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IVIG proves effective for dermatomyositis in phase 3 trial
With use of intravenous immunoglobulin for the treatment of adults with dermatomyositis, a significantly higher percentage of patients experienced at least minimal improvement in disease activity in comparison with placebo in the first-ever phase 3 trial of the blood-product therapy for the condition.
Until this trial, published in the New England Journal of Medicine, there had not been an extensive evaluation of IVIG for the treatment of dermatomyositis, the study’s authors noted.
Glucocorticoids are typically offered as first-line therapy, followed by various immunosuppressants. IVIG is composed of purified liquid IgG concentrates from human plasma. It has been prescribed off label as second- or third-line therapy for dermatomyositis, usually along with immunosuppressive drugs. In European guidelines, it has been recommended as a glucocorticoid-sparing agent for patients with this condition.
“The study provides support that IVIG is effective in treating the signs and symptoms of patients with dermatomyositis, at least in the short term,” said David Fiorentino, MD, PhD, professor of dermatology and associate residency program director at Stanford Health Care, Stanford, California, who was not involved in the study.
“IVIG appears to be effective for patients with any severity level and works relatively quickly [within 1 month of therapy],” he added. “IVIG is effective in treating both the muscle symptoms as well as the rash of dermatomyositis, which is important, as both organ systems can cause significant patient morbidity in this disease.”
Time to improvement was shorter with IVIG than with placebo (a median of 35 days vs. 115 days), said Kathryn H. Dao, MD, associate professor in the division of rheumatic diseases at the University of Texas Southwestern Medical Center, Dallas, who was not involved in the study.
The study’s greatest strengths are its international, multicenter, randomized, placebo-controlled design, Dr. Dao said. In addition, “these patients were permitted to be on background medicines that we typically use in real-world situations.”
Study methodology
Researchers led by Rohit Aggarwal, MD, of the division of rheumatology and clinical immunology at the University of Pittsburgh, recruited patients aged 18-80 years with active dermatomyositis. Individuals were randomly assigned in a 1:1 ratio to receive either IVIG at a dose of 2.0 g/kg of body weight or placebo (0.9% sodium chloride) every 4 weeks for 16 weeks.
Those who were administered placebo and those who did not experience confirmed clinical deterioration while receiving IVIG could participate in an open-label extension phase for another 24 weeks.
The primary endpoint was a response, defined as a Total Improvement Score (TIS) of at least 20 (indicating at least minimal improvement) at week 16 and no confirmed deterioration up to week 16. The TIS is a weighted composite score that reflects the change in a core set of six measures of myositis activity over time. Scores span from 0 to 100, with higher scores indicating more significant improvement.
Secondary endpoints
Key secondary endpoints included moderate improvement (TIS ≥ 40) and major improvement (TIS ≥ 60) and change in score on the Cutaneous Dermatomyositis Disease Area and Severity Index.
A total of 95 patients underwent randomization; 47 patients received IVIG and 48 received placebo. At 16 weeks, a TIS of at least 20 occurred in 37 of 47 (79%) patients who received IVIG and in 21 of 48 (44%) patients with placebo (difference, 35%; 95% confidence interval, 17%-53%; P < .001).
The results with respect to the secondary endpoints, including at least moderate improvement and major improvement, were generally in the same direction as the results of the primary endpoint analysis, except for change in creatine kinase (CK) level (an individual core measure of the TIS), which did not differ meaningfully between the two groups.
Adverse events
Over the course of 40 weeks, 282 treatment-related adverse events were documented among patients who received IVIG. Headache was experienced by 42%, pyrexia by 19%, and nausea by 16%. Nine serious adverse events occurred and were believed to be associated with IVIG, including six thromboembolic events.
Despite the favorable outcome observed with IVIG, in an editorial that accompanied the study, Anthony A. Amato, MD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, noted that “most of the core components of the TIS are subjective. Because of the high percentage of patients who had a response with placebo, large numbers of patients will be needed in future trials to show a significant difference between trial groups, or the primary endpoint would need to be set higher (e.g., a TIS of ≥40).”
Dr. Dao thought it was significant that the study proactively assessed patients for venous thrombotic events (VTEs) after each infusion. There were eight events in six patients who received IVIG. “Of interest and possibly practice changing is the finding that slowing the IVIG infusion rate from 0.12 to 0.04 mL/kg per minute reduced the incidence of VTEs from 1.54/100 patient-months to 0.54/100 patient-months,” she said. “This is important, as it informs clinicians that IVIG infusion rates should be slower for patients with active dermatomyositis to reduce the risk for blood clots.”
Study weaknesses
A considerable proportion of patients with dermatomyositis do not have clinical muscle involvement but do have rash and do not substantially differ in any other ways from those with classic dermatomyositis, Dr. Fiorentino said.
“These patients were not eligible to enter the trial, and so we have no data on the efficacy of IVIG in this population,” he said. “Unfortunately, these patients might now be denied insurance reimbursement for IVIG therapy, given that they are not part of the indicated patient population in the label.”
In addition, there is limited information about Black, Asian, or Hispanic patients because few of those patients participated in the study. That is also the case for patients younger than 18, which for this disease is relevant because incidence peaks in younger patients (juvenile dermatomyositis), Dr. Fiorentino noted.
Among the study’s weaknesses, Dr. Dao noted that more than 70% of participants were women. The study was short in duration, fewer than half of patients underwent muscle biopsy to confirm myositis, and only two thirds of patients underwent electromyography/nerve conduction studies to show evidence of myositis. There was a high placebo response (44%), the CK values were not high at the start of the trial, and they did not change with treatment.
No analysis was performed to evaluate the efficacy of IVIG across dermatomyositis subgroups – defined by autoantibodies – but the study likely was not powered to do so. These subgroups might respond differently to IVIG, yielding important information, Fiorentino said.
The study provided efficacy data for only one formulation of IVIG, Octagam 10%, which was approved for dermatomyositis by the Food and Drug Administration in 2021 on the basis of this trial. However, in the United States, patients with dermatomyositis are treated with multiple brands of IVIG. “The decision around IVIG brand is largely determined by third-party payers, and for the most part, the different brands are used interchangeably from the standpoint of the treating provider,” Dr. Fiorentino said. “This will likely continue to be the case, as the results of this study are generally being extrapolated to all brands of IVIG.”
Multiple IVIG brands that have been used for immune-mediated diseases differ in concentration, content of IgA, sugar concentration, additives, and preparations (for example, the need for reconstitution vs. being ready to use), Dr. Dao said. Octagam 10% is the only brand approved by the FDA for adult dermatomyositis; hence, cost can be an issue for patients if other brands are used off label. The typical cost of IVIG is $100-$400 per gram; a typical course of treatment is estimated to be $30,000-$40,000 per month. “However, if Octagam is not available or a patient has a reaction to it, clinicians may use other IVIG brands as deemed medically necessary to treat their patients,” she said.
Dr. Aggarwal has financial relationships with more than 15 pharmaceutical companies, including Octapharma, which provided financial support for this trial. Some of the coauthors were employees of Octapharma or had financial relationships with the company. Dr. Dao disclosed no relevant financial relationships. Dr. Fiorentino has conducted sponsored research for Pfizer and Argenyx, has received research funding from Serono, and is a paid adviser to Bristol-Myers Squibb, Janssen, Acelyrin, and Corbus.
A version of this article first appeared on Medscape.com.
With use of intravenous immunoglobulin for the treatment of adults with dermatomyositis, a significantly higher percentage of patients experienced at least minimal improvement in disease activity in comparison with placebo in the first-ever phase 3 trial of the blood-product therapy for the condition.
Until this trial, published in the New England Journal of Medicine, there had not been an extensive evaluation of IVIG for the treatment of dermatomyositis, the study’s authors noted.
Glucocorticoids are typically offered as first-line therapy, followed by various immunosuppressants. IVIG is composed of purified liquid IgG concentrates from human plasma. It has been prescribed off label as second- or third-line therapy for dermatomyositis, usually along with immunosuppressive drugs. In European guidelines, it has been recommended as a glucocorticoid-sparing agent for patients with this condition.
“The study provides support that IVIG is effective in treating the signs and symptoms of patients with dermatomyositis, at least in the short term,” said David Fiorentino, MD, PhD, professor of dermatology and associate residency program director at Stanford Health Care, Stanford, California, who was not involved in the study.
“IVIG appears to be effective for patients with any severity level and works relatively quickly [within 1 month of therapy],” he added. “IVIG is effective in treating both the muscle symptoms as well as the rash of dermatomyositis, which is important, as both organ systems can cause significant patient morbidity in this disease.”
Time to improvement was shorter with IVIG than with placebo (a median of 35 days vs. 115 days), said Kathryn H. Dao, MD, associate professor in the division of rheumatic diseases at the University of Texas Southwestern Medical Center, Dallas, who was not involved in the study.
The study’s greatest strengths are its international, multicenter, randomized, placebo-controlled design, Dr. Dao said. In addition, “these patients were permitted to be on background medicines that we typically use in real-world situations.”
Study methodology
Researchers led by Rohit Aggarwal, MD, of the division of rheumatology and clinical immunology at the University of Pittsburgh, recruited patients aged 18-80 years with active dermatomyositis. Individuals were randomly assigned in a 1:1 ratio to receive either IVIG at a dose of 2.0 g/kg of body weight or placebo (0.9% sodium chloride) every 4 weeks for 16 weeks.
Those who were administered placebo and those who did not experience confirmed clinical deterioration while receiving IVIG could participate in an open-label extension phase for another 24 weeks.
The primary endpoint was a response, defined as a Total Improvement Score (TIS) of at least 20 (indicating at least minimal improvement) at week 16 and no confirmed deterioration up to week 16. The TIS is a weighted composite score that reflects the change in a core set of six measures of myositis activity over time. Scores span from 0 to 100, with higher scores indicating more significant improvement.
Secondary endpoints
Key secondary endpoints included moderate improvement (TIS ≥ 40) and major improvement (TIS ≥ 60) and change in score on the Cutaneous Dermatomyositis Disease Area and Severity Index.
A total of 95 patients underwent randomization; 47 patients received IVIG and 48 received placebo. At 16 weeks, a TIS of at least 20 occurred in 37 of 47 (79%) patients who received IVIG and in 21 of 48 (44%) patients with placebo (difference, 35%; 95% confidence interval, 17%-53%; P < .001).
The results with respect to the secondary endpoints, including at least moderate improvement and major improvement, were generally in the same direction as the results of the primary endpoint analysis, except for change in creatine kinase (CK) level (an individual core measure of the TIS), which did not differ meaningfully between the two groups.
Adverse events
Over the course of 40 weeks, 282 treatment-related adverse events were documented among patients who received IVIG. Headache was experienced by 42%, pyrexia by 19%, and nausea by 16%. Nine serious adverse events occurred and were believed to be associated with IVIG, including six thromboembolic events.
Despite the favorable outcome observed with IVIG, in an editorial that accompanied the study, Anthony A. Amato, MD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, noted that “most of the core components of the TIS are subjective. Because of the high percentage of patients who had a response with placebo, large numbers of patients will be needed in future trials to show a significant difference between trial groups, or the primary endpoint would need to be set higher (e.g., a TIS of ≥40).”
Dr. Dao thought it was significant that the study proactively assessed patients for venous thrombotic events (VTEs) after each infusion. There were eight events in six patients who received IVIG. “Of interest and possibly practice changing is the finding that slowing the IVIG infusion rate from 0.12 to 0.04 mL/kg per minute reduced the incidence of VTEs from 1.54/100 patient-months to 0.54/100 patient-months,” she said. “This is important, as it informs clinicians that IVIG infusion rates should be slower for patients with active dermatomyositis to reduce the risk for blood clots.”
Study weaknesses
A considerable proportion of patients with dermatomyositis do not have clinical muscle involvement but do have rash and do not substantially differ in any other ways from those with classic dermatomyositis, Dr. Fiorentino said.
“These patients were not eligible to enter the trial, and so we have no data on the efficacy of IVIG in this population,” he said. “Unfortunately, these patients might now be denied insurance reimbursement for IVIG therapy, given that they are not part of the indicated patient population in the label.”
In addition, there is limited information about Black, Asian, or Hispanic patients because few of those patients participated in the study. That is also the case for patients younger than 18, which for this disease is relevant because incidence peaks in younger patients (juvenile dermatomyositis), Dr. Fiorentino noted.
Among the study’s weaknesses, Dr. Dao noted that more than 70% of participants were women. The study was short in duration, fewer than half of patients underwent muscle biopsy to confirm myositis, and only two thirds of patients underwent electromyography/nerve conduction studies to show evidence of myositis. There was a high placebo response (44%), the CK values were not high at the start of the trial, and they did not change with treatment.
No analysis was performed to evaluate the efficacy of IVIG across dermatomyositis subgroups – defined by autoantibodies – but the study likely was not powered to do so. These subgroups might respond differently to IVIG, yielding important information, Fiorentino said.
The study provided efficacy data for only one formulation of IVIG, Octagam 10%, which was approved for dermatomyositis by the Food and Drug Administration in 2021 on the basis of this trial. However, in the United States, patients with dermatomyositis are treated with multiple brands of IVIG. “The decision around IVIG brand is largely determined by third-party payers, and for the most part, the different brands are used interchangeably from the standpoint of the treating provider,” Dr. Fiorentino said. “This will likely continue to be the case, as the results of this study are generally being extrapolated to all brands of IVIG.”
Multiple IVIG brands that have been used for immune-mediated diseases differ in concentration, content of IgA, sugar concentration, additives, and preparations (for example, the need for reconstitution vs. being ready to use), Dr. Dao said. Octagam 10% is the only brand approved by the FDA for adult dermatomyositis; hence, cost can be an issue for patients if other brands are used off label. The typical cost of IVIG is $100-$400 per gram; a typical course of treatment is estimated to be $30,000-$40,000 per month. “However, if Octagam is not available or a patient has a reaction to it, clinicians may use other IVIG brands as deemed medically necessary to treat their patients,” she said.
Dr. Aggarwal has financial relationships with more than 15 pharmaceutical companies, including Octapharma, which provided financial support for this trial. Some of the coauthors were employees of Octapharma or had financial relationships with the company. Dr. Dao disclosed no relevant financial relationships. Dr. Fiorentino has conducted sponsored research for Pfizer and Argenyx, has received research funding from Serono, and is a paid adviser to Bristol-Myers Squibb, Janssen, Acelyrin, and Corbus.
A version of this article first appeared on Medscape.com.
With use of intravenous immunoglobulin for the treatment of adults with dermatomyositis, a significantly higher percentage of patients experienced at least minimal improvement in disease activity in comparison with placebo in the first-ever phase 3 trial of the blood-product therapy for the condition.
Until this trial, published in the New England Journal of Medicine, there had not been an extensive evaluation of IVIG for the treatment of dermatomyositis, the study’s authors noted.
Glucocorticoids are typically offered as first-line therapy, followed by various immunosuppressants. IVIG is composed of purified liquid IgG concentrates from human plasma. It has been prescribed off label as second- or third-line therapy for dermatomyositis, usually along with immunosuppressive drugs. In European guidelines, it has been recommended as a glucocorticoid-sparing agent for patients with this condition.
“The study provides support that IVIG is effective in treating the signs and symptoms of patients with dermatomyositis, at least in the short term,” said David Fiorentino, MD, PhD, professor of dermatology and associate residency program director at Stanford Health Care, Stanford, California, who was not involved in the study.
“IVIG appears to be effective for patients with any severity level and works relatively quickly [within 1 month of therapy],” he added. “IVIG is effective in treating both the muscle symptoms as well as the rash of dermatomyositis, which is important, as both organ systems can cause significant patient morbidity in this disease.”
Time to improvement was shorter with IVIG than with placebo (a median of 35 days vs. 115 days), said Kathryn H. Dao, MD, associate professor in the division of rheumatic diseases at the University of Texas Southwestern Medical Center, Dallas, who was not involved in the study.
The study’s greatest strengths are its international, multicenter, randomized, placebo-controlled design, Dr. Dao said. In addition, “these patients were permitted to be on background medicines that we typically use in real-world situations.”
Study methodology
Researchers led by Rohit Aggarwal, MD, of the division of rheumatology and clinical immunology at the University of Pittsburgh, recruited patients aged 18-80 years with active dermatomyositis. Individuals were randomly assigned in a 1:1 ratio to receive either IVIG at a dose of 2.0 g/kg of body weight or placebo (0.9% sodium chloride) every 4 weeks for 16 weeks.
Those who were administered placebo and those who did not experience confirmed clinical deterioration while receiving IVIG could participate in an open-label extension phase for another 24 weeks.
The primary endpoint was a response, defined as a Total Improvement Score (TIS) of at least 20 (indicating at least minimal improvement) at week 16 and no confirmed deterioration up to week 16. The TIS is a weighted composite score that reflects the change in a core set of six measures of myositis activity over time. Scores span from 0 to 100, with higher scores indicating more significant improvement.
Secondary endpoints
Key secondary endpoints included moderate improvement (TIS ≥ 40) and major improvement (TIS ≥ 60) and change in score on the Cutaneous Dermatomyositis Disease Area and Severity Index.
A total of 95 patients underwent randomization; 47 patients received IVIG and 48 received placebo. At 16 weeks, a TIS of at least 20 occurred in 37 of 47 (79%) patients who received IVIG and in 21 of 48 (44%) patients with placebo (difference, 35%; 95% confidence interval, 17%-53%; P < .001).
The results with respect to the secondary endpoints, including at least moderate improvement and major improvement, were generally in the same direction as the results of the primary endpoint analysis, except for change in creatine kinase (CK) level (an individual core measure of the TIS), which did not differ meaningfully between the two groups.
Adverse events
Over the course of 40 weeks, 282 treatment-related adverse events were documented among patients who received IVIG. Headache was experienced by 42%, pyrexia by 19%, and nausea by 16%. Nine serious adverse events occurred and were believed to be associated with IVIG, including six thromboembolic events.
Despite the favorable outcome observed with IVIG, in an editorial that accompanied the study, Anthony A. Amato, MD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, noted that “most of the core components of the TIS are subjective. Because of the high percentage of patients who had a response with placebo, large numbers of patients will be needed in future trials to show a significant difference between trial groups, or the primary endpoint would need to be set higher (e.g., a TIS of ≥40).”
Dr. Dao thought it was significant that the study proactively assessed patients for venous thrombotic events (VTEs) after each infusion. There were eight events in six patients who received IVIG. “Of interest and possibly practice changing is the finding that slowing the IVIG infusion rate from 0.12 to 0.04 mL/kg per minute reduced the incidence of VTEs from 1.54/100 patient-months to 0.54/100 patient-months,” she said. “This is important, as it informs clinicians that IVIG infusion rates should be slower for patients with active dermatomyositis to reduce the risk for blood clots.”
Study weaknesses
A considerable proportion of patients with dermatomyositis do not have clinical muscle involvement but do have rash and do not substantially differ in any other ways from those with classic dermatomyositis, Dr. Fiorentino said.
“These patients were not eligible to enter the trial, and so we have no data on the efficacy of IVIG in this population,” he said. “Unfortunately, these patients might now be denied insurance reimbursement for IVIG therapy, given that they are not part of the indicated patient population in the label.”
In addition, there is limited information about Black, Asian, or Hispanic patients because few of those patients participated in the study. That is also the case for patients younger than 18, which for this disease is relevant because incidence peaks in younger patients (juvenile dermatomyositis), Dr. Fiorentino noted.
Among the study’s weaknesses, Dr. Dao noted that more than 70% of participants were women. The study was short in duration, fewer than half of patients underwent muscle biopsy to confirm myositis, and only two thirds of patients underwent electromyography/nerve conduction studies to show evidence of myositis. There was a high placebo response (44%), the CK values were not high at the start of the trial, and they did not change with treatment.
No analysis was performed to evaluate the efficacy of IVIG across dermatomyositis subgroups – defined by autoantibodies – but the study likely was not powered to do so. These subgroups might respond differently to IVIG, yielding important information, Fiorentino said.
The study provided efficacy data for only one formulation of IVIG, Octagam 10%, which was approved for dermatomyositis by the Food and Drug Administration in 2021 on the basis of this trial. However, in the United States, patients with dermatomyositis are treated with multiple brands of IVIG. “The decision around IVIG brand is largely determined by third-party payers, and for the most part, the different brands are used interchangeably from the standpoint of the treating provider,” Dr. Fiorentino said. “This will likely continue to be the case, as the results of this study are generally being extrapolated to all brands of IVIG.”
Multiple IVIG brands that have been used for immune-mediated diseases differ in concentration, content of IgA, sugar concentration, additives, and preparations (for example, the need for reconstitution vs. being ready to use), Dr. Dao said. Octagam 10% is the only brand approved by the FDA for adult dermatomyositis; hence, cost can be an issue for patients if other brands are used off label. The typical cost of IVIG is $100-$400 per gram; a typical course of treatment is estimated to be $30,000-$40,000 per month. “However, if Octagam is not available or a patient has a reaction to it, clinicians may use other IVIG brands as deemed medically necessary to treat their patients,” she said.
Dr. Aggarwal has financial relationships with more than 15 pharmaceutical companies, including Octapharma, which provided financial support for this trial. Some of the coauthors were employees of Octapharma or had financial relationships with the company. Dr. Dao disclosed no relevant financial relationships. Dr. Fiorentino has conducted sponsored research for Pfizer and Argenyx, has received research funding from Serono, and is a paid adviser to Bristol-Myers Squibb, Janssen, Acelyrin, and Corbus.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Biosimilar-to-biosimilar switches deemed safe and effective, systematic review reveals
Switching from one biosimilar medication to another is safe and effective, a new systematic review indicates, even though this clinical practice is not governed by current health authority regulations or guidance.
“No reduction in effectiveness or increase in adverse events was detected in biosimilar-to-biosimilar switching studies conducted to date,” the review’s authors noted in their study, published online in BioDrugs.
“The possibility of multiple switches between biosimilars of the same reference biologic is already a reality, and these types of switches are expected to become more common in the future. ... Although it is not covered by current health authority regulations or guidance,” added the authors, led by Hillel P. Cohen, PhD, executive director of scientific affairs at Sandoz, a division of Novartis.
The researchers searched electronic databases through December 2021 and found 23 observational studies that met their search criteria, of which 13 were published in peer-reviewed journals; the remainder appeared in abstract form. The studies totaled 3,657 patients. The researchers did not identify any randomized clinical trials.
“The studies were heterogeneous in size, design, and endpoints, providing data on safety, effectiveness, immunogenicity, pharmacokinetics, patient retention, patient and physician perceptions, and drug-use patterns,” the authors wrote.
The authors found that the majority of studies evaluated switches between biosimilars of infliximab, but they also identified switches between biosimilars of adalimumab, etanercept, and rituximab.
“Some health care providers are hesitant to switch patients from one biosimilar to another biosimilar because of a perceived lack of clinical data on such switches,” Dr. Cohen said in an interview.
The review’s findings – that there were no clinically relevant differences when switching patients from one biosimilar to another – are consistent with the science, Dr. Cohen said. “Physicians should have confidence that the data demonstrate that safety and effectiveness are not impacted if patients switch from one biosimilar to another biosimilar of the same reference biologic,” he said.
Currently, the published data include biosimilars to only four reference biologics. “However, I anticipate additional biosimilar-to-biosimilar switching data will become available in the future,” Dr. Cohen said. “In fact, several new studies have been published in recent months, after the cut-off date for inclusion in our systematic review.”
Switching common in rheumatology, dermatology, and gastroenterology
Biosimilar-to-biosimilar switching was observed most commonly in rheumatology practice, but also was seen in the specialties of dermatology and gastroenterology.
Jeffrey Weinberg, MD, clinical professor of dermatology, Icahn School of Medicine at Mount Sinai, New York City, said in an interview that the study is among the best to date showing that switching biosimilars does not compromise efficacy or safety.
“I would hypothesize that the interchangeability would apply to psoriasis patients,” Dr. Weinberg said. However, “over the next few years, we will have an increasing number of biosimilars for an increasing number of different molecules. We will need to be vigilant to observe if similar behavior is observed with the biosimilars yet to come.”
Keith Choate, MD, PhD, professor of dermatology, pathology, and genetics, and associate dean for physician-scientist development at Yale University, New Haven, Conn., said that biosimilars have comparable efficacy to the branded medication they replace. “If response is lost to an individual agent, we would not typically then switch to a biosimilar, but would favor another class of therapy or a distinct therapeutic which targets the same pathway.”
When physicians prescribe a biosimilar for rheumatoid arthritis or psoriatic arthritis, in 9 out 10 people, “it’s going to work as well, and it’s not going to cause any more side effects,” said Stanford Shoor, MD, clinical professor of medicine and rheumatology, Stanford (Calif.) University.
The systematic review, even within its limitations, reinforces confidence in the antitumor necrosis factor biosimilars, said Jean-Frederic Colombel, MD, codirector of the Feinstein Inflammatory Bowel Disease Clinical Center at Mount Sinai, New York, and professor of medicine, division of gastroenterology, Icahn School of Medicine at Mount Sinai.
“Still, studies with longer follow-up are needed,” Dr. Colombel said, adding that the remaining questions relate to the efficacy and safety of switching multiple times, which will likely occur in the near future. There will be a “need to provide information to the patient regarding what originator or biosimilar(s) he has been exposed to during the course of his disease.”
Switching will increasingly become the norm, said Miguel Regueiro, MD, chair of the Digestive Disease & Surgery Institute, Cleveland Clinic. In his clinical practice, he has the most experience with Crohn’s disease and ulcerative colitis, and biosimilar-to-biosimilar infliximab switches. “Unless there are data that emerge, I have no concerns with this.”
He added that it’s an “interesting study that affirms my findings in clinical practice – that one can switch from a biosimilar to biosimilar (of the same reference product).”
The review’s results also make sense from an economic standpoint, said Rajat Bhatt, MD, owner of Prime Rheumatology in Richmond, Tex., and an adjunct faculty member at Caribbean Medical University, Willemstad, Curaçao. “Switching to biosimilars will result in cost savings for the health care system.” Patients on certain insurances also will save by switching to a biosimilar with a lower copay.
However, the review is limited by a relatively small number of studies that have provided primary data on this topic, and most of these were switching from infliximab to a biosimilar for inflammatory bowel disease, said Alfred Kim, MD, PhD, an adult rheumatologist at Barnes-Jewish Hospital, St. Louis, and assistant professor of medicine at Washington University in St. Louis.
As with any meta-analysis evaluating a small number of studies, “broad applicability to all conditions and reference/biosimilar pair can only be assumed. Also, many of the studies used for this meta-analysis are observational, which can introduce a variety of biases that can be difficult to adjust for,” Dr. Kim said. “Nevertheless, these analyses are an important first step in validating the [Food and Drug Administration’s] approach to evaluating biosimilars, as the clinical outcomes are consistent between different biosimilars.”
This systematic review is not enough to prove that all patients will do fine when switching from one biosimilar to another, said Florence Aslinia, MD, a gastroenterologist at the University of Kansas Health System in Kansas City. It’s possible that some patients may not do as well, she said, noting that, in one study of patients with inflammatory bowel disease, 10% of patients on a biosimilar infliximab needed to switch back to the originator infliximab (Remicade, Janssen) because of side effects attributed to the biosimilar. The same thing may or may not happen with biosimilar-to-biosimilar switching, and it requires further study.
The authors did not receive any funding for writing this review. Dr. Cohen is an employee of Sandoz, a division of Novartis. He may own stock in Novartis. Two coauthors are also employees of Sandoz. The other three coauthors reported having financial relationships with numerous pharmaceutical companies, including Sandoz and/or Novartis. Dr. Colombel reported financial relationships with many pharmaceutical companies, including Novartis and other manufacturers of biosimilars. Dr. Regueiro reports financial relationships with numerous pharmaceutical companies, including some manufacturers of biosimilars. Dr. Weinberg reported financial relationships with Celgene, AbbVie, Eli Lilly, and Novartis. Kim reports financial relationships with GlaxoSmithKline, Pfizer, and AstraZeneca. Dr. Aslinia, Dr. Shoor, Dr. Choate, and Dr. Bhatt reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Switching from one biosimilar medication to another is safe and effective, a new systematic review indicates, even though this clinical practice is not governed by current health authority regulations or guidance.
“No reduction in effectiveness or increase in adverse events was detected in biosimilar-to-biosimilar switching studies conducted to date,” the review’s authors noted in their study, published online in BioDrugs.
“The possibility of multiple switches between biosimilars of the same reference biologic is already a reality, and these types of switches are expected to become more common in the future. ... Although it is not covered by current health authority regulations or guidance,” added the authors, led by Hillel P. Cohen, PhD, executive director of scientific affairs at Sandoz, a division of Novartis.
The researchers searched electronic databases through December 2021 and found 23 observational studies that met their search criteria, of which 13 were published in peer-reviewed journals; the remainder appeared in abstract form. The studies totaled 3,657 patients. The researchers did not identify any randomized clinical trials.
“The studies were heterogeneous in size, design, and endpoints, providing data on safety, effectiveness, immunogenicity, pharmacokinetics, patient retention, patient and physician perceptions, and drug-use patterns,” the authors wrote.
The authors found that the majority of studies evaluated switches between biosimilars of infliximab, but they also identified switches between biosimilars of adalimumab, etanercept, and rituximab.
“Some health care providers are hesitant to switch patients from one biosimilar to another biosimilar because of a perceived lack of clinical data on such switches,” Dr. Cohen said in an interview.
The review’s findings – that there were no clinically relevant differences when switching patients from one biosimilar to another – are consistent with the science, Dr. Cohen said. “Physicians should have confidence that the data demonstrate that safety and effectiveness are not impacted if patients switch from one biosimilar to another biosimilar of the same reference biologic,” he said.
Currently, the published data include biosimilars to only four reference biologics. “However, I anticipate additional biosimilar-to-biosimilar switching data will become available in the future,” Dr. Cohen said. “In fact, several new studies have been published in recent months, after the cut-off date for inclusion in our systematic review.”
Switching common in rheumatology, dermatology, and gastroenterology
Biosimilar-to-biosimilar switching was observed most commonly in rheumatology practice, but also was seen in the specialties of dermatology and gastroenterology.
Jeffrey Weinberg, MD, clinical professor of dermatology, Icahn School of Medicine at Mount Sinai, New York City, said in an interview that the study is among the best to date showing that switching biosimilars does not compromise efficacy or safety.
“I would hypothesize that the interchangeability would apply to psoriasis patients,” Dr. Weinberg said. However, “over the next few years, we will have an increasing number of biosimilars for an increasing number of different molecules. We will need to be vigilant to observe if similar behavior is observed with the biosimilars yet to come.”
Keith Choate, MD, PhD, professor of dermatology, pathology, and genetics, and associate dean for physician-scientist development at Yale University, New Haven, Conn., said that biosimilars have comparable efficacy to the branded medication they replace. “If response is lost to an individual agent, we would not typically then switch to a biosimilar, but would favor another class of therapy or a distinct therapeutic which targets the same pathway.”
When physicians prescribe a biosimilar for rheumatoid arthritis or psoriatic arthritis, in 9 out 10 people, “it’s going to work as well, and it’s not going to cause any more side effects,” said Stanford Shoor, MD, clinical professor of medicine and rheumatology, Stanford (Calif.) University.
The systematic review, even within its limitations, reinforces confidence in the antitumor necrosis factor biosimilars, said Jean-Frederic Colombel, MD, codirector of the Feinstein Inflammatory Bowel Disease Clinical Center at Mount Sinai, New York, and professor of medicine, division of gastroenterology, Icahn School of Medicine at Mount Sinai.
“Still, studies with longer follow-up are needed,” Dr. Colombel said, adding that the remaining questions relate to the efficacy and safety of switching multiple times, which will likely occur in the near future. There will be a “need to provide information to the patient regarding what originator or biosimilar(s) he has been exposed to during the course of his disease.”
Switching will increasingly become the norm, said Miguel Regueiro, MD, chair of the Digestive Disease & Surgery Institute, Cleveland Clinic. In his clinical practice, he has the most experience with Crohn’s disease and ulcerative colitis, and biosimilar-to-biosimilar infliximab switches. “Unless there are data that emerge, I have no concerns with this.”
He added that it’s an “interesting study that affirms my findings in clinical practice – that one can switch from a biosimilar to biosimilar (of the same reference product).”
The review’s results also make sense from an economic standpoint, said Rajat Bhatt, MD, owner of Prime Rheumatology in Richmond, Tex., and an adjunct faculty member at Caribbean Medical University, Willemstad, Curaçao. “Switching to biosimilars will result in cost savings for the health care system.” Patients on certain insurances also will save by switching to a biosimilar with a lower copay.
However, the review is limited by a relatively small number of studies that have provided primary data on this topic, and most of these were switching from infliximab to a biosimilar for inflammatory bowel disease, said Alfred Kim, MD, PhD, an adult rheumatologist at Barnes-Jewish Hospital, St. Louis, and assistant professor of medicine at Washington University in St. Louis.
As with any meta-analysis evaluating a small number of studies, “broad applicability to all conditions and reference/biosimilar pair can only be assumed. Also, many of the studies used for this meta-analysis are observational, which can introduce a variety of biases that can be difficult to adjust for,” Dr. Kim said. “Nevertheless, these analyses are an important first step in validating the [Food and Drug Administration’s] approach to evaluating biosimilars, as the clinical outcomes are consistent between different biosimilars.”
This systematic review is not enough to prove that all patients will do fine when switching from one biosimilar to another, said Florence Aslinia, MD, a gastroenterologist at the University of Kansas Health System in Kansas City. It’s possible that some patients may not do as well, she said, noting that, in one study of patients with inflammatory bowel disease, 10% of patients on a biosimilar infliximab needed to switch back to the originator infliximab (Remicade, Janssen) because of side effects attributed to the biosimilar. The same thing may or may not happen with biosimilar-to-biosimilar switching, and it requires further study.
The authors did not receive any funding for writing this review. Dr. Cohen is an employee of Sandoz, a division of Novartis. He may own stock in Novartis. Two coauthors are also employees of Sandoz. The other three coauthors reported having financial relationships with numerous pharmaceutical companies, including Sandoz and/or Novartis. Dr. Colombel reported financial relationships with many pharmaceutical companies, including Novartis and other manufacturers of biosimilars. Dr. Regueiro reports financial relationships with numerous pharmaceutical companies, including some manufacturers of biosimilars. Dr. Weinberg reported financial relationships with Celgene, AbbVie, Eli Lilly, and Novartis. Kim reports financial relationships with GlaxoSmithKline, Pfizer, and AstraZeneca. Dr. Aslinia, Dr. Shoor, Dr. Choate, and Dr. Bhatt reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Switching from one biosimilar medication to another is safe and effective, a new systematic review indicates, even though this clinical practice is not governed by current health authority regulations or guidance.
“No reduction in effectiveness or increase in adverse events was detected in biosimilar-to-biosimilar switching studies conducted to date,” the review’s authors noted in their study, published online in BioDrugs.
“The possibility of multiple switches between biosimilars of the same reference biologic is already a reality, and these types of switches are expected to become more common in the future. ... Although it is not covered by current health authority regulations or guidance,” added the authors, led by Hillel P. Cohen, PhD, executive director of scientific affairs at Sandoz, a division of Novartis.
The researchers searched electronic databases through December 2021 and found 23 observational studies that met their search criteria, of which 13 were published in peer-reviewed journals; the remainder appeared in abstract form. The studies totaled 3,657 patients. The researchers did not identify any randomized clinical trials.
“The studies were heterogeneous in size, design, and endpoints, providing data on safety, effectiveness, immunogenicity, pharmacokinetics, patient retention, patient and physician perceptions, and drug-use patterns,” the authors wrote.
The authors found that the majority of studies evaluated switches between biosimilars of infliximab, but they also identified switches between biosimilars of adalimumab, etanercept, and rituximab.
“Some health care providers are hesitant to switch patients from one biosimilar to another biosimilar because of a perceived lack of clinical data on such switches,” Dr. Cohen said in an interview.
The review’s findings – that there were no clinically relevant differences when switching patients from one biosimilar to another – are consistent with the science, Dr. Cohen said. “Physicians should have confidence that the data demonstrate that safety and effectiveness are not impacted if patients switch from one biosimilar to another biosimilar of the same reference biologic,” he said.
Currently, the published data include biosimilars to only four reference biologics. “However, I anticipate additional biosimilar-to-biosimilar switching data will become available in the future,” Dr. Cohen said. “In fact, several new studies have been published in recent months, after the cut-off date for inclusion in our systematic review.”
Switching common in rheumatology, dermatology, and gastroenterology
Biosimilar-to-biosimilar switching was observed most commonly in rheumatology practice, but also was seen in the specialties of dermatology and gastroenterology.
Jeffrey Weinberg, MD, clinical professor of dermatology, Icahn School of Medicine at Mount Sinai, New York City, said in an interview that the study is among the best to date showing that switching biosimilars does not compromise efficacy or safety.
“I would hypothesize that the interchangeability would apply to psoriasis patients,” Dr. Weinberg said. However, “over the next few years, we will have an increasing number of biosimilars for an increasing number of different molecules. We will need to be vigilant to observe if similar behavior is observed with the biosimilars yet to come.”
Keith Choate, MD, PhD, professor of dermatology, pathology, and genetics, and associate dean for physician-scientist development at Yale University, New Haven, Conn., said that biosimilars have comparable efficacy to the branded medication they replace. “If response is lost to an individual agent, we would not typically then switch to a biosimilar, but would favor another class of therapy or a distinct therapeutic which targets the same pathway.”
When physicians prescribe a biosimilar for rheumatoid arthritis or psoriatic arthritis, in 9 out 10 people, “it’s going to work as well, and it’s not going to cause any more side effects,” said Stanford Shoor, MD, clinical professor of medicine and rheumatology, Stanford (Calif.) University.
The systematic review, even within its limitations, reinforces confidence in the antitumor necrosis factor biosimilars, said Jean-Frederic Colombel, MD, codirector of the Feinstein Inflammatory Bowel Disease Clinical Center at Mount Sinai, New York, and professor of medicine, division of gastroenterology, Icahn School of Medicine at Mount Sinai.
“Still, studies with longer follow-up are needed,” Dr. Colombel said, adding that the remaining questions relate to the efficacy and safety of switching multiple times, which will likely occur in the near future. There will be a “need to provide information to the patient regarding what originator or biosimilar(s) he has been exposed to during the course of his disease.”
Switching will increasingly become the norm, said Miguel Regueiro, MD, chair of the Digestive Disease & Surgery Institute, Cleveland Clinic. In his clinical practice, he has the most experience with Crohn’s disease and ulcerative colitis, and biosimilar-to-biosimilar infliximab switches. “Unless there are data that emerge, I have no concerns with this.”
He added that it’s an “interesting study that affirms my findings in clinical practice – that one can switch from a biosimilar to biosimilar (of the same reference product).”
The review’s results also make sense from an economic standpoint, said Rajat Bhatt, MD, owner of Prime Rheumatology in Richmond, Tex., and an adjunct faculty member at Caribbean Medical University, Willemstad, Curaçao. “Switching to biosimilars will result in cost savings for the health care system.” Patients on certain insurances also will save by switching to a biosimilar with a lower copay.
However, the review is limited by a relatively small number of studies that have provided primary data on this topic, and most of these were switching from infliximab to a biosimilar for inflammatory bowel disease, said Alfred Kim, MD, PhD, an adult rheumatologist at Barnes-Jewish Hospital, St. Louis, and assistant professor of medicine at Washington University in St. Louis.
As with any meta-analysis evaluating a small number of studies, “broad applicability to all conditions and reference/biosimilar pair can only be assumed. Also, many of the studies used for this meta-analysis are observational, which can introduce a variety of biases that can be difficult to adjust for,” Dr. Kim said. “Nevertheless, these analyses are an important first step in validating the [Food and Drug Administration’s] approach to evaluating biosimilars, as the clinical outcomes are consistent between different biosimilars.”
This systematic review is not enough to prove that all patients will do fine when switching from one biosimilar to another, said Florence Aslinia, MD, a gastroenterologist at the University of Kansas Health System in Kansas City. It’s possible that some patients may not do as well, she said, noting that, in one study of patients with inflammatory bowel disease, 10% of patients on a biosimilar infliximab needed to switch back to the originator infliximab (Remicade, Janssen) because of side effects attributed to the biosimilar. The same thing may or may not happen with biosimilar-to-biosimilar switching, and it requires further study.
The authors did not receive any funding for writing this review. Dr. Cohen is an employee of Sandoz, a division of Novartis. He may own stock in Novartis. Two coauthors are also employees of Sandoz. The other three coauthors reported having financial relationships with numerous pharmaceutical companies, including Sandoz and/or Novartis. Dr. Colombel reported financial relationships with many pharmaceutical companies, including Novartis and other manufacturers of biosimilars. Dr. Regueiro reports financial relationships with numerous pharmaceutical companies, including some manufacturers of biosimilars. Dr. Weinberg reported financial relationships with Celgene, AbbVie, Eli Lilly, and Novartis. Kim reports financial relationships with GlaxoSmithKline, Pfizer, and AstraZeneca. Dr. Aslinia, Dr. Shoor, Dr. Choate, and Dr. Bhatt reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM BIODRUGS
Navigating patient requests for an emotional support animal
When Serena-Lian Sakheim-Devine’s best friend from childhood died of cancer, she felt sad and lonely while away at college. Wanting something warm to snuggle, she got a guinea pig and named her Basil. Then she got two more and called them Nutmeg and Paprika. The three became her Spice Girls.
“They were of great comfort to me, but also to others at times of need,” said Ms. Sakheim-Devine, 26, who lived with them in a dormitory at Smith College, an all-women’s institution in Northampton, Mass.
Her therapist wrote a letter and sent it to the disability office at Smith, which permitted the guinea pigs as emotional support animals (ESAs). Eventually, though, she wanted a dog to help manage her PTSD, depression, anxiety, and panic attacks. So, she adopted a beagle from a shelter.
Once again, a therapist provided a letter, and Ms. Sakheim-Devine was allowed to keep the beagle, Finnian, then about 13 years old, in her dorm room on the condition that she give up the guinea pigs, which she did.
She and Finnian bonded almost instantly. When she woke up drenched in sweat, unable to move or speak, the dog sensed how tense she was. Finnian licked her hands, got her fingers moving, and helped ground her.
“I didn’t really teach her that. She just knew,” said Ms. Sakheim-Devine, now a safety engineer who lives in New Haven, Conn. “It was incredible how well connected we were, even from the get-go.”
The therapeutic benefits of four-legged friends
Although there is limited scientific literature on the therapeutic use of ESAs, there are well-established benefits of having pets that also apply in these situations. Animals can provide distraction from stress, alleviate loneliness, and instill a sense of responsibility, said Rachel A. Davis, MD, associate professor of psychiatry and neurosurgery at the University of Colorado at Denver, Aurora.
They add structure to a person’s day by needing to be fed at specific times, and they can help the human get exercise. “Patients have reported improved sense of meaning in life and purpose,” Dr. Davis said.
Examples include depression, anxiety, obsessive-compulsive disorder, panic attacks, and PTSD.
ESAs differ from psychiatric service animals, which are trained to perform specific tasks, such as applying deep pressure that calms the owner. By their mere existence, ESAs provide emotional benefits to a person with a mental health disability.
“Social support, even from an animal, can really help people feel less alone, better about themselves, and safer from unpleasantness or even a physical attack,” said David Spiegel, MD, professor and associate chair of psychiatry and behavioral sciences and director of the Center on Stress and Health at Stanford (Calif.) University.
Writing a letter on your patient’s behalf
Writing a letter that serves as proof of a person’s need for an ESA is a request that mental health professionals sometimes receive from patients. The letter can grant access to housing without additional cost regardless of no-pet polices, and some employers may allow an ESA at work as a reasonable accommodation for a psychological disability. Until recently, an ESA could accompany its owner on a plane, but most airlines no longer permit this, partly because some passengers falsely claim their pets as ESAs.
Before crafting a letter for someone with an ESA, Dr. Spiegel asks for the patient’s permission to elaborate on the clinical condition that merits professional help and to explain how the animal relieves associated symptoms.
The Fair Housing Act, a federal law, requires a landlord to grant a reasonable accommodation involving an emotional support or other assistance animal. Such an accommodation honors a request to live on the property despite a no-pets policy. It also waives a pet deposit, fee, or other rules involving animals on the premises.
Landlords are usually supportive of a request to permit an ESA, said Jonathan Betlinski, MD, associate professor and director of the public psychiatry division at Oregon Health and Science University, Portland. None of his patients have experienced any difficulties once they obtained a letter from him.
However, “anytime somebody asks me about a letter for an ESA, that’s the time to have a conversation. It’s not automatic,” Dr. Betlinski said. The discussion involves learning about the type of animal a patient has and how it helps his or her emotional state.
Because of privacy concerns, Dr. Betlinski doesn’t disclose the specific diagnosis in the letter unless the patient signs a release of information. The laws pertaining to ESAs only require his letter to note that an individual has a qualifying diagnosis and that an ESA helps improve symptoms, but it’s not necessary to explain how.
“You can see where writing the letter is a fine balancing act,” he said. But he finds it helpful to mention any training the animal has completed, such as the Canine Good Citizen course sponsored by the American Kennel Club.
Most of the letters Luis Anez, PsyD, a clinical psychologist and associate professor of psychiatry at Yale University, New Haven, Conn., has written for this purpose were in support of ESAs in housing. But he also recalled providing a letter for a patient who was flying to Puerto Rico with an ESA. The letters are generally provided only to established patients with psychiatric diagnoses.
Without a letter, “we’ve seen people say: ‘I’d rather be homeless than part with my dog,’ ”said Dr. Anez, who is also director of Hispanic services at Connecticut Mental Health Center in New Haven, a partnership between Yale and the Connecticut Department of Mental Health and Addiction Services. Before getting an ESA, Dr. Anez recommends that individuals become aware of their landlord’s policies on possible restrictions relating to dog sizes and breeds.
Additional considerations
An ESA doesn’t necessarily have to be a dog. “It certainly could be a cat. It could be a parrot, too,” said Stephen Stern, MD, a psychiatrist in private practice in Mount Kisco, N.Y. But, “if they say that their emotional support animal is an earthworm, that would make you wonder,” he added half-jokingly.
Dr. Stern only writes an ESA letter for a patient with whom he has an ongoing professional relationship. For instance, if he’s treating someone for depression and that patient tells him how the animal helps relieve symptoms, then that is sufficient justification to write a letter.
“Because you know them, you’ve assessed that what they’re saying is plausible,” said Dr. Stern, who is also an adjunct professor of psychiatry at the University of Texas Health Science in San Antonio, where he conducted research on companion dogs for veterans with PTSD and continues to collaborate with colleagues via email and Zoom.
While veterans benefit from ESAs, some live in housing that doesn’t permit animals, said Beth Zimmerman, founder and executive director of Pets for Patriots, a nationally operating nonprofit organization in Long Beach, N.Y., that partners with shelters and animal welfare groups to adopt dogs and cats for companionship and emotional support. She said an ESA can be “a wonderful complement to other forms of therapy that a veteran may undertake.
“Most of the time when the veteran encounters a problem, it’s because the landlord is ill-informed of the law,” Dr. Zimmerman said. “We provide information to the veteran to share with the landlord or building management, and always recommend taking a very amicable approach. In our experience, with very few exceptions, once the landlord understands his or her responsibilities under the law, they will permit the veteran to have that emotional support animal in their dwelling.”
For Kristin Lowe, a chocolate Labrador-Weimaraner mix named Lola provided emotional support from her puppy days until her death at age 12 in May 2021. Ms. Lowe’s psychiatrist provided letters that allowed Lola to live in her apartment and to travel on commercial airline flights.
“She was so connected to me,” said Ms. Lowe, 34, who lives in Denver and works as an administrative office worker in physical therapy. “She was a part of me. She could read every emotion that I had.”
Now, Ms. Lowe relies on Henry, an Australian shepherd puppy, to help her cope with obsessive-compulsive disorder, major depressive disorder, and an eating disorder. She described him as “a very happy little guy and a constant tail wagger – and that lights up something in me.”
More information, which is provided by the U.S. Department of Housing and Urban Development, can be found here.
A version of this article first appeared on Medscape.com.
When Serena-Lian Sakheim-Devine’s best friend from childhood died of cancer, she felt sad and lonely while away at college. Wanting something warm to snuggle, she got a guinea pig and named her Basil. Then she got two more and called them Nutmeg and Paprika. The three became her Spice Girls.
“They were of great comfort to me, but also to others at times of need,” said Ms. Sakheim-Devine, 26, who lived with them in a dormitory at Smith College, an all-women’s institution in Northampton, Mass.
Her therapist wrote a letter and sent it to the disability office at Smith, which permitted the guinea pigs as emotional support animals (ESAs). Eventually, though, she wanted a dog to help manage her PTSD, depression, anxiety, and panic attacks. So, she adopted a beagle from a shelter.
Once again, a therapist provided a letter, and Ms. Sakheim-Devine was allowed to keep the beagle, Finnian, then about 13 years old, in her dorm room on the condition that she give up the guinea pigs, which she did.
She and Finnian bonded almost instantly. When she woke up drenched in sweat, unable to move or speak, the dog sensed how tense she was. Finnian licked her hands, got her fingers moving, and helped ground her.
“I didn’t really teach her that. She just knew,” said Ms. Sakheim-Devine, now a safety engineer who lives in New Haven, Conn. “It was incredible how well connected we were, even from the get-go.”
The therapeutic benefits of four-legged friends
Although there is limited scientific literature on the therapeutic use of ESAs, there are well-established benefits of having pets that also apply in these situations. Animals can provide distraction from stress, alleviate loneliness, and instill a sense of responsibility, said Rachel A. Davis, MD, associate professor of psychiatry and neurosurgery at the University of Colorado at Denver, Aurora.
They add structure to a person’s day by needing to be fed at specific times, and they can help the human get exercise. “Patients have reported improved sense of meaning in life and purpose,” Dr. Davis said.
Examples include depression, anxiety, obsessive-compulsive disorder, panic attacks, and PTSD.
ESAs differ from psychiatric service animals, which are trained to perform specific tasks, such as applying deep pressure that calms the owner. By their mere existence, ESAs provide emotional benefits to a person with a mental health disability.
“Social support, even from an animal, can really help people feel less alone, better about themselves, and safer from unpleasantness or even a physical attack,” said David Spiegel, MD, professor and associate chair of psychiatry and behavioral sciences and director of the Center on Stress and Health at Stanford (Calif.) University.
Writing a letter on your patient’s behalf
Writing a letter that serves as proof of a person’s need for an ESA is a request that mental health professionals sometimes receive from patients. The letter can grant access to housing without additional cost regardless of no-pet polices, and some employers may allow an ESA at work as a reasonable accommodation for a psychological disability. Until recently, an ESA could accompany its owner on a plane, but most airlines no longer permit this, partly because some passengers falsely claim their pets as ESAs.
Before crafting a letter for someone with an ESA, Dr. Spiegel asks for the patient’s permission to elaborate on the clinical condition that merits professional help and to explain how the animal relieves associated symptoms.
The Fair Housing Act, a federal law, requires a landlord to grant a reasonable accommodation involving an emotional support or other assistance animal. Such an accommodation honors a request to live on the property despite a no-pets policy. It also waives a pet deposit, fee, or other rules involving animals on the premises.
Landlords are usually supportive of a request to permit an ESA, said Jonathan Betlinski, MD, associate professor and director of the public psychiatry division at Oregon Health and Science University, Portland. None of his patients have experienced any difficulties once they obtained a letter from him.
However, “anytime somebody asks me about a letter for an ESA, that’s the time to have a conversation. It’s not automatic,” Dr. Betlinski said. The discussion involves learning about the type of animal a patient has and how it helps his or her emotional state.
Because of privacy concerns, Dr. Betlinski doesn’t disclose the specific diagnosis in the letter unless the patient signs a release of information. The laws pertaining to ESAs only require his letter to note that an individual has a qualifying diagnosis and that an ESA helps improve symptoms, but it’s not necessary to explain how.
“You can see where writing the letter is a fine balancing act,” he said. But he finds it helpful to mention any training the animal has completed, such as the Canine Good Citizen course sponsored by the American Kennel Club.
Most of the letters Luis Anez, PsyD, a clinical psychologist and associate professor of psychiatry at Yale University, New Haven, Conn., has written for this purpose were in support of ESAs in housing. But he also recalled providing a letter for a patient who was flying to Puerto Rico with an ESA. The letters are generally provided only to established patients with psychiatric diagnoses.
Without a letter, “we’ve seen people say: ‘I’d rather be homeless than part with my dog,’ ”said Dr. Anez, who is also director of Hispanic services at Connecticut Mental Health Center in New Haven, a partnership between Yale and the Connecticut Department of Mental Health and Addiction Services. Before getting an ESA, Dr. Anez recommends that individuals become aware of their landlord’s policies on possible restrictions relating to dog sizes and breeds.
Additional considerations
An ESA doesn’t necessarily have to be a dog. “It certainly could be a cat. It could be a parrot, too,” said Stephen Stern, MD, a psychiatrist in private practice in Mount Kisco, N.Y. But, “if they say that their emotional support animal is an earthworm, that would make you wonder,” he added half-jokingly.
Dr. Stern only writes an ESA letter for a patient with whom he has an ongoing professional relationship. For instance, if he’s treating someone for depression and that patient tells him how the animal helps relieve symptoms, then that is sufficient justification to write a letter.
“Because you know them, you’ve assessed that what they’re saying is plausible,” said Dr. Stern, who is also an adjunct professor of psychiatry at the University of Texas Health Science in San Antonio, where he conducted research on companion dogs for veterans with PTSD and continues to collaborate with colleagues via email and Zoom.
While veterans benefit from ESAs, some live in housing that doesn’t permit animals, said Beth Zimmerman, founder and executive director of Pets for Patriots, a nationally operating nonprofit organization in Long Beach, N.Y., that partners with shelters and animal welfare groups to adopt dogs and cats for companionship and emotional support. She said an ESA can be “a wonderful complement to other forms of therapy that a veteran may undertake.
“Most of the time when the veteran encounters a problem, it’s because the landlord is ill-informed of the law,” Dr. Zimmerman said. “We provide information to the veteran to share with the landlord or building management, and always recommend taking a very amicable approach. In our experience, with very few exceptions, once the landlord understands his or her responsibilities under the law, they will permit the veteran to have that emotional support animal in their dwelling.”
For Kristin Lowe, a chocolate Labrador-Weimaraner mix named Lola provided emotional support from her puppy days until her death at age 12 in May 2021. Ms. Lowe’s psychiatrist provided letters that allowed Lola to live in her apartment and to travel on commercial airline flights.
“She was so connected to me,” said Ms. Lowe, 34, who lives in Denver and works as an administrative office worker in physical therapy. “She was a part of me. She could read every emotion that I had.”
Now, Ms. Lowe relies on Henry, an Australian shepherd puppy, to help her cope with obsessive-compulsive disorder, major depressive disorder, and an eating disorder. She described him as “a very happy little guy and a constant tail wagger – and that lights up something in me.”
More information, which is provided by the U.S. Department of Housing and Urban Development, can be found here.
A version of this article first appeared on Medscape.com.
When Serena-Lian Sakheim-Devine’s best friend from childhood died of cancer, she felt sad and lonely while away at college. Wanting something warm to snuggle, she got a guinea pig and named her Basil. Then she got two more and called them Nutmeg and Paprika. The three became her Spice Girls.
“They were of great comfort to me, but also to others at times of need,” said Ms. Sakheim-Devine, 26, who lived with them in a dormitory at Smith College, an all-women’s institution in Northampton, Mass.
Her therapist wrote a letter and sent it to the disability office at Smith, which permitted the guinea pigs as emotional support animals (ESAs). Eventually, though, she wanted a dog to help manage her PTSD, depression, anxiety, and panic attacks. So, she adopted a beagle from a shelter.
Once again, a therapist provided a letter, and Ms. Sakheim-Devine was allowed to keep the beagle, Finnian, then about 13 years old, in her dorm room on the condition that she give up the guinea pigs, which she did.
She and Finnian bonded almost instantly. When she woke up drenched in sweat, unable to move or speak, the dog sensed how tense she was. Finnian licked her hands, got her fingers moving, and helped ground her.
“I didn’t really teach her that. She just knew,” said Ms. Sakheim-Devine, now a safety engineer who lives in New Haven, Conn. “It was incredible how well connected we were, even from the get-go.”
The therapeutic benefits of four-legged friends
Although there is limited scientific literature on the therapeutic use of ESAs, there are well-established benefits of having pets that also apply in these situations. Animals can provide distraction from stress, alleviate loneliness, and instill a sense of responsibility, said Rachel A. Davis, MD, associate professor of psychiatry and neurosurgery at the University of Colorado at Denver, Aurora.
They add structure to a person’s day by needing to be fed at specific times, and they can help the human get exercise. “Patients have reported improved sense of meaning in life and purpose,” Dr. Davis said.
Examples include depression, anxiety, obsessive-compulsive disorder, panic attacks, and PTSD.
ESAs differ from psychiatric service animals, which are trained to perform specific tasks, such as applying deep pressure that calms the owner. By their mere existence, ESAs provide emotional benefits to a person with a mental health disability.
“Social support, even from an animal, can really help people feel less alone, better about themselves, and safer from unpleasantness or even a physical attack,” said David Spiegel, MD, professor and associate chair of psychiatry and behavioral sciences and director of the Center on Stress and Health at Stanford (Calif.) University.
Writing a letter on your patient’s behalf
Writing a letter that serves as proof of a person’s need for an ESA is a request that mental health professionals sometimes receive from patients. The letter can grant access to housing without additional cost regardless of no-pet polices, and some employers may allow an ESA at work as a reasonable accommodation for a psychological disability. Until recently, an ESA could accompany its owner on a plane, but most airlines no longer permit this, partly because some passengers falsely claim their pets as ESAs.
Before crafting a letter for someone with an ESA, Dr. Spiegel asks for the patient’s permission to elaborate on the clinical condition that merits professional help and to explain how the animal relieves associated symptoms.
The Fair Housing Act, a federal law, requires a landlord to grant a reasonable accommodation involving an emotional support or other assistance animal. Such an accommodation honors a request to live on the property despite a no-pets policy. It also waives a pet deposit, fee, or other rules involving animals on the premises.
Landlords are usually supportive of a request to permit an ESA, said Jonathan Betlinski, MD, associate professor and director of the public psychiatry division at Oregon Health and Science University, Portland. None of his patients have experienced any difficulties once they obtained a letter from him.
However, “anytime somebody asks me about a letter for an ESA, that’s the time to have a conversation. It’s not automatic,” Dr. Betlinski said. The discussion involves learning about the type of animal a patient has and how it helps his or her emotional state.
Because of privacy concerns, Dr. Betlinski doesn’t disclose the specific diagnosis in the letter unless the patient signs a release of information. The laws pertaining to ESAs only require his letter to note that an individual has a qualifying diagnosis and that an ESA helps improve symptoms, but it’s not necessary to explain how.
“You can see where writing the letter is a fine balancing act,” he said. But he finds it helpful to mention any training the animal has completed, such as the Canine Good Citizen course sponsored by the American Kennel Club.
Most of the letters Luis Anez, PsyD, a clinical psychologist and associate professor of psychiatry at Yale University, New Haven, Conn., has written for this purpose were in support of ESAs in housing. But he also recalled providing a letter for a patient who was flying to Puerto Rico with an ESA. The letters are generally provided only to established patients with psychiatric diagnoses.
Without a letter, “we’ve seen people say: ‘I’d rather be homeless than part with my dog,’ ”said Dr. Anez, who is also director of Hispanic services at Connecticut Mental Health Center in New Haven, a partnership between Yale and the Connecticut Department of Mental Health and Addiction Services. Before getting an ESA, Dr. Anez recommends that individuals become aware of their landlord’s policies on possible restrictions relating to dog sizes and breeds.
Additional considerations
An ESA doesn’t necessarily have to be a dog. “It certainly could be a cat. It could be a parrot, too,” said Stephen Stern, MD, a psychiatrist in private practice in Mount Kisco, N.Y. But, “if they say that their emotional support animal is an earthworm, that would make you wonder,” he added half-jokingly.
Dr. Stern only writes an ESA letter for a patient with whom he has an ongoing professional relationship. For instance, if he’s treating someone for depression and that patient tells him how the animal helps relieve symptoms, then that is sufficient justification to write a letter.
“Because you know them, you’ve assessed that what they’re saying is plausible,” said Dr. Stern, who is also an adjunct professor of psychiatry at the University of Texas Health Science in San Antonio, where he conducted research on companion dogs for veterans with PTSD and continues to collaborate with colleagues via email and Zoom.
While veterans benefit from ESAs, some live in housing that doesn’t permit animals, said Beth Zimmerman, founder and executive director of Pets for Patriots, a nationally operating nonprofit organization in Long Beach, N.Y., that partners with shelters and animal welfare groups to adopt dogs and cats for companionship and emotional support. She said an ESA can be “a wonderful complement to other forms of therapy that a veteran may undertake.
“Most of the time when the veteran encounters a problem, it’s because the landlord is ill-informed of the law,” Dr. Zimmerman said. “We provide information to the veteran to share with the landlord or building management, and always recommend taking a very amicable approach. In our experience, with very few exceptions, once the landlord understands his or her responsibilities under the law, they will permit the veteran to have that emotional support animal in their dwelling.”
For Kristin Lowe, a chocolate Labrador-Weimaraner mix named Lola provided emotional support from her puppy days until her death at age 12 in May 2021. Ms. Lowe’s psychiatrist provided letters that allowed Lola to live in her apartment and to travel on commercial airline flights.
“She was so connected to me,” said Ms. Lowe, 34, who lives in Denver and works as an administrative office worker in physical therapy. “She was a part of me. She could read every emotion that I had.”
Now, Ms. Lowe relies on Henry, an Australian shepherd puppy, to help her cope with obsessive-compulsive disorder, major depressive disorder, and an eating disorder. She described him as “a very happy little guy and a constant tail wagger – and that lights up something in me.”
More information, which is provided by the U.S. Department of Housing and Urban Development, can be found here.
A version of this article first appeared on Medscape.com.
Triaging neurocognitive screening after SARS-CoV-2 infection
The study covered in this summary was published in Research Square as a preprint and has not yet been peer reviewed.
Key takeaways
- Focal cognitive deficits are more prevalent in hospitalized patients than ambulatory patients.
- Objective neurocognitive measures can supply crucial information to guide clinical decisions regarding the need for further imaging or neurologic workup and should be included as endpoints in clinical trials.
Why this matters
- Cognitive complaints commonly occur in patients convalescing from COVID-19, although their cause is frequently unclear.
- The researchers evaluated factors that play a role in cognitive impairment in ambulatory versus hospitalized patients during the subacute stage of recovery.
- These results underscore the significance of assessing both subjective and objective complaints in ascertaining the prevalence of cognitive impairment in recovering patients and research participants.
- The drivers of cognitive complaints are likely different in hospitalized COVID-19 patients in comparison with ambulatory COVID-19 patients, so it’s important to understand these factors in making treatment decisions.
- Biopsychosocial factors appear to be a powerful driver of cognitive complaints in recovering ambulatory patients. They can be treated with interventions targeting anxiety, depression, sleep disturbances, and pain, which may prove to be the most efficient and cost-effective approach to prevent disability in individuals with mild manifestations of COVID-19.
- Objective neurocognitive deficits were more prevalent in hospitalized patients – a marker of greater disease severity – with mainly deficits in memory and psychomotor speed. Factors that contribute to focal cognitive deficits in these individuals are emerging and represent a noteworthy realm for future investigation.
Study design
- The trial prospectively recruited patients from a hospital-wide registry at the Mayo Clinic in Jacksonville, Fla.
- All patients tested positive for SARS-CoV-2 infection on a real-time reverse transcriptase polymerase chain-reaction assay between June 2020 and March 2021.
- Patients were 18 years of age or older.
- The researchers excluded those with a pre-existing major neurocognitive disorder.
- To participate, patients needed access to a desktop or laptop computer to complete a test and survey.
- They responded to a comprehensive neuropsychological questionnaire and a computerized cognitive screen using a remote telemedicine platform.
- The researchers compared rates of subjective and objective neuropsychological impairment between the ambulatory and hospitalized groups. Factors linked to impairment were analyzed separately within each group.
Key results
- After laboratory confirmation of SARS-CoV-2 infection, a total of 102 patients (76 ambulatory, 26 hospitalized) completed the symptom inventory and neurocognitive tests in 24 ± 22 days.
- Hospitalized and ambulatory patients self-reported high rates of cognitive impairment (27%-40%). There were no variations between the groups.
- However, hospitalized patients had more significant rates of objective impairment in visual memory (30% vs. 4%; P = .001) and psychomotor speed (41% vs. 15%; P = .008).
- Objective cognitive test performance was linked to anxiety, depression, fatigue, and pain in the ambulatory but not the hospitalized group.
Limitations
- The sample size of hospitalized patients was small.
- A larger fraction of hospitalized patients in the sample completed outcome assessments, compared with ambulatory patients, indicating that remote computerized testing did not present a disproportionate access barrier for patients with more severe illness.
- Owing to limited instances of delirium, seizures, and stroke, it was not possible to directly consider the contributions of these events to post–COVID-19 subjective complaints and objective impairment.
- The researchers depended on a 45-minute computerized test battery, which eliminates exposure risk and is available to patients in remote locations, but it necessitates computer literacy and access to a home desktop computer. While this requirement may have skewed the sample toward a more socioeconomically advantaged and younger population, there were no differences in age, race, or ethnicity between those who completed the computerized outcome assessments and those who did not. For patients who are able to give consent electronically, computerized testing does not pose an additional barrier.
- As a result of this study’s cross-sectional nature, the researchers could not comment on the natural history and long-term risk of COVID-19 cognitive impairment. It will be crucial to monitor cognitive progression at future time points to assess the rate and predictors of cognitive normalization versus decline.
Study disclosures
- Gregory S. Day, a coauthor, owns stock (greater than $10,000) in ANI Pharmaceuticals, a generic pharmaceutical company. He serves as a topic editor for DynaMed (EBSCO), overseeing development of evidence-based educational content, a consultant for Parabon Nanolabs (advice relevant to National Institutes of Health small business grant submission), and as the clinical director of the Anti-NMDA Receptor Encephalitis Foundation, Canada (uncompensated). The other authors have disclosed no relevant financial relationships.
This is a summary of a preprint research study, “Neurocognitive Screening in Patients Following SARS-CoV-2 Infection: Tools for Triage,” written by Karen Blackmon from Mayo Clinic in Florida, on medRxiv. This study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org. A version of this article first appeared on Medscape.com.
The study covered in this summary was published in Research Square as a preprint and has not yet been peer reviewed.
Key takeaways
- Focal cognitive deficits are more prevalent in hospitalized patients than ambulatory patients.
- Objective neurocognitive measures can supply crucial information to guide clinical decisions regarding the need for further imaging or neurologic workup and should be included as endpoints in clinical trials.
Why this matters
- Cognitive complaints commonly occur in patients convalescing from COVID-19, although their cause is frequently unclear.
- The researchers evaluated factors that play a role in cognitive impairment in ambulatory versus hospitalized patients during the subacute stage of recovery.
- These results underscore the significance of assessing both subjective and objective complaints in ascertaining the prevalence of cognitive impairment in recovering patients and research participants.
- The drivers of cognitive complaints are likely different in hospitalized COVID-19 patients in comparison with ambulatory COVID-19 patients, so it’s important to understand these factors in making treatment decisions.
- Biopsychosocial factors appear to be a powerful driver of cognitive complaints in recovering ambulatory patients. They can be treated with interventions targeting anxiety, depression, sleep disturbances, and pain, which may prove to be the most efficient and cost-effective approach to prevent disability in individuals with mild manifestations of COVID-19.
- Objective neurocognitive deficits were more prevalent in hospitalized patients – a marker of greater disease severity – with mainly deficits in memory and psychomotor speed. Factors that contribute to focal cognitive deficits in these individuals are emerging and represent a noteworthy realm for future investigation.
Study design
- The trial prospectively recruited patients from a hospital-wide registry at the Mayo Clinic in Jacksonville, Fla.
- All patients tested positive for SARS-CoV-2 infection on a real-time reverse transcriptase polymerase chain-reaction assay between June 2020 and March 2021.
- Patients were 18 years of age or older.
- The researchers excluded those with a pre-existing major neurocognitive disorder.
- To participate, patients needed access to a desktop or laptop computer to complete a test and survey.
- They responded to a comprehensive neuropsychological questionnaire and a computerized cognitive screen using a remote telemedicine platform.
- The researchers compared rates of subjective and objective neuropsychological impairment between the ambulatory and hospitalized groups. Factors linked to impairment were analyzed separately within each group.
Key results
- After laboratory confirmation of SARS-CoV-2 infection, a total of 102 patients (76 ambulatory, 26 hospitalized) completed the symptom inventory and neurocognitive tests in 24 ± 22 days.
- Hospitalized and ambulatory patients self-reported high rates of cognitive impairment (27%-40%). There were no variations between the groups.
- However, hospitalized patients had more significant rates of objective impairment in visual memory (30% vs. 4%; P = .001) and psychomotor speed (41% vs. 15%; P = .008).
- Objective cognitive test performance was linked to anxiety, depression, fatigue, and pain in the ambulatory but not the hospitalized group.
Limitations
- The sample size of hospitalized patients was small.
- A larger fraction of hospitalized patients in the sample completed outcome assessments, compared with ambulatory patients, indicating that remote computerized testing did not present a disproportionate access barrier for patients with more severe illness.
- Owing to limited instances of delirium, seizures, and stroke, it was not possible to directly consider the contributions of these events to post–COVID-19 subjective complaints and objective impairment.
- The researchers depended on a 45-minute computerized test battery, which eliminates exposure risk and is available to patients in remote locations, but it necessitates computer literacy and access to a home desktop computer. While this requirement may have skewed the sample toward a more socioeconomically advantaged and younger population, there were no differences in age, race, or ethnicity between those who completed the computerized outcome assessments and those who did not. For patients who are able to give consent electronically, computerized testing does not pose an additional barrier.
- As a result of this study’s cross-sectional nature, the researchers could not comment on the natural history and long-term risk of COVID-19 cognitive impairment. It will be crucial to monitor cognitive progression at future time points to assess the rate and predictors of cognitive normalization versus decline.
Study disclosures
- Gregory S. Day, a coauthor, owns stock (greater than $10,000) in ANI Pharmaceuticals, a generic pharmaceutical company. He serves as a topic editor for DynaMed (EBSCO), overseeing development of evidence-based educational content, a consultant for Parabon Nanolabs (advice relevant to National Institutes of Health small business grant submission), and as the clinical director of the Anti-NMDA Receptor Encephalitis Foundation, Canada (uncompensated). The other authors have disclosed no relevant financial relationships.
This is a summary of a preprint research study, “Neurocognitive Screening in Patients Following SARS-CoV-2 Infection: Tools for Triage,” written by Karen Blackmon from Mayo Clinic in Florida, on medRxiv. This study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org. A version of this article first appeared on Medscape.com.
The study covered in this summary was published in Research Square as a preprint and has not yet been peer reviewed.
Key takeaways
- Focal cognitive deficits are more prevalent in hospitalized patients than ambulatory patients.
- Objective neurocognitive measures can supply crucial information to guide clinical decisions regarding the need for further imaging or neurologic workup and should be included as endpoints in clinical trials.
Why this matters
- Cognitive complaints commonly occur in patients convalescing from COVID-19, although their cause is frequently unclear.
- The researchers evaluated factors that play a role in cognitive impairment in ambulatory versus hospitalized patients during the subacute stage of recovery.
- These results underscore the significance of assessing both subjective and objective complaints in ascertaining the prevalence of cognitive impairment in recovering patients and research participants.
- The drivers of cognitive complaints are likely different in hospitalized COVID-19 patients in comparison with ambulatory COVID-19 patients, so it’s important to understand these factors in making treatment decisions.
- Biopsychosocial factors appear to be a powerful driver of cognitive complaints in recovering ambulatory patients. They can be treated with interventions targeting anxiety, depression, sleep disturbances, and pain, which may prove to be the most efficient and cost-effective approach to prevent disability in individuals with mild manifestations of COVID-19.
- Objective neurocognitive deficits were more prevalent in hospitalized patients – a marker of greater disease severity – with mainly deficits in memory and psychomotor speed. Factors that contribute to focal cognitive deficits in these individuals are emerging and represent a noteworthy realm for future investigation.
Study design
- The trial prospectively recruited patients from a hospital-wide registry at the Mayo Clinic in Jacksonville, Fla.
- All patients tested positive for SARS-CoV-2 infection on a real-time reverse transcriptase polymerase chain-reaction assay between June 2020 and March 2021.
- Patients were 18 years of age or older.
- The researchers excluded those with a pre-existing major neurocognitive disorder.
- To participate, patients needed access to a desktop or laptop computer to complete a test and survey.
- They responded to a comprehensive neuropsychological questionnaire and a computerized cognitive screen using a remote telemedicine platform.
- The researchers compared rates of subjective and objective neuropsychological impairment between the ambulatory and hospitalized groups. Factors linked to impairment were analyzed separately within each group.
Key results
- After laboratory confirmation of SARS-CoV-2 infection, a total of 102 patients (76 ambulatory, 26 hospitalized) completed the symptom inventory and neurocognitive tests in 24 ± 22 days.
- Hospitalized and ambulatory patients self-reported high rates of cognitive impairment (27%-40%). There were no variations between the groups.
- However, hospitalized patients had more significant rates of objective impairment in visual memory (30% vs. 4%; P = .001) and psychomotor speed (41% vs. 15%; P = .008).
- Objective cognitive test performance was linked to anxiety, depression, fatigue, and pain in the ambulatory but not the hospitalized group.
Limitations
- The sample size of hospitalized patients was small.
- A larger fraction of hospitalized patients in the sample completed outcome assessments, compared with ambulatory patients, indicating that remote computerized testing did not present a disproportionate access barrier for patients with more severe illness.
- Owing to limited instances of delirium, seizures, and stroke, it was not possible to directly consider the contributions of these events to post–COVID-19 subjective complaints and objective impairment.
- The researchers depended on a 45-minute computerized test battery, which eliminates exposure risk and is available to patients in remote locations, but it necessitates computer literacy and access to a home desktop computer. While this requirement may have skewed the sample toward a more socioeconomically advantaged and younger population, there were no differences in age, race, or ethnicity between those who completed the computerized outcome assessments and those who did not. For patients who are able to give consent electronically, computerized testing does not pose an additional barrier.
- As a result of this study’s cross-sectional nature, the researchers could not comment on the natural history and long-term risk of COVID-19 cognitive impairment. It will be crucial to monitor cognitive progression at future time points to assess the rate and predictors of cognitive normalization versus decline.
Study disclosures
- Gregory S. Day, a coauthor, owns stock (greater than $10,000) in ANI Pharmaceuticals, a generic pharmaceutical company. He serves as a topic editor for DynaMed (EBSCO), overseeing development of evidence-based educational content, a consultant for Parabon Nanolabs (advice relevant to National Institutes of Health small business grant submission), and as the clinical director of the Anti-NMDA Receptor Encephalitis Foundation, Canada (uncompensated). The other authors have disclosed no relevant financial relationships.
This is a summary of a preprint research study, “Neurocognitive Screening in Patients Following SARS-CoV-2 Infection: Tools for Triage,” written by Karen Blackmon from Mayo Clinic in Florida, on medRxiv. This study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org. A version of this article first appeared on Medscape.com.
Despite the stigma, ECT remains a gold standard
For Clayton Lively, electroconvulsive therapy, or ECT, has been a lifesaver.
“ECT was like a last resort to treat mania and psychosis for bipolar disorder,” said the 31-year-old financial firm associate who lives in Silver Spring, Md. “I had tried lots of different medications.”
The first course of treatments – three times per week for several weeks – was in 2005. They helped tremendously. “I came down from my mania,” Mr. Lively said. “The hallucinations stopped. The psychosis disappeared.”
He reached a point where medications and psychotherapy worked again. And for a decade, his condition was under control.
But in 2017, another episode of hallucinations and mania jolted him off course. Intrusive thoughts returned. For instance, while driving, he would visualize veering off the road. The thoughts were jarring, and yet, he couldn’t stop them from recurring.
“I wasn’t sleeping, and it just kind of wreaked havoc on my life,” Mr. Lively recalled. “I ended up being hospitalized again.”
Once again, ECT came to the rescue – and yet again, in 2018. Now, he’s on an effective maintenance regimen, receiving ECT once every 4 weeks, after tapering down from more frequent sessions.
When a combination of antidepressants and psychotherapy fails to control severe mental illness, there’s hope on the horizon. ECT can be a reliably safe and effective option.
For some patients, using it as maintenance therapy makes sense, said Vaughn McCall, MD, editor-in-chief of The Journal of ECT and professor and chairman of psychiatry at the Medical College of Georgia in Augusta. “I would think of it the same way as you have to treat any chronic illness,” such as blood pressure medicine to keep hypertension in check and dialysis to prevent kidney failure.
Despite a cacophony of contrarian voices – mainly from the Church of Scientology – “the number of psychiatrists who see controversy in ECT is vanishingly small,” Dr. McCall said.
In weighing the pros and cons of ECT, he noted that “when you’re trying to decide if it’s worth doing a treatment, you’re looking at the effectiveness on one hand and the side effects on the other hand.”
The answer to that emerges from several scales measuring patients’ quality of life by posing questions such as: “After receiving ECT, are you more able or less able to take care of yourself, to work, and enjoy the company of other people?”
In the end, Dr. McCall said, “we’ve applied these scales in probably half a dozen studies or more, and they always show that the patients’ qualify of life as a group is improved.”
A recent study published in The Lancet Psychiatry provides a significant degree of reassurance that ECT – also called “electroshock” or colloquially just “shock” therapy – does not increase the risk of serious medical side effects. In fact, the study suggests a potential benefit in reducing suicide risk.
First performed in 1938, the treatment has been well documented in the medical literature. But negative portrayals in books and movies, such as the 1975 film “One Flew Over the Cuckoo’s Nest,” have contributed to casting it in an unfavorable light.
“Unfortunately, over the past decades and years, there’s a lot of stigma and fear around the treatment,” said the study’s lead author, Tyler Kaster, MD, a psychiatrist and clinical fellow in brain stimulation at the University of Toronto.
For the study, Canadian investigators reviewed the admission records of 10,000 patients hospitalized for at least 3 days because of a severe depressive episode. Nearly two-thirds of the patients were women, and the average age for the entire group approached 57 years.
While half of the patients underwent ECT, the others received medication and psychotherapy. Researchers found that the group undergoing ECT did not have a heightened risk of death over the next 30 days and were not any more likely to be hospitalized for a medical problem.
Previous ECT comparative studies were at high risk of bias because of their inability to sufficiently account for confounding variables and differences between those who received the treatment and those who did not. The current study employed “rigorous methods with careful attention to bias and confounding to overcome limitations of previous work,” the authors wrote.
They used propensity score matching, which included more than 75 variables, such as measures of cognitive impairment, depression severity, medication use, other illnesses, and use of psychiatric and various medical services, capacity to consent to treatment, and sociodemographic factors.
“This is really a landmark study in terms of showing the medical safety of ECT,” said Mark S. George, MD, professor of psychiatry and neurology at the Medical University of South Carolina, Charleston, who was not involved in the study.
He added that “ECT is a life-saving treatment” for individuals with severe depression. “It’s good that we have this option for our patients.”
The authors highlight that depression is a major cause of illness and disability worldwide, with many individuals failing to achieve remission from initial therapies. Treatment-resistant depression is often described as being nonresponsive “to two or more medication trials of adequate dose and duration from different classes,” they wrote. In these instances, the authors point out, there is little evidence that psychotherapy would be helpful.
“The reason we consider ECT is someone has very severe depression that hasn’t responded to medications and talk therapy,” Dr. Kaster said. “The advantage of ECT is that it’s very effective in those circumstances.”
Of all therapies for treatment-resistant depression, ECT has the highest success rate, with 60% of patients attaining remission, according to the study, which cites prior research.
Compared with neurosurgery, the procedure is not invasive but requires general anesthesia. While the patient is asleep, Dr. Kaster said, the treating clinician places an electrical stimulus on the patient’s scalp, causing a generalized seizure inside the brain that lasts from 15 seconds to 2 minutes.
A course of ECT usually takes a total of 8-12 treatments, delivered two to three times per week over a month to a month and a half, Dr. George said.
Some patients need a new course of ECT if they relapse after several months. Others are unable to control their depression between courses and require repeated doses for maintenance. The time between these ECT sessions varies for each individual, Dr. George said, but is typically one session every 3-4 weeks.
To improve the odds of staying well, patients typically need to continue taking antidepressants and engaging in psychotherapy.
“It helps improve the efficacy of ECT and also down the road helps prevent relapse,” Dr. Kaster said, noting that “depression is, unfortunately, a chronic illness. We don’t have a cure.”
Murat Altinay, MD, associate professor of psychiatry at the Cleveland Clinic and a mood disorders specialist, said his patients generally need to demonstrate a lack of response to at least three or four antidepressants before he considers recommending ECT.
Confusion, short-term memory impairment, and muscle aches and pains may occur after the procedure, but they are relatively mild. Patients are monitored in a recovery room before discharge from the hospital, Dr. Altinay said.
The first few treatments will affect everyday function. After that initial period, however, people can resume most of their daily activities, he said.
“Maybe they won’t be able to work full-time right away, but anecdotally, we have had patients who were able to go back to the workforce relatively quickly or while they’re getting ECT,” Dr. Altinay said.
More significant adverse events are very rare, he noted, although heart rate and blood pressure can become elevated because of the electrical stimulus.
Dr. Altinay said he is pleased that the large-scale journal article has been published to help dispel myths surrounding ECT. While psychiatrists feel that ECT is generally safe and effective, the public maintains a negative view.
“It is an underutilized treatment,” he said. “In the media, it is almost depicted as a barbaric and archaic treatment in psychiatry.”
Patients are afraid of major side effects such as personality changes. Some fear they will forget someone’s birthday or other important factual information, “but that kind of stuff obviously does not happen,” Dr. Altinay said.
Sometimes it’s not only the patients who are hesitant to try ECT; it’s the family members who express concerns, said Irving Reti, MBBS, professor of psychiatry and neuroscience and director of the brain stimulation program at the Johns Hopkins University, Baltimore.
“It varies from one patient to another how agreeable or reluctant or cautious they are about their treatment if the doctor thinks it’s indicated for them,” Dr. Reti said. “Family members’ concerns may be very legitimate but may also be influenced by stigma and misunderstanding about the treatment. They may also not fully appreciate the severity of their loved one’s depression that warrants the administration of ECT.”
Hospitalized patients who are at risk of suicide have benefited from ECT. “It’s very effective,” he said. “I think it’s still the gold standard for severe treatment-resistant depression and also particularly helpful in people who are acutely suicidal.”
Dr. George cautioned that psychiatrists and the public should beware of questionable online sources that attempt to discredit ECT. “A quick Google search will find plenty of nonmedical doctors, many funded through Scientology, who will speak poorly of ECT. But they do not use evidence-based arguments and commonly do not treat patients,” he said.
“All good practicing psychiatrists that I know are in favor of ECT, as it clearly saves lives,” Dr. George added. “We all hope that the future will provide refinements of ECT, or even disruptive technologies that are more effective and with less hassle and will make ECT as we do it now obsolete. But we are not there yet.”
A version of this article first appeared on Medscape.com.
For Clayton Lively, electroconvulsive therapy, or ECT, has been a lifesaver.
“ECT was like a last resort to treat mania and psychosis for bipolar disorder,” said the 31-year-old financial firm associate who lives in Silver Spring, Md. “I had tried lots of different medications.”
The first course of treatments – three times per week for several weeks – was in 2005. They helped tremendously. “I came down from my mania,” Mr. Lively said. “The hallucinations stopped. The psychosis disappeared.”
He reached a point where medications and psychotherapy worked again. And for a decade, his condition was under control.
But in 2017, another episode of hallucinations and mania jolted him off course. Intrusive thoughts returned. For instance, while driving, he would visualize veering off the road. The thoughts were jarring, and yet, he couldn’t stop them from recurring.
“I wasn’t sleeping, and it just kind of wreaked havoc on my life,” Mr. Lively recalled. “I ended up being hospitalized again.”
Once again, ECT came to the rescue – and yet again, in 2018. Now, he’s on an effective maintenance regimen, receiving ECT once every 4 weeks, after tapering down from more frequent sessions.
When a combination of antidepressants and psychotherapy fails to control severe mental illness, there’s hope on the horizon. ECT can be a reliably safe and effective option.
For some patients, using it as maintenance therapy makes sense, said Vaughn McCall, MD, editor-in-chief of The Journal of ECT and professor and chairman of psychiatry at the Medical College of Georgia in Augusta. “I would think of it the same way as you have to treat any chronic illness,” such as blood pressure medicine to keep hypertension in check and dialysis to prevent kidney failure.
Despite a cacophony of contrarian voices – mainly from the Church of Scientology – “the number of psychiatrists who see controversy in ECT is vanishingly small,” Dr. McCall said.
In weighing the pros and cons of ECT, he noted that “when you’re trying to decide if it’s worth doing a treatment, you’re looking at the effectiveness on one hand and the side effects on the other hand.”
The answer to that emerges from several scales measuring patients’ quality of life by posing questions such as: “After receiving ECT, are you more able or less able to take care of yourself, to work, and enjoy the company of other people?”
In the end, Dr. McCall said, “we’ve applied these scales in probably half a dozen studies or more, and they always show that the patients’ qualify of life as a group is improved.”
A recent study published in The Lancet Psychiatry provides a significant degree of reassurance that ECT – also called “electroshock” or colloquially just “shock” therapy – does not increase the risk of serious medical side effects. In fact, the study suggests a potential benefit in reducing suicide risk.
First performed in 1938, the treatment has been well documented in the medical literature. But negative portrayals in books and movies, such as the 1975 film “One Flew Over the Cuckoo’s Nest,” have contributed to casting it in an unfavorable light.
“Unfortunately, over the past decades and years, there’s a lot of stigma and fear around the treatment,” said the study’s lead author, Tyler Kaster, MD, a psychiatrist and clinical fellow in brain stimulation at the University of Toronto.
For the study, Canadian investigators reviewed the admission records of 10,000 patients hospitalized for at least 3 days because of a severe depressive episode. Nearly two-thirds of the patients were women, and the average age for the entire group approached 57 years.
While half of the patients underwent ECT, the others received medication and psychotherapy. Researchers found that the group undergoing ECT did not have a heightened risk of death over the next 30 days and were not any more likely to be hospitalized for a medical problem.
Previous ECT comparative studies were at high risk of bias because of their inability to sufficiently account for confounding variables and differences between those who received the treatment and those who did not. The current study employed “rigorous methods with careful attention to bias and confounding to overcome limitations of previous work,” the authors wrote.
They used propensity score matching, which included more than 75 variables, such as measures of cognitive impairment, depression severity, medication use, other illnesses, and use of psychiatric and various medical services, capacity to consent to treatment, and sociodemographic factors.
“This is really a landmark study in terms of showing the medical safety of ECT,” said Mark S. George, MD, professor of psychiatry and neurology at the Medical University of South Carolina, Charleston, who was not involved in the study.
He added that “ECT is a life-saving treatment” for individuals with severe depression. “It’s good that we have this option for our patients.”
The authors highlight that depression is a major cause of illness and disability worldwide, with many individuals failing to achieve remission from initial therapies. Treatment-resistant depression is often described as being nonresponsive “to two or more medication trials of adequate dose and duration from different classes,” they wrote. In these instances, the authors point out, there is little evidence that psychotherapy would be helpful.
“The reason we consider ECT is someone has very severe depression that hasn’t responded to medications and talk therapy,” Dr. Kaster said. “The advantage of ECT is that it’s very effective in those circumstances.”
Of all therapies for treatment-resistant depression, ECT has the highest success rate, with 60% of patients attaining remission, according to the study, which cites prior research.
Compared with neurosurgery, the procedure is not invasive but requires general anesthesia. While the patient is asleep, Dr. Kaster said, the treating clinician places an electrical stimulus on the patient’s scalp, causing a generalized seizure inside the brain that lasts from 15 seconds to 2 minutes.
A course of ECT usually takes a total of 8-12 treatments, delivered two to three times per week over a month to a month and a half, Dr. George said.
Some patients need a new course of ECT if they relapse after several months. Others are unable to control their depression between courses and require repeated doses for maintenance. The time between these ECT sessions varies for each individual, Dr. George said, but is typically one session every 3-4 weeks.
To improve the odds of staying well, patients typically need to continue taking antidepressants and engaging in psychotherapy.
“It helps improve the efficacy of ECT and also down the road helps prevent relapse,” Dr. Kaster said, noting that “depression is, unfortunately, a chronic illness. We don’t have a cure.”
Murat Altinay, MD, associate professor of psychiatry at the Cleveland Clinic and a mood disorders specialist, said his patients generally need to demonstrate a lack of response to at least three or four antidepressants before he considers recommending ECT.
Confusion, short-term memory impairment, and muscle aches and pains may occur after the procedure, but they are relatively mild. Patients are monitored in a recovery room before discharge from the hospital, Dr. Altinay said.
The first few treatments will affect everyday function. After that initial period, however, people can resume most of their daily activities, he said.
“Maybe they won’t be able to work full-time right away, but anecdotally, we have had patients who were able to go back to the workforce relatively quickly or while they’re getting ECT,” Dr. Altinay said.
More significant adverse events are very rare, he noted, although heart rate and blood pressure can become elevated because of the electrical stimulus.
Dr. Altinay said he is pleased that the large-scale journal article has been published to help dispel myths surrounding ECT. While psychiatrists feel that ECT is generally safe and effective, the public maintains a negative view.
“It is an underutilized treatment,” he said. “In the media, it is almost depicted as a barbaric and archaic treatment in psychiatry.”
Patients are afraid of major side effects such as personality changes. Some fear they will forget someone’s birthday or other important factual information, “but that kind of stuff obviously does not happen,” Dr. Altinay said.
Sometimes it’s not only the patients who are hesitant to try ECT; it’s the family members who express concerns, said Irving Reti, MBBS, professor of psychiatry and neuroscience and director of the brain stimulation program at the Johns Hopkins University, Baltimore.
“It varies from one patient to another how agreeable or reluctant or cautious they are about their treatment if the doctor thinks it’s indicated for them,” Dr. Reti said. “Family members’ concerns may be very legitimate but may also be influenced by stigma and misunderstanding about the treatment. They may also not fully appreciate the severity of their loved one’s depression that warrants the administration of ECT.”
Hospitalized patients who are at risk of suicide have benefited from ECT. “It’s very effective,” he said. “I think it’s still the gold standard for severe treatment-resistant depression and also particularly helpful in people who are acutely suicidal.”
Dr. George cautioned that psychiatrists and the public should beware of questionable online sources that attempt to discredit ECT. “A quick Google search will find plenty of nonmedical doctors, many funded through Scientology, who will speak poorly of ECT. But they do not use evidence-based arguments and commonly do not treat patients,” he said.
“All good practicing psychiatrists that I know are in favor of ECT, as it clearly saves lives,” Dr. George added. “We all hope that the future will provide refinements of ECT, or even disruptive technologies that are more effective and with less hassle and will make ECT as we do it now obsolete. But we are not there yet.”
A version of this article first appeared on Medscape.com.
For Clayton Lively, electroconvulsive therapy, or ECT, has been a lifesaver.
“ECT was like a last resort to treat mania and psychosis for bipolar disorder,” said the 31-year-old financial firm associate who lives in Silver Spring, Md. “I had tried lots of different medications.”
The first course of treatments – three times per week for several weeks – was in 2005. They helped tremendously. “I came down from my mania,” Mr. Lively said. “The hallucinations stopped. The psychosis disappeared.”
He reached a point where medications and psychotherapy worked again. And for a decade, his condition was under control.
But in 2017, another episode of hallucinations and mania jolted him off course. Intrusive thoughts returned. For instance, while driving, he would visualize veering off the road. The thoughts were jarring, and yet, he couldn’t stop them from recurring.
“I wasn’t sleeping, and it just kind of wreaked havoc on my life,” Mr. Lively recalled. “I ended up being hospitalized again.”
Once again, ECT came to the rescue – and yet again, in 2018. Now, he’s on an effective maintenance regimen, receiving ECT once every 4 weeks, after tapering down from more frequent sessions.
When a combination of antidepressants and psychotherapy fails to control severe mental illness, there’s hope on the horizon. ECT can be a reliably safe and effective option.
For some patients, using it as maintenance therapy makes sense, said Vaughn McCall, MD, editor-in-chief of The Journal of ECT and professor and chairman of psychiatry at the Medical College of Georgia in Augusta. “I would think of it the same way as you have to treat any chronic illness,” such as blood pressure medicine to keep hypertension in check and dialysis to prevent kidney failure.
Despite a cacophony of contrarian voices – mainly from the Church of Scientology – “the number of psychiatrists who see controversy in ECT is vanishingly small,” Dr. McCall said.
In weighing the pros and cons of ECT, he noted that “when you’re trying to decide if it’s worth doing a treatment, you’re looking at the effectiveness on one hand and the side effects on the other hand.”
The answer to that emerges from several scales measuring patients’ quality of life by posing questions such as: “After receiving ECT, are you more able or less able to take care of yourself, to work, and enjoy the company of other people?”
In the end, Dr. McCall said, “we’ve applied these scales in probably half a dozen studies or more, and they always show that the patients’ qualify of life as a group is improved.”
A recent study published in The Lancet Psychiatry provides a significant degree of reassurance that ECT – also called “electroshock” or colloquially just “shock” therapy – does not increase the risk of serious medical side effects. In fact, the study suggests a potential benefit in reducing suicide risk.
First performed in 1938, the treatment has been well documented in the medical literature. But negative portrayals in books and movies, such as the 1975 film “One Flew Over the Cuckoo’s Nest,” have contributed to casting it in an unfavorable light.
“Unfortunately, over the past decades and years, there’s a lot of stigma and fear around the treatment,” said the study’s lead author, Tyler Kaster, MD, a psychiatrist and clinical fellow in brain stimulation at the University of Toronto.
For the study, Canadian investigators reviewed the admission records of 10,000 patients hospitalized for at least 3 days because of a severe depressive episode. Nearly two-thirds of the patients were women, and the average age for the entire group approached 57 years.
While half of the patients underwent ECT, the others received medication and psychotherapy. Researchers found that the group undergoing ECT did not have a heightened risk of death over the next 30 days and were not any more likely to be hospitalized for a medical problem.
Previous ECT comparative studies were at high risk of bias because of their inability to sufficiently account for confounding variables and differences between those who received the treatment and those who did not. The current study employed “rigorous methods with careful attention to bias and confounding to overcome limitations of previous work,” the authors wrote.
They used propensity score matching, which included more than 75 variables, such as measures of cognitive impairment, depression severity, medication use, other illnesses, and use of psychiatric and various medical services, capacity to consent to treatment, and sociodemographic factors.
“This is really a landmark study in terms of showing the medical safety of ECT,” said Mark S. George, MD, professor of psychiatry and neurology at the Medical University of South Carolina, Charleston, who was not involved in the study.
He added that “ECT is a life-saving treatment” for individuals with severe depression. “It’s good that we have this option for our patients.”
The authors highlight that depression is a major cause of illness and disability worldwide, with many individuals failing to achieve remission from initial therapies. Treatment-resistant depression is often described as being nonresponsive “to two or more medication trials of adequate dose and duration from different classes,” they wrote. In these instances, the authors point out, there is little evidence that psychotherapy would be helpful.
“The reason we consider ECT is someone has very severe depression that hasn’t responded to medications and talk therapy,” Dr. Kaster said. “The advantage of ECT is that it’s very effective in those circumstances.”
Of all therapies for treatment-resistant depression, ECT has the highest success rate, with 60% of patients attaining remission, according to the study, which cites prior research.
Compared with neurosurgery, the procedure is not invasive but requires general anesthesia. While the patient is asleep, Dr. Kaster said, the treating clinician places an electrical stimulus on the patient’s scalp, causing a generalized seizure inside the brain that lasts from 15 seconds to 2 minutes.
A course of ECT usually takes a total of 8-12 treatments, delivered two to three times per week over a month to a month and a half, Dr. George said.
Some patients need a new course of ECT if they relapse after several months. Others are unable to control their depression between courses and require repeated doses for maintenance. The time between these ECT sessions varies for each individual, Dr. George said, but is typically one session every 3-4 weeks.
To improve the odds of staying well, patients typically need to continue taking antidepressants and engaging in psychotherapy.
“It helps improve the efficacy of ECT and also down the road helps prevent relapse,” Dr. Kaster said, noting that “depression is, unfortunately, a chronic illness. We don’t have a cure.”
Murat Altinay, MD, associate professor of psychiatry at the Cleveland Clinic and a mood disorders specialist, said his patients generally need to demonstrate a lack of response to at least three or four antidepressants before he considers recommending ECT.
Confusion, short-term memory impairment, and muscle aches and pains may occur after the procedure, but they are relatively mild. Patients are monitored in a recovery room before discharge from the hospital, Dr. Altinay said.
The first few treatments will affect everyday function. After that initial period, however, people can resume most of their daily activities, he said.
“Maybe they won’t be able to work full-time right away, but anecdotally, we have had patients who were able to go back to the workforce relatively quickly or while they’re getting ECT,” Dr. Altinay said.
More significant adverse events are very rare, he noted, although heart rate and blood pressure can become elevated because of the electrical stimulus.
Dr. Altinay said he is pleased that the large-scale journal article has been published to help dispel myths surrounding ECT. While psychiatrists feel that ECT is generally safe and effective, the public maintains a negative view.
“It is an underutilized treatment,” he said. “In the media, it is almost depicted as a barbaric and archaic treatment in psychiatry.”
Patients are afraid of major side effects such as personality changes. Some fear they will forget someone’s birthday or other important factual information, “but that kind of stuff obviously does not happen,” Dr. Altinay said.
Sometimes it’s not only the patients who are hesitant to try ECT; it’s the family members who express concerns, said Irving Reti, MBBS, professor of psychiatry and neuroscience and director of the brain stimulation program at the Johns Hopkins University, Baltimore.
“It varies from one patient to another how agreeable or reluctant or cautious they are about their treatment if the doctor thinks it’s indicated for them,” Dr. Reti said. “Family members’ concerns may be very legitimate but may also be influenced by stigma and misunderstanding about the treatment. They may also not fully appreciate the severity of their loved one’s depression that warrants the administration of ECT.”
Hospitalized patients who are at risk of suicide have benefited from ECT. “It’s very effective,” he said. “I think it’s still the gold standard for severe treatment-resistant depression and also particularly helpful in people who are acutely suicidal.”
Dr. George cautioned that psychiatrists and the public should beware of questionable online sources that attempt to discredit ECT. “A quick Google search will find plenty of nonmedical doctors, many funded through Scientology, who will speak poorly of ECT. But they do not use evidence-based arguments and commonly do not treat patients,” he said.
“All good practicing psychiatrists that I know are in favor of ECT, as it clearly saves lives,” Dr. George added. “We all hope that the future will provide refinements of ECT, or even disruptive technologies that are more effective and with less hassle and will make ECT as we do it now obsolete. But we are not there yet.”
A version of this article first appeared on Medscape.com.
What to do about pandemic PTSD
When the COVID-19 pandemic engulfed the nation well over a year ago, Rebecca Hendrickson, MD, PhD, immersed herself in the shell-shocking revelations that clinicians began posting on social media. The accounts offered just a snapshot of the pandemic’s heavy psychological toll, and Dr. Hendrickson, a psychiatrist at the University of Washington in Seattle and an expert in posttraumatic stress disorder (PTSD), wanted to know more.
She and her colleagues devised a survey to assess the impact of several pandemic-related factors, including increased work hours, social distancing restrictions, and lack of adequate personal protective equipment.
What began as a survey of health care workers soon expanded in scope. Of the more than 600 survey respondents to date, health care workers account for about 60%, while the rest are first responders – police officers, firefighters, paramedics, and emergency medical technicians – and nonclinical personnel, such as security guards and office staff, in health care settings. The respondents range in age from 19 to 72, and hail from all regions of the country.
“Our findings were really striking,” Dr. Hendrickson said, “including very high rates of thoughts of suicide and thoughts of leaving one’s current field, which were both strongly linked to COVID-19–related occupational stress exposure.”
The distress stemmed from a multitude of factors. Among the most demoralizing: witnessing patients die in isolation and being stretched thin to provide optimal care for all patients amid an unrelenting onslaught of COVID-19 cases, she said. For some health care workers, living in the garage or basement – to avoid infecting family members with the virus – also wore on their psyches.
Of all health care workers in the study, more than three-quarters reported symptoms that fell within the clinical range for depression (76%) and anxiety (78%). More than 25% noted that they had lost a family member or close colleague to the virus.
Dr. Hendrickson, who works with military veterans at the VA Puget Sound Hospital System’s Mental Illness Research, Education, and Clinical Center and its PTSD outpatient clinic, hadn’t expected the experience of loss to be so pervasive. She said the sheer number of people who “crossed the threshold” into despair concerned her deeply.
Signs and symptoms of PTSD
PTSD’s prevalence among health care workers has always been variable, said Jessica Gold, MD, assistant professor and director of wellness, engagement, and outreach in the department of psychiatry at Washington University in St. Louis.
As a psychiatrist who sees health care workers in her clinical practice, Dr. Gold has noted poor baseline mental health, including depression and trauma. Significant data have pointed to a relatively higher suicide rate among physicians than among the general population. These problems have been compounded by COVID-19.
“It has been an unrelenting series of new stressors,” she said, citing lack of resources; a feeling of being unable to help; and the high frequency of risk of death to patients, family and friends, and the caregivers themselves as just as few examples. “It is very likely going to increase our baseline trauma, and honestly, I don’t know that we can predict how. To me, ”
PTSD can manifest itself in health care workers in several different ways. A few commonalities Dr. Gold has observed are sleep disruption (including insomnia and nightmares), work avoidance by taking disability or quitting, irritability or other changes in mood, trouble concentrating, and hypervigilance.
She said she has seen physical manifestations of trauma – such as body pain, stomachaches, and teeth grinding, which “you might not realize are at all related to trauma but ultimately are.” Sometimes, she added, “people have panic attacks on the way to work or right when they get to work, or are thinking about work.”
Dr. Gold noted that different types of treatment, such as cognitive-behavioral therapy and eye movement desensitization and reprocessing (EMDR), can be effective for PTSD. Medication is often necessary because of comorbid anxiety, depression, or eating disorders, said Dr. Gold, who is conducting a study on the pandemic’s effects on medical students.
The difficulties in isolating COVID-19 as a contributor
Not all researchers are convinced that a causal relationship has been established between the pandemic and worsening mental health among those in the health care sector.
With provider burnout being a long-standing concern in medicine, Ankur A. Butala, MD, assistant professor of neurology, psychiatry, and behavioral sciences at the Johns Hopkins University, Baltimore, said he remains a bit skeptical that acute stressors during the pandemic amounted to a uniquely potent driving force that can be extrapolated and quantified in a study.
“It’s hard to interpret a chronic, rolling, ongoing trauma like COVID-19 against tools or scales developed to investigate symptoms from a singular and acute trauma, like a school shooting or a [military] firefight,” Dr. Butala said.
In addition, he noted a reluctance to generalizing results from a study in which participants were recruited via social media as opposed to research methods involving more rigorous selection protocols.
Although Dr. Hendrickson acknowledged the study’s limitations, she said her team nonetheless found strong correlations between COVID-19-related stressors and self-reported struggles in completing work-related tasks, as well as increasing thoughts of leaving one’s current field. They adjusted for previous lifetime trauma exposure, age, gender, and a personal history of contracting COVID-19.
The underlying premise of the study could be confirmed with repeated surveys over time, Dr. Butala said, as the COVID-19 pandemic evolves and the vaccination effort unfolds.
Follow-up surveys are being sent to participants every 2 weeks and every 3 months to gauge their mood, for a total follow-up period of 9 months per individual. New participants are still welcome. “We will continue to enroll as long as it seems relevant,” Dr. Hendrickson said.
Carol S. North, MD, MPE, who has added to the growing research on the pandemic’s toll on mental health, noted that because symptom scales do not provide psychiatric diagnoses, it is difficult to attribute the prevalence of psychiatric disorders to the pandemic. Dr. North is chair and professor of crisis psychiatry at UT Southwestern Medical Center in Dallas, and director of the program in trauma and disaster at VA North Texas Health Care System.
The DSM-5 criteria exclude naturally occurring illness, such as a virus (even during a pandemic) as a qualifying trauma for the diagnosis of PTSD. According to current criteria by the American Psychiatric Association, COVID-19 and the pandemic are not defined as trauma, Dr. North said, while noting that “just because it’s not trauma or PTSD does not mean that the pandemic should be discounted as not stressful; people are finding it very stressful.”
Identifying the exact source of distress would still be difficult, Dr. North said, as the pandemic has produced severe economic consequences and prolonged social isolation, as well as occurring alongside nationwide protests over racial and ethnic divisions. Studies to date haven’t effectively separated out for these stressors, making it impossible to weigh their relative impact.
Furthermore, “most of us face many other stressors in our daily lives, such as grief, losses, broken relationships, and personal failures,” she said. “All of these may contribute to psychological distress, and research is needed to determine how much was a product of the virus, other aspects of the pandemic, or unrelated life stressors.”
A rallying cry for new interventions
Despite such doubts, a growing number of studies are reporting that health care workers and first responders are experiencing intensified PTSD, depression, anxiety, and insomnia as a result of the pandemic, said Hrayr Pierre Attarian, MD, professor of neurology at Northwestern University, Chicago. These results should act as a rallying cry for implementing more policies tailored to prevent burnout, he said.
“What we are seeing during this terrible pandemic is burnout on steroids,” said Dr. Attarian, medical director of Northwestern’s Center for Sleep Disorders. There are already high burnout rates, “so this should be doubly important.”
Rooting out this problem starts at the institutional level, but merely advising providers to “be well” wouldn’t make inroads. “There needs to be fluid dialogue between health care workers and the leadership,” he said.
Among his proposed remedies: Access to confidential and free mental health resources, increased administrative support, flexible hours, respect for work-life balance, and forgiveness for occasional errors that don’t result in harm.
“Sometimes even the perception that a mistake has been made is taken as proof of guilt,” Dr. Attarian said. “It is not conducive to wellness. Extra income does not replace a nurturing work environment.”
Furthermore, “as a profession, we must stop glorifying ‘overwork.’ We must stop wearing ‘lack of sleep’ as badge of honor,” he said. “Sleep is a biological imperative like self-preservation, hunger, and thirst. When we don’t sleep anxiety, pain, and depression get amplified. Our perception of distress is off, as is our judgment.”
The Federation of State Physician Health Programs provides a directory that physicians can use for referrals to confidential consultation or treatment.
Christopher Bundy, MD, MPH, executive medical director of Washington Physicians Health Program in Seattle, has been following Dr. Hendrickson’s longitudinal study with keen interest. As president of the Federation of State Physician Health Programs, he hopes to translate the findings into practice.
“Obviously, the COVID-19 pandemic has been a ‘black swan’ in terms of workforce sustainability issues,” Dr. Bundy said, citing “high rates of burnout, disillusionment, and dissatisfaction.” He sees some similarities with his former role in treating war veterans.
“The invisible wounds of combat, the psychological scars don’t really become apparent until after you’re out of the war zone,” said Dr. Bundy, clinical associate professor of psychiatry at the University of Washington.
Likewise, he expects the “emotional chickens will come home to roost as the pandemic subsides.” Until then, “people are just focused on survival, and in doing their jobs and protecting their patients.” Eventually, “their own wounds inside the pandemic will take hold.”
A version of this article first appeared on Medscape.com.
When the COVID-19 pandemic engulfed the nation well over a year ago, Rebecca Hendrickson, MD, PhD, immersed herself in the shell-shocking revelations that clinicians began posting on social media. The accounts offered just a snapshot of the pandemic’s heavy psychological toll, and Dr. Hendrickson, a psychiatrist at the University of Washington in Seattle and an expert in posttraumatic stress disorder (PTSD), wanted to know more.
She and her colleagues devised a survey to assess the impact of several pandemic-related factors, including increased work hours, social distancing restrictions, and lack of adequate personal protective equipment.
What began as a survey of health care workers soon expanded in scope. Of the more than 600 survey respondents to date, health care workers account for about 60%, while the rest are first responders – police officers, firefighters, paramedics, and emergency medical technicians – and nonclinical personnel, such as security guards and office staff, in health care settings. The respondents range in age from 19 to 72, and hail from all regions of the country.
“Our findings were really striking,” Dr. Hendrickson said, “including very high rates of thoughts of suicide and thoughts of leaving one’s current field, which were both strongly linked to COVID-19–related occupational stress exposure.”
The distress stemmed from a multitude of factors. Among the most demoralizing: witnessing patients die in isolation and being stretched thin to provide optimal care for all patients amid an unrelenting onslaught of COVID-19 cases, she said. For some health care workers, living in the garage or basement – to avoid infecting family members with the virus – also wore on their psyches.
Of all health care workers in the study, more than three-quarters reported symptoms that fell within the clinical range for depression (76%) and anxiety (78%). More than 25% noted that they had lost a family member or close colleague to the virus.
Dr. Hendrickson, who works with military veterans at the VA Puget Sound Hospital System’s Mental Illness Research, Education, and Clinical Center and its PTSD outpatient clinic, hadn’t expected the experience of loss to be so pervasive. She said the sheer number of people who “crossed the threshold” into despair concerned her deeply.
Signs and symptoms of PTSD
PTSD’s prevalence among health care workers has always been variable, said Jessica Gold, MD, assistant professor and director of wellness, engagement, and outreach in the department of psychiatry at Washington University in St. Louis.
As a psychiatrist who sees health care workers in her clinical practice, Dr. Gold has noted poor baseline mental health, including depression and trauma. Significant data have pointed to a relatively higher suicide rate among physicians than among the general population. These problems have been compounded by COVID-19.
“It has been an unrelenting series of new stressors,” she said, citing lack of resources; a feeling of being unable to help; and the high frequency of risk of death to patients, family and friends, and the caregivers themselves as just as few examples. “It is very likely going to increase our baseline trauma, and honestly, I don’t know that we can predict how. To me, ”
PTSD can manifest itself in health care workers in several different ways. A few commonalities Dr. Gold has observed are sleep disruption (including insomnia and nightmares), work avoidance by taking disability or quitting, irritability or other changes in mood, trouble concentrating, and hypervigilance.
She said she has seen physical manifestations of trauma – such as body pain, stomachaches, and teeth grinding, which “you might not realize are at all related to trauma but ultimately are.” Sometimes, she added, “people have panic attacks on the way to work or right when they get to work, or are thinking about work.”
Dr. Gold noted that different types of treatment, such as cognitive-behavioral therapy and eye movement desensitization and reprocessing (EMDR), can be effective for PTSD. Medication is often necessary because of comorbid anxiety, depression, or eating disorders, said Dr. Gold, who is conducting a study on the pandemic’s effects on medical students.
The difficulties in isolating COVID-19 as a contributor
Not all researchers are convinced that a causal relationship has been established between the pandemic and worsening mental health among those in the health care sector.
With provider burnout being a long-standing concern in medicine, Ankur A. Butala, MD, assistant professor of neurology, psychiatry, and behavioral sciences at the Johns Hopkins University, Baltimore, said he remains a bit skeptical that acute stressors during the pandemic amounted to a uniquely potent driving force that can be extrapolated and quantified in a study.
“It’s hard to interpret a chronic, rolling, ongoing trauma like COVID-19 against tools or scales developed to investigate symptoms from a singular and acute trauma, like a school shooting or a [military] firefight,” Dr. Butala said.
In addition, he noted a reluctance to generalizing results from a study in which participants were recruited via social media as opposed to research methods involving more rigorous selection protocols.
Although Dr. Hendrickson acknowledged the study’s limitations, she said her team nonetheless found strong correlations between COVID-19-related stressors and self-reported struggles in completing work-related tasks, as well as increasing thoughts of leaving one’s current field. They adjusted for previous lifetime trauma exposure, age, gender, and a personal history of contracting COVID-19.
The underlying premise of the study could be confirmed with repeated surveys over time, Dr. Butala said, as the COVID-19 pandemic evolves and the vaccination effort unfolds.
Follow-up surveys are being sent to participants every 2 weeks and every 3 months to gauge their mood, for a total follow-up period of 9 months per individual. New participants are still welcome. “We will continue to enroll as long as it seems relevant,” Dr. Hendrickson said.
Carol S. North, MD, MPE, who has added to the growing research on the pandemic’s toll on mental health, noted that because symptom scales do not provide psychiatric diagnoses, it is difficult to attribute the prevalence of psychiatric disorders to the pandemic. Dr. North is chair and professor of crisis psychiatry at UT Southwestern Medical Center in Dallas, and director of the program in trauma and disaster at VA North Texas Health Care System.
The DSM-5 criteria exclude naturally occurring illness, such as a virus (even during a pandemic) as a qualifying trauma for the diagnosis of PTSD. According to current criteria by the American Psychiatric Association, COVID-19 and the pandemic are not defined as trauma, Dr. North said, while noting that “just because it’s not trauma or PTSD does not mean that the pandemic should be discounted as not stressful; people are finding it very stressful.”
Identifying the exact source of distress would still be difficult, Dr. North said, as the pandemic has produced severe economic consequences and prolonged social isolation, as well as occurring alongside nationwide protests over racial and ethnic divisions. Studies to date haven’t effectively separated out for these stressors, making it impossible to weigh their relative impact.
Furthermore, “most of us face many other stressors in our daily lives, such as grief, losses, broken relationships, and personal failures,” she said. “All of these may contribute to psychological distress, and research is needed to determine how much was a product of the virus, other aspects of the pandemic, or unrelated life stressors.”
A rallying cry for new interventions
Despite such doubts, a growing number of studies are reporting that health care workers and first responders are experiencing intensified PTSD, depression, anxiety, and insomnia as a result of the pandemic, said Hrayr Pierre Attarian, MD, professor of neurology at Northwestern University, Chicago. These results should act as a rallying cry for implementing more policies tailored to prevent burnout, he said.
“What we are seeing during this terrible pandemic is burnout on steroids,” said Dr. Attarian, medical director of Northwestern’s Center for Sleep Disorders. There are already high burnout rates, “so this should be doubly important.”
Rooting out this problem starts at the institutional level, but merely advising providers to “be well” wouldn’t make inroads. “There needs to be fluid dialogue between health care workers and the leadership,” he said.
Among his proposed remedies: Access to confidential and free mental health resources, increased administrative support, flexible hours, respect for work-life balance, and forgiveness for occasional errors that don’t result in harm.
“Sometimes even the perception that a mistake has been made is taken as proof of guilt,” Dr. Attarian said. “It is not conducive to wellness. Extra income does not replace a nurturing work environment.”
Furthermore, “as a profession, we must stop glorifying ‘overwork.’ We must stop wearing ‘lack of sleep’ as badge of honor,” he said. “Sleep is a biological imperative like self-preservation, hunger, and thirst. When we don’t sleep anxiety, pain, and depression get amplified. Our perception of distress is off, as is our judgment.”
The Federation of State Physician Health Programs provides a directory that physicians can use for referrals to confidential consultation or treatment.
Christopher Bundy, MD, MPH, executive medical director of Washington Physicians Health Program in Seattle, has been following Dr. Hendrickson’s longitudinal study with keen interest. As president of the Federation of State Physician Health Programs, he hopes to translate the findings into practice.
“Obviously, the COVID-19 pandemic has been a ‘black swan’ in terms of workforce sustainability issues,” Dr. Bundy said, citing “high rates of burnout, disillusionment, and dissatisfaction.” He sees some similarities with his former role in treating war veterans.
“The invisible wounds of combat, the psychological scars don’t really become apparent until after you’re out of the war zone,” said Dr. Bundy, clinical associate professor of psychiatry at the University of Washington.
Likewise, he expects the “emotional chickens will come home to roost as the pandemic subsides.” Until then, “people are just focused on survival, and in doing their jobs and protecting their patients.” Eventually, “their own wounds inside the pandemic will take hold.”
A version of this article first appeared on Medscape.com.
When the COVID-19 pandemic engulfed the nation well over a year ago, Rebecca Hendrickson, MD, PhD, immersed herself in the shell-shocking revelations that clinicians began posting on social media. The accounts offered just a snapshot of the pandemic’s heavy psychological toll, and Dr. Hendrickson, a psychiatrist at the University of Washington in Seattle and an expert in posttraumatic stress disorder (PTSD), wanted to know more.
She and her colleagues devised a survey to assess the impact of several pandemic-related factors, including increased work hours, social distancing restrictions, and lack of adequate personal protective equipment.
What began as a survey of health care workers soon expanded in scope. Of the more than 600 survey respondents to date, health care workers account for about 60%, while the rest are first responders – police officers, firefighters, paramedics, and emergency medical technicians – and nonclinical personnel, such as security guards and office staff, in health care settings. The respondents range in age from 19 to 72, and hail from all regions of the country.
“Our findings were really striking,” Dr. Hendrickson said, “including very high rates of thoughts of suicide and thoughts of leaving one’s current field, which were both strongly linked to COVID-19–related occupational stress exposure.”
The distress stemmed from a multitude of factors. Among the most demoralizing: witnessing patients die in isolation and being stretched thin to provide optimal care for all patients amid an unrelenting onslaught of COVID-19 cases, she said. For some health care workers, living in the garage or basement – to avoid infecting family members with the virus – also wore on their psyches.
Of all health care workers in the study, more than three-quarters reported symptoms that fell within the clinical range for depression (76%) and anxiety (78%). More than 25% noted that they had lost a family member or close colleague to the virus.
Dr. Hendrickson, who works with military veterans at the VA Puget Sound Hospital System’s Mental Illness Research, Education, and Clinical Center and its PTSD outpatient clinic, hadn’t expected the experience of loss to be so pervasive. She said the sheer number of people who “crossed the threshold” into despair concerned her deeply.
Signs and symptoms of PTSD
PTSD’s prevalence among health care workers has always been variable, said Jessica Gold, MD, assistant professor and director of wellness, engagement, and outreach in the department of psychiatry at Washington University in St. Louis.
As a psychiatrist who sees health care workers in her clinical practice, Dr. Gold has noted poor baseline mental health, including depression and trauma. Significant data have pointed to a relatively higher suicide rate among physicians than among the general population. These problems have been compounded by COVID-19.
“It has been an unrelenting series of new stressors,” she said, citing lack of resources; a feeling of being unable to help; and the high frequency of risk of death to patients, family and friends, and the caregivers themselves as just as few examples. “It is very likely going to increase our baseline trauma, and honestly, I don’t know that we can predict how. To me, ”
PTSD can manifest itself in health care workers in several different ways. A few commonalities Dr. Gold has observed are sleep disruption (including insomnia and nightmares), work avoidance by taking disability or quitting, irritability or other changes in mood, trouble concentrating, and hypervigilance.
She said she has seen physical manifestations of trauma – such as body pain, stomachaches, and teeth grinding, which “you might not realize are at all related to trauma but ultimately are.” Sometimes, she added, “people have panic attacks on the way to work or right when they get to work, or are thinking about work.”
Dr. Gold noted that different types of treatment, such as cognitive-behavioral therapy and eye movement desensitization and reprocessing (EMDR), can be effective for PTSD. Medication is often necessary because of comorbid anxiety, depression, or eating disorders, said Dr. Gold, who is conducting a study on the pandemic’s effects on medical students.
The difficulties in isolating COVID-19 as a contributor
Not all researchers are convinced that a causal relationship has been established between the pandemic and worsening mental health among those in the health care sector.
With provider burnout being a long-standing concern in medicine, Ankur A. Butala, MD, assistant professor of neurology, psychiatry, and behavioral sciences at the Johns Hopkins University, Baltimore, said he remains a bit skeptical that acute stressors during the pandemic amounted to a uniquely potent driving force that can be extrapolated and quantified in a study.
“It’s hard to interpret a chronic, rolling, ongoing trauma like COVID-19 against tools or scales developed to investigate symptoms from a singular and acute trauma, like a school shooting or a [military] firefight,” Dr. Butala said.
In addition, he noted a reluctance to generalizing results from a study in which participants were recruited via social media as opposed to research methods involving more rigorous selection protocols.
Although Dr. Hendrickson acknowledged the study’s limitations, she said her team nonetheless found strong correlations between COVID-19-related stressors and self-reported struggles in completing work-related tasks, as well as increasing thoughts of leaving one’s current field. They adjusted for previous lifetime trauma exposure, age, gender, and a personal history of contracting COVID-19.
The underlying premise of the study could be confirmed with repeated surveys over time, Dr. Butala said, as the COVID-19 pandemic evolves and the vaccination effort unfolds.
Follow-up surveys are being sent to participants every 2 weeks and every 3 months to gauge their mood, for a total follow-up period of 9 months per individual. New participants are still welcome. “We will continue to enroll as long as it seems relevant,” Dr. Hendrickson said.
Carol S. North, MD, MPE, who has added to the growing research on the pandemic’s toll on mental health, noted that because symptom scales do not provide psychiatric diagnoses, it is difficult to attribute the prevalence of psychiatric disorders to the pandemic. Dr. North is chair and professor of crisis psychiatry at UT Southwestern Medical Center in Dallas, and director of the program in trauma and disaster at VA North Texas Health Care System.
The DSM-5 criteria exclude naturally occurring illness, such as a virus (even during a pandemic) as a qualifying trauma for the diagnosis of PTSD. According to current criteria by the American Psychiatric Association, COVID-19 and the pandemic are not defined as trauma, Dr. North said, while noting that “just because it’s not trauma or PTSD does not mean that the pandemic should be discounted as not stressful; people are finding it very stressful.”
Identifying the exact source of distress would still be difficult, Dr. North said, as the pandemic has produced severe economic consequences and prolonged social isolation, as well as occurring alongside nationwide protests over racial and ethnic divisions. Studies to date haven’t effectively separated out for these stressors, making it impossible to weigh their relative impact.
Furthermore, “most of us face many other stressors in our daily lives, such as grief, losses, broken relationships, and personal failures,” she said. “All of these may contribute to psychological distress, and research is needed to determine how much was a product of the virus, other aspects of the pandemic, or unrelated life stressors.”
A rallying cry for new interventions
Despite such doubts, a growing number of studies are reporting that health care workers and first responders are experiencing intensified PTSD, depression, anxiety, and insomnia as a result of the pandemic, said Hrayr Pierre Attarian, MD, professor of neurology at Northwestern University, Chicago. These results should act as a rallying cry for implementing more policies tailored to prevent burnout, he said.
“What we are seeing during this terrible pandemic is burnout on steroids,” said Dr. Attarian, medical director of Northwestern’s Center for Sleep Disorders. There are already high burnout rates, “so this should be doubly important.”
Rooting out this problem starts at the institutional level, but merely advising providers to “be well” wouldn’t make inroads. “There needs to be fluid dialogue between health care workers and the leadership,” he said.
Among his proposed remedies: Access to confidential and free mental health resources, increased administrative support, flexible hours, respect for work-life balance, and forgiveness for occasional errors that don’t result in harm.
“Sometimes even the perception that a mistake has been made is taken as proof of guilt,” Dr. Attarian said. “It is not conducive to wellness. Extra income does not replace a nurturing work environment.”
Furthermore, “as a profession, we must stop glorifying ‘overwork.’ We must stop wearing ‘lack of sleep’ as badge of honor,” he said. “Sleep is a biological imperative like self-preservation, hunger, and thirst. When we don’t sleep anxiety, pain, and depression get amplified. Our perception of distress is off, as is our judgment.”
The Federation of State Physician Health Programs provides a directory that physicians can use for referrals to confidential consultation or treatment.
Christopher Bundy, MD, MPH, executive medical director of Washington Physicians Health Program in Seattle, has been following Dr. Hendrickson’s longitudinal study with keen interest. As president of the Federation of State Physician Health Programs, he hopes to translate the findings into practice.
“Obviously, the COVID-19 pandemic has been a ‘black swan’ in terms of workforce sustainability issues,” Dr. Bundy said, citing “high rates of burnout, disillusionment, and dissatisfaction.” He sees some similarities with his former role in treating war veterans.
“The invisible wounds of combat, the psychological scars don’t really become apparent until after you’re out of the war zone,” said Dr. Bundy, clinical associate professor of psychiatry at the University of Washington.
Likewise, he expects the “emotional chickens will come home to roost as the pandemic subsides.” Until then, “people are just focused on survival, and in doing their jobs and protecting their patients.” Eventually, “their own wounds inside the pandemic will take hold.”
A version of this article first appeared on Medscape.com.
Trump administration reinstates global gag rule on abortion
President Trump has reinstated and expanded the Mexico City policy prohibiting foreign nongovernmental organizations from offering counseling or referrals for abortion services if they receive funding from the U.S. government.
Mr. Trump’s executive order on Jan. 23 was not unexpected given his conservative platform on reproductive health care; however, he has taken the policy – also known as the global gag rule – further than his predecessors.
Originally instituted under President Reagan, the Mexico City Policy required overseas organizations to certify that they would not “perform or actively promote abortion as a method of family planning” using non–U.S. funds in order to receive family planning aid from the U.S. government. The policy has been rescinded and enforced periodically since 1984, based on the ideologic slant of successive U.S. administrations.
The Trump iteration of the Mexico City Policy “extends the requirements of the reinstated memorandum to global health assistance furnished by all departments and agencies,” according to the White House.
Planned Parenthood Global condemned the expanded policy, which now affects international organizations working on any U.S.–funded global health initiative, including HIV/AIDS prevention and treatment, maternal and child health, and Zika virus programs. These groups will be stripped of all U.S. aid if they also provide abortion counseling, referrals, or services for abortion, even with their own funds.
“This is an unprecedented move, and the most extreme executive action we’ve seen of its kind,” Latanya Mapp Frett, executive director, said in a statement. “The global gag rule, as it existed under previous anti–women’s health presidents, was deeply harmful. But this action will be catastrophic for all communities, especially those relying on U.S. funding to address HIV/AIDS and maternal health care, and the fight against Zika.”
The expansion of the Mexico City Policy “certainly does presage negative things for abortion and contraception” under the new administration, said Sarah W. Prager, MD, of the department of obstetrics and gynecology at the University of Washington, Seattle. “Another example is the [Jan. 24] passage in the House of Representatives of H.R. 7, which would make permanent the Hyde Amendment and deny our most disadvantaged women access to abortion.”
The American Association of Pro-Life Obstetricians and Gynecologists took a different stance. “The Mexico City Policy was instituted to prevent the U.S. from forcing taxpayers to fund abortion overseas,” said Donna J. Harrison, MD, executive director. “This policy has been intermittently in place since 1984 and represents no departure from previous policies implemented by pro-life presidents.”
AAPLOG supports reinstating this policy because elective abortion “is not a part of essential women’s health care, and, in fact, is an elective procedure,” Dr. Harrison said.
President Trump has reinstated and expanded the Mexico City policy prohibiting foreign nongovernmental organizations from offering counseling or referrals for abortion services if they receive funding from the U.S. government.
Mr. Trump’s executive order on Jan. 23 was not unexpected given his conservative platform on reproductive health care; however, he has taken the policy – also known as the global gag rule – further than his predecessors.
Originally instituted under President Reagan, the Mexico City Policy required overseas organizations to certify that they would not “perform or actively promote abortion as a method of family planning” using non–U.S. funds in order to receive family planning aid from the U.S. government. The policy has been rescinded and enforced periodically since 1984, based on the ideologic slant of successive U.S. administrations.
The Trump iteration of the Mexico City Policy “extends the requirements of the reinstated memorandum to global health assistance furnished by all departments and agencies,” according to the White House.
Planned Parenthood Global condemned the expanded policy, which now affects international organizations working on any U.S.–funded global health initiative, including HIV/AIDS prevention and treatment, maternal and child health, and Zika virus programs. These groups will be stripped of all U.S. aid if they also provide abortion counseling, referrals, or services for abortion, even with their own funds.
“This is an unprecedented move, and the most extreme executive action we’ve seen of its kind,” Latanya Mapp Frett, executive director, said in a statement. “The global gag rule, as it existed under previous anti–women’s health presidents, was deeply harmful. But this action will be catastrophic for all communities, especially those relying on U.S. funding to address HIV/AIDS and maternal health care, and the fight against Zika.”
The expansion of the Mexico City Policy “certainly does presage negative things for abortion and contraception” under the new administration, said Sarah W. Prager, MD, of the department of obstetrics and gynecology at the University of Washington, Seattle. “Another example is the [Jan. 24] passage in the House of Representatives of H.R. 7, which would make permanent the Hyde Amendment and deny our most disadvantaged women access to abortion.”
The American Association of Pro-Life Obstetricians and Gynecologists took a different stance. “The Mexico City Policy was instituted to prevent the U.S. from forcing taxpayers to fund abortion overseas,” said Donna J. Harrison, MD, executive director. “This policy has been intermittently in place since 1984 and represents no departure from previous policies implemented by pro-life presidents.”
AAPLOG supports reinstating this policy because elective abortion “is not a part of essential women’s health care, and, in fact, is an elective procedure,” Dr. Harrison said.
President Trump has reinstated and expanded the Mexico City policy prohibiting foreign nongovernmental organizations from offering counseling or referrals for abortion services if they receive funding from the U.S. government.
Mr. Trump’s executive order on Jan. 23 was not unexpected given his conservative platform on reproductive health care; however, he has taken the policy – also known as the global gag rule – further than his predecessors.
Originally instituted under President Reagan, the Mexico City Policy required overseas organizations to certify that they would not “perform or actively promote abortion as a method of family planning” using non–U.S. funds in order to receive family planning aid from the U.S. government. The policy has been rescinded and enforced periodically since 1984, based on the ideologic slant of successive U.S. administrations.
The Trump iteration of the Mexico City Policy “extends the requirements of the reinstated memorandum to global health assistance furnished by all departments and agencies,” according to the White House.
Planned Parenthood Global condemned the expanded policy, which now affects international organizations working on any U.S.–funded global health initiative, including HIV/AIDS prevention and treatment, maternal and child health, and Zika virus programs. These groups will be stripped of all U.S. aid if they also provide abortion counseling, referrals, or services for abortion, even with their own funds.
“This is an unprecedented move, and the most extreme executive action we’ve seen of its kind,” Latanya Mapp Frett, executive director, said in a statement. “The global gag rule, as it existed under previous anti–women’s health presidents, was deeply harmful. But this action will be catastrophic for all communities, especially those relying on U.S. funding to address HIV/AIDS and maternal health care, and the fight against Zika.”
The expansion of the Mexico City Policy “certainly does presage negative things for abortion and contraception” under the new administration, said Sarah W. Prager, MD, of the department of obstetrics and gynecology at the University of Washington, Seattle. “Another example is the [Jan. 24] passage in the House of Representatives of H.R. 7, which would make permanent the Hyde Amendment and deny our most disadvantaged women access to abortion.”
The American Association of Pro-Life Obstetricians and Gynecologists took a different stance. “The Mexico City Policy was instituted to prevent the U.S. from forcing taxpayers to fund abortion overseas,” said Donna J. Harrison, MD, executive director. “This policy has been intermittently in place since 1984 and represents no departure from previous policies implemented by pro-life presidents.”
AAPLOG supports reinstating this policy because elective abortion “is not a part of essential women’s health care, and, in fact, is an elective procedure,” Dr. Harrison said.
ACGME seeks to return trainees’ maximum shifts to 24 hours
First-year residents may be permitted to work up to 24 consecutive hours – 8 hours longer than they can now – under a proposal from a task force of the Accreditation Council for Graduate Medical Education (ACGME).
The ACGME Duty Hour Task Force proposes to raise first-year trainees’ work hour limit from 16 hours, reverting to the 24-hour maximum that remained in effect until 2011 – and the existing limit in place for all other residents.
“There is better team continuity of care provided with less micromanagement of resident duty hours,” said Thomas J. Nasca, MD, ACGME chief executive and vice chairman of the task force.
The ACGME instituted the 16-hour cap for first-year residents in the wake of a December 2008 report released by the Institute of Medicine (IOM), “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety.” The ACGME also prohibited 30-hour shifts, which some trainees had been clocking.
“Every 5 years, the ACGME reviews its program requirements,” Dr. Nasca said. “That’s a promise we made to the community and to the public” in July 2003. The most recent changes occurred in July 2011.
Since then, some faculty have contended that shorter work hour limits for the first-year residents are accelerating the frequency of patient transitions and disrupting continuity of care. Many educators also noted that residents would gain more knowledge by monitoring a hospitalized patient during the initial 24 hours.
The American College of Physicians “approves and commends ACGME for explicitly addressing [resident] well being in the Common Program Requirements,” ACP President Nitin S. Damle, MD, said in a statement. “We support ACGME in removing the standard limiting duty hours for PGY-1 residents to no more than 16 hours. By mandating different hours for PGY-residents and more senior residents, the old standard disrupted the continuity of the resident team and resulted in considerable unintended consequences without commensurate improvement in patient safety or educational outcomes.”
The ACP does not support a proposed additional 4-hour extension to the current 4-hour extension to a 24-hour call shift. “We believe that the [current] 24+ rule adequately addresses all clinical and educational needs,” Dr. Damle said in the statement. “The new standard places residents at risk for 28 consecutive hours of duty.”
The proposed revisions to training requirements also include phasing out the term “duty” hours in favor of “clinical experience and education,” highlighting that residents’ responsibility to patients takes precedence over any adherence to a schedule or clock. Working a certain number of hospital hours is only one aspect of delivering safe and quality care, the ACGME Duty Hour Task Force noted in its proposal.
The proposal does not change the following, which all are averaged over a period of 4 weeks: a maximum of 80 hours per week, 1 day free from clinical experience or education in 7, and in-house call no more often than every third night.
“It is important to note that the absence of a common 16-hour limit does not imply that programs may no longer configure their clinical schedules in 16-hour increments if that is the preferred option for a given setting or clinical context,” Dr. Nasca wrote in a Nov. 4 letter to the graduate medical education community.
In its December 2008 report, the IOM noted that revamping residents’ work hours alone offered no guarantee of patient safety. It called for increased supervision by seasoned physicians, restrictions on patient caseloads based on residents’ levels of experience and specialty, overlap in schedules around shift changes to decrease the possibility of error in transitioning patients from one provider to another, and broad-based research to examine the outcomes from these changes.
“Surgical residents, when they’re operating, come under very direct supervision by attending physicians,” said Jay Bhattacharya, MD, professor of medicine at Stanford (Calif.) University, who served on the 2008 IOM committee. “That supervision is generally pretty good. Even for a tired resident, the supervision makes it so that the fatigue the trainee faces doesn’t endanger the patient.”
Acknowledging the emerging evidence that physicians are at heightened risk for burnout and perhaps depression, the proposal underscores the need for residency programs and institutions to prioritize the well-being of residents as well as nurses and other hospital personnel.
“Burnout and depression impair a physician’s ability to provide excellent care. Self-care is an important aspect of professionalism, and a skill that must be learned and nurtured under the guidance and role modeling of faculty members,” Dr. Nasca wrote in his Nov. 4 letter.
If the proposal is approved by the ACGME board of directors in February, the changes will be rolled out in July.
The ACGME accepted comments on the proposal through Dec. 19; comments will be reviewed and considered before a final set of proposed requirements are sent to the ACGME board for approval.
“We’re here to serve the public, and so the focus is on the comments that reflect the most recent and comprehensive evidence and educational outcomes rather than the individual opinions we receive,” Dr. Nasca said.
First-year residents may be permitted to work up to 24 consecutive hours – 8 hours longer than they can now – under a proposal from a task force of the Accreditation Council for Graduate Medical Education (ACGME).
The ACGME Duty Hour Task Force proposes to raise first-year trainees’ work hour limit from 16 hours, reverting to the 24-hour maximum that remained in effect until 2011 – and the existing limit in place for all other residents.
“There is better team continuity of care provided with less micromanagement of resident duty hours,” said Thomas J. Nasca, MD, ACGME chief executive and vice chairman of the task force.
The ACGME instituted the 16-hour cap for first-year residents in the wake of a December 2008 report released by the Institute of Medicine (IOM), “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety.” The ACGME also prohibited 30-hour shifts, which some trainees had been clocking.
“Every 5 years, the ACGME reviews its program requirements,” Dr. Nasca said. “That’s a promise we made to the community and to the public” in July 2003. The most recent changes occurred in July 2011.
Since then, some faculty have contended that shorter work hour limits for the first-year residents are accelerating the frequency of patient transitions and disrupting continuity of care. Many educators also noted that residents would gain more knowledge by monitoring a hospitalized patient during the initial 24 hours.
The American College of Physicians “approves and commends ACGME for explicitly addressing [resident] well being in the Common Program Requirements,” ACP President Nitin S. Damle, MD, said in a statement. “We support ACGME in removing the standard limiting duty hours for PGY-1 residents to no more than 16 hours. By mandating different hours for PGY-residents and more senior residents, the old standard disrupted the continuity of the resident team and resulted in considerable unintended consequences without commensurate improvement in patient safety or educational outcomes.”
The ACP does not support a proposed additional 4-hour extension to the current 4-hour extension to a 24-hour call shift. “We believe that the [current] 24+ rule adequately addresses all clinical and educational needs,” Dr. Damle said in the statement. “The new standard places residents at risk for 28 consecutive hours of duty.”
The proposed revisions to training requirements also include phasing out the term “duty” hours in favor of “clinical experience and education,” highlighting that residents’ responsibility to patients takes precedence over any adherence to a schedule or clock. Working a certain number of hospital hours is only one aspect of delivering safe and quality care, the ACGME Duty Hour Task Force noted in its proposal.
The proposal does not change the following, which all are averaged over a period of 4 weeks: a maximum of 80 hours per week, 1 day free from clinical experience or education in 7, and in-house call no more often than every third night.
“It is important to note that the absence of a common 16-hour limit does not imply that programs may no longer configure their clinical schedules in 16-hour increments if that is the preferred option for a given setting or clinical context,” Dr. Nasca wrote in a Nov. 4 letter to the graduate medical education community.
In its December 2008 report, the IOM noted that revamping residents’ work hours alone offered no guarantee of patient safety. It called for increased supervision by seasoned physicians, restrictions on patient caseloads based on residents’ levels of experience and specialty, overlap in schedules around shift changes to decrease the possibility of error in transitioning patients from one provider to another, and broad-based research to examine the outcomes from these changes.
“Surgical residents, when they’re operating, come under very direct supervision by attending physicians,” said Jay Bhattacharya, MD, professor of medicine at Stanford (Calif.) University, who served on the 2008 IOM committee. “That supervision is generally pretty good. Even for a tired resident, the supervision makes it so that the fatigue the trainee faces doesn’t endanger the patient.”
Acknowledging the emerging evidence that physicians are at heightened risk for burnout and perhaps depression, the proposal underscores the need for residency programs and institutions to prioritize the well-being of residents as well as nurses and other hospital personnel.
“Burnout and depression impair a physician’s ability to provide excellent care. Self-care is an important aspect of professionalism, and a skill that must be learned and nurtured under the guidance and role modeling of faculty members,” Dr. Nasca wrote in his Nov. 4 letter.
If the proposal is approved by the ACGME board of directors in February, the changes will be rolled out in July.
The ACGME accepted comments on the proposal through Dec. 19; comments will be reviewed and considered before a final set of proposed requirements are sent to the ACGME board for approval.
“We’re here to serve the public, and so the focus is on the comments that reflect the most recent and comprehensive evidence and educational outcomes rather than the individual opinions we receive,” Dr. Nasca said.
First-year residents may be permitted to work up to 24 consecutive hours – 8 hours longer than they can now – under a proposal from a task force of the Accreditation Council for Graduate Medical Education (ACGME).
The ACGME Duty Hour Task Force proposes to raise first-year trainees’ work hour limit from 16 hours, reverting to the 24-hour maximum that remained in effect until 2011 – and the existing limit in place for all other residents.
“There is better team continuity of care provided with less micromanagement of resident duty hours,” said Thomas J. Nasca, MD, ACGME chief executive and vice chairman of the task force.
The ACGME instituted the 16-hour cap for first-year residents in the wake of a December 2008 report released by the Institute of Medicine (IOM), “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety.” The ACGME also prohibited 30-hour shifts, which some trainees had been clocking.
“Every 5 years, the ACGME reviews its program requirements,” Dr. Nasca said. “That’s a promise we made to the community and to the public” in July 2003. The most recent changes occurred in July 2011.
Since then, some faculty have contended that shorter work hour limits for the first-year residents are accelerating the frequency of patient transitions and disrupting continuity of care. Many educators also noted that residents would gain more knowledge by monitoring a hospitalized patient during the initial 24 hours.
The American College of Physicians “approves and commends ACGME for explicitly addressing [resident] well being in the Common Program Requirements,” ACP President Nitin S. Damle, MD, said in a statement. “We support ACGME in removing the standard limiting duty hours for PGY-1 residents to no more than 16 hours. By mandating different hours for PGY-residents and more senior residents, the old standard disrupted the continuity of the resident team and resulted in considerable unintended consequences without commensurate improvement in patient safety or educational outcomes.”
The ACP does not support a proposed additional 4-hour extension to the current 4-hour extension to a 24-hour call shift. “We believe that the [current] 24+ rule adequately addresses all clinical and educational needs,” Dr. Damle said in the statement. “The new standard places residents at risk for 28 consecutive hours of duty.”
The proposed revisions to training requirements also include phasing out the term “duty” hours in favor of “clinical experience and education,” highlighting that residents’ responsibility to patients takes precedence over any adherence to a schedule or clock. Working a certain number of hospital hours is only one aspect of delivering safe and quality care, the ACGME Duty Hour Task Force noted in its proposal.
The proposal does not change the following, which all are averaged over a period of 4 weeks: a maximum of 80 hours per week, 1 day free from clinical experience or education in 7, and in-house call no more often than every third night.
“It is important to note that the absence of a common 16-hour limit does not imply that programs may no longer configure their clinical schedules in 16-hour increments if that is the preferred option for a given setting or clinical context,” Dr. Nasca wrote in a Nov. 4 letter to the graduate medical education community.
In its December 2008 report, the IOM noted that revamping residents’ work hours alone offered no guarantee of patient safety. It called for increased supervision by seasoned physicians, restrictions on patient caseloads based on residents’ levels of experience and specialty, overlap in schedules around shift changes to decrease the possibility of error in transitioning patients from one provider to another, and broad-based research to examine the outcomes from these changes.
“Surgical residents, when they’re operating, come under very direct supervision by attending physicians,” said Jay Bhattacharya, MD, professor of medicine at Stanford (Calif.) University, who served on the 2008 IOM committee. “That supervision is generally pretty good. Even for a tired resident, the supervision makes it so that the fatigue the trainee faces doesn’t endanger the patient.”
Acknowledging the emerging evidence that physicians are at heightened risk for burnout and perhaps depression, the proposal underscores the need for residency programs and institutions to prioritize the well-being of residents as well as nurses and other hospital personnel.
“Burnout and depression impair a physician’s ability to provide excellent care. Self-care is an important aspect of professionalism, and a skill that must be learned and nurtured under the guidance and role modeling of faculty members,” Dr. Nasca wrote in his Nov. 4 letter.
If the proposal is approved by the ACGME board of directors in February, the changes will be rolled out in July.
The ACGME accepted comments on the proposal through Dec. 19; comments will be reviewed and considered before a final set of proposed requirements are sent to the ACGME board for approval.
“We’re here to serve the public, and so the focus is on the comments that reflect the most recent and comprehensive evidence and educational outcomes rather than the individual opinions we receive,” Dr. Nasca said.
ACGME seeks to return trainees’ maximum shifts to 24 hours
First-year residents may be permitted to work up to 24 consecutive hours – 8 hours longer than they can now – under a proposal from a task force of the Accreditation Council for Graduate Medical Education (ACGME).
The ACGME Duty Hour Task Force proposes to raise first-year trainees’ work hour limit from 16 hours, reverting to the 24-hour maximum that remained in effect until 2011 – and the existing limit in place for all other residents.
“There is better team continuity of care provided with less micromanagement of resident duty hours,” said Thomas J. Nasca, MD, ACGME chief executive and vice chairman of the task force.
The ACGME instituted the 16-hour cap for first-year residents in the wake of a December 2008 report released by the Institute of Medicine (IOM), “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety.” The ACGME also prohibited 30-hour shifts, which some trainees had been clocking.
“Every 5 years, the ACGME reviews its program requirements,” Dr. Nasca said. “That’s a promise we made to the community and to the public” in July 2003. The most recent changes occurred in July 2011.
Since then, some faculty have contended that shorter work hour limits for the first-year residents are accelerating the frequency of patient transitions and disrupting continuity of care. Many educators also noted that residents would gain more knowledge by monitoring a hospitalized patient during the initial 24 hours.
The proposed changes are “encouraging and courageous,” according to R. James Valentine, MD, FACS, president of the Western Surgical Association.
“This is a real world scenario,” said Dr. Valentine, professor of vascular surgery at Vanderbilt University, Nashville, Tenn. “Medicine is such a complex system. It is not easily constrained by time limitations.”
Requiring a physician to transition a patient’s care at a specific time may help promote the trainee’s well-being; however, it also “robs the resident of the opportunity to see the disease progress and to see the response to the treatment that is being offered. The new rules help strike a balance between bedside education and rest,” he added.
The proposed revisions to training requirements also include phasing out the term “duty” hours in favor of “clinical experience and education,” highlighting that residents’ responsibility to patients takes precedence over any adherence to a schedule or clock. Working a certain number of hospital hours is only one aspect of delivering safe and quality care, the ACGME Duty Hour Task Force noted in its proposal.
The proposal does not change the following, which all are averaged over a period of 4 weeks: a maximum of 80 hours per week, 1 day free from clinical experience or education in 7, and in-house call no more often than every third night.
“It is important to note that the absence of a common 16-hour limit does not imply that programs may no longer configure their clinical schedules in 16-hour increments if that is the preferred option for a given setting or clinical context,” Dr. Nasca wrote in a Nov. 4 letter to the graduate medical education community.
In its December 2008 report, the IOM noted that revamping residents’ work hours alone offered no guarantee of patient safety. It called for increased supervision by seasoned physicians, restrictions on patient caseloads based on residents’ levels of experience and specialty, overlap in schedules around shift changes to decrease the possibility of error in transitioning patients from one provider to another, and broad-based research to examine the outcomes from these changes.
“Surgical residents, when they’re operating, come under very direct supervision by attending physicians,” said Jay Bhattacharya, MD, professor of medicine at Stanford (Calif.) University, who served on the 2008 IOM committee. “That supervision is generally pretty good. Even for a tired resident, the supervision makes it so that the fatigue the trainee faces doesn’t endanger the patient.”
Acknowledging the emerging evidence that physicians are at heightened risk for burnout and perhaps depression, the proposal underscores the need for residency programs and institutions to prioritize the well-being of residents as well as nurses and other hospital personnel.
“Burnout and depression impair a physician’s ability to provide excellent care. Self-care is an important aspect of professionalism, and a skill that must be learned and nurtured under the guidance and role modeling of faculty members,” Dr. Nasca wrote in his Nov. 4 letter.
If the proposal is approved by the ACGME board of directors in February, the changes will be rolled out in July.
The proposal is open to public comment through Dec. 19; comments will be reviewed and considered before a final set of proposed requirements are sent to the ACGME board for approval.
“We’re here to serve the public, and so the focus is on the comments that reflect the most recent and comprehensive evidence and educational outcomes rather than the individual opinions we receive,” Dr. Nasca said.
First-year residents may be permitted to work up to 24 consecutive hours – 8 hours longer than they can now – under a proposal from a task force of the Accreditation Council for Graduate Medical Education (ACGME).
The ACGME Duty Hour Task Force proposes to raise first-year trainees’ work hour limit from 16 hours, reverting to the 24-hour maximum that remained in effect until 2011 – and the existing limit in place for all other residents.
“There is better team continuity of care provided with less micromanagement of resident duty hours,” said Thomas J. Nasca, MD, ACGME chief executive and vice chairman of the task force.
The ACGME instituted the 16-hour cap for first-year residents in the wake of a December 2008 report released by the Institute of Medicine (IOM), “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety.” The ACGME also prohibited 30-hour shifts, which some trainees had been clocking.
“Every 5 years, the ACGME reviews its program requirements,” Dr. Nasca said. “That’s a promise we made to the community and to the public” in July 2003. The most recent changes occurred in July 2011.
Since then, some faculty have contended that shorter work hour limits for the first-year residents are accelerating the frequency of patient transitions and disrupting continuity of care. Many educators also noted that residents would gain more knowledge by monitoring a hospitalized patient during the initial 24 hours.
The proposed changes are “encouraging and courageous,” according to R. James Valentine, MD, FACS, president of the Western Surgical Association.
“This is a real world scenario,” said Dr. Valentine, professor of vascular surgery at Vanderbilt University, Nashville, Tenn. “Medicine is such a complex system. It is not easily constrained by time limitations.”
Requiring a physician to transition a patient’s care at a specific time may help promote the trainee’s well-being; however, it also “robs the resident of the opportunity to see the disease progress and to see the response to the treatment that is being offered. The new rules help strike a balance between bedside education and rest,” he added.
The proposed revisions to training requirements also include phasing out the term “duty” hours in favor of “clinical experience and education,” highlighting that residents’ responsibility to patients takes precedence over any adherence to a schedule or clock. Working a certain number of hospital hours is only one aspect of delivering safe and quality care, the ACGME Duty Hour Task Force noted in its proposal.
The proposal does not change the following, which all are averaged over a period of 4 weeks: a maximum of 80 hours per week, 1 day free from clinical experience or education in 7, and in-house call no more often than every third night.
“It is important to note that the absence of a common 16-hour limit does not imply that programs may no longer configure their clinical schedules in 16-hour increments if that is the preferred option for a given setting or clinical context,” Dr. Nasca wrote in a Nov. 4 letter to the graduate medical education community.
In its December 2008 report, the IOM noted that revamping residents’ work hours alone offered no guarantee of patient safety. It called for increased supervision by seasoned physicians, restrictions on patient caseloads based on residents’ levels of experience and specialty, overlap in schedules around shift changes to decrease the possibility of error in transitioning patients from one provider to another, and broad-based research to examine the outcomes from these changes.
“Surgical residents, when they’re operating, come under very direct supervision by attending physicians,” said Jay Bhattacharya, MD, professor of medicine at Stanford (Calif.) University, who served on the 2008 IOM committee. “That supervision is generally pretty good. Even for a tired resident, the supervision makes it so that the fatigue the trainee faces doesn’t endanger the patient.”
Acknowledging the emerging evidence that physicians are at heightened risk for burnout and perhaps depression, the proposal underscores the need for residency programs and institutions to prioritize the well-being of residents as well as nurses and other hospital personnel.
“Burnout and depression impair a physician’s ability to provide excellent care. Self-care is an important aspect of professionalism, and a skill that must be learned and nurtured under the guidance and role modeling of faculty members,” Dr. Nasca wrote in his Nov. 4 letter.
If the proposal is approved by the ACGME board of directors in February, the changes will be rolled out in July.
The proposal is open to public comment through Dec. 19; comments will be reviewed and considered before a final set of proposed requirements are sent to the ACGME board for approval.
“We’re here to serve the public, and so the focus is on the comments that reflect the most recent and comprehensive evidence and educational outcomes rather than the individual opinions we receive,” Dr. Nasca said.
First-year residents may be permitted to work up to 24 consecutive hours – 8 hours longer than they can now – under a proposal from a task force of the Accreditation Council for Graduate Medical Education (ACGME).
The ACGME Duty Hour Task Force proposes to raise first-year trainees’ work hour limit from 16 hours, reverting to the 24-hour maximum that remained in effect until 2011 – and the existing limit in place for all other residents.
“There is better team continuity of care provided with less micromanagement of resident duty hours,” said Thomas J. Nasca, MD, ACGME chief executive and vice chairman of the task force.
The ACGME instituted the 16-hour cap for first-year residents in the wake of a December 2008 report released by the Institute of Medicine (IOM), “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety.” The ACGME also prohibited 30-hour shifts, which some trainees had been clocking.
“Every 5 years, the ACGME reviews its program requirements,” Dr. Nasca said. “That’s a promise we made to the community and to the public” in July 2003. The most recent changes occurred in July 2011.
Since then, some faculty have contended that shorter work hour limits for the first-year residents are accelerating the frequency of patient transitions and disrupting continuity of care. Many educators also noted that residents would gain more knowledge by monitoring a hospitalized patient during the initial 24 hours.
The proposed changes are “encouraging and courageous,” according to R. James Valentine, MD, FACS, president of the Western Surgical Association.
“This is a real world scenario,” said Dr. Valentine, professor of vascular surgery at Vanderbilt University, Nashville, Tenn. “Medicine is such a complex system. It is not easily constrained by time limitations.”
Requiring a physician to transition a patient’s care at a specific time may help promote the trainee’s well-being; however, it also “robs the resident of the opportunity to see the disease progress and to see the response to the treatment that is being offered. The new rules help strike a balance between bedside education and rest,” he added.
The proposed revisions to training requirements also include phasing out the term “duty” hours in favor of “clinical experience and education,” highlighting that residents’ responsibility to patients takes precedence over any adherence to a schedule or clock. Working a certain number of hospital hours is only one aspect of delivering safe and quality care, the ACGME Duty Hour Task Force noted in its proposal.
The proposal does not change the following, which all are averaged over a period of 4 weeks: a maximum of 80 hours per week, 1 day free from clinical experience or education in 7, and in-house call no more often than every third night.
“It is important to note that the absence of a common 16-hour limit does not imply that programs may no longer configure their clinical schedules in 16-hour increments if that is the preferred option for a given setting or clinical context,” Dr. Nasca wrote in a Nov. 4 letter to the graduate medical education community.
In its December 2008 report, the IOM noted that revamping residents’ work hours alone offered no guarantee of patient safety. It called for increased supervision by seasoned physicians, restrictions on patient caseloads based on residents’ levels of experience and specialty, overlap in schedules around shift changes to decrease the possibility of error in transitioning patients from one provider to another, and broad-based research to examine the outcomes from these changes.
“Surgical residents, when they’re operating, come under very direct supervision by attending physicians,” said Jay Bhattacharya, MD, professor of medicine at Stanford (Calif.) University, who served on the 2008 IOM committee. “That supervision is generally pretty good. Even for a tired resident, the supervision makes it so that the fatigue the trainee faces doesn’t endanger the patient.”
Acknowledging the emerging evidence that physicians are at heightened risk for burnout and perhaps depression, the proposal underscores the need for residency programs and institutions to prioritize the well-being of residents as well as nurses and other hospital personnel.
“Burnout and depression impair a physician’s ability to provide excellent care. Self-care is an important aspect of professionalism, and a skill that must be learned and nurtured under the guidance and role modeling of faculty members,” Dr. Nasca wrote in his Nov. 4 letter.
If the proposal is approved by the ACGME board of directors in February, the changes will be rolled out in July.
The proposal is open to public comment through Dec. 19; comments will be reviewed and considered before a final set of proposed requirements are sent to the ACGME board for approval.
“We’re here to serve the public, and so the focus is on the comments that reflect the most recent and comprehensive evidence and educational outcomes rather than the individual opinions we receive,” Dr. Nasca said.