psychiatrist said. After several more couple’s sessions, it was apparent the HIV-positive partner wanted out of the relationship, according to the psychiatrist’s account. The physician referred them to a couples’ therapist for ongoing treatment.
“During that same session, the HIV positive partner disclosed his recent behaviors and, as a result, they decided not to have further sexual contact until they could explore this further in therapy,” the psychiatrist wrote. “At last communication the couple decided to end the relationship, and the HIV negative partner remained negative.”
A version of this article first appeared on Medscape.com.
A psychiatrist was treating a couple individually, one of whom was HIV-positive. During a session, the infected partner revealed he was having sex with other men outside the relationship and not using safe sex practices.
“He was being treated for major depression and anxiety at the time,” explained the anonymous psychiatrist. “I strongly encouraged him to tell his partner, but he was scared of doing so. He stated that they had not been using safe sex practices between the two of them, but he was willing to start at that point.”
At a session with the HIV-negative partner, the psychiatrist inquired about the couple’s current sex practices. The HIV-negative partner reported no changes and said the two continued to have sex without condoms, said the psychiatrist, who shared the experience in Medscape’s Ethics 2020 Survey open-ended questions.
“My dilemma now was whether or not to inform him about his partner’s ‘extracurricular sex behavior,’ the psychiatrist said. “Since he was now at greater risk of contracting HIV, I felt compelled to do something to intervene.”
What would you do in this situation?
according to responses from the Ethics 2020 Report. When asked to share their toughest ethical dilemma, one internist for example, wrote, “I have couples as patients, and it is very challenging if they reveal infidelity or separate/divorce; I cannot reveal info to the spouse, but it makes me very uncomfortable caring for both.” Similarly, an obstetrician-gynecologist wrote about her experience counseling patients who reveal extramarital affairs.
“Women confide deeply with their gynecologist, and although I was not successful in rescuing 100% of them, the majority accepted my counseling and saved their marriages,” the anonymous ob/gyn wrote. “In every case in which my patient was willing to resume her marital relationship, I always ensured that she advised her spouse of the infidelity, and the couple was referred to a qualified provider for marriage counseling.”
When a sexually transmitted infection (STI) comes into play however, physicians describe a deeper level of internal conflict. A family physician wrote her top ethical dilemma was “Cheating spouses and STIs: how do you get the other spouse treated?” An ob-gyn stated that, “disclosure of STI status in couples when this may indicate infidelity,” was a frequent ethical issue in her specialty. Commenters on Medscape’s recent story, “The Secret I’ll Take to my Grave: Doc Reveals,” also raised the uncomfortable topic. One physician recalled a deaf female patient who requested in writing not to test for syphilis and not to discuss the issue with her husband. “Patient knew that she had syphilis, but she did not want her husband to know,” the physician wrote.
It’s not uncommon for physicians to encounter such scenarios when treating long-term couples, especially in the digital era, said Shannon Dowler, MD, chief medical officer for North Carolina Medicaid and a family physician at the Buncombe County STI Clinic.
“This is definitely something I think we see more of in our age of ‘hookup apps’ and easier access to casual sexual connections than we did before,” said Dr. Dowler, who serves on the CDC Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment.
The topic is particularly timely because of the pandemic’s impact on STI testing and the expected rise in sexually transmitted infection rates over the next year, Dr. Dowler notes.
“People weren’t necessarily coming in for routine screening or testing during the pandemic because they didn’t want to take a chance on being exposed to COVID,” she said. “But also, the reagent used for testing for certain types of transmitted infections was in short supply because they use that same reagent for the COVID test. We had shortages of STI testing in many parts of the country. I expect what we’re going to see over the next year are a lot of diagnoses that were missed during the pandemic and a lot of asymptomatic spread.”
What do the experts suggest?
Caring for spouses or two partners when an STI is discovered can be challenging for physicians, particularly in small towns where many people know each other, said Kenneth Goodman, PhD, founder and director of the Institute for Bioethics and Health Policy at the University of Miami.
“This can be a real challenge for family physicians and others in a small town,” he said. “If you discover one partner is positive for a sexually transmitted infection and the other is negative, then you’ve got a challenge to manage. The way to do that is to start with moral persuasion, namely you tell your patient, ‘You really need to disclose this. Because when he or she gets it, chances are, you’re going to be the prime suspect.’ “
Dr. Dowler, who practices in an STI clinic, said she once diagnosed a sexually transmitted infection in a patient who was married to one of Dowler’s coworkers. The patient would not allow the partner to be notified, she said. In this case, Dr. Dowler practiced expedited partner therapy (EPT), the clinical practice of treating sex partners of patients diagnosed with chlamydia or gonorrhea by giving the patient prescriptions or medications to take to the partner without having first examined the partner. The practice is legal to some extent in all states, Dr. Dowler said, but some states have different rules about how the practice can be utilized.
Physicians are obligated to report communicable diseases to their local health department, Dr. Goodman said. The health department would then do contract tracing and be responsible for conveying the STI diagnosis to any relevant parties. Even so, Dr. Goodman said physicians have a moral obligation to strongly encourage patients to divulge the infection to their partner.
“Doctors should work on being persuasive to change behavior,” he said. “Tell your patients to do the right thing and follow up with them. You should tell patients they have a responsibility to disclose a sexually transmitted infection to any of their partners and a responsibility not to have unprotected sex. Doctors can be very powerful advocates for that.”
Dr. Dowler said if she is treating two partners, and one is diagnosed with a sexually transmitted infection, she generally asks the patient for their consent to disclose the diagnosis to the partner. She ensures a witness, usually a nurse, is present when she asks. If consent is refused, Dr. Dowler guides her treatment to be as protective as possible, she said. A helpful resource for patients is Tellyourpartner.org, a website that sends an anonymous text or email about infection exposure and provides guidance on treatment locations and options.
Of course, if the sexually transmitted infection is HIV, another set of rules apply. As of 2021, 35 states have laws that criminalize HIV exposure. Laws vary, but many hold patients criminally liable if they knowingly expose another party to HIV. Many states and some cities also have ‘partner notification’ laws that require health providers to disclose an HIV diagnosis to the patient’s sex partners or to report the names of sex partners to the health department, if known.
However, case law on a physician’s duty to warn is mixed, and doctors’ responsibility for STI reporting and partner notification is determined by individual states. Making matters more complex is the fact that some states have recently changed their HIV control requirements, Dr. Dowler said. In North Carolina for example, patients living with HIV who have been virally suppressed for 6 months and who are adherent to medications, are no longer in violation of the control measure if they do not disclose their HIV diagnosis to sex partners or if they don’t wear a condom.
“This means physicians would not have to report a virally suppressed, adequately treated HIV-positive patient who is having unprotected sex or take measures to inform any known sex partners of the diagnosis,” she said. “The landscape is constantly changing so physicians have to be vigilant about their state public health statutes. It’s a tricky area. It takes an already complicated topic and makes it just a little more complicated.”
Consider drafting a policy
It’s a good idea to have a policy in place at your practice that addresses such ethical dilemmas before they occur, says Michael Heitt, PsyD, a clinical psychologist on the faculty of Loyola University Maryland in Baltimore, and a member of the Maryland Psychological Association’s Ethics Committee. Dr. Heitt developed a model of ethical reasoning called CLEAR Lenses, which stands for Clinical, Legal, Ethical, Administrative, and Risk management. The approach encourages clinicians to identify often competing factors in the decision-making process before choosing a course of action to take.
In the situation of an unfaithful spouse who contracted an STI for example, the physician should consider clinical issues such as the medical likelihood the unaware partner has the STI, and legal issues such as maintaining the confidentiality of all patient information and possible mandated reporting of STI data, Dr. Heitt said. The lenses overlap since confidentiality is also a key ethical issue, and other ethical issues involve the balance of helping the unaware spouse and not harming the infected spouse, he explained. Administrative issues might include how medical records are maintained and whether the physician documents information about patients’ family members in the medical record, while risk management elements may include informed consent, documentation, and consultation.
“So, if the physician has a policy about how such matters are dealt with, and patients are informed about this when they come to the practice, this can guide the physician much more easily through this sticky situation,” Dr. Heitt said. “Documentation of the decision-making process in the medical record demonstrates the physician’s thought process should it ever be challenged in the future, and consultation with peers (while disguising the identity of the patients, of course) sets a foundation of what a ‘reasonable standard’ might be in such situations.”
There is also the conflict-avoidant approach, Dr. Heitt said, in which the physician could perform “routine” STI testing if the unaware spouse was due for an appointment soon.
“But of course, this is far from avoiding any conflict; it just kicks the can down the road as there will surely be conflict — and plenty of confusion — if the wife tests positive for an STI,” he said. “In most situations, it is usually best to be brave, do the hard work upfront, and deal with the tough situation then, rather than trying to avoid the probable inevitable difficult conversation.”
As for the psychiatrist who was treating the cheating HIV-positive partner, the physician ultimately convinced both patients to come in for a couple’s session. The doctor allowed for a 2-hour timeframe to encourage discussion of any conflicts and unresolved issues, the psychiatrist said. After several more couple’s sessions, it was apparent the HIV-positive partner wanted out of the relationship, according to the psychiatrist’s account. The physician referred them to a couples’ therapist for ongoing treatment.
“During that same session, the HIV positive partner disclosed his recent behaviors and, as a result, they decided not to have further sexual contact until they could explore this further in therapy,” the psychiatrist wrote. “At last communication the couple decided to end the relationship, and the HIV negative partner remained negative.”
A version of this article first appeared on Medscape.com.
What are the legal risks of practicing laser cutaneous surgery?
The physician-patient relationship is a key factor in preventing litigation following cutaneous laser surgery, according to Mathew M. Avram, MD, JD.
“Numerous studies indicate that good communication and rapport are the most important means to avoid a lawsuit,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “It is helpful to say that the outcome was not optimal or what you were anticipating. Communicate your plan [for the complication] clearly and honestly to your patient. The patient may not understand the severity of the complication. If they don’t, they will either leave it alone or they will go elsewhere and may receive poor care.” He added that in New England, “we have some stoic patients who may say ‘I don’t want to bother the doctor’ or ‘It’s my fault for having the procedure done.’ ”
Establishing effective communication with patients from the outset is good practice, he continued, because 75% of physicians in low-risk specialties will face a malpractice claim by age 65. Nearly a decade ago Dr. Avram, H. Ray Jalian, MD, and Chris Jalian, JD, published results from a national legal database analysis identifying common errors and risk factors for litigation in cutaneous surgery. Their search yielded 1,807 documents with 174 unique legal claims involving injury from a cutaneous laser treatment, from 1985 to 2012. The most common litigated procedures were laser hair removal, rejuvenation (mostly related to intense pulsed-light treatments), and laser treatment of leg veins, while the most common injuries sustained were burns, scars, and pigmentary changes. The most common causes of legal action were lack of informed consent and fraud.
Among the 120 cases with public decisions, cases favored the plaintiff 51% of the time. “That’s unusual,” said Dr. Avram, president of American Society for Dermatologic Surgery. “Usually, physicians do better, but I think the fact that they’re cosmetic cases probably shades things a little bit.” The median monetary award was $350,000 and ranged from $5,000 to $2,145,000. The two largest judgments were for improper use of topical anesthesia that led to deaths of patients in laser hair removal cases.
In a separate analysis, the same authors searched an online national database to identify the incidence of medical professional liability claims resulting from cutaneous laser surgery performed by nonphysician operators (NPOs) from 1999 to 2012. Among the 175 cases identified, 43% involved an NPO. “In fact, the cases involving NPOs exploded over a 4-year period; they grew from 36% in 2008 of cases to 78% in 2011,” Dr. Avram said. “This was even more true for laser hair removal.”
The practice setting turned out to be a factor. Only 23% of NPO litigation involving laser procedures arose in medical office settings, while 77% of cases involving NPOs were performed outside of traditional medical settings such as in salons and medical spas – mostly for laser hair removal. “We updated this information by examining the setting for nonphysician operator litigation between 2012 and 2017 and found that 66% of cases involving NPOs were performed outside of a traditional medical setting, while 34% of NPO litigation arose in medical office settings,” Dr. Avram said during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “That’s close to a 2 to 1 ratio.”
In an analysis of medical professional liability claims involving Mohs surgery from 1989 to 2011, 26 of the 42 cases identified involved a primary defendant who was not a Mohs surgeon. In the 26 cases, the most common reasons for lawsuits were failure or delay of diagnosis of a skin cancer, cosmetic outcome issues, lack of informed consent, and delay or failure to refer to a Mohs surgeon. Of the cases that involved Mohs surgeons, the most common causes were lack of proper informed consent and cosmetic outcome issues, but “these cases were overwhelmingly decided in favor of the surgeons,” said Dr. Avram, one of the study authors.
On a related note, Dr. Avram underscored the importance of biopsy-site photography, “because patients and physicians misidentify biopsy sites too commonly,” he said. In a single-center study of 34 biopsy sites of cutaneous head and neck malignancies, patients misidentified the biopsy site 4-7 weeks out in 29% of the cases. Blinded dermatologists and the patient misidentified the biopsy site in 12% of the cases. “Good biopsy site photography should be mandatory in your practice,” he advised.
Clinicians can avoid cutaneous laser surgery complications only by not treating patients. “Complications and side effects are inevitable; you need to know your limits,” he said. “Even in skilled hands, if you treat enough patients, you will encounter challenging side effects. Do not perform a procedure that might produce a side effect that you cannot recognize and treat.”
The best way to avoid complications is to trust your eyes – not the laser – since the same device made by the same manufacturer may produce highly different outputs at the same setting (see J Am Acad Dermatol. 2016;74[5]:807-19).
“Moreover, lasers can produce much different energies after they have been serviced,” Dr. Avram said. “Do not memorize settings. Do not blindly replicate recommended settings from a colleague or a device manufacturer,” he advised. “Some devices are not externally calibrated. Therefore, the settings on one device may not translate the same way to yours. Often, device manufacturers underplay the settings. Safe and unsafe laser endpoints and close observation are the best means to avoiding clinical complications. That means you follow clinical endpoints, not fluences. The key clinical finding is the endpoint, not the energy setting.”
Temporary and expected side effects include erythema, edema, and purpura. “With these it’s just handholding and unlikely to lead to any legal consequences,” he continued. “With temporary hyperpigmentation that can occur with laser hair removal, time is one your side, because typically this will resolve before any litigation progresses. Permanent side effects from lasers and light sources and injectables are a different issue, things like permanent hypopigmentation, depigmentation, and scarring. These are most likely to produce liability.”
In Dr. Avram’s opinion, complications are best handled with widespread communication. “There is a temptation to avoid a patient with a poor outcome or side effect,” he said. “This is bad medicine and rightfully angers your patient and increases the risk of a lawsuit. [Resist] the temptation to avoid showing a poor outcome to a colleague. Many complications can be significantly improved or cleared with timely and appropriate interventions. You should always document your efforts.”
Dr. Avram disclosed that he has received consulting fees from Allergan and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.
The physician-patient relationship is a key factor in preventing litigation following cutaneous laser surgery, according to Mathew M. Avram, MD, JD.
“Numerous studies indicate that good communication and rapport are the most important means to avoid a lawsuit,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “It is helpful to say that the outcome was not optimal or what you were anticipating. Communicate your plan [for the complication] clearly and honestly to your patient. The patient may not understand the severity of the complication. If they don’t, they will either leave it alone or they will go elsewhere and may receive poor care.” He added that in New England, “we have some stoic patients who may say ‘I don’t want to bother the doctor’ or ‘It’s my fault for having the procedure done.’ ”
Establishing effective communication with patients from the outset is good practice, he continued, because 75% of physicians in low-risk specialties will face a malpractice claim by age 65. Nearly a decade ago Dr. Avram, H. Ray Jalian, MD, and Chris Jalian, JD, published results from a national legal database analysis identifying common errors and risk factors for litigation in cutaneous surgery. Their search yielded 1,807 documents with 174 unique legal claims involving injury from a cutaneous laser treatment, from 1985 to 2012. The most common litigated procedures were laser hair removal, rejuvenation (mostly related to intense pulsed-light treatments), and laser treatment of leg veins, while the most common injuries sustained were burns, scars, and pigmentary changes. The most common causes of legal action were lack of informed consent and fraud.
Among the 120 cases with public decisions, cases favored the plaintiff 51% of the time. “That’s unusual,” said Dr. Avram, president of American Society for Dermatologic Surgery. “Usually, physicians do better, but I think the fact that they’re cosmetic cases probably shades things a little bit.” The median monetary award was $350,000 and ranged from $5,000 to $2,145,000. The two largest judgments were for improper use of topical anesthesia that led to deaths of patients in laser hair removal cases.
In a separate analysis, the same authors searched an online national database to identify the incidence of medical professional liability claims resulting from cutaneous laser surgery performed by nonphysician operators (NPOs) from 1999 to 2012. Among the 175 cases identified, 43% involved an NPO. “In fact, the cases involving NPOs exploded over a 4-year period; they grew from 36% in 2008 of cases to 78% in 2011,” Dr. Avram said. “This was even more true for laser hair removal.”
The practice setting turned out to be a factor. Only 23% of NPO litigation involving laser procedures arose in medical office settings, while 77% of cases involving NPOs were performed outside of traditional medical settings such as in salons and medical spas – mostly for laser hair removal. “We updated this information by examining the setting for nonphysician operator litigation between 2012 and 2017 and found that 66% of cases involving NPOs were performed outside of a traditional medical setting, while 34% of NPO litigation arose in medical office settings,” Dr. Avram said during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “That’s close to a 2 to 1 ratio.”
In an analysis of medical professional liability claims involving Mohs surgery from 1989 to 2011, 26 of the 42 cases identified involved a primary defendant who was not a Mohs surgeon. In the 26 cases, the most common reasons for lawsuits were failure or delay of diagnosis of a skin cancer, cosmetic outcome issues, lack of informed consent, and delay or failure to refer to a Mohs surgeon. Of the cases that involved Mohs surgeons, the most common causes were lack of proper informed consent and cosmetic outcome issues, but “these cases were overwhelmingly decided in favor of the surgeons,” said Dr. Avram, one of the study authors.
On a related note, Dr. Avram underscored the importance of biopsy-site photography, “because patients and physicians misidentify biopsy sites too commonly,” he said. In a single-center study of 34 biopsy sites of cutaneous head and neck malignancies, patients misidentified the biopsy site 4-7 weeks out in 29% of the cases. Blinded dermatologists and the patient misidentified the biopsy site in 12% of the cases. “Good biopsy site photography should be mandatory in your practice,” he advised.
Clinicians can avoid cutaneous laser surgery complications only by not treating patients. “Complications and side effects are inevitable; you need to know your limits,” he said. “Even in skilled hands, if you treat enough patients, you will encounter challenging side effects. Do not perform a procedure that might produce a side effect that you cannot recognize and treat.”
The best way to avoid complications is to trust your eyes – not the laser – since the same device made by the same manufacturer may produce highly different outputs at the same setting (see J Am Acad Dermatol. 2016;74[5]:807-19).
“Moreover, lasers can produce much different energies after they have been serviced,” Dr. Avram said. “Do not memorize settings. Do not blindly replicate recommended settings from a colleague or a device manufacturer,” he advised. “Some devices are not externally calibrated. Therefore, the settings on one device may not translate the same way to yours. Often, device manufacturers underplay the settings. Safe and unsafe laser endpoints and close observation are the best means to avoiding clinical complications. That means you follow clinical endpoints, not fluences. The key clinical finding is the endpoint, not the energy setting.”
Temporary and expected side effects include erythema, edema, and purpura. “With these it’s just handholding and unlikely to lead to any legal consequences,” he continued. “With temporary hyperpigmentation that can occur with laser hair removal, time is one your side, because typically this will resolve before any litigation progresses. Permanent side effects from lasers and light sources and injectables are a different issue, things like permanent hypopigmentation, depigmentation, and scarring. These are most likely to produce liability.”
In Dr. Avram’s opinion, complications are best handled with widespread communication. “There is a temptation to avoid a patient with a poor outcome or side effect,” he said. “This is bad medicine and rightfully angers your patient and increases the risk of a lawsuit. [Resist] the temptation to avoid showing a poor outcome to a colleague. Many complications can be significantly improved or cleared with timely and appropriate interventions. You should always document your efforts.”
Dr. Avram disclosed that he has received consulting fees from Allergan and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.
The physician-patient relationship is a key factor in preventing litigation following cutaneous laser surgery, according to Mathew M. Avram, MD, JD.
“Numerous studies indicate that good communication and rapport are the most important means to avoid a lawsuit,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “It is helpful to say that the outcome was not optimal or what you were anticipating. Communicate your plan [for the complication] clearly and honestly to your patient. The patient may not understand the severity of the complication. If they don’t, they will either leave it alone or they will go elsewhere and may receive poor care.” He added that in New England, “we have some stoic patients who may say ‘I don’t want to bother the doctor’ or ‘It’s my fault for having the procedure done.’ ”
Establishing effective communication with patients from the outset is good practice, he continued, because 75% of physicians in low-risk specialties will face a malpractice claim by age 65. Nearly a decade ago Dr. Avram, H. Ray Jalian, MD, and Chris Jalian, JD, published results from a national legal database analysis identifying common errors and risk factors for litigation in cutaneous surgery. Their search yielded 1,807 documents with 174 unique legal claims involving injury from a cutaneous laser treatment, from 1985 to 2012. The most common litigated procedures were laser hair removal, rejuvenation (mostly related to intense pulsed-light treatments), and laser treatment of leg veins, while the most common injuries sustained were burns, scars, and pigmentary changes. The most common causes of legal action were lack of informed consent and fraud.
Among the 120 cases with public decisions, cases favored the plaintiff 51% of the time. “That’s unusual,” said Dr. Avram, president of American Society for Dermatologic Surgery. “Usually, physicians do better, but I think the fact that they’re cosmetic cases probably shades things a little bit.” The median monetary award was $350,000 and ranged from $5,000 to $2,145,000. The two largest judgments were for improper use of topical anesthesia that led to deaths of patients in laser hair removal cases.
In a separate analysis, the same authors searched an online national database to identify the incidence of medical professional liability claims resulting from cutaneous laser surgery performed by nonphysician operators (NPOs) from 1999 to 2012. Among the 175 cases identified, 43% involved an NPO. “In fact, the cases involving NPOs exploded over a 4-year period; they grew from 36% in 2008 of cases to 78% in 2011,” Dr. Avram said. “This was even more true for laser hair removal.”
The practice setting turned out to be a factor. Only 23% of NPO litigation involving laser procedures arose in medical office settings, while 77% of cases involving NPOs were performed outside of traditional medical settings such as in salons and medical spas – mostly for laser hair removal. “We updated this information by examining the setting for nonphysician operator litigation between 2012 and 2017 and found that 66% of cases involving NPOs were performed outside of a traditional medical setting, while 34% of NPO litigation arose in medical office settings,” Dr. Avram said during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “That’s close to a 2 to 1 ratio.”
In an analysis of medical professional liability claims involving Mohs surgery from 1989 to 2011, 26 of the 42 cases identified involved a primary defendant who was not a Mohs surgeon. In the 26 cases, the most common reasons for lawsuits were failure or delay of diagnosis of a skin cancer, cosmetic outcome issues, lack of informed consent, and delay or failure to refer to a Mohs surgeon. Of the cases that involved Mohs surgeons, the most common causes were lack of proper informed consent and cosmetic outcome issues, but “these cases were overwhelmingly decided in favor of the surgeons,” said Dr. Avram, one of the study authors.
On a related note, Dr. Avram underscored the importance of biopsy-site photography, “because patients and physicians misidentify biopsy sites too commonly,” he said. In a single-center study of 34 biopsy sites of cutaneous head and neck malignancies, patients misidentified the biopsy site 4-7 weeks out in 29% of the cases. Blinded dermatologists and the patient misidentified the biopsy site in 12% of the cases. “Good biopsy site photography should be mandatory in your practice,” he advised.
Clinicians can avoid cutaneous laser surgery complications only by not treating patients. “Complications and side effects are inevitable; you need to know your limits,” he said. “Even in skilled hands, if you treat enough patients, you will encounter challenging side effects. Do not perform a procedure that might produce a side effect that you cannot recognize and treat.”
The best way to avoid complications is to trust your eyes – not the laser – since the same device made by the same manufacturer may produce highly different outputs at the same setting (see J Am Acad Dermatol. 2016;74[5]:807-19).
“Moreover, lasers can produce much different energies after they have been serviced,” Dr. Avram said. “Do not memorize settings. Do not blindly replicate recommended settings from a colleague or a device manufacturer,” he advised. “Some devices are not externally calibrated. Therefore, the settings on one device may not translate the same way to yours. Often, device manufacturers underplay the settings. Safe and unsafe laser endpoints and close observation are the best means to avoiding clinical complications. That means you follow clinical endpoints, not fluences. The key clinical finding is the endpoint, not the energy setting.”
Temporary and expected side effects include erythema, edema, and purpura. “With these it’s just handholding and unlikely to lead to any legal consequences,” he continued. “With temporary hyperpigmentation that can occur with laser hair removal, time is one your side, because typically this will resolve before any litigation progresses. Permanent side effects from lasers and light sources and injectables are a different issue, things like permanent hypopigmentation, depigmentation, and scarring. These are most likely to produce liability.”
In Dr. Avram’s opinion, complications are best handled with widespread communication. “There is a temptation to avoid a patient with a poor outcome or side effect,” he said. “This is bad medicine and rightfully angers your patient and increases the risk of a lawsuit. [Resist] the temptation to avoid showing a poor outcome to a colleague. Many complications can be significantly improved or cleared with timely and appropriate interventions. You should always document your efforts.”
Dr. Avram disclosed that he has received consulting fees from Allergan and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.
FROM A LASER & AESTHETIC SKIN THERAPY COURSE
Ulcer on the Leg
The Diagnosis: Calcinosis Cutis Due to Systemic Sclerosis Sine Scleroderma
Laboratory evaluation was notable for high titers of antinuclear antibodies (>1/320; reference range, 0–1/80) and positive anticentromere antibodies. There were no other relevant laboratory findings; phosphocalcic metabolism was within normal limits, and urinary sediment was normal. Biopsy of the edge of the ulcer revealed basophilic material compatible with calcium deposits. In a 3D volume rendering reconstruction from the lower limb scanner, grouped calcifications were observed in subcutaneous cellular tissue near the ulcer (Figure). The patient had a restrictive ventilatory pattern observed in a pulmonary function test. An esophageal motility study was normal.
The patient was diagnosed with systemic sclerosis sine scleroderma (ssSSc) type II because she met the 4 criteria established by Poormoghim et al1 : (1) Raynaud phenomenon or a peripheral vascular equivalent (ie, digital pitting scars, digital-tip ulcers, digital-tip gangrene, abnormal nail fold capillaries); (2) positive antinuclear antibodies; (3) distal esophageal hypomotility, small bowel hypomotility, pulmonary interstitial fibrosis, primary pulmonary arterial hypertension (without fibrosis), cardiac involvement typical of scleroderma, or renal failure; and (4) no other defined connective tissue or other disease as a cause of the prior conditions.
Systemic sclerosis is a chronic disease characterized by progressive fibrosis of the skin and other internal organs—especially the lungs, kidneys, digestive tract, and heart—as well as generalized vascular dysfunction. Cutaneous induration is its hallmark; however, up to 10% of affected patients have ssSSc.2 This entity is characterized by the total or partial absence of cutaneous manifestations of systemic sclerosis with the occurrence of internal organ involvement and serologic abnormalities. There are 3 types of ssSSc depending on the grade of skin involvement. Type I is characterized by the lack of any typical cutaneous stigmata of the disease. Type II is without sclerodactyly but can coexist with other cutaneous findings such as calcifications, telangiectases, or pitting scars. Type III is characterized clinically by internal organ involvement, typical of systemic sclerosis, that has appeared before skin changes.2
An abnormal deposit of calcium in the cutaneous and subcutaneous tissue is called calcinosis cutis. There are 5 subtypes of calcinosis cutis: dystrophic, metastatic, idiopathic, iatrogenic, and calciphylaxis. Dystrophic skin calcifications may appear in patients with connective tissue diseases such as dermatomyositis or systemic sclerosis.3 Up to 25% of patients with systemic sclerosis can develop calcinosis cutis due to local tissue damage, with normal phosphocalcic metabolism.3
Calcinosis cutis is more common in patients with systemic sclerosis and positive anticentromere antibodies.4 The calcifications usually are located in areas that are subject to repeated trauma, such as the fingers or arms, though other locations have been described such as cervical, paraspinal, or on the hips.5,6 Our patient developed calcifications on both legs, which represent atypical areas for this process.
Dermatomyositis also can present with calcinosis cutis. There are 4 patterns of calcification: superficial nodulelike calcified masses; deep calcified masses; deep sheetlike calcifications within the fascial planes; and a rare, diffuse, superficial lacy and reticular calcification that involves almost the entire body surface area.7 Patients with calcinosis cutis secondary to dermatomyositis usually develop proximal muscle weakness, high titers of creatine kinase, heliotrope rash, or interstitial lung disease with specific antibodies.
Calciphylaxis is a serious disorder involving the calcification of dermal and subcutaneous arterioles and capillaries. It presents with painful cutaneous areas of necrosis.
Venous ulcers also can present with secondary dystrophic calcification due to local tissue damage. These patients usually have cutaneous signs of chronic venous insufficiency. Our patient denied prior trauma to the area; therefore, a traumatic ulcer with secondary calcification was ruled out.
The most concerning complication of calcinosis cutis is the development of ulcers, which occurred in 154 of 316 calcinoses (48.7%) in patients with systemic sclerosis and secondary calcifications.8 These ulcers can cause disabling pain or become superinfected, as in our patient.
There currently is no drug capable of removing dystrophic calcifications, but diltiazem, minocycline, or colchicine can reduce their size and prevent their progression. In the event of neurologic compromise or intractable pain, the treatment of choice is surgical removal of the calcification.9 Curettage, intralesional sodium thiosulfate, and intravenous sodium thiosulfate also have been suggested as therapeutic options.10 Antibiotic treatment was carried out in our patient, which controlled the superinfection of the ulcers. Diltiazem also was started, with stabilization of the calcium deposits without a reduction in their size.
There are few studies evaluating the presence of nondigital ulcers in patients with systemic sclerosis. Shanmugam et al11 calculated a 4% (N=249) prevalence of ulcers in the lower limbs of systemic sclerosis patients. In a study by Bohelay et al12 of 45 patients, the estimated prevalence of lower limb ulcers was 12.8%, and the etiologies consisted of 22 cases of venous insufficiency (49%), 21 cases of ischemic causes (47%), and 2 cases of other causes (4%).
We present the case of a woman with ssSSc who developed dystrophic calcinosis cutis in atypical areas with secondary ulceration and superinfection. The skin usually plays a key role in the diagnosis of systemic sclerosis, as sclerodactyly and the characteristic generalized skin induration stand out in affected individuals. Although our patient was diagnosed with ssSSc, her skin manifestations also were crucial for the diagnosis, as she had ulcers on the lower limbs.
- Poormoghim H, Lucas M, Fertig N, et al. Systemic sclerosis sine scleroderma: demographic, clinical, and serologic features and survival in forty-eight patients. Arthritis Rheum. 2000;43:444-451.
- Kucharz EJ, Kopec´-Me˛ drek M. Systemic sclerosis sine scleroderma. Adv Clin Exp Med. 2017;26:875-880.
- Valenzuela A, Baron M, Herrick AL, et al. Calcinosis is associated with digital ulcers and osteoporosis in patients with systemic sclerosis: a scleroderma clinical trials consortium study. Semin Arthritis Rheum. 2016;46:344-349.
- D’Aoust J, Hudson M, Tatibouet S, et al. Clinical and serologic correlates of antiPM/Scl antibodies in systemic sclerosis: a multicenter study of 763 patients. Arthritis Rheum. 2014;66:1608-1615.
- Contreras I, Sallés M, Mínguez S, et al. Hard paracervical tumor in a patient with limited systemic sclerosis. Rheumatol Clin. 2014; 10:336-337.
- Meriglier E, Lafourcade F, Gombert B, et al. Giant calcinosis revealing systemic sclerosis. Int J Rheum Dis. 2019;22:1787-1788.
- Chung CH. Calcinosis universalis in juvenile dermatomyositis [published online September 24, 2020]. Chonnam Med J. 2020;56:212-213.
- Bartoli F, Fiori G, Braschi F, et al. Calcinosis in systemic sclerosis: subsets, distribution and complications [published online May 30, 2016]. Rheumatology (Oxford). 2016;55:1610-1614.
- Jung H, Lee D, Cho J, et al. Surgical treatment of extensive tumoral calcinosis associated with systemic sclerosis. Korean J Thorac Cardiovasc Surg. 2015;48:151-154.
- Badawi AH, Patel V, Warner AE, et al. Dystrophic calcinosis cutis: treatment with intravenous sodium thiosulfate. Cutis. 2020;106:E15-E17.
- Shanmugam V, Price P, Attinger C, et al. Lower extremity ulcers in systemic sclerosis: features and response to therapy [published online August 18, 2010]. Int J Rheumatol. doi:10.1155/2010/747946
- Bohelay G, Blaise S, Levy P, et al. Lower-limb ulcers in systemic sclerosis: a multicentre retrospective case-control study. Acta Derm Venereol. 2018;98:677-682.
The Diagnosis: Calcinosis Cutis Due to Systemic Sclerosis Sine Scleroderma
Laboratory evaluation was notable for high titers of antinuclear antibodies (>1/320; reference range, 0–1/80) and positive anticentromere antibodies. There were no other relevant laboratory findings; phosphocalcic metabolism was within normal limits, and urinary sediment was normal. Biopsy of the edge of the ulcer revealed basophilic material compatible with calcium deposits. In a 3D volume rendering reconstruction from the lower limb scanner, grouped calcifications were observed in subcutaneous cellular tissue near the ulcer (Figure). The patient had a restrictive ventilatory pattern observed in a pulmonary function test. An esophageal motility study was normal.
The patient was diagnosed with systemic sclerosis sine scleroderma (ssSSc) type II because she met the 4 criteria established by Poormoghim et al1 : (1) Raynaud phenomenon or a peripheral vascular equivalent (ie, digital pitting scars, digital-tip ulcers, digital-tip gangrene, abnormal nail fold capillaries); (2) positive antinuclear antibodies; (3) distal esophageal hypomotility, small bowel hypomotility, pulmonary interstitial fibrosis, primary pulmonary arterial hypertension (without fibrosis), cardiac involvement typical of scleroderma, or renal failure; and (4) no other defined connective tissue or other disease as a cause of the prior conditions.
Systemic sclerosis is a chronic disease characterized by progressive fibrosis of the skin and other internal organs—especially the lungs, kidneys, digestive tract, and heart—as well as generalized vascular dysfunction. Cutaneous induration is its hallmark; however, up to 10% of affected patients have ssSSc.2 This entity is characterized by the total or partial absence of cutaneous manifestations of systemic sclerosis with the occurrence of internal organ involvement and serologic abnormalities. There are 3 types of ssSSc depending on the grade of skin involvement. Type I is characterized by the lack of any typical cutaneous stigmata of the disease. Type II is without sclerodactyly but can coexist with other cutaneous findings such as calcifications, telangiectases, or pitting scars. Type III is characterized clinically by internal organ involvement, typical of systemic sclerosis, that has appeared before skin changes.2
An abnormal deposit of calcium in the cutaneous and subcutaneous tissue is called calcinosis cutis. There are 5 subtypes of calcinosis cutis: dystrophic, metastatic, idiopathic, iatrogenic, and calciphylaxis. Dystrophic skin calcifications may appear in patients with connective tissue diseases such as dermatomyositis or systemic sclerosis.3 Up to 25% of patients with systemic sclerosis can develop calcinosis cutis due to local tissue damage, with normal phosphocalcic metabolism.3
Calcinosis cutis is more common in patients with systemic sclerosis and positive anticentromere antibodies.4 The calcifications usually are located in areas that are subject to repeated trauma, such as the fingers or arms, though other locations have been described such as cervical, paraspinal, or on the hips.5,6 Our patient developed calcifications on both legs, which represent atypical areas for this process.
Dermatomyositis also can present with calcinosis cutis. There are 4 patterns of calcification: superficial nodulelike calcified masses; deep calcified masses; deep sheetlike calcifications within the fascial planes; and a rare, diffuse, superficial lacy and reticular calcification that involves almost the entire body surface area.7 Patients with calcinosis cutis secondary to dermatomyositis usually develop proximal muscle weakness, high titers of creatine kinase, heliotrope rash, or interstitial lung disease with specific antibodies.
Calciphylaxis is a serious disorder involving the calcification of dermal and subcutaneous arterioles and capillaries. It presents with painful cutaneous areas of necrosis.
Venous ulcers also can present with secondary dystrophic calcification due to local tissue damage. These patients usually have cutaneous signs of chronic venous insufficiency. Our patient denied prior trauma to the area; therefore, a traumatic ulcer with secondary calcification was ruled out.
The most concerning complication of calcinosis cutis is the development of ulcers, which occurred in 154 of 316 calcinoses (48.7%) in patients with systemic sclerosis and secondary calcifications.8 These ulcers can cause disabling pain or become superinfected, as in our patient.
There currently is no drug capable of removing dystrophic calcifications, but diltiazem, minocycline, or colchicine can reduce their size and prevent their progression. In the event of neurologic compromise or intractable pain, the treatment of choice is surgical removal of the calcification.9 Curettage, intralesional sodium thiosulfate, and intravenous sodium thiosulfate also have been suggested as therapeutic options.10 Antibiotic treatment was carried out in our patient, which controlled the superinfection of the ulcers. Diltiazem also was started, with stabilization of the calcium deposits without a reduction in their size.
There are few studies evaluating the presence of nondigital ulcers in patients with systemic sclerosis. Shanmugam et al11 calculated a 4% (N=249) prevalence of ulcers in the lower limbs of systemic sclerosis patients. In a study by Bohelay et al12 of 45 patients, the estimated prevalence of lower limb ulcers was 12.8%, and the etiologies consisted of 22 cases of venous insufficiency (49%), 21 cases of ischemic causes (47%), and 2 cases of other causes (4%).
We present the case of a woman with ssSSc who developed dystrophic calcinosis cutis in atypical areas with secondary ulceration and superinfection. The skin usually plays a key role in the diagnosis of systemic sclerosis, as sclerodactyly and the characteristic generalized skin induration stand out in affected individuals. Although our patient was diagnosed with ssSSc, her skin manifestations also were crucial for the diagnosis, as she had ulcers on the lower limbs.
The Diagnosis: Calcinosis Cutis Due to Systemic Sclerosis Sine Scleroderma
Laboratory evaluation was notable for high titers of antinuclear antibodies (>1/320; reference range, 0–1/80) and positive anticentromere antibodies. There were no other relevant laboratory findings; phosphocalcic metabolism was within normal limits, and urinary sediment was normal. Biopsy of the edge of the ulcer revealed basophilic material compatible with calcium deposits. In a 3D volume rendering reconstruction from the lower limb scanner, grouped calcifications were observed in subcutaneous cellular tissue near the ulcer (Figure). The patient had a restrictive ventilatory pattern observed in a pulmonary function test. An esophageal motility study was normal.
The patient was diagnosed with systemic sclerosis sine scleroderma (ssSSc) type II because she met the 4 criteria established by Poormoghim et al1 : (1) Raynaud phenomenon or a peripheral vascular equivalent (ie, digital pitting scars, digital-tip ulcers, digital-tip gangrene, abnormal nail fold capillaries); (2) positive antinuclear antibodies; (3) distal esophageal hypomotility, small bowel hypomotility, pulmonary interstitial fibrosis, primary pulmonary arterial hypertension (without fibrosis), cardiac involvement typical of scleroderma, or renal failure; and (4) no other defined connective tissue or other disease as a cause of the prior conditions.
Systemic sclerosis is a chronic disease characterized by progressive fibrosis of the skin and other internal organs—especially the lungs, kidneys, digestive tract, and heart—as well as generalized vascular dysfunction. Cutaneous induration is its hallmark; however, up to 10% of affected patients have ssSSc.2 This entity is characterized by the total or partial absence of cutaneous manifestations of systemic sclerosis with the occurrence of internal organ involvement and serologic abnormalities. There are 3 types of ssSSc depending on the grade of skin involvement. Type I is characterized by the lack of any typical cutaneous stigmata of the disease. Type II is without sclerodactyly but can coexist with other cutaneous findings such as calcifications, telangiectases, or pitting scars. Type III is characterized clinically by internal organ involvement, typical of systemic sclerosis, that has appeared before skin changes.2
An abnormal deposit of calcium in the cutaneous and subcutaneous tissue is called calcinosis cutis. There are 5 subtypes of calcinosis cutis: dystrophic, metastatic, idiopathic, iatrogenic, and calciphylaxis. Dystrophic skin calcifications may appear in patients with connective tissue diseases such as dermatomyositis or systemic sclerosis.3 Up to 25% of patients with systemic sclerosis can develop calcinosis cutis due to local tissue damage, with normal phosphocalcic metabolism.3
Calcinosis cutis is more common in patients with systemic sclerosis and positive anticentromere antibodies.4 The calcifications usually are located in areas that are subject to repeated trauma, such as the fingers or arms, though other locations have been described such as cervical, paraspinal, or on the hips.5,6 Our patient developed calcifications on both legs, which represent atypical areas for this process.
Dermatomyositis also can present with calcinosis cutis. There are 4 patterns of calcification: superficial nodulelike calcified masses; deep calcified masses; deep sheetlike calcifications within the fascial planes; and a rare, diffuse, superficial lacy and reticular calcification that involves almost the entire body surface area.7 Patients with calcinosis cutis secondary to dermatomyositis usually develop proximal muscle weakness, high titers of creatine kinase, heliotrope rash, or interstitial lung disease with specific antibodies.
Calciphylaxis is a serious disorder involving the calcification of dermal and subcutaneous arterioles and capillaries. It presents with painful cutaneous areas of necrosis.
Venous ulcers also can present with secondary dystrophic calcification due to local tissue damage. These patients usually have cutaneous signs of chronic venous insufficiency. Our patient denied prior trauma to the area; therefore, a traumatic ulcer with secondary calcification was ruled out.
The most concerning complication of calcinosis cutis is the development of ulcers, which occurred in 154 of 316 calcinoses (48.7%) in patients with systemic sclerosis and secondary calcifications.8 These ulcers can cause disabling pain or become superinfected, as in our patient.
There currently is no drug capable of removing dystrophic calcifications, but diltiazem, minocycline, or colchicine can reduce their size and prevent their progression. In the event of neurologic compromise or intractable pain, the treatment of choice is surgical removal of the calcification.9 Curettage, intralesional sodium thiosulfate, and intravenous sodium thiosulfate also have been suggested as therapeutic options.10 Antibiotic treatment was carried out in our patient, which controlled the superinfection of the ulcers. Diltiazem also was started, with stabilization of the calcium deposits without a reduction in their size.
There are few studies evaluating the presence of nondigital ulcers in patients with systemic sclerosis. Shanmugam et al11 calculated a 4% (N=249) prevalence of ulcers in the lower limbs of systemic sclerosis patients. In a study by Bohelay et al12 of 45 patients, the estimated prevalence of lower limb ulcers was 12.8%, and the etiologies consisted of 22 cases of venous insufficiency (49%), 21 cases of ischemic causes (47%), and 2 cases of other causes (4%).
We present the case of a woman with ssSSc who developed dystrophic calcinosis cutis in atypical areas with secondary ulceration and superinfection. The skin usually plays a key role in the diagnosis of systemic sclerosis, as sclerodactyly and the characteristic generalized skin induration stand out in affected individuals. Although our patient was diagnosed with ssSSc, her skin manifestations also were crucial for the diagnosis, as she had ulcers on the lower limbs.
- Poormoghim H, Lucas M, Fertig N, et al. Systemic sclerosis sine scleroderma: demographic, clinical, and serologic features and survival in forty-eight patients. Arthritis Rheum. 2000;43:444-451.
- Kucharz EJ, Kopec´-Me˛ drek M. Systemic sclerosis sine scleroderma. Adv Clin Exp Med. 2017;26:875-880.
- Valenzuela A, Baron M, Herrick AL, et al. Calcinosis is associated with digital ulcers and osteoporosis in patients with systemic sclerosis: a scleroderma clinical trials consortium study. Semin Arthritis Rheum. 2016;46:344-349.
- D’Aoust J, Hudson M, Tatibouet S, et al. Clinical and serologic correlates of antiPM/Scl antibodies in systemic sclerosis: a multicenter study of 763 patients. Arthritis Rheum. 2014;66:1608-1615.
- Contreras I, Sallés M, Mínguez S, et al. Hard paracervical tumor in a patient with limited systemic sclerosis. Rheumatol Clin. 2014; 10:336-337.
- Meriglier E, Lafourcade F, Gombert B, et al. Giant calcinosis revealing systemic sclerosis. Int J Rheum Dis. 2019;22:1787-1788.
- Chung CH. Calcinosis universalis in juvenile dermatomyositis [published online September 24, 2020]. Chonnam Med J. 2020;56:212-213.
- Bartoli F, Fiori G, Braschi F, et al. Calcinosis in systemic sclerosis: subsets, distribution and complications [published online May 30, 2016]. Rheumatology (Oxford). 2016;55:1610-1614.
- Jung H, Lee D, Cho J, et al. Surgical treatment of extensive tumoral calcinosis associated with systemic sclerosis. Korean J Thorac Cardiovasc Surg. 2015;48:151-154.
- Badawi AH, Patel V, Warner AE, et al. Dystrophic calcinosis cutis: treatment with intravenous sodium thiosulfate. Cutis. 2020;106:E15-E17.
- Shanmugam V, Price P, Attinger C, et al. Lower extremity ulcers in systemic sclerosis: features and response to therapy [published online August 18, 2010]. Int J Rheumatol. doi:10.1155/2010/747946
- Bohelay G, Blaise S, Levy P, et al. Lower-limb ulcers in systemic sclerosis: a multicentre retrospective case-control study. Acta Derm Venereol. 2018;98:677-682.
- Poormoghim H, Lucas M, Fertig N, et al. Systemic sclerosis sine scleroderma: demographic, clinical, and serologic features and survival in forty-eight patients. Arthritis Rheum. 2000;43:444-451.
- Kucharz EJ, Kopec´-Me˛ drek M. Systemic sclerosis sine scleroderma. Adv Clin Exp Med. 2017;26:875-880.
- Valenzuela A, Baron M, Herrick AL, et al. Calcinosis is associated with digital ulcers and osteoporosis in patients with systemic sclerosis: a scleroderma clinical trials consortium study. Semin Arthritis Rheum. 2016;46:344-349.
- D’Aoust J, Hudson M, Tatibouet S, et al. Clinical and serologic correlates of antiPM/Scl antibodies in systemic sclerosis: a multicenter study of 763 patients. Arthritis Rheum. 2014;66:1608-1615.
- Contreras I, Sallés M, Mínguez S, et al. Hard paracervical tumor in a patient with limited systemic sclerosis. Rheumatol Clin. 2014; 10:336-337.
- Meriglier E, Lafourcade F, Gombert B, et al. Giant calcinosis revealing systemic sclerosis. Int J Rheum Dis. 2019;22:1787-1788.
- Chung CH. Calcinosis universalis in juvenile dermatomyositis [published online September 24, 2020]. Chonnam Med J. 2020;56:212-213.
- Bartoli F, Fiori G, Braschi F, et al. Calcinosis in systemic sclerosis: subsets, distribution and complications [published online May 30, 2016]. Rheumatology (Oxford). 2016;55:1610-1614.
- Jung H, Lee D, Cho J, et al. Surgical treatment of extensive tumoral calcinosis associated with systemic sclerosis. Korean J Thorac Cardiovasc Surg. 2015;48:151-154.
- Badawi AH, Patel V, Warner AE, et al. Dystrophic calcinosis cutis: treatment with intravenous sodium thiosulfate. Cutis. 2020;106:E15-E17.
- Shanmugam V, Price P, Attinger C, et al. Lower extremity ulcers in systemic sclerosis: features and response to therapy [published online August 18, 2010]. Int J Rheumatol. doi:10.1155/2010/747946
- Bohelay G, Blaise S, Levy P, et al. Lower-limb ulcers in systemic sclerosis: a multicentre retrospective case-control study. Acta Derm Venereol. 2018;98:677-682.
A 49-year-old woman with type 2 diabetes mellitus, morbid obesity, pulmonary fibrosis, and pulmonary arterial hypertension presented to our hospital with an ulcer on the left leg of unknown etiology that was superinfected by multidrug-resistant Klebsiella according to bacterial culture. She had an axillary temperature of 38.6 °C. She underwent amputation of the second and third toes on the left foot 5 years prior to presentation due to distal necrotic ulcers of ischemic origin. Physical examination revealed an 8×2-cm deep ulcer with abrupt edges on the left leg with fibrin and a purulent exudate. Deep palpation of the perilesional skin revealed indurated subcutaneous nodules. She also had scars on the fingertips of both hands with no induration on the rest of the skin surface. Capillaroscopy showed no pathologic findings. Blood cultures were performed, and she was admitted to the hospital for intravenous antibiotic therapy. During ulcer debridement, some solid whitish material was released.
CDC endorses Pfizer’s COVID-19 vaccine for young kids
– meaning the shots are now available for immediate use.
The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.
President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.
The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.
“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.
“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.
Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.
“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.
She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.
“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.
The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.
To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.
The CDC also addressed the question of kids who are close to age 12 when they get their first dose.
In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.
For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.
COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.
In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.
Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.
Weighing benefits and risks
In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.
These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.
No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.
Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.
Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.
Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.
Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.
Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.
The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.
What about benefits?
Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.
The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.
For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.
CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.
The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.
CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.
This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.
– meaning the shots are now available for immediate use.
The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.
President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.
The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.
“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.
“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.
Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.
“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.
She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.
“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.
The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.
To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.
The CDC also addressed the question of kids who are close to age 12 when they get their first dose.
In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.
For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.
COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.
In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.
Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.
Weighing benefits and risks
In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.
These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.
No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.
Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.
Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.
Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.
Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.
Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.
The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.
What about benefits?
Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.
The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.
For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.
CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.
The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.
CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.
This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.
– meaning the shots are now available for immediate use.
The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.
President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.
The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.
“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.
“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.
Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.
“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.
She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.
“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.
The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.
To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.
The CDC also addressed the question of kids who are close to age 12 when they get their first dose.
In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.
For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.
COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.
In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.
Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.
Weighing benefits and risks
In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.
These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.
No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.
Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.
Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.
Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.
Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.
Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.
The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.
What about benefits?
Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.
The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.
For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.
CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.
The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.
CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.
This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.
Expert shares eye protection tips for cutaneous laser surgery
Suzanne L. Kilmer, MD, will never forget the day when the center of her vision became blurry after performing cutaneous laser surgery.
The laser light reflected off the patient’s protective eye shield and caused a photo-induced foveal injury to Dr. Kilmer’s eye even though she was wearing protective goggles. “It was like the central part of my vision was browned out,” Dr. Kilmer, director of the Laser and Skin Surgery Center of Northern California, Sacramento, recalled during a virtual course on laser and aesthetic skin therapy. “My injury completely resolved, but you may not get so lucky. You can really get into trouble with longer pulse widths and higher-energy lasers.”
The injury occurred, she said, because the goggles she wore were sufficient for 1,064-nm wavelengths, but she was treating the patient with a 532 nm–wavelength laser. “I did not have the protection I needed,” she said. “You have to make sure to check the glasses yourself before you treat so that what happened to me doesn’t happen to you.”
Dr. Kilmer, who is also a clinical professor of dermatology at the University of California, Davis, said that during cutaneous laser surgery, “we want to pay attention all the time to minimize our risk.” She also recommended to make sure “all personnel in the room have had good safety training and have baseline eye exams. The door needs to be closed. The windows need to be covered, and you need a warning sign on the door that contains the specific wavelength, pulse width, and energy being used.”
The most important element of the sign, she added, pertains to the wavelength, because that determines the most appropriate goggles or eyewear to use “to ensure that you have an optical density high enough to protect your eyes.”
She advised using only eyewear designed for the specific laser wavelength being used, and to check the optical density prior to firing the laser. “You want the optical density to be greater than 4-6; you want as much protection as possible,” Dr. Kilmer said. “If you’re using a 1,064-nm laser and a 532-nm laser, you want glasses that protect you from both of those wavelengths. Multi- and dual-wavelength glasses are now available. The newer eyewear also allows you to see much better so there’s less risk with you taking it off the goggles [during the procedure].”
Dr. Kilmer recommends keeping a set of goggles outside of the procedure room door that matches every set of goggles being used in the room. “In one room, you may have several different lasers,” she said. “So you want some way to ‘attach’ the goggles to that particular laser, whether it’s a tray or some type of a coding system – some way to keep those together.”
For eye shield protection, the David-Baker lid clamp and the Jaeger plate are appropriate for ablative laser resurfacing, but most dermatologists use individual steel eye shields that are placed externally or internally. “Make sure you have different-sized eye shields on hand,” she advised during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine.
“Depending on what you’re performing, you will need anywhere from neonate size to larger adult size. Some adults may require child-size shields,” she said, noting that there are external eye shields that can be cleaned after each use. “But we tend to use LASER-Aid disposable eye shields, which have metal in the middle and stick over the eyelid. You only use these when you’re working outside of the orbital rim. If you’re treating within the orbital rim, you have to use an internal eye shield.”
She reported having no relevant financial disclosures related to her presentation.
Suzanne L. Kilmer, MD, will never forget the day when the center of her vision became blurry after performing cutaneous laser surgery.
The laser light reflected off the patient’s protective eye shield and caused a photo-induced foveal injury to Dr. Kilmer’s eye even though she was wearing protective goggles. “It was like the central part of my vision was browned out,” Dr. Kilmer, director of the Laser and Skin Surgery Center of Northern California, Sacramento, recalled during a virtual course on laser and aesthetic skin therapy. “My injury completely resolved, but you may not get so lucky. You can really get into trouble with longer pulse widths and higher-energy lasers.”
The injury occurred, she said, because the goggles she wore were sufficient for 1,064-nm wavelengths, but she was treating the patient with a 532 nm–wavelength laser. “I did not have the protection I needed,” she said. “You have to make sure to check the glasses yourself before you treat so that what happened to me doesn’t happen to you.”
Dr. Kilmer, who is also a clinical professor of dermatology at the University of California, Davis, said that during cutaneous laser surgery, “we want to pay attention all the time to minimize our risk.” She also recommended to make sure “all personnel in the room have had good safety training and have baseline eye exams. The door needs to be closed. The windows need to be covered, and you need a warning sign on the door that contains the specific wavelength, pulse width, and energy being used.”
The most important element of the sign, she added, pertains to the wavelength, because that determines the most appropriate goggles or eyewear to use “to ensure that you have an optical density high enough to protect your eyes.”
She advised using only eyewear designed for the specific laser wavelength being used, and to check the optical density prior to firing the laser. “You want the optical density to be greater than 4-6; you want as much protection as possible,” Dr. Kilmer said. “If you’re using a 1,064-nm laser and a 532-nm laser, you want glasses that protect you from both of those wavelengths. Multi- and dual-wavelength glasses are now available. The newer eyewear also allows you to see much better so there’s less risk with you taking it off the goggles [during the procedure].”
Dr. Kilmer recommends keeping a set of goggles outside of the procedure room door that matches every set of goggles being used in the room. “In one room, you may have several different lasers,” she said. “So you want some way to ‘attach’ the goggles to that particular laser, whether it’s a tray or some type of a coding system – some way to keep those together.”
For eye shield protection, the David-Baker lid clamp and the Jaeger plate are appropriate for ablative laser resurfacing, but most dermatologists use individual steel eye shields that are placed externally or internally. “Make sure you have different-sized eye shields on hand,” she advised during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine.
“Depending on what you’re performing, you will need anywhere from neonate size to larger adult size. Some adults may require child-size shields,” she said, noting that there are external eye shields that can be cleaned after each use. “But we tend to use LASER-Aid disposable eye shields, which have metal in the middle and stick over the eyelid. You only use these when you’re working outside of the orbital rim. If you’re treating within the orbital rim, you have to use an internal eye shield.”
She reported having no relevant financial disclosures related to her presentation.
Suzanne L. Kilmer, MD, will never forget the day when the center of her vision became blurry after performing cutaneous laser surgery.
The laser light reflected off the patient’s protective eye shield and caused a photo-induced foveal injury to Dr. Kilmer’s eye even though she was wearing protective goggles. “It was like the central part of my vision was browned out,” Dr. Kilmer, director of the Laser and Skin Surgery Center of Northern California, Sacramento, recalled during a virtual course on laser and aesthetic skin therapy. “My injury completely resolved, but you may not get so lucky. You can really get into trouble with longer pulse widths and higher-energy lasers.”
The injury occurred, she said, because the goggles she wore were sufficient for 1,064-nm wavelengths, but she was treating the patient with a 532 nm–wavelength laser. “I did not have the protection I needed,” she said. “You have to make sure to check the glasses yourself before you treat so that what happened to me doesn’t happen to you.”
Dr. Kilmer, who is also a clinical professor of dermatology at the University of California, Davis, said that during cutaneous laser surgery, “we want to pay attention all the time to minimize our risk.” She also recommended to make sure “all personnel in the room have had good safety training and have baseline eye exams. The door needs to be closed. The windows need to be covered, and you need a warning sign on the door that contains the specific wavelength, pulse width, and energy being used.”
The most important element of the sign, she added, pertains to the wavelength, because that determines the most appropriate goggles or eyewear to use “to ensure that you have an optical density high enough to protect your eyes.”
She advised using only eyewear designed for the specific laser wavelength being used, and to check the optical density prior to firing the laser. “You want the optical density to be greater than 4-6; you want as much protection as possible,” Dr. Kilmer said. “If you’re using a 1,064-nm laser and a 532-nm laser, you want glasses that protect you from both of those wavelengths. Multi- and dual-wavelength glasses are now available. The newer eyewear also allows you to see much better so there’s less risk with you taking it off the goggles [during the procedure].”
Dr. Kilmer recommends keeping a set of goggles outside of the procedure room door that matches every set of goggles being used in the room. “In one room, you may have several different lasers,” she said. “So you want some way to ‘attach’ the goggles to that particular laser, whether it’s a tray or some type of a coding system – some way to keep those together.”
For eye shield protection, the David-Baker lid clamp and the Jaeger plate are appropriate for ablative laser resurfacing, but most dermatologists use individual steel eye shields that are placed externally or internally. “Make sure you have different-sized eye shields on hand,” she advised during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine.
“Depending on what you’re performing, you will need anywhere from neonate size to larger adult size. Some adults may require child-size shields,” she said, noting that there are external eye shields that can be cleaned after each use. “But we tend to use LASER-Aid disposable eye shields, which have metal in the middle and stick over the eyelid. You only use these when you’re working outside of the orbital rim. If you’re treating within the orbital rim, you have to use an internal eye shield.”
She reported having no relevant financial disclosures related to her presentation.
FROM A LASER & AESTHETIC SKIN THERAPY COURSE
COVID-19 vaccines provide 5 times the protection of natural immunity, CDC study says
new study published recently in the CDC’s Morbidity and Mortality Weekly Report.
, according to aThe research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.
“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.
“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”
Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.
The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.
Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.
Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.
Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.
Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.
A version of this article first appeared on WebMD.com.
new study published recently in the CDC’s Morbidity and Mortality Weekly Report.
, according to aThe research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.
“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.
“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”
Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.
The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.
Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.
Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.
Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.
Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.
A version of this article first appeared on WebMD.com.
new study published recently in the CDC’s Morbidity and Mortality Weekly Report.
, according to aThe research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.
“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.
“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”
Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.
The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.
Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.
Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.
Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.
Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.
A version of this article first appeared on WebMD.com.
Hair follicle miniaturization common in persistent chemo-induced alopecia, case series suggests
and treatment with minoxidil (sometimes with antiandrogen therapy) was associated with improved hair density, according to a recently published retrospective case series.
“An improvement in hair density was observed in most of the patients treated with topical minoxidil or LDOM [low-dose oral minoxidil], with a more favorable outcome seen with LDOM with or without antiandrogens,” reported Bevin Bhoyrul, MBBS, of Sinclair Dermatology in Melbourne and coauthors from the United Kingdom and Germany.
The findings, published in JAMA Dermatology, suggest that pCIA “may be at least partly reversible,” they wrote.
The investigators analyzed the clinicopathologic characteristics of pCIA in 100 patients presenting to the hair clinics, as well as the results of trichoscopy performed in 90 of the patients and biopsies in 18. The researchers also assessed the effectiveness of treatment in 49 of these patients who met their criteria of completing at least 6 months of therapy with minoxidil.
Almost all patients in their series – 92% – were treated with taxanes and had more severe alopecia than those who weren’t exposed to taxanes (a median Sinclair scale grade of 4 vs. 2). Defined as absent or incomplete hair regrowth 6 months or more after completion of chemotherapy, pCIA has been increasingly reported in the literature, the authors note.
Of the 100 patients, all but one of whom were women, 39 had globally-reduced hair density that also involved the occipital area (diffuse alopecia), and 55 patients had thinning of the centroparietal scalp hair in a female pattern hair loss (FPHL) distribution. Patients presented between November 2011 and February 2020 and had a mean age of 54. The Sinclair scale, which grades from 1 to 5, was used to assess the severity of hair loss in these patients.
Five female patients had bitemporal recession or balding of the crown in a male pattern hair loss (MPHL) distribution, and the one male patient had extensive baldness resembling Hamilton-Norwood type VII.
The vast majority of patients who had trichoscopy performed – 88% – had trichoscopic features that were “indistinguishable from those of androgenetic alopecia,” most commonly hair shaft diameter variability, increased vellus hairs, and predominant single-hair follicular units, the authors reported.
Of the 18 patients who had biopsies, 14 had androgenetic alopecia-like features with decreased terminal hairs, increased vellus hairs, and fibrous streamers. The reduced terminal-to-vellus ratio characterizes hair follicle miniaturization, a hallmark of androgenetic alopecia, they said. (Two patients had cicatricial alopecia, and two had features of both.)
“The predominant phenotypes of pCIA show prominent vellus hairs both clinically and histologically, suggesting that terminal hair follicles undergo miniaturization,” Dr. Bhoyrul and coauthors wrote. Among the 49 patients who completed 6 months or more of treatment, the median Sinclair grade improved from 4 to 3 in 21 patients who received topical minoxidil for a median duration of 17 months; from 4 to 2.5 in 18 patients who received LDOM for a median duration of 29 months; and from 5 to 3 in 10 patients who received LDOM combined with an antiandrogen, such as spironolactone, for a median of 33 months.
Almost three-quarters of the patients in the series received adjuvant hormone therapy, which is independently associated with hair loss, the authors noted. However, there was no statistically significant difference in the pattern or severity of alopecia between patients who were treated with endocrine therapy and those who weren’t.
Asked to comment on the study and on the care of patients with pCIA, Maria K. Hordinsky, MD, professor and chair of dermatology at the University of Minnesota, Minneapolis, and an expert in hair diseases, said the case series points to the value of biopsies in patients with pCIA.
“Some patients really do have a loss of hair follicles,” she said. “But if you do a biopsy and see this miniaturization of the hair follicles, then we have tools to stimulate the hair follicles to become more normal. ... These patients can be successfully treated.”
For patients who do not want to do a biopsy, a therapeutic trial is acceptable. “But knowing helps set expectations for people,” she said. “If the follicles are really small, it will take months [of therapy].”
In addition to topical minoxidil, which she said “is always a good tool,” and LDOM, which is “becoming very popular,” Dr. Hordinsky has used low-level laser light successfully. She cautioned against the use of spironolactone and other hair-growth promoting therapies with potentially significant hormonal impacts unless there is discussion between the dermatologist, oncologist, and patient.
The authors of the case series called in their conclusion for wider use of hair-protective strategies such as scalp hypothermia. But Dr. Hordinsky said that, in the United States, there are divergent opinions among oncologists and among cancer centers on the use of scalp cooling and whether or not it might lessen response to chemotherapy.
More research is needed, she noted, on chemotherapy-induced hair loss in patients of different races and ethnicities. Of the 100 patients in the case series, 91 were European; others were Afro Caribbean, Middle Eastern, and South Asian.
Dr. Bhoyrul is supported by the Geoffrey Dowling Fellowship from the British Association of Dermatologists. One coauthor disclosed serving as a principal investigator and/or scientific board member for various pharmaceutical companies, outside of the submitted study. There were no other disclosures reported. Dr. Hordinsky, the immediate past president of the American Hair Research Society and a section editor for hair diseases in UpToDate, had no relevant disclosures.
and treatment with minoxidil (sometimes with antiandrogen therapy) was associated with improved hair density, according to a recently published retrospective case series.
“An improvement in hair density was observed in most of the patients treated with topical minoxidil or LDOM [low-dose oral minoxidil], with a more favorable outcome seen with LDOM with or without antiandrogens,” reported Bevin Bhoyrul, MBBS, of Sinclair Dermatology in Melbourne and coauthors from the United Kingdom and Germany.
The findings, published in JAMA Dermatology, suggest that pCIA “may be at least partly reversible,” they wrote.
The investigators analyzed the clinicopathologic characteristics of pCIA in 100 patients presenting to the hair clinics, as well as the results of trichoscopy performed in 90 of the patients and biopsies in 18. The researchers also assessed the effectiveness of treatment in 49 of these patients who met their criteria of completing at least 6 months of therapy with minoxidil.
Almost all patients in their series – 92% – were treated with taxanes and had more severe alopecia than those who weren’t exposed to taxanes (a median Sinclair scale grade of 4 vs. 2). Defined as absent or incomplete hair regrowth 6 months or more after completion of chemotherapy, pCIA has been increasingly reported in the literature, the authors note.
Of the 100 patients, all but one of whom were women, 39 had globally-reduced hair density that also involved the occipital area (diffuse alopecia), and 55 patients had thinning of the centroparietal scalp hair in a female pattern hair loss (FPHL) distribution. Patients presented between November 2011 and February 2020 and had a mean age of 54. The Sinclair scale, which grades from 1 to 5, was used to assess the severity of hair loss in these patients.
Five female patients had bitemporal recession or balding of the crown in a male pattern hair loss (MPHL) distribution, and the one male patient had extensive baldness resembling Hamilton-Norwood type VII.
The vast majority of patients who had trichoscopy performed – 88% – had trichoscopic features that were “indistinguishable from those of androgenetic alopecia,” most commonly hair shaft diameter variability, increased vellus hairs, and predominant single-hair follicular units, the authors reported.
Of the 18 patients who had biopsies, 14 had androgenetic alopecia-like features with decreased terminal hairs, increased vellus hairs, and fibrous streamers. The reduced terminal-to-vellus ratio characterizes hair follicle miniaturization, a hallmark of androgenetic alopecia, they said. (Two patients had cicatricial alopecia, and two had features of both.)
“The predominant phenotypes of pCIA show prominent vellus hairs both clinically and histologically, suggesting that terminal hair follicles undergo miniaturization,” Dr. Bhoyrul and coauthors wrote. Among the 49 patients who completed 6 months or more of treatment, the median Sinclair grade improved from 4 to 3 in 21 patients who received topical minoxidil for a median duration of 17 months; from 4 to 2.5 in 18 patients who received LDOM for a median duration of 29 months; and from 5 to 3 in 10 patients who received LDOM combined with an antiandrogen, such as spironolactone, for a median of 33 months.
Almost three-quarters of the patients in the series received adjuvant hormone therapy, which is independently associated with hair loss, the authors noted. However, there was no statistically significant difference in the pattern or severity of alopecia between patients who were treated with endocrine therapy and those who weren’t.
Asked to comment on the study and on the care of patients with pCIA, Maria K. Hordinsky, MD, professor and chair of dermatology at the University of Minnesota, Minneapolis, and an expert in hair diseases, said the case series points to the value of biopsies in patients with pCIA.
“Some patients really do have a loss of hair follicles,” she said. “But if you do a biopsy and see this miniaturization of the hair follicles, then we have tools to stimulate the hair follicles to become more normal. ... These patients can be successfully treated.”
For patients who do not want to do a biopsy, a therapeutic trial is acceptable. “But knowing helps set expectations for people,” she said. “If the follicles are really small, it will take months [of therapy].”
In addition to topical minoxidil, which she said “is always a good tool,” and LDOM, which is “becoming very popular,” Dr. Hordinsky has used low-level laser light successfully. She cautioned against the use of spironolactone and other hair-growth promoting therapies with potentially significant hormonal impacts unless there is discussion between the dermatologist, oncologist, and patient.
The authors of the case series called in their conclusion for wider use of hair-protective strategies such as scalp hypothermia. But Dr. Hordinsky said that, in the United States, there are divergent opinions among oncologists and among cancer centers on the use of scalp cooling and whether or not it might lessen response to chemotherapy.
More research is needed, she noted, on chemotherapy-induced hair loss in patients of different races and ethnicities. Of the 100 patients in the case series, 91 were European; others were Afro Caribbean, Middle Eastern, and South Asian.
Dr. Bhoyrul is supported by the Geoffrey Dowling Fellowship from the British Association of Dermatologists. One coauthor disclosed serving as a principal investigator and/or scientific board member for various pharmaceutical companies, outside of the submitted study. There were no other disclosures reported. Dr. Hordinsky, the immediate past president of the American Hair Research Society and a section editor for hair diseases in UpToDate, had no relevant disclosures.
and treatment with minoxidil (sometimes with antiandrogen therapy) was associated with improved hair density, according to a recently published retrospective case series.
“An improvement in hair density was observed in most of the patients treated with topical minoxidil or LDOM [low-dose oral minoxidil], with a more favorable outcome seen with LDOM with or without antiandrogens,” reported Bevin Bhoyrul, MBBS, of Sinclair Dermatology in Melbourne and coauthors from the United Kingdom and Germany.
The findings, published in JAMA Dermatology, suggest that pCIA “may be at least partly reversible,” they wrote.
The investigators analyzed the clinicopathologic characteristics of pCIA in 100 patients presenting to the hair clinics, as well as the results of trichoscopy performed in 90 of the patients and biopsies in 18. The researchers also assessed the effectiveness of treatment in 49 of these patients who met their criteria of completing at least 6 months of therapy with minoxidil.
Almost all patients in their series – 92% – were treated with taxanes and had more severe alopecia than those who weren’t exposed to taxanes (a median Sinclair scale grade of 4 vs. 2). Defined as absent or incomplete hair regrowth 6 months or more after completion of chemotherapy, pCIA has been increasingly reported in the literature, the authors note.
Of the 100 patients, all but one of whom were women, 39 had globally-reduced hair density that also involved the occipital area (diffuse alopecia), and 55 patients had thinning of the centroparietal scalp hair in a female pattern hair loss (FPHL) distribution. Patients presented between November 2011 and February 2020 and had a mean age of 54. The Sinclair scale, which grades from 1 to 5, was used to assess the severity of hair loss in these patients.
Five female patients had bitemporal recession or balding of the crown in a male pattern hair loss (MPHL) distribution, and the one male patient had extensive baldness resembling Hamilton-Norwood type VII.
The vast majority of patients who had trichoscopy performed – 88% – had trichoscopic features that were “indistinguishable from those of androgenetic alopecia,” most commonly hair shaft diameter variability, increased vellus hairs, and predominant single-hair follicular units, the authors reported.
Of the 18 patients who had biopsies, 14 had androgenetic alopecia-like features with decreased terminal hairs, increased vellus hairs, and fibrous streamers. The reduced terminal-to-vellus ratio characterizes hair follicle miniaturization, a hallmark of androgenetic alopecia, they said. (Two patients had cicatricial alopecia, and two had features of both.)
“The predominant phenotypes of pCIA show prominent vellus hairs both clinically and histologically, suggesting that terminal hair follicles undergo miniaturization,” Dr. Bhoyrul and coauthors wrote. Among the 49 patients who completed 6 months or more of treatment, the median Sinclair grade improved from 4 to 3 in 21 patients who received topical minoxidil for a median duration of 17 months; from 4 to 2.5 in 18 patients who received LDOM for a median duration of 29 months; and from 5 to 3 in 10 patients who received LDOM combined with an antiandrogen, such as spironolactone, for a median of 33 months.
Almost three-quarters of the patients in the series received adjuvant hormone therapy, which is independently associated with hair loss, the authors noted. However, there was no statistically significant difference in the pattern or severity of alopecia between patients who were treated with endocrine therapy and those who weren’t.
Asked to comment on the study and on the care of patients with pCIA, Maria K. Hordinsky, MD, professor and chair of dermatology at the University of Minnesota, Minneapolis, and an expert in hair diseases, said the case series points to the value of biopsies in patients with pCIA.
“Some patients really do have a loss of hair follicles,” she said. “But if you do a biopsy and see this miniaturization of the hair follicles, then we have tools to stimulate the hair follicles to become more normal. ... These patients can be successfully treated.”
For patients who do not want to do a biopsy, a therapeutic trial is acceptable. “But knowing helps set expectations for people,” she said. “If the follicles are really small, it will take months [of therapy].”
In addition to topical minoxidil, which she said “is always a good tool,” and LDOM, which is “becoming very popular,” Dr. Hordinsky has used low-level laser light successfully. She cautioned against the use of spironolactone and other hair-growth promoting therapies with potentially significant hormonal impacts unless there is discussion between the dermatologist, oncologist, and patient.
The authors of the case series called in their conclusion for wider use of hair-protective strategies such as scalp hypothermia. But Dr. Hordinsky said that, in the United States, there are divergent opinions among oncologists and among cancer centers on the use of scalp cooling and whether or not it might lessen response to chemotherapy.
More research is needed, she noted, on chemotherapy-induced hair loss in patients of different races and ethnicities. Of the 100 patients in the case series, 91 were European; others were Afro Caribbean, Middle Eastern, and South Asian.
Dr. Bhoyrul is supported by the Geoffrey Dowling Fellowship from the British Association of Dermatologists. One coauthor disclosed serving as a principal investigator and/or scientific board member for various pharmaceutical companies, outside of the submitted study. There were no other disclosures reported. Dr. Hordinsky, the immediate past president of the American Hair Research Society and a section editor for hair diseases in UpToDate, had no relevant disclosures.
FROM JAMA DERMATOLOGY
Clinical Edge Journal Scan Commentary: Psoriasis November 2021
Biologic therapy is generally reserved for patients with more moderate-to-severe psoriasis, often defined as BSA ≥10% or PASI of ≥10. Notably, these criteria are all clinician-performed. The Dermatology Life Quality Index (DLQI) measures the impact of the disease on the patient with a score of 0-5, 6-10, and 11-30 indicating mild, moderate, and severe disease, respectively. In a cross-sectional, observational study, 72.4% of psoriasis patients who qualified for systemic therapy initiation based on PASI and/or BSA had a DLQI of less than 10. Conversely, 10.4% of patients with a DLQI score higher than 10 did not qualify for systemic therapy based on PASI and/or BSA. This study highlights the complementary value of considering both clinician and patient determinants of disease severity when choosing a psoriasis therapy (Barbieri JS et al.)
With so many therapeutic options, it is increasingly common for patients to switch from one biologic to another. Many factors that go into the decision to switch therapies. A retrospective study of 115 adult patients with psoriasis found that the primary factor driving switching was lack of sufficient efficacy in treating skin disease. Having concomitant psoriatic arthritis increased the likelihood of switching by 2.69-fold (Akdogan N et al.). These findings suggest that shared decision making with dermatology, rheumatology, and the patient may help in choosing a treatment plan that best addresses both skin and joints.
One consideration when counseling patients about their likelihood of response to a second or third biologic is that in several clinical trials, biologic-naïve patients tend to have higher PASI responses to biologics than do heavier and biologic-experienced patients. A recent retrospective study found that receiving one or more biologic receiving was associated with a lower likelihood of achieving a PASI75 response to guselkumab (Hung YT et al.). However, in a real-life multicenter study including 57 adult patients with moderate-to-severe psoriasis receiving risankizumab, more biologic-experienced patients reached PASI 100 at weeks 36 and 52 (71.8% and 69.2%, respectively) compared with biologic-naïve patients (50.0% and 37.5%, respectively) (Gerdes S et al.). While both studies were small and no firm conclusions or comparisons can be drawn, real-world data from large multicenter studies that evaluate multiple therapies may guide us in choosing the best therapy for challenging patients who are often underrepresented in clinical trials. Understanding how switching within vs. between classes (TNF, IL-17, and IL-23 inhibitors) impacts efficacy will also help in making choices about biologic switches.
Biologic therapy is generally reserved for patients with more moderate-to-severe psoriasis, often defined as BSA ≥10% or PASI of ≥10. Notably, these criteria are all clinician-performed. The Dermatology Life Quality Index (DLQI) measures the impact of the disease on the patient with a score of 0-5, 6-10, and 11-30 indicating mild, moderate, and severe disease, respectively. In a cross-sectional, observational study, 72.4% of psoriasis patients who qualified for systemic therapy initiation based on PASI and/or BSA had a DLQI of less than 10. Conversely, 10.4% of patients with a DLQI score higher than 10 did not qualify for systemic therapy based on PASI and/or BSA. This study highlights the complementary value of considering both clinician and patient determinants of disease severity when choosing a psoriasis therapy (Barbieri JS et al.)
With so many therapeutic options, it is increasingly common for patients to switch from one biologic to another. Many factors that go into the decision to switch therapies. A retrospective study of 115 adult patients with psoriasis found that the primary factor driving switching was lack of sufficient efficacy in treating skin disease. Having concomitant psoriatic arthritis increased the likelihood of switching by 2.69-fold (Akdogan N et al.). These findings suggest that shared decision making with dermatology, rheumatology, and the patient may help in choosing a treatment plan that best addresses both skin and joints.
One consideration when counseling patients about their likelihood of response to a second or third biologic is that in several clinical trials, biologic-naïve patients tend to have higher PASI responses to biologics than do heavier and biologic-experienced patients. A recent retrospective study found that receiving one or more biologic receiving was associated with a lower likelihood of achieving a PASI75 response to guselkumab (Hung YT et al.). However, in a real-life multicenter study including 57 adult patients with moderate-to-severe psoriasis receiving risankizumab, more biologic-experienced patients reached PASI 100 at weeks 36 and 52 (71.8% and 69.2%, respectively) compared with biologic-naïve patients (50.0% and 37.5%, respectively) (Gerdes S et al.). While both studies were small and no firm conclusions or comparisons can be drawn, real-world data from large multicenter studies that evaluate multiple therapies may guide us in choosing the best therapy for challenging patients who are often underrepresented in clinical trials. Understanding how switching within vs. between classes (TNF, IL-17, and IL-23 inhibitors) impacts efficacy will also help in making choices about biologic switches.
Biologic therapy is generally reserved for patients with more moderate-to-severe psoriasis, often defined as BSA ≥10% or PASI of ≥10. Notably, these criteria are all clinician-performed. The Dermatology Life Quality Index (DLQI) measures the impact of the disease on the patient with a score of 0-5, 6-10, and 11-30 indicating mild, moderate, and severe disease, respectively. In a cross-sectional, observational study, 72.4% of psoriasis patients who qualified for systemic therapy initiation based on PASI and/or BSA had a DLQI of less than 10. Conversely, 10.4% of patients with a DLQI score higher than 10 did not qualify for systemic therapy based on PASI and/or BSA. This study highlights the complementary value of considering both clinician and patient determinants of disease severity when choosing a psoriasis therapy (Barbieri JS et al.)
With so many therapeutic options, it is increasingly common for patients to switch from one biologic to another. Many factors that go into the decision to switch therapies. A retrospective study of 115 adult patients with psoriasis found that the primary factor driving switching was lack of sufficient efficacy in treating skin disease. Having concomitant psoriatic arthritis increased the likelihood of switching by 2.69-fold (Akdogan N et al.). These findings suggest that shared decision making with dermatology, rheumatology, and the patient may help in choosing a treatment plan that best addresses both skin and joints.
One consideration when counseling patients about their likelihood of response to a second or third biologic is that in several clinical trials, biologic-naïve patients tend to have higher PASI responses to biologics than do heavier and biologic-experienced patients. A recent retrospective study found that receiving one or more biologic receiving was associated with a lower likelihood of achieving a PASI75 response to guselkumab (Hung YT et al.). However, in a real-life multicenter study including 57 adult patients with moderate-to-severe psoriasis receiving risankizumab, more biologic-experienced patients reached PASI 100 at weeks 36 and 52 (71.8% and 69.2%, respectively) compared with biologic-naïve patients (50.0% and 37.5%, respectively) (Gerdes S et al.). While both studies were small and no firm conclusions or comparisons can be drawn, real-world data from large multicenter studies that evaluate multiple therapies may guide us in choosing the best therapy for challenging patients who are often underrepresented in clinical trials. Understanding how switching within vs. between classes (TNF, IL-17, and IL-23 inhibitors) impacts efficacy will also help in making choices about biologic switches.
ERs are swamped with seriously ill patients, although many don’t have COVID
Inside the emergency department at Sparrow Hospital in Lansing, Mich., staff members are struggling to care for patients showing up much sicker than they’ve ever seen.
Tiffani Dusang, the ER’s nursing director, practically vibrates with pent-up anxiety, looking at patients lying on a long line of stretchers pushed up against the beige walls of the hospital hallways. “It’s hard to watch,” she said in a warm Texas twang.
But there’s nothing she can do. The ER’s 72 rooms are already filled.
“I always feel very, very bad when I walk down the hallway and see that people are in pain, or needing to sleep, or needing quiet. But they have to be in the hallway with, as you can see, 10 or 15 people walking by every minute,” Ms. Dusang said.
The scene is a stark contrast to where this emergency department — and thousands of others — were at the start of the pandemic. Except for initial hot spots like New York City, in spring 2020 many ERs across the country were often eerily empty. Terrified of contracting COVID-19, people who were sick with other things did their best to stay away from hospitals. Visits to emergency rooms dropped to half their typical levels, according to the Epic Health Research Network, and didn’t fully rebound until this summer.
But now, they’re too full.
Months of treatment delays have exacerbated chronic conditions and worsened symptoms. Doctors and nurses say the severity of illness ranges widely and includes abdominal pain, respiratory problems, blood clots, heart conditions and suicide attempts, among other conditions.
But they can hardly be accommodated. Emergency departments, ideally, are meant to be brief ports in a storm, with patients staying just long enough to be sent home with instructions to follow up with primary care physicians, or sufficiently stabilized to be transferred “upstairs” to inpatient or intensive care units.
Except now those long-term care floors are full too, with a mix of covid and non-covid patients. People coming to the ER get warehoused for hours, even days, forcing ER staffers to perform long-term care roles they weren’t trained to do.
At Sparrow, space is a valuable commodity in the ER: A separate section of the hospital was turned into an overflow unit. Stretchers stack up in halls. A row of brown reclining chairs lines a wall, intended for patients who aren’t sick enough for a stretcher but are too sick to stay in the main waiting room.
Forget privacy, Alejos Perrientoz learned when he arrived. He came to the ER because his arm had been tingling and painful for over a week. He couldn’t hold a cup of coffee. A nurse gave him a full physical exam in a brown recliner, which made him self-conscious about having his shirt lifted in front of strangers. “I felt a little uncomfortable,” he whispered. “But I have no choice, you know? I’m in the hallway. There’s no rooms.
“We could have done the physical in the parking lot,” he added, managing a laugh.
Even patients who arrive by ambulance are not guaranteed a room: One nurse runs triage, screening those who absolutely need a bed, and those who can be put in the waiting area.
“I hate that we even have to make that determination,” MS. Dusang said. Lately, staff members have been pulling out some patients already in the ER’s rooms when others arrive who are more critically ill. “No one likes to take someone out of the privacy of their room and say, ‘We’re going to put you in a hallway because we need to get care to someone else.’”
ER patients have grown sicker
“We are hearing from members in every part of the country,” said Dr. Lisa Moreno, president of the American Academy of Emergency Medicine. “The Midwest, the South, the Northeast, the West … they are seeing this exact same phenomenon.”
Although the number of ER visits returned to pre-COVID levels this summer, admission rates, from the ER to the hospital’s inpatient floors, are still almost 20% higher. That’s according to the most recent analysis by the Epic Health Research Network, which pulls data from more than 120 million patients across the country.
“It’s an early indicator that what’s happening in the ED is that we’re seeing more acute cases than we were pre-pandemic,” said Caleb Cox, a data scientist at Epic.
Less acute cases, such as people with health issues like rashes or conjunctivitis, still aren’t going to the ER as much as they used to. Instead, they may be opting for an urgent care center or their primary care doctor, Mr. Cox explained. Meanwhile, there has been an increase in people coming to the ER with more serious conditions, like strokes and heart attacks.
So, even though the total number of patients coming to ERs is about the same as before the pandemic, “that’s absolutely going to feel like [if I’m an ER doctor or nurse] I’m seeing more patients and I’m seeing more acute patients,” Mr. Cox said.
Dr. Moreno, the AAEM president, works at an emergency department in New Orleans. She said the level of illness, and the inability to admit patients quickly and move them to beds upstairs, has created a level of chaos she described as “not even humane.”
At the beginning of a recent shift, she heard a patient crying nearby and went to investigate. It was a paraplegic man who’d recently had surgery for colon cancer. His large post-operative wound was sealed with a device called a wound vac, which pulls fluid from the wound into a drainage tube attached to a portable vacuum pump.
But the wound vac had malfunctioned, which is why he had come to the ER. Staffers were so busy, however, that by the time Dr. Moreno came in, the fluid from his wound was leaking everywhere.
“When I went in, the bed was covered,” she recalled. “I mean, he was lying in a puddle of secretions from this wound. And he was crying, because he said to me, ‘I’m paralyzed. I can’t move to get away from all these secretions, and I know I’m going to end up getting an infection. I know I’m going to end up getting an ulcer. I’ve been laying in this for, like, eight or nine hours.’”
The nurse in charge of his care told Dr. Moreno she simply hadn’t had time to help this patient yet. “She said, ‘I’ve had so many patients to take care of, and so many critical patients. I started [an IV] drip on this person. This person is on a cardiac monitor. I just didn’t have time to get in there.’”
“This is not humane care,” Dr. Moreno said. “This is horrible care.”
But it’s what can happen when emergency department staffers don’t have the resources they need to deal with the onslaught of competing demands.
“All the nurses and doctors had the highest level of intent to do the right thing for the person,” Dr. Moreno said. “But because of the high acuity of … a large number of patients, the staffing ratio of nurse to patient, even the staffing ratio of doctor to patient, this guy did not get the care that he deserved to get, just as a human being.”
The instance of unintended neglect that Dr. Moreno saw is extreme, and not the experience of most patients who arrive at ERs these days. But the problem is not new: Even before the pandemic, ER overcrowding had been a “widespread problem and a source of patient harm, according to a recent commentary in NEJM Catalyst Innovations in Care Delivery.
“ED crowding is not an issue of inconvenience,” the authors wrote. “There is incontrovertible evidence that ED crowding leads to significant patient harm, including morbidity and mortality related to consequential delays of treatment for both high- and low-acuity patients.”
And already-overwhelmed staffers are burning out.
Burnout feeds staffing shortages, and vice versa
Every morning, Tiffani Dusang wakes up and checks her Sparrow email with one singular hope: that she will not see yet another nurse resignation letter in her inbox.
“I cannot tell you how many of them [the nurses] tell me they went home crying” after their shifts, she said.
Despite Ms. Dusang’s best efforts to support her staffers, they’re leaving too fast to be replaced, either to take higher-paying gigs as a travel nurse, to try a less-stressful type of nursing, or simply walking away from the profession entirely.
Kelly Spitz has been an emergency department nurse at Sparrow for 10 years. But, lately, she has also fantasized about leaving. “It has crossed my mind several times,” she said, and yet she continues to come back. “Because I have a team here. And I love what I do.” But then she started to cry. The issue is not the hard work, or even the stress. She struggles with not being able to give her patients the kind of care and attention she wants to give them, and that they need and deserve, she said.
She often thinks about a patient whose test results revealed terminal cancer, she said. Ms. Spitz spent all day working the phones, hustling case managers, trying to get hospice care set up in the man’s home. He was going to die, and she just didn’t want him to have to die in the hospital, where only one visitor was allowed. She wanted to get him home, and back with his family.
Finally, after many hours, they found an ambulance to take him home.
Three days later, the man’s family members called Ms. Spitz: He had died surrounded by family. They were calling to thank her.
“I felt like I did my job there, because I got him home,” she said. But that’s a rare feeling these days. “I just hope it gets better. I hope it gets better soon.”
Around 4 p.m. at Sparrow Hospital as one shift approached its end, Ms. Dusang faced a new crisis: The overnight shift was more short-staffed than usual.
“Can we get two inpatient nurses?” she asked, hoping to borrow two nurses from one of the hospital floors upstairs.
“Already tried,” replied nurse Troy Latunski.
Without more staff, it’s going to be hard to care for new patients who come in overnight — from car crashes to seizures or other emergencies.
But Mr. Latunski had a plan: He would go home, snatch a few hours of sleep and return at 11 p.m. to work the overnight shift in the ER’s overflow unit. That meant he would be largely caring for eight patients, alone. On just a few short hours of sleep. But lately that seemed to be their only, and best, option.
Ms. Dusang considered for a moment, took a deep breath and nodded. “OK,” she said.
“Go home. Get some sleep. Thank you,” she added, shooting Mr. Latunski a grateful smile. And then she pivoted, because another nurse was approaching with an urgent question. On to the next crisis.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. This story is part of a partnership that includes Michigan Radio, NPR and KHN.
Inside the emergency department at Sparrow Hospital in Lansing, Mich., staff members are struggling to care for patients showing up much sicker than they’ve ever seen.
Tiffani Dusang, the ER’s nursing director, practically vibrates with pent-up anxiety, looking at patients lying on a long line of stretchers pushed up against the beige walls of the hospital hallways. “It’s hard to watch,” she said in a warm Texas twang.
But there’s nothing she can do. The ER’s 72 rooms are already filled.
“I always feel very, very bad when I walk down the hallway and see that people are in pain, or needing to sleep, or needing quiet. But they have to be in the hallway with, as you can see, 10 or 15 people walking by every minute,” Ms. Dusang said.
The scene is a stark contrast to where this emergency department — and thousands of others — were at the start of the pandemic. Except for initial hot spots like New York City, in spring 2020 many ERs across the country were often eerily empty. Terrified of contracting COVID-19, people who were sick with other things did their best to stay away from hospitals. Visits to emergency rooms dropped to half their typical levels, according to the Epic Health Research Network, and didn’t fully rebound until this summer.
But now, they’re too full.
Months of treatment delays have exacerbated chronic conditions and worsened symptoms. Doctors and nurses say the severity of illness ranges widely and includes abdominal pain, respiratory problems, blood clots, heart conditions and suicide attempts, among other conditions.
But they can hardly be accommodated. Emergency departments, ideally, are meant to be brief ports in a storm, with patients staying just long enough to be sent home with instructions to follow up with primary care physicians, or sufficiently stabilized to be transferred “upstairs” to inpatient or intensive care units.
Except now those long-term care floors are full too, with a mix of covid and non-covid patients. People coming to the ER get warehoused for hours, even days, forcing ER staffers to perform long-term care roles they weren’t trained to do.
At Sparrow, space is a valuable commodity in the ER: A separate section of the hospital was turned into an overflow unit. Stretchers stack up in halls. A row of brown reclining chairs lines a wall, intended for patients who aren’t sick enough for a stretcher but are too sick to stay in the main waiting room.
Forget privacy, Alejos Perrientoz learned when he arrived. He came to the ER because his arm had been tingling and painful for over a week. He couldn’t hold a cup of coffee. A nurse gave him a full physical exam in a brown recliner, which made him self-conscious about having his shirt lifted in front of strangers. “I felt a little uncomfortable,” he whispered. “But I have no choice, you know? I’m in the hallway. There’s no rooms.
“We could have done the physical in the parking lot,” he added, managing a laugh.
Even patients who arrive by ambulance are not guaranteed a room: One nurse runs triage, screening those who absolutely need a bed, and those who can be put in the waiting area.
“I hate that we even have to make that determination,” MS. Dusang said. Lately, staff members have been pulling out some patients already in the ER’s rooms when others arrive who are more critically ill. “No one likes to take someone out of the privacy of their room and say, ‘We’re going to put you in a hallway because we need to get care to someone else.’”
ER patients have grown sicker
“We are hearing from members in every part of the country,” said Dr. Lisa Moreno, president of the American Academy of Emergency Medicine. “The Midwest, the South, the Northeast, the West … they are seeing this exact same phenomenon.”
Although the number of ER visits returned to pre-COVID levels this summer, admission rates, from the ER to the hospital’s inpatient floors, are still almost 20% higher. That’s according to the most recent analysis by the Epic Health Research Network, which pulls data from more than 120 million patients across the country.
“It’s an early indicator that what’s happening in the ED is that we’re seeing more acute cases than we were pre-pandemic,” said Caleb Cox, a data scientist at Epic.
Less acute cases, such as people with health issues like rashes or conjunctivitis, still aren’t going to the ER as much as they used to. Instead, they may be opting for an urgent care center or their primary care doctor, Mr. Cox explained. Meanwhile, there has been an increase in people coming to the ER with more serious conditions, like strokes and heart attacks.
So, even though the total number of patients coming to ERs is about the same as before the pandemic, “that’s absolutely going to feel like [if I’m an ER doctor or nurse] I’m seeing more patients and I’m seeing more acute patients,” Mr. Cox said.
Dr. Moreno, the AAEM president, works at an emergency department in New Orleans. She said the level of illness, and the inability to admit patients quickly and move them to beds upstairs, has created a level of chaos she described as “not even humane.”
At the beginning of a recent shift, she heard a patient crying nearby and went to investigate. It was a paraplegic man who’d recently had surgery for colon cancer. His large post-operative wound was sealed with a device called a wound vac, which pulls fluid from the wound into a drainage tube attached to a portable vacuum pump.
But the wound vac had malfunctioned, which is why he had come to the ER. Staffers were so busy, however, that by the time Dr. Moreno came in, the fluid from his wound was leaking everywhere.
“When I went in, the bed was covered,” she recalled. “I mean, he was lying in a puddle of secretions from this wound. And he was crying, because he said to me, ‘I’m paralyzed. I can’t move to get away from all these secretions, and I know I’m going to end up getting an infection. I know I’m going to end up getting an ulcer. I’ve been laying in this for, like, eight or nine hours.’”
The nurse in charge of his care told Dr. Moreno she simply hadn’t had time to help this patient yet. “She said, ‘I’ve had so many patients to take care of, and so many critical patients. I started [an IV] drip on this person. This person is on a cardiac monitor. I just didn’t have time to get in there.’”
“This is not humane care,” Dr. Moreno said. “This is horrible care.”
But it’s what can happen when emergency department staffers don’t have the resources they need to deal with the onslaught of competing demands.
“All the nurses and doctors had the highest level of intent to do the right thing for the person,” Dr. Moreno said. “But because of the high acuity of … a large number of patients, the staffing ratio of nurse to patient, even the staffing ratio of doctor to patient, this guy did not get the care that he deserved to get, just as a human being.”
The instance of unintended neglect that Dr. Moreno saw is extreme, and not the experience of most patients who arrive at ERs these days. But the problem is not new: Even before the pandemic, ER overcrowding had been a “widespread problem and a source of patient harm, according to a recent commentary in NEJM Catalyst Innovations in Care Delivery.
“ED crowding is not an issue of inconvenience,” the authors wrote. “There is incontrovertible evidence that ED crowding leads to significant patient harm, including morbidity and mortality related to consequential delays of treatment for both high- and low-acuity patients.”
And already-overwhelmed staffers are burning out.
Burnout feeds staffing shortages, and vice versa
Every morning, Tiffani Dusang wakes up and checks her Sparrow email with one singular hope: that she will not see yet another nurse resignation letter in her inbox.
“I cannot tell you how many of them [the nurses] tell me they went home crying” after their shifts, she said.
Despite Ms. Dusang’s best efforts to support her staffers, they’re leaving too fast to be replaced, either to take higher-paying gigs as a travel nurse, to try a less-stressful type of nursing, or simply walking away from the profession entirely.
Kelly Spitz has been an emergency department nurse at Sparrow for 10 years. But, lately, she has also fantasized about leaving. “It has crossed my mind several times,” she said, and yet she continues to come back. “Because I have a team here. And I love what I do.” But then she started to cry. The issue is not the hard work, or even the stress. She struggles with not being able to give her patients the kind of care and attention she wants to give them, and that they need and deserve, she said.
She often thinks about a patient whose test results revealed terminal cancer, she said. Ms. Spitz spent all day working the phones, hustling case managers, trying to get hospice care set up in the man’s home. He was going to die, and she just didn’t want him to have to die in the hospital, where only one visitor was allowed. She wanted to get him home, and back with his family.
Finally, after many hours, they found an ambulance to take him home.
Three days later, the man’s family members called Ms. Spitz: He had died surrounded by family. They were calling to thank her.
“I felt like I did my job there, because I got him home,” she said. But that’s a rare feeling these days. “I just hope it gets better. I hope it gets better soon.”
Around 4 p.m. at Sparrow Hospital as one shift approached its end, Ms. Dusang faced a new crisis: The overnight shift was more short-staffed than usual.
“Can we get two inpatient nurses?” she asked, hoping to borrow two nurses from one of the hospital floors upstairs.
“Already tried,” replied nurse Troy Latunski.
Without more staff, it’s going to be hard to care for new patients who come in overnight — from car crashes to seizures or other emergencies.
But Mr. Latunski had a plan: He would go home, snatch a few hours of sleep and return at 11 p.m. to work the overnight shift in the ER’s overflow unit. That meant he would be largely caring for eight patients, alone. On just a few short hours of sleep. But lately that seemed to be their only, and best, option.
Ms. Dusang considered for a moment, took a deep breath and nodded. “OK,” she said.
“Go home. Get some sleep. Thank you,” she added, shooting Mr. Latunski a grateful smile. And then she pivoted, because another nurse was approaching with an urgent question. On to the next crisis.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. This story is part of a partnership that includes Michigan Radio, NPR and KHN.
Inside the emergency department at Sparrow Hospital in Lansing, Mich., staff members are struggling to care for patients showing up much sicker than they’ve ever seen.
Tiffani Dusang, the ER’s nursing director, practically vibrates with pent-up anxiety, looking at patients lying on a long line of stretchers pushed up against the beige walls of the hospital hallways. “It’s hard to watch,” she said in a warm Texas twang.
But there’s nothing she can do. The ER’s 72 rooms are already filled.
“I always feel very, very bad when I walk down the hallway and see that people are in pain, or needing to sleep, or needing quiet. But they have to be in the hallway with, as you can see, 10 or 15 people walking by every minute,” Ms. Dusang said.
The scene is a stark contrast to where this emergency department — and thousands of others — were at the start of the pandemic. Except for initial hot spots like New York City, in spring 2020 many ERs across the country were often eerily empty. Terrified of contracting COVID-19, people who were sick with other things did their best to stay away from hospitals. Visits to emergency rooms dropped to half their typical levels, according to the Epic Health Research Network, and didn’t fully rebound until this summer.
But now, they’re too full.
Months of treatment delays have exacerbated chronic conditions and worsened symptoms. Doctors and nurses say the severity of illness ranges widely and includes abdominal pain, respiratory problems, blood clots, heart conditions and suicide attempts, among other conditions.
But they can hardly be accommodated. Emergency departments, ideally, are meant to be brief ports in a storm, with patients staying just long enough to be sent home with instructions to follow up with primary care physicians, or sufficiently stabilized to be transferred “upstairs” to inpatient or intensive care units.
Except now those long-term care floors are full too, with a mix of covid and non-covid patients. People coming to the ER get warehoused for hours, even days, forcing ER staffers to perform long-term care roles they weren’t trained to do.
At Sparrow, space is a valuable commodity in the ER: A separate section of the hospital was turned into an overflow unit. Stretchers stack up in halls. A row of brown reclining chairs lines a wall, intended for patients who aren’t sick enough for a stretcher but are too sick to stay in the main waiting room.
Forget privacy, Alejos Perrientoz learned when he arrived. He came to the ER because his arm had been tingling and painful for over a week. He couldn’t hold a cup of coffee. A nurse gave him a full physical exam in a brown recliner, which made him self-conscious about having his shirt lifted in front of strangers. “I felt a little uncomfortable,” he whispered. “But I have no choice, you know? I’m in the hallway. There’s no rooms.
“We could have done the physical in the parking lot,” he added, managing a laugh.
Even patients who arrive by ambulance are not guaranteed a room: One nurse runs triage, screening those who absolutely need a bed, and those who can be put in the waiting area.
“I hate that we even have to make that determination,” MS. Dusang said. Lately, staff members have been pulling out some patients already in the ER’s rooms when others arrive who are more critically ill. “No one likes to take someone out of the privacy of their room and say, ‘We’re going to put you in a hallway because we need to get care to someone else.’”
ER patients have grown sicker
“We are hearing from members in every part of the country,” said Dr. Lisa Moreno, president of the American Academy of Emergency Medicine. “The Midwest, the South, the Northeast, the West … they are seeing this exact same phenomenon.”
Although the number of ER visits returned to pre-COVID levels this summer, admission rates, from the ER to the hospital’s inpatient floors, are still almost 20% higher. That’s according to the most recent analysis by the Epic Health Research Network, which pulls data from more than 120 million patients across the country.
“It’s an early indicator that what’s happening in the ED is that we’re seeing more acute cases than we were pre-pandemic,” said Caleb Cox, a data scientist at Epic.
Less acute cases, such as people with health issues like rashes or conjunctivitis, still aren’t going to the ER as much as they used to. Instead, they may be opting for an urgent care center or their primary care doctor, Mr. Cox explained. Meanwhile, there has been an increase in people coming to the ER with more serious conditions, like strokes and heart attacks.
So, even though the total number of patients coming to ERs is about the same as before the pandemic, “that’s absolutely going to feel like [if I’m an ER doctor or nurse] I’m seeing more patients and I’m seeing more acute patients,” Mr. Cox said.
Dr. Moreno, the AAEM president, works at an emergency department in New Orleans. She said the level of illness, and the inability to admit patients quickly and move them to beds upstairs, has created a level of chaos she described as “not even humane.”
At the beginning of a recent shift, she heard a patient crying nearby and went to investigate. It was a paraplegic man who’d recently had surgery for colon cancer. His large post-operative wound was sealed with a device called a wound vac, which pulls fluid from the wound into a drainage tube attached to a portable vacuum pump.
But the wound vac had malfunctioned, which is why he had come to the ER. Staffers were so busy, however, that by the time Dr. Moreno came in, the fluid from his wound was leaking everywhere.
“When I went in, the bed was covered,” she recalled. “I mean, he was lying in a puddle of secretions from this wound. And he was crying, because he said to me, ‘I’m paralyzed. I can’t move to get away from all these secretions, and I know I’m going to end up getting an infection. I know I’m going to end up getting an ulcer. I’ve been laying in this for, like, eight or nine hours.’”
The nurse in charge of his care told Dr. Moreno she simply hadn’t had time to help this patient yet. “She said, ‘I’ve had so many patients to take care of, and so many critical patients. I started [an IV] drip on this person. This person is on a cardiac monitor. I just didn’t have time to get in there.’”
“This is not humane care,” Dr. Moreno said. “This is horrible care.”
But it’s what can happen when emergency department staffers don’t have the resources they need to deal with the onslaught of competing demands.
“All the nurses and doctors had the highest level of intent to do the right thing for the person,” Dr. Moreno said. “But because of the high acuity of … a large number of patients, the staffing ratio of nurse to patient, even the staffing ratio of doctor to patient, this guy did not get the care that he deserved to get, just as a human being.”
The instance of unintended neglect that Dr. Moreno saw is extreme, and not the experience of most patients who arrive at ERs these days. But the problem is not new: Even before the pandemic, ER overcrowding had been a “widespread problem and a source of patient harm, according to a recent commentary in NEJM Catalyst Innovations in Care Delivery.
“ED crowding is not an issue of inconvenience,” the authors wrote. “There is incontrovertible evidence that ED crowding leads to significant patient harm, including morbidity and mortality related to consequential delays of treatment for both high- and low-acuity patients.”
And already-overwhelmed staffers are burning out.
Burnout feeds staffing shortages, and vice versa
Every morning, Tiffani Dusang wakes up and checks her Sparrow email with one singular hope: that she will not see yet another nurse resignation letter in her inbox.
“I cannot tell you how many of them [the nurses] tell me they went home crying” after their shifts, she said.
Despite Ms. Dusang’s best efforts to support her staffers, they’re leaving too fast to be replaced, either to take higher-paying gigs as a travel nurse, to try a less-stressful type of nursing, or simply walking away from the profession entirely.
Kelly Spitz has been an emergency department nurse at Sparrow for 10 years. But, lately, she has also fantasized about leaving. “It has crossed my mind several times,” she said, and yet she continues to come back. “Because I have a team here. And I love what I do.” But then she started to cry. The issue is not the hard work, or even the stress. She struggles with not being able to give her patients the kind of care and attention she wants to give them, and that they need and deserve, she said.
She often thinks about a patient whose test results revealed terminal cancer, she said. Ms. Spitz spent all day working the phones, hustling case managers, trying to get hospice care set up in the man’s home. He was going to die, and she just didn’t want him to have to die in the hospital, where only one visitor was allowed. She wanted to get him home, and back with his family.
Finally, after many hours, they found an ambulance to take him home.
Three days later, the man’s family members called Ms. Spitz: He had died surrounded by family. They were calling to thank her.
“I felt like I did my job there, because I got him home,” she said. But that’s a rare feeling these days. “I just hope it gets better. I hope it gets better soon.”
Around 4 p.m. at Sparrow Hospital as one shift approached its end, Ms. Dusang faced a new crisis: The overnight shift was more short-staffed than usual.
“Can we get two inpatient nurses?” she asked, hoping to borrow two nurses from one of the hospital floors upstairs.
“Already tried,” replied nurse Troy Latunski.
Without more staff, it’s going to be hard to care for new patients who come in overnight — from car crashes to seizures or other emergencies.
But Mr. Latunski had a plan: He would go home, snatch a few hours of sleep and return at 11 p.m. to work the overnight shift in the ER’s overflow unit. That meant he would be largely caring for eight patients, alone. On just a few short hours of sleep. But lately that seemed to be their only, and best, option.
Ms. Dusang considered for a moment, took a deep breath and nodded. “OK,” she said.
“Go home. Get some sleep. Thank you,” she added, shooting Mr. Latunski a grateful smile. And then she pivoted, because another nurse was approaching with an urgent question. On to the next crisis.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. This story is part of a partnership that includes Michigan Radio, NPR and KHN.
Multiple DMTs linked to alopecia, especially in women
a new study finds.
From 2009 to 2019, the Food and Drug Administration received 7,978 reports of new-onset alopecia in patients taking DMTs, particularly teriflunomide (3,255, 40.8%; 90% female), dimethyl fumarate (1,641, 20.6%; 89% female), natalizumab (955, 12.0%; 92% female), and fingolimod (776, 9.7% of the total reports; 93% female), several researchers reported at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC). Of these, only teriflunomide had previously been linked to alopecia, study coauthor Ahmed Obeidat, MD, PhD, a neurologist at the Medical College of Wisconsin, Milwaukee, said in an interview.
“Our finding of frequent reports of alopecia on DMTs studied calls for further investigation into the subject,” Dr. Obeidat said. “Alopecia can cause deep personal impacts and can be a source of significant psychological concern for some patients.”
According to Dr. Obeidat, alopecia has been linked to the only a few DMTs – cladribine and the interferons – in addition to teriflunomide. “To our surprise, we received anecdotal reports of hair thinning from several of our MS patients treated with various other [DMTs]. Upon further investigation, we could not find substantial literature to explain this phenomenon which led us to conduct our investigation.”
Dr. Obeidat and colleagues identified DMT-related alopecia cases (18.3%) among 43,655 reports in the skin and subcutaneous tissue disorder category in the FDA Adverse Event Reporting System. Other DMTs with more than 1 case report were interferon beta-1a (635, 8.0%; 92% female), glatiramer acetate (332, 4.2%; 87% female), ocrelizumab (142, 1.8%; 94% female), interferon beta-1b (126, 1.6%; 95% female), alemtuzumab (86, 1.1%; 88% female), cladribine (17, 0.2%; 65% female), and rituximab (10, 0.1%; 90% female).
The average age for the case reports varied from 42 to 51 years for most of the drugs except alemtuzumab (mean age, 40 years) and cladribine (average age, 38 years), which had low numbers of cases.
Siponimod (three cases) and ozanimod (no cases) were not included in the age and gender analyses.
Why do so many women seem to be affected, well beyond their percentage of MS cases overall? The answer is unclear, said medical student Mokshal H. Porwal, the study’s lead author. “There could be a biological explanation,” Mr. Porwal said, “or women may report cases more often: “Earlier studies suggested that alopecia may affect women more adversely in terms of body image as well as overall psychological well-being, compared to males.”
The researchers also noted that patients – not medical professionals – provided most of the case reports in the FDA database. “We believe this indicates that alopecia is a patient-centered concern that may have a larger impact on their lives than what the health care teams may perceive,” Mr. Porwal said. “Oftentimes, we as health care providers, look for the more acute and apparent adverse events, which can overshadow issues such as hair thinning/alopecia that could have even greater psychological impacts on our patients.”
Dr. Obeidat said there are still multiple mysteries about DMT and alopecia risk: the true incidence of cases per DMT or DMT class, the mechanism(s) behind a link, the permanent or transient nature of the alopecia cases, and the risk factors in individual patients.
Going forward, he said, “we advise clinicians to discuss hair thinning or alopecia as a possible side effect that has been reported in association with all DMTs in the real-world, postmarketing era.”
No study funding was reported. Dr. Obeidat reported various disclosures; the other authors reported no disclosures.
a new study finds.
From 2009 to 2019, the Food and Drug Administration received 7,978 reports of new-onset alopecia in patients taking DMTs, particularly teriflunomide (3,255, 40.8%; 90% female), dimethyl fumarate (1,641, 20.6%; 89% female), natalizumab (955, 12.0%; 92% female), and fingolimod (776, 9.7% of the total reports; 93% female), several researchers reported at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC). Of these, only teriflunomide had previously been linked to alopecia, study coauthor Ahmed Obeidat, MD, PhD, a neurologist at the Medical College of Wisconsin, Milwaukee, said in an interview.
“Our finding of frequent reports of alopecia on DMTs studied calls for further investigation into the subject,” Dr. Obeidat said. “Alopecia can cause deep personal impacts and can be a source of significant psychological concern for some patients.”
According to Dr. Obeidat, alopecia has been linked to the only a few DMTs – cladribine and the interferons – in addition to teriflunomide. “To our surprise, we received anecdotal reports of hair thinning from several of our MS patients treated with various other [DMTs]. Upon further investigation, we could not find substantial literature to explain this phenomenon which led us to conduct our investigation.”
Dr. Obeidat and colleagues identified DMT-related alopecia cases (18.3%) among 43,655 reports in the skin and subcutaneous tissue disorder category in the FDA Adverse Event Reporting System. Other DMTs with more than 1 case report were interferon beta-1a (635, 8.0%; 92% female), glatiramer acetate (332, 4.2%; 87% female), ocrelizumab (142, 1.8%; 94% female), interferon beta-1b (126, 1.6%; 95% female), alemtuzumab (86, 1.1%; 88% female), cladribine (17, 0.2%; 65% female), and rituximab (10, 0.1%; 90% female).
The average age for the case reports varied from 42 to 51 years for most of the drugs except alemtuzumab (mean age, 40 years) and cladribine (average age, 38 years), which had low numbers of cases.
Siponimod (three cases) and ozanimod (no cases) were not included in the age and gender analyses.
Why do so many women seem to be affected, well beyond their percentage of MS cases overall? The answer is unclear, said medical student Mokshal H. Porwal, the study’s lead author. “There could be a biological explanation,” Mr. Porwal said, “or women may report cases more often: “Earlier studies suggested that alopecia may affect women more adversely in terms of body image as well as overall psychological well-being, compared to males.”
The researchers also noted that patients – not medical professionals – provided most of the case reports in the FDA database. “We believe this indicates that alopecia is a patient-centered concern that may have a larger impact on their lives than what the health care teams may perceive,” Mr. Porwal said. “Oftentimes, we as health care providers, look for the more acute and apparent adverse events, which can overshadow issues such as hair thinning/alopecia that could have even greater psychological impacts on our patients.”
Dr. Obeidat said there are still multiple mysteries about DMT and alopecia risk: the true incidence of cases per DMT or DMT class, the mechanism(s) behind a link, the permanent or transient nature of the alopecia cases, and the risk factors in individual patients.
Going forward, he said, “we advise clinicians to discuss hair thinning or alopecia as a possible side effect that has been reported in association with all DMTs in the real-world, postmarketing era.”
No study funding was reported. Dr. Obeidat reported various disclosures; the other authors reported no disclosures.
a new study finds.
From 2009 to 2019, the Food and Drug Administration received 7,978 reports of new-onset alopecia in patients taking DMTs, particularly teriflunomide (3,255, 40.8%; 90% female), dimethyl fumarate (1,641, 20.6%; 89% female), natalizumab (955, 12.0%; 92% female), and fingolimod (776, 9.7% of the total reports; 93% female), several researchers reported at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC). Of these, only teriflunomide had previously been linked to alopecia, study coauthor Ahmed Obeidat, MD, PhD, a neurologist at the Medical College of Wisconsin, Milwaukee, said in an interview.
“Our finding of frequent reports of alopecia on DMTs studied calls for further investigation into the subject,” Dr. Obeidat said. “Alopecia can cause deep personal impacts and can be a source of significant psychological concern for some patients.”
According to Dr. Obeidat, alopecia has been linked to the only a few DMTs – cladribine and the interferons – in addition to teriflunomide. “To our surprise, we received anecdotal reports of hair thinning from several of our MS patients treated with various other [DMTs]. Upon further investigation, we could not find substantial literature to explain this phenomenon which led us to conduct our investigation.”
Dr. Obeidat and colleagues identified DMT-related alopecia cases (18.3%) among 43,655 reports in the skin and subcutaneous tissue disorder category in the FDA Adverse Event Reporting System. Other DMTs with more than 1 case report were interferon beta-1a (635, 8.0%; 92% female), glatiramer acetate (332, 4.2%; 87% female), ocrelizumab (142, 1.8%; 94% female), interferon beta-1b (126, 1.6%; 95% female), alemtuzumab (86, 1.1%; 88% female), cladribine (17, 0.2%; 65% female), and rituximab (10, 0.1%; 90% female).
The average age for the case reports varied from 42 to 51 years for most of the drugs except alemtuzumab (mean age, 40 years) and cladribine (average age, 38 years), which had low numbers of cases.
Siponimod (three cases) and ozanimod (no cases) were not included in the age and gender analyses.
Why do so many women seem to be affected, well beyond their percentage of MS cases overall? The answer is unclear, said medical student Mokshal H. Porwal, the study’s lead author. “There could be a biological explanation,” Mr. Porwal said, “or women may report cases more often: “Earlier studies suggested that alopecia may affect women more adversely in terms of body image as well as overall psychological well-being, compared to males.”
The researchers also noted that patients – not medical professionals – provided most of the case reports in the FDA database. “We believe this indicates that alopecia is a patient-centered concern that may have a larger impact on their lives than what the health care teams may perceive,” Mr. Porwal said. “Oftentimes, we as health care providers, look for the more acute and apparent adverse events, which can overshadow issues such as hair thinning/alopecia that could have even greater psychological impacts on our patients.”
Dr. Obeidat said there are still multiple mysteries about DMT and alopecia risk: the true incidence of cases per DMT or DMT class, the mechanism(s) behind a link, the permanent or transient nature of the alopecia cases, and the risk factors in individual patients.
Going forward, he said, “we advise clinicians to discuss hair thinning or alopecia as a possible side effect that has been reported in association with all DMTs in the real-world, postmarketing era.”
No study funding was reported. Dr. Obeidat reported various disclosures; the other authors reported no disclosures.
FROM CMSC 2021