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Need for Low-Dose Steroids to Prevent Relapse in GPA Vasculitis Depends on Treatment Regimen
WASHINGTON — Patients with granulomatosis with polyangiitis (GPA) completely tapered off prednisone have a more than fourfold risk of relapse by 6 months, compared with those tapered to 5 mg/day of prednisone; however, this benefit was only seen in patients not on rituximab, according to new research presented at the annual meeting of the American College of Rheumatology (ACR).
“For patients treated with rituximab, fully tapering off glucocorticoids is reasonable to consider as the first approach,” said Peter Merkel, MD, MPH, chief of the division of rheumatology at the University of Pennsylvania, Philadelphia, during his presentation of the findings.
Although a low dose of glucocorticoids can prevent some minor relapses in patients on other treatment regimens such as methotrexate or azathioprine, “fully tapering off prednisone presents relatively little risk of major relapse, and that major relapse can be treated rather quickly,” Merkel added.
The Assessment of Prednisone in Remission (TAPIR) trial enrolled 143 patients with GPA who were in remission (defined as a Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis [BVAS/WG] of 0) within 1 year of treatment to induce remission for active disease and who were taking 5-10 mg of prednisone per day. After all patients tapered to 5 mg/day of prednisone, 71 patients completely tapered off prednisone over 4 weeks and remained off glucocorticoids until month 6. The remaining patients maintained a 5-mg/day dose over the study period. Placement in either treatment group was randomized, and patients continued other immunosuppressive therapy during the study.
Researchers evaluated the rate of relapse by 6 months, defined as a physician’s decision to increase the dose of glucocorticoids to treat GPA, in both groups.
Across all participants, the median age was 58 years, and 52% of patients were male. Most patients were White, and 47% of all patients were prescribed rituximab.
At 6 months, 15.5% of participants who completely tapered off prednisone experienced a relapse of GPA, compared with 4.2% of those taking low-dose prednisone. Time to relapse was also shorter in the 0-mg prednisone group (P = .026), and relapses occurred continually over 6 months, Merkel said.
When stratified by rituximab use, relapse rates at 6 months between the 5-mg and 0-mg prednisone groups in patients taking rituximab showed no difference. Among patients not taking rituximab, those who completely stopped prednisone were nine and a half times as likely to experience relapse as those in the low-dose group.
Despite these differences in relapse rates, “surprisingly, there were no differences in patient-reported outcomes [such as pain interference, physical function, and fatigue],” Merkel said.
Across all patients, all but one relapse was characterized as minor. There were five serious adverse events and 10 infections in the 0-mg group versus one adverse event and 4 infections in the 5-mg group, but these differences were not statistically significant.
In patients who relapsed, musculoskeletal and ear, nose, and throat manifestations of GPA were most common, and these are “the kind of stuff we see that is helped by low-dose glucocorticoids,” Merkel said.
It’s a good sign that for patients who were completely weaned off glucocorticoids, nearly all relapses were minor, Galina Marder, MD, a rheumatologist and associate professor of medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, said in an interview. She was not involved with the research.
The study “can reinforce the message [of] trying to get them off steroids completely [when possible],” she said.
The findings also provide insight for future clinical trials, Merkel noted. For patients taking non–rituximab-based regimens, completely tapering off glucocorticoids or maintaining a low dose can affect study outcomes.
“[These data are] even more important for clinical trials because they are [reinforcing] the fact that you can have a diminishing signal if you allow some patients to stay on 5 mg prednisone” when GPA flares are the primary outcome, Marder added.
The Vasculitis Clinical Research Consortium received funding for this research through grants from the National Institutes of Health. Merkel has disclosed financial relationships with AbbVie/Abbott, Amgen, argenx, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Cabaletta, ChemoCentryx, CSL Behring, Dynacure, Eicos, Electra, EMD Serono, Forbius, Genentech/Roche, Genzyme/Sanofi, GSK, HI-Bio, Inmagene, InflaRx, Janssen, Kiniksa, Kyverna, Magenta, MiroBio, Neutrolis, Novartis, NS Pharma, Pfizer, Regeneron, Sanofi, Sparrow, Takeda, Talaris, UpToDate, and Visterra. Marder consults for Amgen and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
WASHINGTON — Patients with granulomatosis with polyangiitis (GPA) completely tapered off prednisone have a more than fourfold risk of relapse by 6 months, compared with those tapered to 5 mg/day of prednisone; however, this benefit was only seen in patients not on rituximab, according to new research presented at the annual meeting of the American College of Rheumatology (ACR).
“For patients treated with rituximab, fully tapering off glucocorticoids is reasonable to consider as the first approach,” said Peter Merkel, MD, MPH, chief of the division of rheumatology at the University of Pennsylvania, Philadelphia, during his presentation of the findings.
Although a low dose of glucocorticoids can prevent some minor relapses in patients on other treatment regimens such as methotrexate or azathioprine, “fully tapering off prednisone presents relatively little risk of major relapse, and that major relapse can be treated rather quickly,” Merkel added.
The Assessment of Prednisone in Remission (TAPIR) trial enrolled 143 patients with GPA who were in remission (defined as a Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis [BVAS/WG] of 0) within 1 year of treatment to induce remission for active disease and who were taking 5-10 mg of prednisone per day. After all patients tapered to 5 mg/day of prednisone, 71 patients completely tapered off prednisone over 4 weeks and remained off glucocorticoids until month 6. The remaining patients maintained a 5-mg/day dose over the study period. Placement in either treatment group was randomized, and patients continued other immunosuppressive therapy during the study.
Researchers evaluated the rate of relapse by 6 months, defined as a physician’s decision to increase the dose of glucocorticoids to treat GPA, in both groups.
Across all participants, the median age was 58 years, and 52% of patients were male. Most patients were White, and 47% of all patients were prescribed rituximab.
At 6 months, 15.5% of participants who completely tapered off prednisone experienced a relapse of GPA, compared with 4.2% of those taking low-dose prednisone. Time to relapse was also shorter in the 0-mg prednisone group (P = .026), and relapses occurred continually over 6 months, Merkel said.
When stratified by rituximab use, relapse rates at 6 months between the 5-mg and 0-mg prednisone groups in patients taking rituximab showed no difference. Among patients not taking rituximab, those who completely stopped prednisone were nine and a half times as likely to experience relapse as those in the low-dose group.
Despite these differences in relapse rates, “surprisingly, there were no differences in patient-reported outcomes [such as pain interference, physical function, and fatigue],” Merkel said.
Across all patients, all but one relapse was characterized as minor. There were five serious adverse events and 10 infections in the 0-mg group versus one adverse event and 4 infections in the 5-mg group, but these differences were not statistically significant.
In patients who relapsed, musculoskeletal and ear, nose, and throat manifestations of GPA were most common, and these are “the kind of stuff we see that is helped by low-dose glucocorticoids,” Merkel said.
It’s a good sign that for patients who were completely weaned off glucocorticoids, nearly all relapses were minor, Galina Marder, MD, a rheumatologist and associate professor of medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, said in an interview. She was not involved with the research.
The study “can reinforce the message [of] trying to get them off steroids completely [when possible],” she said.
The findings also provide insight for future clinical trials, Merkel noted. For patients taking non–rituximab-based regimens, completely tapering off glucocorticoids or maintaining a low dose can affect study outcomes.
“[These data are] even more important for clinical trials because they are [reinforcing] the fact that you can have a diminishing signal if you allow some patients to stay on 5 mg prednisone” when GPA flares are the primary outcome, Marder added.
The Vasculitis Clinical Research Consortium received funding for this research through grants from the National Institutes of Health. Merkel has disclosed financial relationships with AbbVie/Abbott, Amgen, argenx, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Cabaletta, ChemoCentryx, CSL Behring, Dynacure, Eicos, Electra, EMD Serono, Forbius, Genentech/Roche, Genzyme/Sanofi, GSK, HI-Bio, Inmagene, InflaRx, Janssen, Kiniksa, Kyverna, Magenta, MiroBio, Neutrolis, Novartis, NS Pharma, Pfizer, Regeneron, Sanofi, Sparrow, Takeda, Talaris, UpToDate, and Visterra. Marder consults for Amgen and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
WASHINGTON — Patients with granulomatosis with polyangiitis (GPA) completely tapered off prednisone have a more than fourfold risk of relapse by 6 months, compared with those tapered to 5 mg/day of prednisone; however, this benefit was only seen in patients not on rituximab, according to new research presented at the annual meeting of the American College of Rheumatology (ACR).
“For patients treated with rituximab, fully tapering off glucocorticoids is reasonable to consider as the first approach,” said Peter Merkel, MD, MPH, chief of the division of rheumatology at the University of Pennsylvania, Philadelphia, during his presentation of the findings.
Although a low dose of glucocorticoids can prevent some minor relapses in patients on other treatment regimens such as methotrexate or azathioprine, “fully tapering off prednisone presents relatively little risk of major relapse, and that major relapse can be treated rather quickly,” Merkel added.
The Assessment of Prednisone in Remission (TAPIR) trial enrolled 143 patients with GPA who were in remission (defined as a Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis [BVAS/WG] of 0) within 1 year of treatment to induce remission for active disease and who were taking 5-10 mg of prednisone per day. After all patients tapered to 5 mg/day of prednisone, 71 patients completely tapered off prednisone over 4 weeks and remained off glucocorticoids until month 6. The remaining patients maintained a 5-mg/day dose over the study period. Placement in either treatment group was randomized, and patients continued other immunosuppressive therapy during the study.
Researchers evaluated the rate of relapse by 6 months, defined as a physician’s decision to increase the dose of glucocorticoids to treat GPA, in both groups.
Across all participants, the median age was 58 years, and 52% of patients were male. Most patients were White, and 47% of all patients were prescribed rituximab.
At 6 months, 15.5% of participants who completely tapered off prednisone experienced a relapse of GPA, compared with 4.2% of those taking low-dose prednisone. Time to relapse was also shorter in the 0-mg prednisone group (P = .026), and relapses occurred continually over 6 months, Merkel said.
When stratified by rituximab use, relapse rates at 6 months between the 5-mg and 0-mg prednisone groups in patients taking rituximab showed no difference. Among patients not taking rituximab, those who completely stopped prednisone were nine and a half times as likely to experience relapse as those in the low-dose group.
Despite these differences in relapse rates, “surprisingly, there were no differences in patient-reported outcomes [such as pain interference, physical function, and fatigue],” Merkel said.
Across all patients, all but one relapse was characterized as minor. There were five serious adverse events and 10 infections in the 0-mg group versus one adverse event and 4 infections in the 5-mg group, but these differences were not statistically significant.
In patients who relapsed, musculoskeletal and ear, nose, and throat manifestations of GPA were most common, and these are “the kind of stuff we see that is helped by low-dose glucocorticoids,” Merkel said.
It’s a good sign that for patients who were completely weaned off glucocorticoids, nearly all relapses were minor, Galina Marder, MD, a rheumatologist and associate professor of medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, said in an interview. She was not involved with the research.
The study “can reinforce the message [of] trying to get them off steroids completely [when possible],” she said.
The findings also provide insight for future clinical trials, Merkel noted. For patients taking non–rituximab-based regimens, completely tapering off glucocorticoids or maintaining a low dose can affect study outcomes.
“[These data are] even more important for clinical trials because they are [reinforcing] the fact that you can have a diminishing signal if you allow some patients to stay on 5 mg prednisone” when GPA flares are the primary outcome, Marder added.
The Vasculitis Clinical Research Consortium received funding for this research through grants from the National Institutes of Health. Merkel has disclosed financial relationships with AbbVie/Abbott, Amgen, argenx, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Cabaletta, ChemoCentryx, CSL Behring, Dynacure, Eicos, Electra, EMD Serono, Forbius, Genentech/Roche, Genzyme/Sanofi, GSK, HI-Bio, Inmagene, InflaRx, Janssen, Kiniksa, Kyverna, Magenta, MiroBio, Neutrolis, Novartis, NS Pharma, Pfizer, Regeneron, Sanofi, Sparrow, Takeda, Talaris, UpToDate, and Visterra. Marder consults for Amgen and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
FROM ACR 2024
Prostate Cancer: Has Active Surveillance Solved the Problem of Overtreatment?
“Overtreatment of men with limited longevity for intermediate- and high-risk tumors has not only failed to improve but has actually worsened over the last 20 years,” Timothy Daskivich, MD, MSHPM, with Cedars-Sinai Medical Center, Los Angeles, said in an interview.
“Many doctors assume that the increase in uptake of active surveillance for low-risk prostate cancers has solved the problem of overtreatment, but this trend has not affected overtreatment of men with low likelihood of living long enough to benefit from treatment who have higher-risk tumors,” Daskivich said.
The study was published online on November 11 in JAMA Internal Medicine.
‘Concerning’ Real-World Data
For men with low- and intermediate-risk prostate cancer expected to live fewer than 10 years, prostate cancer screening and aggressive treatment are not recommended.
Daskivich and colleagues analyzed data on 243,928 men (mean age, 66 years) in the Veterans Affairs (VA) Health System with clinically localized prostate cancer diagnosed between 2000 and 2019.
About 21% had LE < 10 years, and about 4% had LE < 5 years, according to the validated age-adjusted Prostate Cancer Comorbidity Index.
Overtreatment was defined as aggressive treatment (surgery or radiation) in those with LE < 10 years and low- to intermediate-risk disease and in those with LE < 5 years and high-risk disease, in line with current guidelines.
Among men with LE < 10 years, the proportion of men overtreated with surgery or radiotherapy for low-risk disease decreased 22% but increased 22% for intermediate-risk disease during the study period.
Among men with LE < 5 years, the proportion of men treated with definitive treatment for high-risk disease increased 29%.
“While lower-risk tumors are treated less aggressively across the board, including in men with limited longevity, it seems that we are more indiscriminately treating men with higher-risk disease without considering their expected longevity,” Daskivich said in an interview.
Is This Happening in the General US Population?
Daskivich noted that the sample included a large sample of men diagnosed with localized prostate cancer in the VA Health System.
“Rates of overtreatment are likely to be lower in the VA [Health System], so the problem may be worse in the community setting. The VA [Health System] has been exemplary in its uptake of active surveillance for low-risk cancers, leading the effort to reduce overtreatment of men with low-risk cancers. However, the problem of overtreatment of men with limited longevity persists in the VA [Health System], underscoring the pervasiveness of this problem,” he explained.
“We don’t have a perfect head-to-head comparison of overtreatment in the VA setting vs in the community. [However, one study shows] that this is not a VA-specific phenomenon and that there is an increase in overtreatment of men with limited longevity in a Medicare population as well,” Daskivich noted.
Is Overtreatment All Bad?
Overtreatment of prostate cancer, especially in cases where the cancer is unlikely to progress or cause symptoms, can lead to significant physical, psychological, and financial harms, Christopher Anderson, MD, urologist with Columbia University Irving Medical Center in New York City, who wasn’t involved in the study, noted in an interview.
In the study by Daskivich and colleagues, over three quarters of the overtreatment was radiation therapy, which carries the risk for urinary, bowel, and sexual issues.
“Overscreening, which can lead to overtreatment, is a core issue,” Anderson said. It’s easy to order a “simple” prostate-specific antigen blood test, but in an older man with limited LE, that can lead to a host of further testing, he said.
Stopping the pipeline of overscreening that then feeds into the cascade of overtreatment is the first step in addressing the problem of prostate cancer overtreatment, Nancy Li Schoenborn, MD, MHS, with Johns Hopkins University School of Medicine, Baltimore, and Louise C. Walter, MD, with University of California San Francisco, wrote in an editorial in JAMA Internal Medicine.
Considering LE during screening decision-making is “fundamental to reducing harms of prostate cancer overdiagnosis and overtreatment” because limited LE increases the likelihood of experiencing “harms all along the diagnostic and treatment cascade following screening,” the editorial writers said.
The time spent diagnosing, monitoring, and treating asymptomatic prostate cancer in men with limited LE distracts from monitoring and treating chronic symptomatic life-limiting illnesses, they noted.
Tough to Talk About?
Anderson noted that, in general, doctors are not great at estimating and counseling patients on LE. “It’s sometimes difficult to have that conversation,” he said.
Daskivich said physicians may fail to include average LE when advising patients on treatments because they believe that the patients do not want to discuss this topic. “Yet, in interviews with patients, we found that prostate cancer patients reported they wanted this information,” he continued, in an interview.
Solving the problem of overscreening and overtreatment will require a “multifaceted approach, including improving access to life expectancy data at the point of care for providers, educating providers on how to communicate this information, and improving data sources to predict longevity,” Daskivich said.
He said it’s equally important to note that some men with prostate cancer may choose treatment even if they have a limited longevity.
“Not all patients will choose conservative management, even if it is recommended by guidelines. However, they need to be given the opportunity to make a good decision for themselves with the best possible data,” Daskivich said.
This work was supported in part by a US Department of VA Merit Review. Daskivich reported receiving personal fees from the Medical Education Speakers Network, EDAP, and RAND; research support from Lantheus and Janssen; and a patent pending for a system for healthcare visit quality assessment outside the submitted work. Schoenborn, Walter, and Anderson had no relevant disclosures.
A version of this article appeared on Medscape.com.
“Overtreatment of men with limited longevity for intermediate- and high-risk tumors has not only failed to improve but has actually worsened over the last 20 years,” Timothy Daskivich, MD, MSHPM, with Cedars-Sinai Medical Center, Los Angeles, said in an interview.
“Many doctors assume that the increase in uptake of active surveillance for low-risk prostate cancers has solved the problem of overtreatment, but this trend has not affected overtreatment of men with low likelihood of living long enough to benefit from treatment who have higher-risk tumors,” Daskivich said.
The study was published online on November 11 in JAMA Internal Medicine.
‘Concerning’ Real-World Data
For men with low- and intermediate-risk prostate cancer expected to live fewer than 10 years, prostate cancer screening and aggressive treatment are not recommended.
Daskivich and colleagues analyzed data on 243,928 men (mean age, 66 years) in the Veterans Affairs (VA) Health System with clinically localized prostate cancer diagnosed between 2000 and 2019.
About 21% had LE < 10 years, and about 4% had LE < 5 years, according to the validated age-adjusted Prostate Cancer Comorbidity Index.
Overtreatment was defined as aggressive treatment (surgery or radiation) in those with LE < 10 years and low- to intermediate-risk disease and in those with LE < 5 years and high-risk disease, in line with current guidelines.
Among men with LE < 10 years, the proportion of men overtreated with surgery or radiotherapy for low-risk disease decreased 22% but increased 22% for intermediate-risk disease during the study period.
Among men with LE < 5 years, the proportion of men treated with definitive treatment for high-risk disease increased 29%.
“While lower-risk tumors are treated less aggressively across the board, including in men with limited longevity, it seems that we are more indiscriminately treating men with higher-risk disease without considering their expected longevity,” Daskivich said in an interview.
Is This Happening in the General US Population?
Daskivich noted that the sample included a large sample of men diagnosed with localized prostate cancer in the VA Health System.
“Rates of overtreatment are likely to be lower in the VA [Health System], so the problem may be worse in the community setting. The VA [Health System] has been exemplary in its uptake of active surveillance for low-risk cancers, leading the effort to reduce overtreatment of men with low-risk cancers. However, the problem of overtreatment of men with limited longevity persists in the VA [Health System], underscoring the pervasiveness of this problem,” he explained.
“We don’t have a perfect head-to-head comparison of overtreatment in the VA setting vs in the community. [However, one study shows] that this is not a VA-specific phenomenon and that there is an increase in overtreatment of men with limited longevity in a Medicare population as well,” Daskivich noted.
Is Overtreatment All Bad?
Overtreatment of prostate cancer, especially in cases where the cancer is unlikely to progress or cause symptoms, can lead to significant physical, psychological, and financial harms, Christopher Anderson, MD, urologist with Columbia University Irving Medical Center in New York City, who wasn’t involved in the study, noted in an interview.
In the study by Daskivich and colleagues, over three quarters of the overtreatment was radiation therapy, which carries the risk for urinary, bowel, and sexual issues.
“Overscreening, which can lead to overtreatment, is a core issue,” Anderson said. It’s easy to order a “simple” prostate-specific antigen blood test, but in an older man with limited LE, that can lead to a host of further testing, he said.
Stopping the pipeline of overscreening that then feeds into the cascade of overtreatment is the first step in addressing the problem of prostate cancer overtreatment, Nancy Li Schoenborn, MD, MHS, with Johns Hopkins University School of Medicine, Baltimore, and Louise C. Walter, MD, with University of California San Francisco, wrote in an editorial in JAMA Internal Medicine.
Considering LE during screening decision-making is “fundamental to reducing harms of prostate cancer overdiagnosis and overtreatment” because limited LE increases the likelihood of experiencing “harms all along the diagnostic and treatment cascade following screening,” the editorial writers said.
The time spent diagnosing, monitoring, and treating asymptomatic prostate cancer in men with limited LE distracts from monitoring and treating chronic symptomatic life-limiting illnesses, they noted.
Tough to Talk About?
Anderson noted that, in general, doctors are not great at estimating and counseling patients on LE. “It’s sometimes difficult to have that conversation,” he said.
Daskivich said physicians may fail to include average LE when advising patients on treatments because they believe that the patients do not want to discuss this topic. “Yet, in interviews with patients, we found that prostate cancer patients reported they wanted this information,” he continued, in an interview.
Solving the problem of overscreening and overtreatment will require a “multifaceted approach, including improving access to life expectancy data at the point of care for providers, educating providers on how to communicate this information, and improving data sources to predict longevity,” Daskivich said.
He said it’s equally important to note that some men with prostate cancer may choose treatment even if they have a limited longevity.
“Not all patients will choose conservative management, even if it is recommended by guidelines. However, they need to be given the opportunity to make a good decision for themselves with the best possible data,” Daskivich said.
This work was supported in part by a US Department of VA Merit Review. Daskivich reported receiving personal fees from the Medical Education Speakers Network, EDAP, and RAND; research support from Lantheus and Janssen; and a patent pending for a system for healthcare visit quality assessment outside the submitted work. Schoenborn, Walter, and Anderson had no relevant disclosures.
A version of this article appeared on Medscape.com.
“Overtreatment of men with limited longevity for intermediate- and high-risk tumors has not only failed to improve but has actually worsened over the last 20 years,” Timothy Daskivich, MD, MSHPM, with Cedars-Sinai Medical Center, Los Angeles, said in an interview.
“Many doctors assume that the increase in uptake of active surveillance for low-risk prostate cancers has solved the problem of overtreatment, but this trend has not affected overtreatment of men with low likelihood of living long enough to benefit from treatment who have higher-risk tumors,” Daskivich said.
The study was published online on November 11 in JAMA Internal Medicine.
‘Concerning’ Real-World Data
For men with low- and intermediate-risk prostate cancer expected to live fewer than 10 years, prostate cancer screening and aggressive treatment are not recommended.
Daskivich and colleagues analyzed data on 243,928 men (mean age, 66 years) in the Veterans Affairs (VA) Health System with clinically localized prostate cancer diagnosed between 2000 and 2019.
About 21% had LE < 10 years, and about 4% had LE < 5 years, according to the validated age-adjusted Prostate Cancer Comorbidity Index.
Overtreatment was defined as aggressive treatment (surgery or radiation) in those with LE < 10 years and low- to intermediate-risk disease and in those with LE < 5 years and high-risk disease, in line with current guidelines.
Among men with LE < 10 years, the proportion of men overtreated with surgery or radiotherapy for low-risk disease decreased 22% but increased 22% for intermediate-risk disease during the study period.
Among men with LE < 5 years, the proportion of men treated with definitive treatment for high-risk disease increased 29%.
“While lower-risk tumors are treated less aggressively across the board, including in men with limited longevity, it seems that we are more indiscriminately treating men with higher-risk disease without considering their expected longevity,” Daskivich said in an interview.
Is This Happening in the General US Population?
Daskivich noted that the sample included a large sample of men diagnosed with localized prostate cancer in the VA Health System.
“Rates of overtreatment are likely to be lower in the VA [Health System], so the problem may be worse in the community setting. The VA [Health System] has been exemplary in its uptake of active surveillance for low-risk cancers, leading the effort to reduce overtreatment of men with low-risk cancers. However, the problem of overtreatment of men with limited longevity persists in the VA [Health System], underscoring the pervasiveness of this problem,” he explained.
“We don’t have a perfect head-to-head comparison of overtreatment in the VA setting vs in the community. [However, one study shows] that this is not a VA-specific phenomenon and that there is an increase in overtreatment of men with limited longevity in a Medicare population as well,” Daskivich noted.
Is Overtreatment All Bad?
Overtreatment of prostate cancer, especially in cases where the cancer is unlikely to progress or cause symptoms, can lead to significant physical, psychological, and financial harms, Christopher Anderson, MD, urologist with Columbia University Irving Medical Center in New York City, who wasn’t involved in the study, noted in an interview.
In the study by Daskivich and colleagues, over three quarters of the overtreatment was radiation therapy, which carries the risk for urinary, bowel, and sexual issues.
“Overscreening, which can lead to overtreatment, is a core issue,” Anderson said. It’s easy to order a “simple” prostate-specific antigen blood test, but in an older man with limited LE, that can lead to a host of further testing, he said.
Stopping the pipeline of overscreening that then feeds into the cascade of overtreatment is the first step in addressing the problem of prostate cancer overtreatment, Nancy Li Schoenborn, MD, MHS, with Johns Hopkins University School of Medicine, Baltimore, and Louise C. Walter, MD, with University of California San Francisco, wrote in an editorial in JAMA Internal Medicine.
Considering LE during screening decision-making is “fundamental to reducing harms of prostate cancer overdiagnosis and overtreatment” because limited LE increases the likelihood of experiencing “harms all along the diagnostic and treatment cascade following screening,” the editorial writers said.
The time spent diagnosing, monitoring, and treating asymptomatic prostate cancer in men with limited LE distracts from monitoring and treating chronic symptomatic life-limiting illnesses, they noted.
Tough to Talk About?
Anderson noted that, in general, doctors are not great at estimating and counseling patients on LE. “It’s sometimes difficult to have that conversation,” he said.
Daskivich said physicians may fail to include average LE when advising patients on treatments because they believe that the patients do not want to discuss this topic. “Yet, in interviews with patients, we found that prostate cancer patients reported they wanted this information,” he continued, in an interview.
Solving the problem of overscreening and overtreatment will require a “multifaceted approach, including improving access to life expectancy data at the point of care for providers, educating providers on how to communicate this information, and improving data sources to predict longevity,” Daskivich said.
He said it’s equally important to note that some men with prostate cancer may choose treatment even if they have a limited longevity.
“Not all patients will choose conservative management, even if it is recommended by guidelines. However, they need to be given the opportunity to make a good decision for themselves with the best possible data,” Daskivich said.
This work was supported in part by a US Department of VA Merit Review. Daskivich reported receiving personal fees from the Medical Education Speakers Network, EDAP, and RAND; research support from Lantheus and Janssen; and a patent pending for a system for healthcare visit quality assessment outside the submitted work. Schoenborn, Walter, and Anderson had no relevant disclosures.
A version of this article appeared on Medscape.com.
First Phase 3 Drug Trial in IgG4-Related Disease Has Success
WASHINGTON — The B cell–depleting agent inebilizumab (Uplizna) dramatically reduced the risk of flares and increased year-long remission of IgG4-related disease (RD), new research has found.
In a phase 3, multicenter, double-blind, randomized, placebo-controlled trial of 135 adults with active IgG4-RD, treatment with inebilizumab resulted in a significant 87% reduction in flare risk and nearly fivefold greater likelihood of flare-free remission at 1 year. The results were published online November 14 in The New England Journal of Medicine and were presented at the annual meeting of the American College of Rheumatology (ACR).
The drug’s manufacturer, Amgen, released top-line results of the trial, called MITIGATE, in June 2024.
Until now, the mainstay of management for the chronic multiorgan disease IgG4-RD has been glucocorticoids, which can cause numerous adverse effects. “It is hoped that inebilizumab can be used as an important steroid-sparing medication in this disease to reduce steroid toxicity,” lead author John H. Stone, MD, professor of medicine at Harvard Medical School, Boston, Massachusetts, said in an interview, noting that it may not entirely eliminate the need for steroid treatment, but for many, it appears to work after the remission induction period as a monotherapy without steroids.
Asked to comment, Leonard H. Calabrese, DO, head of the Section of Clinical Immunology and manager of the Clinical Immunology Clinic at the Cleveland Clinic, Ohio, said: “There has been anecdotal or observational evidence for some effect with other immunosuppressive agents, including rituximab, but no robust clinical trial until this study. This clearly has demonstrated efficacy by reducing the risk of flares. And most importantly, putting people into remission means no active disease in any given organ. ... This gives us another tool in the toolbox to attack B cell–directed diseases, and I think it really makes a lot of sense.”
Calabrese cautioned, though, that “this is a disease that extends over many years. This is just a 1-year study. Label extensions will be important.”
And several questions remain, Calabrese noted: “How long do patients need to remain on drug? What will happen when the drug is stopped? Can they be retreated? These are the natural questions that arise in any sentinel study like this. But this is extremely encouraging. And I think it’s great for patients. I also think it’s a clarion call to increase awareness about this disease since there’s now strong evidence of effective treatment.”
Underrecognized, Often Misdiagnosed as Cancer
Indeed, IgG4-RD, a chronic, relapsing, autoimmune, fibro-inflammatory multiorgan disease, was only first described in Japan in 2003. Since then, it has been reported all over the world yet remains vastly underrecognized. It is often misdiagnosed as cancer because it produces lesions in multiple organs. It received an ICD-10 code only about a year ago. A previous study estimated a prevalence of about 5.3 persons per 100,000 but that is likely to be a three- to fourfold underestimate, said Stone, who is also executive chairman of the IgG4ward! Foundation.
“Nobody had heard of the disease until about 20 years ago. ... And there are many people in the world who have still not heard of it despite the fact that it is a multiorgan autoimmune disease and is probably as common, or more common, than many other diseases that rheumatologists spend a lot of time thinking about, such as scleroderma.”
While knowledge about the disease is increasing in rheumatology circles, it’s less well-recognized among many of the specialties where patients present, depending on the location of their lesions. These include gastroenterology, ophthalmology, pulmonary medicine, neurology, and nephrology. “All would be likely to see this disease,” Stone said.
The disease can be mistaken for tumors in many of those locations and even as metastatic cancer, he noted, adding that “any time a patient has a mass lesion in a typical organ, the pancreas, the major salivary glands, the lungs, or the kidneys, this should be on the differential diagnosis.”
The diagnosis of IgG4-RD is a clinical one, involving “quadrangulation between clinical features, serological findings, IgG4 levels in the blood, radiology studies, and then pathology biopsies when those are available,” Stone said.
Calabrese characterized the current situation as “we’re all blind men on the elephant. To the neurologist or the neurosurgeon, it’s a mass in the brain. It could present to the ophthalmologist as an [eye] tumor. It can be thyroid gland failure, pulmonary disease, retroperitoneal fibrosis, hepatobiliary disease, and beyond. So, whoever sees that patient, there’s often a long lag time in recognizing it.”
And interestingly, Stone noted that unlike other autoimmune diseases, IgG4-RD primarily affects middle-aged men rather than younger-to-middle-aged women. And when IgG4-RD is diagnosed, glucocorticoid treatment can be particularly toxic when the pancreas is involved, heightening the risk for hyperglycemia and potentially causing diabetes.
Dramatic Improvement in Flares, Remission Achievement
MITIGATE is a phase 3, multicenter, double-blind, randomized, placebo-controlled trial in which 135 adults (mean age 58.2 years, 88 men) with active IgG4-RD were randomized 1:1 to receive 300-mg intravenous infusions of inebilizumab or placebo on days 1 and 15, and again at week 26. At baseline, 62 (45.9%) participants had newly diagnosed IgG4-RD and 73 (54.1%) had recurrent disease.
Both groups received identical glucocorticoid tapers. Overall, 127 (94.1%) completed the 52 weeks of treatment.
By 52 weeks, only seven patients in the inebilizumab group (10%) had experienced disease flares vs 40 (60%) in the placebo group, a significant difference with a hazard ratio of 0.13 (P < .001).
The percentage of participants achieving flare-free, treatment-free complete remission was 59 with inebilizumab (57%), compared with just 15 (22%) in the placebo group (odds ratio [OR], 4.68; P < .001). And for flare-free, glucocorticoid-free complete remission, those proportions were 40 (59%) vs 15 (22%), respectively (OR, 4.96; P < .001).
Excluding the 8-week glucocorticoid taper period, mean total glucocorticoid use was 1264.2 mg less in the inebilizumab than the placebo group, a significant reduction. Overall, 61 participants (90%) were able to entirely discontinue glucocorticoids during the trial, compared with just 25 (37%) in the placebo group.
Adverse events of grade 3 or higher occurred in 12 participants (18%) in the inebilizumab group and 8 (12%) in the placebo group; serious adverse events occurred in 12 (18%) and 6 (9%), respectively. However, no serious adverse event occurred in more than one participant, and there were no deaths. Adverse events led to withdrawal from the trial in six patients (9%) in the inebilizumab group and three patients (4%) in the placebo group.
Adverse events that occurred in more than 10% of participants in the inebilizumab group were COVID-19 in 16 participants (24%), lymphopenia in 11 (16%), and urinary tract infection in 8 (12%).
Importantly, Stone noted, B-cell depletion can reduce responses to vaccines, so patients should receive all recommended vaccinations, including COVID-19, influenza, respiratory syncytial virus, and others, prior to initiating therapy.
Uplizna (inebilizumab-cdon) was approved by the Food and Drug Administration (FDA) for the treatment of neuromyelitis optica spectrum disorder in 2020. In October 2024, the FDA granted Amgen breakthrough therapy designation for use in IgG4-RD. The company is also developing the drug for use in myasthenia gravis.
The study was funded by Amgen. Stone has reported being a consultant for Amgen, Zenas, Argenx, Bristol Myers Squibb, Novartis, Sanofi, and Horizon Pharma. Calabrese has reported being a consultant and/or speaker for Amgen, AstraZeneca, Jansen, Sanofi, and UCB.
A version of this article first appeared on Medscape.com.
WASHINGTON — The B cell–depleting agent inebilizumab (Uplizna) dramatically reduced the risk of flares and increased year-long remission of IgG4-related disease (RD), new research has found.
In a phase 3, multicenter, double-blind, randomized, placebo-controlled trial of 135 adults with active IgG4-RD, treatment with inebilizumab resulted in a significant 87% reduction in flare risk and nearly fivefold greater likelihood of flare-free remission at 1 year. The results were published online November 14 in The New England Journal of Medicine and were presented at the annual meeting of the American College of Rheumatology (ACR).
The drug’s manufacturer, Amgen, released top-line results of the trial, called MITIGATE, in June 2024.
Until now, the mainstay of management for the chronic multiorgan disease IgG4-RD has been glucocorticoids, which can cause numerous adverse effects. “It is hoped that inebilizumab can be used as an important steroid-sparing medication in this disease to reduce steroid toxicity,” lead author John H. Stone, MD, professor of medicine at Harvard Medical School, Boston, Massachusetts, said in an interview, noting that it may not entirely eliminate the need for steroid treatment, but for many, it appears to work after the remission induction period as a monotherapy without steroids.
Asked to comment, Leonard H. Calabrese, DO, head of the Section of Clinical Immunology and manager of the Clinical Immunology Clinic at the Cleveland Clinic, Ohio, said: “There has been anecdotal or observational evidence for some effect with other immunosuppressive agents, including rituximab, but no robust clinical trial until this study. This clearly has demonstrated efficacy by reducing the risk of flares. And most importantly, putting people into remission means no active disease in any given organ. ... This gives us another tool in the toolbox to attack B cell–directed diseases, and I think it really makes a lot of sense.”
Calabrese cautioned, though, that “this is a disease that extends over many years. This is just a 1-year study. Label extensions will be important.”
And several questions remain, Calabrese noted: “How long do patients need to remain on drug? What will happen when the drug is stopped? Can they be retreated? These are the natural questions that arise in any sentinel study like this. But this is extremely encouraging. And I think it’s great for patients. I also think it’s a clarion call to increase awareness about this disease since there’s now strong evidence of effective treatment.”
Underrecognized, Often Misdiagnosed as Cancer
Indeed, IgG4-RD, a chronic, relapsing, autoimmune, fibro-inflammatory multiorgan disease, was only first described in Japan in 2003. Since then, it has been reported all over the world yet remains vastly underrecognized. It is often misdiagnosed as cancer because it produces lesions in multiple organs. It received an ICD-10 code only about a year ago. A previous study estimated a prevalence of about 5.3 persons per 100,000 but that is likely to be a three- to fourfold underestimate, said Stone, who is also executive chairman of the IgG4ward! Foundation.
“Nobody had heard of the disease until about 20 years ago. ... And there are many people in the world who have still not heard of it despite the fact that it is a multiorgan autoimmune disease and is probably as common, or more common, than many other diseases that rheumatologists spend a lot of time thinking about, such as scleroderma.”
While knowledge about the disease is increasing in rheumatology circles, it’s less well-recognized among many of the specialties where patients present, depending on the location of their lesions. These include gastroenterology, ophthalmology, pulmonary medicine, neurology, and nephrology. “All would be likely to see this disease,” Stone said.
The disease can be mistaken for tumors in many of those locations and even as metastatic cancer, he noted, adding that “any time a patient has a mass lesion in a typical organ, the pancreas, the major salivary glands, the lungs, or the kidneys, this should be on the differential diagnosis.”
The diagnosis of IgG4-RD is a clinical one, involving “quadrangulation between clinical features, serological findings, IgG4 levels in the blood, radiology studies, and then pathology biopsies when those are available,” Stone said.
Calabrese characterized the current situation as “we’re all blind men on the elephant. To the neurologist or the neurosurgeon, it’s a mass in the brain. It could present to the ophthalmologist as an [eye] tumor. It can be thyroid gland failure, pulmonary disease, retroperitoneal fibrosis, hepatobiliary disease, and beyond. So, whoever sees that patient, there’s often a long lag time in recognizing it.”
And interestingly, Stone noted that unlike other autoimmune diseases, IgG4-RD primarily affects middle-aged men rather than younger-to-middle-aged women. And when IgG4-RD is diagnosed, glucocorticoid treatment can be particularly toxic when the pancreas is involved, heightening the risk for hyperglycemia and potentially causing diabetes.
Dramatic Improvement in Flares, Remission Achievement
MITIGATE is a phase 3, multicenter, double-blind, randomized, placebo-controlled trial in which 135 adults (mean age 58.2 years, 88 men) with active IgG4-RD were randomized 1:1 to receive 300-mg intravenous infusions of inebilizumab or placebo on days 1 and 15, and again at week 26. At baseline, 62 (45.9%) participants had newly diagnosed IgG4-RD and 73 (54.1%) had recurrent disease.
Both groups received identical glucocorticoid tapers. Overall, 127 (94.1%) completed the 52 weeks of treatment.
By 52 weeks, only seven patients in the inebilizumab group (10%) had experienced disease flares vs 40 (60%) in the placebo group, a significant difference with a hazard ratio of 0.13 (P < .001).
The percentage of participants achieving flare-free, treatment-free complete remission was 59 with inebilizumab (57%), compared with just 15 (22%) in the placebo group (odds ratio [OR], 4.68; P < .001). And for flare-free, glucocorticoid-free complete remission, those proportions were 40 (59%) vs 15 (22%), respectively (OR, 4.96; P < .001).
Excluding the 8-week glucocorticoid taper period, mean total glucocorticoid use was 1264.2 mg less in the inebilizumab than the placebo group, a significant reduction. Overall, 61 participants (90%) were able to entirely discontinue glucocorticoids during the trial, compared with just 25 (37%) in the placebo group.
Adverse events of grade 3 or higher occurred in 12 participants (18%) in the inebilizumab group and 8 (12%) in the placebo group; serious adverse events occurred in 12 (18%) and 6 (9%), respectively. However, no serious adverse event occurred in more than one participant, and there were no deaths. Adverse events led to withdrawal from the trial in six patients (9%) in the inebilizumab group and three patients (4%) in the placebo group.
Adverse events that occurred in more than 10% of participants in the inebilizumab group were COVID-19 in 16 participants (24%), lymphopenia in 11 (16%), and urinary tract infection in 8 (12%).
Importantly, Stone noted, B-cell depletion can reduce responses to vaccines, so patients should receive all recommended vaccinations, including COVID-19, influenza, respiratory syncytial virus, and others, prior to initiating therapy.
Uplizna (inebilizumab-cdon) was approved by the Food and Drug Administration (FDA) for the treatment of neuromyelitis optica spectrum disorder in 2020. In October 2024, the FDA granted Amgen breakthrough therapy designation for use in IgG4-RD. The company is also developing the drug for use in myasthenia gravis.
The study was funded by Amgen. Stone has reported being a consultant for Amgen, Zenas, Argenx, Bristol Myers Squibb, Novartis, Sanofi, and Horizon Pharma. Calabrese has reported being a consultant and/or speaker for Amgen, AstraZeneca, Jansen, Sanofi, and UCB.
A version of this article first appeared on Medscape.com.
WASHINGTON — The B cell–depleting agent inebilizumab (Uplizna) dramatically reduced the risk of flares and increased year-long remission of IgG4-related disease (RD), new research has found.
In a phase 3, multicenter, double-blind, randomized, placebo-controlled trial of 135 adults with active IgG4-RD, treatment with inebilizumab resulted in a significant 87% reduction in flare risk and nearly fivefold greater likelihood of flare-free remission at 1 year. The results were published online November 14 in The New England Journal of Medicine and were presented at the annual meeting of the American College of Rheumatology (ACR).
The drug’s manufacturer, Amgen, released top-line results of the trial, called MITIGATE, in June 2024.
Until now, the mainstay of management for the chronic multiorgan disease IgG4-RD has been glucocorticoids, which can cause numerous adverse effects. “It is hoped that inebilizumab can be used as an important steroid-sparing medication in this disease to reduce steroid toxicity,” lead author John H. Stone, MD, professor of medicine at Harvard Medical School, Boston, Massachusetts, said in an interview, noting that it may not entirely eliminate the need for steroid treatment, but for many, it appears to work after the remission induction period as a monotherapy without steroids.
Asked to comment, Leonard H. Calabrese, DO, head of the Section of Clinical Immunology and manager of the Clinical Immunology Clinic at the Cleveland Clinic, Ohio, said: “There has been anecdotal or observational evidence for some effect with other immunosuppressive agents, including rituximab, but no robust clinical trial until this study. This clearly has demonstrated efficacy by reducing the risk of flares. And most importantly, putting people into remission means no active disease in any given organ. ... This gives us another tool in the toolbox to attack B cell–directed diseases, and I think it really makes a lot of sense.”
Calabrese cautioned, though, that “this is a disease that extends over many years. This is just a 1-year study. Label extensions will be important.”
And several questions remain, Calabrese noted: “How long do patients need to remain on drug? What will happen when the drug is stopped? Can they be retreated? These are the natural questions that arise in any sentinel study like this. But this is extremely encouraging. And I think it’s great for patients. I also think it’s a clarion call to increase awareness about this disease since there’s now strong evidence of effective treatment.”
Underrecognized, Often Misdiagnosed as Cancer
Indeed, IgG4-RD, a chronic, relapsing, autoimmune, fibro-inflammatory multiorgan disease, was only first described in Japan in 2003. Since then, it has been reported all over the world yet remains vastly underrecognized. It is often misdiagnosed as cancer because it produces lesions in multiple organs. It received an ICD-10 code only about a year ago. A previous study estimated a prevalence of about 5.3 persons per 100,000 but that is likely to be a three- to fourfold underestimate, said Stone, who is also executive chairman of the IgG4ward! Foundation.
“Nobody had heard of the disease until about 20 years ago. ... And there are many people in the world who have still not heard of it despite the fact that it is a multiorgan autoimmune disease and is probably as common, or more common, than many other diseases that rheumatologists spend a lot of time thinking about, such as scleroderma.”
While knowledge about the disease is increasing in rheumatology circles, it’s less well-recognized among many of the specialties where patients present, depending on the location of their lesions. These include gastroenterology, ophthalmology, pulmonary medicine, neurology, and nephrology. “All would be likely to see this disease,” Stone said.
The disease can be mistaken for tumors in many of those locations and even as metastatic cancer, he noted, adding that “any time a patient has a mass lesion in a typical organ, the pancreas, the major salivary glands, the lungs, or the kidneys, this should be on the differential diagnosis.”
The diagnosis of IgG4-RD is a clinical one, involving “quadrangulation between clinical features, serological findings, IgG4 levels in the blood, radiology studies, and then pathology biopsies when those are available,” Stone said.
Calabrese characterized the current situation as “we’re all blind men on the elephant. To the neurologist or the neurosurgeon, it’s a mass in the brain. It could present to the ophthalmologist as an [eye] tumor. It can be thyroid gland failure, pulmonary disease, retroperitoneal fibrosis, hepatobiliary disease, and beyond. So, whoever sees that patient, there’s often a long lag time in recognizing it.”
And interestingly, Stone noted that unlike other autoimmune diseases, IgG4-RD primarily affects middle-aged men rather than younger-to-middle-aged women. And when IgG4-RD is diagnosed, glucocorticoid treatment can be particularly toxic when the pancreas is involved, heightening the risk for hyperglycemia and potentially causing diabetes.
Dramatic Improvement in Flares, Remission Achievement
MITIGATE is a phase 3, multicenter, double-blind, randomized, placebo-controlled trial in which 135 adults (mean age 58.2 years, 88 men) with active IgG4-RD were randomized 1:1 to receive 300-mg intravenous infusions of inebilizumab or placebo on days 1 and 15, and again at week 26. At baseline, 62 (45.9%) participants had newly diagnosed IgG4-RD and 73 (54.1%) had recurrent disease.
Both groups received identical glucocorticoid tapers. Overall, 127 (94.1%) completed the 52 weeks of treatment.
By 52 weeks, only seven patients in the inebilizumab group (10%) had experienced disease flares vs 40 (60%) in the placebo group, a significant difference with a hazard ratio of 0.13 (P < .001).
The percentage of participants achieving flare-free, treatment-free complete remission was 59 with inebilizumab (57%), compared with just 15 (22%) in the placebo group (odds ratio [OR], 4.68; P < .001). And for flare-free, glucocorticoid-free complete remission, those proportions were 40 (59%) vs 15 (22%), respectively (OR, 4.96; P < .001).
Excluding the 8-week glucocorticoid taper period, mean total glucocorticoid use was 1264.2 mg less in the inebilizumab than the placebo group, a significant reduction. Overall, 61 participants (90%) were able to entirely discontinue glucocorticoids during the trial, compared with just 25 (37%) in the placebo group.
Adverse events of grade 3 or higher occurred in 12 participants (18%) in the inebilizumab group and 8 (12%) in the placebo group; serious adverse events occurred in 12 (18%) and 6 (9%), respectively. However, no serious adverse event occurred in more than one participant, and there were no deaths. Adverse events led to withdrawal from the trial in six patients (9%) in the inebilizumab group and three patients (4%) in the placebo group.
Adverse events that occurred in more than 10% of participants in the inebilizumab group were COVID-19 in 16 participants (24%), lymphopenia in 11 (16%), and urinary tract infection in 8 (12%).
Importantly, Stone noted, B-cell depletion can reduce responses to vaccines, so patients should receive all recommended vaccinations, including COVID-19, influenza, respiratory syncytial virus, and others, prior to initiating therapy.
Uplizna (inebilizumab-cdon) was approved by the Food and Drug Administration (FDA) for the treatment of neuromyelitis optica spectrum disorder in 2020. In October 2024, the FDA granted Amgen breakthrough therapy designation for use in IgG4-RD. The company is also developing the drug for use in myasthenia gravis.
The study was funded by Amgen. Stone has reported being a consultant for Amgen, Zenas, Argenx, Bristol Myers Squibb, Novartis, Sanofi, and Horizon Pharma. Calabrese has reported being a consultant and/or speaker for Amgen, AstraZeneca, Jansen, Sanofi, and UCB.
A version of this article first appeared on Medscape.com.
FROM ACR 2024
How Do Novel CRC Blood Tests Fare Against Established Tests?
TOPLINE:
METHODOLOGY:
- Researchers estimated the clinical and economic impacts of emerging blood- and stool-based CRC screening tests with established alternatives in average-risk adults aged 45 years and older.
- The established screening tools were colonoscopy, a fecal immunochemical test (FIT), and a multitarget stool DNA test (MT-sDNA, Exact Sciences Cologuard).
- The four emerging screening methods were two cf-bDNA tests (Guardant Shield and Freenome); an enhanced, a next-generation multitarget stool test (ngMT-sDNA), and a novel FIT-RNA test (Geneoscopy ColoSense).
TAKEAWAY:
- Assuming 100% participation in all screening steps, colonoscopy and FIT yielded reductions of more than 70% in CRC incidence and 75% in mortality vs no screening.
- The MT-sDNA test reduced CRC incidence by 68% and mortality by 73%, with similar rates for the ngMT-sDNA and FIT-RNA tests vs no screening. The cf-bDNA tests yielded CRC incidence and mortality reductions of only 42% and 56%.
- Colonoscopy and FIT were more effective and less costly than the cf-bDNA and MT-sDNA tests, and the MT-sDNA test was more effective and less costly than the cf-bDNA test.
- Population benefits from blood tests were seen only in those who declined colonoscopy and stool tests. Substituting a blood test for those already using colonoscopy or stool tests led to worse population-level outcomes.
IN PRACTICE:
“First-generation novel cf-bDNA tests have the potential to decrease meaningfully the incidence and mortality of CRC compared with no screening but substantially less profoundly than screening colonoscopy or stool tests. Net population benefit or harm can follow incorporation of first-generation cf-bDNA CRC screening tests into practice, depending on the balance between bringing unscreened persons into screening (addition) vs shifting persons away from the more effective strategies of colonoscopy or stool testing (substitution),” the authors concluded.
SOURCE:
The study, with first author Uri Ladabaum, MD, MS, Stanford University School of Medicine, California, was published online in Annals of Internal Medicine.
LIMITATIONS:
Limitations included test-specific participation patterns being unknown over time.
DISCLOSURES:
Disclosure forms for the authors are available with the article online. Funding was provided by the Gorrindo Family Fund.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers estimated the clinical and economic impacts of emerging blood- and stool-based CRC screening tests with established alternatives in average-risk adults aged 45 years and older.
- The established screening tools were colonoscopy, a fecal immunochemical test (FIT), and a multitarget stool DNA test (MT-sDNA, Exact Sciences Cologuard).
- The four emerging screening methods were two cf-bDNA tests (Guardant Shield and Freenome); an enhanced, a next-generation multitarget stool test (ngMT-sDNA), and a novel FIT-RNA test (Geneoscopy ColoSense).
TAKEAWAY:
- Assuming 100% participation in all screening steps, colonoscopy and FIT yielded reductions of more than 70% in CRC incidence and 75% in mortality vs no screening.
- The MT-sDNA test reduced CRC incidence by 68% and mortality by 73%, with similar rates for the ngMT-sDNA and FIT-RNA tests vs no screening. The cf-bDNA tests yielded CRC incidence and mortality reductions of only 42% and 56%.
- Colonoscopy and FIT were more effective and less costly than the cf-bDNA and MT-sDNA tests, and the MT-sDNA test was more effective and less costly than the cf-bDNA test.
- Population benefits from blood tests were seen only in those who declined colonoscopy and stool tests. Substituting a blood test for those already using colonoscopy or stool tests led to worse population-level outcomes.
IN PRACTICE:
“First-generation novel cf-bDNA tests have the potential to decrease meaningfully the incidence and mortality of CRC compared with no screening but substantially less profoundly than screening colonoscopy or stool tests. Net population benefit or harm can follow incorporation of first-generation cf-bDNA CRC screening tests into practice, depending on the balance between bringing unscreened persons into screening (addition) vs shifting persons away from the more effective strategies of colonoscopy or stool testing (substitution),” the authors concluded.
SOURCE:
The study, with first author Uri Ladabaum, MD, MS, Stanford University School of Medicine, California, was published online in Annals of Internal Medicine.
LIMITATIONS:
Limitations included test-specific participation patterns being unknown over time.
DISCLOSURES:
Disclosure forms for the authors are available with the article online. Funding was provided by the Gorrindo Family Fund.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers estimated the clinical and economic impacts of emerging blood- and stool-based CRC screening tests with established alternatives in average-risk adults aged 45 years and older.
- The established screening tools were colonoscopy, a fecal immunochemical test (FIT), and a multitarget stool DNA test (MT-sDNA, Exact Sciences Cologuard).
- The four emerging screening methods were two cf-bDNA tests (Guardant Shield and Freenome); an enhanced, a next-generation multitarget stool test (ngMT-sDNA), and a novel FIT-RNA test (Geneoscopy ColoSense).
TAKEAWAY:
- Assuming 100% participation in all screening steps, colonoscopy and FIT yielded reductions of more than 70% in CRC incidence and 75% in mortality vs no screening.
- The MT-sDNA test reduced CRC incidence by 68% and mortality by 73%, with similar rates for the ngMT-sDNA and FIT-RNA tests vs no screening. The cf-bDNA tests yielded CRC incidence and mortality reductions of only 42% and 56%.
- Colonoscopy and FIT were more effective and less costly than the cf-bDNA and MT-sDNA tests, and the MT-sDNA test was more effective and less costly than the cf-bDNA test.
- Population benefits from blood tests were seen only in those who declined colonoscopy and stool tests. Substituting a blood test for those already using colonoscopy or stool tests led to worse population-level outcomes.
IN PRACTICE:
“First-generation novel cf-bDNA tests have the potential to decrease meaningfully the incidence and mortality of CRC compared with no screening but substantially less profoundly than screening colonoscopy or stool tests. Net population benefit or harm can follow incorporation of first-generation cf-bDNA CRC screening tests into practice, depending on the balance between bringing unscreened persons into screening (addition) vs shifting persons away from the more effective strategies of colonoscopy or stool testing (substitution),” the authors concluded.
SOURCE:
The study, with first author Uri Ladabaum, MD, MS, Stanford University School of Medicine, California, was published online in Annals of Internal Medicine.
LIMITATIONS:
Limitations included test-specific participation patterns being unknown over time.
DISCLOSURES:
Disclosure forms for the authors are available with the article online. Funding was provided by the Gorrindo Family Fund.
A version of this article appeared on Medscape.com.
Revumenib Approved for R/R Acute Leukemia With KMT2A Translocation
The approval makes the oral small-molecule menin inhibitor the first pharmaceutical to carry the indication. It blocks the binding of menin to mutated KMT2A fusion proteins, tamping down the process that leads to the disease.
Although a relatively uncommon form of leukemia, KMT2A rearrangements are a major driver of acute leukemia in infants.
Approval was based on a single-arm of the open-label AUGMENT-101 trial with 104 adult and pediatric patients with the mutation. Pediatric patients were at least 30 days old.
The rate of complete remission (CR) plus CR with partial hematologic recovery was 21.2% (22 patients) with a median duration of 6.4 months. The median time to remission was 1.9 months.
Eighty-three patients required blood cell and/or platelet transfusions at baseline; 12 (14%) did not need transfusions for 56 days afterward. Of the 21 who were transfusion free at baseline, 10 (48%) remained so over the same period.
The most common adverse reactions in 20% or more of patients were hemorrhage, nausea, increased phosphate, musculoskeletal pain, infection, increased aspartate aminotransferase, febrile neutropenia, increased alanine aminotransferase, increased intact parathyroid hormone, bacterial infection, diarrhea, differentiation syndrome, electrocardiogram QT prolonged, decreased phosphate, increased triglycerides, decreased potassium, decreased appetite, constipation, edema, viral infection, fatigue, and increased alkaline phosphatase.
The recommended dose varies by weight and concomitant use of strong CYP3A4 inhibitors. Because of an anticipated delay in commercial availability, the lowest strength dose of revumenib will be available through an expanded access program for patients who weigh < 40 kg.
A version of this article appeared on Medscape.com.
The approval makes the oral small-molecule menin inhibitor the first pharmaceutical to carry the indication. It blocks the binding of menin to mutated KMT2A fusion proteins, tamping down the process that leads to the disease.
Although a relatively uncommon form of leukemia, KMT2A rearrangements are a major driver of acute leukemia in infants.
Approval was based on a single-arm of the open-label AUGMENT-101 trial with 104 adult and pediatric patients with the mutation. Pediatric patients were at least 30 days old.
The rate of complete remission (CR) plus CR with partial hematologic recovery was 21.2% (22 patients) with a median duration of 6.4 months. The median time to remission was 1.9 months.
Eighty-three patients required blood cell and/or platelet transfusions at baseline; 12 (14%) did not need transfusions for 56 days afterward. Of the 21 who were transfusion free at baseline, 10 (48%) remained so over the same period.
The most common adverse reactions in 20% or more of patients were hemorrhage, nausea, increased phosphate, musculoskeletal pain, infection, increased aspartate aminotransferase, febrile neutropenia, increased alanine aminotransferase, increased intact parathyroid hormone, bacterial infection, diarrhea, differentiation syndrome, electrocardiogram QT prolonged, decreased phosphate, increased triglycerides, decreased potassium, decreased appetite, constipation, edema, viral infection, fatigue, and increased alkaline phosphatase.
The recommended dose varies by weight and concomitant use of strong CYP3A4 inhibitors. Because of an anticipated delay in commercial availability, the lowest strength dose of revumenib will be available through an expanded access program for patients who weigh < 40 kg.
A version of this article appeared on Medscape.com.
The approval makes the oral small-molecule menin inhibitor the first pharmaceutical to carry the indication. It blocks the binding of menin to mutated KMT2A fusion proteins, tamping down the process that leads to the disease.
Although a relatively uncommon form of leukemia, KMT2A rearrangements are a major driver of acute leukemia in infants.
Approval was based on a single-arm of the open-label AUGMENT-101 trial with 104 adult and pediatric patients with the mutation. Pediatric patients were at least 30 days old.
The rate of complete remission (CR) plus CR with partial hematologic recovery was 21.2% (22 patients) with a median duration of 6.4 months. The median time to remission was 1.9 months.
Eighty-three patients required blood cell and/or platelet transfusions at baseline; 12 (14%) did not need transfusions for 56 days afterward. Of the 21 who were transfusion free at baseline, 10 (48%) remained so over the same period.
The most common adverse reactions in 20% or more of patients were hemorrhage, nausea, increased phosphate, musculoskeletal pain, infection, increased aspartate aminotransferase, febrile neutropenia, increased alanine aminotransferase, increased intact parathyroid hormone, bacterial infection, diarrhea, differentiation syndrome, electrocardiogram QT prolonged, decreased phosphate, increased triglycerides, decreased potassium, decreased appetite, constipation, edema, viral infection, fatigue, and increased alkaline phosphatase.
The recommended dose varies by weight and concomitant use of strong CYP3A4 inhibitors. Because of an anticipated delay in commercial availability, the lowest strength dose of revumenib will be available through an expanded access program for patients who weigh < 40 kg.
A version of this article appeared on Medscape.com.
New Strategy Led to Modest Decline in Antibiotic Misuse
TOPLINE:
particularly in general practice.
METHODOLOGY:
- Researchers conducted this study to assess the impact of an intervention on antibiotic prescribing and dispensing for common infections.
- Healthcare professionals from general practice, out-of-hours services, nursing homes, and community pharmacies in France, Greece, Lithuania, Poland, and Spain registered their interactions with patients related to antibiotic prescribing and dispensing both prior to and following the intervention.
- Overall, 407 healthcare professionals participated in the first registration, of whom 345 undertook the intervention and participated in the second registration; they documented 10,744 infections during the initial registration and 10,132 cases during the second period.
- The 5-hour intervention included evaluating and discussing feedback on the outcomes of the initial registration, improving communication skills, and offering communication tools.
- The impact of this intervention was calculated from potential unnecessary antibiotic prescriptions, non–first-line antibiotic choices, and percentage of good and wrong safety advice given for each prescription.
TAKEAWAY:
- General practice clinicians showed a significant overall reduction in unnecessary antibiotic prescriptions from 72.2% during the first registration to 65.2% after the intervention (P < .001), with variations across countries ranging from a 19.9% reduction in Lithuania to a 1.3% increase in Greece.
- Out-of-hours services showed a minimal change in unnecessary antibiotic prescribing from 52.5% to 52.1%, whereas nursing homes showed a slight increase from 56.1% to 58.6%.
- Community pharmacies showed significant improvements, with the provision of correct advice increasing by 17% (P < .001) and safety checks improving from 47% to 55.3% in 1 year (P < .001).
- However, the choice of non–first-line antibiotics significantly increased by 29.2% in the second registration period (P < .001).
IN PRACTICE:
“These findings highlight the need for alternative and tailored approaches in antimicrobial stewardship programs in long-term care facilities, with a greater focus on nurses. This includes implementing hygiene measures and empowering nurses to improve the diagnosis of suspected infections, such as urinary tract infections, while debunking prevalent myths and providing clear-cut information for better management of these common infections,” the authors wrote.
SOURCE:
The study was led by Ana García-Sangenís, of Fundació Institut Universitari per a la Recerca a l’Atenció Primària de Salut Jordi Gol i Gurina, Barcelona, Spain, and was published online on November 12, 2024, in Family Practice.
LIMITATIONS:
The study lacked a control group, which limited the ability to attribute changes solely to the intervention. The voluntary participation of healthcare professionals might have introduced selection bias, as participants might have had a greater interest in quality improvement programs than the general population of healthcare providers. Clinical outcomes were not evaluated, which may have created ambiguity regarding whether complication rates or clinical failures varied between the groups.
DISCLOSURES:
This study received funding from the European Union’s Third Health Programme. One author reported receiving fees from pharmaceutical companies and acting as a member of the board of Steno Diabetes Center, Odense, Denmark.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
particularly in general practice.
METHODOLOGY:
- Researchers conducted this study to assess the impact of an intervention on antibiotic prescribing and dispensing for common infections.
- Healthcare professionals from general practice, out-of-hours services, nursing homes, and community pharmacies in France, Greece, Lithuania, Poland, and Spain registered their interactions with patients related to antibiotic prescribing and dispensing both prior to and following the intervention.
- Overall, 407 healthcare professionals participated in the first registration, of whom 345 undertook the intervention and participated in the second registration; they documented 10,744 infections during the initial registration and 10,132 cases during the second period.
- The 5-hour intervention included evaluating and discussing feedback on the outcomes of the initial registration, improving communication skills, and offering communication tools.
- The impact of this intervention was calculated from potential unnecessary antibiotic prescriptions, non–first-line antibiotic choices, and percentage of good and wrong safety advice given for each prescription.
TAKEAWAY:
- General practice clinicians showed a significant overall reduction in unnecessary antibiotic prescriptions from 72.2% during the first registration to 65.2% after the intervention (P < .001), with variations across countries ranging from a 19.9% reduction in Lithuania to a 1.3% increase in Greece.
- Out-of-hours services showed a minimal change in unnecessary antibiotic prescribing from 52.5% to 52.1%, whereas nursing homes showed a slight increase from 56.1% to 58.6%.
- Community pharmacies showed significant improvements, with the provision of correct advice increasing by 17% (P < .001) and safety checks improving from 47% to 55.3% in 1 year (P < .001).
- However, the choice of non–first-line antibiotics significantly increased by 29.2% in the second registration period (P < .001).
IN PRACTICE:
“These findings highlight the need for alternative and tailored approaches in antimicrobial stewardship programs in long-term care facilities, with a greater focus on nurses. This includes implementing hygiene measures and empowering nurses to improve the diagnosis of suspected infections, such as urinary tract infections, while debunking prevalent myths and providing clear-cut information for better management of these common infections,” the authors wrote.
SOURCE:
The study was led by Ana García-Sangenís, of Fundació Institut Universitari per a la Recerca a l’Atenció Primària de Salut Jordi Gol i Gurina, Barcelona, Spain, and was published online on November 12, 2024, in Family Practice.
LIMITATIONS:
The study lacked a control group, which limited the ability to attribute changes solely to the intervention. The voluntary participation of healthcare professionals might have introduced selection bias, as participants might have had a greater interest in quality improvement programs than the general population of healthcare providers. Clinical outcomes were not evaluated, which may have created ambiguity regarding whether complication rates or clinical failures varied between the groups.
DISCLOSURES:
This study received funding from the European Union’s Third Health Programme. One author reported receiving fees from pharmaceutical companies and acting as a member of the board of Steno Diabetes Center, Odense, Denmark.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
particularly in general practice.
METHODOLOGY:
- Researchers conducted this study to assess the impact of an intervention on antibiotic prescribing and dispensing for common infections.
- Healthcare professionals from general practice, out-of-hours services, nursing homes, and community pharmacies in France, Greece, Lithuania, Poland, and Spain registered their interactions with patients related to antibiotic prescribing and dispensing both prior to and following the intervention.
- Overall, 407 healthcare professionals participated in the first registration, of whom 345 undertook the intervention and participated in the second registration; they documented 10,744 infections during the initial registration and 10,132 cases during the second period.
- The 5-hour intervention included evaluating and discussing feedback on the outcomes of the initial registration, improving communication skills, and offering communication tools.
- The impact of this intervention was calculated from potential unnecessary antibiotic prescriptions, non–first-line antibiotic choices, and percentage of good and wrong safety advice given for each prescription.
TAKEAWAY:
- General practice clinicians showed a significant overall reduction in unnecessary antibiotic prescriptions from 72.2% during the first registration to 65.2% after the intervention (P < .001), with variations across countries ranging from a 19.9% reduction in Lithuania to a 1.3% increase in Greece.
- Out-of-hours services showed a minimal change in unnecessary antibiotic prescribing from 52.5% to 52.1%, whereas nursing homes showed a slight increase from 56.1% to 58.6%.
- Community pharmacies showed significant improvements, with the provision of correct advice increasing by 17% (P < .001) and safety checks improving from 47% to 55.3% in 1 year (P < .001).
- However, the choice of non–first-line antibiotics significantly increased by 29.2% in the second registration period (P < .001).
IN PRACTICE:
“These findings highlight the need for alternative and tailored approaches in antimicrobial stewardship programs in long-term care facilities, with a greater focus on nurses. This includes implementing hygiene measures and empowering nurses to improve the diagnosis of suspected infections, such as urinary tract infections, while debunking prevalent myths and providing clear-cut information for better management of these common infections,” the authors wrote.
SOURCE:
The study was led by Ana García-Sangenís, of Fundació Institut Universitari per a la Recerca a l’Atenció Primària de Salut Jordi Gol i Gurina, Barcelona, Spain, and was published online on November 12, 2024, in Family Practice.
LIMITATIONS:
The study lacked a control group, which limited the ability to attribute changes solely to the intervention. The voluntary participation of healthcare professionals might have introduced selection bias, as participants might have had a greater interest in quality improvement programs than the general population of healthcare providers. Clinical outcomes were not evaluated, which may have created ambiguity regarding whether complication rates or clinical failures varied between the groups.
DISCLOSURES:
This study received funding from the European Union’s Third Health Programme. One author reported receiving fees from pharmaceutical companies and acting as a member of the board of Steno Diabetes Center, Odense, Denmark.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Tips on Handling a Negative Patient Review
LAS VEGAS —
“It said something like, ‘Do not see Joe the fake doctor. Joe should have his medical license pulled. He didn’t listen to me. He threw drugs at me and he only talked to me for 5 minutes,’ ” Cari, who practices at the University of Colorado Anschutz Medical Campus, Aurora, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Being early in my practice, that hurt; it was a jab to the heart. I had about 20-30 five-star reviews, but I laser-focused on the bad one.”
When a review questions competence, it can feel personal, he continued, even though it often reflects the reviewer’s emotions or experience. Cari, a former Marine, said that clinicians can mitigate emotional responses to negative reviews by building emotional resilience. He draws inspiration from Stoicism (the school of philosophy that originated during the Hellenistic period), which emphasizes developing inner resilience, managing emotions, “and cultivating virtues such as wisdom, courage, and self-discipline,” he said.
Cari often cites a quote from Marcus Aurelius, the former Roman Emperor and Stoic philosopher: “You have power over your mind — not outside events. Realize this, and you will find strength.” Another quote that changed his perspective comes from the Stoic Epictetus: “We cannot control the external events around us, but we can control our reactions to them.”
On a practical level, Cari shared several ways that clinicians can cultivate emotional resilience when faced with a negative review.
Practice mindfulness. Reading reviews in a nonjudgmental way “allows us to pause, reflect, and respond thoughtfully rather than react emotionally,” he explained. He also recommended setting clear boundaries between work and personal life to prevent burnout and maintain a healthy work–life balance. Realizing he needed time to decompress after a previous job that involved a 1-hour drive, he began listening to audiobooks on his way home. “I set that time aside for myself to listen, relax, and let all my troubles from work melt away,” Cari said.
Develop a support network. This includes both professionals, such as therapists, and personal connections, such as colleagues, mentors, and friends.
Practice self-care. Whether it’s yoga, running, jogging, spending time with loved ones, or playing with your dog, find activities that help you recharge. “Most importantly, get some rest and take a vacation,” Cari advised. “Your body is like a machine. If you do not rest it and take care of it, it will slowly breakdown and burnout.”
Practice equanimity. Cari defined this as mental calmness, composure, and evenness of temper, especially in a difficult situation. “Maintaining a calm and balanced state of mind, regardless of external circumstances, is a core Stoic and military practice,” he said.
According to data he attributed to reviewtrackers, an estimated 60% of reviews are influenced by the reviewer’s personal stress or mood, “so don’t take [bad reviews] personally,” he said. Instead, view criticism as an opportunity for self-improvement and to gain insight into others’ perspectives. Cari recommended practicing indifference to both praise and blame. “Do not seek validation or be disheartened by negative reviews,” he said. “Remain focused on your own standards of excellence.”
Cari has reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
LAS VEGAS —
“It said something like, ‘Do not see Joe the fake doctor. Joe should have his medical license pulled. He didn’t listen to me. He threw drugs at me and he only talked to me for 5 minutes,’ ” Cari, who practices at the University of Colorado Anschutz Medical Campus, Aurora, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Being early in my practice, that hurt; it was a jab to the heart. I had about 20-30 five-star reviews, but I laser-focused on the bad one.”
When a review questions competence, it can feel personal, he continued, even though it often reflects the reviewer’s emotions or experience. Cari, a former Marine, said that clinicians can mitigate emotional responses to negative reviews by building emotional resilience. He draws inspiration from Stoicism (the school of philosophy that originated during the Hellenistic period), which emphasizes developing inner resilience, managing emotions, “and cultivating virtues such as wisdom, courage, and self-discipline,” he said.
Cari often cites a quote from Marcus Aurelius, the former Roman Emperor and Stoic philosopher: “You have power over your mind — not outside events. Realize this, and you will find strength.” Another quote that changed his perspective comes from the Stoic Epictetus: “We cannot control the external events around us, but we can control our reactions to them.”
On a practical level, Cari shared several ways that clinicians can cultivate emotional resilience when faced with a negative review.
Practice mindfulness. Reading reviews in a nonjudgmental way “allows us to pause, reflect, and respond thoughtfully rather than react emotionally,” he explained. He also recommended setting clear boundaries between work and personal life to prevent burnout and maintain a healthy work–life balance. Realizing he needed time to decompress after a previous job that involved a 1-hour drive, he began listening to audiobooks on his way home. “I set that time aside for myself to listen, relax, and let all my troubles from work melt away,” Cari said.
Develop a support network. This includes both professionals, such as therapists, and personal connections, such as colleagues, mentors, and friends.
Practice self-care. Whether it’s yoga, running, jogging, spending time with loved ones, or playing with your dog, find activities that help you recharge. “Most importantly, get some rest and take a vacation,” Cari advised. “Your body is like a machine. If you do not rest it and take care of it, it will slowly breakdown and burnout.”
Practice equanimity. Cari defined this as mental calmness, composure, and evenness of temper, especially in a difficult situation. “Maintaining a calm and balanced state of mind, regardless of external circumstances, is a core Stoic and military practice,” he said.
According to data he attributed to reviewtrackers, an estimated 60% of reviews are influenced by the reviewer’s personal stress or mood, “so don’t take [bad reviews] personally,” he said. Instead, view criticism as an opportunity for self-improvement and to gain insight into others’ perspectives. Cari recommended practicing indifference to both praise and blame. “Do not seek validation or be disheartened by negative reviews,” he said. “Remain focused on your own standards of excellence.”
Cari has reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
LAS VEGAS —
“It said something like, ‘Do not see Joe the fake doctor. Joe should have his medical license pulled. He didn’t listen to me. He threw drugs at me and he only talked to me for 5 minutes,’ ” Cari, who practices at the University of Colorado Anschutz Medical Campus, Aurora, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Being early in my practice, that hurt; it was a jab to the heart. I had about 20-30 five-star reviews, but I laser-focused on the bad one.”
When a review questions competence, it can feel personal, he continued, even though it often reflects the reviewer’s emotions or experience. Cari, a former Marine, said that clinicians can mitigate emotional responses to negative reviews by building emotional resilience. He draws inspiration from Stoicism (the school of philosophy that originated during the Hellenistic period), which emphasizes developing inner resilience, managing emotions, “and cultivating virtues such as wisdom, courage, and self-discipline,” he said.
Cari often cites a quote from Marcus Aurelius, the former Roman Emperor and Stoic philosopher: “You have power over your mind — not outside events. Realize this, and you will find strength.” Another quote that changed his perspective comes from the Stoic Epictetus: “We cannot control the external events around us, but we can control our reactions to them.”
On a practical level, Cari shared several ways that clinicians can cultivate emotional resilience when faced with a negative review.
Practice mindfulness. Reading reviews in a nonjudgmental way “allows us to pause, reflect, and respond thoughtfully rather than react emotionally,” he explained. He also recommended setting clear boundaries between work and personal life to prevent burnout and maintain a healthy work–life balance. Realizing he needed time to decompress after a previous job that involved a 1-hour drive, he began listening to audiobooks on his way home. “I set that time aside for myself to listen, relax, and let all my troubles from work melt away,” Cari said.
Develop a support network. This includes both professionals, such as therapists, and personal connections, such as colleagues, mentors, and friends.
Practice self-care. Whether it’s yoga, running, jogging, spending time with loved ones, or playing with your dog, find activities that help you recharge. “Most importantly, get some rest and take a vacation,” Cari advised. “Your body is like a machine. If you do not rest it and take care of it, it will slowly breakdown and burnout.”
Practice equanimity. Cari defined this as mental calmness, composure, and evenness of temper, especially in a difficult situation. “Maintaining a calm and balanced state of mind, regardless of external circumstances, is a core Stoic and military practice,” he said.
According to data he attributed to reviewtrackers, an estimated 60% of reviews are influenced by the reviewer’s personal stress or mood, “so don’t take [bad reviews] personally,” he said. Instead, view criticism as an opportunity for self-improvement and to gain insight into others’ perspectives. Cari recommended practicing indifference to both praise and blame. “Do not seek validation or be disheartened by negative reviews,” he said. “Remain focused on your own standards of excellence.”
Cari has reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM SDPA 24
Expert Reviews Options for Revitalizing Dystrophic Nails
LAS VEGAS —
“With the fingernails, we don’t often see onychomycosis, but with toenails, we certainly do,” Tracey C. Vlahovic, DPM, a professor at the Samuel Merritt University College of Podiatric Medicine, Oakland, California, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “But toenails are subject to a lot of forces beyond just fungal [infections]. We have the wear and tear of wearing shoes, gait, and other physical activity.”
For example, she continued, some runners develop second-toenail dystrophy “because there’s constant repetitive trauma to the toenail, and [poorly fitting] shoes can contribute to that. Biomechanical issues are a unique consideration when you’re dealing with toenail issues.”
Vlahovic highlighted several options that can help improve the appearance of dystrophic nails as they recover or grow back:
Urea nail preparations: To temporarily soften the nail.
Genadur (hydroxypropyl chitosan): This product “is used mainly for psoriatic nails, but I use it for all different kinds of nail dystrophy,” she said.
DermaNail (acetyl mandelic acid solution): This can be used for brittle nails and fingernails. Vlahovic said she recommends it be used on toenails “in addition to the onychomycosis and other nail dystrophy treatments that I’m doing because it really helps to hydrate the nail unit.”
Kerasal Fungal Nail Renewal (ingredients include propylene glycol, urea, glycerin, and lactic acid): This product is used “for smoothing out the appearance of the nail,” she said.
KeryFlex: Applied in an office setting, this resin-based product restores the appearance of an individual’s natural nails. “It comes in two colors [and] absorbs the shock of what is going on mechanically with the feet,” Vlahovic said. “So, if I’m treating a ballet dancer performing en pointe, or a soccer player, it’s something I can use to protect the nail, but also to make it cosmetically more acceptable.”
NECPro: A nail reconstruction method that involves the use of a composite used mainly by podiatrists, it “helps you not only create a barrier, but to create a natural-looking color that matches your own nail color,” she said.
In Vlahovic’s experience, KeryFlex and NECPro last 6-8 weeks. “You can use nail polish on top of them if you’d like, but they’re basically cosmetic barriers to protect the nail unit,” she said.
Vlahovic has disclosed being a consultant and investigator for Ortho Dermatologics and Sagis Diagnostics.
A version of this article appeared on Medscape.com.
LAS VEGAS —
“With the fingernails, we don’t often see onychomycosis, but with toenails, we certainly do,” Tracey C. Vlahovic, DPM, a professor at the Samuel Merritt University College of Podiatric Medicine, Oakland, California, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “But toenails are subject to a lot of forces beyond just fungal [infections]. We have the wear and tear of wearing shoes, gait, and other physical activity.”
For example, she continued, some runners develop second-toenail dystrophy “because there’s constant repetitive trauma to the toenail, and [poorly fitting] shoes can contribute to that. Biomechanical issues are a unique consideration when you’re dealing with toenail issues.”
Vlahovic highlighted several options that can help improve the appearance of dystrophic nails as they recover or grow back:
Urea nail preparations: To temporarily soften the nail.
Genadur (hydroxypropyl chitosan): This product “is used mainly for psoriatic nails, but I use it for all different kinds of nail dystrophy,” she said.
DermaNail (acetyl mandelic acid solution): This can be used for brittle nails and fingernails. Vlahovic said she recommends it be used on toenails “in addition to the onychomycosis and other nail dystrophy treatments that I’m doing because it really helps to hydrate the nail unit.”
Kerasal Fungal Nail Renewal (ingredients include propylene glycol, urea, glycerin, and lactic acid): This product is used “for smoothing out the appearance of the nail,” she said.
KeryFlex: Applied in an office setting, this resin-based product restores the appearance of an individual’s natural nails. “It comes in two colors [and] absorbs the shock of what is going on mechanically with the feet,” Vlahovic said. “So, if I’m treating a ballet dancer performing en pointe, or a soccer player, it’s something I can use to protect the nail, but also to make it cosmetically more acceptable.”
NECPro: A nail reconstruction method that involves the use of a composite used mainly by podiatrists, it “helps you not only create a barrier, but to create a natural-looking color that matches your own nail color,” she said.
In Vlahovic’s experience, KeryFlex and NECPro last 6-8 weeks. “You can use nail polish on top of them if you’d like, but they’re basically cosmetic barriers to protect the nail unit,” she said.
Vlahovic has disclosed being a consultant and investigator for Ortho Dermatologics and Sagis Diagnostics.
A version of this article appeared on Medscape.com.
LAS VEGAS —
“With the fingernails, we don’t often see onychomycosis, but with toenails, we certainly do,” Tracey C. Vlahovic, DPM, a professor at the Samuel Merritt University College of Podiatric Medicine, Oakland, California, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “But toenails are subject to a lot of forces beyond just fungal [infections]. We have the wear and tear of wearing shoes, gait, and other physical activity.”
For example, she continued, some runners develop second-toenail dystrophy “because there’s constant repetitive trauma to the toenail, and [poorly fitting] shoes can contribute to that. Biomechanical issues are a unique consideration when you’re dealing with toenail issues.”
Vlahovic highlighted several options that can help improve the appearance of dystrophic nails as they recover or grow back:
Urea nail preparations: To temporarily soften the nail.
Genadur (hydroxypropyl chitosan): This product “is used mainly for psoriatic nails, but I use it for all different kinds of nail dystrophy,” she said.
DermaNail (acetyl mandelic acid solution): This can be used for brittle nails and fingernails. Vlahovic said she recommends it be used on toenails “in addition to the onychomycosis and other nail dystrophy treatments that I’m doing because it really helps to hydrate the nail unit.”
Kerasal Fungal Nail Renewal (ingredients include propylene glycol, urea, glycerin, and lactic acid): This product is used “for smoothing out the appearance of the nail,” she said.
KeryFlex: Applied in an office setting, this resin-based product restores the appearance of an individual’s natural nails. “It comes in two colors [and] absorbs the shock of what is going on mechanically with the feet,” Vlahovic said. “So, if I’m treating a ballet dancer performing en pointe, or a soccer player, it’s something I can use to protect the nail, but also to make it cosmetically more acceptable.”
NECPro: A nail reconstruction method that involves the use of a composite used mainly by podiatrists, it “helps you not only create a barrier, but to create a natural-looking color that matches your own nail color,” she said.
In Vlahovic’s experience, KeryFlex and NECPro last 6-8 weeks. “You can use nail polish on top of them if you’d like, but they’re basically cosmetic barriers to protect the nail unit,” she said.
Vlahovic has disclosed being a consultant and investigator for Ortho Dermatologics and Sagis Diagnostics.
A version of this article appeared on Medscape.com.
FROM SDPA 24
Key Updates in Resuscitation Procedure After Drowning
New recommendations on rescuing adults and children who have drowned include an important update for healthcare professionals, trained rescuers, and untrained lay rescuers.
The American Heart Association (AHA) and the American Academy of Pediatrics (AAP) have issued recommendations that highlight delivering rescue breaths as well as calling 911 and performing chest compressions in cardiopulmonary resuscitation (CPR) as first steps when a person pulled from the water is in cardiac arrest.
This is the first collaboration between the two organizations on resuscitation after drowning. The recommendations were published simultaneously in Circulation and Pediatrics.
Included in the recommendations are two key principles:
- Anyone pulled from the water who has no signs of normal breathing or consciousness should be presumed to be in cardiac arrest.
- Rescuers should immediately start CPR that includes rescue breathing in addition to chest compressions. Multiple large studies show more people with cardiac arrest from noncardiac causes such as drowning survive when CPR includes rescue breaths, compared with hands-only CPR (calling 911 and pushing hard and fast in the center of the chest).
If someone is untrained, unwilling, or unable to give breaths, they can perform chest compressions until help arrives, the recommendations advise.
Reasoning Behind the Update
The authors, led by writing group cochair Tracy E. McCallin, MD, associate professor in the division of pediatric emergency medicine at Rainbow Babies and Children’s Hospital in Cleveland , Ohio, explained that drowning generally advances from initial respiratory arrest from submersion-related hypoxia to cardiac arrest, and therefore it can be difficult to distinguish respiratory arrest from cardiac arrest because pulses are difficult to accurately palpate within the recommended 10-second window.
“Therefore, resuscitation from cardiac arrest due to this specific circumstance must focus on restoring breathing as much as it does circulation,” the authors wrote.
Resuscitation after drowning may begin in the water with rescue breathing when safely provided by trained rescuers and should continue with chest compressions, once the drowned person and the rescuer are on land or in a boat, the report authors wrote.
“The focused update on drowning contains the most up-to-date, evidence-based recommendations on how to resuscitate someone who has drowned,” McCallin states in a press release.
In addition to the new guidance on rescue breaths, the update includes new topics that the AHA has not previously addressed with treatment recommendations, such as oxygen administration after drowning; automated external defibrillator use in cardiac arrest after drowning and public-access defibrillation programs.
Pediatricians Can Help Spread the Word
Alexandra Stern, MD, assistant professor in the Department of Pediatrics at University of Florida, Gainesville, who was not part of the update, said pediatricians can help disseminate this new information.
“Water safety is a topic frequently discussed as a pediatrician, with focus often being on primary prevention of drowning,” she said. “We stress the importance of the multiple layers of protection against drowning, such as touch supervision (staying within arm’s length); secure fencing, access to appropriate life jackets, and teaching our children to swim. Learning CPR is a large part of these measures and continuing these discussions with our patients and families is important.”
She added that updating the recommended procedures will likely require changes to all forms of education and community outreach regarding drowning from basic life support classes to more advanced lifeguard training. She noted that the update provides practical guidance not just for trained rescuers and healthcare professionals, but also for family members.
The paper notes that drowning is the third leading cause of death from unintentional injury globally, accounting for 7% of all injury-related deaths. In the United States, drowning is the leading cause of death in children aged 1-4 years and the second leading cause of death from unintentional injury in children aged 5-14 years.
The update is based on systematic reviews from 2021 to 2023 performed by the International Liaison Committee on Resuscitation related to the resuscitation of drowning.
The authors and Stern reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
New recommendations on rescuing adults and children who have drowned include an important update for healthcare professionals, trained rescuers, and untrained lay rescuers.
The American Heart Association (AHA) and the American Academy of Pediatrics (AAP) have issued recommendations that highlight delivering rescue breaths as well as calling 911 and performing chest compressions in cardiopulmonary resuscitation (CPR) as first steps when a person pulled from the water is in cardiac arrest.
This is the first collaboration between the two organizations on resuscitation after drowning. The recommendations were published simultaneously in Circulation and Pediatrics.
Included in the recommendations are two key principles:
- Anyone pulled from the water who has no signs of normal breathing or consciousness should be presumed to be in cardiac arrest.
- Rescuers should immediately start CPR that includes rescue breathing in addition to chest compressions. Multiple large studies show more people with cardiac arrest from noncardiac causes such as drowning survive when CPR includes rescue breaths, compared with hands-only CPR (calling 911 and pushing hard and fast in the center of the chest).
If someone is untrained, unwilling, or unable to give breaths, they can perform chest compressions until help arrives, the recommendations advise.
Reasoning Behind the Update
The authors, led by writing group cochair Tracy E. McCallin, MD, associate professor in the division of pediatric emergency medicine at Rainbow Babies and Children’s Hospital in Cleveland , Ohio, explained that drowning generally advances from initial respiratory arrest from submersion-related hypoxia to cardiac arrest, and therefore it can be difficult to distinguish respiratory arrest from cardiac arrest because pulses are difficult to accurately palpate within the recommended 10-second window.
“Therefore, resuscitation from cardiac arrest due to this specific circumstance must focus on restoring breathing as much as it does circulation,” the authors wrote.
Resuscitation after drowning may begin in the water with rescue breathing when safely provided by trained rescuers and should continue with chest compressions, once the drowned person and the rescuer are on land or in a boat, the report authors wrote.
“The focused update on drowning contains the most up-to-date, evidence-based recommendations on how to resuscitate someone who has drowned,” McCallin states in a press release.
In addition to the new guidance on rescue breaths, the update includes new topics that the AHA has not previously addressed with treatment recommendations, such as oxygen administration after drowning; automated external defibrillator use in cardiac arrest after drowning and public-access defibrillation programs.
Pediatricians Can Help Spread the Word
Alexandra Stern, MD, assistant professor in the Department of Pediatrics at University of Florida, Gainesville, who was not part of the update, said pediatricians can help disseminate this new information.
“Water safety is a topic frequently discussed as a pediatrician, with focus often being on primary prevention of drowning,” she said. “We stress the importance of the multiple layers of protection against drowning, such as touch supervision (staying within arm’s length); secure fencing, access to appropriate life jackets, and teaching our children to swim. Learning CPR is a large part of these measures and continuing these discussions with our patients and families is important.”
She added that updating the recommended procedures will likely require changes to all forms of education and community outreach regarding drowning from basic life support classes to more advanced lifeguard training. She noted that the update provides practical guidance not just for trained rescuers and healthcare professionals, but also for family members.
The paper notes that drowning is the third leading cause of death from unintentional injury globally, accounting for 7% of all injury-related deaths. In the United States, drowning is the leading cause of death in children aged 1-4 years and the second leading cause of death from unintentional injury in children aged 5-14 years.
The update is based on systematic reviews from 2021 to 2023 performed by the International Liaison Committee on Resuscitation related to the resuscitation of drowning.
The authors and Stern reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
New recommendations on rescuing adults and children who have drowned include an important update for healthcare professionals, trained rescuers, and untrained lay rescuers.
The American Heart Association (AHA) and the American Academy of Pediatrics (AAP) have issued recommendations that highlight delivering rescue breaths as well as calling 911 and performing chest compressions in cardiopulmonary resuscitation (CPR) as first steps when a person pulled from the water is in cardiac arrest.
This is the first collaboration between the two organizations on resuscitation after drowning. The recommendations were published simultaneously in Circulation and Pediatrics.
Included in the recommendations are two key principles:
- Anyone pulled from the water who has no signs of normal breathing or consciousness should be presumed to be in cardiac arrest.
- Rescuers should immediately start CPR that includes rescue breathing in addition to chest compressions. Multiple large studies show more people with cardiac arrest from noncardiac causes such as drowning survive when CPR includes rescue breaths, compared with hands-only CPR (calling 911 and pushing hard and fast in the center of the chest).
If someone is untrained, unwilling, or unable to give breaths, they can perform chest compressions until help arrives, the recommendations advise.
Reasoning Behind the Update
The authors, led by writing group cochair Tracy E. McCallin, MD, associate professor in the division of pediatric emergency medicine at Rainbow Babies and Children’s Hospital in Cleveland , Ohio, explained that drowning generally advances from initial respiratory arrest from submersion-related hypoxia to cardiac arrest, and therefore it can be difficult to distinguish respiratory arrest from cardiac arrest because pulses are difficult to accurately palpate within the recommended 10-second window.
“Therefore, resuscitation from cardiac arrest due to this specific circumstance must focus on restoring breathing as much as it does circulation,” the authors wrote.
Resuscitation after drowning may begin in the water with rescue breathing when safely provided by trained rescuers and should continue with chest compressions, once the drowned person and the rescuer are on land or in a boat, the report authors wrote.
“The focused update on drowning contains the most up-to-date, evidence-based recommendations on how to resuscitate someone who has drowned,” McCallin states in a press release.
In addition to the new guidance on rescue breaths, the update includes new topics that the AHA has not previously addressed with treatment recommendations, such as oxygen administration after drowning; automated external defibrillator use in cardiac arrest after drowning and public-access defibrillation programs.
Pediatricians Can Help Spread the Word
Alexandra Stern, MD, assistant professor in the Department of Pediatrics at University of Florida, Gainesville, who was not part of the update, said pediatricians can help disseminate this new information.
“Water safety is a topic frequently discussed as a pediatrician, with focus often being on primary prevention of drowning,” she said. “We stress the importance of the multiple layers of protection against drowning, such as touch supervision (staying within arm’s length); secure fencing, access to appropriate life jackets, and teaching our children to swim. Learning CPR is a large part of these measures and continuing these discussions with our patients and families is important.”
She added that updating the recommended procedures will likely require changes to all forms of education and community outreach regarding drowning from basic life support classes to more advanced lifeguard training. She noted that the update provides practical guidance not just for trained rescuers and healthcare professionals, but also for family members.
The paper notes that drowning is the third leading cause of death from unintentional injury globally, accounting for 7% of all injury-related deaths. In the United States, drowning is the leading cause of death in children aged 1-4 years and the second leading cause of death from unintentional injury in children aged 5-14 years.
The update is based on systematic reviews from 2021 to 2023 performed by the International Liaison Committee on Resuscitation related to the resuscitation of drowning.
The authors and Stern reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
From Pediatrics
From Primary Care to Specialization: How PAs Make a Specialty Switch
Physician assistants (PAs) are educated as generalists — with the ability to switch medical specialties during their careers. Andrzej Kozikowski, PhD, senior director of research at the National Commission on Certification of Physician Assistants (NCCPA), said that having that kind of career flexibility is often a motivating factor for students who pursue the PA path.
“If you look at the research literature on physicians, you can see that choosing a specialty can be quite stressful,” he told this news organization. “It’s a lifelong decision. You have to commit to a residency, maybe fellowship training, and if you don’t like it and want to switch your specialty, you have to go back and do it again. It’s a decision that weighs heavily on your [physicians] shoulders.”
The PA profession, however, offers lateral movement. Rachel Porter, PhD, interim director of preclinical education at PA program, Duke University, Durham, North Carolina, said that the didactic portion of a PA’s medical education is very broad to support that kind of flexibility. And most PA students, depending on their program, have the opportunity to go through several clinical rotations to see which specialty might be the best fit.
“That initial medical education is meant to provide a good foundation across all systems, across all age groups, subpopulations, and settings — hospital, ambulatory, or outpatient,” she explained. “Once they are exposed to clinical experiences later, we find that students discover their niche and where they want to be once they start their career.”
Making a Lateral Move
According to the 2022 Statistical Profile of Board-Certified PAs by Specialty, based on a survey conducted by the NCCPA, approximately half of board-certified PAs have switched to a different specialty at least once during their career. Nearly 31% have done so at least twice.
Eric Van Hecke, DMSc, MPAS, PA-C, CAQ-EM, assistant professor and PA program director at Concordia University, St. Paul in St. Paul, Minnesota, works in emergency medicine, thanks to his clinical rotations during PA school, which helped him determine that a surgical specialty was not for him.
“I did some surgical rotations, and I found I hated being in the operating room,” he said. “I didn’t like the way PAs were utilized there. But then, toward the end of my PA program, I had the opportunity to do an emergency department rotation and found it was a much better fit.”
Other PAs, however, may not be as lucky to find the right practice straight out of school. Some may be limited by job availability in a specific geographic area, while others may feel more comfortable starting in a hospital setting. Lyndsey Milcarek, PA-C, MPH, a PA in Buffalo, New York, said she started in a primary care role after school but moved to geriatric home health after a year. Then, 3 years later, she switched specialties again to join an emergency department. She said her decisions to move were largely driven by organizational issues.
“In one case, I saw the organization was headed for a buyout and I wanted to get ahead of it,” she said. “In another, the workload was a lot, and you couldn’t go home at the end of your shift if there were still patients to see. It was a recipe for burnout.”
Amanda Michaud, DMSc, PA-C, in Jacksonville, Florida, said she initially enjoyed the “fast-paced environment” of emergency medicine after graduating from PA school. But when her family was looking at a move out of state, she started to consider a specialty change and ultimately ended up joining an allergy practice.
“I wanted to have a more nine-to-five kind of job. I wanted my weekends. I had missed a lot of holidays with my family,” she said. “But I also was interested in becoming more of an expert in a particular field. In the ER, you become an expert in saving lives and stabilizing patients. But I wanted an opportunity to truly learn the medicine and science behind one area.”
Understand Your Why — and Do the Work
The reasons a PA might choose to make a specialty switch aren’t unlike the reasons a corporate attorney might want to practice family law or a nurse practitioner might want to switch from the ICU to the pediatric ward. People might consider it a change of scenery. Some may be looking to relocate, support a better work-life balance, reduce their stress, expand their skills and knowledge, find a more palatable work environment, or make more money. But those who have made lateral moves said it isn’t as easy as it may look.
“It will take time, not just to learn the new specialty but to understand how your new practice does things,” said Michaud. “You need to expect a huge learning curve ahead when you make a change.”
Milcarek added that PAs who are considering a switch should think long and hard about the kind of environment they want to work in and, as they look at other departments or practices, spend time talking to and shadowing PAs to understand what working there will look like. Just because a particular specialty has a reputation for being low stress (or high paying) doesn’t mean that’s what you’ll find once you come on board. So much depends on your employer — and the people you work with.
“There are a lot of opportunities for PA jobs, but employers aren’t always transparent about workflows and management,” Milcarek said. “You want to have good intel upfront before you make a decision.”
Kozikowski agreed. “It takes a while to adapt to a new environment and to understand how things are done,” he explained. “Research suggests that having a good network, mentors, and good onboarding programs are really important. It’s not just finding continuing medical education, you also need to have the right support system in place.”
Despite the challenges involved with a specialty switch, Milcarek said her moves have made her a stronger overall clinician.
“I have a unique perspective because I’ve worked in so many different areas,” she said. “I’ve learned a lot in each and can apply those things in my new roles. I feel fortunate that I’ve been able to make these switches and continue to learn and grow and become a better PA.”
A version of this article first appeared on Medscape.com.
Physician assistants (PAs) are educated as generalists — with the ability to switch medical specialties during their careers. Andrzej Kozikowski, PhD, senior director of research at the National Commission on Certification of Physician Assistants (NCCPA), said that having that kind of career flexibility is often a motivating factor for students who pursue the PA path.
“If you look at the research literature on physicians, you can see that choosing a specialty can be quite stressful,” he told this news organization. “It’s a lifelong decision. You have to commit to a residency, maybe fellowship training, and if you don’t like it and want to switch your specialty, you have to go back and do it again. It’s a decision that weighs heavily on your [physicians] shoulders.”
The PA profession, however, offers lateral movement. Rachel Porter, PhD, interim director of preclinical education at PA program, Duke University, Durham, North Carolina, said that the didactic portion of a PA’s medical education is very broad to support that kind of flexibility. And most PA students, depending on their program, have the opportunity to go through several clinical rotations to see which specialty might be the best fit.
“That initial medical education is meant to provide a good foundation across all systems, across all age groups, subpopulations, and settings — hospital, ambulatory, or outpatient,” she explained. “Once they are exposed to clinical experiences later, we find that students discover their niche and where they want to be once they start their career.”
Making a Lateral Move
According to the 2022 Statistical Profile of Board-Certified PAs by Specialty, based on a survey conducted by the NCCPA, approximately half of board-certified PAs have switched to a different specialty at least once during their career. Nearly 31% have done so at least twice.
Eric Van Hecke, DMSc, MPAS, PA-C, CAQ-EM, assistant professor and PA program director at Concordia University, St. Paul in St. Paul, Minnesota, works in emergency medicine, thanks to his clinical rotations during PA school, which helped him determine that a surgical specialty was not for him.
“I did some surgical rotations, and I found I hated being in the operating room,” he said. “I didn’t like the way PAs were utilized there. But then, toward the end of my PA program, I had the opportunity to do an emergency department rotation and found it was a much better fit.”
Other PAs, however, may not be as lucky to find the right practice straight out of school. Some may be limited by job availability in a specific geographic area, while others may feel more comfortable starting in a hospital setting. Lyndsey Milcarek, PA-C, MPH, a PA in Buffalo, New York, said she started in a primary care role after school but moved to geriatric home health after a year. Then, 3 years later, she switched specialties again to join an emergency department. She said her decisions to move were largely driven by organizational issues.
“In one case, I saw the organization was headed for a buyout and I wanted to get ahead of it,” she said. “In another, the workload was a lot, and you couldn’t go home at the end of your shift if there were still patients to see. It was a recipe for burnout.”
Amanda Michaud, DMSc, PA-C, in Jacksonville, Florida, said she initially enjoyed the “fast-paced environment” of emergency medicine after graduating from PA school. But when her family was looking at a move out of state, she started to consider a specialty change and ultimately ended up joining an allergy practice.
“I wanted to have a more nine-to-five kind of job. I wanted my weekends. I had missed a lot of holidays with my family,” she said. “But I also was interested in becoming more of an expert in a particular field. In the ER, you become an expert in saving lives and stabilizing patients. But I wanted an opportunity to truly learn the medicine and science behind one area.”
Understand Your Why — and Do the Work
The reasons a PA might choose to make a specialty switch aren’t unlike the reasons a corporate attorney might want to practice family law or a nurse practitioner might want to switch from the ICU to the pediatric ward. People might consider it a change of scenery. Some may be looking to relocate, support a better work-life balance, reduce their stress, expand their skills and knowledge, find a more palatable work environment, or make more money. But those who have made lateral moves said it isn’t as easy as it may look.
“It will take time, not just to learn the new specialty but to understand how your new practice does things,” said Michaud. “You need to expect a huge learning curve ahead when you make a change.”
Milcarek added that PAs who are considering a switch should think long and hard about the kind of environment they want to work in and, as they look at other departments or practices, spend time talking to and shadowing PAs to understand what working there will look like. Just because a particular specialty has a reputation for being low stress (or high paying) doesn’t mean that’s what you’ll find once you come on board. So much depends on your employer — and the people you work with.
“There are a lot of opportunities for PA jobs, but employers aren’t always transparent about workflows and management,” Milcarek said. “You want to have good intel upfront before you make a decision.”
Kozikowski agreed. “It takes a while to adapt to a new environment and to understand how things are done,” he explained. “Research suggests that having a good network, mentors, and good onboarding programs are really important. It’s not just finding continuing medical education, you also need to have the right support system in place.”
Despite the challenges involved with a specialty switch, Milcarek said her moves have made her a stronger overall clinician.
“I have a unique perspective because I’ve worked in so many different areas,” she said. “I’ve learned a lot in each and can apply those things in my new roles. I feel fortunate that I’ve been able to make these switches and continue to learn and grow and become a better PA.”
A version of this article first appeared on Medscape.com.
Physician assistants (PAs) are educated as generalists — with the ability to switch medical specialties during their careers. Andrzej Kozikowski, PhD, senior director of research at the National Commission on Certification of Physician Assistants (NCCPA), said that having that kind of career flexibility is often a motivating factor for students who pursue the PA path.
“If you look at the research literature on physicians, you can see that choosing a specialty can be quite stressful,” he told this news organization. “It’s a lifelong decision. You have to commit to a residency, maybe fellowship training, and if you don’t like it and want to switch your specialty, you have to go back and do it again. It’s a decision that weighs heavily on your [physicians] shoulders.”
The PA profession, however, offers lateral movement. Rachel Porter, PhD, interim director of preclinical education at PA program, Duke University, Durham, North Carolina, said that the didactic portion of a PA’s medical education is very broad to support that kind of flexibility. And most PA students, depending on their program, have the opportunity to go through several clinical rotations to see which specialty might be the best fit.
“That initial medical education is meant to provide a good foundation across all systems, across all age groups, subpopulations, and settings — hospital, ambulatory, or outpatient,” she explained. “Once they are exposed to clinical experiences later, we find that students discover their niche and where they want to be once they start their career.”
Making a Lateral Move
According to the 2022 Statistical Profile of Board-Certified PAs by Specialty, based on a survey conducted by the NCCPA, approximately half of board-certified PAs have switched to a different specialty at least once during their career. Nearly 31% have done so at least twice.
Eric Van Hecke, DMSc, MPAS, PA-C, CAQ-EM, assistant professor and PA program director at Concordia University, St. Paul in St. Paul, Minnesota, works in emergency medicine, thanks to his clinical rotations during PA school, which helped him determine that a surgical specialty was not for him.
“I did some surgical rotations, and I found I hated being in the operating room,” he said. “I didn’t like the way PAs were utilized there. But then, toward the end of my PA program, I had the opportunity to do an emergency department rotation and found it was a much better fit.”
Other PAs, however, may not be as lucky to find the right practice straight out of school. Some may be limited by job availability in a specific geographic area, while others may feel more comfortable starting in a hospital setting. Lyndsey Milcarek, PA-C, MPH, a PA in Buffalo, New York, said she started in a primary care role after school but moved to geriatric home health after a year. Then, 3 years later, she switched specialties again to join an emergency department. She said her decisions to move were largely driven by organizational issues.
“In one case, I saw the organization was headed for a buyout and I wanted to get ahead of it,” she said. “In another, the workload was a lot, and you couldn’t go home at the end of your shift if there were still patients to see. It was a recipe for burnout.”
Amanda Michaud, DMSc, PA-C, in Jacksonville, Florida, said she initially enjoyed the “fast-paced environment” of emergency medicine after graduating from PA school. But when her family was looking at a move out of state, she started to consider a specialty change and ultimately ended up joining an allergy practice.
“I wanted to have a more nine-to-five kind of job. I wanted my weekends. I had missed a lot of holidays with my family,” she said. “But I also was interested in becoming more of an expert in a particular field. In the ER, you become an expert in saving lives and stabilizing patients. But I wanted an opportunity to truly learn the medicine and science behind one area.”
Understand Your Why — and Do the Work
The reasons a PA might choose to make a specialty switch aren’t unlike the reasons a corporate attorney might want to practice family law or a nurse practitioner might want to switch from the ICU to the pediatric ward. People might consider it a change of scenery. Some may be looking to relocate, support a better work-life balance, reduce their stress, expand their skills and knowledge, find a more palatable work environment, or make more money. But those who have made lateral moves said it isn’t as easy as it may look.
“It will take time, not just to learn the new specialty but to understand how your new practice does things,” said Michaud. “You need to expect a huge learning curve ahead when you make a change.”
Milcarek added that PAs who are considering a switch should think long and hard about the kind of environment they want to work in and, as they look at other departments or practices, spend time talking to and shadowing PAs to understand what working there will look like. Just because a particular specialty has a reputation for being low stress (or high paying) doesn’t mean that’s what you’ll find once you come on board. So much depends on your employer — and the people you work with.
“There are a lot of opportunities for PA jobs, but employers aren’t always transparent about workflows and management,” Milcarek said. “You want to have good intel upfront before you make a decision.”
Kozikowski agreed. “It takes a while to adapt to a new environment and to understand how things are done,” he explained. “Research suggests that having a good network, mentors, and good onboarding programs are really important. It’s not just finding continuing medical education, you also need to have the right support system in place.”
Despite the challenges involved with a specialty switch, Milcarek said her moves have made her a stronger overall clinician.
“I have a unique perspective because I’ve worked in so many different areas,” she said. “I’ve learned a lot in each and can apply those things in my new roles. I feel fortunate that I’ve been able to make these switches and continue to learn and grow and become a better PA.”
A version of this article first appeared on Medscape.com.