User login
Large COVID-19 dataset: Kidney injury in >35% of those in hospital
As a new report shows that over a third of U.S. patients hospitalized with COVID-19 developed acute kidney injury (AKI), and nearly 15% of these patients needed dialysis, experts in the field are calling for more robust research into multiple aspects of this increasingly important issue.
Among 5,449 patients admitted to 13 Northwell Health New York–based hospitals between March and April 2020, 36.6% (1,993) developed AKI.
– the rate of kidney injury was 89.7% among ventilated patients, compared with 21.7% among other patients.
AKI in COVID-19 was also linked to a poor prognosis: 35% of those who developed AKI had died at the time of publication.
The study includes the largest defined cohort of hospitalized COVID-19 patients to date with a focus on AKI, says Jamie S. Hirsch, MD, of Northwell Health in Great Neck, N.Y., and colleagues in their article published online in Kidney International.
The findings track with those of a study of New York hospitals published online in The Lancet. In that dataset, just under a third (31%) of critically ill patients developed severe kidney damage and needed dialysis.
Both of these studies help solidify the experiences of clinicians on the ground, with many U.S. hospitals in the early phases of the pandemic underestimating the problem of AKI and having to scramble to find enough dialysis machines and dialysate solution to treat the most severely affected patients.
“We hope to learn more about the COVID-19–related AKI in the coming weeks, and that by sharing what we have learned from our patients, other doctors and their patients can benefit,” said senior author of the new study, Kenar D. Jhaveri, MD, associated chief of nephrology at Hofstra/Northwell.
The new report also comes as scientists from the National Institute of Diabetes and Digestive and Kidney Diseases highlighted the importance of AKI as a sequela of COVID-19 in an editorial published in Diabetes Care.
They, too, said that it is vitally important to better understand what is happening, as more and more hospitals will face COVID-19 patients with this complication.
“The natural history and heterogeneity of the kidney disease caused by COVID-19 need to be unraveled,” one of the authors, Robert A. Star, MD, director of the division of kidney, urologic, and hematologic diseases at NIDDK, said in an interview.
Such research is key because “low kidney function is an exclusion criterion in current studies” examining antiviral medications in COVID-19, he said. “Clinical trials are needed to test therapeutic interventions to prevent or treat COVID-19–induced AKI.”
Extremely ill patients develop AKI as their condition deteriorates
Identifying risk factors for the development of AKI in COVID-19 will be critical in helping shed more light on diagnostic and predictive biomarkers, Dr. Star said.
Dr. Hirsch and colleagues said that extremely ill patients often develop kidney failure as their condition deteriorates, and this happens quickly. Indeed, the clearest risk factors for the development of AKI were “the need for ventilator support or vasopressor drug treatment.”
Other independent predictors of AKI were older age, black race, diabetes, hypertension, and cardiovascular disease.
Of those on mechanical ventilation overall in the more than 5,000-patient study, almost a quarter (23.2%) developed AKI and needed renal replacement therapy, which consisted of either intermittent or continuous hemodialysis.
Dr. Star and associates wrote that these numbers are important because of the knock-on effects.
“Hemodialysis in critically ill infected patients is associated with significant clotting complications and mortality as well as increased infection risk to staff,” they pointed out.
Dr. Star said that “the incidence rate of AKI reported in this study is higher than what had been previously reported by others in the United States and China and may reflect differences in population demographics, severity of illness, prevalence of comorbidities, socioeconomic factors, patient volume overwhelming hospital capacity, or other factors not yet determined.
“It may be caused by dehydration (volume depletion), heart failure, the inflammatory response to the virus (cytokine storm), respiratory failure, clotting of blood vessels (hypercoagulation), muscle tissue breakdown (rhabdomyolysis), and/or a direct viral infection of the kidney,” he said.
Renal biopsies from patients with AKI may help shed some light
The editorialists went on to say that findings from kidney biopsies of COVID-19 patients with AKI may help shed some light on this condition.
“While difficult to perform, kidney biopsies from patients with early AKI could help us understand the underlying pathophysiologies at the cellular and molecular level and begin to target specific treatments to specific subgroups of patients,” they wrote.
The authors noted that, as part of funding opportunities provided by the National Institutes of Health for COVID-19 research, the NIDDK has published a Notice of Special Interest outlining the most urgent areas in need of research, with one of the focuses being on the kidney.
“As the research community emerges from the crisis situation, there should be renewed efforts for multidisciplinary research to conduct integrated basic, translational, and clinical studies aimed at greatly increasing the knowledge base to understand how both the current COVID-19 threat and future health threats affect both healthy people and people with chronic diseases and conditions,” the editorials noted.
The authors of the Diabetes Care editorial have reported no relevant financial relationships. Dr. Jhaveri has reported being a consultant for Astex Pharmaceuticals.
A version of this article originally appeared on Medscape.com.
As a new report shows that over a third of U.S. patients hospitalized with COVID-19 developed acute kidney injury (AKI), and nearly 15% of these patients needed dialysis, experts in the field are calling for more robust research into multiple aspects of this increasingly important issue.
Among 5,449 patients admitted to 13 Northwell Health New York–based hospitals between March and April 2020, 36.6% (1,993) developed AKI.
– the rate of kidney injury was 89.7% among ventilated patients, compared with 21.7% among other patients.
AKI in COVID-19 was also linked to a poor prognosis: 35% of those who developed AKI had died at the time of publication.
The study includes the largest defined cohort of hospitalized COVID-19 patients to date with a focus on AKI, says Jamie S. Hirsch, MD, of Northwell Health in Great Neck, N.Y., and colleagues in their article published online in Kidney International.
The findings track with those of a study of New York hospitals published online in The Lancet. In that dataset, just under a third (31%) of critically ill patients developed severe kidney damage and needed dialysis.
Both of these studies help solidify the experiences of clinicians on the ground, with many U.S. hospitals in the early phases of the pandemic underestimating the problem of AKI and having to scramble to find enough dialysis machines and dialysate solution to treat the most severely affected patients.
“We hope to learn more about the COVID-19–related AKI in the coming weeks, and that by sharing what we have learned from our patients, other doctors and their patients can benefit,” said senior author of the new study, Kenar D. Jhaveri, MD, associated chief of nephrology at Hofstra/Northwell.
The new report also comes as scientists from the National Institute of Diabetes and Digestive and Kidney Diseases highlighted the importance of AKI as a sequela of COVID-19 in an editorial published in Diabetes Care.
They, too, said that it is vitally important to better understand what is happening, as more and more hospitals will face COVID-19 patients with this complication.
“The natural history and heterogeneity of the kidney disease caused by COVID-19 need to be unraveled,” one of the authors, Robert A. Star, MD, director of the division of kidney, urologic, and hematologic diseases at NIDDK, said in an interview.
Such research is key because “low kidney function is an exclusion criterion in current studies” examining antiviral medications in COVID-19, he said. “Clinical trials are needed to test therapeutic interventions to prevent or treat COVID-19–induced AKI.”
Extremely ill patients develop AKI as their condition deteriorates
Identifying risk factors for the development of AKI in COVID-19 will be critical in helping shed more light on diagnostic and predictive biomarkers, Dr. Star said.
Dr. Hirsch and colleagues said that extremely ill patients often develop kidney failure as their condition deteriorates, and this happens quickly. Indeed, the clearest risk factors for the development of AKI were “the need for ventilator support or vasopressor drug treatment.”
Other independent predictors of AKI were older age, black race, diabetes, hypertension, and cardiovascular disease.
Of those on mechanical ventilation overall in the more than 5,000-patient study, almost a quarter (23.2%) developed AKI and needed renal replacement therapy, which consisted of either intermittent or continuous hemodialysis.
Dr. Star and associates wrote that these numbers are important because of the knock-on effects.
“Hemodialysis in critically ill infected patients is associated with significant clotting complications and mortality as well as increased infection risk to staff,” they pointed out.
Dr. Star said that “the incidence rate of AKI reported in this study is higher than what had been previously reported by others in the United States and China and may reflect differences in population demographics, severity of illness, prevalence of comorbidities, socioeconomic factors, patient volume overwhelming hospital capacity, or other factors not yet determined.
“It may be caused by dehydration (volume depletion), heart failure, the inflammatory response to the virus (cytokine storm), respiratory failure, clotting of blood vessels (hypercoagulation), muscle tissue breakdown (rhabdomyolysis), and/or a direct viral infection of the kidney,” he said.
Renal biopsies from patients with AKI may help shed some light
The editorialists went on to say that findings from kidney biopsies of COVID-19 patients with AKI may help shed some light on this condition.
“While difficult to perform, kidney biopsies from patients with early AKI could help us understand the underlying pathophysiologies at the cellular and molecular level and begin to target specific treatments to specific subgroups of patients,” they wrote.
The authors noted that, as part of funding opportunities provided by the National Institutes of Health for COVID-19 research, the NIDDK has published a Notice of Special Interest outlining the most urgent areas in need of research, with one of the focuses being on the kidney.
“As the research community emerges from the crisis situation, there should be renewed efforts for multidisciplinary research to conduct integrated basic, translational, and clinical studies aimed at greatly increasing the knowledge base to understand how both the current COVID-19 threat and future health threats affect both healthy people and people with chronic diseases and conditions,” the editorials noted.
The authors of the Diabetes Care editorial have reported no relevant financial relationships. Dr. Jhaveri has reported being a consultant for Astex Pharmaceuticals.
A version of this article originally appeared on Medscape.com.
As a new report shows that over a third of U.S. patients hospitalized with COVID-19 developed acute kidney injury (AKI), and nearly 15% of these patients needed dialysis, experts in the field are calling for more robust research into multiple aspects of this increasingly important issue.
Among 5,449 patients admitted to 13 Northwell Health New York–based hospitals between March and April 2020, 36.6% (1,993) developed AKI.
– the rate of kidney injury was 89.7% among ventilated patients, compared with 21.7% among other patients.
AKI in COVID-19 was also linked to a poor prognosis: 35% of those who developed AKI had died at the time of publication.
The study includes the largest defined cohort of hospitalized COVID-19 patients to date with a focus on AKI, says Jamie S. Hirsch, MD, of Northwell Health in Great Neck, N.Y., and colleagues in their article published online in Kidney International.
The findings track with those of a study of New York hospitals published online in The Lancet. In that dataset, just under a third (31%) of critically ill patients developed severe kidney damage and needed dialysis.
Both of these studies help solidify the experiences of clinicians on the ground, with many U.S. hospitals in the early phases of the pandemic underestimating the problem of AKI and having to scramble to find enough dialysis machines and dialysate solution to treat the most severely affected patients.
“We hope to learn more about the COVID-19–related AKI in the coming weeks, and that by sharing what we have learned from our patients, other doctors and their patients can benefit,” said senior author of the new study, Kenar D. Jhaveri, MD, associated chief of nephrology at Hofstra/Northwell.
The new report also comes as scientists from the National Institute of Diabetes and Digestive and Kidney Diseases highlighted the importance of AKI as a sequela of COVID-19 in an editorial published in Diabetes Care.
They, too, said that it is vitally important to better understand what is happening, as more and more hospitals will face COVID-19 patients with this complication.
“The natural history and heterogeneity of the kidney disease caused by COVID-19 need to be unraveled,” one of the authors, Robert A. Star, MD, director of the division of kidney, urologic, and hematologic diseases at NIDDK, said in an interview.
Such research is key because “low kidney function is an exclusion criterion in current studies” examining antiviral medications in COVID-19, he said. “Clinical trials are needed to test therapeutic interventions to prevent or treat COVID-19–induced AKI.”
Extremely ill patients develop AKI as their condition deteriorates
Identifying risk factors for the development of AKI in COVID-19 will be critical in helping shed more light on diagnostic and predictive biomarkers, Dr. Star said.
Dr. Hirsch and colleagues said that extremely ill patients often develop kidney failure as their condition deteriorates, and this happens quickly. Indeed, the clearest risk factors for the development of AKI were “the need for ventilator support or vasopressor drug treatment.”
Other independent predictors of AKI were older age, black race, diabetes, hypertension, and cardiovascular disease.
Of those on mechanical ventilation overall in the more than 5,000-patient study, almost a quarter (23.2%) developed AKI and needed renal replacement therapy, which consisted of either intermittent or continuous hemodialysis.
Dr. Star and associates wrote that these numbers are important because of the knock-on effects.
“Hemodialysis in critically ill infected patients is associated with significant clotting complications and mortality as well as increased infection risk to staff,” they pointed out.
Dr. Star said that “the incidence rate of AKI reported in this study is higher than what had been previously reported by others in the United States and China and may reflect differences in population demographics, severity of illness, prevalence of comorbidities, socioeconomic factors, patient volume overwhelming hospital capacity, or other factors not yet determined.
“It may be caused by dehydration (volume depletion), heart failure, the inflammatory response to the virus (cytokine storm), respiratory failure, clotting of blood vessels (hypercoagulation), muscle tissue breakdown (rhabdomyolysis), and/or a direct viral infection of the kidney,” he said.
Renal biopsies from patients with AKI may help shed some light
The editorialists went on to say that findings from kidney biopsies of COVID-19 patients with AKI may help shed some light on this condition.
“While difficult to perform, kidney biopsies from patients with early AKI could help us understand the underlying pathophysiologies at the cellular and molecular level and begin to target specific treatments to specific subgroups of patients,” they wrote.
The authors noted that, as part of funding opportunities provided by the National Institutes of Health for COVID-19 research, the NIDDK has published a Notice of Special Interest outlining the most urgent areas in need of research, with one of the focuses being on the kidney.
“As the research community emerges from the crisis situation, there should be renewed efforts for multidisciplinary research to conduct integrated basic, translational, and clinical studies aimed at greatly increasing the knowledge base to understand how both the current COVID-19 threat and future health threats affect both healthy people and people with chronic diseases and conditions,” the editorials noted.
The authors of the Diabetes Care editorial have reported no relevant financial relationships. Dr. Jhaveri has reported being a consultant for Astex Pharmaceuticals.
A version of this article originally appeared on Medscape.com.
Endocrinologists adapt to telehealth, deferrals during COVID-19
James V. Hennessey, MD, has been working from home, like so many others, since the lockdowns went into effect. The director of clinical endocrinology at Beth Israel Deaconess Medical Center in Boston has felt surprisingly heartened by his experience.
“So far, these [video-based] discussions have been reassuring,” he said in an interview. “The images generating the referral have been available for review, and we’ve been able to reassure the patients that there are no danger signs in their histories.” Dr. Hennessey noted that for patients who agree to thyroid nodule consultations via video consult, the arrangement has allowed for the assessment of difficulty swallowing and other obvious difficulties.
While Dr. Hennessey has not yet encountered anything serious during his virtual consults, such as a rapidly growing anaplastic thyroid cancer, “it will only take some time before we hear of one, I’m sure,” he observed.
Surprisingly productive
During the COVID-19 pandemic, many physicians have been forced to innovate and turn aspects of their practices virtual. Use of telehealth services has increased by 50% in the United States since the start of the pandemic, according to research by Frost and Sullivan consultants. Three endocrinologists report that telehealth, although not always ideal, may provide more information than expected.
Recent recommendations say physicians should defer biopsies of asymptomatic thyroid nodules until the risk for COVID-19 has passed. As a result, some patients may experience increased anxiety because of such delays. But cases determined to require more urgent care should not be delayed, says the guidance.
Trevor E. Angell, MD, concurred that it’s possible to safely defer thyroid nodule assessment. “I would agree that with appropriate risk stratification by symptom assessment, ultrasound, and lab testing, thyroid nodules can be safely triaged for delayed evaluation,” said Dr. Angell, an assistant professor of clinical medicine and associate medical director of the thyroid center at the University of Southern California, in Los Angeles.
“I have found that patients with thyroid nodules that are not highly suspicious are reasonably reassured that the delay in obtaining FNA [fine needle aspiration] is very unlikely to have an impact on the ultimate outcome,” he said in an interview.
But he does have concerns that many of the investigations needed to make a decision about whether treatment can be deferred are also on hold.
“In many settings, including my own institution, nonurgent radiology studies are not being performed,” he noted. And “patients are reluctant to go to an ultrasound evaluation or a laboratory to perform testing” because of worries about COVID-19. “For possible thyroid nodules that have not yet been evaluated, this presents difficulty in getting the accurate ultrasound risk stratification and/or calcitonin testing that would help determine the need for immediate FNA biopsy or surgical consideration.”
And for patients in whom surgery has already been recommended, because of “indeterminate FNA cytology or suspicious molecular test result,” there is likely to be even more anxiety, Dr. Angell said.
“Most patients happy” with video visits
Victor J. Bernet, MD, American Thyroid Association president-elect, noted that, while his practice already had planned to start doing some video visits in April, the process was by necessity jump-started in March.
“Currently, about 90%-95% of our appointments are video visit or phone-call based,” he said in an interview. “Most patients seem to actually be happy with the video visit experience,” he said. “Some patients were very happy that they were given the opportunity to not have to come into the clinic in person at this point in time.”
Dr. Bernet agreed that video consults can be productive in identifying some important clinical information. “I have had at least a few patients with obvious goiter or nodule,” said Dr. Bernet, an associate professor and chair of the division of endocrinology at the Mayo Clinic in Jacksonville, Fla. “I also had a patient with hyperthyroidism from Graves disease and we were able to assess her for tremor over video.”
In the latter case, “we had the patient place a sheet of paper on the top of her hand while her arm was extended, which is the technique that can be used in person as well, and helps amplify the ability to detect if a fine tremor is present.”
“It was obvious that this patient had a tremor by video,” Dr. Bernet said.
In addition to tremor, video visits can be helpful in “looking for the presence of thyroid eye disease, enlarged thyroid, and possibly even skin changes.” Video may also be useful in evaluating respiratory effort and some cognitive behaviors, Dr. Bernet noted.
Starting to think about elective procedures again
As centers in the United States begin to reopen and permit elective procedures again, patients being considered for FNAs will likely be reintroduced according to the level of need, Dr. Hennessey noted. “Those with clear indications for FNA will be the first (to be scheduled),” while those who had very-low-risk findings, such as small nodules and cysts, “have already been deferred to 6- or 12-month follow-up ultrasounds, and decisions regarding FNAs will be made based on clinical course.”
Dr. Angell agrees that efforts to address the most urgent cases once centers reopen will be of the utmost importance. “To the greatest extent possible, providers should work together to coordinate the rescheduling of patients for FNA or surgery to avoid any further delay for those at most risk,” he said.Dr. Hennessey, Dr. Angell, and Dr. Bernet have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
James V. Hennessey, MD, has been working from home, like so many others, since the lockdowns went into effect. The director of clinical endocrinology at Beth Israel Deaconess Medical Center in Boston has felt surprisingly heartened by his experience.
“So far, these [video-based] discussions have been reassuring,” he said in an interview. “The images generating the referral have been available for review, and we’ve been able to reassure the patients that there are no danger signs in their histories.” Dr. Hennessey noted that for patients who agree to thyroid nodule consultations via video consult, the arrangement has allowed for the assessment of difficulty swallowing and other obvious difficulties.
While Dr. Hennessey has not yet encountered anything serious during his virtual consults, such as a rapidly growing anaplastic thyroid cancer, “it will only take some time before we hear of one, I’m sure,” he observed.
Surprisingly productive
During the COVID-19 pandemic, many physicians have been forced to innovate and turn aspects of their practices virtual. Use of telehealth services has increased by 50% in the United States since the start of the pandemic, according to research by Frost and Sullivan consultants. Three endocrinologists report that telehealth, although not always ideal, may provide more information than expected.
Recent recommendations say physicians should defer biopsies of asymptomatic thyroid nodules until the risk for COVID-19 has passed. As a result, some patients may experience increased anxiety because of such delays. But cases determined to require more urgent care should not be delayed, says the guidance.
Trevor E. Angell, MD, concurred that it’s possible to safely defer thyroid nodule assessment. “I would agree that with appropriate risk stratification by symptom assessment, ultrasound, and lab testing, thyroid nodules can be safely triaged for delayed evaluation,” said Dr. Angell, an assistant professor of clinical medicine and associate medical director of the thyroid center at the University of Southern California, in Los Angeles.
“I have found that patients with thyroid nodules that are not highly suspicious are reasonably reassured that the delay in obtaining FNA [fine needle aspiration] is very unlikely to have an impact on the ultimate outcome,” he said in an interview.
But he does have concerns that many of the investigations needed to make a decision about whether treatment can be deferred are also on hold.
“In many settings, including my own institution, nonurgent radiology studies are not being performed,” he noted. And “patients are reluctant to go to an ultrasound evaluation or a laboratory to perform testing” because of worries about COVID-19. “For possible thyroid nodules that have not yet been evaluated, this presents difficulty in getting the accurate ultrasound risk stratification and/or calcitonin testing that would help determine the need for immediate FNA biopsy or surgical consideration.”
And for patients in whom surgery has already been recommended, because of “indeterminate FNA cytology or suspicious molecular test result,” there is likely to be even more anxiety, Dr. Angell said.
“Most patients happy” with video visits
Victor J. Bernet, MD, American Thyroid Association president-elect, noted that, while his practice already had planned to start doing some video visits in April, the process was by necessity jump-started in March.
“Currently, about 90%-95% of our appointments are video visit or phone-call based,” he said in an interview. “Most patients seem to actually be happy with the video visit experience,” he said. “Some patients were very happy that they were given the opportunity to not have to come into the clinic in person at this point in time.”
Dr. Bernet agreed that video consults can be productive in identifying some important clinical information. “I have had at least a few patients with obvious goiter or nodule,” said Dr. Bernet, an associate professor and chair of the division of endocrinology at the Mayo Clinic in Jacksonville, Fla. “I also had a patient with hyperthyroidism from Graves disease and we were able to assess her for tremor over video.”
In the latter case, “we had the patient place a sheet of paper on the top of her hand while her arm was extended, which is the technique that can be used in person as well, and helps amplify the ability to detect if a fine tremor is present.”
“It was obvious that this patient had a tremor by video,” Dr. Bernet said.
In addition to tremor, video visits can be helpful in “looking for the presence of thyroid eye disease, enlarged thyroid, and possibly even skin changes.” Video may also be useful in evaluating respiratory effort and some cognitive behaviors, Dr. Bernet noted.
Starting to think about elective procedures again
As centers in the United States begin to reopen and permit elective procedures again, patients being considered for FNAs will likely be reintroduced according to the level of need, Dr. Hennessey noted. “Those with clear indications for FNA will be the first (to be scheduled),” while those who had very-low-risk findings, such as small nodules and cysts, “have already been deferred to 6- or 12-month follow-up ultrasounds, and decisions regarding FNAs will be made based on clinical course.”
Dr. Angell agrees that efforts to address the most urgent cases once centers reopen will be of the utmost importance. “To the greatest extent possible, providers should work together to coordinate the rescheduling of patients for FNA or surgery to avoid any further delay for those at most risk,” he said.Dr. Hennessey, Dr. Angell, and Dr. Bernet have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
James V. Hennessey, MD, has been working from home, like so many others, since the lockdowns went into effect. The director of clinical endocrinology at Beth Israel Deaconess Medical Center in Boston has felt surprisingly heartened by his experience.
“So far, these [video-based] discussions have been reassuring,” he said in an interview. “The images generating the referral have been available for review, and we’ve been able to reassure the patients that there are no danger signs in their histories.” Dr. Hennessey noted that for patients who agree to thyroid nodule consultations via video consult, the arrangement has allowed for the assessment of difficulty swallowing and other obvious difficulties.
While Dr. Hennessey has not yet encountered anything serious during his virtual consults, such as a rapidly growing anaplastic thyroid cancer, “it will only take some time before we hear of one, I’m sure,” he observed.
Surprisingly productive
During the COVID-19 pandemic, many physicians have been forced to innovate and turn aspects of their practices virtual. Use of telehealth services has increased by 50% in the United States since the start of the pandemic, according to research by Frost and Sullivan consultants. Three endocrinologists report that telehealth, although not always ideal, may provide more information than expected.
Recent recommendations say physicians should defer biopsies of asymptomatic thyroid nodules until the risk for COVID-19 has passed. As a result, some patients may experience increased anxiety because of such delays. But cases determined to require more urgent care should not be delayed, says the guidance.
Trevor E. Angell, MD, concurred that it’s possible to safely defer thyroid nodule assessment. “I would agree that with appropriate risk stratification by symptom assessment, ultrasound, and lab testing, thyroid nodules can be safely triaged for delayed evaluation,” said Dr. Angell, an assistant professor of clinical medicine and associate medical director of the thyroid center at the University of Southern California, in Los Angeles.
“I have found that patients with thyroid nodules that are not highly suspicious are reasonably reassured that the delay in obtaining FNA [fine needle aspiration] is very unlikely to have an impact on the ultimate outcome,” he said in an interview.
But he does have concerns that many of the investigations needed to make a decision about whether treatment can be deferred are also on hold.
“In many settings, including my own institution, nonurgent radiology studies are not being performed,” he noted. And “patients are reluctant to go to an ultrasound evaluation or a laboratory to perform testing” because of worries about COVID-19. “For possible thyroid nodules that have not yet been evaluated, this presents difficulty in getting the accurate ultrasound risk stratification and/or calcitonin testing that would help determine the need for immediate FNA biopsy or surgical consideration.”
And for patients in whom surgery has already been recommended, because of “indeterminate FNA cytology or suspicious molecular test result,” there is likely to be even more anxiety, Dr. Angell said.
“Most patients happy” with video visits
Victor J. Bernet, MD, American Thyroid Association president-elect, noted that, while his practice already had planned to start doing some video visits in April, the process was by necessity jump-started in March.
“Currently, about 90%-95% of our appointments are video visit or phone-call based,” he said in an interview. “Most patients seem to actually be happy with the video visit experience,” he said. “Some patients were very happy that they were given the opportunity to not have to come into the clinic in person at this point in time.”
Dr. Bernet agreed that video consults can be productive in identifying some important clinical information. “I have had at least a few patients with obvious goiter or nodule,” said Dr. Bernet, an associate professor and chair of the division of endocrinology at the Mayo Clinic in Jacksonville, Fla. “I also had a patient with hyperthyroidism from Graves disease and we were able to assess her for tremor over video.”
In the latter case, “we had the patient place a sheet of paper on the top of her hand while her arm was extended, which is the technique that can be used in person as well, and helps amplify the ability to detect if a fine tremor is present.”
“It was obvious that this patient had a tremor by video,” Dr. Bernet said.
In addition to tremor, video visits can be helpful in “looking for the presence of thyroid eye disease, enlarged thyroid, and possibly even skin changes.” Video may also be useful in evaluating respiratory effort and some cognitive behaviors, Dr. Bernet noted.
Starting to think about elective procedures again
As centers in the United States begin to reopen and permit elective procedures again, patients being considered for FNAs will likely be reintroduced according to the level of need, Dr. Hennessey noted. “Those with clear indications for FNA will be the first (to be scheduled),” while those who had very-low-risk findings, such as small nodules and cysts, “have already been deferred to 6- or 12-month follow-up ultrasounds, and decisions regarding FNAs will be made based on clinical course.”
Dr. Angell agrees that efforts to address the most urgent cases once centers reopen will be of the utmost importance. “To the greatest extent possible, providers should work together to coordinate the rescheduling of patients for FNA or surgery to avoid any further delay for those at most risk,” he said.Dr. Hennessey, Dr. Angell, and Dr. Bernet have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
COVID-19: Defer ‘bread and butter’ procedure for thyroid nodules
With a few notable exceptions, the majority of fine needle aspiration (FNA) biopsies of thyroid nodules should be delayed until the risk of COVID-19, and the burden on resources, has lessened, according to expert consensus.
“Our group recommends that FNA biopsy of most asymptomatic thyroid nodules – taking into account the sonographic characteristics and patients’ clinical picture – be deferred to a later time, when risk of exposure to COVID-19 is more manageable and resource restriction is no longer a concern,” said the endocrinologists, writing in a guest editorial in Clinical Thyroidology.
All elective procedures have been canceled under guidance of the Centers for Disease Control and Prevention, in conjunction with the U.S. surgeon general, in response to the COVID-19 pandemic. However, thyroid nodule FNAs, though elective, fall into the category of being considered medically necessary and potentially prolonging life expectancy
Yet, with approximately 90% of asymptomatic thyroid nodules turning out to be benign and little evidence that early detection and treatment affects disease outcomes, there is a strong argument for deferral in most cases, stressed Ming Lee, MD, and colleagues, of the endocrinology division at Phoenix (Ariz.) Veterans Affairs Health Care System (PVAHCS), who convened a multidisciplinary meeting to address the urgent issue.
Patients should instead be interviewed by an endocrinologist (preferably via telehealth) to collect their clinical history as well as assess their perception of the disease and risk of malignancy, senior author S. Mitchell Harman, MD, chief of PVAHCS, said in an interview.
“The principal guiding factor should be the objectively assessed likelihood of malignancy of the individual patient’s nodule(s),” he said.
“In my opinion, we should also factor in the patient’s level of anxiety, since some patients are more sanguine about risk than others and our goal is to provide relief of anxiety as well as to determine need for, and course of, subsequent treatment,” Dr. Harman added.
Vast majority of malignant thyroid nodules are DTC, which is ‘indolent’
Dr. Lee and colleagues noted that, even of the 10% of thyroid nodules that do prove to be malignant, the vast majority of these (90%) are differentiated thyroid cancers (DTC). In general, patients with DTC “follow an indolent course and have excellent outcomes.”
“There is little evidence that early detection and treatment of DTC significantly alters disease outcomes as the overall mortality rate for DTC has remained low, at around 0.5%,” they wrote.
They also noted that ultrasound features of thyroid nodules can help guide priority for the future timing of an FNA procedure, but should not be the sole basis for deciding on immediate thyroid FNA or surgery.
Exceptions to the rule
Exceptions for considering FNA include more urgent thyroid disease diagnoses, including those that are symptomatic:
Suspected medullary thyroid cancer
“Regarding medullary thyroid cancer (MTC), early diagnosis and surgery do significantly improve outcomes, therefore, delaying FNA of nodules harboring MTC could be potentially injurious,” the authors said.
They suggested, however, measuring calcitonin levels instead, which they noted “is still controversial” in the United States, but “we feel it would be justified in patients with thyroid nodules that would usually be indicated for FNA.”
Those with a family history of MTC, or nodules located in the posterior upper third of lateral lobes (the usual location of MTC), should have calcitonin levels measured.
If calcitonin levels are above 10 pg/mL, “FNA should be offered as early as possible.”
“Significantly elevated serum calcitonin levels (e.g., > 100 pg/mL) should be considered an indication for surgery without cytologic confirmation by FNA,” they added.
Anaplastic thyroid cancer
Anaplastic thyroid cancer, though rare, “is one of the few occasions when thyroid surgery should be performed on an urgent basis, as this condition can worsen very rapidly.
“Patients typically present with a rapidly enlarging thyroid mass that is associated with compressive symptoms, such as dysphagia and dyspnea,” they observed.
In this instance, although FNA is part of the preoperative work-up, it is often nondiagnostic and could require additional sampling.
“At the time of this pandemic, it is reasonable that after a multidisciplinary discussion, such patients with the appropriate clinical scenario be referred for thyroid surgery, with or without prior FNA, based on the team’s judgment,” the authors recommended.
Long-standing thyroid masses
These are usually large and/or closely associated with vital structures, such as the trachea and esophagus, and when such masses cause compressive symptoms, thyroid surgery typically is warranted.
And although prior FNA is helpful to obtain a cytologic diagnosis, as this may change the extent of surgery, it may not always be essential.
Broadly, symptomatic patients with compressive symptoms threatening vital structures can be directly referred to a surgeon, with the timing for surgery jointly decided based on the severity of symptoms, rapidity of disease progression, local COVID-19 status, and available resources.
“During the pandemic, we believe that the vast majority of thyroid FNAs should be considered optional, and extent of surgery can be determined by pathological analysis of frozen sections intraoperatively,” they wrote.
“The value of FNA in these situations is less compelling in the current COVID-19 setting, as the basis of decision for surgery has been already determined,” the authors explained.
If urgent FNA needed, screen patient for COVID-19 and use PPE
Should the need for an urgent thyroid FNA occur, patients should be screened and tested for COVID-19 by a clinician wearing personal protective equipment (PPE), said Dr. Lee and colleagues.
“It is crucial to carefully weigh the risks of COVID-19 exposure, availability of resources, and urgency of these procedures for each patient in our individual practice settings,” they noted.
As restrictions eventually loosen, precautions will still be necessary to some degree, Dr. Harman said.
“I do not consider FNA a ‘high-risk’ procedure in the era of COVID-19, since it does not routinely result in profuse aerosolization of respiratory fluids,” he said in an interview.
“However, patients do sometimes cough or choke due to pressure on the neck and the operator is, of necessity, very close to the patient’s face. Therefore, when we resume FNA, patients will be screened for symptoms of COVID-19 infection and both the operator and the patient will be masked,” Dr. Harman continued.
“We routinely wear gloves, [and] whether the operator will wear a surgical or an N95 mask, disposable gown, etc, will depend on CDC guidance and guidance received from our VA infectious disease experts as it is applied specifically to each patient evaluation.”
The authors have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
With a few notable exceptions, the majority of fine needle aspiration (FNA) biopsies of thyroid nodules should be delayed until the risk of COVID-19, and the burden on resources, has lessened, according to expert consensus.
“Our group recommends that FNA biopsy of most asymptomatic thyroid nodules – taking into account the sonographic characteristics and patients’ clinical picture – be deferred to a later time, when risk of exposure to COVID-19 is more manageable and resource restriction is no longer a concern,” said the endocrinologists, writing in a guest editorial in Clinical Thyroidology.
All elective procedures have been canceled under guidance of the Centers for Disease Control and Prevention, in conjunction with the U.S. surgeon general, in response to the COVID-19 pandemic. However, thyroid nodule FNAs, though elective, fall into the category of being considered medically necessary and potentially prolonging life expectancy
Yet, with approximately 90% of asymptomatic thyroid nodules turning out to be benign and little evidence that early detection and treatment affects disease outcomes, there is a strong argument for deferral in most cases, stressed Ming Lee, MD, and colleagues, of the endocrinology division at Phoenix (Ariz.) Veterans Affairs Health Care System (PVAHCS), who convened a multidisciplinary meeting to address the urgent issue.
Patients should instead be interviewed by an endocrinologist (preferably via telehealth) to collect their clinical history as well as assess their perception of the disease and risk of malignancy, senior author S. Mitchell Harman, MD, chief of PVAHCS, said in an interview.
“The principal guiding factor should be the objectively assessed likelihood of malignancy of the individual patient’s nodule(s),” he said.
“In my opinion, we should also factor in the patient’s level of anxiety, since some patients are more sanguine about risk than others and our goal is to provide relief of anxiety as well as to determine need for, and course of, subsequent treatment,” Dr. Harman added.
Vast majority of malignant thyroid nodules are DTC, which is ‘indolent’
Dr. Lee and colleagues noted that, even of the 10% of thyroid nodules that do prove to be malignant, the vast majority of these (90%) are differentiated thyroid cancers (DTC). In general, patients with DTC “follow an indolent course and have excellent outcomes.”
“There is little evidence that early detection and treatment of DTC significantly alters disease outcomes as the overall mortality rate for DTC has remained low, at around 0.5%,” they wrote.
They also noted that ultrasound features of thyroid nodules can help guide priority for the future timing of an FNA procedure, but should not be the sole basis for deciding on immediate thyroid FNA or surgery.
Exceptions to the rule
Exceptions for considering FNA include more urgent thyroid disease diagnoses, including those that are symptomatic:
Suspected medullary thyroid cancer
“Regarding medullary thyroid cancer (MTC), early diagnosis and surgery do significantly improve outcomes, therefore, delaying FNA of nodules harboring MTC could be potentially injurious,” the authors said.
They suggested, however, measuring calcitonin levels instead, which they noted “is still controversial” in the United States, but “we feel it would be justified in patients with thyroid nodules that would usually be indicated for FNA.”
Those with a family history of MTC, or nodules located in the posterior upper third of lateral lobes (the usual location of MTC), should have calcitonin levels measured.
If calcitonin levels are above 10 pg/mL, “FNA should be offered as early as possible.”
“Significantly elevated serum calcitonin levels (e.g., > 100 pg/mL) should be considered an indication for surgery without cytologic confirmation by FNA,” they added.
Anaplastic thyroid cancer
Anaplastic thyroid cancer, though rare, “is one of the few occasions when thyroid surgery should be performed on an urgent basis, as this condition can worsen very rapidly.
“Patients typically present with a rapidly enlarging thyroid mass that is associated with compressive symptoms, such as dysphagia and dyspnea,” they observed.
In this instance, although FNA is part of the preoperative work-up, it is often nondiagnostic and could require additional sampling.
“At the time of this pandemic, it is reasonable that after a multidisciplinary discussion, such patients with the appropriate clinical scenario be referred for thyroid surgery, with or without prior FNA, based on the team’s judgment,” the authors recommended.
Long-standing thyroid masses
These are usually large and/or closely associated with vital structures, such as the trachea and esophagus, and when such masses cause compressive symptoms, thyroid surgery typically is warranted.
And although prior FNA is helpful to obtain a cytologic diagnosis, as this may change the extent of surgery, it may not always be essential.
Broadly, symptomatic patients with compressive symptoms threatening vital structures can be directly referred to a surgeon, with the timing for surgery jointly decided based on the severity of symptoms, rapidity of disease progression, local COVID-19 status, and available resources.
“During the pandemic, we believe that the vast majority of thyroid FNAs should be considered optional, and extent of surgery can be determined by pathological analysis of frozen sections intraoperatively,” they wrote.
“The value of FNA in these situations is less compelling in the current COVID-19 setting, as the basis of decision for surgery has been already determined,” the authors explained.
If urgent FNA needed, screen patient for COVID-19 and use PPE
Should the need for an urgent thyroid FNA occur, patients should be screened and tested for COVID-19 by a clinician wearing personal protective equipment (PPE), said Dr. Lee and colleagues.
“It is crucial to carefully weigh the risks of COVID-19 exposure, availability of resources, and urgency of these procedures for each patient in our individual practice settings,” they noted.
As restrictions eventually loosen, precautions will still be necessary to some degree, Dr. Harman said.
“I do not consider FNA a ‘high-risk’ procedure in the era of COVID-19, since it does not routinely result in profuse aerosolization of respiratory fluids,” he said in an interview.
“However, patients do sometimes cough or choke due to pressure on the neck and the operator is, of necessity, very close to the patient’s face. Therefore, when we resume FNA, patients will be screened for symptoms of COVID-19 infection and both the operator and the patient will be masked,” Dr. Harman continued.
“We routinely wear gloves, [and] whether the operator will wear a surgical or an N95 mask, disposable gown, etc, will depend on CDC guidance and guidance received from our VA infectious disease experts as it is applied specifically to each patient evaluation.”
The authors have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
With a few notable exceptions, the majority of fine needle aspiration (FNA) biopsies of thyroid nodules should be delayed until the risk of COVID-19, and the burden on resources, has lessened, according to expert consensus.
“Our group recommends that FNA biopsy of most asymptomatic thyroid nodules – taking into account the sonographic characteristics and patients’ clinical picture – be deferred to a later time, when risk of exposure to COVID-19 is more manageable and resource restriction is no longer a concern,” said the endocrinologists, writing in a guest editorial in Clinical Thyroidology.
All elective procedures have been canceled under guidance of the Centers for Disease Control and Prevention, in conjunction with the U.S. surgeon general, in response to the COVID-19 pandemic. However, thyroid nodule FNAs, though elective, fall into the category of being considered medically necessary and potentially prolonging life expectancy
Yet, with approximately 90% of asymptomatic thyroid nodules turning out to be benign and little evidence that early detection and treatment affects disease outcomes, there is a strong argument for deferral in most cases, stressed Ming Lee, MD, and colleagues, of the endocrinology division at Phoenix (Ariz.) Veterans Affairs Health Care System (PVAHCS), who convened a multidisciplinary meeting to address the urgent issue.
Patients should instead be interviewed by an endocrinologist (preferably via telehealth) to collect their clinical history as well as assess their perception of the disease and risk of malignancy, senior author S. Mitchell Harman, MD, chief of PVAHCS, said in an interview.
“The principal guiding factor should be the objectively assessed likelihood of malignancy of the individual patient’s nodule(s),” he said.
“In my opinion, we should also factor in the patient’s level of anxiety, since some patients are more sanguine about risk than others and our goal is to provide relief of anxiety as well as to determine need for, and course of, subsequent treatment,” Dr. Harman added.
Vast majority of malignant thyroid nodules are DTC, which is ‘indolent’
Dr. Lee and colleagues noted that, even of the 10% of thyroid nodules that do prove to be malignant, the vast majority of these (90%) are differentiated thyroid cancers (DTC). In general, patients with DTC “follow an indolent course and have excellent outcomes.”
“There is little evidence that early detection and treatment of DTC significantly alters disease outcomes as the overall mortality rate for DTC has remained low, at around 0.5%,” they wrote.
They also noted that ultrasound features of thyroid nodules can help guide priority for the future timing of an FNA procedure, but should not be the sole basis for deciding on immediate thyroid FNA or surgery.
Exceptions to the rule
Exceptions for considering FNA include more urgent thyroid disease diagnoses, including those that are symptomatic:
Suspected medullary thyroid cancer
“Regarding medullary thyroid cancer (MTC), early diagnosis and surgery do significantly improve outcomes, therefore, delaying FNA of nodules harboring MTC could be potentially injurious,” the authors said.
They suggested, however, measuring calcitonin levels instead, which they noted “is still controversial” in the United States, but “we feel it would be justified in patients with thyroid nodules that would usually be indicated for FNA.”
Those with a family history of MTC, or nodules located in the posterior upper third of lateral lobes (the usual location of MTC), should have calcitonin levels measured.
If calcitonin levels are above 10 pg/mL, “FNA should be offered as early as possible.”
“Significantly elevated serum calcitonin levels (e.g., > 100 pg/mL) should be considered an indication for surgery without cytologic confirmation by FNA,” they added.
Anaplastic thyroid cancer
Anaplastic thyroid cancer, though rare, “is one of the few occasions when thyroid surgery should be performed on an urgent basis, as this condition can worsen very rapidly.
“Patients typically present with a rapidly enlarging thyroid mass that is associated with compressive symptoms, such as dysphagia and dyspnea,” they observed.
In this instance, although FNA is part of the preoperative work-up, it is often nondiagnostic and could require additional sampling.
“At the time of this pandemic, it is reasonable that after a multidisciplinary discussion, such patients with the appropriate clinical scenario be referred for thyroid surgery, with or without prior FNA, based on the team’s judgment,” the authors recommended.
Long-standing thyroid masses
These are usually large and/or closely associated with vital structures, such as the trachea and esophagus, and when such masses cause compressive symptoms, thyroid surgery typically is warranted.
And although prior FNA is helpful to obtain a cytologic diagnosis, as this may change the extent of surgery, it may not always be essential.
Broadly, symptomatic patients with compressive symptoms threatening vital structures can be directly referred to a surgeon, with the timing for surgery jointly decided based on the severity of symptoms, rapidity of disease progression, local COVID-19 status, and available resources.
“During the pandemic, we believe that the vast majority of thyroid FNAs should be considered optional, and extent of surgery can be determined by pathological analysis of frozen sections intraoperatively,” they wrote.
“The value of FNA in these situations is less compelling in the current COVID-19 setting, as the basis of decision for surgery has been already determined,” the authors explained.
If urgent FNA needed, screen patient for COVID-19 and use PPE
Should the need for an urgent thyroid FNA occur, patients should be screened and tested for COVID-19 by a clinician wearing personal protective equipment (PPE), said Dr. Lee and colleagues.
“It is crucial to carefully weigh the risks of COVID-19 exposure, availability of resources, and urgency of these procedures for each patient in our individual practice settings,” they noted.
As restrictions eventually loosen, precautions will still be necessary to some degree, Dr. Harman said.
“I do not consider FNA a ‘high-risk’ procedure in the era of COVID-19, since it does not routinely result in profuse aerosolization of respiratory fluids,” he said in an interview.
“However, patients do sometimes cough or choke due to pressure on the neck and the operator is, of necessity, very close to the patient’s face. Therefore, when we resume FNA, patients will be screened for symptoms of COVID-19 infection and both the operator and the patient will be masked,” Dr. Harman continued.
“We routinely wear gloves, [and] whether the operator will wear a surgical or an N95 mask, disposable gown, etc, will depend on CDC guidance and guidance received from our VA infectious disease experts as it is applied specifically to each patient evaluation.”
The authors have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Rapid response to PTSD therapy may predict long-term improvement
Patients who experience a rapid response to cognitive processing therapy (CPT) for posttraumatic stress disorder have a greater likelihood of sustained improvement, new research suggests.
A study of 136 veterans with PTSD showed that those who responded quickly to a 3-week CPT program were significantly more likely to report lower symptom scores 3 months post treatment, compared with those participants who responded more slowly.
The results add to previous evidence that intensified, short-term treatment programs can accomplish long-term benefits, noted the investigators, led by Jenna Bagley, Rush University Medical Center, Chicago.
“These findings show promise for the success of condensed evidence-based, trauma-focused interventions,” they added.
Ms. Bagley was scheduled to present the study in March at the Anxiety and Depression Association of America (ADAA) Conference 2020. That conference was canceled because of the coronavirus pandemic.
Reducing high dropout rates
PTSD treatments such as CPT and prolonged exposure have been shown to have high efficacy, but they also have been shown to have a nearly 40% dropout rate, the researchers note.
This problem has prompted a focus on shorter-term interventions that can deliver intensified treatment before participants drop out. However, evidence has been lacking as to the sustainability of symptom improvements that occur in a short period.
The researchers evaluated data on 136 veterans (66% men; mean age, 41 years) with PTSD who completed a non–Veterans Affairs, 3-week CPT-based intensive treatment program. Follow-up assessments were carried out at 3 months.
Symptom reduction rates represented the number of days from intake in the program to the first day a reduction was reported of at least 15 points on the PTSD Checklist for DSM-5 (PCL-5), which was indicative of a clinically meaningful improvement.
Results showed representing greater ongoing symptoms (P = .04).
The amount of time to reach the 15-point reduction also predicted symptom reductions at the 3-month follow-up, even when controlling for the total change in PCL-5 score during the program (P = .03) and when controlling for type of trauma, such as combat or military sexual trauma.
Another puzzle piece?
Commenting on the study, David C. Rozek, PhD, assistant professor at the University of Central Florida, Orlando, said the findings are encouraging, particularly in terms of improvements seen with shorter treatment programs.
“Sudden gains are important to look at in all treatments,” said Dr. Rozek, who was not involved with the research.
“Seeing that these sudden gains occur in intensive treatment and predict long-term outcome provides another piece of the puzzle and provides additional support to intensive treatments,” he added.
Dr. Rozek noted that he has also observed this with patients. However, they, along with mental health practitioners, often question whether short-term improvements will last.
“There is some concern that a rapid drop in a patient’s symptoms could be an increased risk for a rebound,” he said.
“However, that is when the skills learned in therapy can kick in and provide [patients] tools to use in their everyday life and to help continue recovering,” he added.
Dr. Rozek was scheduled to report results from a pilot study on his own experience at the canceled ADAA meeting. The study was about an even shorter, 7-day intensive CPT program (CPT-7) conducted through the National Center for Veterans Studies.
The program involved one daily individual CPT-7 session with a mental health provider in the morning followed by optional group recreational activities in the afternoon. Twelve military personnel in two cohorts with either PTSD or subthreshold PTSD, defined as having all but one symptom cluster present, were included in the study.
Keep patients engaged
Preliminary results showed reductions in PCL-5 scores from pre- to posttreatment of approximately 40% (P < .001).
“Just over 50% of patients left [the program] with symptoms below probable PTSD diagnosis on a self-report measure,” Dr. Rozek said.
Importantly, none of the participants dropped out of the treatment, but Dr. Rozek said that this was not necessarily surprising because of the nature of the program.
“These patients are brought in as a cohort and form some bonds, as they all have experienced traumatic events, although often [they have had] very different traumas,” he said.
“We’ve found that by doing daily treatment, it is more accessible and removes barriers, as it is often easier to take a week or a few weeks off at a time and participate in treatment than the logistics of weekly treatment,” he added.
Dr. Rozek said he suspects two key factors may predict treatment response in such programs – cognitive flexibility and emotion regulation.
“Patients who come into treatment and are extremely rigid in their thinking and are unable to manage their emotions may be slower to respond to treatment,” he noted.
“That being said, there are a variety of treatments that target these factors in different ways. Now we need to do the work to determine which treatments work for whom.”
The findings on longer-term durability of rapid improvement bode well for the program. “Although the work in treatment is hard, they patients really start to see the gains quickly, within a week or weeks instead of months,” Dr. Rozek said.
“This is rewarding in itself, and I would say is a strong factor for keeping patients engaged,” he concluded.
Dr. Rozek has received research funding from the National Institutes of Health, the Department of Defense, the Bob Woodruff Foundation, and the Boeing Corporation.
A version of this article originally appeared on Medscape.com.
Patients who experience a rapid response to cognitive processing therapy (CPT) for posttraumatic stress disorder have a greater likelihood of sustained improvement, new research suggests.
A study of 136 veterans with PTSD showed that those who responded quickly to a 3-week CPT program were significantly more likely to report lower symptom scores 3 months post treatment, compared with those participants who responded more slowly.
The results add to previous evidence that intensified, short-term treatment programs can accomplish long-term benefits, noted the investigators, led by Jenna Bagley, Rush University Medical Center, Chicago.
“These findings show promise for the success of condensed evidence-based, trauma-focused interventions,” they added.
Ms. Bagley was scheduled to present the study in March at the Anxiety and Depression Association of America (ADAA) Conference 2020. That conference was canceled because of the coronavirus pandemic.
Reducing high dropout rates
PTSD treatments such as CPT and prolonged exposure have been shown to have high efficacy, but they also have been shown to have a nearly 40% dropout rate, the researchers note.
This problem has prompted a focus on shorter-term interventions that can deliver intensified treatment before participants drop out. However, evidence has been lacking as to the sustainability of symptom improvements that occur in a short period.
The researchers evaluated data on 136 veterans (66% men; mean age, 41 years) with PTSD who completed a non–Veterans Affairs, 3-week CPT-based intensive treatment program. Follow-up assessments were carried out at 3 months.
Symptom reduction rates represented the number of days from intake in the program to the first day a reduction was reported of at least 15 points on the PTSD Checklist for DSM-5 (PCL-5), which was indicative of a clinically meaningful improvement.
Results showed representing greater ongoing symptoms (P = .04).
The amount of time to reach the 15-point reduction also predicted symptom reductions at the 3-month follow-up, even when controlling for the total change in PCL-5 score during the program (P = .03) and when controlling for type of trauma, such as combat or military sexual trauma.
Another puzzle piece?
Commenting on the study, David C. Rozek, PhD, assistant professor at the University of Central Florida, Orlando, said the findings are encouraging, particularly in terms of improvements seen with shorter treatment programs.
“Sudden gains are important to look at in all treatments,” said Dr. Rozek, who was not involved with the research.
“Seeing that these sudden gains occur in intensive treatment and predict long-term outcome provides another piece of the puzzle and provides additional support to intensive treatments,” he added.
Dr. Rozek noted that he has also observed this with patients. However, they, along with mental health practitioners, often question whether short-term improvements will last.
“There is some concern that a rapid drop in a patient’s symptoms could be an increased risk for a rebound,” he said.
“However, that is when the skills learned in therapy can kick in and provide [patients] tools to use in their everyday life and to help continue recovering,” he added.
Dr. Rozek was scheduled to report results from a pilot study on his own experience at the canceled ADAA meeting. The study was about an even shorter, 7-day intensive CPT program (CPT-7) conducted through the National Center for Veterans Studies.
The program involved one daily individual CPT-7 session with a mental health provider in the morning followed by optional group recreational activities in the afternoon. Twelve military personnel in two cohorts with either PTSD or subthreshold PTSD, defined as having all but one symptom cluster present, were included in the study.
Keep patients engaged
Preliminary results showed reductions in PCL-5 scores from pre- to posttreatment of approximately 40% (P < .001).
“Just over 50% of patients left [the program] with symptoms below probable PTSD diagnosis on a self-report measure,” Dr. Rozek said.
Importantly, none of the participants dropped out of the treatment, but Dr. Rozek said that this was not necessarily surprising because of the nature of the program.
“These patients are brought in as a cohort and form some bonds, as they all have experienced traumatic events, although often [they have had] very different traumas,” he said.
“We’ve found that by doing daily treatment, it is more accessible and removes barriers, as it is often easier to take a week or a few weeks off at a time and participate in treatment than the logistics of weekly treatment,” he added.
Dr. Rozek said he suspects two key factors may predict treatment response in such programs – cognitive flexibility and emotion regulation.
“Patients who come into treatment and are extremely rigid in their thinking and are unable to manage their emotions may be slower to respond to treatment,” he noted.
“That being said, there are a variety of treatments that target these factors in different ways. Now we need to do the work to determine which treatments work for whom.”
The findings on longer-term durability of rapid improvement bode well for the program. “Although the work in treatment is hard, they patients really start to see the gains quickly, within a week or weeks instead of months,” Dr. Rozek said.
“This is rewarding in itself, and I would say is a strong factor for keeping patients engaged,” he concluded.
Dr. Rozek has received research funding from the National Institutes of Health, the Department of Defense, the Bob Woodruff Foundation, and the Boeing Corporation.
A version of this article originally appeared on Medscape.com.
Patients who experience a rapid response to cognitive processing therapy (CPT) for posttraumatic stress disorder have a greater likelihood of sustained improvement, new research suggests.
A study of 136 veterans with PTSD showed that those who responded quickly to a 3-week CPT program were significantly more likely to report lower symptom scores 3 months post treatment, compared with those participants who responded more slowly.
The results add to previous evidence that intensified, short-term treatment programs can accomplish long-term benefits, noted the investigators, led by Jenna Bagley, Rush University Medical Center, Chicago.
“These findings show promise for the success of condensed evidence-based, trauma-focused interventions,” they added.
Ms. Bagley was scheduled to present the study in March at the Anxiety and Depression Association of America (ADAA) Conference 2020. That conference was canceled because of the coronavirus pandemic.
Reducing high dropout rates
PTSD treatments such as CPT and prolonged exposure have been shown to have high efficacy, but they also have been shown to have a nearly 40% dropout rate, the researchers note.
This problem has prompted a focus on shorter-term interventions that can deliver intensified treatment before participants drop out. However, evidence has been lacking as to the sustainability of symptom improvements that occur in a short period.
The researchers evaluated data on 136 veterans (66% men; mean age, 41 years) with PTSD who completed a non–Veterans Affairs, 3-week CPT-based intensive treatment program. Follow-up assessments were carried out at 3 months.
Symptom reduction rates represented the number of days from intake in the program to the first day a reduction was reported of at least 15 points on the PTSD Checklist for DSM-5 (PCL-5), which was indicative of a clinically meaningful improvement.
Results showed representing greater ongoing symptoms (P = .04).
The amount of time to reach the 15-point reduction also predicted symptom reductions at the 3-month follow-up, even when controlling for the total change in PCL-5 score during the program (P = .03) and when controlling for type of trauma, such as combat or military sexual trauma.
Another puzzle piece?
Commenting on the study, David C. Rozek, PhD, assistant professor at the University of Central Florida, Orlando, said the findings are encouraging, particularly in terms of improvements seen with shorter treatment programs.
“Sudden gains are important to look at in all treatments,” said Dr. Rozek, who was not involved with the research.
“Seeing that these sudden gains occur in intensive treatment and predict long-term outcome provides another piece of the puzzle and provides additional support to intensive treatments,” he added.
Dr. Rozek noted that he has also observed this with patients. However, they, along with mental health practitioners, often question whether short-term improvements will last.
“There is some concern that a rapid drop in a patient’s symptoms could be an increased risk for a rebound,” he said.
“However, that is when the skills learned in therapy can kick in and provide [patients] tools to use in their everyday life and to help continue recovering,” he added.
Dr. Rozek was scheduled to report results from a pilot study on his own experience at the canceled ADAA meeting. The study was about an even shorter, 7-day intensive CPT program (CPT-7) conducted through the National Center for Veterans Studies.
The program involved one daily individual CPT-7 session with a mental health provider in the morning followed by optional group recreational activities in the afternoon. Twelve military personnel in two cohorts with either PTSD or subthreshold PTSD, defined as having all but one symptom cluster present, were included in the study.
Keep patients engaged
Preliminary results showed reductions in PCL-5 scores from pre- to posttreatment of approximately 40% (P < .001).
“Just over 50% of patients left [the program] with symptoms below probable PTSD diagnosis on a self-report measure,” Dr. Rozek said.
Importantly, none of the participants dropped out of the treatment, but Dr. Rozek said that this was not necessarily surprising because of the nature of the program.
“These patients are brought in as a cohort and form some bonds, as they all have experienced traumatic events, although often [they have had] very different traumas,” he said.
“We’ve found that by doing daily treatment, it is more accessible and removes barriers, as it is often easier to take a week or a few weeks off at a time and participate in treatment than the logistics of weekly treatment,” he added.
Dr. Rozek said he suspects two key factors may predict treatment response in such programs – cognitive flexibility and emotion regulation.
“Patients who come into treatment and are extremely rigid in their thinking and are unable to manage their emotions may be slower to respond to treatment,” he noted.
“That being said, there are a variety of treatments that target these factors in different ways. Now we need to do the work to determine which treatments work for whom.”
The findings on longer-term durability of rapid improvement bode well for the program. “Although the work in treatment is hard, they patients really start to see the gains quickly, within a week or weeks instead of months,” Dr. Rozek said.
“This is rewarding in itself, and I would say is a strong factor for keeping patients engaged,” he concluded.
Dr. Rozek has received research funding from the National Institutes of Health, the Department of Defense, the Bob Woodruff Foundation, and the Boeing Corporation.
A version of this article originally appeared on Medscape.com.
IV esketamine, ketamine equally effective for resistant depression
Intravenous (IV) esketamine is as safe and effective as IV ketamine for patients with treatment-resistant depression, new research suggests.
“Our study was the first randomized clinical trial directly comparing ketamine and esketamine in treatment-resistant depression,” senior investigator Lucas C. Quarantini, MD, PhD, division of psychiatry, Professor Edgard Santos University Hospital, Federal University of Bahia, Salvador, Brazil, said in an interview.
The findings showed that esketamine was not inferior to ketamine in remission of depressive symptoms 24 hours after a single IV dose, and the two treatments had similar side effect profiles, Dr. Quarantini said.
Furthermore, “our results showed that only the number of treatment failures was an important factor for the remission of symptoms,” he added.
The findings were scheduled to be presented at the Anxiety and Depression Association of America (ADAA) Conference 2020, along with publication in the Journal of Affective Disorders (2020 Mar 1;264:527-34). However, the ADAA conference was canceled in the wake of the coronavirus pandemic.
More treatment options
The randomized, double-blind noninferiority trial compared IV racemic ketamine and esketamine, two formulations of the glutamate NMDA receptor modulator drug. It included 63 participants (61.9% women; mean age, 47 years) with treatment-resistant major depressive disorder, as determined by DSM-5 criteria.
Participants were enrolled between March 2017 and June 2018 and randomized to receive a single subanesthetic dose of racemic ketamine (0.5 mg/kg; n = 29) or esketamine (0.25 mg/kg; n = 34) for 40 minutes.
Results showed esketamine to be noninferior to ketamine as determined by the Montgomery-Åsberg Depression Rating Scale (MADRS).
The difference of just 5.3% confirmed noninferiority.
Although ketamine showed a tendency to have a longer-lasting antidepressant effect compared with esketamine, the difference did not reach statistical significance and should be evaluated in future studies, the investigators noted.
Both treatments were safe and well tolerated. Consistent with previous studies, the most frequent side effects were dissociative symptoms, including derealization, depersonalization, and cardiovascular changes, and increased blood pressure and heart rate, which occurred equally in both groups. There were no serious adverse events in either study group.
The investigators noted that most of the previous research examining antidepressant effects of ketamine has used the IV racemic type. The current findings are particularly important for situations in which ketamine or intranasal esketamine, which was recently approved by the Food and Drug Administration, are unavailable, Dr. Quarantini said.
“What our study adds to what has been previously published is that the only way to really analyze if two drugs are equivalent is to compare them in a head-to-head trial; and that was what we did,” he said.
“Our findings bring a greater basis for practitioners from locations where intravenous esketamine is more easily obtainable than ketamine to use it as an affordable option for treating depressive patients,” Dr. Quarantini added.
“Since this [lack of availability] is the scenario here in Brazil, and probably in many other countries, all patients from these locations will benefit from this finding,” he said.
While further evaluating the study results to determine which clinical characteristics were predictive of remission of depressive symptoms, the researchers assessed several key factors. The median duration of disease progression was 12 months, median number of depressive episodes was five, and median number of therapeutic treatment failures was three.
The investigators also looked at the number of suicide attempts and degree of dissociative behavior.
Of these factors, the number of therapeutic failures was the only significant predictor of symptom remission, with an odds ratio of 1.46 for each prior therapeutic failure (95% CI, 1.08-1.99).
“To date, we have not found [other] studies with similar data,” Dr. Quarantini noted.
“Identifying remission predictors may contribute to selecting more suitable candidates for the intervention and result in more individualized and effective patient management,” the investigators wrote.
Consistent findings
Commenting on the findings, Gerard Sanacora, MD, PhD, professor of psychiatry at Yale University, New Haven, Conn., noted that key study limitations include the small sample size and lack of a placebo group.
Nevertheless, “I think it is fair to say that it is unlikely that the treatments are markedly different in their effects on depression over 24 hours,” he said in an interview.
Dr. Sanacora, director of the Yale Depression Research Program, was not involved with the current research.
The findings are “consistent with what we can extrapolate from other clinical trials examining racemic ketamine and esketamine separately,” he said.
Dr. Sanacora noted that because esketamine has been previously shown to be a more potent anesthetic than arketamine, the other component of racemic ketamine, it is “the primary form of ketamine used as an anesthetic agent in several regions of the world with the idea that it may be more selective for the desired anesthetic effect.”
Even with its limitations, the study does offer some notable yet preliminary insights, he added.
“It is interesting to see varying degrees of numerical differences between the two treatments at different time points,” Dr. Sanacora said. In addition, “there may be some differing effects between the two treatments over time, but we really do not have enough data to say much of anything [about that] with confidence at this point.”
The study was supported by the Programa de Pesquisa para o SUS through Fundação de Amparo à Pesquisa do Estado da Bahia. Dr. Quarantini has reported receiving consulting fees from Allergan, Abbott, Janssen Pharmaceuticals, and Lundbeck, and research fees from Janssen Pharmaceuticals. The other study authors’ disclosures are listed in the published article. Dr. Sanacora has reported consulting and/or conducting research from several pharmaceutical companies. He also holds shares in BioHaven Pharmaceuticals and is coinventor on a patent called “Glutamate Agents in the Treatment of Mental Disorders.”
A version of this article originally appeared on Medscape.com.
Intravenous (IV) esketamine is as safe and effective as IV ketamine for patients with treatment-resistant depression, new research suggests.
“Our study was the first randomized clinical trial directly comparing ketamine and esketamine in treatment-resistant depression,” senior investigator Lucas C. Quarantini, MD, PhD, division of psychiatry, Professor Edgard Santos University Hospital, Federal University of Bahia, Salvador, Brazil, said in an interview.
The findings showed that esketamine was not inferior to ketamine in remission of depressive symptoms 24 hours after a single IV dose, and the two treatments had similar side effect profiles, Dr. Quarantini said.
Furthermore, “our results showed that only the number of treatment failures was an important factor for the remission of symptoms,” he added.
The findings were scheduled to be presented at the Anxiety and Depression Association of America (ADAA) Conference 2020, along with publication in the Journal of Affective Disorders (2020 Mar 1;264:527-34). However, the ADAA conference was canceled in the wake of the coronavirus pandemic.
More treatment options
The randomized, double-blind noninferiority trial compared IV racemic ketamine and esketamine, two formulations of the glutamate NMDA receptor modulator drug. It included 63 participants (61.9% women; mean age, 47 years) with treatment-resistant major depressive disorder, as determined by DSM-5 criteria.
Participants were enrolled between March 2017 and June 2018 and randomized to receive a single subanesthetic dose of racemic ketamine (0.5 mg/kg; n = 29) or esketamine (0.25 mg/kg; n = 34) for 40 minutes.
Results showed esketamine to be noninferior to ketamine as determined by the Montgomery-Åsberg Depression Rating Scale (MADRS).
The difference of just 5.3% confirmed noninferiority.
Although ketamine showed a tendency to have a longer-lasting antidepressant effect compared with esketamine, the difference did not reach statistical significance and should be evaluated in future studies, the investigators noted.
Both treatments were safe and well tolerated. Consistent with previous studies, the most frequent side effects were dissociative symptoms, including derealization, depersonalization, and cardiovascular changes, and increased blood pressure and heart rate, which occurred equally in both groups. There were no serious adverse events in either study group.
The investigators noted that most of the previous research examining antidepressant effects of ketamine has used the IV racemic type. The current findings are particularly important for situations in which ketamine or intranasal esketamine, which was recently approved by the Food and Drug Administration, are unavailable, Dr. Quarantini said.
“What our study adds to what has been previously published is that the only way to really analyze if two drugs are equivalent is to compare them in a head-to-head trial; and that was what we did,” he said.
“Our findings bring a greater basis for practitioners from locations where intravenous esketamine is more easily obtainable than ketamine to use it as an affordable option for treating depressive patients,” Dr. Quarantini added.
“Since this [lack of availability] is the scenario here in Brazil, and probably in many other countries, all patients from these locations will benefit from this finding,” he said.
While further evaluating the study results to determine which clinical characteristics were predictive of remission of depressive symptoms, the researchers assessed several key factors. The median duration of disease progression was 12 months, median number of depressive episodes was five, and median number of therapeutic treatment failures was three.
The investigators also looked at the number of suicide attempts and degree of dissociative behavior.
Of these factors, the number of therapeutic failures was the only significant predictor of symptom remission, with an odds ratio of 1.46 for each prior therapeutic failure (95% CI, 1.08-1.99).
“To date, we have not found [other] studies with similar data,” Dr. Quarantini noted.
“Identifying remission predictors may contribute to selecting more suitable candidates for the intervention and result in more individualized and effective patient management,” the investigators wrote.
Consistent findings
Commenting on the findings, Gerard Sanacora, MD, PhD, professor of psychiatry at Yale University, New Haven, Conn., noted that key study limitations include the small sample size and lack of a placebo group.
Nevertheless, “I think it is fair to say that it is unlikely that the treatments are markedly different in their effects on depression over 24 hours,” he said in an interview.
Dr. Sanacora, director of the Yale Depression Research Program, was not involved with the current research.
The findings are “consistent with what we can extrapolate from other clinical trials examining racemic ketamine and esketamine separately,” he said.
Dr. Sanacora noted that because esketamine has been previously shown to be a more potent anesthetic than arketamine, the other component of racemic ketamine, it is “the primary form of ketamine used as an anesthetic agent in several regions of the world with the idea that it may be more selective for the desired anesthetic effect.”
Even with its limitations, the study does offer some notable yet preliminary insights, he added.
“It is interesting to see varying degrees of numerical differences between the two treatments at different time points,” Dr. Sanacora said. In addition, “there may be some differing effects between the two treatments over time, but we really do not have enough data to say much of anything [about that] with confidence at this point.”
The study was supported by the Programa de Pesquisa para o SUS through Fundação de Amparo à Pesquisa do Estado da Bahia. Dr. Quarantini has reported receiving consulting fees from Allergan, Abbott, Janssen Pharmaceuticals, and Lundbeck, and research fees from Janssen Pharmaceuticals. The other study authors’ disclosures are listed in the published article. Dr. Sanacora has reported consulting and/or conducting research from several pharmaceutical companies. He also holds shares in BioHaven Pharmaceuticals and is coinventor on a patent called “Glutamate Agents in the Treatment of Mental Disorders.”
A version of this article originally appeared on Medscape.com.
Intravenous (IV) esketamine is as safe and effective as IV ketamine for patients with treatment-resistant depression, new research suggests.
“Our study was the first randomized clinical trial directly comparing ketamine and esketamine in treatment-resistant depression,” senior investigator Lucas C. Quarantini, MD, PhD, division of psychiatry, Professor Edgard Santos University Hospital, Federal University of Bahia, Salvador, Brazil, said in an interview.
The findings showed that esketamine was not inferior to ketamine in remission of depressive symptoms 24 hours after a single IV dose, and the two treatments had similar side effect profiles, Dr. Quarantini said.
Furthermore, “our results showed that only the number of treatment failures was an important factor for the remission of symptoms,” he added.
The findings were scheduled to be presented at the Anxiety and Depression Association of America (ADAA) Conference 2020, along with publication in the Journal of Affective Disorders (2020 Mar 1;264:527-34). However, the ADAA conference was canceled in the wake of the coronavirus pandemic.
More treatment options
The randomized, double-blind noninferiority trial compared IV racemic ketamine and esketamine, two formulations of the glutamate NMDA receptor modulator drug. It included 63 participants (61.9% women; mean age, 47 years) with treatment-resistant major depressive disorder, as determined by DSM-5 criteria.
Participants were enrolled between March 2017 and June 2018 and randomized to receive a single subanesthetic dose of racemic ketamine (0.5 mg/kg; n = 29) or esketamine (0.25 mg/kg; n = 34) for 40 minutes.
Results showed esketamine to be noninferior to ketamine as determined by the Montgomery-Åsberg Depression Rating Scale (MADRS).
The difference of just 5.3% confirmed noninferiority.
Although ketamine showed a tendency to have a longer-lasting antidepressant effect compared with esketamine, the difference did not reach statistical significance and should be evaluated in future studies, the investigators noted.
Both treatments were safe and well tolerated. Consistent with previous studies, the most frequent side effects were dissociative symptoms, including derealization, depersonalization, and cardiovascular changes, and increased blood pressure and heart rate, which occurred equally in both groups. There were no serious adverse events in either study group.
The investigators noted that most of the previous research examining antidepressant effects of ketamine has used the IV racemic type. The current findings are particularly important for situations in which ketamine or intranasal esketamine, which was recently approved by the Food and Drug Administration, are unavailable, Dr. Quarantini said.
“What our study adds to what has been previously published is that the only way to really analyze if two drugs are equivalent is to compare them in a head-to-head trial; and that was what we did,” he said.
“Our findings bring a greater basis for practitioners from locations where intravenous esketamine is more easily obtainable than ketamine to use it as an affordable option for treating depressive patients,” Dr. Quarantini added.
“Since this [lack of availability] is the scenario here in Brazil, and probably in many other countries, all patients from these locations will benefit from this finding,” he said.
While further evaluating the study results to determine which clinical characteristics were predictive of remission of depressive symptoms, the researchers assessed several key factors. The median duration of disease progression was 12 months, median number of depressive episodes was five, and median number of therapeutic treatment failures was three.
The investigators also looked at the number of suicide attempts and degree of dissociative behavior.
Of these factors, the number of therapeutic failures was the only significant predictor of symptom remission, with an odds ratio of 1.46 for each prior therapeutic failure (95% CI, 1.08-1.99).
“To date, we have not found [other] studies with similar data,” Dr. Quarantini noted.
“Identifying remission predictors may contribute to selecting more suitable candidates for the intervention and result in more individualized and effective patient management,” the investigators wrote.
Consistent findings
Commenting on the findings, Gerard Sanacora, MD, PhD, professor of psychiatry at Yale University, New Haven, Conn., noted that key study limitations include the small sample size and lack of a placebo group.
Nevertheless, “I think it is fair to say that it is unlikely that the treatments are markedly different in their effects on depression over 24 hours,” he said in an interview.
Dr. Sanacora, director of the Yale Depression Research Program, was not involved with the current research.
The findings are “consistent with what we can extrapolate from other clinical trials examining racemic ketamine and esketamine separately,” he said.
Dr. Sanacora noted that because esketamine has been previously shown to be a more potent anesthetic than arketamine, the other component of racemic ketamine, it is “the primary form of ketamine used as an anesthetic agent in several regions of the world with the idea that it may be more selective for the desired anesthetic effect.”
Even with its limitations, the study does offer some notable yet preliminary insights, he added.
“It is interesting to see varying degrees of numerical differences between the two treatments at different time points,” Dr. Sanacora said. In addition, “there may be some differing effects between the two treatments over time, but we really do not have enough data to say much of anything [about that] with confidence at this point.”
The study was supported by the Programa de Pesquisa para o SUS through Fundação de Amparo à Pesquisa do Estado da Bahia. Dr. Quarantini has reported receiving consulting fees from Allergan, Abbott, Janssen Pharmaceuticals, and Lundbeck, and research fees from Janssen Pharmaceuticals. The other study authors’ disclosures are listed in the published article. Dr. Sanacora has reported consulting and/or conducting research from several pharmaceutical companies. He also holds shares in BioHaven Pharmaceuticals and is coinventor on a patent called “Glutamate Agents in the Treatment of Mental Disorders.”
A version of this article originally appeared on Medscape.com.
First guidelines to address thyroid disease surgery
offering evidence-based recommendations on the wide-ranging aspects of thyroidectomy and the management of benign, as well as malignant, thyroid nodules and cancer.
Whereas various endocrine and thyroid societies issue guidelines on many aspects of the management of thyroid disease, the new AAES guidelines are the first specifically to address surgical management of thyroid disease in adults.
“These guidelines truly focus on the surgical decision-making and management of thyroid disease. However, there is something for all clinicians who take care of patients with thyroid disease,” lead author Kepal N. Patel, MD, of NYU Langone Health in New York City, said in an interview.
The guidelines, published in the Annals of Surgery, include a total of 66 recommendations from a multidisciplinary panel of 19 experts who reviewed medical literature spanning 1985-2018.
More than 100,000 thyroidectomies are performed each year in the United States alone, and as surgical indications and treatment paradigms evolve, the need for surgical guidance is more important than ever, Dr. Patel said.
“Such transformations have propagated differences in clinical interpretation and management, and as a result, clinical uncertainty, and even controversy, have emerged,” he said. “Recognizing the importance of these changes, the AAES determined that evidence-based clinical guidelines were necessary to enhance the safe and effective surgical treatment of benign and malignant thyroid disease.”
Key areas addressed in the guidelines include the addition of new cytologic and pathologic diagnostic criteria, molecular profiling tests, operative techniques, and adjuncts, as well as the nuances surrounding the sometimes challenging newer concept of “borderline” thyroid tumors, Dr. Patel noted.
In terms of imaging recommendations, for instance, the guidelines recommend the preoperative use of computed tomography or magnetic resonance imaging, as stated in Recommendation 6: “CT or MRI with intravenous contrast should be used preoperatively as an adjunct to ultrasound in selected patients with clinical suspicion for advanced locoregional thyroid cancer.” The recommendation is cited as being “strong,” with a “low quality of evidence.”
Further diagnostic recommendations cover issues that include voice assessment, the risk for vocal fold dysfunction related to thyroid disease and surgery, and the use of fine-needle aspiration biopsy in evaluating suspicious thyroid nodules and lymph nodes.
The guidelines also address the indications for thyroidectomy, with recommendations regarding the extent and outcomes of surgery spanning different categories of thyroid disease. A key recommendation along those lines, for instance, indicates that, when possible, thyroidectomy should be performed by surgeons who perform a high volume of such procedures.
Approaches for safe and effective perioperative management are also covered, and include measures to prevent complications and the use of thyroid tissue diagnosis during surgery, such as core-needle biopsy of the thyroid and cervical lymph nodes, and incisional biopsy of the thyroid, nodal dissection, and concurrent parathyroidectomy.
Other recommendations address the optimal management of thyroid cancer, with an emphasis on a personalized, evidence-based approach tailored to the patient’s situation and preferences.
The authors underscored that, as technology rapidly evolves, “in the future, this work will certainly and rightly need to be done again.” In the meantime, they wrote, recommendations should be relevant to “the target audience [of] the practicing surgeon in a community hospital, academic center, or training program.”
An AAES press release noted that “the members of the expert panel hope their efforts will meet the need for evidence-based recommendations to ‘define practice, personalize care, stratify risk, reduce health care costs, improve outcomes, and identify rational challenges for future efforts.’ ”
The authors of the guidelines reported no conflicts of interest in regard to the guidelines, although the article lists disclosures for six authors.
This article first appeared on Medscape.com.
offering evidence-based recommendations on the wide-ranging aspects of thyroidectomy and the management of benign, as well as malignant, thyroid nodules and cancer.
Whereas various endocrine and thyroid societies issue guidelines on many aspects of the management of thyroid disease, the new AAES guidelines are the first specifically to address surgical management of thyroid disease in adults.
“These guidelines truly focus on the surgical decision-making and management of thyroid disease. However, there is something for all clinicians who take care of patients with thyroid disease,” lead author Kepal N. Patel, MD, of NYU Langone Health in New York City, said in an interview.
The guidelines, published in the Annals of Surgery, include a total of 66 recommendations from a multidisciplinary panel of 19 experts who reviewed medical literature spanning 1985-2018.
More than 100,000 thyroidectomies are performed each year in the United States alone, and as surgical indications and treatment paradigms evolve, the need for surgical guidance is more important than ever, Dr. Patel said.
“Such transformations have propagated differences in clinical interpretation and management, and as a result, clinical uncertainty, and even controversy, have emerged,” he said. “Recognizing the importance of these changes, the AAES determined that evidence-based clinical guidelines were necessary to enhance the safe and effective surgical treatment of benign and malignant thyroid disease.”
Key areas addressed in the guidelines include the addition of new cytologic and pathologic diagnostic criteria, molecular profiling tests, operative techniques, and adjuncts, as well as the nuances surrounding the sometimes challenging newer concept of “borderline” thyroid tumors, Dr. Patel noted.
In terms of imaging recommendations, for instance, the guidelines recommend the preoperative use of computed tomography or magnetic resonance imaging, as stated in Recommendation 6: “CT or MRI with intravenous contrast should be used preoperatively as an adjunct to ultrasound in selected patients with clinical suspicion for advanced locoregional thyroid cancer.” The recommendation is cited as being “strong,” with a “low quality of evidence.”
Further diagnostic recommendations cover issues that include voice assessment, the risk for vocal fold dysfunction related to thyroid disease and surgery, and the use of fine-needle aspiration biopsy in evaluating suspicious thyroid nodules and lymph nodes.
The guidelines also address the indications for thyroidectomy, with recommendations regarding the extent and outcomes of surgery spanning different categories of thyroid disease. A key recommendation along those lines, for instance, indicates that, when possible, thyroidectomy should be performed by surgeons who perform a high volume of such procedures.
Approaches for safe and effective perioperative management are also covered, and include measures to prevent complications and the use of thyroid tissue diagnosis during surgery, such as core-needle biopsy of the thyroid and cervical lymph nodes, and incisional biopsy of the thyroid, nodal dissection, and concurrent parathyroidectomy.
Other recommendations address the optimal management of thyroid cancer, with an emphasis on a personalized, evidence-based approach tailored to the patient’s situation and preferences.
The authors underscored that, as technology rapidly evolves, “in the future, this work will certainly and rightly need to be done again.” In the meantime, they wrote, recommendations should be relevant to “the target audience [of] the practicing surgeon in a community hospital, academic center, or training program.”
An AAES press release noted that “the members of the expert panel hope their efforts will meet the need for evidence-based recommendations to ‘define practice, personalize care, stratify risk, reduce health care costs, improve outcomes, and identify rational challenges for future efforts.’ ”
The authors of the guidelines reported no conflicts of interest in regard to the guidelines, although the article lists disclosures for six authors.
This article first appeared on Medscape.com.
offering evidence-based recommendations on the wide-ranging aspects of thyroidectomy and the management of benign, as well as malignant, thyroid nodules and cancer.
Whereas various endocrine and thyroid societies issue guidelines on many aspects of the management of thyroid disease, the new AAES guidelines are the first specifically to address surgical management of thyroid disease in adults.
“These guidelines truly focus on the surgical decision-making and management of thyroid disease. However, there is something for all clinicians who take care of patients with thyroid disease,” lead author Kepal N. Patel, MD, of NYU Langone Health in New York City, said in an interview.
The guidelines, published in the Annals of Surgery, include a total of 66 recommendations from a multidisciplinary panel of 19 experts who reviewed medical literature spanning 1985-2018.
More than 100,000 thyroidectomies are performed each year in the United States alone, and as surgical indications and treatment paradigms evolve, the need for surgical guidance is more important than ever, Dr. Patel said.
“Such transformations have propagated differences in clinical interpretation and management, and as a result, clinical uncertainty, and even controversy, have emerged,” he said. “Recognizing the importance of these changes, the AAES determined that evidence-based clinical guidelines were necessary to enhance the safe and effective surgical treatment of benign and malignant thyroid disease.”
Key areas addressed in the guidelines include the addition of new cytologic and pathologic diagnostic criteria, molecular profiling tests, operative techniques, and adjuncts, as well as the nuances surrounding the sometimes challenging newer concept of “borderline” thyroid tumors, Dr. Patel noted.
In terms of imaging recommendations, for instance, the guidelines recommend the preoperative use of computed tomography or magnetic resonance imaging, as stated in Recommendation 6: “CT or MRI with intravenous contrast should be used preoperatively as an adjunct to ultrasound in selected patients with clinical suspicion for advanced locoregional thyroid cancer.” The recommendation is cited as being “strong,” with a “low quality of evidence.”
Further diagnostic recommendations cover issues that include voice assessment, the risk for vocal fold dysfunction related to thyroid disease and surgery, and the use of fine-needle aspiration biopsy in evaluating suspicious thyroid nodules and lymph nodes.
The guidelines also address the indications for thyroidectomy, with recommendations regarding the extent and outcomes of surgery spanning different categories of thyroid disease. A key recommendation along those lines, for instance, indicates that, when possible, thyroidectomy should be performed by surgeons who perform a high volume of such procedures.
Approaches for safe and effective perioperative management are also covered, and include measures to prevent complications and the use of thyroid tissue diagnosis during surgery, such as core-needle biopsy of the thyroid and cervical lymph nodes, and incisional biopsy of the thyroid, nodal dissection, and concurrent parathyroidectomy.
Other recommendations address the optimal management of thyroid cancer, with an emphasis on a personalized, evidence-based approach tailored to the patient’s situation and preferences.
The authors underscored that, as technology rapidly evolves, “in the future, this work will certainly and rightly need to be done again.” In the meantime, they wrote, recommendations should be relevant to “the target audience [of] the practicing surgeon in a community hospital, academic center, or training program.”
An AAES press release noted that “the members of the expert panel hope their efforts will meet the need for evidence-based recommendations to ‘define practice, personalize care, stratify risk, reduce health care costs, improve outcomes, and identify rational challenges for future efforts.’ ”
The authors of the guidelines reported no conflicts of interest in regard to the guidelines, although the article lists disclosures for six authors.
This article first appeared on Medscape.com.
Shared medical appointments educate and encourage MS patients
WEST PALM BEACH, FLA. – according to a presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis.
“At first, this may sound to patients like an awkward concept – they may say, ‘Why would I want to have a medical appointment with other people?’ ” Mary R. Rensel, MD, who is the director of the program at the Mellen Center for Multiple Sclerosis, Cleveland Clinic Foundation, said. “But once they get there, it’s wonderful to see what happens – patients start to encourage each other and share resources, and it’s enjoyable for the patients and providers alike,” she said.
The main objective of the shared appointments concept was to increase education regarding comorbidity prevention and management of MS, however, importantly, if patients wish to discuss any issues privately, they are accommodated. In addition, family members, children, and caregivers are all welcome to attend. “Caregivers need support as well, so their participation is welcome,” Dr. Rensel said.
A significant benefit of the program is the extended time with providers – an hour and a half – which is a substantially longer period than patients and providers typically spend together, Dr. Rensel noted. “Medical visits are often so rushed, but this gives us much more time together, to learn more and talk about things like brain health,” she said.
With guidance from a multidisciplinary team including nurses, wellness providers, psychologists, and other experts, there are currently seven meeting themes that are rotated through the year, focusing on a variety of subjects. One, for instance, includes education from a nutritionist, and the center includes a kitchen for the group to learn about and try recipes. Other sessions include chair yoga, art therapy, guided imagery, and exercise physiology.
The Cleveland Clinic is a leader in the concept of SMA and offers it to as many as 360 disease states. With the pilot program now underway for more than 3 years, Dr. Rensel and her team conducted a study to investigate its effects.
For the study, the authors collected clinical data on 50 patients who had attended at least one session between January 2016 and June 2019. Among the patients, 94% were female, 80% had relapsing-remitting MS, and mean age was 50. Patients had a mean Determined Disease Steps (PDSS) score of 3.1 plus or minus 2.4 and the average 25-foot walk and nine-hole peg test (dominant hand) times were 9.4 plus or minus 7.8 seconds and 25.8 plus or minus 9.1 seconds, respectively.
The most common comorbidity was depression/anxiety, occurring in 44% of patients, however after participation in the shared medical appointment program, their mean Patient Health Questionnaire-9 scores, with higher scores indicative of worse depression, decreased from pretreatment scores of 7.3 plus or minus 5.5 to posttreatment scores of 5.1 plus or minus 5.6 (P = .001).
Notably, the program appears to have had a positive effect on patients’ use of health care services – while there was a significant decrease in the mean number of emergency room visits (n = 13 to n = 2; P = .0005), the results showed a favorable increase in mean number of follow-up visits with attendees’ primary care providers (n = 19 to n = 41; P = 3.47), physical therapists (n = 15 to n = 27; P = .004), or psychologists (n = 6 to n = 19; P = .003).
“The study was to evaluate the effect of the program after even just one appointment, and we found it really seemed to increase the use of more appropriate care, with less ER utilization and more visits to primary care,” Dr. Rensel said. The study even showed a small but significant reduction in pre- and postoutcome body mass index (BMI, 30.2 plus or minus 7.3 vs. 28.8 plus or minus 7.1; P = .03).
A critical metric that was not measured in the study – the effect of social interaction and camaraderie in a condition that can, for many, feel socially isolating – is clearly profound, Dr. Rensel said.
Amar Dhand, MD, associate professor of neurology at Brigham and Women’s Hospital, Harvard University, Boston, agreed that the peer support in such medical group settings can be highly valuable.
“Shared medical appointments offer an opportunity for peer-to-peer engagement, support, and education,” he said in an interview. “For many patients, this is a chance to bond with persons who are coexperiencing similar problems, allowing new social connections to emerge.”
Dr. Dhand, who spoke on the issue of the importance of social networks at the meeting, noted that, although there are numerous benefits with shared medical appointments, not all patients may respond well.
“Health care settings are one place to stimulate community among peers. This is one important ingredient of addressing social isolation,” he said. “However, there remain challenges such as sustainability of such relationships, paradoxical depression when persons see others with more severe disease, and infrastructure to support such programs.”
The findings from the study, however, do suggest favorable responses, he noted.
“I think, mechanistically, improved psychosocial outcomes are the most pertinent to the intervention,” Dr. Dhand said. “The health care utilization may be attributed to other factors and will need to be assessed in a case control design.”
Key benefits of the shared medical appointment concept
A recent article from Cleveland Clinic researchers reviewing the concept of shared medical appointments summarizes that the programs offer benefits based on nine key principles:
- Group exposure in shared medical appointments combats isolation, which in turn helps to remove doubts about one’s ability to manage illness.
- Patients learn about disease self-management vicariously by witnessing others’ illness experiences.
- Patients feel inspired by seeing others who are coping well.
- Group dynamics lead patients and providers to developing more equitable relationships.
- Providers feel increased appreciation and rapport toward colleagues leading to increased efficiency.
- Providers learn from the patients how better to meet their patients’ needs.
- Adequate time allotment of the SMA leads patients to feel supported.
- Patients receive professional expertise from the provider in combination with firsthand information from peers, resulting in more robust health knowledge.
- Patients have the opportunity to see how the physicians interact with fellow patients, which allows them to get to know the physician and better determine their level of trust.
The take-home message from the shared medical appointments concept is that “it may hit a quadruple aim,” Dr. Rensel said. “Access, cost, outcomes, and provider satisfaction.”
The Shared Medical Appointments program received a grant from Genzyme. Dr. Rensel reported consulting or advisory board relationships with Serono, Biogen, Teva, Genzyme, Novartis, and the National Multiple Sclerosis Society. Dr. Dhand had no disclosures to report.
WEST PALM BEACH, FLA. – according to a presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis.
“At first, this may sound to patients like an awkward concept – they may say, ‘Why would I want to have a medical appointment with other people?’ ” Mary R. Rensel, MD, who is the director of the program at the Mellen Center for Multiple Sclerosis, Cleveland Clinic Foundation, said. “But once they get there, it’s wonderful to see what happens – patients start to encourage each other and share resources, and it’s enjoyable for the patients and providers alike,” she said.
The main objective of the shared appointments concept was to increase education regarding comorbidity prevention and management of MS, however, importantly, if patients wish to discuss any issues privately, they are accommodated. In addition, family members, children, and caregivers are all welcome to attend. “Caregivers need support as well, so their participation is welcome,” Dr. Rensel said.
A significant benefit of the program is the extended time with providers – an hour and a half – which is a substantially longer period than patients and providers typically spend together, Dr. Rensel noted. “Medical visits are often so rushed, but this gives us much more time together, to learn more and talk about things like brain health,” she said.
With guidance from a multidisciplinary team including nurses, wellness providers, psychologists, and other experts, there are currently seven meeting themes that are rotated through the year, focusing on a variety of subjects. One, for instance, includes education from a nutritionist, and the center includes a kitchen for the group to learn about and try recipes. Other sessions include chair yoga, art therapy, guided imagery, and exercise physiology.
The Cleveland Clinic is a leader in the concept of SMA and offers it to as many as 360 disease states. With the pilot program now underway for more than 3 years, Dr. Rensel and her team conducted a study to investigate its effects.
For the study, the authors collected clinical data on 50 patients who had attended at least one session between January 2016 and June 2019. Among the patients, 94% were female, 80% had relapsing-remitting MS, and mean age was 50. Patients had a mean Determined Disease Steps (PDSS) score of 3.1 plus or minus 2.4 and the average 25-foot walk and nine-hole peg test (dominant hand) times were 9.4 plus or minus 7.8 seconds and 25.8 plus or minus 9.1 seconds, respectively.
The most common comorbidity was depression/anxiety, occurring in 44% of patients, however after participation in the shared medical appointment program, their mean Patient Health Questionnaire-9 scores, with higher scores indicative of worse depression, decreased from pretreatment scores of 7.3 plus or minus 5.5 to posttreatment scores of 5.1 plus or minus 5.6 (P = .001).
Notably, the program appears to have had a positive effect on patients’ use of health care services – while there was a significant decrease in the mean number of emergency room visits (n = 13 to n = 2; P = .0005), the results showed a favorable increase in mean number of follow-up visits with attendees’ primary care providers (n = 19 to n = 41; P = 3.47), physical therapists (n = 15 to n = 27; P = .004), or psychologists (n = 6 to n = 19; P = .003).
“The study was to evaluate the effect of the program after even just one appointment, and we found it really seemed to increase the use of more appropriate care, with less ER utilization and more visits to primary care,” Dr. Rensel said. The study even showed a small but significant reduction in pre- and postoutcome body mass index (BMI, 30.2 plus or minus 7.3 vs. 28.8 plus or minus 7.1; P = .03).
A critical metric that was not measured in the study – the effect of social interaction and camaraderie in a condition that can, for many, feel socially isolating – is clearly profound, Dr. Rensel said.
Amar Dhand, MD, associate professor of neurology at Brigham and Women’s Hospital, Harvard University, Boston, agreed that the peer support in such medical group settings can be highly valuable.
“Shared medical appointments offer an opportunity for peer-to-peer engagement, support, and education,” he said in an interview. “For many patients, this is a chance to bond with persons who are coexperiencing similar problems, allowing new social connections to emerge.”
Dr. Dhand, who spoke on the issue of the importance of social networks at the meeting, noted that, although there are numerous benefits with shared medical appointments, not all patients may respond well.
“Health care settings are one place to stimulate community among peers. This is one important ingredient of addressing social isolation,” he said. “However, there remain challenges such as sustainability of such relationships, paradoxical depression when persons see others with more severe disease, and infrastructure to support such programs.”
The findings from the study, however, do suggest favorable responses, he noted.
“I think, mechanistically, improved psychosocial outcomes are the most pertinent to the intervention,” Dr. Dhand said. “The health care utilization may be attributed to other factors and will need to be assessed in a case control design.”
Key benefits of the shared medical appointment concept
A recent article from Cleveland Clinic researchers reviewing the concept of shared medical appointments summarizes that the programs offer benefits based on nine key principles:
- Group exposure in shared medical appointments combats isolation, which in turn helps to remove doubts about one’s ability to manage illness.
- Patients learn about disease self-management vicariously by witnessing others’ illness experiences.
- Patients feel inspired by seeing others who are coping well.
- Group dynamics lead patients and providers to developing more equitable relationships.
- Providers feel increased appreciation and rapport toward colleagues leading to increased efficiency.
- Providers learn from the patients how better to meet their patients’ needs.
- Adequate time allotment of the SMA leads patients to feel supported.
- Patients receive professional expertise from the provider in combination with firsthand information from peers, resulting in more robust health knowledge.
- Patients have the opportunity to see how the physicians interact with fellow patients, which allows them to get to know the physician and better determine their level of trust.
The take-home message from the shared medical appointments concept is that “it may hit a quadruple aim,” Dr. Rensel said. “Access, cost, outcomes, and provider satisfaction.”
The Shared Medical Appointments program received a grant from Genzyme. Dr. Rensel reported consulting or advisory board relationships with Serono, Biogen, Teva, Genzyme, Novartis, and the National Multiple Sclerosis Society. Dr. Dhand had no disclosures to report.
WEST PALM BEACH, FLA. – according to a presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis.
“At first, this may sound to patients like an awkward concept – they may say, ‘Why would I want to have a medical appointment with other people?’ ” Mary R. Rensel, MD, who is the director of the program at the Mellen Center for Multiple Sclerosis, Cleveland Clinic Foundation, said. “But once they get there, it’s wonderful to see what happens – patients start to encourage each other and share resources, and it’s enjoyable for the patients and providers alike,” she said.
The main objective of the shared appointments concept was to increase education regarding comorbidity prevention and management of MS, however, importantly, if patients wish to discuss any issues privately, they are accommodated. In addition, family members, children, and caregivers are all welcome to attend. “Caregivers need support as well, so their participation is welcome,” Dr. Rensel said.
A significant benefit of the program is the extended time with providers – an hour and a half – which is a substantially longer period than patients and providers typically spend together, Dr. Rensel noted. “Medical visits are often so rushed, but this gives us much more time together, to learn more and talk about things like brain health,” she said.
With guidance from a multidisciplinary team including nurses, wellness providers, psychologists, and other experts, there are currently seven meeting themes that are rotated through the year, focusing on a variety of subjects. One, for instance, includes education from a nutritionist, and the center includes a kitchen for the group to learn about and try recipes. Other sessions include chair yoga, art therapy, guided imagery, and exercise physiology.
The Cleveland Clinic is a leader in the concept of SMA and offers it to as many as 360 disease states. With the pilot program now underway for more than 3 years, Dr. Rensel and her team conducted a study to investigate its effects.
For the study, the authors collected clinical data on 50 patients who had attended at least one session between January 2016 and June 2019. Among the patients, 94% were female, 80% had relapsing-remitting MS, and mean age was 50. Patients had a mean Determined Disease Steps (PDSS) score of 3.1 plus or minus 2.4 and the average 25-foot walk and nine-hole peg test (dominant hand) times were 9.4 plus or minus 7.8 seconds and 25.8 plus or minus 9.1 seconds, respectively.
The most common comorbidity was depression/anxiety, occurring in 44% of patients, however after participation in the shared medical appointment program, their mean Patient Health Questionnaire-9 scores, with higher scores indicative of worse depression, decreased from pretreatment scores of 7.3 plus or minus 5.5 to posttreatment scores of 5.1 plus or minus 5.6 (P = .001).
Notably, the program appears to have had a positive effect on patients’ use of health care services – while there was a significant decrease in the mean number of emergency room visits (n = 13 to n = 2; P = .0005), the results showed a favorable increase in mean number of follow-up visits with attendees’ primary care providers (n = 19 to n = 41; P = 3.47), physical therapists (n = 15 to n = 27; P = .004), or psychologists (n = 6 to n = 19; P = .003).
“The study was to evaluate the effect of the program after even just one appointment, and we found it really seemed to increase the use of more appropriate care, with less ER utilization and more visits to primary care,” Dr. Rensel said. The study even showed a small but significant reduction in pre- and postoutcome body mass index (BMI, 30.2 plus or minus 7.3 vs. 28.8 plus or minus 7.1; P = .03).
A critical metric that was not measured in the study – the effect of social interaction and camaraderie in a condition that can, for many, feel socially isolating – is clearly profound, Dr. Rensel said.
Amar Dhand, MD, associate professor of neurology at Brigham and Women’s Hospital, Harvard University, Boston, agreed that the peer support in such medical group settings can be highly valuable.
“Shared medical appointments offer an opportunity for peer-to-peer engagement, support, and education,” he said in an interview. “For many patients, this is a chance to bond with persons who are coexperiencing similar problems, allowing new social connections to emerge.”
Dr. Dhand, who spoke on the issue of the importance of social networks at the meeting, noted that, although there are numerous benefits with shared medical appointments, not all patients may respond well.
“Health care settings are one place to stimulate community among peers. This is one important ingredient of addressing social isolation,” he said. “However, there remain challenges such as sustainability of such relationships, paradoxical depression when persons see others with more severe disease, and infrastructure to support such programs.”
The findings from the study, however, do suggest favorable responses, he noted.
“I think, mechanistically, improved psychosocial outcomes are the most pertinent to the intervention,” Dr. Dhand said. “The health care utilization may be attributed to other factors and will need to be assessed in a case control design.”
Key benefits of the shared medical appointment concept
A recent article from Cleveland Clinic researchers reviewing the concept of shared medical appointments summarizes that the programs offer benefits based on nine key principles:
- Group exposure in shared medical appointments combats isolation, which in turn helps to remove doubts about one’s ability to manage illness.
- Patients learn about disease self-management vicariously by witnessing others’ illness experiences.
- Patients feel inspired by seeing others who are coping well.
- Group dynamics lead patients and providers to developing more equitable relationships.
- Providers feel increased appreciation and rapport toward colleagues leading to increased efficiency.
- Providers learn from the patients how better to meet their patients’ needs.
- Adequate time allotment of the SMA leads patients to feel supported.
- Patients receive professional expertise from the provider in combination with firsthand information from peers, resulting in more robust health knowledge.
- Patients have the opportunity to see how the physicians interact with fellow patients, which allows them to get to know the physician and better determine their level of trust.
The take-home message from the shared medical appointments concept is that “it may hit a quadruple aim,” Dr. Rensel said. “Access, cost, outcomes, and provider satisfaction.”
The Shared Medical Appointments program received a grant from Genzyme. Dr. Rensel reported consulting or advisory board relationships with Serono, Biogen, Teva, Genzyme, Novartis, and the National Multiple Sclerosis Society. Dr. Dhand had no disclosures to report.
REPORTING FROM ACTRIMS FORUM 2020
Incomplete MS relapse recovery predicted greater long-term disability
WEST PALM BEACH, FLA. – Failure to recover completely from early relapses in multiple sclerosis (MS) is significantly associated with higher long-term disability, according to research presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Incomplete recovery thus should be given more consideration when evaluating research and clinical practice outcomes, the study investigators cautioned.
“We found that the recovery from early relapses is an important predictor of future disability,” first author Marinos G. Sotiropoulos, MD, of the department of neurology, Brigham and Women’s Hospital, Boston, said in an interview. “It should be incorporated in future predictive models of disease severity and clinical trials, [and] it could be useful in clinical decision making as well.”
Incomplete recovery from relapses is known to be linked to disability progression and to the likelihood of transitioning to secondary progressive MS. Research on its role in longer-term outcomes is lacking, however.
To investigate the effect of incomplete relapse recovery in the first 3 years of MS on rates of disability at 10 years, Dr. Sotiropoulos and colleagues evaluated data on 360 patients enrolled in the CLIMB (Comprehensive Longitudinal Investigation in Multiple Sclerosis at Brigham and Women’s Hospital) study. CLIMB is a natural history study spanning 20 years, with more than 2,000 patients.
Patients were included if at least 8.5 years had passed since their first documented symptom, if they were at least 18 years at their first visit to the Partners MS Center, if that visit occurred within 1 year of their first symptom, and if they had a diagnosis of relapsing-remitting MS or secondary progressive MS.
Among the 308 patients included in the study, 74% were female and 89% were white, with a mean age at the first symptom of 35.9 years.
A total of 403 early attacks from those 308 patients were included in the study. Half of the attacks (50.4%) were followed by incomplete recovery after 6 months, defined specifically as an increase in the Expanded Disability Status Scale (EDSS) scores from baseline to at least 6 months after the onset of the attack.
As of their 10-year visit, 27.3% of patients had a normal examination, defined as EDSS 0, and 64.1% had no significant disability (EDSS less than 2). The mean EDSS at 10 years was 1.52.
Patients’ recovery index, defined as the percentage of early attacks that recovered completely, was significantly associated with 10-year EDSS scores (P less than .001).
Patient age at first symptom was also a significant predictor of 10-year disability (P less than .004). Factors that were significantly associated with incomplete relapse recovery were the duration of time from first symptom (P less than .001) and moderate severity of the relapse (P = .029).
With the type of drug treatment likely representing an important factor in whether a patient has incomplete relapse recovery, the issue should be the subject of further research, Dr. Sotiropoulos said.
“This is something that is important to look at because none of the clinical trials for the drugs we currently have looked at relapse recovery as an outcome,” he explained.
“There have been some post hoc analyses [that] have shown that some of the new medications can improve recovery from relapses, but there is a lot to look into now that we know relapse recovery is an important clinical parameter,” he said. “We have to factor in the treatment effect in preventing residual disability after relapses.”
The findings suggest that “patients with incomplete early recovery might be considered for highly effective disease-modifying therapy,” added senior author Tanuja Chitnis, MD, also of the department of neurology at Brigham and Women’s Hospital. “We are now analyzing the biological mechanisms associated with relapse recovery.”
The authors of a recent study that echoes the importance of relapse recovery call it “the forgotten variable in multiple sclerosis clinical trials.” In that study, the researchers found an increased likelihood of a benign disease course among patients who received immediate disease-modifying therapy (DMT) initiation after failing to have a good recovery from an initial relapse (Neurol Neuroimmunol Neuroinflamm. 2019 Dec 17;7[2]).
“Some clinicians may choose to hold off DMTs because the patient may not have high disease activity levels,” Burcu Zeydan, MD, a coauthor of that study and an assistant professor of radiology in the Center of MS and Autoimmune Neurology at the Mayo Clinic, Rochester, Minn., said in an interview.
“What these studies add is that, if a patient is a poor recoverer despite not having highly active disease, that patient should be considered for immediate treatment initiation,” she said. “Otherwise, there is the possibility of a next relapse, which may not happen often. But when it happens, it may lead to more residual deficit with additional disability burden.”
The CLIMB study received funding from Mallinckrodt and the National MS Society Nancy Davis Center Without Walls. Dr. Sotiropoulos has received research support from Mallinckrodt. Dr. Chitnis has served on advisory boards for Biogen, Novartis, and Sanofi-Genzyme, and she has received research support from the Department of Defense, National MS Society, Guthy-Jackson Charitable Foundation, Novartis, Octave, Serono, and Verily. Dr. Zeydan had no disclosures to report.
SOURCE: Sotiropoulos MG et al. ACTRIMS Forum 2020. Abstract LB 317.
WEST PALM BEACH, FLA. – Failure to recover completely from early relapses in multiple sclerosis (MS) is significantly associated with higher long-term disability, according to research presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Incomplete recovery thus should be given more consideration when evaluating research and clinical practice outcomes, the study investigators cautioned.
“We found that the recovery from early relapses is an important predictor of future disability,” first author Marinos G. Sotiropoulos, MD, of the department of neurology, Brigham and Women’s Hospital, Boston, said in an interview. “It should be incorporated in future predictive models of disease severity and clinical trials, [and] it could be useful in clinical decision making as well.”
Incomplete recovery from relapses is known to be linked to disability progression and to the likelihood of transitioning to secondary progressive MS. Research on its role in longer-term outcomes is lacking, however.
To investigate the effect of incomplete relapse recovery in the first 3 years of MS on rates of disability at 10 years, Dr. Sotiropoulos and colleagues evaluated data on 360 patients enrolled in the CLIMB (Comprehensive Longitudinal Investigation in Multiple Sclerosis at Brigham and Women’s Hospital) study. CLIMB is a natural history study spanning 20 years, with more than 2,000 patients.
Patients were included if at least 8.5 years had passed since their first documented symptom, if they were at least 18 years at their first visit to the Partners MS Center, if that visit occurred within 1 year of their first symptom, and if they had a diagnosis of relapsing-remitting MS or secondary progressive MS.
Among the 308 patients included in the study, 74% were female and 89% were white, with a mean age at the first symptom of 35.9 years.
A total of 403 early attacks from those 308 patients were included in the study. Half of the attacks (50.4%) were followed by incomplete recovery after 6 months, defined specifically as an increase in the Expanded Disability Status Scale (EDSS) scores from baseline to at least 6 months after the onset of the attack.
As of their 10-year visit, 27.3% of patients had a normal examination, defined as EDSS 0, and 64.1% had no significant disability (EDSS less than 2). The mean EDSS at 10 years was 1.52.
Patients’ recovery index, defined as the percentage of early attacks that recovered completely, was significantly associated with 10-year EDSS scores (P less than .001).
Patient age at first symptom was also a significant predictor of 10-year disability (P less than .004). Factors that were significantly associated with incomplete relapse recovery were the duration of time from first symptom (P less than .001) and moderate severity of the relapse (P = .029).
With the type of drug treatment likely representing an important factor in whether a patient has incomplete relapse recovery, the issue should be the subject of further research, Dr. Sotiropoulos said.
“This is something that is important to look at because none of the clinical trials for the drugs we currently have looked at relapse recovery as an outcome,” he explained.
“There have been some post hoc analyses [that] have shown that some of the new medications can improve recovery from relapses, but there is a lot to look into now that we know relapse recovery is an important clinical parameter,” he said. “We have to factor in the treatment effect in preventing residual disability after relapses.”
The findings suggest that “patients with incomplete early recovery might be considered for highly effective disease-modifying therapy,” added senior author Tanuja Chitnis, MD, also of the department of neurology at Brigham and Women’s Hospital. “We are now analyzing the biological mechanisms associated with relapse recovery.”
The authors of a recent study that echoes the importance of relapse recovery call it “the forgotten variable in multiple sclerosis clinical trials.” In that study, the researchers found an increased likelihood of a benign disease course among patients who received immediate disease-modifying therapy (DMT) initiation after failing to have a good recovery from an initial relapse (Neurol Neuroimmunol Neuroinflamm. 2019 Dec 17;7[2]).
“Some clinicians may choose to hold off DMTs because the patient may not have high disease activity levels,” Burcu Zeydan, MD, a coauthor of that study and an assistant professor of radiology in the Center of MS and Autoimmune Neurology at the Mayo Clinic, Rochester, Minn., said in an interview.
“What these studies add is that, if a patient is a poor recoverer despite not having highly active disease, that patient should be considered for immediate treatment initiation,” she said. “Otherwise, there is the possibility of a next relapse, which may not happen often. But when it happens, it may lead to more residual deficit with additional disability burden.”
The CLIMB study received funding from Mallinckrodt and the National MS Society Nancy Davis Center Without Walls. Dr. Sotiropoulos has received research support from Mallinckrodt. Dr. Chitnis has served on advisory boards for Biogen, Novartis, and Sanofi-Genzyme, and she has received research support from the Department of Defense, National MS Society, Guthy-Jackson Charitable Foundation, Novartis, Octave, Serono, and Verily. Dr. Zeydan had no disclosures to report.
SOURCE: Sotiropoulos MG et al. ACTRIMS Forum 2020. Abstract LB 317.
WEST PALM BEACH, FLA. – Failure to recover completely from early relapses in multiple sclerosis (MS) is significantly associated with higher long-term disability, according to research presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Incomplete recovery thus should be given more consideration when evaluating research and clinical practice outcomes, the study investigators cautioned.
“We found that the recovery from early relapses is an important predictor of future disability,” first author Marinos G. Sotiropoulos, MD, of the department of neurology, Brigham and Women’s Hospital, Boston, said in an interview. “It should be incorporated in future predictive models of disease severity and clinical trials, [and] it could be useful in clinical decision making as well.”
Incomplete recovery from relapses is known to be linked to disability progression and to the likelihood of transitioning to secondary progressive MS. Research on its role in longer-term outcomes is lacking, however.
To investigate the effect of incomplete relapse recovery in the first 3 years of MS on rates of disability at 10 years, Dr. Sotiropoulos and colleagues evaluated data on 360 patients enrolled in the CLIMB (Comprehensive Longitudinal Investigation in Multiple Sclerosis at Brigham and Women’s Hospital) study. CLIMB is a natural history study spanning 20 years, with more than 2,000 patients.
Patients were included if at least 8.5 years had passed since their first documented symptom, if they were at least 18 years at their first visit to the Partners MS Center, if that visit occurred within 1 year of their first symptom, and if they had a diagnosis of relapsing-remitting MS or secondary progressive MS.
Among the 308 patients included in the study, 74% were female and 89% were white, with a mean age at the first symptom of 35.9 years.
A total of 403 early attacks from those 308 patients were included in the study. Half of the attacks (50.4%) were followed by incomplete recovery after 6 months, defined specifically as an increase in the Expanded Disability Status Scale (EDSS) scores from baseline to at least 6 months after the onset of the attack.
As of their 10-year visit, 27.3% of patients had a normal examination, defined as EDSS 0, and 64.1% had no significant disability (EDSS less than 2). The mean EDSS at 10 years was 1.52.
Patients’ recovery index, defined as the percentage of early attacks that recovered completely, was significantly associated with 10-year EDSS scores (P less than .001).
Patient age at first symptom was also a significant predictor of 10-year disability (P less than .004). Factors that were significantly associated with incomplete relapse recovery were the duration of time from first symptom (P less than .001) and moderate severity of the relapse (P = .029).
With the type of drug treatment likely representing an important factor in whether a patient has incomplete relapse recovery, the issue should be the subject of further research, Dr. Sotiropoulos said.
“This is something that is important to look at because none of the clinical trials for the drugs we currently have looked at relapse recovery as an outcome,” he explained.
“There have been some post hoc analyses [that] have shown that some of the new medications can improve recovery from relapses, but there is a lot to look into now that we know relapse recovery is an important clinical parameter,” he said. “We have to factor in the treatment effect in preventing residual disability after relapses.”
The findings suggest that “patients with incomplete early recovery might be considered for highly effective disease-modifying therapy,” added senior author Tanuja Chitnis, MD, also of the department of neurology at Brigham and Women’s Hospital. “We are now analyzing the biological mechanisms associated with relapse recovery.”
The authors of a recent study that echoes the importance of relapse recovery call it “the forgotten variable in multiple sclerosis clinical trials.” In that study, the researchers found an increased likelihood of a benign disease course among patients who received immediate disease-modifying therapy (DMT) initiation after failing to have a good recovery from an initial relapse (Neurol Neuroimmunol Neuroinflamm. 2019 Dec 17;7[2]).
“Some clinicians may choose to hold off DMTs because the patient may not have high disease activity levels,” Burcu Zeydan, MD, a coauthor of that study and an assistant professor of radiology in the Center of MS and Autoimmune Neurology at the Mayo Clinic, Rochester, Minn., said in an interview.
“What these studies add is that, if a patient is a poor recoverer despite not having highly active disease, that patient should be considered for immediate treatment initiation,” she said. “Otherwise, there is the possibility of a next relapse, which may not happen often. But when it happens, it may lead to more residual deficit with additional disability burden.”
The CLIMB study received funding from Mallinckrodt and the National MS Society Nancy Davis Center Without Walls. Dr. Sotiropoulos has received research support from Mallinckrodt. Dr. Chitnis has served on advisory boards for Biogen, Novartis, and Sanofi-Genzyme, and she has received research support from the Department of Defense, National MS Society, Guthy-Jackson Charitable Foundation, Novartis, Octave, Serono, and Verily. Dr. Zeydan had no disclosures to report.
SOURCE: Sotiropoulos MG et al. ACTRIMS Forum 2020. Abstract LB 317.
REPORTING FROM ACTRIMS FORUM 2020
Functional connectivity model identifies MS impairment
WEST PALM BEACH, FLA. – A machine learning model that combines data on the brain’s functional connectivity with clinical information such as age, sex and disease duration shows the potential to provide an accurate assessment of clinical impairment in patients with multiple sclerosis (MS).
“This is the first study to show that dynamic functional connectivity is useful to identify the impairment level in MS, and can be used for personalized treatment by clinicians,” first author Ceren Tozlu, PhD, of Weill Cornell Medicine, New York, said in an interview.
“We found out that structural connectivity is the most important feature that distinguishes MS patients from healthy controls, while dynamic functional connectivity was more discriminative compared to the static functional connectivity in MS patient classification regarding their impairment level.”
The findings were presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Statistical assessment of the clinical impairment of MS using MRI is hindered by a relatively weak correlation between the impairment and disease burden, such as lesion load.
However, the brain’s functional connectivity network, which is indicative of the disruption of the transmission of signals of gray matter regions, could provide a deeper understanding of connectome-level mechanisms that underlie variability in MS-related impairments, Dr. Tozlu and colleagues say.
With no previous study pulling together multimodal imaging data including static and dynamic functional connectivity to classify MS patients with a clinically significant impairment versus non–clinically significant impairment, Dr. Tozlu and the team sought to build a machine-learning–based model to do so.
For the study, they enrolled 79 patients with MS, including 42 with Expanded Disability Status scores of 2 or higher, representing clinically significant impairment at baseline.
The patients, who had a mean age of 45 years, were 66% female and had a mean disease duration of 12.48 years. The ensemble model that was used incorporated functional connectivity and a clinical dataset of age, sex, and disease duration. Functional connectivity was measured by evaluating blood oxygen level dependent (BOLD) signal activity between 86 FreeSurfer-based gray matter regions.
“Functional connectivity is a statistical correlation (Pearson’s correlation coefficient) between two time series of BOLD signals measured on two distinct region of interest of the brain during MRI scan,” Dr. Tozlu explained. “In our study, BOLD time series were measured using resting-state functional MRI technique that last 7 minutes.”
The ensemble model was able to classify low-adapting MS patients with an area under ROC curve (AUC) of 0.638 and a balanced accuracy of 0.659. The model performed well in accurately classifying the MS patients with clinically significant impairment with a sensitivity of 0.719.
“The models in which we applied functional and structural connectivity showed a high performance in classifying MS patients regarding their impairment level,” Dr. Tozlu said.
She noted that “these models may be extended to predict change in impairment level in a longitudinal study, for instance, identifying MS patients who may have a clinically significant impairment.”
In further evaluating which particular functional connections were most related to MS disease activity, Dr. Tozlu and colleagues found the most discriminative areas were between the right superior parietal and right inferior temporal, between right lateral occipital and left pericalcarine, and between right pericalcarine and right side of frontal pole.
If further validated, the approach could have important, broader clinical implications, Dr. Tozlu said.
“If the validation of these models on a larger dataset is successful, this model may be used to decide for personalized treatment,” Dr. Tozlu added. “The model could offer guidance in providing more powerful treatment for MS patients who may have a clinically significant impairment and less powerful treatment for MS patients who may not have a clinically significant impairment in order to avoid the side effects of treatments.
“Therefore, we believe that dynamics in functional connectivity should be taken into account in the next studies in MS.”
In commenting on the research, Eric Klawiter, MD, associate professor of neurology, Harvard Medical School and associate neurologist at Massachusetts General Hospital, both in Boston, said the findings offer valuable insights in the use of machine learning and MS imaging.
“This research shows very nicely the power of machine learning and connectivity techniques to differentiate MS phenotypes based on disability level,” he said in an interview.
“The future direction of this work is to develop predictive markers for disability progression and this would have significant impact in how we evaluate newly diagnosed patients and counsel their treatment decisions.”
Dr. Tozlu and Dr. Klawiter had no disclosures to report.
SOURCE: Tozlu C et al. ACTRIMS Forum 2020. Abstract P025.
WEST PALM BEACH, FLA. – A machine learning model that combines data on the brain’s functional connectivity with clinical information such as age, sex and disease duration shows the potential to provide an accurate assessment of clinical impairment in patients with multiple sclerosis (MS).
“This is the first study to show that dynamic functional connectivity is useful to identify the impairment level in MS, and can be used for personalized treatment by clinicians,” first author Ceren Tozlu, PhD, of Weill Cornell Medicine, New York, said in an interview.
“We found out that structural connectivity is the most important feature that distinguishes MS patients from healthy controls, while dynamic functional connectivity was more discriminative compared to the static functional connectivity in MS patient classification regarding their impairment level.”
The findings were presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Statistical assessment of the clinical impairment of MS using MRI is hindered by a relatively weak correlation between the impairment and disease burden, such as lesion load.
However, the brain’s functional connectivity network, which is indicative of the disruption of the transmission of signals of gray matter regions, could provide a deeper understanding of connectome-level mechanisms that underlie variability in MS-related impairments, Dr. Tozlu and colleagues say.
With no previous study pulling together multimodal imaging data including static and dynamic functional connectivity to classify MS patients with a clinically significant impairment versus non–clinically significant impairment, Dr. Tozlu and the team sought to build a machine-learning–based model to do so.
For the study, they enrolled 79 patients with MS, including 42 with Expanded Disability Status scores of 2 or higher, representing clinically significant impairment at baseline.
The patients, who had a mean age of 45 years, were 66% female and had a mean disease duration of 12.48 years. The ensemble model that was used incorporated functional connectivity and a clinical dataset of age, sex, and disease duration. Functional connectivity was measured by evaluating blood oxygen level dependent (BOLD) signal activity between 86 FreeSurfer-based gray matter regions.
“Functional connectivity is a statistical correlation (Pearson’s correlation coefficient) between two time series of BOLD signals measured on two distinct region of interest of the brain during MRI scan,” Dr. Tozlu explained. “In our study, BOLD time series were measured using resting-state functional MRI technique that last 7 minutes.”
The ensemble model was able to classify low-adapting MS patients with an area under ROC curve (AUC) of 0.638 and a balanced accuracy of 0.659. The model performed well in accurately classifying the MS patients with clinically significant impairment with a sensitivity of 0.719.
“The models in which we applied functional and structural connectivity showed a high performance in classifying MS patients regarding their impairment level,” Dr. Tozlu said.
She noted that “these models may be extended to predict change in impairment level in a longitudinal study, for instance, identifying MS patients who may have a clinically significant impairment.”
In further evaluating which particular functional connections were most related to MS disease activity, Dr. Tozlu and colleagues found the most discriminative areas were between the right superior parietal and right inferior temporal, between right lateral occipital and left pericalcarine, and between right pericalcarine and right side of frontal pole.
If further validated, the approach could have important, broader clinical implications, Dr. Tozlu said.
“If the validation of these models on a larger dataset is successful, this model may be used to decide for personalized treatment,” Dr. Tozlu added. “The model could offer guidance in providing more powerful treatment for MS patients who may have a clinically significant impairment and less powerful treatment for MS patients who may not have a clinically significant impairment in order to avoid the side effects of treatments.
“Therefore, we believe that dynamics in functional connectivity should be taken into account in the next studies in MS.”
In commenting on the research, Eric Klawiter, MD, associate professor of neurology, Harvard Medical School and associate neurologist at Massachusetts General Hospital, both in Boston, said the findings offer valuable insights in the use of machine learning and MS imaging.
“This research shows very nicely the power of machine learning and connectivity techniques to differentiate MS phenotypes based on disability level,” he said in an interview.
“The future direction of this work is to develop predictive markers for disability progression and this would have significant impact in how we evaluate newly diagnosed patients and counsel their treatment decisions.”
Dr. Tozlu and Dr. Klawiter had no disclosures to report.
SOURCE: Tozlu C et al. ACTRIMS Forum 2020. Abstract P025.
WEST PALM BEACH, FLA. – A machine learning model that combines data on the brain’s functional connectivity with clinical information such as age, sex and disease duration shows the potential to provide an accurate assessment of clinical impairment in patients with multiple sclerosis (MS).
“This is the first study to show that dynamic functional connectivity is useful to identify the impairment level in MS, and can be used for personalized treatment by clinicians,” first author Ceren Tozlu, PhD, of Weill Cornell Medicine, New York, said in an interview.
“We found out that structural connectivity is the most important feature that distinguishes MS patients from healthy controls, while dynamic functional connectivity was more discriminative compared to the static functional connectivity in MS patient classification regarding their impairment level.”
The findings were presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Statistical assessment of the clinical impairment of MS using MRI is hindered by a relatively weak correlation between the impairment and disease burden, such as lesion load.
However, the brain’s functional connectivity network, which is indicative of the disruption of the transmission of signals of gray matter regions, could provide a deeper understanding of connectome-level mechanisms that underlie variability in MS-related impairments, Dr. Tozlu and colleagues say.
With no previous study pulling together multimodal imaging data including static and dynamic functional connectivity to classify MS patients with a clinically significant impairment versus non–clinically significant impairment, Dr. Tozlu and the team sought to build a machine-learning–based model to do so.
For the study, they enrolled 79 patients with MS, including 42 with Expanded Disability Status scores of 2 or higher, representing clinically significant impairment at baseline.
The patients, who had a mean age of 45 years, were 66% female and had a mean disease duration of 12.48 years. The ensemble model that was used incorporated functional connectivity and a clinical dataset of age, sex, and disease duration. Functional connectivity was measured by evaluating blood oxygen level dependent (BOLD) signal activity between 86 FreeSurfer-based gray matter regions.
“Functional connectivity is a statistical correlation (Pearson’s correlation coefficient) between two time series of BOLD signals measured on two distinct region of interest of the brain during MRI scan,” Dr. Tozlu explained. “In our study, BOLD time series were measured using resting-state functional MRI technique that last 7 minutes.”
The ensemble model was able to classify low-adapting MS patients with an area under ROC curve (AUC) of 0.638 and a balanced accuracy of 0.659. The model performed well in accurately classifying the MS patients with clinically significant impairment with a sensitivity of 0.719.
“The models in which we applied functional and structural connectivity showed a high performance in classifying MS patients regarding their impairment level,” Dr. Tozlu said.
She noted that “these models may be extended to predict change in impairment level in a longitudinal study, for instance, identifying MS patients who may have a clinically significant impairment.”
In further evaluating which particular functional connections were most related to MS disease activity, Dr. Tozlu and colleagues found the most discriminative areas were between the right superior parietal and right inferior temporal, between right lateral occipital and left pericalcarine, and between right pericalcarine and right side of frontal pole.
If further validated, the approach could have important, broader clinical implications, Dr. Tozlu said.
“If the validation of these models on a larger dataset is successful, this model may be used to decide for personalized treatment,” Dr. Tozlu added. “The model could offer guidance in providing more powerful treatment for MS patients who may have a clinically significant impairment and less powerful treatment for MS patients who may not have a clinically significant impairment in order to avoid the side effects of treatments.
“Therefore, we believe that dynamics in functional connectivity should be taken into account in the next studies in MS.”
In commenting on the research, Eric Klawiter, MD, associate professor of neurology, Harvard Medical School and associate neurologist at Massachusetts General Hospital, both in Boston, said the findings offer valuable insights in the use of machine learning and MS imaging.
“This research shows very nicely the power of machine learning and connectivity techniques to differentiate MS phenotypes based on disability level,” he said in an interview.
“The future direction of this work is to develop predictive markers for disability progression and this would have significant impact in how we evaluate newly diagnosed patients and counsel their treatment decisions.”
Dr. Tozlu and Dr. Klawiter had no disclosures to report.
SOURCE: Tozlu C et al. ACTRIMS Forum 2020. Abstract P025.
REPORTING FROM ACTRIMS FORUM 2020
Key clinical point:
Major finding: The model classified low-adapting MS patients with an ROC curve (AUC) of 0.638 and a balanced accuracy of 0.659.
Study details: Modeling study based on 79 patients with MS, including low adapters.
Disclosures: Dr. Tozlu and Dr. Klawiter had no disclosures to report.
Source: Tozlu C et al. ACTRIMS Forum 2020. Abstract P025.
Cancer increase observed in modern era of MS drugs
WEST PALM BEACH, FLA. – Cancer incidence among patients with multiple sclerosis (MS) treated after the advent of immune therapies showed an increase, compared with prior generations, according to a large study of Norwegian MS patients.
“We detected a similar cancer risk among MS patients, compared to the general Norwegian population before 1996, [however] MS patients had increased risk of cancer compared to the general population after 1996,” first author Nina Grytten, PhD, of the department of neurology at the Norwegian Multiple Sclerosis Centre, Bergen, Norway, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
“This finding suggests that clinicians should be aware of this increased risk of cancer when caring for MS patients.”
With the widespread use of disease-modifying therapies (DMTs) in patients with MS, such findings are always of interest to clinicians and patients alike, commented ACTRIMS president, Jeffrey A. Cohen, MD.
“Something that’s already on the mind of most people with MS is what are the long-term safety characteristics of these medicines because we’re talking about a life-long therapy for most people,” Dr. Cohen, who is the director of Experimental Therapeutics at the Mellen Center for MS Treatment and Research at the Cleveland Clinic, said in an interview.
“With such a large sample size and such a long study, this is on one hand reassuring and tells us the cancer risk is likely low, but it also suggests that it’s something we should pay attention to,” he said.
In previous research, Dr. Grytten and her team identified an increased risk of cancer among patients with MS in Norway, but conflicting results have been reported in other studies looking at cancer risk and MS.
The authors therefore sought to dig deeper into the risk in the Norwegian population, looking into the specifics of cancer incidence according to sex and the period of diagnosis.
For the study, they identified a total of 6,638 patients with MS from previous prevalence studies in Norway, as well as in the Norwegian MS Registry and Biobank.
The data from the cohort was matched with 36,957 Norwegian citizens without MS in a 5:1 ratio, with the participants matched according to age, gender, and county. The cohort was further linked to data from the Norwegian Cancer Registry for additional information on the year and type of cancer diagnosis, as well as cause and year of death data. The participants were born between 1930 and 1979.
Over the course of the full 65-year observation period, the cancer diagnosis rates were similar between participants with MS (774; 11.2%) and those without MS (4,017; 10.6%).
And in looking at cancer incidence rate ratios of those with MS, compared with controls between the years 1953 and 1995, the rate was similar (IRR, 1.05; 95% confidence interval, 0.97-1.14). However, after 1995, the rate increased, with a higher cancer incidence among MS patients, compared with those without MS (IRR, 1.40; 95% CI, 1.30-1.51).
Cancer rates were additionally higher among those with MS in cancers of various organs, including the brain (IRR, 1.75; 95% CI, 1.28-2.40), meninges (IRR, 2.28; 95% CI, 1.47-3.53), urinary organs (IRR, 2.06; 95% CI, 1.52-2.79), digestive system (IRR, 1.47; 95% CI, 1.20-1.80), endocrine glands (IRR, 1.64; 95% CI, 1.06-2.54), and respiratory organs (IRR, 2.05; 95% CI, 1.55-2.07).
Dr. Grytten noted, however, that the study cannot rule out various other possible causes for the differences. For instance, “cancer in urinary system and respiratory organs showed increased risk in MS both before and after introduction of disease-modifying therapies,” she noted. “Those are possibly caused by smoking, which is a habit more common among MS patients in Norway.”
Furthermore, “increased cancer in the central nervous system in MS could possibly be explained by frequent use of magnetic resonance imaging and the ability to detect CNS cancer at early stages.”
“There is increasing evidence that patients with MS are also more susceptible to other diseases, and increased cancer risk seems to be one of these comorbidities.”
However, the finding that increased cancers were observed after 1996 in other organs in MS patients as well does raise the issue of a possible role of DMTs.
Of note, mitoxantrone has been associated with an increased risk of leukemia and colorectal cancer.
And “other immunosuppressant drugs, including the MS drug fingolimod, are believed to possibly be linked to an increased cancer risk, although evidence has not yet been established,” Dr. Grytten said.
“The increased risk of cancer associated with MS was detected in the era of disease-modifying treatment of MS, and this association suggests that DMTs might possibly increase cancer risk.”
In general, “clinicians should be aware of comorbidity in MS,” Dr. Grytten said. “More data is needed on the long-time effects of immunomodulatory treatment.”
Dr. Cohen added that, in addition to mitoxantrone, azathioprine and cyclophosphamide have shown risk, but “clinical trials and follow-up studies of individual MS DMTs have not shown clear cut increased risk of cancer, which is reassuring.”
“Nevertheless, this study suggests that, in aggregate, there may be a mild increased risk. There are many other potential explanations, so the research needs to be followed up,” he said.
Dr. Cohen reported receiving personal compensation for consulting for Adamas, Convelo, MedDay, Mylan, and Population Council; and serving as an Editor of Multiple Sclerosis Journal.
SOURCE: Torkildsen NG et al. ACTRIMS Forum 2020, Abstract P126.
WEST PALM BEACH, FLA. – Cancer incidence among patients with multiple sclerosis (MS) treated after the advent of immune therapies showed an increase, compared with prior generations, according to a large study of Norwegian MS patients.
“We detected a similar cancer risk among MS patients, compared to the general Norwegian population before 1996, [however] MS patients had increased risk of cancer compared to the general population after 1996,” first author Nina Grytten, PhD, of the department of neurology at the Norwegian Multiple Sclerosis Centre, Bergen, Norway, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
“This finding suggests that clinicians should be aware of this increased risk of cancer when caring for MS patients.”
With the widespread use of disease-modifying therapies (DMTs) in patients with MS, such findings are always of interest to clinicians and patients alike, commented ACTRIMS president, Jeffrey A. Cohen, MD.
“Something that’s already on the mind of most people with MS is what are the long-term safety characteristics of these medicines because we’re talking about a life-long therapy for most people,” Dr. Cohen, who is the director of Experimental Therapeutics at the Mellen Center for MS Treatment and Research at the Cleveland Clinic, said in an interview.
“With such a large sample size and such a long study, this is on one hand reassuring and tells us the cancer risk is likely low, but it also suggests that it’s something we should pay attention to,” he said.
In previous research, Dr. Grytten and her team identified an increased risk of cancer among patients with MS in Norway, but conflicting results have been reported in other studies looking at cancer risk and MS.
The authors therefore sought to dig deeper into the risk in the Norwegian population, looking into the specifics of cancer incidence according to sex and the period of diagnosis.
For the study, they identified a total of 6,638 patients with MS from previous prevalence studies in Norway, as well as in the Norwegian MS Registry and Biobank.
The data from the cohort was matched with 36,957 Norwegian citizens without MS in a 5:1 ratio, with the participants matched according to age, gender, and county. The cohort was further linked to data from the Norwegian Cancer Registry for additional information on the year and type of cancer diagnosis, as well as cause and year of death data. The participants were born between 1930 and 1979.
Over the course of the full 65-year observation period, the cancer diagnosis rates were similar between participants with MS (774; 11.2%) and those without MS (4,017; 10.6%).
And in looking at cancer incidence rate ratios of those with MS, compared with controls between the years 1953 and 1995, the rate was similar (IRR, 1.05; 95% confidence interval, 0.97-1.14). However, after 1995, the rate increased, with a higher cancer incidence among MS patients, compared with those without MS (IRR, 1.40; 95% CI, 1.30-1.51).
Cancer rates were additionally higher among those with MS in cancers of various organs, including the brain (IRR, 1.75; 95% CI, 1.28-2.40), meninges (IRR, 2.28; 95% CI, 1.47-3.53), urinary organs (IRR, 2.06; 95% CI, 1.52-2.79), digestive system (IRR, 1.47; 95% CI, 1.20-1.80), endocrine glands (IRR, 1.64; 95% CI, 1.06-2.54), and respiratory organs (IRR, 2.05; 95% CI, 1.55-2.07).
Dr. Grytten noted, however, that the study cannot rule out various other possible causes for the differences. For instance, “cancer in urinary system and respiratory organs showed increased risk in MS both before and after introduction of disease-modifying therapies,” she noted. “Those are possibly caused by smoking, which is a habit more common among MS patients in Norway.”
Furthermore, “increased cancer in the central nervous system in MS could possibly be explained by frequent use of magnetic resonance imaging and the ability to detect CNS cancer at early stages.”
“There is increasing evidence that patients with MS are also more susceptible to other diseases, and increased cancer risk seems to be one of these comorbidities.”
However, the finding that increased cancers were observed after 1996 in other organs in MS patients as well does raise the issue of a possible role of DMTs.
Of note, mitoxantrone has been associated with an increased risk of leukemia and colorectal cancer.
And “other immunosuppressant drugs, including the MS drug fingolimod, are believed to possibly be linked to an increased cancer risk, although evidence has not yet been established,” Dr. Grytten said.
“The increased risk of cancer associated with MS was detected in the era of disease-modifying treatment of MS, and this association suggests that DMTs might possibly increase cancer risk.”
In general, “clinicians should be aware of comorbidity in MS,” Dr. Grytten said. “More data is needed on the long-time effects of immunomodulatory treatment.”
Dr. Cohen added that, in addition to mitoxantrone, azathioprine and cyclophosphamide have shown risk, but “clinical trials and follow-up studies of individual MS DMTs have not shown clear cut increased risk of cancer, which is reassuring.”
“Nevertheless, this study suggests that, in aggregate, there may be a mild increased risk. There are many other potential explanations, so the research needs to be followed up,” he said.
Dr. Cohen reported receiving personal compensation for consulting for Adamas, Convelo, MedDay, Mylan, and Population Council; and serving as an Editor of Multiple Sclerosis Journal.
SOURCE: Torkildsen NG et al. ACTRIMS Forum 2020, Abstract P126.
WEST PALM BEACH, FLA. – Cancer incidence among patients with multiple sclerosis (MS) treated after the advent of immune therapies showed an increase, compared with prior generations, according to a large study of Norwegian MS patients.
“We detected a similar cancer risk among MS patients, compared to the general Norwegian population before 1996, [however] MS patients had increased risk of cancer compared to the general population after 1996,” first author Nina Grytten, PhD, of the department of neurology at the Norwegian Multiple Sclerosis Centre, Bergen, Norway, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
“This finding suggests that clinicians should be aware of this increased risk of cancer when caring for MS patients.”
With the widespread use of disease-modifying therapies (DMTs) in patients with MS, such findings are always of interest to clinicians and patients alike, commented ACTRIMS president, Jeffrey A. Cohen, MD.
“Something that’s already on the mind of most people with MS is what are the long-term safety characteristics of these medicines because we’re talking about a life-long therapy for most people,” Dr. Cohen, who is the director of Experimental Therapeutics at the Mellen Center for MS Treatment and Research at the Cleveland Clinic, said in an interview.
“With such a large sample size and such a long study, this is on one hand reassuring and tells us the cancer risk is likely low, but it also suggests that it’s something we should pay attention to,” he said.
In previous research, Dr. Grytten and her team identified an increased risk of cancer among patients with MS in Norway, but conflicting results have been reported in other studies looking at cancer risk and MS.
The authors therefore sought to dig deeper into the risk in the Norwegian population, looking into the specifics of cancer incidence according to sex and the period of diagnosis.
For the study, they identified a total of 6,638 patients with MS from previous prevalence studies in Norway, as well as in the Norwegian MS Registry and Biobank.
The data from the cohort was matched with 36,957 Norwegian citizens without MS in a 5:1 ratio, with the participants matched according to age, gender, and county. The cohort was further linked to data from the Norwegian Cancer Registry for additional information on the year and type of cancer diagnosis, as well as cause and year of death data. The participants were born between 1930 and 1979.
Over the course of the full 65-year observation period, the cancer diagnosis rates were similar between participants with MS (774; 11.2%) and those without MS (4,017; 10.6%).
And in looking at cancer incidence rate ratios of those with MS, compared with controls between the years 1953 and 1995, the rate was similar (IRR, 1.05; 95% confidence interval, 0.97-1.14). However, after 1995, the rate increased, with a higher cancer incidence among MS patients, compared with those without MS (IRR, 1.40; 95% CI, 1.30-1.51).
Cancer rates were additionally higher among those with MS in cancers of various organs, including the brain (IRR, 1.75; 95% CI, 1.28-2.40), meninges (IRR, 2.28; 95% CI, 1.47-3.53), urinary organs (IRR, 2.06; 95% CI, 1.52-2.79), digestive system (IRR, 1.47; 95% CI, 1.20-1.80), endocrine glands (IRR, 1.64; 95% CI, 1.06-2.54), and respiratory organs (IRR, 2.05; 95% CI, 1.55-2.07).
Dr. Grytten noted, however, that the study cannot rule out various other possible causes for the differences. For instance, “cancer in urinary system and respiratory organs showed increased risk in MS both before and after introduction of disease-modifying therapies,” she noted. “Those are possibly caused by smoking, which is a habit more common among MS patients in Norway.”
Furthermore, “increased cancer in the central nervous system in MS could possibly be explained by frequent use of magnetic resonance imaging and the ability to detect CNS cancer at early stages.”
“There is increasing evidence that patients with MS are also more susceptible to other diseases, and increased cancer risk seems to be one of these comorbidities.”
However, the finding that increased cancers were observed after 1996 in other organs in MS patients as well does raise the issue of a possible role of DMTs.
Of note, mitoxantrone has been associated with an increased risk of leukemia and colorectal cancer.
And “other immunosuppressant drugs, including the MS drug fingolimod, are believed to possibly be linked to an increased cancer risk, although evidence has not yet been established,” Dr. Grytten said.
“The increased risk of cancer associated with MS was detected in the era of disease-modifying treatment of MS, and this association suggests that DMTs might possibly increase cancer risk.”
In general, “clinicians should be aware of comorbidity in MS,” Dr. Grytten said. “More data is needed on the long-time effects of immunomodulatory treatment.”
Dr. Cohen added that, in addition to mitoxantrone, azathioprine and cyclophosphamide have shown risk, but “clinical trials and follow-up studies of individual MS DMTs have not shown clear cut increased risk of cancer, which is reassuring.”
“Nevertheless, this study suggests that, in aggregate, there may be a mild increased risk. There are many other potential explanations, so the research needs to be followed up,” he said.
Dr. Cohen reported receiving personal compensation for consulting for Adamas, Convelo, MedDay, Mylan, and Population Council; and serving as an Editor of Multiple Sclerosis Journal.
SOURCE: Torkildsen NG et al. ACTRIMS Forum 2020, Abstract P126.
REPORTING FROM ACTRIMS FORUM 2020