Cardiac stress testing before hip and knee replacements has dropped steadily since 2006, according to results from a new study that also showed major cardiac complications to be low in the absence of stress testing – even among people with established risk factors.

Routine stress testing before noncardiac surgeries has come under fire in recent decades as an overuse of resources and a burden on patients. Practice guidelines issued in 2007 and 2014 by the American College of Cardiology and the American Heart Association sought to limit the use of preoperative testing to patients with specific cardiovascular risk factors who might have their management changed by the test results.

For their study, published online in JAMA Cardiology, Daniel S. Rubin, MD, of the University of Chicago and colleagues looked at employee-based insurance data, which included Medicare Advantage claims, for more than 800,000 total hip or knee arthroplasties (28% hip and 72% knee replacements) conducted between 2004 and 2017.

While some 10% of the cohort (mean age 62, 58% women) received a stress test in the 2 months before surgery, the investigators found that the frequency of preoperative stress testing dropped annually starting in late 2006, when it peaked at about 14%, to about 7% in 2017. Older age, male sex and a Revised Cardiac Risk Index score of 1 or greater were all associated with a higher likelihood of being tested.

The overall frequency of myocardial infarction or cardiac arrest was 0.24%, occurring in 1,677 of 686,067 patients. While the rate was higher in patients with at least one RCRI condition, this did not differ significantly between those who received a preoperative stress test and those who did not (0.60%; 221 of 36,554 vs. 0.57%; 694 of 122,466 patients.

The 2007 and 2014 ACC/AHA guidelines make clear that patients with zero RCRI conditions – which comprise a history of ischemic heart disease, heart failure, insulin therapy for diabetes, cerebrovascular disease, or chronic kidney disease – should not receive a stress test before an intermediate-risk surgery such as a hip or knee replacement. But in this study, Dr. Rubin and his colleagues found that almost half of patients who had no RCRI risk factors were stress tested anyway. This means, Dr. Rubin said in an interview, that “there’s still room for improvement” in reducing testing.

“I never want to question how a physician chooses to practice, but I have to applaud physicians for reining in the use of this test. We’re using less of this test and yet the incidence of myocardial infarction and cardiac arrest is also going down, which also calls into question whether we’re getting better at choosing the right patients for the test; or the test doesn’t impact outcomes; or overall health of these patients is improving,” he said.

One surprise finding in the study, Dr. Rubin noted, was a higher rate of complications among people without RCRI conditions who were stress tested, compared with those who were not, with a mean complication rate of 0.27%, compared with 0.14% among those who did not receive a test (P < .001). “The RCRI doesn’t capture certain things,” Dr. Rubin said. “And we know that no risk stratification tool is going to capture everything.”

The RCRI, he noted, is based on a clinical history. “If you haven’t been diagnosed yet, it won’t appear as a risk factor, even if you’re clearly at risk. The question then becomes for a physician, do you do the test or not? On a day-to-day basis it’s hard to make that decision because you want what’s best for the individual patient – and it’s hard to generalize from a study of 800,000 people what’s right for that one patient. That said, it doesn’t appear that stress testing improves outcomes and a decrease in testing appears appropriate.”

Dr. Rubin and his colleagues described as a weakness of their study that it did not capture the full scope of preoperative stress testing among Medicare patients, who are older and therefore more likely to be tested.

That the 2007 and 2014 practice guidelines bore on the drop in testing was not demonstrated by Dr. Rubin and colleagues’ study, which saw declines begin even before the guidelines were published. Nonetheless, the results appear to validate the approach advocated in the guidelines, said guideline coauthor Joshua Beckman, MD, of Vanderbilt University, whose recent research has focused on identifying risk factors for MI after noncardiac surgery.

“I hope that the guidelines have helped in changing the culture for the use of preoperative stress testing as a regular thing,” Dr. Beckman said in an interview. “In fact, the guidelines say you shouldn’t do anything before an operation that you wouldn’t do anyway. So these findings are certainly in agreement with what we’re suggesting and support the idea that unless you have something that is unstable or active, stress testing isn’t likely to help.”

Annemarie Thompson, MD, of Duke University in Durham, N.C., another coauthor on the 2014 guidelines, commented in an interview that Dr. Rubin and colleagues’ findings of a doubled rate of complications among people without RCRI conditions who were stress tested, compared with those who were not might mean something “other than just sheer overuse or overordering of tests inappropriately.”

Rather, she said, physicians might be seeing something in the clinic that cannot be captured by a screening tool reliant on existing diagnoses. “Maybe when they’re sitting in front of you in a clinic, they’re so immobile that you’re left wondering. Or maybe they haven’t been seen by a doctor in a long time,” Dr. Thompson said. “So they don’t have diagnoses if they haven’t been followed. I think what [this finding] shows is that clinicians are detecting something. They may not know what it is. But we have to give a little wiggle room to the clinician who is sitting there looking at a patient who looks like they may not make it through surgery.”

Dr. Thompson said it would be helpful, after a big-data study like this one, to go through the clinical histories of those patients – in this study fewer than 100 – who had no RCRI risk factors and yet were stress tested and ended up having complications. “Until then we’re not going to solve the mystery,” she said. “But it’s a very, very interesting study.”

Dr. Rubin is the president of DRDR Mobile Health, a company that creates mobile applications for health care and from which he has not received compensation. One of his coauthors on the study, Dr. Peter Nagele, reported fee income from Roche Diagnostics. Dr. Beckman disclosed personal fees from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, and other pharmaceutical manufacturers. Dr. Thompson has no disclosures.

SOURCE: Rubin et al. JAMA Cardiol. 2020 Sep 30. doi: 10.1001/jamacardio.2020.4311.

Cardiac stress testing before hip and knee replacements has dropped steadily since 2006, according to results from a new study that also showed major cardiac complications to be low in the absence of stress testing – even among people with established risk factors.

Routine stress testing before noncardiac surgeries has come under fire in recent decades as an overuse of resources and a burden on patients. Practice guidelines issued in 2007 and 2014 by the American College of Cardiology and the American Heart Association sought to limit the use of preoperative testing to patients with specific cardiovascular risk factors who might have their management changed by the test results.

For their study, published online in JAMA Cardiology, Daniel S. Rubin, MD, of the University of Chicago and colleagues looked at employee-based insurance data, which included Medicare Advantage claims, for more than 800,000 total hip or knee arthroplasties (28% hip and 72% knee replacements) conducted between 2004 and 2017.

While some 10% of the cohort (mean age 62, 58% women) received a stress test in the 2 months before surgery, the investigators found that the frequency of preoperative stress testing dropped annually starting in late 2006, when it peaked at about 14%, to about 7% in 2017. Older age, male sex and a Revised Cardiac Risk Index score of 1 or greater were all associated with a higher likelihood of being tested.

The overall frequency of myocardial infarction or cardiac arrest was 0.24%, occurring in 1,677 of 686,067 patients. While the rate was higher in patients with at least one RCRI condition, this did not differ significantly between those who received a preoperative stress test and those who did not (0.60%; 221 of 36,554 vs. 0.57%; 694 of 122,466 patients.

The 2007 and 2014 ACC/AHA guidelines make clear that patients with zero RCRI conditions – which comprise a history of ischemic heart disease, heart failure, insulin therapy for diabetes, cerebrovascular disease, or chronic kidney disease – should not receive a stress test before an intermediate-risk surgery such as a hip or knee replacement. But in this study, Dr. Rubin and his colleagues found that almost half of patients who had no RCRI risk factors were stress tested anyway. This means, Dr. Rubin said in an interview, that “there’s still room for improvement” in reducing testing.

“I never want to question how a physician chooses to practice, but I have to applaud physicians for reining in the use of this test. We’re using less of this test and yet the incidence of myocardial infarction and cardiac arrest is also going down, which also calls into question whether we’re getting better at choosing the right patients for the test; or the test doesn’t impact outcomes; or overall health of these patients is improving,” he said.

One surprise finding in the study, Dr. Rubin noted, was a higher rate of complications among people without RCRI conditions who were stress tested, compared with those who were not, with a mean complication rate of 0.27%, compared with 0.14% among those who did not receive a test (P < .001). “The RCRI doesn’t capture certain things,” Dr. Rubin said. “And we know that no risk stratification tool is going to capture everything.”

The RCRI, he noted, is based on a clinical history. “If you haven’t been diagnosed yet, it won’t appear as a risk factor, even if you’re clearly at risk. The question then becomes for a physician, do you do the test or not? On a day-to-day basis it’s hard to make that decision because you want what’s best for the individual patient – and it’s hard to generalize from a study of 800,000 people what’s right for that one patient. That said, it doesn’t appear that stress testing improves outcomes and a decrease in testing appears appropriate.”

Dr. Rubin and his colleagues described as a weakness of their study that it did not capture the full scope of preoperative stress testing among Medicare patients, who are older and therefore more likely to be tested.

That the 2007 and 2014 practice guidelines bore on the drop in testing was not demonstrated by Dr. Rubin and colleagues’ study, which saw declines begin even before the guidelines were published. Nonetheless, the results appear to validate the approach advocated in the guidelines, said guideline coauthor Joshua Beckman, MD, of Vanderbilt University, whose recent research has focused on identifying risk factors for MI after noncardiac surgery.

“I hope that the guidelines have helped in changing the culture for the use of preoperative stress testing as a regular thing,” Dr. Beckman said in an interview. “In fact, the guidelines say you shouldn’t do anything before an operation that you wouldn’t do anyway. So these findings are certainly in agreement with what we’re suggesting and support the idea that unless you have something that is unstable or active, stress testing isn’t likely to help.”

Annemarie Thompson, MD, of Duke University in Durham, N.C., another coauthor on the 2014 guidelines, commented in an interview that Dr. Rubin and colleagues’ findings of a doubled rate of complications among people without RCRI conditions who were stress tested, compared with those who were not might mean something “other than just sheer overuse or overordering of tests inappropriately.”

Rather, she said, physicians might be seeing something in the clinic that cannot be captured by a screening tool reliant on existing diagnoses. “Maybe when they’re sitting in front of you in a clinic, they’re so immobile that you’re left wondering. Or maybe they haven’t been seen by a doctor in a long time,” Dr. Thompson said. “So they don’t have diagnoses if they haven’t been followed. I think what [this finding] shows is that clinicians are detecting something. They may not know what it is. But we have to give a little wiggle room to the clinician who is sitting there looking at a patient who looks like they may not make it through surgery.”

Dr. Thompson said it would be helpful, after a big-data study like this one, to go through the clinical histories of those patients – in this study fewer than 100 – who had no RCRI risk factors and yet were stress tested and ended up having complications. “Until then we’re not going to solve the mystery,” she said. “But it’s a very, very interesting study.”

Dr. Rubin is the president of DRDR Mobile Health, a company that creates mobile applications for health care and from which he has not received compensation. One of his coauthors on the study, Dr. Peter Nagele, reported fee income from Roche Diagnostics. Dr. Beckman disclosed personal fees from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, and other pharmaceutical manufacturers. Dr. Thompson has no disclosures.

SOURCE: Rubin et al. JAMA Cardiol. 2020 Sep 30. doi: 10.1001/jamacardio.2020.4311.

Cardiac stress testing before hip and knee replacements has dropped steadily since 2006, according to results from a new study that also showed major cardiac complications to be low in the absence of stress testing – even among people with established risk factors.

Routine stress testing before noncardiac surgeries has come under fire in recent decades as an overuse of resources and a burden on patients. Practice guidelines issued in 2007 and 2014 by the American College of Cardiology and the American Heart Association sought to limit the use of preoperative testing to patients with specific cardiovascular risk factors who might have their management changed by the test results.

For their study, published online in JAMA Cardiology, Daniel S. Rubin, MD, of the University of Chicago and colleagues looked at employee-based insurance data, which included Medicare Advantage claims, for more than 800,000 total hip or knee arthroplasties (28% hip and 72% knee replacements) conducted between 2004 and 2017.

While some 10% of the cohort (mean age 62, 58% women) received a stress test in the 2 months before surgery, the investigators found that the frequency of preoperative stress testing dropped annually starting in late 2006, when it peaked at about 14%, to about 7% in 2017. Older age, male sex and a Revised Cardiac Risk Index score of 1 or greater were all associated with a higher likelihood of being tested.

The overall frequency of myocardial infarction or cardiac arrest was 0.24%, occurring in 1,677 of 686,067 patients. While the rate was higher in patients with at least one RCRI condition, this did not differ significantly between those who received a preoperative stress test and those who did not (0.60%; 221 of 36,554 vs. 0.57%; 694 of 122,466 patients.

The 2007 and 2014 ACC/AHA guidelines make clear that patients with zero RCRI conditions – which comprise a history of ischemic heart disease, heart failure, insulin therapy for diabetes, cerebrovascular disease, or chronic kidney disease – should not receive a stress test before an intermediate-risk surgery such as a hip or knee replacement. But in this study, Dr. Rubin and his colleagues found that almost half of patients who had no RCRI risk factors were stress tested anyway. This means, Dr. Rubin said in an interview, that “there’s still room for improvement” in reducing testing.

“I never want to question how a physician chooses to practice, but I have to applaud physicians for reining in the use of this test. We’re using less of this test and yet the incidence of myocardial infarction and cardiac arrest is also going down, which also calls into question whether we’re getting better at choosing the right patients for the test; or the test doesn’t impact outcomes; or overall health of these patients is improving,” he said.

One surprise finding in the study, Dr. Rubin noted, was a higher rate of complications among people without RCRI conditions who were stress tested, compared with those who were not, with a mean complication rate of 0.27%, compared with 0.14% among those who did not receive a test (P < .001). “The RCRI doesn’t capture certain things,” Dr. Rubin said. “And we know that no risk stratification tool is going to capture everything.”

The RCRI, he noted, is based on a clinical history. “If you haven’t been diagnosed yet, it won’t appear as a risk factor, even if you’re clearly at risk. The question then becomes for a physician, do you do the test or not? On a day-to-day basis it’s hard to make that decision because you want what’s best for the individual patient – and it’s hard to generalize from a study of 800,000 people what’s right for that one patient. That said, it doesn’t appear that stress testing improves outcomes and a decrease in testing appears appropriate.”

Dr. Rubin and his colleagues described as a weakness of their study that it did not capture the full scope of preoperative stress testing among Medicare patients, who are older and therefore more likely to be tested.

That the 2007 and 2014 practice guidelines bore on the drop in testing was not demonstrated by Dr. Rubin and colleagues’ study, which saw declines begin even before the guidelines were published. Nonetheless, the results appear to validate the approach advocated in the guidelines, said guideline coauthor Joshua Beckman, MD, of Vanderbilt University, whose recent research has focused on identifying risk factors for MI after noncardiac surgery.

“I hope that the guidelines have helped in changing the culture for the use of preoperative stress testing as a regular thing,” Dr. Beckman said in an interview. “In fact, the guidelines say you shouldn’t do anything before an operation that you wouldn’t do anyway. So these findings are certainly in agreement with what we’re suggesting and support the idea that unless you have something that is unstable or active, stress testing isn’t likely to help.”

Annemarie Thompson, MD, of Duke University in Durham, N.C., another coauthor on the 2014 guidelines, commented in an interview that Dr. Rubin and colleagues’ findings of a doubled rate of complications among people without RCRI conditions who were stress tested, compared with those who were not might mean something “other than just sheer overuse or overordering of tests inappropriately.”

Rather, she said, physicians might be seeing something in the clinic that cannot be captured by a screening tool reliant on existing diagnoses. “Maybe when they’re sitting in front of you in a clinic, they’re so immobile that you’re left wondering. Or maybe they haven’t been seen by a doctor in a long time,” Dr. Thompson said. “So they don’t have diagnoses if they haven’t been followed. I think what [this finding] shows is that clinicians are detecting something. They may not know what it is. But we have to give a little wiggle room to the clinician who is sitting there looking at a patient who looks like they may not make it through surgery.”

Dr. Thompson said it would be helpful, after a big-data study like this one, to go through the clinical histories of those patients – in this study fewer than 100 – who had no RCRI risk factors and yet were stress tested and ended up having complications. “Until then we’re not going to solve the mystery,” she said. “But it’s a very, very interesting study.”

Dr. Rubin is the president of DRDR Mobile Health, a company that creates mobile applications for health care and from which he has not received compensation. One of his coauthors on the study, Dr. Peter Nagele, reported fee income from Roche Diagnostics. Dr. Beckman disclosed personal fees from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, and other pharmaceutical manufacturers. Dr. Thompson has no disclosures.

SOURCE: Rubin et al. JAMA Cardiol. 2020 Sep 30. doi: 10.1001/jamacardio.2020.4311.

The Food and Drug Administration has updated its page on Essure information for patients and health care providers to add additional information on adverse events reported by its manufacturer.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Essure was a permanent implantable birth control device approved by the FDA in 2002. FDA ordered Bayer in 2016 to conduct a postmarket surveillance study of Essure following reports of safety concerns, and expanded the study from 3 years to 5 years in 2018. Bayer voluntarily removed Essure from the market at the end of 2018, citing low sales after a “black box” warning was placed on the device. All devices were returned to the company by the end of 2019.

Bayer is required to report variances in Medical Device Reporting (MDR) requirements of Essure related to litigation to the FDA, which includes adverse events such death, serious injury, and “malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.” The reports are limited to events Bayer becomes aware of between November 2016 and November 2020. Bayer will continue to provide these reports until April 2021.

The FDA emphasized that the collected data are based on social media reports and already may be reported to the FDA, rather than being a collection of new events. “The limited information provided in the reports prevents the ability to draw any conclusions as to whether the device, or its removal, caused or contributed to any of the events in the reports,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the Center for Devices and Radiological Health, said in an FDA In Brief statement on Aug. 11.

The FDA first uploaded an Essure MDR variance spreadsheet in August 2020, listing 1,453 events, consisting of 53 reports of deaths, 1,376 reports of serious injury, and 24 reports of device malfunction that occurred as of June 2020. In September 2020, FDA uploaded a second variance spreadsheet, which added another 1,934 events that occurred as of July.
 

Interim analysis of postmarketing surveillance study

An interim analysis of 1,128 patients from 67 centers in the Essure postmarket surveillance study, which compared women who received Essure with those who received laparoscopic tubal sterilization, revealed that 94.6% (265 of 280 patients) in the Essure group had a successful implantation of the device, compared with 99.6% of women who achieved bilateral tubal occlusion from laparoscopic tubal sterilization.

Regarding safety, 9.1% of women in the Essure group and 4.5% in the laparoscopic tubal sterilization group reported chronic lower abdominal and/or pelvic pain, and 16.3% in the Essure group and 10.2% in the laparoscopic tubal sterilization group reported new or worsening abnormal uterine bleeding. In the Essure group, 22.3% of women said they experienced hypersensitivity, an allergic reaction, and new “autoimmune-like reactions” compared with 12.5% of women in the laparoscopic tubal sterilization group.

The interim analysis also showed 19.7% of women in the Essure group and 3.0% in the laparoscopic tubal sterilization group underwent gynecologic surgical procedures, which were “driven primarily by Essure removal and endometrial ablation procedures in Essure patients.” Device removal occurred in 6.8% of women with the Essure device.
 

Consistent data on Essure

An FDA search of the Manufacturer and User Facility Device Experience (MAUDE) database in January of 2020 revealed 47,856 medical device reports of Essure between November 2002 and December 2019. The most common adverse events observed during this period were:

• Pain or abdominal pain (32,901 cases).
• Heavy or irregular menses (14,573 cases). Headache (8,570 cases).
• Device fragment or foreign body in a patient (8,501 cases).
• Perforation (7,825 cases).
• Fatigue (7,083 cases).
• Gain or loss in weight (5,980 cases).
• Anxiety and/or depression (5,366 cases).
• Rash and/or hypersensitivity (5,077 cases)
• Hair loss (4,999 cases).

Problems with the device itself included reports of:

• Device incompatibility such as an allergy (7,515 cases).
• The device migrating (4,535 cases).
• The device breaking or fracturing (2,297 cases).
• The device dislodging or dislocating (1,797 cases).
• Improper operation including implant failure and pregnancy (1,058 cases).

In 2019, Essure received 15,083 medical device reports, an increase from 6,000 reports in 2018 and 11,854 reports in 2017.

To date, nearly 39,000 women in the United States have made claims to injuries related to the Essure device. In August, Bayer announced it would pay approximately $1.6 billion U.S. dollars to settle 90% of these cases in exchange for claimants to “dismiss their cases or not file.” Bayer also said in a press release that the settlement is not an admission of wrongdoing or liability on the part of the company.

In an interview, Catherine Cansino, MD, MPH, of the department of obstetrics and gynecology at the University of California, Davis, said the latest adverse event reports show “consistent info from [the] MAUDE database when comparing 2019 to previous years, highlighting most common problems related to pain and heavy or irregular bleeding.”

She emphasized ob.gyns with patients who have an Essure device should “consider Essure-related etiology that may necessitate device removal when evaluating patients with gynecological problems, especially with regard to abdominal/pelvic pain and heavy/irregular bleeding.”

Dr. Cansino reported no relevant financial disclosures. She is a member of the Ob.Gyn. News Editorial Advisory Board.

The Food and Drug Administration has updated its page on Essure information for patients and health care providers to add additional information on adverse events reported by its manufacturer.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Essure was a permanent implantable birth control device approved by the FDA in 2002. FDA ordered Bayer in 2016 to conduct a postmarket surveillance study of Essure following reports of safety concerns, and expanded the study from 3 years to 5 years in 2018. Bayer voluntarily removed Essure from the market at the end of 2018, citing low sales after a “black box” warning was placed on the device. All devices were returned to the company by the end of 2019.

Bayer is required to report variances in Medical Device Reporting (MDR) requirements of Essure related to litigation to the FDA, which includes adverse events such death, serious injury, and “malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.” The reports are limited to events Bayer becomes aware of between November 2016 and November 2020. Bayer will continue to provide these reports until April 2021.

The FDA emphasized that the collected data are based on social media reports and already may be reported to the FDA, rather than being a collection of new events. “The limited information provided in the reports prevents the ability to draw any conclusions as to whether the device, or its removal, caused or contributed to any of the events in the reports,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the Center for Devices and Radiological Health, said in an FDA In Brief statement on Aug. 11.

The FDA first uploaded an Essure MDR variance spreadsheet in August 2020, listing 1,453 events, consisting of 53 reports of deaths, 1,376 reports of serious injury, and 24 reports of device malfunction that occurred as of June 2020. In September 2020, FDA uploaded a second variance spreadsheet, which added another 1,934 events that occurred as of July.
 

Interim analysis of postmarketing surveillance study

An interim analysis of 1,128 patients from 67 centers in the Essure postmarket surveillance study, which compared women who received Essure with those who received laparoscopic tubal sterilization, revealed that 94.6% (265 of 280 patients) in the Essure group had a successful implantation of the device, compared with 99.6% of women who achieved bilateral tubal occlusion from laparoscopic tubal sterilization.

Regarding safety, 9.1% of women in the Essure group and 4.5% in the laparoscopic tubal sterilization group reported chronic lower abdominal and/or pelvic pain, and 16.3% in the Essure group and 10.2% in the laparoscopic tubal sterilization group reported new or worsening abnormal uterine bleeding. In the Essure group, 22.3% of women said they experienced hypersensitivity, an allergic reaction, and new “autoimmune-like reactions” compared with 12.5% of women in the laparoscopic tubal sterilization group.

The interim analysis also showed 19.7% of women in the Essure group and 3.0% in the laparoscopic tubal sterilization group underwent gynecologic surgical procedures, which were “driven primarily by Essure removal and endometrial ablation procedures in Essure patients.” Device removal occurred in 6.8% of women with the Essure device.
 

Consistent data on Essure

An FDA search of the Manufacturer and User Facility Device Experience (MAUDE) database in January of 2020 revealed 47,856 medical device reports of Essure between November 2002 and December 2019. The most common adverse events observed during this period were:

• Pain or abdominal pain (32,901 cases).
• Heavy or irregular menses (14,573 cases). Headache (8,570 cases).
• Device fragment or foreign body in a patient (8,501 cases).
• Perforation (7,825 cases).
• Fatigue (7,083 cases).
• Gain or loss in weight (5,980 cases).
• Anxiety and/or depression (5,366 cases).
• Rash and/or hypersensitivity (5,077 cases)
• Hair loss (4,999 cases).

Problems with the device itself included reports of:

• Device incompatibility such as an allergy (7,515 cases).
• The device migrating (4,535 cases).
• The device breaking or fracturing (2,297 cases).
• The device dislodging or dislocating (1,797 cases).
• Improper operation including implant failure and pregnancy (1,058 cases).

In 2019, Essure received 15,083 medical device reports, an increase from 6,000 reports in 2018 and 11,854 reports in 2017.

To date, nearly 39,000 women in the United States have made claims to injuries related to the Essure device. In August, Bayer announced it would pay approximately $1.6 billion U.S. dollars to settle 90% of these cases in exchange for claimants to “dismiss their cases or not file.” Bayer also said in a press release that the settlement is not an admission of wrongdoing or liability on the part of the company.

In an interview, Catherine Cansino, MD, MPH, of the department of obstetrics and gynecology at the University of California, Davis, said the latest adverse event reports show “consistent info from [the] MAUDE database when comparing 2019 to previous years, highlighting most common problems related to pain and heavy or irregular bleeding.”

She emphasized ob.gyns with patients who have an Essure device should “consider Essure-related etiology that may necessitate device removal when evaluating patients with gynecological problems, especially with regard to abdominal/pelvic pain and heavy/irregular bleeding.”

Dr. Cansino reported no relevant financial disclosures. She is a member of the Ob.Gyn. News Editorial Advisory Board.

The Food and Drug Administration has updated its page on Essure information for patients and health care providers to add additional information on adverse events reported by its manufacturer.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Essure was a permanent implantable birth control device approved by the FDA in 2002. FDA ordered Bayer in 2016 to conduct a postmarket surveillance study of Essure following reports of safety concerns, and expanded the study from 3 years to 5 years in 2018. Bayer voluntarily removed Essure from the market at the end of 2018, citing low sales after a “black box” warning was placed on the device. All devices were returned to the company by the end of 2019.

Bayer is required to report variances in Medical Device Reporting (MDR) requirements of Essure related to litigation to the FDA, which includes adverse events such death, serious injury, and “malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.” The reports are limited to events Bayer becomes aware of between November 2016 and November 2020. Bayer will continue to provide these reports until April 2021.

The FDA emphasized that the collected data are based on social media reports and already may be reported to the FDA, rather than being a collection of new events. “The limited information provided in the reports prevents the ability to draw any conclusions as to whether the device, or its removal, caused or contributed to any of the events in the reports,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the Center for Devices and Radiological Health, said in an FDA In Brief statement on Aug. 11.

The FDA first uploaded an Essure MDR variance spreadsheet in August 2020, listing 1,453 events, consisting of 53 reports of deaths, 1,376 reports of serious injury, and 24 reports of device malfunction that occurred as of June 2020. In September 2020, FDA uploaded a second variance spreadsheet, which added another 1,934 events that occurred as of July.
 

Interim analysis of postmarketing surveillance study

An interim analysis of 1,128 patients from 67 centers in the Essure postmarket surveillance study, which compared women who received Essure with those who received laparoscopic tubal sterilization, revealed that 94.6% (265 of 280 patients) in the Essure group had a successful implantation of the device, compared with 99.6% of women who achieved bilateral tubal occlusion from laparoscopic tubal sterilization.

Regarding safety, 9.1% of women in the Essure group and 4.5% in the laparoscopic tubal sterilization group reported chronic lower abdominal and/or pelvic pain, and 16.3% in the Essure group and 10.2% in the laparoscopic tubal sterilization group reported new or worsening abnormal uterine bleeding. In the Essure group, 22.3% of women said they experienced hypersensitivity, an allergic reaction, and new “autoimmune-like reactions” compared with 12.5% of women in the laparoscopic tubal sterilization group.

The interim analysis also showed 19.7% of women in the Essure group and 3.0% in the laparoscopic tubal sterilization group underwent gynecologic surgical procedures, which were “driven primarily by Essure removal and endometrial ablation procedures in Essure patients.” Device removal occurred in 6.8% of women with the Essure device.
 

Consistent data on Essure

An FDA search of the Manufacturer and User Facility Device Experience (MAUDE) database in January of 2020 revealed 47,856 medical device reports of Essure between November 2002 and December 2019. The most common adverse events observed during this period were:

• Pain or abdominal pain (32,901 cases).
• Heavy or irregular menses (14,573 cases). Headache (8,570 cases).
• Device fragment or foreign body in a patient (8,501 cases).
• Perforation (7,825 cases).
• Fatigue (7,083 cases).
• Gain or loss in weight (5,980 cases).
• Anxiety and/or depression (5,366 cases).
• Rash and/or hypersensitivity (5,077 cases)
• Hair loss (4,999 cases).

Problems with the device itself included reports of:

• Device incompatibility such as an allergy (7,515 cases).
• The device migrating (4,535 cases).
• The device breaking or fracturing (2,297 cases).
• The device dislodging or dislocating (1,797 cases).
• Improper operation including implant failure and pregnancy (1,058 cases).

In 2019, Essure received 15,083 medical device reports, an increase from 6,000 reports in 2018 and 11,854 reports in 2017.

To date, nearly 39,000 women in the United States have made claims to injuries related to the Essure device. In August, Bayer announced it would pay approximately $1.6 billion U.S. dollars to settle 90% of these cases in exchange for claimants to “dismiss their cases or not file.” Bayer also said in a press release that the settlement is not an admission of wrongdoing or liability on the part of the company.

In an interview, Catherine Cansino, MD, MPH, of the department of obstetrics and gynecology at the University of California, Davis, said the latest adverse event reports show “consistent info from [the] MAUDE database when comparing 2019 to previous years, highlighting most common problems related to pain and heavy or irregular bleeding.”

She emphasized ob.gyns with patients who have an Essure device should “consider Essure-related etiology that may necessitate device removal when evaluating patients with gynecological problems, especially with regard to abdominal/pelvic pain and heavy/irregular bleeding.”

Dr. Cansino reported no relevant financial disclosures. She is a member of the Ob.Gyn. News Editorial Advisory Board.

Black children and children living in urban areas are less likely to have opioid-related poisoning or withdrawal but more likely to experience abuse or dependence, compared with their White or rural/suburban counterparts, according to a study of 3.2 million Medicaid-enrolled children in North Carolina.

Analysis of the almost 138,000 prescription fills also showed that Black and urban children in North Carolina were less likely to fill a opioid prescription, suggesting a need “for future studies to explore racial and geographic opioid-related inequities in children,” Kelby W. Brown, MA, and associates at Duke University, Durham, N.C., said Oct. 5 in Health Affairs.

In 2016-2018, the prevalence of opioid-related adverse events, such as poisoning or withdrawal, was 24.0 per 100,000 children among Blacks aged 1-17 years, compared with 27.5 per 100,000 for whites. For other opioid-related harms such as abuse or dependence, the order was reversed: 60.2 for Blacks and 51.7 for Whites, the investigators reported. Children of all other races were lowest in both measures.

Geography also appears to play a part. The children in urban areas had the lowest rate of adverse events – 23.2 per 100,000 vs. 26.2 (suburban) and 26.7 (rural) – and the highest rate of other opioid-related harms – 58.1 vs. 49.0 (suburban) and 38.7 (rural), the Medicaid claims data showed.

Analysis of prescription fills revealed that black children aged 1-17 years had a significantly lower rate (2.7%) than Whites (3.1%) or those of other races (3.0%) and that urban children were significantly less likely to fill a prescription (2.7%) for opioids than the other two groups (suburban, 3.1%; rural, 3.4%), Mr. Brown and associates said.

The prescription data also showed that 48.4% of children aged 6-17 years who had an adverse event had filled a prescription for an opioid in the previous 6 months, compared with just 9.4% of those with other opioid-related harms. The median length of time since the last fill? Three days for children with an adverse event and 67 days for those with other harms, they said.

And those prescriptions, it turns out, were not coming just from the physicians of North Carolina. Physicians, with 35.5% of the prescription load, were the main source, but 33.3% of opioid fills in 2016-2018 came from dentists, and another 17.7% were written by advanced practice providers. Among physicians, the leading opioid-prescribing specialists were surgeons, with 17.3% of the total, the investigators reported.

“The distinct and separate groups of clinicians who prescribe opioids to children suggest the need for pediatric opioid prescribing guidelines, particularly for postprocedural pain,” Mr. Brown and associates wrote.

rfranki@mdedge.com

SOURCE: Brown KW et al. Health Aff. 2020;39(10):1737-42.

Black children and children living in urban areas are less likely to have opioid-related poisoning or withdrawal but more likely to experience abuse or dependence, compared with their White or rural/suburban counterparts, according to a study of 3.2 million Medicaid-enrolled children in North Carolina.

Analysis of the almost 138,000 prescription fills also showed that Black and urban children in North Carolina were less likely to fill a opioid prescription, suggesting a need “for future studies to explore racial and geographic opioid-related inequities in children,” Kelby W. Brown, MA, and associates at Duke University, Durham, N.C., said Oct. 5 in Health Affairs.

In 2016-2018, the prevalence of opioid-related adverse events, such as poisoning or withdrawal, was 24.0 per 100,000 children among Blacks aged 1-17 years, compared with 27.5 per 100,000 for whites. For other opioid-related harms such as abuse or dependence, the order was reversed: 60.2 for Blacks and 51.7 for Whites, the investigators reported. Children of all other races were lowest in both measures.

Geography also appears to play a part. The children in urban areas had the lowest rate of adverse events – 23.2 per 100,000 vs. 26.2 (suburban) and 26.7 (rural) – and the highest rate of other opioid-related harms – 58.1 vs. 49.0 (suburban) and 38.7 (rural), the Medicaid claims data showed.

Analysis of prescription fills revealed that black children aged 1-17 years had a significantly lower rate (2.7%) than Whites (3.1%) or those of other races (3.0%) and that urban children were significantly less likely to fill a prescription (2.7%) for opioids than the other two groups (suburban, 3.1%; rural, 3.4%), Mr. Brown and associates said.

The prescription data also showed that 48.4% of children aged 6-17 years who had an adverse event had filled a prescription for an opioid in the previous 6 months, compared with just 9.4% of those with other opioid-related harms. The median length of time since the last fill? Three days for children with an adverse event and 67 days for those with other harms, they said.

And those prescriptions, it turns out, were not coming just from the physicians of North Carolina. Physicians, with 35.5% of the prescription load, were the main source, but 33.3% of opioid fills in 2016-2018 came from dentists, and another 17.7% were written by advanced practice providers. Among physicians, the leading opioid-prescribing specialists were surgeons, with 17.3% of the total, the investigators reported.

“The distinct and separate groups of clinicians who prescribe opioids to children suggest the need for pediatric opioid prescribing guidelines, particularly for postprocedural pain,” Mr. Brown and associates wrote.

rfranki@mdedge.com

SOURCE: Brown KW et al. Health Aff. 2020;39(10):1737-42.

Black children and children living in urban areas are less likely to have opioid-related poisoning or withdrawal but more likely to experience abuse or dependence, compared with their White or rural/suburban counterparts, according to a study of 3.2 million Medicaid-enrolled children in North Carolina.

Analysis of the almost 138,000 prescription fills also showed that Black and urban children in North Carolina were less likely to fill a opioid prescription, suggesting a need “for future studies to explore racial and geographic opioid-related inequities in children,” Kelby W. Brown, MA, and associates at Duke University, Durham, N.C., said Oct. 5 in Health Affairs.

In 2016-2018, the prevalence of opioid-related adverse events, such as poisoning or withdrawal, was 24.0 per 100,000 children among Blacks aged 1-17 years, compared with 27.5 per 100,000 for whites. For other opioid-related harms such as abuse or dependence, the order was reversed: 60.2 for Blacks and 51.7 for Whites, the investigators reported. Children of all other races were lowest in both measures.

Geography also appears to play a part. The children in urban areas had the lowest rate of adverse events – 23.2 per 100,000 vs. 26.2 (suburban) and 26.7 (rural) – and the highest rate of other opioid-related harms – 58.1 vs. 49.0 (suburban) and 38.7 (rural), the Medicaid claims data showed.

Analysis of prescription fills revealed that black children aged 1-17 years had a significantly lower rate (2.7%) than Whites (3.1%) or those of other races (3.0%) and that urban children were significantly less likely to fill a prescription (2.7%) for opioids than the other two groups (suburban, 3.1%; rural, 3.4%), Mr. Brown and associates said.

The prescription data also showed that 48.4% of children aged 6-17 years who had an adverse event had filled a prescription for an opioid in the previous 6 months, compared with just 9.4% of those with other opioid-related harms. The median length of time since the last fill? Three days for children with an adverse event and 67 days for those with other harms, they said.

And those prescriptions, it turns out, were not coming just from the physicians of North Carolina. Physicians, with 35.5% of the prescription load, were the main source, but 33.3% of opioid fills in 2016-2018 came from dentists, and another 17.7% were written by advanced practice providers. Among physicians, the leading opioid-prescribing specialists were surgeons, with 17.3% of the total, the investigators reported.

“The distinct and separate groups of clinicians who prescribe opioids to children suggest the need for pediatric opioid prescribing guidelines, particularly for postprocedural pain,” Mr. Brown and associates wrote.

rfranki@mdedge.com

SOURCE: Brown KW et al. Health Aff. 2020;39(10):1737-42.

Music listening and singing each showed early, promising evidence for producing cardiovascular benefits, part of a burgeoning area of research that is exploring and documenting ways to effectively use music to improve health.

A study run at four centers in Italy randomized 159 patients with heart failure, primarily New York Heart Association class I or II disease, to either a daily regimen of at least 30 minutes spent listening to music daily or to a control group that received usual care with no music prescription. After 3 months, the 82 patients in the daily music-listening group had a statistically significant improvement in their Minnesota Living with Heart Failure Questionnaire scores, compared with 77 controls for the study’s primary outcome measure. The results also showed significant benefits, compared with placebo, for other, secondary efficacy measures including improvements in anxiety, depression, sleep quality, and cognition.

Although the results are considered preliminary, they drew significant attention when published in July 2020 (J Card Fail. 2020 Jul 1;26[7]:541-9), where it was accompanied by two editorials in the same issue as well as an editor’s statement. All these commentators as well as other experts interested in music as medicine gathered to further discuss the topic during a panel session at the virtual annual meeting of the Heart Failure Society of America.

Music as a calming influence

The source of the primary benefits seen in this Italian study likely involved “emotional, psychological, and relaxation,” suggested Jerome L. Fleg, MD, program officer for clinical cardiovascular disease at the National Heart, Lung, and Blood Institute in Bethesda, Md. Researchers had used calming potential as a major criterion when selecting the 80 classical pieces that the heart failure patients in the intervention arm of the study could shuffle on their play lists.

“The tempo/rhythm was set up in a range between 60 and 80 beats per minute, because this range mirrors the human heart rate and facilitates relaxation,” the investigators said in their published report. Unfortunately, noted Dr. Fleg, the study lacked physiologic and biomarker measurements that could have provided objective evidence of effects from music. And the study failed to include a control arm of patients instructed to spend 30 minutes a day resting and relaxing without instruction to listen to music, he noted.

Dr. Fleg had authored one of the July editorials, where he said “It is hoped that findings from these studies and others can expand the scientific evidence for music-based interventions and bring these therapies into clinical practice. The current study from Burrai et al. is a positive step in this direction for patients with heart failure.” (J Card Fail. 2020 Jul 1;26[7]: 550-1). What’s needed now, he added during the virtual session, are “more objective data” to better and more comprehensively document the benefits from a music-based intervention in patients with heart failure.
 

An add-on to standard care

The findings in heart failure patients follows a growing literature that’s shown music can generate a restful state by doing things like activating autonomic parasympathetic outflow while dampening sympathetic outflow. This produces moderation in mood and emotion as well as depressed heart rate, lowered blood pressure, and slowed respiration, commented Emmeline Edwards, PhD director of the division of extramural research of the National Center for Complementary and Integrative Health in Bethesda, Md. Music also seems able to stimulate higher-order brain regions that can result in reduced psychological stress, anxiety, and depression.

“It’s a promising protective intervention to add to standard care for cardiac patients,” Dr. Edwards said during the virtual session. “Music is part of the toolbox for managing symptoms and improving health and well-being.”

“Music is not a substitute for standard therapy, but could add to it,” declared Dr. Fleg.

The already-established intervention known as music therapy has identified music’s ability to modulate breathing as an important mediator of music’s effect.

“Breathing is one of the few physiological processes that can be voluntarily controlled making it a viable target for intervention,” noted opera soprano Renée Fleming and Sheri L. Robb, PhD, in the second editorial that accompanied the Italian heart failure report (J Card Fail. 2020 Jul 1;26[7]:552-4). The music-listening intervention “may have had more effect if they had used compositional features [of the music] to teach patients how to structure their breathing,” said Dr. Robb, a music therapist at Indiana University–Purdue University Indianapolis, during the virtual session.

Another variable to consider is the type of music. “What is the emotional response to the music, and how does that affect heart rate,” wondered Dr. Robb, a professor at the Indiana University School of Nursing in Indianapolis.

Music as exercise

The division that Dr. Edwards directs recently funded a pilot study that assessed the feasibility of using music to stimulate activity and improve breathing another way, by repurposing singing as a novel form of rehabilitative exercise.

The pilot study enrolled patients with coronary disease into a randomized study that tested whether a 14-minute session of supervised singing could produce acute improvement in vascular function, “a biomarker for the risk of future cardiovascular disease events,” explained Jacqueline P. Kulinski, MD, a preventive cardiologist at the Medical College of Wisconsin in Milwaukee. Dr. Kulinski did not report details of her yet-unpublished study, but said that her initial findings held promise for developing musical activities such as singing as a novel way to stimulate therapeutic physical activity in patients with heart disease.

“It’s exciting to see this signal” of benefit. “I envision music therapy as a part of cardiac rehabilitation, or an alternative for patients who can’t participate in traditional rehab,” Dr. Kulinski said during the virtual session. “I think of singing as a physical activity, as exercise, and using this exercise as medicine.”

Harmonizing with the NIH

“Singing is like swimming: You need to hold your breath,” agreed Ms. Fleming, who participated on the virtual panel and has spearheaded a collaboration between the National Institutes of Health and the Kennedy Center for the Performing Arts, the Sound Health Initiative, that’s coordinating research into the connections between music and health. Ms. Fleming helped launch the Sound Health Initiative in 2017 by coauthoring a JAMA article with the NIH director that spelled out the rationale and goals of the project (JAMA. 2017 Jun 27;317[24]:2470-1), and by launching a lecture tour on the topic in a presentation she calls Music and the Mind.

Andrew Eccles

Ms. Fleming has given her talk in more than 30 locations worldwide, and she’s found that “audiences love” the combination of neuroscience and music that her talks cover, she said. Her lectures highlight that, in addition to cardiovascular disease, the potential for music therapy and related interventions has been shown in patients with disorders that include autism, psychosis, pain, Parkinson’s disease, Alzheimer’s disease, and epilepsy.

The research highlighted in the session “opens new doors to prevention and treatment strategies using music for patients with heart failure and cardiovascular disease,” summed up Biykem Bozkurt, MD, professor of medicine at the Baylor College of Medicine in Houston and president of the Heart Failure Society of America, who helped organize the virtual session.

Dr. Fleg, Dr. Edwards, Dr. Robb, Dr Kulinski, Ms. Fleming, and Dr. Bozkurt had no relevant financial disclosures.
 

mzoler@mdedge.com
 

Music listening and singing each showed early, promising evidence for producing cardiovascular benefits, part of a burgeoning area of research that is exploring and documenting ways to effectively use music to improve health.

A study run at four centers in Italy randomized 159 patients with heart failure, primarily New York Heart Association class I or II disease, to either a daily regimen of at least 30 minutes spent listening to music daily or to a control group that received usual care with no music prescription. After 3 months, the 82 patients in the daily music-listening group had a statistically significant improvement in their Minnesota Living with Heart Failure Questionnaire scores, compared with 77 controls for the study’s primary outcome measure. The results also showed significant benefits, compared with placebo, for other, secondary efficacy measures including improvements in anxiety, depression, sleep quality, and cognition.

Although the results are considered preliminary, they drew significant attention when published in July 2020 (J Card Fail. 2020 Jul 1;26[7]:541-9), where it was accompanied by two editorials in the same issue as well as an editor’s statement. All these commentators as well as other experts interested in music as medicine gathered to further discuss the topic during a panel session at the virtual annual meeting of the Heart Failure Society of America.

Music as a calming influence

The source of the primary benefits seen in this Italian study likely involved “emotional, psychological, and relaxation,” suggested Jerome L. Fleg, MD, program officer for clinical cardiovascular disease at the National Heart, Lung, and Blood Institute in Bethesda, Md. Researchers had used calming potential as a major criterion when selecting the 80 classical pieces that the heart failure patients in the intervention arm of the study could shuffle on their play lists.

“The tempo/rhythm was set up in a range between 60 and 80 beats per minute, because this range mirrors the human heart rate and facilitates relaxation,” the investigators said in their published report. Unfortunately, noted Dr. Fleg, the study lacked physiologic and biomarker measurements that could have provided objective evidence of effects from music. And the study failed to include a control arm of patients instructed to spend 30 minutes a day resting and relaxing without instruction to listen to music, he noted.

Dr. Fleg had authored one of the July editorials, where he said “It is hoped that findings from these studies and others can expand the scientific evidence for music-based interventions and bring these therapies into clinical practice. The current study from Burrai et al. is a positive step in this direction for patients with heart failure.” (J Card Fail. 2020 Jul 1;26[7]: 550-1). What’s needed now, he added during the virtual session, are “more objective data” to better and more comprehensively document the benefits from a music-based intervention in patients with heart failure.
 

An add-on to standard care

The findings in heart failure patients follows a growing literature that’s shown music can generate a restful state by doing things like activating autonomic parasympathetic outflow while dampening sympathetic outflow. This produces moderation in mood and emotion as well as depressed heart rate, lowered blood pressure, and slowed respiration, commented Emmeline Edwards, PhD director of the division of extramural research of the National Center for Complementary and Integrative Health in Bethesda, Md. Music also seems able to stimulate higher-order brain regions that can result in reduced psychological stress, anxiety, and depression.

“It’s a promising protective intervention to add to standard care for cardiac patients,” Dr. Edwards said during the virtual session. “Music is part of the toolbox for managing symptoms and improving health and well-being.”

“Music is not a substitute for standard therapy, but could add to it,” declared Dr. Fleg.

The already-established intervention known as music therapy has identified music’s ability to modulate breathing as an important mediator of music’s effect.

“Breathing is one of the few physiological processes that can be voluntarily controlled making it a viable target for intervention,” noted opera soprano Renée Fleming and Sheri L. Robb, PhD, in the second editorial that accompanied the Italian heart failure report (J Card Fail. 2020 Jul 1;26[7]:552-4). The music-listening intervention “may have had more effect if they had used compositional features [of the music] to teach patients how to structure their breathing,” said Dr. Robb, a music therapist at Indiana University–Purdue University Indianapolis, during the virtual session.

Another variable to consider is the type of music. “What is the emotional response to the music, and how does that affect heart rate,” wondered Dr. Robb, a professor at the Indiana University School of Nursing in Indianapolis.

Music as exercise

The division that Dr. Edwards directs recently funded a pilot study that assessed the feasibility of using music to stimulate activity and improve breathing another way, by repurposing singing as a novel form of rehabilitative exercise.

The pilot study enrolled patients with coronary disease into a randomized study that tested whether a 14-minute session of supervised singing could produce acute improvement in vascular function, “a biomarker for the risk of future cardiovascular disease events,” explained Jacqueline P. Kulinski, MD, a preventive cardiologist at the Medical College of Wisconsin in Milwaukee. Dr. Kulinski did not report details of her yet-unpublished study, but said that her initial findings held promise for developing musical activities such as singing as a novel way to stimulate therapeutic physical activity in patients with heart disease.

“It’s exciting to see this signal” of benefit. “I envision music therapy as a part of cardiac rehabilitation, or an alternative for patients who can’t participate in traditional rehab,” Dr. Kulinski said during the virtual session. “I think of singing as a physical activity, as exercise, and using this exercise as medicine.”

Harmonizing with the NIH

“Singing is like swimming: You need to hold your breath,” agreed Ms. Fleming, who participated on the virtual panel and has spearheaded a collaboration between the National Institutes of Health and the Kennedy Center for the Performing Arts, the Sound Health Initiative, that’s coordinating research into the connections between music and health. Ms. Fleming helped launch the Sound Health Initiative in 2017 by coauthoring a JAMA article with the NIH director that spelled out the rationale and goals of the project (JAMA. 2017 Jun 27;317[24]:2470-1), and by launching a lecture tour on the topic in a presentation she calls Music and the Mind.

Andrew Eccles

Ms. Fleming has given her talk in more than 30 locations worldwide, and she’s found that “audiences love” the combination of neuroscience and music that her talks cover, she said. Her lectures highlight that, in addition to cardiovascular disease, the potential for music therapy and related interventions has been shown in patients with disorders that include autism, psychosis, pain, Parkinson’s disease, Alzheimer’s disease, and epilepsy.

The research highlighted in the session “opens new doors to prevention and treatment strategies using music for patients with heart failure and cardiovascular disease,” summed up Biykem Bozkurt, MD, professor of medicine at the Baylor College of Medicine in Houston and president of the Heart Failure Society of America, who helped organize the virtual session.

Dr. Fleg, Dr. Edwards, Dr. Robb, Dr Kulinski, Ms. Fleming, and Dr. Bozkurt had no relevant financial disclosures.
 

mzoler@mdedge.com
 

Music listening and singing each showed early, promising evidence for producing cardiovascular benefits, part of a burgeoning area of research that is exploring and documenting ways to effectively use music to improve health.

A study run at four centers in Italy randomized 159 patients with heart failure, primarily New York Heart Association class I or II disease, to either a daily regimen of at least 30 minutes spent listening to music daily or to a control group that received usual care with no music prescription. After 3 months, the 82 patients in the daily music-listening group had a statistically significant improvement in their Minnesota Living with Heart Failure Questionnaire scores, compared with 77 controls for the study’s primary outcome measure. The results also showed significant benefits, compared with placebo, for other, secondary efficacy measures including improvements in anxiety, depression, sleep quality, and cognition.

Although the results are considered preliminary, they drew significant attention when published in July 2020 (J Card Fail. 2020 Jul 1;26[7]:541-9), where it was accompanied by two editorials in the same issue as well as an editor’s statement. All these commentators as well as other experts interested in music as medicine gathered to further discuss the topic during a panel session at the virtual annual meeting of the Heart Failure Society of America.

Music as a calming influence

The source of the primary benefits seen in this Italian study likely involved “emotional, psychological, and relaxation,” suggested Jerome L. Fleg, MD, program officer for clinical cardiovascular disease at the National Heart, Lung, and Blood Institute in Bethesda, Md. Researchers had used calming potential as a major criterion when selecting the 80 classical pieces that the heart failure patients in the intervention arm of the study could shuffle on their play lists.

“The tempo/rhythm was set up in a range between 60 and 80 beats per minute, because this range mirrors the human heart rate and facilitates relaxation,” the investigators said in their published report. Unfortunately, noted Dr. Fleg, the study lacked physiologic and biomarker measurements that could have provided objective evidence of effects from music. And the study failed to include a control arm of patients instructed to spend 30 minutes a day resting and relaxing without instruction to listen to music, he noted.

Dr. Fleg had authored one of the July editorials, where he said “It is hoped that findings from these studies and others can expand the scientific evidence for music-based interventions and bring these therapies into clinical practice. The current study from Burrai et al. is a positive step in this direction for patients with heart failure.” (J Card Fail. 2020 Jul 1;26[7]: 550-1). What’s needed now, he added during the virtual session, are “more objective data” to better and more comprehensively document the benefits from a music-based intervention in patients with heart failure.
 

An add-on to standard care

The findings in heart failure patients follows a growing literature that’s shown music can generate a restful state by doing things like activating autonomic parasympathetic outflow while dampening sympathetic outflow. This produces moderation in mood and emotion as well as depressed heart rate, lowered blood pressure, and slowed respiration, commented Emmeline Edwards, PhD director of the division of extramural research of the National Center for Complementary and Integrative Health in Bethesda, Md. Music also seems able to stimulate higher-order brain regions that can result in reduced psychological stress, anxiety, and depression.

“It’s a promising protective intervention to add to standard care for cardiac patients,” Dr. Edwards said during the virtual session. “Music is part of the toolbox for managing symptoms and improving health and well-being.”

“Music is not a substitute for standard therapy, but could add to it,” declared Dr. Fleg.

The already-established intervention known as music therapy has identified music’s ability to modulate breathing as an important mediator of music’s effect.

“Breathing is one of the few physiological processes that can be voluntarily controlled making it a viable target for intervention,” noted opera soprano Renée Fleming and Sheri L. Robb, PhD, in the second editorial that accompanied the Italian heart failure report (J Card Fail. 2020 Jul 1;26[7]:552-4). The music-listening intervention “may have had more effect if they had used compositional features [of the music] to teach patients how to structure their breathing,” said Dr. Robb, a music therapist at Indiana University–Purdue University Indianapolis, during the virtual session.

Another variable to consider is the type of music. “What is the emotional response to the music, and how does that affect heart rate,” wondered Dr. Robb, a professor at the Indiana University School of Nursing in Indianapolis.

Music as exercise

The division that Dr. Edwards directs recently funded a pilot study that assessed the feasibility of using music to stimulate activity and improve breathing another way, by repurposing singing as a novel form of rehabilitative exercise.

The pilot study enrolled patients with coronary disease into a randomized study that tested whether a 14-minute session of supervised singing could produce acute improvement in vascular function, “a biomarker for the risk of future cardiovascular disease events,” explained Jacqueline P. Kulinski, MD, a preventive cardiologist at the Medical College of Wisconsin in Milwaukee. Dr. Kulinski did not report details of her yet-unpublished study, but said that her initial findings held promise for developing musical activities such as singing as a novel way to stimulate therapeutic physical activity in patients with heart disease.

“It’s exciting to see this signal” of benefit. “I envision music therapy as a part of cardiac rehabilitation, or an alternative for patients who can’t participate in traditional rehab,” Dr. Kulinski said during the virtual session. “I think of singing as a physical activity, as exercise, and using this exercise as medicine.”

Harmonizing with the NIH

“Singing is like swimming: You need to hold your breath,” agreed Ms. Fleming, who participated on the virtual panel and has spearheaded a collaboration between the National Institutes of Health and the Kennedy Center for the Performing Arts, the Sound Health Initiative, that’s coordinating research into the connections between music and health. Ms. Fleming helped launch the Sound Health Initiative in 2017 by coauthoring a JAMA article with the NIH director that spelled out the rationale and goals of the project (JAMA. 2017 Jun 27;317[24]:2470-1), and by launching a lecture tour on the topic in a presentation she calls Music and the Mind.

Andrew Eccles

Ms. Fleming has given her talk in more than 30 locations worldwide, and she’s found that “audiences love” the combination of neuroscience and music that her talks cover, she said. Her lectures highlight that, in addition to cardiovascular disease, the potential for music therapy and related interventions has been shown in patients with disorders that include autism, psychosis, pain, Parkinson’s disease, Alzheimer’s disease, and epilepsy.

The research highlighted in the session “opens new doors to prevention and treatment strategies using music for patients with heart failure and cardiovascular disease,” summed up Biykem Bozkurt, MD, professor of medicine at the Baylor College of Medicine in Houston and president of the Heart Failure Society of America, who helped organize the virtual session.

Dr. Fleg, Dr. Edwards, Dr. Robb, Dr Kulinski, Ms. Fleming, and Dr. Bozkurt had no relevant financial disclosures.
 

mzoler@mdedge.com
 

Spain and China used very different public health responses to the COVID-19 crisis, and that has had significant consequences in terms of the mental health as well as physical health of the two countries’ citizens, Roger Ho, MD, reported at the virtual congress of the European College of Neuropsychopharmacology.
 

Dr. Ho, a psychiatrist at the National University of Singapore, presented a first-of-its-kind cross-cultural comparative study of the impact of the COVID-19 pandemic in two epicenters on opposite sides of the world. A total of 1,539 participants drawn from the general populations in the two countries completed the online National University of Singapore COVID-19 Questionnaire. The survey was conducted in late February/early March in China and in mid-April in Spain, times of intense disease activity in the countries.

The questionnaire assesses knowledge and concerns about COVID, precautionary measures taken in the last 14 days, contact history, and physical symptoms related to COVID in the last 14 days. The pandemic’s psychological impact was evaluated using the Impact of Event Scale–Revised (IES-R). Participants also completed the Depression, Anxiety, and Stress-21 Scale (DASS-21).

Of note, the pandemic has taken a vastly greater physical toll in Spain than China. As of May 5, there were 83,000 confirmed cases of COVID-19 in China, with a population of 1.39 billion, compared with 248,000 in Spain, with a population of 46.9 million. The Spanish case rate of 5,500 per 1 million population was 100 times greater than China’s; the Spanish mortality rate of 585 per million was 185-fold greater.
 

Mental health findings

Spaniards experienced significantly higher levels of stress and depression as reflected in DASS-21 subscale scores of 14.22 and 8.65, respectively, compared with 7.86 and 6.38, in Chinese respondents. Spanish subjects also reported greater anxiety levels than the Chinese on the DASS-21 anxiety subscale, although not to a statistically significant extent. Yet, counterintuitively, given the DASS-21 results, the pandemic had a greater adverse psychological impact on the Chinese subjects as reflected in their significantly higher average IES-D score of 30.76 versus 27.64 in Spain. Dr. Ho offered a hypothesis as to why: The survey documented that many Chinese respondents felt socially stigmatized, and that their nation had been discriminated against by the rest of the world because the pandemic started in China.

Satisfaction with the public health response

Spanish respondents reported less confidence in their COVID-related medical services.

“This could be due to the rising number of infected health care workers in Spain. In contrast, the Chinese had more confidence in their medical services, probably because the government quickly deployed medical personnel and treated COVID-19 patients at rapidly built hospitals,” according to Dr. Ho.

Spain and other European countries shared four shortcomings in their pandemic response, he continued: lack of personal protective equipment for health care workers, delay in developing response strategies, a shortage of hospital beds, and inability to protect vulnerable elderly individuals from infection in nursing homes.

Experiencing cough, shortness of breath, myalgia, or other physical symptoms potentially associated with COVID-19 within the past 14 days was associated with worse depression, anxiety, and stress scores in both China and Spain. This underscores from a mental health standpoint the importance of rapid and accurate testing for the infection, Dr. Ho said.

Significantly more Spanish respondents felt there was too much unnecessary worry about COVID-19, suggesting a need for better health education regarding the pandemic.
 

Use of face masks

Consistent use of face masks regardless of the presence or absence of symptoms was far more common in the Chinese epicenter, where, unlike in Spain, this precautionary measure was associated with significantly lower IES-R and DASS-21 scores.

“One of the important findings in our study is that wearing a face mask seems to protect the mental health in China, but for the Spanish, wearing a face mask was associated with higher IES-R scores,” Dr. Ho said. “We understand that it is difficult for Europeans to accept the need to use masks for healthy people because mask-wearing suggests vulnerability to sickness and concealment of identity. The Chinese have a collective culture. They believe they should wear a face mask to protect their health and that of other people.”

Dr. Ho reported no financial conflicts regarding his study, conducted with coinvestigators at Huaibei (China) Normal University and Complutense University of Madrid.
 

bjancin@mdedge.com

SOURCE: Ho R. ECNP 2020, Session ISE01.

Spain and China used very different public health responses to the COVID-19 crisis, and that has had significant consequences in terms of the mental health as well as physical health of the two countries’ citizens, Roger Ho, MD, reported at the virtual congress of the European College of Neuropsychopharmacology.
 

Dr. Ho, a psychiatrist at the National University of Singapore, presented a first-of-its-kind cross-cultural comparative study of the impact of the COVID-19 pandemic in two epicenters on opposite sides of the world. A total of 1,539 participants drawn from the general populations in the two countries completed the online National University of Singapore COVID-19 Questionnaire. The survey was conducted in late February/early March in China and in mid-April in Spain, times of intense disease activity in the countries.

The questionnaire assesses knowledge and concerns about COVID, precautionary measures taken in the last 14 days, contact history, and physical symptoms related to COVID in the last 14 days. The pandemic’s psychological impact was evaluated using the Impact of Event Scale–Revised (IES-R). Participants also completed the Depression, Anxiety, and Stress-21 Scale (DASS-21).

Of note, the pandemic has taken a vastly greater physical toll in Spain than China. As of May 5, there were 83,000 confirmed cases of COVID-19 in China, with a population of 1.39 billion, compared with 248,000 in Spain, with a population of 46.9 million. The Spanish case rate of 5,500 per 1 million population was 100 times greater than China’s; the Spanish mortality rate of 585 per million was 185-fold greater.
 

Mental health findings

Spaniards experienced significantly higher levels of stress and depression as reflected in DASS-21 subscale scores of 14.22 and 8.65, respectively, compared with 7.86 and 6.38, in Chinese respondents. Spanish subjects also reported greater anxiety levels than the Chinese on the DASS-21 anxiety subscale, although not to a statistically significant extent. Yet, counterintuitively, given the DASS-21 results, the pandemic had a greater adverse psychological impact on the Chinese subjects as reflected in their significantly higher average IES-D score of 30.76 versus 27.64 in Spain. Dr. Ho offered a hypothesis as to why: The survey documented that many Chinese respondents felt socially stigmatized, and that their nation had been discriminated against by the rest of the world because the pandemic started in China.

Satisfaction with the public health response

Spanish respondents reported less confidence in their COVID-related medical services.

“This could be due to the rising number of infected health care workers in Spain. In contrast, the Chinese had more confidence in their medical services, probably because the government quickly deployed medical personnel and treated COVID-19 patients at rapidly built hospitals,” according to Dr. Ho.

Spain and other European countries shared four shortcomings in their pandemic response, he continued: lack of personal protective equipment for health care workers, delay in developing response strategies, a shortage of hospital beds, and inability to protect vulnerable elderly individuals from infection in nursing homes.

Experiencing cough, shortness of breath, myalgia, or other physical symptoms potentially associated with COVID-19 within the past 14 days was associated with worse depression, anxiety, and stress scores in both China and Spain. This underscores from a mental health standpoint the importance of rapid and accurate testing for the infection, Dr. Ho said.

Significantly more Spanish respondents felt there was too much unnecessary worry about COVID-19, suggesting a need for better health education regarding the pandemic.
 

Use of face masks

Consistent use of face masks regardless of the presence or absence of symptoms was far more common in the Chinese epicenter, where, unlike in Spain, this precautionary measure was associated with significantly lower IES-R and DASS-21 scores.

“One of the important findings in our study is that wearing a face mask seems to protect the mental health in China, but for the Spanish, wearing a face mask was associated with higher IES-R scores,” Dr. Ho said. “We understand that it is difficult for Europeans to accept the need to use masks for healthy people because mask-wearing suggests vulnerability to sickness and concealment of identity. The Chinese have a collective culture. They believe they should wear a face mask to protect their health and that of other people.”

Dr. Ho reported no financial conflicts regarding his study, conducted with coinvestigators at Huaibei (China) Normal University and Complutense University of Madrid.
 

bjancin@mdedge.com

SOURCE: Ho R. ECNP 2020, Session ISE01.

Spain and China used very different public health responses to the COVID-19 crisis, and that has had significant consequences in terms of the mental health as well as physical health of the two countries’ citizens, Roger Ho, MD, reported at the virtual congress of the European College of Neuropsychopharmacology.
 

Dr. Ho, a psychiatrist at the National University of Singapore, presented a first-of-its-kind cross-cultural comparative study of the impact of the COVID-19 pandemic in two epicenters on opposite sides of the world. A total of 1,539 participants drawn from the general populations in the two countries completed the online National University of Singapore COVID-19 Questionnaire. The survey was conducted in late February/early March in China and in mid-April in Spain, times of intense disease activity in the countries.

The questionnaire assesses knowledge and concerns about COVID, precautionary measures taken in the last 14 days, contact history, and physical symptoms related to COVID in the last 14 days. The pandemic’s psychological impact was evaluated using the Impact of Event Scale–Revised (IES-R). Participants also completed the Depression, Anxiety, and Stress-21 Scale (DASS-21).

Of note, the pandemic has taken a vastly greater physical toll in Spain than China. As of May 5, there were 83,000 confirmed cases of COVID-19 in China, with a population of 1.39 billion, compared with 248,000 in Spain, with a population of 46.9 million. The Spanish case rate of 5,500 per 1 million population was 100 times greater than China’s; the Spanish mortality rate of 585 per million was 185-fold greater.
 

Mental health findings

Spaniards experienced significantly higher levels of stress and depression as reflected in DASS-21 subscale scores of 14.22 and 8.65, respectively, compared with 7.86 and 6.38, in Chinese respondents. Spanish subjects also reported greater anxiety levels than the Chinese on the DASS-21 anxiety subscale, although not to a statistically significant extent. Yet, counterintuitively, given the DASS-21 results, the pandemic had a greater adverse psychological impact on the Chinese subjects as reflected in their significantly higher average IES-D score of 30.76 versus 27.64 in Spain. Dr. Ho offered a hypothesis as to why: The survey documented that many Chinese respondents felt socially stigmatized, and that their nation had been discriminated against by the rest of the world because the pandemic started in China.

Satisfaction with the public health response

Spanish respondents reported less confidence in their COVID-related medical services.

“This could be due to the rising number of infected health care workers in Spain. In contrast, the Chinese had more confidence in their medical services, probably because the government quickly deployed medical personnel and treated COVID-19 patients at rapidly built hospitals,” according to Dr. Ho.

Spain and other European countries shared four shortcomings in their pandemic response, he continued: lack of personal protective equipment for health care workers, delay in developing response strategies, a shortage of hospital beds, and inability to protect vulnerable elderly individuals from infection in nursing homes.

Experiencing cough, shortness of breath, myalgia, or other physical symptoms potentially associated with COVID-19 within the past 14 days was associated with worse depression, anxiety, and stress scores in both China and Spain. This underscores from a mental health standpoint the importance of rapid and accurate testing for the infection, Dr. Ho said.

Significantly more Spanish respondents felt there was too much unnecessary worry about COVID-19, suggesting a need for better health education regarding the pandemic.
 

Use of face masks

Consistent use of face masks regardless of the presence or absence of symptoms was far more common in the Chinese epicenter, where, unlike in Spain, this precautionary measure was associated with significantly lower IES-R and DASS-21 scores.

“One of the important findings in our study is that wearing a face mask seems to protect the mental health in China, but for the Spanish, wearing a face mask was associated with higher IES-R scores,” Dr. Ho said. “We understand that it is difficult for Europeans to accept the need to use masks for healthy people because mask-wearing suggests vulnerability to sickness and concealment of identity. The Chinese have a collective culture. They believe they should wear a face mask to protect their health and that of other people.”

Dr. Ho reported no financial conflicts regarding his study, conducted with coinvestigators at Huaibei (China) Normal University and Complutense University of Madrid.
 

bjancin@mdedge.com

SOURCE: Ho R. ECNP 2020, Session ISE01.

President Donald Trump’s COVID-19 diagnosis is raising fresh questions about the White House’s strategy for testing and containing the virus for a president whose cavalier attitude about the coronavirus has persisted since it landed on American shores.

The president has said others are tested before getting close to him, appearing to hold it as an iron shield of safety. He has largely eschewed mask-wearing and social distancing in meetings, travel and public events, while holding rallies for thousands of often maskless supporters.

The Trump administration has increasingly pinned its coronavirus testing strategy for the nation on antigen tests, which do not need a traditional lab for processing and quickly return results to patients. But the results are less accurate than those of the slower PCR tests. 

An early antigen test used by the White House was woefully inaccurate. But the new antigen test the White House is using has not been independently evaluated for accuracy and reliability. Moreover, this is the kit the Trump administration is pushing out to thousands of nursing homes to test residents and staff.

Testing “isn’t a ‘get out of jail free card,’” said Dr. Alan Wells, medical director of clinical labs at the University of Pittsburgh Medical Center and creator of its test for the novel coronavirus. In general, antigen tests can miss up to half the cases that are detected by polymerase chain reaction tests, depending on the population of patients tested, he said.

The White House said the president’s diagnosis was confirmed with a PCR test but declined to say which test delivered his initial result. The White House has been using a new antigen test from Abbott Laboratories to screen its staff for COVID-19, according to two administration officials. 

The test, known as BinaxNOW, received an emergency use authorization from the Food and Drug Administration in August. It produces results in 15 minutes. Yet little is independently known about how effective it is. According to the company, the test is 97% accurate in detecting positives and 98.5% accurate in identifying those without disease. Abbott’s stated performance of its antigen test was based on examining people within 7 days of COVID symptoms appearing.

The president and first lady have both had symptoms, according to White House chief of staff Mark Meadows and the first lady’s Twitter account. The president was admitted to Walter Reed National Military Medical Center on Friday evening “out of an abundance of caution,” White House press secretary Kayleigh McEnany said in a statement.

Vice President Mike Pence is also tested daily for the virus and tested negative, spokesperson Devin O’Malley said Friday, but he did not respond to a follow-up question about which test was used.

Trump heavily promoted another Abbott rapid testing device, the ID NOW, earlier this year. But that test relies on different technology than the newer Abbott antigen test.

“I have not seen any independent evaluation of the Binax assay in the literature or in the blogs,” Wells said. “It is an unknown.”

The Department of Health and Human Services announced in August that it had signed a $760 million contract with Abbott for 150 million BinaxNOW antigen tests, which are now being distributed to nursing homes and historically black colleges and universities, as well as to governors to help inform decisions about opening and closing schools. The Big Ten football conference has also pinned playing hopes on the deployment of antigen tests following Trump’s political pressure.

However, even senior federal officials concede that a test alone isn’t likely to stop the spread of a virus that has sickened more than 7 million Americans.

“Testing does not substitute for avoiding crowded indoor spaces, washing hands, or wearing a mask when you can’t physically distance; further, a negative test today does not mean that you won’t be positive tomorrow,” Adm. Brett Giroir, the senior HHS official helming the administration’s testing effort, said in a statement at the time.

Trump could be part of a “super-spreading event,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Given the timing of Trump’s positive test — which he announced on Twitter early Friday – his infection “likely happened 5 or more days ago,” Osterholm said. “If so, then he was widely infectious as early as Tuesday,” the day of the first presidential debate in Cleveland.

At least seven people who attended a Rose Garden announcement last Saturday, when Trump announced his nomination of Judge Amy Coney Barrett to the Supreme Court, have since tested positive for the coronavirus. They include Trump’s former adviser Kellyanne Conway, Republican Sens. Mike Lee and Thom Tillis, and the president of the University of Notre Dame, the Rev. John Jenkins.

“Having that many infected people there all at one time, we’re still going to see transmission coming off that event for a couple days,” Osterholm said.

Osterholm notes that about 20% of infected people lead to 80% of COVID-19 cases, because “super spreaders” can infect so many people at once.

He notes that participants and audience members at Tuesday’s debate were separated by at least 6 feet. But 6 feet isn’t always enough to prevent infection, he said.

While many COVID-19 infections appear to be spread by respiratory droplets, which usually fall to the ground within 6 feet, people who are singing or speaking loudly can project virus much further. Evidence also suggests that the novel coronavirus can spread through aerosols, floating in the air like a speck of dust.

“I wonder how much virus was floating in that room that night,” Osterholm said.

Other experts say it’s too soon to say whether Trump was infected in a super-spreader event. “The president and his wife have had many exposures to many people in enclosed venues without protection,” so they could have been infected at any number of places, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. 

Although Democratic presidential candidate and former Vice President Joe Biden tested negative for the virus with a PCR test Friday, experts note that false-negative results are common in the first few days after infection. Test results over the next several days will yield more useful information.

It can take more than a week for the virus to reproduce enough to be detected, Wells said: “You are probably not detectable for 3, 5, 7, even 10 days after you’re exposed.”

In Minnesota, where Trump held an outdoor campaign rally in Duluth with hundreds of attendees Wednesday, health officials warned that a 14-day quarantine is necessary, regardless of test results.

“Anyone who was a direct contact of President Trump or known COVID-19 cases needs to quarantine and should get tested,” the Minnesota Department of Health said.

Ongoing lapses in test result reporting could hamper efforts to track and isolate sick people. As of Sept. 10, 21 states and the District of Columbia were not reporting all antigen test results, according to a KHN investigation, a lapse in reporting that officials say leaves them blind to disease spread. Since then, public health departments in Arizona, North Carolina and South Dakota all have announced plans to add antigen testing to their case reporting.

Requests for comment to the D.C. Department of Health were referred to Mayor Muriel Bowser’s office, which did not respond. District health officials told KHN in early September that the White House does not report antigen test results to them – a potential violation of federal law under the CARES Act, which says any institution performing tests to diagnose COVID-19 must report all results to local or state public health departments.

Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said it’s not surprising that Trump tested positive, given that so many of his close associates – including his national security adviser and Secret Service officers – have also been infected by the virus.

“When you look at the number of social contacts and travel schedules, it’s not surprising,” Adalja said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

President Donald Trump’s COVID-19 diagnosis is raising fresh questions about the White House’s strategy for testing and containing the virus for a president whose cavalier attitude about the coronavirus has persisted since it landed on American shores.

The president has said others are tested before getting close to him, appearing to hold it as an iron shield of safety. He has largely eschewed mask-wearing and social distancing in meetings, travel and public events, while holding rallies for thousands of often maskless supporters.

The Trump administration has increasingly pinned its coronavirus testing strategy for the nation on antigen tests, which do not need a traditional lab for processing and quickly return results to patients. But the results are less accurate than those of the slower PCR tests. 

An early antigen test used by the White House was woefully inaccurate. But the new antigen test the White House is using has not been independently evaluated for accuracy and reliability. Moreover, this is the kit the Trump administration is pushing out to thousands of nursing homes to test residents and staff.

Testing “isn’t a ‘get out of jail free card,’” said Dr. Alan Wells, medical director of clinical labs at the University of Pittsburgh Medical Center and creator of its test for the novel coronavirus. In general, antigen tests can miss up to half the cases that are detected by polymerase chain reaction tests, depending on the population of patients tested, he said.

The White House said the president’s diagnosis was confirmed with a PCR test but declined to say which test delivered his initial result. The White House has been using a new antigen test from Abbott Laboratories to screen its staff for COVID-19, according to two administration officials. 

The test, known as BinaxNOW, received an emergency use authorization from the Food and Drug Administration in August. It produces results in 15 minutes. Yet little is independently known about how effective it is. According to the company, the test is 97% accurate in detecting positives and 98.5% accurate in identifying those without disease. Abbott’s stated performance of its antigen test was based on examining people within 7 days of COVID symptoms appearing.

The president and first lady have both had symptoms, according to White House chief of staff Mark Meadows and the first lady’s Twitter account. The president was admitted to Walter Reed National Military Medical Center on Friday evening “out of an abundance of caution,” White House press secretary Kayleigh McEnany said in a statement.

Vice President Mike Pence is also tested daily for the virus and tested negative, spokesperson Devin O’Malley said Friday, but he did not respond to a follow-up question about which test was used.

Trump heavily promoted another Abbott rapid testing device, the ID NOW, earlier this year. But that test relies on different technology than the newer Abbott antigen test.

“I have not seen any independent evaluation of the Binax assay in the literature or in the blogs,” Wells said. “It is an unknown.”

The Department of Health and Human Services announced in August that it had signed a $760 million contract with Abbott for 150 million BinaxNOW antigen tests, which are now being distributed to nursing homes and historically black colleges and universities, as well as to governors to help inform decisions about opening and closing schools. The Big Ten football conference has also pinned playing hopes on the deployment of antigen tests following Trump’s political pressure.

However, even senior federal officials concede that a test alone isn’t likely to stop the spread of a virus that has sickened more than 7 million Americans.

“Testing does not substitute for avoiding crowded indoor spaces, washing hands, or wearing a mask when you can’t physically distance; further, a negative test today does not mean that you won’t be positive tomorrow,” Adm. Brett Giroir, the senior HHS official helming the administration’s testing effort, said in a statement at the time.

Trump could be part of a “super-spreading event,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Given the timing of Trump’s positive test — which he announced on Twitter early Friday – his infection “likely happened 5 or more days ago,” Osterholm said. “If so, then he was widely infectious as early as Tuesday,” the day of the first presidential debate in Cleveland.

At least seven people who attended a Rose Garden announcement last Saturday, when Trump announced his nomination of Judge Amy Coney Barrett to the Supreme Court, have since tested positive for the coronavirus. They include Trump’s former adviser Kellyanne Conway, Republican Sens. Mike Lee and Thom Tillis, and the president of the University of Notre Dame, the Rev. John Jenkins.

“Having that many infected people there all at one time, we’re still going to see transmission coming off that event for a couple days,” Osterholm said.

Osterholm notes that about 20% of infected people lead to 80% of COVID-19 cases, because “super spreaders” can infect so many people at once.

He notes that participants and audience members at Tuesday’s debate were separated by at least 6 feet. But 6 feet isn’t always enough to prevent infection, he said.

While many COVID-19 infections appear to be spread by respiratory droplets, which usually fall to the ground within 6 feet, people who are singing or speaking loudly can project virus much further. Evidence also suggests that the novel coronavirus can spread through aerosols, floating in the air like a speck of dust.

“I wonder how much virus was floating in that room that night,” Osterholm said.

Other experts say it’s too soon to say whether Trump was infected in a super-spreader event. “The president and his wife have had many exposures to many people in enclosed venues without protection,” so they could have been infected at any number of places, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. 

Although Democratic presidential candidate and former Vice President Joe Biden tested negative for the virus with a PCR test Friday, experts note that false-negative results are common in the first few days after infection. Test results over the next several days will yield more useful information.

It can take more than a week for the virus to reproduce enough to be detected, Wells said: “You are probably not detectable for 3, 5, 7, even 10 days after you’re exposed.”

In Minnesota, where Trump held an outdoor campaign rally in Duluth with hundreds of attendees Wednesday, health officials warned that a 14-day quarantine is necessary, regardless of test results.

“Anyone who was a direct contact of President Trump or known COVID-19 cases needs to quarantine and should get tested,” the Minnesota Department of Health said.

Ongoing lapses in test result reporting could hamper efforts to track and isolate sick people. As of Sept. 10, 21 states and the District of Columbia were not reporting all antigen test results, according to a KHN investigation, a lapse in reporting that officials say leaves them blind to disease spread. Since then, public health departments in Arizona, North Carolina and South Dakota all have announced plans to add antigen testing to their case reporting.

Requests for comment to the D.C. Department of Health were referred to Mayor Muriel Bowser’s office, which did not respond. District health officials told KHN in early September that the White House does not report antigen test results to them – a potential violation of federal law under the CARES Act, which says any institution performing tests to diagnose COVID-19 must report all results to local or state public health departments.

Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said it’s not surprising that Trump tested positive, given that so many of his close associates – including his national security adviser and Secret Service officers – have also been infected by the virus.

“When you look at the number of social contacts and travel schedules, it’s not surprising,” Adalja said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

President Donald Trump’s COVID-19 diagnosis is raising fresh questions about the White House’s strategy for testing and containing the virus for a president whose cavalier attitude about the coronavirus has persisted since it landed on American shores.

The president has said others are tested before getting close to him, appearing to hold it as an iron shield of safety. He has largely eschewed mask-wearing and social distancing in meetings, travel and public events, while holding rallies for thousands of often maskless supporters.

The Trump administration has increasingly pinned its coronavirus testing strategy for the nation on antigen tests, which do not need a traditional lab for processing and quickly return results to patients. But the results are less accurate than those of the slower PCR tests. 

An early antigen test used by the White House was woefully inaccurate. But the new antigen test the White House is using has not been independently evaluated for accuracy and reliability. Moreover, this is the kit the Trump administration is pushing out to thousands of nursing homes to test residents and staff.

Testing “isn’t a ‘get out of jail free card,’” said Dr. Alan Wells, medical director of clinical labs at the University of Pittsburgh Medical Center and creator of its test for the novel coronavirus. In general, antigen tests can miss up to half the cases that are detected by polymerase chain reaction tests, depending on the population of patients tested, he said.

The White House said the president’s diagnosis was confirmed with a PCR test but declined to say which test delivered his initial result. The White House has been using a new antigen test from Abbott Laboratories to screen its staff for COVID-19, according to two administration officials. 

The test, known as BinaxNOW, received an emergency use authorization from the Food and Drug Administration in August. It produces results in 15 minutes. Yet little is independently known about how effective it is. According to the company, the test is 97% accurate in detecting positives and 98.5% accurate in identifying those without disease. Abbott’s stated performance of its antigen test was based on examining people within 7 days of COVID symptoms appearing.

The president and first lady have both had symptoms, according to White House chief of staff Mark Meadows and the first lady’s Twitter account. The president was admitted to Walter Reed National Military Medical Center on Friday evening “out of an abundance of caution,” White House press secretary Kayleigh McEnany said in a statement.

Vice President Mike Pence is also tested daily for the virus and tested negative, spokesperson Devin O’Malley said Friday, but he did not respond to a follow-up question about which test was used.

Trump heavily promoted another Abbott rapid testing device, the ID NOW, earlier this year. But that test relies on different technology than the newer Abbott antigen test.

“I have not seen any independent evaluation of the Binax assay in the literature or in the blogs,” Wells said. “It is an unknown.”

The Department of Health and Human Services announced in August that it had signed a $760 million contract with Abbott for 150 million BinaxNOW antigen tests, which are now being distributed to nursing homes and historically black colleges and universities, as well as to governors to help inform decisions about opening and closing schools. The Big Ten football conference has also pinned playing hopes on the deployment of antigen tests following Trump’s political pressure.

However, even senior federal officials concede that a test alone isn’t likely to stop the spread of a virus that has sickened more than 7 million Americans.

“Testing does not substitute for avoiding crowded indoor spaces, washing hands, or wearing a mask when you can’t physically distance; further, a negative test today does not mean that you won’t be positive tomorrow,” Adm. Brett Giroir, the senior HHS official helming the administration’s testing effort, said in a statement at the time.

Trump could be part of a “super-spreading event,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Given the timing of Trump’s positive test — which he announced on Twitter early Friday – his infection “likely happened 5 or more days ago,” Osterholm said. “If so, then he was widely infectious as early as Tuesday,” the day of the first presidential debate in Cleveland.

At least seven people who attended a Rose Garden announcement last Saturday, when Trump announced his nomination of Judge Amy Coney Barrett to the Supreme Court, have since tested positive for the coronavirus. They include Trump’s former adviser Kellyanne Conway, Republican Sens. Mike Lee and Thom Tillis, and the president of the University of Notre Dame, the Rev. John Jenkins.

“Having that many infected people there all at one time, we’re still going to see transmission coming off that event for a couple days,” Osterholm said.

Osterholm notes that about 20% of infected people lead to 80% of COVID-19 cases, because “super spreaders” can infect so many people at once.

He notes that participants and audience members at Tuesday’s debate were separated by at least 6 feet. But 6 feet isn’t always enough to prevent infection, he said.

While many COVID-19 infections appear to be spread by respiratory droplets, which usually fall to the ground within 6 feet, people who are singing or speaking loudly can project virus much further. Evidence also suggests that the novel coronavirus can spread through aerosols, floating in the air like a speck of dust.

“I wonder how much virus was floating in that room that night,” Osterholm said.

Other experts say it’s too soon to say whether Trump was infected in a super-spreader event. “The president and his wife have had many exposures to many people in enclosed venues without protection,” so they could have been infected at any number of places, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. 

Although Democratic presidential candidate and former Vice President Joe Biden tested negative for the virus with a PCR test Friday, experts note that false-negative results are common in the first few days after infection. Test results over the next several days will yield more useful information.

It can take more than a week for the virus to reproduce enough to be detected, Wells said: “You are probably not detectable for 3, 5, 7, even 10 days after you’re exposed.”

In Minnesota, where Trump held an outdoor campaign rally in Duluth with hundreds of attendees Wednesday, health officials warned that a 14-day quarantine is necessary, regardless of test results.

“Anyone who was a direct contact of President Trump or known COVID-19 cases needs to quarantine and should get tested,” the Minnesota Department of Health said.

Ongoing lapses in test result reporting could hamper efforts to track and isolate sick people. As of Sept. 10, 21 states and the District of Columbia were not reporting all antigen test results, according to a KHN investigation, a lapse in reporting that officials say leaves them blind to disease spread. Since then, public health departments in Arizona, North Carolina and South Dakota all have announced plans to add antigen testing to their case reporting.

Requests for comment to the D.C. Department of Health were referred to Mayor Muriel Bowser’s office, which did not respond. District health officials told KHN in early September that the White House does not report antigen test results to them – a potential violation of federal law under the CARES Act, which says any institution performing tests to diagnose COVID-19 must report all results to local or state public health departments.

Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said it’s not surprising that Trump tested positive, given that so many of his close associates – including his national security adviser and Secret Service officers – have also been infected by the virus.

“When you look at the number of social contacts and travel schedules, it’s not surprising,” Adalja said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

We think of a patient’s recovery happening in multiple locations – in a hospital room or a rehabilitation facility, for example. But many clinicians may not consider the opportunity to aid healing that lies in the waiting room.

The waiting room is where a patient’s loved ones often are and they, sometimes more than anyone, can unlock the path to a patient’s quicker recovery. Friends and family can offer encouragement, as they have an existing bond of trust that can help if a patient needs reinforcement to take their medications or follow other health care advice. But if loved ones are going to help patients, they need help from clinicians. Beyond being potential allies, they are also hurting, experiencing worry or confusion in a world of medical jargon.

The coronavirus changes the relationship of patients and their loved ones, as patients are often isolated or limited in the number of visitors they are allowed to see. A smartphone replaces the smiling faces of friends and relatives at their bedside, and a text is a poor substitute for a hug.

The Hospitalist asked some experienced hospitalists for insight on how best to communicate with patients’ loved ones to improve outcomes for all, medically and emotionally.
 

Team approach

“Patients feel isolated, terrified, and vulnerable but still need an advocate in the hospital, so daily communication with a patient’s loved one is important to give a sense that the patient is looked after,” said Kari Esbensen, MD, PhD, a hospitalist and palliative care expert at Emory University Hospital Midtown, Atlanta.

Glenn Rosenbluth, MD, a pediatric hospitalist and director, quality and safety programs, at the University of California, San Francisco, Benioff Children’s Hospital, agreed. He said that the most important thing is to communicate, period.

“We fall into this pattern of ‘out of sight, out of mind,’ ” he said. “We need to take the extra step to find out who a patient’s loved ones are. If it is a clinical visit, ask the patient, or maybe get the information from a caseworker, or just pay attention to who is dropping in to see the patient. Having a second person available to jot down notes, or having a handy list of questions – it all helps the patient. We forget that sometimes it can seem like a whirlwind for the patient when they are hurting. We have to remember that a loved one is important to a patient’s care team and we need to include them, empower them, and show that we want to hear their voices.”

Dr. Esbensen said it is critical to start off on the right foot when communicating with a patient’s loved one, especially during the current pandemic.

“With COVID-19, the most important thing is to speak honestly, to say hope for the best but prepare for the worst-case scenario,” Dr. Esbensen said. “We’ve seen that conditions can shift dramatically in short periods of time. The loved one needs to have a sense of the positive and negative possibilities. Families tend to lack understanding of the changes in the patient that are caused by COVID-19. The patient can come out of the hospital debilitated, very different than when they entered the hospital, and we need to warn people close to them about this. Unrealistic expectations need to be guarded against if a patient’s loved ones are going to help.”

Perhaps the best form of communication with a patient’s loved ones is an often-forgotten skill: listening.

“Get an idea from the patient’s loved ones of what the issues are, as well as their idea of what they think of the disease and how it spreads,” Dr. Esbensen said. “Sometimes they are right on target but sometimes there are misinterpretations and we need to help them understand it better. It’s not a ‘one-size-fits-all’ speech that we should give, but try to say, ‘tell me what you think is going on, what you think you’ve heard, and what you’re worried about,’ and learn what is most important to the patient. Start on those terms and adapt; this way you can correct and address what makes them most fearful, which can be different for each loved one. For some, the concern could be that they have children or other vulnerable people in the house. Finding out these other issues is important.”

“A lot of people just want information and want to be helpful, but we also need to realize that, while we are caring for many patients, this one person is the patient they are focused on,” said Laura Nell Hodo, MD, a pediatric hospitalist at Kravis Children’s Hospital at Mount Sinai in New York. “Don’t rush, and if you know that a patient’s loved one needs more time, make sure it can be found – if not then, at least later on the phone. Fifteen to 20 minutes may be what’s needed, and you can’t shortchange them.”

Dr. Hodo said that a patient’s loved ones often do not realize it is possible to receive phone calls from hospitalists. “We need to remind them that they can get in touch with us. We have to remember how helpless they can feel and how they want to understand what is happening in the hospital.”

For medical adherence issues, sometimes it is best to communicate with the patient and loved one at the same time, Dr. Hodo advised. “Whether it’s for medication or postdischarge exercises, if they both receive the information together it can reinforce adherence. But you also need to remember that the patient may only want a loved one told about certain things, or possibly nothing at all. We need to make sure we understand the patient’s wishes, regardless of whether we think a person close to them can be an ally or not.”

Dr. Esbensen also noted that a loved one can give hospitalists important clues to the emotional components of a patient’s care.

“I remember a patient whose wife told me how he worked in a garage, how he was strong and did not want people to think he was a weak guy just because of what was happening to him,” Dr. Esbensen said. “I didn’t know that he felt he might be perceived in this way. I mentioned to him how I learned he was a good mechanic and he perked up and felt seen in a different light. These things make a difference.”

But when is the best time to speak with a patient’s loved ones? Since much communication is done via phone during the pandemic, there are different philosophies.

“We had a debate among colleagues to see how each of us did it,” Dr. Esbensen said. “Some try to call after each patient encounter, while they are outside the room and it’s fresh in their mind, but others find it better to make the call after their rounds, to give the person their full attention. Most of the time I try to do it that way.”

She noted that, in the current environment, a phone call may be better than a face-to-face conversation with patients’ loved ones.

“We’re covered in so much gear to protect us from the coronavirus that it can feel like a great distance exists between us and the person with whom we’re speaking,” she said. “It’s strange, but the phone can make the conversation seem more relaxed and may get people to open up more.”
 

Even when they leave

All the hospitalists affirmed that loved ones can make a big difference for the patient through all aspects of care. Long after a patient returns home, the support of loved ones can have a profound impact in speeding healing and improving long-term outcomes.

Dr. Esbensen said COVID-19 and other serious illnesses can leave a patient needing support, and maybe a “push” when feeling low keeps them from adhering to medical advice.

“It’s not just in the hospital but after discharge,” she said. “A person offering support can really help patients throughout their journey, and much success in recovering from illness occurs after the transition home. Having the support of that one person a patient trusts can be critical.”

Dr. Hodo believes that the coronavirus pandemic could forever change the way hospitalists communicate with patients and their loved ones.

“I work in pediatrics and we know serious medical decisions can’t be made without guardians or parents,” she said. “But in adult medicine doctors may not automatically ask the patient about calling someone for input on decision-making. With COVID, you cannot assume a patient is on their own, because there are protocols keeping people from physically being present in the patient’s room. My experience from working in adult coronavirus units is that the thinking about the loved ones’ role in patient care – and communication with them – might just change. … At least, I hope so.”
 

Quick takeaways for hospitalists

• Get beyond personal protective equipment. A conversation with a patient’s loved one might be easier to achieve via phone, without all the protective gear in the way.
• Encourage adherence. Speaking with patients and loved ones together may be more effective. They may reach agreement quicker on how best to adhere to medical advice.
• Loved ones offer clues. They might give you a better sense of a patient’s worries, or help you to connect better with those in your care.
• Be present. You have a long to-do list but do not let empathy fall off it, even if you feel overwhelmed.

We think of a patient’s recovery happening in multiple locations – in a hospital room or a rehabilitation facility, for example. But many clinicians may not consider the opportunity to aid healing that lies in the waiting room.

The waiting room is where a patient’s loved ones often are and they, sometimes more than anyone, can unlock the path to a patient’s quicker recovery. Friends and family can offer encouragement, as they have an existing bond of trust that can help if a patient needs reinforcement to take their medications or follow other health care advice. But if loved ones are going to help patients, they need help from clinicians. Beyond being potential allies, they are also hurting, experiencing worry or confusion in a world of medical jargon.

The coronavirus changes the relationship of patients and their loved ones, as patients are often isolated or limited in the number of visitors they are allowed to see. A smartphone replaces the smiling faces of friends and relatives at their bedside, and a text is a poor substitute for a hug.

The Hospitalist asked some experienced hospitalists for insight on how best to communicate with patients’ loved ones to improve outcomes for all, medically and emotionally.
 

Team approach

“Patients feel isolated, terrified, and vulnerable but still need an advocate in the hospital, so daily communication with a patient’s loved one is important to give a sense that the patient is looked after,” said Kari Esbensen, MD, PhD, a hospitalist and palliative care expert at Emory University Hospital Midtown, Atlanta.

Glenn Rosenbluth, MD, a pediatric hospitalist and director, quality and safety programs, at the University of California, San Francisco, Benioff Children’s Hospital, agreed. He said that the most important thing is to communicate, period.

“We fall into this pattern of ‘out of sight, out of mind,’ ” he said. “We need to take the extra step to find out who a patient’s loved ones are. If it is a clinical visit, ask the patient, or maybe get the information from a caseworker, or just pay attention to who is dropping in to see the patient. Having a second person available to jot down notes, or having a handy list of questions – it all helps the patient. We forget that sometimes it can seem like a whirlwind for the patient when they are hurting. We have to remember that a loved one is important to a patient’s care team and we need to include them, empower them, and show that we want to hear their voices.”

Dr. Esbensen said it is critical to start off on the right foot when communicating with a patient’s loved one, especially during the current pandemic.

“With COVID-19, the most important thing is to speak honestly, to say hope for the best but prepare for the worst-case scenario,” Dr. Esbensen said. “We’ve seen that conditions can shift dramatically in short periods of time. The loved one needs to have a sense of the positive and negative possibilities. Families tend to lack understanding of the changes in the patient that are caused by COVID-19. The patient can come out of the hospital debilitated, very different than when they entered the hospital, and we need to warn people close to them about this. Unrealistic expectations need to be guarded against if a patient’s loved ones are going to help.”

Perhaps the best form of communication with a patient’s loved ones is an often-forgotten skill: listening.

“Get an idea from the patient’s loved ones of what the issues are, as well as their idea of what they think of the disease and how it spreads,” Dr. Esbensen said. “Sometimes they are right on target but sometimes there are misinterpretations and we need to help them understand it better. It’s not a ‘one-size-fits-all’ speech that we should give, but try to say, ‘tell me what you think is going on, what you think you’ve heard, and what you’re worried about,’ and learn what is most important to the patient. Start on those terms and adapt; this way you can correct and address what makes them most fearful, which can be different for each loved one. For some, the concern could be that they have children or other vulnerable people in the house. Finding out these other issues is important.”

“A lot of people just want information and want to be helpful, but we also need to realize that, while we are caring for many patients, this one person is the patient they are focused on,” said Laura Nell Hodo, MD, a pediatric hospitalist at Kravis Children’s Hospital at Mount Sinai in New York. “Don’t rush, and if you know that a patient’s loved one needs more time, make sure it can be found – if not then, at least later on the phone. Fifteen to 20 minutes may be what’s needed, and you can’t shortchange them.”

Dr. Hodo said that a patient’s loved ones often do not realize it is possible to receive phone calls from hospitalists. “We need to remind them that they can get in touch with us. We have to remember how helpless they can feel and how they want to understand what is happening in the hospital.”

For medical adherence issues, sometimes it is best to communicate with the patient and loved one at the same time, Dr. Hodo advised. “Whether it’s for medication or postdischarge exercises, if they both receive the information together it can reinforce adherence. But you also need to remember that the patient may only want a loved one told about certain things, or possibly nothing at all. We need to make sure we understand the patient’s wishes, regardless of whether we think a person close to them can be an ally or not.”

Dr. Esbensen also noted that a loved one can give hospitalists important clues to the emotional components of a patient’s care.

“I remember a patient whose wife told me how he worked in a garage, how he was strong and did not want people to think he was a weak guy just because of what was happening to him,” Dr. Esbensen said. “I didn’t know that he felt he might be perceived in this way. I mentioned to him how I learned he was a good mechanic and he perked up and felt seen in a different light. These things make a difference.”

But when is the best time to speak with a patient’s loved ones? Since much communication is done via phone during the pandemic, there are different philosophies.

“We had a debate among colleagues to see how each of us did it,” Dr. Esbensen said. “Some try to call after each patient encounter, while they are outside the room and it’s fresh in their mind, but others find it better to make the call after their rounds, to give the person their full attention. Most of the time I try to do it that way.”

She noted that, in the current environment, a phone call may be better than a face-to-face conversation with patients’ loved ones.

“We’re covered in so much gear to protect us from the coronavirus that it can feel like a great distance exists between us and the person with whom we’re speaking,” she said. “It’s strange, but the phone can make the conversation seem more relaxed and may get people to open up more.”
 

Even when they leave

All the hospitalists affirmed that loved ones can make a big difference for the patient through all aspects of care. Long after a patient returns home, the support of loved ones can have a profound impact in speeding healing and improving long-term outcomes.

Dr. Esbensen said COVID-19 and other serious illnesses can leave a patient needing support, and maybe a “push” when feeling low keeps them from adhering to medical advice.

“It’s not just in the hospital but after discharge,” she said. “A person offering support can really help patients throughout their journey, and much success in recovering from illness occurs after the transition home. Having the support of that one person a patient trusts can be critical.”

Dr. Hodo believes that the coronavirus pandemic could forever change the way hospitalists communicate with patients and their loved ones.

“I work in pediatrics and we know serious medical decisions can’t be made without guardians or parents,” she said. “But in adult medicine doctors may not automatically ask the patient about calling someone for input on decision-making. With COVID, you cannot assume a patient is on their own, because there are protocols keeping people from physically being present in the patient’s room. My experience from working in adult coronavirus units is that the thinking about the loved ones’ role in patient care – and communication with them – might just change. … At least, I hope so.”
 

Quick takeaways for hospitalists

• Get beyond personal protective equipment. A conversation with a patient’s loved one might be easier to achieve via phone, without all the protective gear in the way.
• Encourage adherence. Speaking with patients and loved ones together may be more effective. They may reach agreement quicker on how best to adhere to medical advice.
• Loved ones offer clues. They might give you a better sense of a patient’s worries, or help you to connect better with those in your care.
• Be present. You have a long to-do list but do not let empathy fall off it, even if you feel overwhelmed.

We think of a patient’s recovery happening in multiple locations – in a hospital room or a rehabilitation facility, for example. But many clinicians may not consider the opportunity to aid healing that lies in the waiting room.

The waiting room is where a patient’s loved ones often are and they, sometimes more than anyone, can unlock the path to a patient’s quicker recovery. Friends and family can offer encouragement, as they have an existing bond of trust that can help if a patient needs reinforcement to take their medications or follow other health care advice. But if loved ones are going to help patients, they need help from clinicians. Beyond being potential allies, they are also hurting, experiencing worry or confusion in a world of medical jargon.

The coronavirus changes the relationship of patients and their loved ones, as patients are often isolated or limited in the number of visitors they are allowed to see. A smartphone replaces the smiling faces of friends and relatives at their bedside, and a text is a poor substitute for a hug.

The Hospitalist asked some experienced hospitalists for insight on how best to communicate with patients’ loved ones to improve outcomes for all, medically and emotionally.
 

Team approach

“Patients feel isolated, terrified, and vulnerable but still need an advocate in the hospital, so daily communication with a patient’s loved one is important to give a sense that the patient is looked after,” said Kari Esbensen, MD, PhD, a hospitalist and palliative care expert at Emory University Hospital Midtown, Atlanta.

Glenn Rosenbluth, MD, a pediatric hospitalist and director, quality and safety programs, at the University of California, San Francisco, Benioff Children’s Hospital, agreed. He said that the most important thing is to communicate, period.

“We fall into this pattern of ‘out of sight, out of mind,’ ” he said. “We need to take the extra step to find out who a patient’s loved ones are. If it is a clinical visit, ask the patient, or maybe get the information from a caseworker, or just pay attention to who is dropping in to see the patient. Having a second person available to jot down notes, or having a handy list of questions – it all helps the patient. We forget that sometimes it can seem like a whirlwind for the patient when they are hurting. We have to remember that a loved one is important to a patient’s care team and we need to include them, empower them, and show that we want to hear their voices.”

Dr. Esbensen said it is critical to start off on the right foot when communicating with a patient’s loved one, especially during the current pandemic.

“With COVID-19, the most important thing is to speak honestly, to say hope for the best but prepare for the worst-case scenario,” Dr. Esbensen said. “We’ve seen that conditions can shift dramatically in short periods of time. The loved one needs to have a sense of the positive and negative possibilities. Families tend to lack understanding of the changes in the patient that are caused by COVID-19. The patient can come out of the hospital debilitated, very different than when they entered the hospital, and we need to warn people close to them about this. Unrealistic expectations need to be guarded against if a patient’s loved ones are going to help.”

Perhaps the best form of communication with a patient’s loved ones is an often-forgotten skill: listening.

“Get an idea from the patient’s loved ones of what the issues are, as well as their idea of what they think of the disease and how it spreads,” Dr. Esbensen said. “Sometimes they are right on target but sometimes there are misinterpretations and we need to help them understand it better. It’s not a ‘one-size-fits-all’ speech that we should give, but try to say, ‘tell me what you think is going on, what you think you’ve heard, and what you’re worried about,’ and learn what is most important to the patient. Start on those terms and adapt; this way you can correct and address what makes them most fearful, which can be different for each loved one. For some, the concern could be that they have children or other vulnerable people in the house. Finding out these other issues is important.”

“A lot of people just want information and want to be helpful, but we also need to realize that, while we are caring for many patients, this one person is the patient they are focused on,” said Laura Nell Hodo, MD, a pediatric hospitalist at Kravis Children’s Hospital at Mount Sinai in New York. “Don’t rush, and if you know that a patient’s loved one needs more time, make sure it can be found – if not then, at least later on the phone. Fifteen to 20 minutes may be what’s needed, and you can’t shortchange them.”

Dr. Hodo said that a patient’s loved ones often do not realize it is possible to receive phone calls from hospitalists. “We need to remind them that they can get in touch with us. We have to remember how helpless they can feel and how they want to understand what is happening in the hospital.”

For medical adherence issues, sometimes it is best to communicate with the patient and loved one at the same time, Dr. Hodo advised. “Whether it’s for medication or postdischarge exercises, if they both receive the information together it can reinforce adherence. But you also need to remember that the patient may only want a loved one told about certain things, or possibly nothing at all. We need to make sure we understand the patient’s wishes, regardless of whether we think a person close to them can be an ally or not.”

Dr. Esbensen also noted that a loved one can give hospitalists important clues to the emotional components of a patient’s care.

“I remember a patient whose wife told me how he worked in a garage, how he was strong and did not want people to think he was a weak guy just because of what was happening to him,” Dr. Esbensen said. “I didn’t know that he felt he might be perceived in this way. I mentioned to him how I learned he was a good mechanic and he perked up and felt seen in a different light. These things make a difference.”

But when is the best time to speak with a patient’s loved ones? Since much communication is done via phone during the pandemic, there are different philosophies.

“We had a debate among colleagues to see how each of us did it,” Dr. Esbensen said. “Some try to call after each patient encounter, while they are outside the room and it’s fresh in their mind, but others find it better to make the call after their rounds, to give the person their full attention. Most of the time I try to do it that way.”

She noted that, in the current environment, a phone call may be better than a face-to-face conversation with patients’ loved ones.

“We’re covered in so much gear to protect us from the coronavirus that it can feel like a great distance exists between us and the person with whom we’re speaking,” she said. “It’s strange, but the phone can make the conversation seem more relaxed and may get people to open up more.”
 

Even when they leave

All the hospitalists affirmed that loved ones can make a big difference for the patient through all aspects of care. Long after a patient returns home, the support of loved ones can have a profound impact in speeding healing and improving long-term outcomes.

Dr. Esbensen said COVID-19 and other serious illnesses can leave a patient needing support, and maybe a “push” when feeling low keeps them from adhering to medical advice.

“It’s not just in the hospital but after discharge,” she said. “A person offering support can really help patients throughout their journey, and much success in recovering from illness occurs after the transition home. Having the support of that one person a patient trusts can be critical.”

Dr. Hodo believes that the coronavirus pandemic could forever change the way hospitalists communicate with patients and their loved ones.

“I work in pediatrics and we know serious medical decisions can’t be made without guardians or parents,” she said. “But in adult medicine doctors may not automatically ask the patient about calling someone for input on decision-making. With COVID, you cannot assume a patient is on their own, because there are protocols keeping people from physically being present in the patient’s room. My experience from working in adult coronavirus units is that the thinking about the loved ones’ role in patient care – and communication with them – might just change. … At least, I hope so.”
 

Quick takeaways for hospitalists

• Get beyond personal protective equipment. A conversation with a patient’s loved one might be easier to achieve via phone, without all the protective gear in the way.
• Encourage adherence. Speaking with patients and loved ones together may be more effective. They may reach agreement quicker on how best to adhere to medical advice.
• Loved ones offer clues. They might give you a better sense of a patient’s worries, or help you to connect better with those in your care.
• Be present. You have a long to-do list but do not let empathy fall off it, even if you feel overwhelmed.

Current and former users of e-cigarettes are more likely to report sleep deprivation, compared with those who have never used e-cigarettes, according to the first study to evaluate the association in a large, nationally representative population of young adults.

“The e-cigarette use and sleep deprivation association seems to have a dose-response nature as the point estimate of the association increased with increased exposure to e-cigarette,” Sina Kianersi, DVM, and associates at Indiana University, Bloomington, said in Addictive Behaviors.

Sleep deprivation was 49% more prevalent among everyday users of e-cigarettes, compared with nonusers. Prevalence ratios for former users (1.31) and occasional users (1.25) also showed significantly higher sleep deprivation, compared with nonusers, they reported based on a bivariate analysis of data from young adults aged 18-24 years who participated in the 2017 and 2018 Behavioral Risk Factor Surveillance System surveys.

After adjustment for multiple confounders, young adults who currently used e-cigarettes every day were 42% more likely to report sleep deprivation than those who never used e-cigarettes, a difference that was statistically significant. The prevalence of sleep deprivation among those who used e-cigarettes on some days was not significantly higher (prevalence ratio, 1.08), but the ratio between former users and never users was a significant 1.17, the investigators said.

“The nicotine in the inhaled e-cigarette aerosols may have negative effects on sleep architecture and disturb the neurotransmitters that regulate sleep cycle,” they suggested, and since higher doses of nicotine produce greater reductions in sleep duration, “those who use e-cigarette on a daily basis might consume higher doses of nicotine, compared to some days, former, and never users, and therefore get fewer hours of sleep.”

Nicotine withdrawal, on the other hand, has been found to increase sleep duration in a dose-dependent manner, which “could explain the smaller [prevalence ratios] observed for the association between e-cigarette use and sleep deprivation among former and some days e-cigarette users,” Dr. Kianersi and associates added.

The bivariate analysis involved 18,945 survey respondents, of whom 16,427 were included in the fully adjusted model using 12 confounding factors.

rfranki@mdedge.com

SOURCE: Kianersi S et al. Addict Behav. 2020 Sep 6. doi: 10.1016/j.addbeh.2020.106646.

Current and former users of e-cigarettes are more likely to report sleep deprivation, compared with those who have never used e-cigarettes, according to the first study to evaluate the association in a large, nationally representative population of young adults.

“The e-cigarette use and sleep deprivation association seems to have a dose-response nature as the point estimate of the association increased with increased exposure to e-cigarette,” Sina Kianersi, DVM, and associates at Indiana University, Bloomington, said in Addictive Behaviors.

Sleep deprivation was 49% more prevalent among everyday users of e-cigarettes, compared with nonusers. Prevalence ratios for former users (1.31) and occasional users (1.25) also showed significantly higher sleep deprivation, compared with nonusers, they reported based on a bivariate analysis of data from young adults aged 18-24 years who participated in the 2017 and 2018 Behavioral Risk Factor Surveillance System surveys.

After adjustment for multiple confounders, young adults who currently used e-cigarettes every day were 42% more likely to report sleep deprivation than those who never used e-cigarettes, a difference that was statistically significant. The prevalence of sleep deprivation among those who used e-cigarettes on some days was not significantly higher (prevalence ratio, 1.08), but the ratio between former users and never users was a significant 1.17, the investigators said.

“The nicotine in the inhaled e-cigarette aerosols may have negative effects on sleep architecture and disturb the neurotransmitters that regulate sleep cycle,” they suggested, and since higher doses of nicotine produce greater reductions in sleep duration, “those who use e-cigarette on a daily basis might consume higher doses of nicotine, compared to some days, former, and never users, and therefore get fewer hours of sleep.”

Nicotine withdrawal, on the other hand, has been found to increase sleep duration in a dose-dependent manner, which “could explain the smaller [prevalence ratios] observed for the association between e-cigarette use and sleep deprivation among former and some days e-cigarette users,” Dr. Kianersi and associates added.

The bivariate analysis involved 18,945 survey respondents, of whom 16,427 were included in the fully adjusted model using 12 confounding factors.

rfranki@mdedge.com

SOURCE: Kianersi S et al. Addict Behav. 2020 Sep 6. doi: 10.1016/j.addbeh.2020.106646.

Current and former users of e-cigarettes are more likely to report sleep deprivation, compared with those who have never used e-cigarettes, according to the first study to evaluate the association in a large, nationally representative population of young adults.

“The e-cigarette use and sleep deprivation association seems to have a dose-response nature as the point estimate of the association increased with increased exposure to e-cigarette,” Sina Kianersi, DVM, and associates at Indiana University, Bloomington, said in Addictive Behaviors.

Sleep deprivation was 49% more prevalent among everyday users of e-cigarettes, compared with nonusers. Prevalence ratios for former users (1.31) and occasional users (1.25) also showed significantly higher sleep deprivation, compared with nonusers, they reported based on a bivariate analysis of data from young adults aged 18-24 years who participated in the 2017 and 2018 Behavioral Risk Factor Surveillance System surveys.

After adjustment for multiple confounders, young adults who currently used e-cigarettes every day were 42% more likely to report sleep deprivation than those who never used e-cigarettes, a difference that was statistically significant. The prevalence of sleep deprivation among those who used e-cigarettes on some days was not significantly higher (prevalence ratio, 1.08), but the ratio between former users and never users was a significant 1.17, the investigators said.

“The nicotine in the inhaled e-cigarette aerosols may have negative effects on sleep architecture and disturb the neurotransmitters that regulate sleep cycle,” they suggested, and since higher doses of nicotine produce greater reductions in sleep duration, “those who use e-cigarette on a daily basis might consume higher doses of nicotine, compared to some days, former, and never users, and therefore get fewer hours of sleep.”

Nicotine withdrawal, on the other hand, has been found to increase sleep duration in a dose-dependent manner, which “could explain the smaller [prevalence ratios] observed for the association between e-cigarette use and sleep deprivation among former and some days e-cigarette users,” Dr. Kianersi and associates added.

The bivariate analysis involved 18,945 survey respondents, of whom 16,427 were included in the fully adjusted model using 12 confounding factors.

rfranki@mdedge.com

SOURCE: Kianersi S et al. Addict Behav. 2020 Sep 6. doi: 10.1016/j.addbeh.2020.106646.

To the Editor:

Immunosuppressed patients are at particular risk for disseminated mycobacterial infections. A locus minoris resistentiae offers less resistance to the infectious spread of these microorganisms. We present a case of Mycobacterium chelonae infection preferentially involving striae distensae.

A 30-year-old man with chronic eosinophilic pneumonia requiring high-dose corticosteroid therapy presented with widespread skin lesions. He reported no history of cutaneous trauma or aquatic activities. Physical examination revealed the patient was markedly cushingoid with generalized cutaneous atrophy and widespread striae. Multiple erythematous papules surrounded a large ulceration on the dorsal aspect of the left hand. Depressed erythematous plaques and several small crusted erosions extended up the left lower leg (Figure 1) to the knee. Strikingly, numerous brown and pink papules and small plaques on the left thigh were primarily confined within striae (Figure 2).

A biopsy of the left thigh revealed granulomatous inflammation (Figure 3) with numerous acid-fast bacilli (Figure 4). Broad-spectrum coverage for fast-growing acid-fast bacilli with amikacin, ceftriaxone, levofloxacin, and clarithromycin was initiated with steady improvement of the eruption. Tissue culture subsequently grew Mycobacterium abscessus-chelonae, and therapy was narrowed to clarithromycin and moxifloxacin.

Mycobacterium chelonae is a rapidly growing mycobacteria isolated from soil and water worldwide, and human skin is a commensal organism. Cutaneous infections have been associated with traumatic injury, tattooing, surgery, cosmetic procedures, vascular access sites, and acupuncture.¹ Most cases of cutaneous M chelonae infection begin as a violaceous nodule. Over weeks to months, the localized infection progresses to multiple papules, nodules, draining abscesses, or ulcers. Infections tend to disseminate in immunosuppressed patients, and granulomatous inflammation may not be seen.¹

Atypical mycobacterial infection occurring within striae distensae is an example of locus minoris resistentiae—a place of less resistance. Wolf et al² hypothesized that locus minoris resistentiae could explain the occurrence of an isotopic response or the occurrence of a new skin disorder at the site of a previously healed skin condition. They suggested that the same site could be affected by 2 unrelated diseases at different times due to an inherited or acquired susceptibility in the area.² Herpes zoster serves as a primary example of Wolf phenomenon, as numerous conditions including granuloma annulare, pseudolymphoma, Bowen disease, and acne have reportedly emerged in its wake.³

Although locus minoris resistentiae does not specifically involve traumatized skin, it must be distinguished from the Koebner phenomenon, characterized by the appearance of isomorphic lesions in areas of otherwise healthy skin subjected to cutaneous injury, as well as the pseudo-Koebner phenomenon, a similar process involving infectious agents.³

In our patient, striae distensae represented areas of increased predisposition to infection. The catabolic effect of high corticosteroid levels on fibroblast activity decreased collagen deposition in the dermal matrix, leading to the formation of linear bands of atrophic skin.⁴ The elastic fiber network in striae distensae is reduced and reorganized compared to normal skin, in which an intertwining elastic system forms a continuum from the dermoepidermal junction to the deep dermis.⁵ The number of vertically oriented fibrillin microfibrils subjacent to the dermoepidermal junction and elastin fibers in the papillary dermis is comparatively diminished such that the elastin and fibrillin fibers in the deep dermis run more horizontally compared to normal skin.⁴ Consequently, collagen alignment in striae distensae demonstrates more anisotropy, or directionally dependent variability, and the dermal matrix is looser and more floccular than the surrounding skin.⁶ These alterations of dermal architecture likely provide a mechanical advantage for intradermal spread of M chelonae within striae.

Other dermatoses have been observed to occur within striae distensae, specifically leukemia cutis, urticarial vasculitis, lupus erythematosus, keloids, linear focal elastosis, chronic graft-vs-host disease, psoriasis, gestational pemphigoid, and vitiligo.⁷ Given the dissimilarities of these conditions, the distinctive milieu of striae must provide an invitation—a locus minoris resistentiae—for secondary pathology.

Chronic corticosteroid use leads to both immunosuppression and striae distensae, effectively creating a perfect storm for an atypical mycobacterial skin infection demonstrating locus minoris resistentiae. The immunosuppressed state makes patients more susceptible to infection, and striae distensae may serve as a conduit for the offending organisms.

Acknowledgments—We are indebted to Letty Peterson, MD (Vidalia, Georgia), for her referral of this case, and to Stephen Mullins, MD (Augusta, Georgia), for his dermatopathology services.

To the Editor:

Immunosuppressed patients are at particular risk for disseminated mycobacterial infections. A locus minoris resistentiae offers less resistance to the infectious spread of these microorganisms. We present a case of Mycobacterium chelonae infection preferentially involving striae distensae.

A 30-year-old man with chronic eosinophilic pneumonia requiring high-dose corticosteroid therapy presented with widespread skin lesions. He reported no history of cutaneous trauma or aquatic activities. Physical examination revealed the patient was markedly cushingoid with generalized cutaneous atrophy and widespread striae. Multiple erythematous papules surrounded a large ulceration on the dorsal aspect of the left hand. Depressed erythematous plaques and several small crusted erosions extended up the left lower leg (Figure 1) to the knee. Strikingly, numerous brown and pink papules and small plaques on the left thigh were primarily confined within striae (Figure 2).

A biopsy of the left thigh revealed granulomatous inflammation (Figure 3) with numerous acid-fast bacilli (Figure 4). Broad-spectrum coverage for fast-growing acid-fast bacilli with amikacin, ceftriaxone, levofloxacin, and clarithromycin was initiated with steady improvement of the eruption. Tissue culture subsequently grew Mycobacterium abscessus-chelonae, and therapy was narrowed to clarithromycin and moxifloxacin.

Mycobacterium chelonae is a rapidly growing mycobacteria isolated from soil and water worldwide, and human skin is a commensal organism. Cutaneous infections have been associated with traumatic injury, tattooing, surgery, cosmetic procedures, vascular access sites, and acupuncture.¹ Most cases of cutaneous M chelonae infection begin as a violaceous nodule. Over weeks to months, the localized infection progresses to multiple papules, nodules, draining abscesses, or ulcers. Infections tend to disseminate in immunosuppressed patients, and granulomatous inflammation may not be seen.¹

Atypical mycobacterial infection occurring within striae distensae is an example of locus minoris resistentiae—a place of less resistance. Wolf et al² hypothesized that locus minoris resistentiae could explain the occurrence of an isotopic response or the occurrence of a new skin disorder at the site of a previously healed skin condition. They suggested that the same site could be affected by 2 unrelated diseases at different times due to an inherited or acquired susceptibility in the area.² Herpes zoster serves as a primary example of Wolf phenomenon, as numerous conditions including granuloma annulare, pseudolymphoma, Bowen disease, and acne have reportedly emerged in its wake.³

Although locus minoris resistentiae does not specifically involve traumatized skin, it must be distinguished from the Koebner phenomenon, characterized by the appearance of isomorphic lesions in areas of otherwise healthy skin subjected to cutaneous injury, as well as the pseudo-Koebner phenomenon, a similar process involving infectious agents.³

In our patient, striae distensae represented areas of increased predisposition to infection. The catabolic effect of high corticosteroid levels on fibroblast activity decreased collagen deposition in the dermal matrix, leading to the formation of linear bands of atrophic skin.⁴ The elastic fiber network in striae distensae is reduced and reorganized compared to normal skin, in which an intertwining elastic system forms a continuum from the dermoepidermal junction to the deep dermis.⁵ The number of vertically oriented fibrillin microfibrils subjacent to the dermoepidermal junction and elastin fibers in the papillary dermis is comparatively diminished such that the elastin and fibrillin fibers in the deep dermis run more horizontally compared to normal skin.⁴ Consequently, collagen alignment in striae distensae demonstrates more anisotropy, or directionally dependent variability, and the dermal matrix is looser and more floccular than the surrounding skin.⁶ These alterations of dermal architecture likely provide a mechanical advantage for intradermal spread of M chelonae within striae.

Other dermatoses have been observed to occur within striae distensae, specifically leukemia cutis, urticarial vasculitis, lupus erythematosus, keloids, linear focal elastosis, chronic graft-vs-host disease, psoriasis, gestational pemphigoid, and vitiligo.⁷ Given the dissimilarities of these conditions, the distinctive milieu of striae must provide an invitation—a locus minoris resistentiae—for secondary pathology.

Chronic corticosteroid use leads to both immunosuppression and striae distensae, effectively creating a perfect storm for an atypical mycobacterial skin infection demonstrating locus minoris resistentiae. The immunosuppressed state makes patients more susceptible to infection, and striae distensae may serve as a conduit for the offending organisms.

Acknowledgments—We are indebted to Letty Peterson, MD (Vidalia, Georgia), for her referral of this case, and to Stephen Mullins, MD (Augusta, Georgia), for his dermatopathology services.

To the Editor:

Immunosuppressed patients are at particular risk for disseminated mycobacterial infections. A locus minoris resistentiae offers less resistance to the infectious spread of these microorganisms. We present a case of Mycobacterium chelonae infection preferentially involving striae distensae.

A 30-year-old man with chronic eosinophilic pneumonia requiring high-dose corticosteroid therapy presented with widespread skin lesions. He reported no history of cutaneous trauma or aquatic activities. Physical examination revealed the patient was markedly cushingoid with generalized cutaneous atrophy and widespread striae. Multiple erythematous papules surrounded a large ulceration on the dorsal aspect of the left hand. Depressed erythematous plaques and several small crusted erosions extended up the left lower leg (Figure 1) to the knee. Strikingly, numerous brown and pink papules and small plaques on the left thigh were primarily confined within striae (Figure 2).

A biopsy of the left thigh revealed granulomatous inflammation (Figure 3) with numerous acid-fast bacilli (Figure 4). Broad-spectrum coverage for fast-growing acid-fast bacilli with amikacin, ceftriaxone, levofloxacin, and clarithromycin was initiated with steady improvement of the eruption. Tissue culture subsequently grew Mycobacterium abscessus-chelonae, and therapy was narrowed to clarithromycin and moxifloxacin.

Mycobacterium chelonae is a rapidly growing mycobacteria isolated from soil and water worldwide, and human skin is a commensal organism. Cutaneous infections have been associated with traumatic injury, tattooing, surgery, cosmetic procedures, vascular access sites, and acupuncture.¹ Most cases of cutaneous M chelonae infection begin as a violaceous nodule. Over weeks to months, the localized infection progresses to multiple papules, nodules, draining abscesses, or ulcers. Infections tend to disseminate in immunosuppressed patients, and granulomatous inflammation may not be seen.¹

Atypical mycobacterial infection occurring within striae distensae is an example of locus minoris resistentiae—a place of less resistance. Wolf et al² hypothesized that locus minoris resistentiae could explain the occurrence of an isotopic response or the occurrence of a new skin disorder at the site of a previously healed skin condition. They suggested that the same site could be affected by 2 unrelated diseases at different times due to an inherited or acquired susceptibility in the area.² Herpes zoster serves as a primary example of Wolf phenomenon, as numerous conditions including granuloma annulare, pseudolymphoma, Bowen disease, and acne have reportedly emerged in its wake.³

Although locus minoris resistentiae does not specifically involve traumatized skin, it must be distinguished from the Koebner phenomenon, characterized by the appearance of isomorphic lesions in areas of otherwise healthy skin subjected to cutaneous injury, as well as the pseudo-Koebner phenomenon, a similar process involving infectious agents.³

In our patient, striae distensae represented areas of increased predisposition to infection. The catabolic effect of high corticosteroid levels on fibroblast activity decreased collagen deposition in the dermal matrix, leading to the formation of linear bands of atrophic skin.⁴ The elastic fiber network in striae distensae is reduced and reorganized compared to normal skin, in which an intertwining elastic system forms a continuum from the dermoepidermal junction to the deep dermis.⁵ The number of vertically oriented fibrillin microfibrils subjacent to the dermoepidermal junction and elastin fibers in the papillary dermis is comparatively diminished such that the elastin and fibrillin fibers in the deep dermis run more horizontally compared to normal skin.⁴ Consequently, collagen alignment in striae distensae demonstrates more anisotropy, or directionally dependent variability, and the dermal matrix is looser and more floccular than the surrounding skin.⁶ These alterations of dermal architecture likely provide a mechanical advantage for intradermal spread of M chelonae within striae.

Other dermatoses have been observed to occur within striae distensae, specifically leukemia cutis, urticarial vasculitis, lupus erythematosus, keloids, linear focal elastosis, chronic graft-vs-host disease, psoriasis, gestational pemphigoid, and vitiligo.⁷ Given the dissimilarities of these conditions, the distinctive milieu of striae must provide an invitation—a locus minoris resistentiae—for secondary pathology.

Chronic corticosteroid use leads to both immunosuppression and striae distensae, effectively creating a perfect storm for an atypical mycobacterial skin infection demonstrating locus minoris resistentiae. The immunosuppressed state makes patients more susceptible to infection, and striae distensae may serve as a conduit for the offending organisms.

Acknowledgments—We are indebted to Letty Peterson, MD (Vidalia, Georgia), for her referral of this case, and to Stephen Mullins, MD (Augusta, Georgia), for his dermatopathology services.