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Women thrive on baroreflex activation for heart failure
The striking gains in functional capacity and quality of life conferred by baroreflex activation therapy in patients with heart failure, as shown in the pivotal phase 3 clinical trial for this novel intervention, were at least as great in women as in men, JoAnn Lindenfeld, MD, said at the European Society of Cardiology Heart Failure Discoveries virtual meeting.
The results of the multicenter, prospective, randomized BeAT-HF trial led to marketing approval of the BaroStim Neo system for improvement in symptoms of heart failure with reduced ejection fraction (HFrEF) by the Food and Drug Administration in August 2019. Dr. Lindenfeld presented a fresh breakdown of the results by gender which showed, intriguingly, that the improvement in all study endpoints was consistently numerically greater in the women – sometimes startlingly so – although these gender differences in response didn’t achieve statistical significance. The 6-month randomized trial was underpowered for drawing definitive conclusions on that score, with a study population of only 53 women and 211 men. So the investigator remained circumspect.
“We think that what this study shows us is that women have at least equivalent improvement as men in this population. I don’t think we can conclude from this study yet that it’s better, but it’s certainly in all these parameters as least as good. And I think this is a population in which we’ve seen that improving symptoms and functional capacity is very important,” said Dr. Lindenfeld, professor of medicine and director of advanced heart failure/cardiac transplantation at Vanderbilt University, Nashville, Tenn.
The FDA approval was restricted to patients like those enrolled in BeAT-HF: that is, individuals with New York Heart Association functional class III heart failure, a left ventricular ejection fraction of 35% or less while on stable optimal medical therapy, and ineligibility for cardiac resynchronization therapy according to current guidelines. Seventy-eight percent of BeAT-HF participants had an implantable cardioverter-defibrillator.
Participants were randomized to baroreflex activation therapy (BAT) plus optimal medical therapy or to optimal medical therapy alone. The three coprimary endpoints were change from baseline to 6 months in 6-minute hall walk distance (6MHW), scores on the Minnesota Living with Heart Failure Questionnaire (MLHF), and N-terminal pro-B-type natriuretic peptide (NT-proBNP).
In the overall study population, 6MHW increased by 60 m in the BAT group and decreased by 8 m in controls; MLHF scores dropped by 14 and 6 points, respectively; and NT-proBNP fell by an average of 25% with BAT while rising by 3% in controls.
Very often, just a 5-point reduction in MLHF score is considered a clinically meaningful improvement in quality of life, the cardiologist noted.
The gender-based analysis is where things got particularly interesting.
The investigators defined a clinically relevant response as a greater than 10% increase from baseline on the 6MHW, at least a one-class improvement in NYHA class, or a reduction of 5 points or more on the MLHF. Among subjects in the BAT group, 70% of women and 60% of men met the clinically relevant response standard in terms of 6MHW, as did 70% of women and 64% of men for improvement in NYHA class, and 78% of women and 66% of men for MLHF score.
Eighty-seven percent of women and 68% of men on BAT had a clinically relevant response on at least one of these endpoints, as did about 28% of controls. Moreover, 31% of women in the BAT group were clinically relevant responders on at least two endpoints, compared with 19% of BAT men and 4% and 9% of controls.
Women dominate super-responder category
In order to be classified as a super responder, a patient had to demonstrate a greater than 20% increase in 6MHW, improvement in NYHA class I status, or at least a 10-point improvement in MLHF score. Ninety-one percent of women on BAT achieved super-responder status for at least one of these endpoints, compared with 76% of men. Forty-three percent of women and 24% of men in the BAT group were super responders in at least two domains, as were 8% and 11% of female and male controls, Dr. Lindenfeld continued.
Discussant Ewa Anita Jankowska, MD, PhD, deemed the BeAT-HF results on the therapeutic benefits of this autonomic modulation strategy “quite convincing.”
“We need to acknowledge that in recent years we have been spoiled a bit by the huge trials in heart failure where the ultimate goal was a reduction in mortality. But I think this is the time when we should think about the patients who want to live – here, now – with a better life. Patients expect symptomatic benefits. There is a substantial group of patients who are symptomatic even though they receive quite extensive neurohormonal blockage and who are not suitable for CRT. This study demonstrates that, for this group of patients, BAT can bring really significant symptomatic benefits,” she said.
“If you think about a treatment that provides patients who are NYHA class III an increase in 6MHW of 60 meters, that’s really something. And 20% of patients went from NYHA class III to class I – that’s really something, too,” added Dr. Jankowska, professor of medicine and head of the laboratory of applied research on the cardiovascular system at Wroclaw (Poland) University.
How baroreflex activation therapy works
The BaroStim system consists of a 2-mm unipolar electrode on a 7-mm backer that is placed over the carotid sinus. It is supported by a small generator with a 4- to 5-year battery life implanted under the collarbone, along with radiofrequency telemetry capability and programming flexibility.
Stimulation of the carotid baroreceptor promotes an integrated autonomic nervous system response which enhances parasympathetic activity and inhibits sympathetic nervous system activity. The result, as shown in numerous earlier proof-of-concept studies, is a reduced heart rate, decreased ventricular remodeling, enhanced diuresis, increased vasodilation, a drop in elevated blood pressure, and decreased renin secretion – all achieved nonpharmacologically.
The study was sponsored by CVRx. Dr. Lindenfeld reported serving as a consultant to CVRx, Abbott, AstraZeneca, Boehringer Ingelheim, Edwards Lifesciences, Impulse Dynamics, and VWave.
The striking gains in functional capacity and quality of life conferred by baroreflex activation therapy in patients with heart failure, as shown in the pivotal phase 3 clinical trial for this novel intervention, were at least as great in women as in men, JoAnn Lindenfeld, MD, said at the European Society of Cardiology Heart Failure Discoveries virtual meeting.
The results of the multicenter, prospective, randomized BeAT-HF trial led to marketing approval of the BaroStim Neo system for improvement in symptoms of heart failure with reduced ejection fraction (HFrEF) by the Food and Drug Administration in August 2019. Dr. Lindenfeld presented a fresh breakdown of the results by gender which showed, intriguingly, that the improvement in all study endpoints was consistently numerically greater in the women – sometimes startlingly so – although these gender differences in response didn’t achieve statistical significance. The 6-month randomized trial was underpowered for drawing definitive conclusions on that score, with a study population of only 53 women and 211 men. So the investigator remained circumspect.
“We think that what this study shows us is that women have at least equivalent improvement as men in this population. I don’t think we can conclude from this study yet that it’s better, but it’s certainly in all these parameters as least as good. And I think this is a population in which we’ve seen that improving symptoms and functional capacity is very important,” said Dr. Lindenfeld, professor of medicine and director of advanced heart failure/cardiac transplantation at Vanderbilt University, Nashville, Tenn.
The FDA approval was restricted to patients like those enrolled in BeAT-HF: that is, individuals with New York Heart Association functional class III heart failure, a left ventricular ejection fraction of 35% or less while on stable optimal medical therapy, and ineligibility for cardiac resynchronization therapy according to current guidelines. Seventy-eight percent of BeAT-HF participants had an implantable cardioverter-defibrillator.
Participants were randomized to baroreflex activation therapy (BAT) plus optimal medical therapy or to optimal medical therapy alone. The three coprimary endpoints were change from baseline to 6 months in 6-minute hall walk distance (6MHW), scores on the Minnesota Living with Heart Failure Questionnaire (MLHF), and N-terminal pro-B-type natriuretic peptide (NT-proBNP).
In the overall study population, 6MHW increased by 60 m in the BAT group and decreased by 8 m in controls; MLHF scores dropped by 14 and 6 points, respectively; and NT-proBNP fell by an average of 25% with BAT while rising by 3% in controls.
Very often, just a 5-point reduction in MLHF score is considered a clinically meaningful improvement in quality of life, the cardiologist noted.
The gender-based analysis is where things got particularly interesting.
The investigators defined a clinically relevant response as a greater than 10% increase from baseline on the 6MHW, at least a one-class improvement in NYHA class, or a reduction of 5 points or more on the MLHF. Among subjects in the BAT group, 70% of women and 60% of men met the clinically relevant response standard in terms of 6MHW, as did 70% of women and 64% of men for improvement in NYHA class, and 78% of women and 66% of men for MLHF score.
Eighty-seven percent of women and 68% of men on BAT had a clinically relevant response on at least one of these endpoints, as did about 28% of controls. Moreover, 31% of women in the BAT group were clinically relevant responders on at least two endpoints, compared with 19% of BAT men and 4% and 9% of controls.
Women dominate super-responder category
In order to be classified as a super responder, a patient had to demonstrate a greater than 20% increase in 6MHW, improvement in NYHA class I status, or at least a 10-point improvement in MLHF score. Ninety-one percent of women on BAT achieved super-responder status for at least one of these endpoints, compared with 76% of men. Forty-three percent of women and 24% of men in the BAT group were super responders in at least two domains, as were 8% and 11% of female and male controls, Dr. Lindenfeld continued.
Discussant Ewa Anita Jankowska, MD, PhD, deemed the BeAT-HF results on the therapeutic benefits of this autonomic modulation strategy “quite convincing.”
“We need to acknowledge that in recent years we have been spoiled a bit by the huge trials in heart failure where the ultimate goal was a reduction in mortality. But I think this is the time when we should think about the patients who want to live – here, now – with a better life. Patients expect symptomatic benefits. There is a substantial group of patients who are symptomatic even though they receive quite extensive neurohormonal blockage and who are not suitable for CRT. This study demonstrates that, for this group of patients, BAT can bring really significant symptomatic benefits,” she said.
“If you think about a treatment that provides patients who are NYHA class III an increase in 6MHW of 60 meters, that’s really something. And 20% of patients went from NYHA class III to class I – that’s really something, too,” added Dr. Jankowska, professor of medicine and head of the laboratory of applied research on the cardiovascular system at Wroclaw (Poland) University.
How baroreflex activation therapy works
The BaroStim system consists of a 2-mm unipolar electrode on a 7-mm backer that is placed over the carotid sinus. It is supported by a small generator with a 4- to 5-year battery life implanted under the collarbone, along with radiofrequency telemetry capability and programming flexibility.
Stimulation of the carotid baroreceptor promotes an integrated autonomic nervous system response which enhances parasympathetic activity and inhibits sympathetic nervous system activity. The result, as shown in numerous earlier proof-of-concept studies, is a reduced heart rate, decreased ventricular remodeling, enhanced diuresis, increased vasodilation, a drop in elevated blood pressure, and decreased renin secretion – all achieved nonpharmacologically.
The study was sponsored by CVRx. Dr. Lindenfeld reported serving as a consultant to CVRx, Abbott, AstraZeneca, Boehringer Ingelheim, Edwards Lifesciences, Impulse Dynamics, and VWave.
The striking gains in functional capacity and quality of life conferred by baroreflex activation therapy in patients with heart failure, as shown in the pivotal phase 3 clinical trial for this novel intervention, were at least as great in women as in men, JoAnn Lindenfeld, MD, said at the European Society of Cardiology Heart Failure Discoveries virtual meeting.
The results of the multicenter, prospective, randomized BeAT-HF trial led to marketing approval of the BaroStim Neo system for improvement in symptoms of heart failure with reduced ejection fraction (HFrEF) by the Food and Drug Administration in August 2019. Dr. Lindenfeld presented a fresh breakdown of the results by gender which showed, intriguingly, that the improvement in all study endpoints was consistently numerically greater in the women – sometimes startlingly so – although these gender differences in response didn’t achieve statistical significance. The 6-month randomized trial was underpowered for drawing definitive conclusions on that score, with a study population of only 53 women and 211 men. So the investigator remained circumspect.
“We think that what this study shows us is that women have at least equivalent improvement as men in this population. I don’t think we can conclude from this study yet that it’s better, but it’s certainly in all these parameters as least as good. And I think this is a population in which we’ve seen that improving symptoms and functional capacity is very important,” said Dr. Lindenfeld, professor of medicine and director of advanced heart failure/cardiac transplantation at Vanderbilt University, Nashville, Tenn.
The FDA approval was restricted to patients like those enrolled in BeAT-HF: that is, individuals with New York Heart Association functional class III heart failure, a left ventricular ejection fraction of 35% or less while on stable optimal medical therapy, and ineligibility for cardiac resynchronization therapy according to current guidelines. Seventy-eight percent of BeAT-HF participants had an implantable cardioverter-defibrillator.
Participants were randomized to baroreflex activation therapy (BAT) plus optimal medical therapy or to optimal medical therapy alone. The three coprimary endpoints were change from baseline to 6 months in 6-minute hall walk distance (6MHW), scores on the Minnesota Living with Heart Failure Questionnaire (MLHF), and N-terminal pro-B-type natriuretic peptide (NT-proBNP).
In the overall study population, 6MHW increased by 60 m in the BAT group and decreased by 8 m in controls; MLHF scores dropped by 14 and 6 points, respectively; and NT-proBNP fell by an average of 25% with BAT while rising by 3% in controls.
Very often, just a 5-point reduction in MLHF score is considered a clinically meaningful improvement in quality of life, the cardiologist noted.
The gender-based analysis is where things got particularly interesting.
The investigators defined a clinically relevant response as a greater than 10% increase from baseline on the 6MHW, at least a one-class improvement in NYHA class, or a reduction of 5 points or more on the MLHF. Among subjects in the BAT group, 70% of women and 60% of men met the clinically relevant response standard in terms of 6MHW, as did 70% of women and 64% of men for improvement in NYHA class, and 78% of women and 66% of men for MLHF score.
Eighty-seven percent of women and 68% of men on BAT had a clinically relevant response on at least one of these endpoints, as did about 28% of controls. Moreover, 31% of women in the BAT group were clinically relevant responders on at least two endpoints, compared with 19% of BAT men and 4% and 9% of controls.
Women dominate super-responder category
In order to be classified as a super responder, a patient had to demonstrate a greater than 20% increase in 6MHW, improvement in NYHA class I status, or at least a 10-point improvement in MLHF score. Ninety-one percent of women on BAT achieved super-responder status for at least one of these endpoints, compared with 76% of men. Forty-three percent of women and 24% of men in the BAT group were super responders in at least two domains, as were 8% and 11% of female and male controls, Dr. Lindenfeld continued.
Discussant Ewa Anita Jankowska, MD, PhD, deemed the BeAT-HF results on the therapeutic benefits of this autonomic modulation strategy “quite convincing.”
“We need to acknowledge that in recent years we have been spoiled a bit by the huge trials in heart failure where the ultimate goal was a reduction in mortality. But I think this is the time when we should think about the patients who want to live – here, now – with a better life. Patients expect symptomatic benefits. There is a substantial group of patients who are symptomatic even though they receive quite extensive neurohormonal blockage and who are not suitable for CRT. This study demonstrates that, for this group of patients, BAT can bring really significant symptomatic benefits,” she said.
“If you think about a treatment that provides patients who are NYHA class III an increase in 6MHW of 60 meters, that’s really something. And 20% of patients went from NYHA class III to class I – that’s really something, too,” added Dr. Jankowska, professor of medicine and head of the laboratory of applied research on the cardiovascular system at Wroclaw (Poland) University.
How baroreflex activation therapy works
The BaroStim system consists of a 2-mm unipolar electrode on a 7-mm backer that is placed over the carotid sinus. It is supported by a small generator with a 4- to 5-year battery life implanted under the collarbone, along with radiofrequency telemetry capability and programming flexibility.
Stimulation of the carotid baroreceptor promotes an integrated autonomic nervous system response which enhances parasympathetic activity and inhibits sympathetic nervous system activity. The result, as shown in numerous earlier proof-of-concept studies, is a reduced heart rate, decreased ventricular remodeling, enhanced diuresis, increased vasodilation, a drop in elevated blood pressure, and decreased renin secretion – all achieved nonpharmacologically.
The study was sponsored by CVRx. Dr. Lindenfeld reported serving as a consultant to CVRx, Abbott, AstraZeneca, Boehringer Ingelheim, Edwards Lifesciences, Impulse Dynamics, and VWave.
FROM ESC HEART FAILURE 2020
Inside Mercy’s mission to care for non-COVID patients in Los Angeles
When the hospital ship USNS Mercy departed San Diego’s Naval Station North Island on March 23, 2020, to support the Department of Defense efforts in Los Angeles during the coronavirus outbreak, Commander Erin Blevins remembers the crew’s excitement was palpable.
“We normally do partnerships abroad and respond to tsunamis and earthquakes,” said Cdr. Blevins, MD, a pediatric hematologist-oncologist who served as director of medical services for the mission. “This was a slight change in situation, but still disaster relief in the form of a pandemic. We switched our mindset to putting together the best experts for an infectious disease pandemic versus an earthquake disaster relief.”
A new mission
The 1,000-bed Mercy ship – a converted San Clemente–class oil tanker that was delivered in 1986 – spent nearly 50 days pier side in Los Angeles as a referral hospital for non–COVID-19 patients, so that clinicians at Los Angeles area hospitals could care for an anticipated surge of COVID-19 patients. “We went into it with expectations of, ‘We’ll treat as many patients as you need us to take,” Cdr. Blevins recalled. “I don’t even think Los Angeles [health officials] knew exactly where they were going to peak and what the need was going to be.”
Between March 29 and May 15, about 1,071 medical personnel aboard the Mercy cared for 77 patients with an average age of 53 years who were referred from 11 Los Angeles area hospitals. The physicians, nurses, and other medical support personnel were drawn from military treatment facilities across the country. “We had additional people join us as we scoped the mission to be more medically heavy and surgically light,” said Captain John Rotruck, MD, an anesthesiologist who is commanding officer of Mercy’s medical treatment facility. “We did adjust to make sure that we had the right staffing mix to meet the parameters that we were assigned. That was the crux of the change: a change in flavors of staffing to ensure that we focused on ICU and ward medical care as opposed to very heavy surgical care in support of a combat operation.”
About 10% of the team consisted of reservists who volunteered for the mission. “There’s no way you could have walked around the ship and known who was active duty and who was reservist,” said Capt. Rotruck, who was formerly chief of staff at Walter Reed National Military Medical Center, Bethesda, Md. “They worked together so well, and I think that marriage of active duty who are used to working in a military medical treatment facility – in our case, a Navy medical treatment facility – together with our reservist physician colleagues who work in civilian facilities around the country, was beneficial. It was a synergistic relationship. I think both sides walked away learning quite a bit from each other.”
Start with screening
All crew members underwent a temperature check and completed a health screening questionnaire: once before departing their home of record and again before boarding Mercy. Based on those results, crew members and medical staff were screened for COVID-19 and tested as needed in order to minimize the risk of an outbreak aboard the ship.
Fewer than 1% of crew members developed COVID-19 or tested positive for the virus during the mission, according to Capt. Rotruck. Affected individuals were isolated and quarantined. “All staff have recovered and are doing well,” he said.
Mercy personnel worked with local health officials to ensure that all patients transferred to the ship tested negative for COVID-19. Physicians aboard the Mercy then worked directly with the patients’ civilian physician to ensure a safe and thorough turnover process before the patients were transferred.
From basic medical to trauma care
Care aboard the ship, which consists of open-bay medical wards, ranged from basic medical and surgical care to critical care and trauma. The most common procedures were cholecystectomies and orthopedic procedures, and the average length of stay was 4-5 days, according to Cdr. Blevins. Over the course of the mission, the medical professionals conducted 36 surgeries, 77 x-ray exams, 26 CT scans, and administered hundreds of ancillary studies ranging from routine labs to high-end x-rays and blood transfusion support.
“Within our ICU, we did have some end-of-life patients who ended up dying on our ship in comfort care,” Cdr. Blevins said. “Fortunately, we had a wonderful ICU team who had a great deal of experience with end-of-life care and were able to take care of these patients very comfortably and ensure good communication with family and loved ones during that time. In most instances we tried to make sure that people got to FaceTime or video chat with their loved one before they passed away.”
The Mercy, which includes 12 operating rooms, four x-ray units, and one CAT-scan unit, was not equipped to deliver pediatric or obstetrical care. Other unavailable services included psychiatry, oncology, cardiac and thoracic surgery, nuclear medicine, MRI, mammography, electrophysiology, cardiac catheterization, negative-pressure isolation, speech therapy, and occupational therapy.
Not your typical hospital experience
But for patients who did receive medical care aboard the Mercy – which made three 150-day deployments in recent years for the military-led humanitarian response known as Pacific Partnership in 2015, 2016, and 2018 – it was an experience that they are unlikely to forget.
“Every time a patient left the ship, our team on the ground surveyed them to see how their experience was and see what we could do to improve,” Cdr. Blevins said. “Across the board, they were all very appreciative of the medical care. We had a couple of veterans on board. They got [USNS Mercy] hats on their way out and seemed to very much enjoy a slightly different experience than they would get at a regular hospital.”
Capt. Rotruck added that the enthusiasm crew members had for supporting fellow Americans “really energized our team and really saturated that caring aspect of the people who interacted directly with patients,” he said. “It wasn’t just the physicians and nurses, but it was the staff delivering the food and coming to take blood samples and every other interaction that the patients had with our team. I think they really felt that enthusiasm for being there and supporting our neighbors in LA [Los Angeles].”
Crew life aboard the Mercy
Just as with any hospital on shore, personnel aboard the Mercy practiced preventive hygiene measures recommended by the Centers for Disease Control and Prevention to help prevent the spread of COVID-19, such as wearing cloth face masks, spacing out tables in the dining hall, closing indoor gyms, and devising creative ways to stay physically fit. Popular options included jogging around the perimeter of the ship and practicing yoga and calisthenics on the deck, “making sure you were physically distanced appropriately, and when you were done, putting your mask back on,” Cdr. Blevins said. Others supplemented their workouts with a pull-up bar on the deck. “In addition, we have a series of ramps that run on the starboard side of the ship that we can use for patient movement with litters on wheels or patient beds,” Capt. Rotruck said. “The uphill portion of those ramps represents a good workout opportunity as well.”
Downtime in an era of physical distancing also afforded crew members the opportunity to call or FaceTime with loved ones, watch streamed TV shows and movies, and work on their own professional development. Some continued with coursework for online degree programs offered by colleges and universities they were enrolled in, while some enlisted personnel used the time to complete the Navy Enlisted Warfare Qualification Programs Instruction, which issues the basic overarching requirements for the qualification and designation of all enlisted warfare programs.
“As you can imagine, people spend a lot of time learning how the ship works and how it integrates into larger naval forces and so forth,” Capt. Rotruck said. “Not just our ship but also other ships: their weapons systems and defense mechanisms and navigation systems. We had people spending a significant amount of time working on that. We had people complete their Enlisted Surface Warfare qualification while we were on the mission.”
End of the mission
Mercy returned to its home base in San Diego on May 15, but about 60 medical personnel stayed behind in Los Angeles to support Federal Emergency Management Agency (FEMA), state, and local health care professionals. Some worked at a site where clinicians provided care for COVID-19–positive patients who had been transferred from area skilled nursing facilities.
In addition, a team consisting of one nurse and five corpsmen “would go out to individual skilled nursing facilities and mainly conduct assessments and training, such as training in donning proper PPE [personal protective equipment] and determining what needs they had,” Capt. Rotruck said. “They met those needs if possible or [communicated with California officials] and let them know what the requirements were and what the needs were in that facility.” The assignment for those who stayed behind ended on May 31.
On the opposite coast, Mercy’s sister ship, USNS Comfort, arrived in New York Harbor from Norfolk, Va., on March 30 and spent 3½ weeks assisting area hospitals in the COVID-19 pandemic fight. A few days into the mission, Comfort’s internal spaces were reconfigured to create separate COVID-negative and COVID-positive sections. Medical teams aboard the ship cared for a total of 182 patients during the assignment.
Looking back on Mercy’s mission, Cdr. Blevins marveled at the sense of teamwork that unfolded. “We have quarterly training exercises with a core set of personnel, [and] we train getting ready for activation in 5 days,” she said. “All of that training kicks in and it comes to fruition in a mission like this. It was terrific to see a group of very disparate subject matter experts from all over the country come together with one purpose: which was to serve our own country during the pandemic.”
Capt. Rotruck pointed out that the experience enabled enlisted and nonenlisted physicians to maintain their skill sets during a time when military and civilian hospitals had stopped doing elective procedures and routine appointments. “The fact that those people were able to come on board the ship and continue to conduct their medical practice and maintain their skills and competencies in an environment that they weren’t quite used to is great,” he said. “Otherwise, some of those medical personnel would have been sitting idle, wherever they were from. This is the power of Navy medicine on behalf of our country.”
When the hospital ship USNS Mercy departed San Diego’s Naval Station North Island on March 23, 2020, to support the Department of Defense efforts in Los Angeles during the coronavirus outbreak, Commander Erin Blevins remembers the crew’s excitement was palpable.
“We normally do partnerships abroad and respond to tsunamis and earthquakes,” said Cdr. Blevins, MD, a pediatric hematologist-oncologist who served as director of medical services for the mission. “This was a slight change in situation, but still disaster relief in the form of a pandemic. We switched our mindset to putting together the best experts for an infectious disease pandemic versus an earthquake disaster relief.”
A new mission
The 1,000-bed Mercy ship – a converted San Clemente–class oil tanker that was delivered in 1986 – spent nearly 50 days pier side in Los Angeles as a referral hospital for non–COVID-19 patients, so that clinicians at Los Angeles area hospitals could care for an anticipated surge of COVID-19 patients. “We went into it with expectations of, ‘We’ll treat as many patients as you need us to take,” Cdr. Blevins recalled. “I don’t even think Los Angeles [health officials] knew exactly where they were going to peak and what the need was going to be.”
Between March 29 and May 15, about 1,071 medical personnel aboard the Mercy cared for 77 patients with an average age of 53 years who were referred from 11 Los Angeles area hospitals. The physicians, nurses, and other medical support personnel were drawn from military treatment facilities across the country. “We had additional people join us as we scoped the mission to be more medically heavy and surgically light,” said Captain John Rotruck, MD, an anesthesiologist who is commanding officer of Mercy’s medical treatment facility. “We did adjust to make sure that we had the right staffing mix to meet the parameters that we were assigned. That was the crux of the change: a change in flavors of staffing to ensure that we focused on ICU and ward medical care as opposed to very heavy surgical care in support of a combat operation.”
About 10% of the team consisted of reservists who volunteered for the mission. “There’s no way you could have walked around the ship and known who was active duty and who was reservist,” said Capt. Rotruck, who was formerly chief of staff at Walter Reed National Military Medical Center, Bethesda, Md. “They worked together so well, and I think that marriage of active duty who are used to working in a military medical treatment facility – in our case, a Navy medical treatment facility – together with our reservist physician colleagues who work in civilian facilities around the country, was beneficial. It was a synergistic relationship. I think both sides walked away learning quite a bit from each other.”
Start with screening
All crew members underwent a temperature check and completed a health screening questionnaire: once before departing their home of record and again before boarding Mercy. Based on those results, crew members and medical staff were screened for COVID-19 and tested as needed in order to minimize the risk of an outbreak aboard the ship.
Fewer than 1% of crew members developed COVID-19 or tested positive for the virus during the mission, according to Capt. Rotruck. Affected individuals were isolated and quarantined. “All staff have recovered and are doing well,” he said.
Mercy personnel worked with local health officials to ensure that all patients transferred to the ship tested negative for COVID-19. Physicians aboard the Mercy then worked directly with the patients’ civilian physician to ensure a safe and thorough turnover process before the patients were transferred.
From basic medical to trauma care
Care aboard the ship, which consists of open-bay medical wards, ranged from basic medical and surgical care to critical care and trauma. The most common procedures were cholecystectomies and orthopedic procedures, and the average length of stay was 4-5 days, according to Cdr. Blevins. Over the course of the mission, the medical professionals conducted 36 surgeries, 77 x-ray exams, 26 CT scans, and administered hundreds of ancillary studies ranging from routine labs to high-end x-rays and blood transfusion support.
“Within our ICU, we did have some end-of-life patients who ended up dying on our ship in comfort care,” Cdr. Blevins said. “Fortunately, we had a wonderful ICU team who had a great deal of experience with end-of-life care and were able to take care of these patients very comfortably and ensure good communication with family and loved ones during that time. In most instances we tried to make sure that people got to FaceTime or video chat with their loved one before they passed away.”
The Mercy, which includes 12 operating rooms, four x-ray units, and one CAT-scan unit, was not equipped to deliver pediatric or obstetrical care. Other unavailable services included psychiatry, oncology, cardiac and thoracic surgery, nuclear medicine, MRI, mammography, electrophysiology, cardiac catheterization, negative-pressure isolation, speech therapy, and occupational therapy.
Not your typical hospital experience
But for patients who did receive medical care aboard the Mercy – which made three 150-day deployments in recent years for the military-led humanitarian response known as Pacific Partnership in 2015, 2016, and 2018 – it was an experience that they are unlikely to forget.
“Every time a patient left the ship, our team on the ground surveyed them to see how their experience was and see what we could do to improve,” Cdr. Blevins said. “Across the board, they were all very appreciative of the medical care. We had a couple of veterans on board. They got [USNS Mercy] hats on their way out and seemed to very much enjoy a slightly different experience than they would get at a regular hospital.”
Capt. Rotruck added that the enthusiasm crew members had for supporting fellow Americans “really energized our team and really saturated that caring aspect of the people who interacted directly with patients,” he said. “It wasn’t just the physicians and nurses, but it was the staff delivering the food and coming to take blood samples and every other interaction that the patients had with our team. I think they really felt that enthusiasm for being there and supporting our neighbors in LA [Los Angeles].”
Crew life aboard the Mercy
Just as with any hospital on shore, personnel aboard the Mercy practiced preventive hygiene measures recommended by the Centers for Disease Control and Prevention to help prevent the spread of COVID-19, such as wearing cloth face masks, spacing out tables in the dining hall, closing indoor gyms, and devising creative ways to stay physically fit. Popular options included jogging around the perimeter of the ship and practicing yoga and calisthenics on the deck, “making sure you were physically distanced appropriately, and when you were done, putting your mask back on,” Cdr. Blevins said. Others supplemented their workouts with a pull-up bar on the deck. “In addition, we have a series of ramps that run on the starboard side of the ship that we can use for patient movement with litters on wheels or patient beds,” Capt. Rotruck said. “The uphill portion of those ramps represents a good workout opportunity as well.”
Downtime in an era of physical distancing also afforded crew members the opportunity to call or FaceTime with loved ones, watch streamed TV shows and movies, and work on their own professional development. Some continued with coursework for online degree programs offered by colleges and universities they were enrolled in, while some enlisted personnel used the time to complete the Navy Enlisted Warfare Qualification Programs Instruction, which issues the basic overarching requirements for the qualification and designation of all enlisted warfare programs.
“As you can imagine, people spend a lot of time learning how the ship works and how it integrates into larger naval forces and so forth,” Capt. Rotruck said. “Not just our ship but also other ships: their weapons systems and defense mechanisms and navigation systems. We had people spending a significant amount of time working on that. We had people complete their Enlisted Surface Warfare qualification while we were on the mission.”
End of the mission
Mercy returned to its home base in San Diego on May 15, but about 60 medical personnel stayed behind in Los Angeles to support Federal Emergency Management Agency (FEMA), state, and local health care professionals. Some worked at a site where clinicians provided care for COVID-19–positive patients who had been transferred from area skilled nursing facilities.
In addition, a team consisting of one nurse and five corpsmen “would go out to individual skilled nursing facilities and mainly conduct assessments and training, such as training in donning proper PPE [personal protective equipment] and determining what needs they had,” Capt. Rotruck said. “They met those needs if possible or [communicated with California officials] and let them know what the requirements were and what the needs were in that facility.” The assignment for those who stayed behind ended on May 31.
On the opposite coast, Mercy’s sister ship, USNS Comfort, arrived in New York Harbor from Norfolk, Va., on March 30 and spent 3½ weeks assisting area hospitals in the COVID-19 pandemic fight. A few days into the mission, Comfort’s internal spaces were reconfigured to create separate COVID-negative and COVID-positive sections. Medical teams aboard the ship cared for a total of 182 patients during the assignment.
Looking back on Mercy’s mission, Cdr. Blevins marveled at the sense of teamwork that unfolded. “We have quarterly training exercises with a core set of personnel, [and] we train getting ready for activation in 5 days,” she said. “All of that training kicks in and it comes to fruition in a mission like this. It was terrific to see a group of very disparate subject matter experts from all over the country come together with one purpose: which was to serve our own country during the pandemic.”
Capt. Rotruck pointed out that the experience enabled enlisted and nonenlisted physicians to maintain their skill sets during a time when military and civilian hospitals had stopped doing elective procedures and routine appointments. “The fact that those people were able to come on board the ship and continue to conduct their medical practice and maintain their skills and competencies in an environment that they weren’t quite used to is great,” he said. “Otherwise, some of those medical personnel would have been sitting idle, wherever they were from. This is the power of Navy medicine on behalf of our country.”
When the hospital ship USNS Mercy departed San Diego’s Naval Station North Island on March 23, 2020, to support the Department of Defense efforts in Los Angeles during the coronavirus outbreak, Commander Erin Blevins remembers the crew’s excitement was palpable.
“We normally do partnerships abroad and respond to tsunamis and earthquakes,” said Cdr. Blevins, MD, a pediatric hematologist-oncologist who served as director of medical services for the mission. “This was a slight change in situation, but still disaster relief in the form of a pandemic. We switched our mindset to putting together the best experts for an infectious disease pandemic versus an earthquake disaster relief.”
A new mission
The 1,000-bed Mercy ship – a converted San Clemente–class oil tanker that was delivered in 1986 – spent nearly 50 days pier side in Los Angeles as a referral hospital for non–COVID-19 patients, so that clinicians at Los Angeles area hospitals could care for an anticipated surge of COVID-19 patients. “We went into it with expectations of, ‘We’ll treat as many patients as you need us to take,” Cdr. Blevins recalled. “I don’t even think Los Angeles [health officials] knew exactly where they were going to peak and what the need was going to be.”
Between March 29 and May 15, about 1,071 medical personnel aboard the Mercy cared for 77 patients with an average age of 53 years who were referred from 11 Los Angeles area hospitals. The physicians, nurses, and other medical support personnel were drawn from military treatment facilities across the country. “We had additional people join us as we scoped the mission to be more medically heavy and surgically light,” said Captain John Rotruck, MD, an anesthesiologist who is commanding officer of Mercy’s medical treatment facility. “We did adjust to make sure that we had the right staffing mix to meet the parameters that we were assigned. That was the crux of the change: a change in flavors of staffing to ensure that we focused on ICU and ward medical care as opposed to very heavy surgical care in support of a combat operation.”
About 10% of the team consisted of reservists who volunteered for the mission. “There’s no way you could have walked around the ship and known who was active duty and who was reservist,” said Capt. Rotruck, who was formerly chief of staff at Walter Reed National Military Medical Center, Bethesda, Md. “They worked together so well, and I think that marriage of active duty who are used to working in a military medical treatment facility – in our case, a Navy medical treatment facility – together with our reservist physician colleagues who work in civilian facilities around the country, was beneficial. It was a synergistic relationship. I think both sides walked away learning quite a bit from each other.”
Start with screening
All crew members underwent a temperature check and completed a health screening questionnaire: once before departing their home of record and again before boarding Mercy. Based on those results, crew members and medical staff were screened for COVID-19 and tested as needed in order to minimize the risk of an outbreak aboard the ship.
Fewer than 1% of crew members developed COVID-19 or tested positive for the virus during the mission, according to Capt. Rotruck. Affected individuals were isolated and quarantined. “All staff have recovered and are doing well,” he said.
Mercy personnel worked with local health officials to ensure that all patients transferred to the ship tested negative for COVID-19. Physicians aboard the Mercy then worked directly with the patients’ civilian physician to ensure a safe and thorough turnover process before the patients were transferred.
From basic medical to trauma care
Care aboard the ship, which consists of open-bay medical wards, ranged from basic medical and surgical care to critical care and trauma. The most common procedures were cholecystectomies and orthopedic procedures, and the average length of stay was 4-5 days, according to Cdr. Blevins. Over the course of the mission, the medical professionals conducted 36 surgeries, 77 x-ray exams, 26 CT scans, and administered hundreds of ancillary studies ranging from routine labs to high-end x-rays and blood transfusion support.
“Within our ICU, we did have some end-of-life patients who ended up dying on our ship in comfort care,” Cdr. Blevins said. “Fortunately, we had a wonderful ICU team who had a great deal of experience with end-of-life care and were able to take care of these patients very comfortably and ensure good communication with family and loved ones during that time. In most instances we tried to make sure that people got to FaceTime or video chat with their loved one before they passed away.”
The Mercy, which includes 12 operating rooms, four x-ray units, and one CAT-scan unit, was not equipped to deliver pediatric or obstetrical care. Other unavailable services included psychiatry, oncology, cardiac and thoracic surgery, nuclear medicine, MRI, mammography, electrophysiology, cardiac catheterization, negative-pressure isolation, speech therapy, and occupational therapy.
Not your typical hospital experience
But for patients who did receive medical care aboard the Mercy – which made three 150-day deployments in recent years for the military-led humanitarian response known as Pacific Partnership in 2015, 2016, and 2018 – it was an experience that they are unlikely to forget.
“Every time a patient left the ship, our team on the ground surveyed them to see how their experience was and see what we could do to improve,” Cdr. Blevins said. “Across the board, they were all very appreciative of the medical care. We had a couple of veterans on board. They got [USNS Mercy] hats on their way out and seemed to very much enjoy a slightly different experience than they would get at a regular hospital.”
Capt. Rotruck added that the enthusiasm crew members had for supporting fellow Americans “really energized our team and really saturated that caring aspect of the people who interacted directly with patients,” he said. “It wasn’t just the physicians and nurses, but it was the staff delivering the food and coming to take blood samples and every other interaction that the patients had with our team. I think they really felt that enthusiasm for being there and supporting our neighbors in LA [Los Angeles].”
Crew life aboard the Mercy
Just as with any hospital on shore, personnel aboard the Mercy practiced preventive hygiene measures recommended by the Centers for Disease Control and Prevention to help prevent the spread of COVID-19, such as wearing cloth face masks, spacing out tables in the dining hall, closing indoor gyms, and devising creative ways to stay physically fit. Popular options included jogging around the perimeter of the ship and practicing yoga and calisthenics on the deck, “making sure you were physically distanced appropriately, and when you were done, putting your mask back on,” Cdr. Blevins said. Others supplemented their workouts with a pull-up bar on the deck. “In addition, we have a series of ramps that run on the starboard side of the ship that we can use for patient movement with litters on wheels or patient beds,” Capt. Rotruck said. “The uphill portion of those ramps represents a good workout opportunity as well.”
Downtime in an era of physical distancing also afforded crew members the opportunity to call or FaceTime with loved ones, watch streamed TV shows and movies, and work on their own professional development. Some continued with coursework for online degree programs offered by colleges and universities they were enrolled in, while some enlisted personnel used the time to complete the Navy Enlisted Warfare Qualification Programs Instruction, which issues the basic overarching requirements for the qualification and designation of all enlisted warfare programs.
“As you can imagine, people spend a lot of time learning how the ship works and how it integrates into larger naval forces and so forth,” Capt. Rotruck said. “Not just our ship but also other ships: their weapons systems and defense mechanisms and navigation systems. We had people spending a significant amount of time working on that. We had people complete their Enlisted Surface Warfare qualification while we were on the mission.”
End of the mission
Mercy returned to its home base in San Diego on May 15, but about 60 medical personnel stayed behind in Los Angeles to support Federal Emergency Management Agency (FEMA), state, and local health care professionals. Some worked at a site where clinicians provided care for COVID-19–positive patients who had been transferred from area skilled nursing facilities.
In addition, a team consisting of one nurse and five corpsmen “would go out to individual skilled nursing facilities and mainly conduct assessments and training, such as training in donning proper PPE [personal protective equipment] and determining what needs they had,” Capt. Rotruck said. “They met those needs if possible or [communicated with California officials] and let them know what the requirements were and what the needs were in that facility.” The assignment for those who stayed behind ended on May 31.
On the opposite coast, Mercy’s sister ship, USNS Comfort, arrived in New York Harbor from Norfolk, Va., on March 30 and spent 3½ weeks assisting area hospitals in the COVID-19 pandemic fight. A few days into the mission, Comfort’s internal spaces were reconfigured to create separate COVID-negative and COVID-positive sections. Medical teams aboard the ship cared for a total of 182 patients during the assignment.
Looking back on Mercy’s mission, Cdr. Blevins marveled at the sense of teamwork that unfolded. “We have quarterly training exercises with a core set of personnel, [and] we train getting ready for activation in 5 days,” she said. “All of that training kicks in and it comes to fruition in a mission like this. It was terrific to see a group of very disparate subject matter experts from all over the country come together with one purpose: which was to serve our own country during the pandemic.”
Capt. Rotruck pointed out that the experience enabled enlisted and nonenlisted physicians to maintain their skill sets during a time when military and civilian hospitals had stopped doing elective procedures and routine appointments. “The fact that those people were able to come on board the ship and continue to conduct their medical practice and maintain their skills and competencies in an environment that they weren’t quite used to is great,” he said. “Otherwise, some of those medical personnel would have been sitting idle, wherever they were from. This is the power of Navy medicine on behalf of our country.”
Daily Recap: ED visits for life-threatening conditions plummet; COVID-19 imaging strategies for kids
Here are the stories our MDedge editors across specialties think you need to know about today:
ED visits drop for life-threatening conditions
Emergency department visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency, according to new research from the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” the researchers wrote in the Morbidity and Mortality Weekly Report. Read more.
Expert recommendations for pediatric COVID-19 imaging
A team of pulmonologists has synthesized the clinical and imaging characteristics of COVID-19 in children, and has issued recommendations for ordering imaging studies in suspected cases of the infection.
Current recommendations from the American College of Radiology (ACR) do not include chest computed tomography (CT) or chest radiography (CXR) as an upfront test to diagnose pediatric COVID-19, but the tests may still have a role in clinical monitoring, especially in patients with a moderate to severe disease course. The potential benefits of utilizing radiologic evaluation – such as establishing a baseline for monitoring disease progression – must be balanced with potential drawbacks, including radiation exposure and reduced availability of imaging resources owing to necessary cleaning and air turnover time.
Based on the most recent international guidelines for pediatric COVID-19 patient management, the authors developed an algorithm for performing imaging studies in suspected cases of COVID-19 pneumonia. The purpose of the tool is to support clinical decision-making around the utilization of CXR and CT to evaluate pediatric COVID-19 pneumonia. “The step by step algorithm addresses the selection, sequence and timing of imaging studies with multiple images illustrating key findings of COVID-19 pneumonia in the pediatric age group,” said Mary Cataletto, MD, of NYU Langone Health in Mineola, N.Y. Read more.
Cortisol levels on COVID-19 admission may be a marker of severity
Patients with COVID-19 who have high levels of the steroid hormone cortisol on admission to the hospital have a substantially increased risk of dying, according to new study findings.
Researchers assessed 535 patients admitted to major London hospitals. Of these, 403 patients were diagnosed with COVID-19 based on a positive result on real-time polymerase chain reaction testing or a strong clinical and radiological suspicion, despite a negative test. Mean cortisol concentrations in patients with COVID-19 were significantly higher than those not diagnosed with the virus and as of May 8, significantly more patients with COVID-19 died than those without (27.8% vs 6.8%).
Measuring cortisol on admission is potentially “another simple marker to use alongside oxygen saturation levels to help us identify which patients need to be admitted immediately, and which may not,” said Waljit S. Dhillo, MBBS, PhD, head of the division of diabetes, endocrinology and metabolism at Imperial College London.
“Having an early indicator of which patients may deteriorate more quickly will help us with providing the best level of care as quickly as possible. In addition, we can also take cortisol levels into account when we are working out how best to treat our patients,” he said. Read more.
Normal-weight prediabetes patients can benefit from lifestyle changes
Adults of normal weight with prediabetes may derive at least as much benefit from lifestyle health coaching programs as adults who are overweight or obese, results of a recent nonrandomized, real-world study show.
Fasting plasma glucose (FPG) normalized in about 63% of prediabetic adults with normal body mass index (BMI) participating in a personalized coaching program that emphasized exercise, nutrition, and weight management. In contrast, FPG normalized in about 52% of overweight and 44% of obese prediabetic individuals participating in the program.
“It is interesting to note that, although the normal weight group lost the least amount of weight, they still benefited from the lifestyle health coaching program... having a resultant greatest decrease in fasting plasma glucose and normalization to a range of someone without prediabetes,” said researcher Mandy Salmon, MS, a medical student at the University of Pennsylvania, Philadelphia. She presented the findings at the virtual annual scientific sessions of the American Diabetes Association. Read more.
Diabetes-related amputations rise in older adults
The recent resurgence in diabetes-related lower-extremity amputations in the United States is not limited to younger adults, according to the author of a recent study that documents similar increases among an older population of Medicare beneficiaries.
While the rate of amputations fell among these older adults from 2000 to 2009, it increased significantly from 2009 to 2017, albeit at a “less severe rate” than recently reported in younger populations, according to study investigator Jessica Harding, PhD, an assistant professor in the department of surgery at Emory University, Atlanta. Dr. Harding reported the results at the virtual annual scientific sessions of the American Diabetes Association.
The rate of nontraumatic lower extremity amputation (NLEA) was ticking upward by more than 1% per year over the 2009-2017 period. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
ED visits drop for life-threatening conditions
Emergency department visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency, according to new research from the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” the researchers wrote in the Morbidity and Mortality Weekly Report. Read more.
Expert recommendations for pediatric COVID-19 imaging
A team of pulmonologists has synthesized the clinical and imaging characteristics of COVID-19 in children, and has issued recommendations for ordering imaging studies in suspected cases of the infection.
Current recommendations from the American College of Radiology (ACR) do not include chest computed tomography (CT) or chest radiography (CXR) as an upfront test to diagnose pediatric COVID-19, but the tests may still have a role in clinical monitoring, especially in patients with a moderate to severe disease course. The potential benefits of utilizing radiologic evaluation – such as establishing a baseline for monitoring disease progression – must be balanced with potential drawbacks, including radiation exposure and reduced availability of imaging resources owing to necessary cleaning and air turnover time.
Based on the most recent international guidelines for pediatric COVID-19 patient management, the authors developed an algorithm for performing imaging studies in suspected cases of COVID-19 pneumonia. The purpose of the tool is to support clinical decision-making around the utilization of CXR and CT to evaluate pediatric COVID-19 pneumonia. “The step by step algorithm addresses the selection, sequence and timing of imaging studies with multiple images illustrating key findings of COVID-19 pneumonia in the pediatric age group,” said Mary Cataletto, MD, of NYU Langone Health in Mineola, N.Y. Read more.
Cortisol levels on COVID-19 admission may be a marker of severity
Patients with COVID-19 who have high levels of the steroid hormone cortisol on admission to the hospital have a substantially increased risk of dying, according to new study findings.
Researchers assessed 535 patients admitted to major London hospitals. Of these, 403 patients were diagnosed with COVID-19 based on a positive result on real-time polymerase chain reaction testing or a strong clinical and radiological suspicion, despite a negative test. Mean cortisol concentrations in patients with COVID-19 were significantly higher than those not diagnosed with the virus and as of May 8, significantly more patients with COVID-19 died than those without (27.8% vs 6.8%).
Measuring cortisol on admission is potentially “another simple marker to use alongside oxygen saturation levels to help us identify which patients need to be admitted immediately, and which may not,” said Waljit S. Dhillo, MBBS, PhD, head of the division of diabetes, endocrinology and metabolism at Imperial College London.
“Having an early indicator of which patients may deteriorate more quickly will help us with providing the best level of care as quickly as possible. In addition, we can also take cortisol levels into account when we are working out how best to treat our patients,” he said. Read more.
Normal-weight prediabetes patients can benefit from lifestyle changes
Adults of normal weight with prediabetes may derive at least as much benefit from lifestyle health coaching programs as adults who are overweight or obese, results of a recent nonrandomized, real-world study show.
Fasting plasma glucose (FPG) normalized in about 63% of prediabetic adults with normal body mass index (BMI) participating in a personalized coaching program that emphasized exercise, nutrition, and weight management. In contrast, FPG normalized in about 52% of overweight and 44% of obese prediabetic individuals participating in the program.
“It is interesting to note that, although the normal weight group lost the least amount of weight, they still benefited from the lifestyle health coaching program... having a resultant greatest decrease in fasting plasma glucose and normalization to a range of someone without prediabetes,” said researcher Mandy Salmon, MS, a medical student at the University of Pennsylvania, Philadelphia. She presented the findings at the virtual annual scientific sessions of the American Diabetes Association. Read more.
Diabetes-related amputations rise in older adults
The recent resurgence in diabetes-related lower-extremity amputations in the United States is not limited to younger adults, according to the author of a recent study that documents similar increases among an older population of Medicare beneficiaries.
While the rate of amputations fell among these older adults from 2000 to 2009, it increased significantly from 2009 to 2017, albeit at a “less severe rate” than recently reported in younger populations, according to study investigator Jessica Harding, PhD, an assistant professor in the department of surgery at Emory University, Atlanta. Dr. Harding reported the results at the virtual annual scientific sessions of the American Diabetes Association.
The rate of nontraumatic lower extremity amputation (NLEA) was ticking upward by more than 1% per year over the 2009-2017 period. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
ED visits drop for life-threatening conditions
Emergency department visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency, according to new research from the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” the researchers wrote in the Morbidity and Mortality Weekly Report. Read more.
Expert recommendations for pediatric COVID-19 imaging
A team of pulmonologists has synthesized the clinical and imaging characteristics of COVID-19 in children, and has issued recommendations for ordering imaging studies in suspected cases of the infection.
Current recommendations from the American College of Radiology (ACR) do not include chest computed tomography (CT) or chest radiography (CXR) as an upfront test to diagnose pediatric COVID-19, but the tests may still have a role in clinical monitoring, especially in patients with a moderate to severe disease course. The potential benefits of utilizing radiologic evaluation – such as establishing a baseline for monitoring disease progression – must be balanced with potential drawbacks, including radiation exposure and reduced availability of imaging resources owing to necessary cleaning and air turnover time.
Based on the most recent international guidelines for pediatric COVID-19 patient management, the authors developed an algorithm for performing imaging studies in suspected cases of COVID-19 pneumonia. The purpose of the tool is to support clinical decision-making around the utilization of CXR and CT to evaluate pediatric COVID-19 pneumonia. “The step by step algorithm addresses the selection, sequence and timing of imaging studies with multiple images illustrating key findings of COVID-19 pneumonia in the pediatric age group,” said Mary Cataletto, MD, of NYU Langone Health in Mineola, N.Y. Read more.
Cortisol levels on COVID-19 admission may be a marker of severity
Patients with COVID-19 who have high levels of the steroid hormone cortisol on admission to the hospital have a substantially increased risk of dying, according to new study findings.
Researchers assessed 535 patients admitted to major London hospitals. Of these, 403 patients were diagnosed with COVID-19 based on a positive result on real-time polymerase chain reaction testing or a strong clinical and radiological suspicion, despite a negative test. Mean cortisol concentrations in patients with COVID-19 were significantly higher than those not diagnosed with the virus and as of May 8, significantly more patients with COVID-19 died than those without (27.8% vs 6.8%).
Measuring cortisol on admission is potentially “another simple marker to use alongside oxygen saturation levels to help us identify which patients need to be admitted immediately, and which may not,” said Waljit S. Dhillo, MBBS, PhD, head of the division of diabetes, endocrinology and metabolism at Imperial College London.
“Having an early indicator of which patients may deteriorate more quickly will help us with providing the best level of care as quickly as possible. In addition, we can also take cortisol levels into account when we are working out how best to treat our patients,” he said. Read more.
Normal-weight prediabetes patients can benefit from lifestyle changes
Adults of normal weight with prediabetes may derive at least as much benefit from lifestyle health coaching programs as adults who are overweight or obese, results of a recent nonrandomized, real-world study show.
Fasting plasma glucose (FPG) normalized in about 63% of prediabetic adults with normal body mass index (BMI) participating in a personalized coaching program that emphasized exercise, nutrition, and weight management. In contrast, FPG normalized in about 52% of overweight and 44% of obese prediabetic individuals participating in the program.
“It is interesting to note that, although the normal weight group lost the least amount of weight, they still benefited from the lifestyle health coaching program... having a resultant greatest decrease in fasting plasma glucose and normalization to a range of someone without prediabetes,” said researcher Mandy Salmon, MS, a medical student at the University of Pennsylvania, Philadelphia. She presented the findings at the virtual annual scientific sessions of the American Diabetes Association. Read more.
Diabetes-related amputations rise in older adults
The recent resurgence in diabetes-related lower-extremity amputations in the United States is not limited to younger adults, according to the author of a recent study that documents similar increases among an older population of Medicare beneficiaries.
While the rate of amputations fell among these older adults from 2000 to 2009, it increased significantly from 2009 to 2017, albeit at a “less severe rate” than recently reported in younger populations, according to study investigator Jessica Harding, PhD, an assistant professor in the department of surgery at Emory University, Atlanta. Dr. Harding reported the results at the virtual annual scientific sessions of the American Diabetes Association.
The rate of nontraumatic lower extremity amputation (NLEA) was ticking upward by more than 1% per year over the 2009-2017 period. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Five healthy lifestyle choices tied to dramatic cut in dementia risk
Klodian Dhana, MD, PhD, department of internal medicine, Rush University Medical Center, Chicago, said in an interview.
“I hope this study will motivate people to engage in a healthy lifestyle by not smoking, being physically and cognitively active, and having a high-quality diet,” lead investigatorThe study was published online June 17 in Neurology.
Risk-modifying behaviors
To help quantify the impact of a healthy life on risk for Alzheimer’s dementia, Dr. Dhana and colleagues reviewed data from two longitudinal study populations: the Chicago Health and Aging Project (CHAP), with 1,845 participants, and the Memory and Aging Project (MAP), with 920 participants.
They defined a healthy lifestyle score on the basis of the following factors: not smoking; engaging in 150 min/wk or more of physical exercise of moderate to vigorous intensity; light to moderate alcohol consumption (between 1 and less than 15 g/day for women and between 1 and less than 30 g/day for men); consuming a high-quality Mediterranean-DASH Diet Intervention for Neurodegenerative Delay diet (upper 40%); and engaging in late-life cognitive activities (upper 40%). The overall score ranged from 0 to 5.
At baseline, the mean age of participants was 73.2 years in the CHAP study and 81.1 years in the MAP study; 62.4% of the CHAP participants and 75.2% of the MAP participants were women.
During a median follow-up of 5.8 years in CHAP and 6.0 years in MAP, a total of 379 and 229 participants, respectively, developed Alzheimer’s dementia. Rates of dementia decreased with an increasing number of healthy lifestyle behaviors.
In multivariable-adjusted models across the two cohorts, the risk for Alzheimer’s dementia was 27% lower with each additional healthy lifestyle factor (pooled hazard ratio, 0.73; 95% confidence interval, 0.66-0.80).
Compared with individuals with a healthy lifestyle score of 0-1, the risk was 37% lower (pooled HR, 0.63; 95% CI, 0.47-0.84) for those with two or three healthy lifestyle factors and 60% lower (pooled HR, 0.40; 95% CI, 0.28-0.56) for those with four or five healthy lifestyle factors.
“From these findings and the fact that the lifestyle factors we studied are modifiable and in direct control of the individual, it is imperative to promote them concurrently among older adults as a strategy to delay or prevent Alzheimer’s dementia,” Dr. Dhana and colleagues concluded.
In a statement, Dallas Anderson, PhD, program director, division of neuroscience, National Institute on Aging, said the findings help “paint the picture of how multiple factors are likely playing parts in Alzheimer’s disease risk.”
“It’s not a clear cause-and-effect result, but a strong finding because of the dual data sets and combination of modifiable lifestyle factors that appear to lead to risk reduction,” Dr. Anderson added.
Essential questions remain
Commenting on the new study, Luca Giliberto, MD, PhD, neurologist with the Litwin-Zucker Research Center for Alzheimer’s Disease and Memory Disorders at the Feinstein Institutes for Medical Research in Manhasset, N.Y., said this analysis is “further demonstration that a healthy lifestyle is essential to overcome or curb” the risk for Alzheimer’s disease.
“What needs to be determined is how early should we start ‘behaving.’ We should all aim to score four to five factors across our entire lifespan, but this is not always feasible. So, when is the time to behave? Also, what is the relative weight of each of these factors?” said Dr. Giliberto.
Of note, he added, although addressing vascular risk factors such as hypertension, hyperlipidemia, and diabetes “may require an extensive mindful and logistic effort, a healthy diet is effortlessly achieved in some countries, where both the DASH and MIND diets do not need to be ‘prescribed’ but are rather culturally engraved in the population.
“This is, in part, related to the wide availability of high-quality food in these countries, which is not the same in the U.S. This work is one more demonstration of the need to revisit our take on quality of food in the U.S.,” said Dr. Giliberto.
Numerous clinical trials testing lifestyle interventions for dementia prevention are currently underway. The MIND Diet Intervention to Prevent Alzheimer’s Disease, for example, is an interventional clinical trial comparing parallel groups with two different diets. MIND has enrolled more than 600 participants and is ongoing. The anticipated completion date is 2021. Another is the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER), a multisite randomized clinical trial evaluating whether lifestyle interventions – including exercise, cognitively stimulating activities, and the MIND diet – may protect cognitive function in older adults who are at increased risk for cognitive decline.
Funding for the current study was provided by the National Institutes of Health and the National Institute on Aging. Dr. Dhana and Dr. Giliberto have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Klodian Dhana, MD, PhD, department of internal medicine, Rush University Medical Center, Chicago, said in an interview.
“I hope this study will motivate people to engage in a healthy lifestyle by not smoking, being physically and cognitively active, and having a high-quality diet,” lead investigatorThe study was published online June 17 in Neurology.
Risk-modifying behaviors
To help quantify the impact of a healthy life on risk for Alzheimer’s dementia, Dr. Dhana and colleagues reviewed data from two longitudinal study populations: the Chicago Health and Aging Project (CHAP), with 1,845 participants, and the Memory and Aging Project (MAP), with 920 participants.
They defined a healthy lifestyle score on the basis of the following factors: not smoking; engaging in 150 min/wk or more of physical exercise of moderate to vigorous intensity; light to moderate alcohol consumption (between 1 and less than 15 g/day for women and between 1 and less than 30 g/day for men); consuming a high-quality Mediterranean-DASH Diet Intervention for Neurodegenerative Delay diet (upper 40%); and engaging in late-life cognitive activities (upper 40%). The overall score ranged from 0 to 5.
At baseline, the mean age of participants was 73.2 years in the CHAP study and 81.1 years in the MAP study; 62.4% of the CHAP participants and 75.2% of the MAP participants were women.
During a median follow-up of 5.8 years in CHAP and 6.0 years in MAP, a total of 379 and 229 participants, respectively, developed Alzheimer’s dementia. Rates of dementia decreased with an increasing number of healthy lifestyle behaviors.
In multivariable-adjusted models across the two cohorts, the risk for Alzheimer’s dementia was 27% lower with each additional healthy lifestyle factor (pooled hazard ratio, 0.73; 95% confidence interval, 0.66-0.80).
Compared with individuals with a healthy lifestyle score of 0-1, the risk was 37% lower (pooled HR, 0.63; 95% CI, 0.47-0.84) for those with two or three healthy lifestyle factors and 60% lower (pooled HR, 0.40; 95% CI, 0.28-0.56) for those with four or five healthy lifestyle factors.
“From these findings and the fact that the lifestyle factors we studied are modifiable and in direct control of the individual, it is imperative to promote them concurrently among older adults as a strategy to delay or prevent Alzheimer’s dementia,” Dr. Dhana and colleagues concluded.
In a statement, Dallas Anderson, PhD, program director, division of neuroscience, National Institute on Aging, said the findings help “paint the picture of how multiple factors are likely playing parts in Alzheimer’s disease risk.”
“It’s not a clear cause-and-effect result, but a strong finding because of the dual data sets and combination of modifiable lifestyle factors that appear to lead to risk reduction,” Dr. Anderson added.
Essential questions remain
Commenting on the new study, Luca Giliberto, MD, PhD, neurologist with the Litwin-Zucker Research Center for Alzheimer’s Disease and Memory Disorders at the Feinstein Institutes for Medical Research in Manhasset, N.Y., said this analysis is “further demonstration that a healthy lifestyle is essential to overcome or curb” the risk for Alzheimer’s disease.
“What needs to be determined is how early should we start ‘behaving.’ We should all aim to score four to five factors across our entire lifespan, but this is not always feasible. So, when is the time to behave? Also, what is the relative weight of each of these factors?” said Dr. Giliberto.
Of note, he added, although addressing vascular risk factors such as hypertension, hyperlipidemia, and diabetes “may require an extensive mindful and logistic effort, a healthy diet is effortlessly achieved in some countries, where both the DASH and MIND diets do not need to be ‘prescribed’ but are rather culturally engraved in the population.
“This is, in part, related to the wide availability of high-quality food in these countries, which is not the same in the U.S. This work is one more demonstration of the need to revisit our take on quality of food in the U.S.,” said Dr. Giliberto.
Numerous clinical trials testing lifestyle interventions for dementia prevention are currently underway. The MIND Diet Intervention to Prevent Alzheimer’s Disease, for example, is an interventional clinical trial comparing parallel groups with two different diets. MIND has enrolled more than 600 participants and is ongoing. The anticipated completion date is 2021. Another is the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER), a multisite randomized clinical trial evaluating whether lifestyle interventions – including exercise, cognitively stimulating activities, and the MIND diet – may protect cognitive function in older adults who are at increased risk for cognitive decline.
Funding for the current study was provided by the National Institutes of Health and the National Institute on Aging. Dr. Dhana and Dr. Giliberto have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Klodian Dhana, MD, PhD, department of internal medicine, Rush University Medical Center, Chicago, said in an interview.
“I hope this study will motivate people to engage in a healthy lifestyle by not smoking, being physically and cognitively active, and having a high-quality diet,” lead investigatorThe study was published online June 17 in Neurology.
Risk-modifying behaviors
To help quantify the impact of a healthy life on risk for Alzheimer’s dementia, Dr. Dhana and colleagues reviewed data from two longitudinal study populations: the Chicago Health and Aging Project (CHAP), with 1,845 participants, and the Memory and Aging Project (MAP), with 920 participants.
They defined a healthy lifestyle score on the basis of the following factors: not smoking; engaging in 150 min/wk or more of physical exercise of moderate to vigorous intensity; light to moderate alcohol consumption (between 1 and less than 15 g/day for women and between 1 and less than 30 g/day for men); consuming a high-quality Mediterranean-DASH Diet Intervention for Neurodegenerative Delay diet (upper 40%); and engaging in late-life cognitive activities (upper 40%). The overall score ranged from 0 to 5.
At baseline, the mean age of participants was 73.2 years in the CHAP study and 81.1 years in the MAP study; 62.4% of the CHAP participants and 75.2% of the MAP participants were women.
During a median follow-up of 5.8 years in CHAP and 6.0 years in MAP, a total of 379 and 229 participants, respectively, developed Alzheimer’s dementia. Rates of dementia decreased with an increasing number of healthy lifestyle behaviors.
In multivariable-adjusted models across the two cohorts, the risk for Alzheimer’s dementia was 27% lower with each additional healthy lifestyle factor (pooled hazard ratio, 0.73; 95% confidence interval, 0.66-0.80).
Compared with individuals with a healthy lifestyle score of 0-1, the risk was 37% lower (pooled HR, 0.63; 95% CI, 0.47-0.84) for those with two or three healthy lifestyle factors and 60% lower (pooled HR, 0.40; 95% CI, 0.28-0.56) for those with four or five healthy lifestyle factors.
“From these findings and the fact that the lifestyle factors we studied are modifiable and in direct control of the individual, it is imperative to promote them concurrently among older adults as a strategy to delay or prevent Alzheimer’s dementia,” Dr. Dhana and colleagues concluded.
In a statement, Dallas Anderson, PhD, program director, division of neuroscience, National Institute on Aging, said the findings help “paint the picture of how multiple factors are likely playing parts in Alzheimer’s disease risk.”
“It’s not a clear cause-and-effect result, but a strong finding because of the dual data sets and combination of modifiable lifestyle factors that appear to lead to risk reduction,” Dr. Anderson added.
Essential questions remain
Commenting on the new study, Luca Giliberto, MD, PhD, neurologist with the Litwin-Zucker Research Center for Alzheimer’s Disease and Memory Disorders at the Feinstein Institutes for Medical Research in Manhasset, N.Y., said this analysis is “further demonstration that a healthy lifestyle is essential to overcome or curb” the risk for Alzheimer’s disease.
“What needs to be determined is how early should we start ‘behaving.’ We should all aim to score four to five factors across our entire lifespan, but this is not always feasible. So, when is the time to behave? Also, what is the relative weight of each of these factors?” said Dr. Giliberto.
Of note, he added, although addressing vascular risk factors such as hypertension, hyperlipidemia, and diabetes “may require an extensive mindful and logistic effort, a healthy diet is effortlessly achieved in some countries, where both the DASH and MIND diets do not need to be ‘prescribed’ but are rather culturally engraved in the population.
“This is, in part, related to the wide availability of high-quality food in these countries, which is not the same in the U.S. This work is one more demonstration of the need to revisit our take on quality of food in the U.S.,” said Dr. Giliberto.
Numerous clinical trials testing lifestyle interventions for dementia prevention are currently underway. The MIND Diet Intervention to Prevent Alzheimer’s Disease, for example, is an interventional clinical trial comparing parallel groups with two different diets. MIND has enrolled more than 600 participants and is ongoing. The anticipated completion date is 2021. Another is the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER), a multisite randomized clinical trial evaluating whether lifestyle interventions – including exercise, cognitively stimulating activities, and the MIND diet – may protect cognitive function in older adults who are at increased risk for cognitive decline.
Funding for the current study was provided by the National Institutes of Health and the National Institute on Aging. Dr. Dhana and Dr. Giliberto have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM NEUROLOGY
Guidance on infection prevention for health care personnel
As we reopen our offices we are faced with the challenge of determining the best way to do it safely – protecting ourselves, our staff, and our patients.
In this column we will focus on selected details of the recommendations from IDSA and the CDC that may be helpful in primary care offices.
Face masks
Many clinicians have asked whether a physician should use a mask while seeing patients without COVID-19 in the office, and if yes, which type. The IDSA guideline states that mask usage is imperative for reducing the risk of health care workers contracting COVID-19.1 The evidence is derived from a number of sources, including a retrospective study from Wuhan (China) University that examined two groups of health care workers during the outbreak. The first group wore N95 masks and washed their hands frequently, while the second group did not wear masks and washed their hands less frequently. In the group that took greater actions to protect themselves, none of the 493 staff members contracted COVID-19, compared with 10 of 213 staff members in the other group. The decrease in infection rate occurred in the group that wore masks despite the fact that this group had 733% more exposure to COVID-19 patients.2 Further evidence came from a case-control study done in hospitals in Hong Kong during the 2003 SARS-CoV outbreak.3 This study showed that mask wearing was the most significant intervention for reducing infection, followed by gowning, and then handwashing. These findings make it clear that mask usage is a must for all health care providers who may be caring for patients who could have COVID-19.
The guideline also reviews evidence about the use of surgical masks versus N95 masks. On reviewing indirect evidence from the SARS-CoV epidemic, IDSA found that wearing any mask – surgical or N95 – led to a large reduction in the risk of developing an infection. In this systematic review of five observational studies in health care personnel, for those wearing surgical masks, the odds ratio for developing an infection was 0.13 (95% CI, 0.03-0.62), and for those wearing N95 masks, the odds ratio was 0.12 (95% CI, 0.06-0.26). There was not a significant difference between risk reductions for those who wore surgical masks and N95 masks, respectively.1,4 The IDSA guideline panel recommended “that health care personnel caring for patients with suspected or known COVID-19 use either a surgical mask or N95 respirator ... as part of appropriate PPE.” Since there is not a significant difference in outcomes between those who use surgical masks and those who use N95 respirators, and the IDSA guideline states either type of mask is considered appropriate when taking care of patients with suspected or known COVID-19, in our opinion, use of surgical masks rather than N95s is sufficient when performing low-risk activities. Such activities include seeing patients who do not have a high likelihood of COVID-19 in the office setting.
The IDSA recommendation also discusses universal masking, defined as both patients and clinicians wearing masks. The recommendation is supported by the findings of a study in which universal mask usage was used to prevent the spread of H1N 1 during the 2009 outbreak. In this study of staff members and patients exposed to H1N1 who all wore masks, only 0.48% of 836 acquired infection. In the same study, not wearing a mask by either the provider or patient increased the risk of infection.5 Also, in a prospective study of hematopoietic stem cell transplant patients, universal masking caused infection rates to drop from 10.3% to 4.4%.6
The IDSA guideline states the following: “There may be some, albeit uncertain, benefit to universal masking in the absence of resource constraints. However, the benefits of universal masking with surgical masks should be weighed against the risk of increasing the PPE burn rate and contextualized to the background COVID-19 prevalence rate for asymptomatic or minimally symptomatic HCPs [health care providers] and visitors.”1
The CDC’s guidance statement says the following: “Continued community transmission has increased the number of individuals potentially exposed to and infectious with SARS-CoV-2. Fever and symptom screening have proven to be relatively ineffective in identifying all infected individuals, including HCPs. Symptom screening also will not identify individuals who are infected but otherwise asymptomatic or pre-symptomatic; additional interventions are needed to limit the unrecognized introduction of SARS-CoV-2 into healthcare settings by these individuals. As part of aggressive source control measures, healthcare facilities should consider implementing policies requiring everyone entering the facility to wear a cloth face covering (if tolerated) while in the building, regardless of symptoms.”7
It is our opinion, based on the CDC and IDSA recommendations, that both clinicians and patients should be required to wear masks when patients are seen in the office if possible. Many offices have instituted a policy that says, if a patient refuses to wear a mask during an office visit, then the patient will not be seen.
Eye protection
Many clinicians are uncertain about whether eye protection needs to be used when seeing asymptomatic patients. The IDSA acknowledges that there are not studies that have looked critically at eye protection, but the society also acknowledges “appropriate personal protective equipment includes, in addition to a mask or respirator, eye protection, gown and gloves.”1 In addition, the CDC recommends that, for healthcare workers located in areas with moderate or higher prevalence of COVID-19, HCPs should wear eye protection in addition to facemasks since they may encounter asymptomatic individuals with COVID-19.
Gowns and gloves
Gowns and gloves are recommended as a part of personal protective gear when caring for patients who have COVID-19. The IDSA guideline is clear in its recommendations, but does not cite evidence for having no gloves versus having gloves. Furthermore, they state that the evidence is insufficient to recommend double gloves, with the top glove used to take off a personal protective gown, and the inner glove discarded after the gown is removed. The CDC do not make recommendations for routine use of gloves in the care of patients who do not have COVID-19, even in areas where there may be asymptomatic COVID-19, and recommends standard precautions, specifically practicing hand hygiene before and after patient contact.8
The Bottom Line
When seeing patients with COVID-19, N-95 masks, goggles or face shields, gowns, and gloves should be used, with hand hygiene routinely practiced before and after seeing patients. For offices seeing patients not suspected of having COVID-19, the IDSA guideline clarifies that there is not a statistical difference in acquisition of infection with the use of surgical face masks vs N95 respirators. According to the CDC recommendations, eye protection in addition to facemasks should be used by the health care provider, and masks should be worn by patients. Hand hygiene should be used routinely before and after all patient contact. With use of these approaches, it should be safe for offices to reopen and see patients.
Neil Skolnik, MD, is professor of family and community medicine at the Thomas Jefferson University, Philadelphia, and associate director of the Family Medicine Residency Program at Abington (Pa.) Jefferson Health. Jeffrey Matthews, DO, is a second-year resident in the Family Medicine Residency at Abington Jefferson Health. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.
References
1. Lynch JB, Davitkov P, Anderson DJ, et al. COVID-19 Guideline, Part 2: Infection Prevention. IDSA Home. https://www.idsociety.org/practice-guideline/covid-19-guideline-infection-prevention/. April 27, 2020. Accessed June 10, 2020.
2. J Hosp Infect. 2020 May;105(1):104-5.
3. Lancet. 2003;361(9368):1519-20.
4. Influenza Other Respir Viruses. 2020 Apr 4. doi: 2020;10.1111/irv.12745.
5. J Hosp Infect. 2010;74(3):271-7.
6. Clin Infect Dis. 2016;63(8):999-1006.
7. Centers for Disease Control and Prevention. Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. Accessed Jun 16, 2020.
8. Centers for Disease Control and Prevention. Healthcare Infection Prevention and Control FAQs for COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-faq.html. Accessed June 15, 2020.
As we reopen our offices we are faced with the challenge of determining the best way to do it safely – protecting ourselves, our staff, and our patients.
In this column we will focus on selected details of the recommendations from IDSA and the CDC that may be helpful in primary care offices.
Face masks
Many clinicians have asked whether a physician should use a mask while seeing patients without COVID-19 in the office, and if yes, which type. The IDSA guideline states that mask usage is imperative for reducing the risk of health care workers contracting COVID-19.1 The evidence is derived from a number of sources, including a retrospective study from Wuhan (China) University that examined two groups of health care workers during the outbreak. The first group wore N95 masks and washed their hands frequently, while the second group did not wear masks and washed their hands less frequently. In the group that took greater actions to protect themselves, none of the 493 staff members contracted COVID-19, compared with 10 of 213 staff members in the other group. The decrease in infection rate occurred in the group that wore masks despite the fact that this group had 733% more exposure to COVID-19 patients.2 Further evidence came from a case-control study done in hospitals in Hong Kong during the 2003 SARS-CoV outbreak.3 This study showed that mask wearing was the most significant intervention for reducing infection, followed by gowning, and then handwashing. These findings make it clear that mask usage is a must for all health care providers who may be caring for patients who could have COVID-19.
The guideline also reviews evidence about the use of surgical masks versus N95 masks. On reviewing indirect evidence from the SARS-CoV epidemic, IDSA found that wearing any mask – surgical or N95 – led to a large reduction in the risk of developing an infection. In this systematic review of five observational studies in health care personnel, for those wearing surgical masks, the odds ratio for developing an infection was 0.13 (95% CI, 0.03-0.62), and for those wearing N95 masks, the odds ratio was 0.12 (95% CI, 0.06-0.26). There was not a significant difference between risk reductions for those who wore surgical masks and N95 masks, respectively.1,4 The IDSA guideline panel recommended “that health care personnel caring for patients with suspected or known COVID-19 use either a surgical mask or N95 respirator ... as part of appropriate PPE.” Since there is not a significant difference in outcomes between those who use surgical masks and those who use N95 respirators, and the IDSA guideline states either type of mask is considered appropriate when taking care of patients with suspected or known COVID-19, in our opinion, use of surgical masks rather than N95s is sufficient when performing low-risk activities. Such activities include seeing patients who do not have a high likelihood of COVID-19 in the office setting.
The IDSA recommendation also discusses universal masking, defined as both patients and clinicians wearing masks. The recommendation is supported by the findings of a study in which universal mask usage was used to prevent the spread of H1N 1 during the 2009 outbreak. In this study of staff members and patients exposed to H1N1 who all wore masks, only 0.48% of 836 acquired infection. In the same study, not wearing a mask by either the provider or patient increased the risk of infection.5 Also, in a prospective study of hematopoietic stem cell transplant patients, universal masking caused infection rates to drop from 10.3% to 4.4%.6
The IDSA guideline states the following: “There may be some, albeit uncertain, benefit to universal masking in the absence of resource constraints. However, the benefits of universal masking with surgical masks should be weighed against the risk of increasing the PPE burn rate and contextualized to the background COVID-19 prevalence rate for asymptomatic or minimally symptomatic HCPs [health care providers] and visitors.”1
The CDC’s guidance statement says the following: “Continued community transmission has increased the number of individuals potentially exposed to and infectious with SARS-CoV-2. Fever and symptom screening have proven to be relatively ineffective in identifying all infected individuals, including HCPs. Symptom screening also will not identify individuals who are infected but otherwise asymptomatic or pre-symptomatic; additional interventions are needed to limit the unrecognized introduction of SARS-CoV-2 into healthcare settings by these individuals. As part of aggressive source control measures, healthcare facilities should consider implementing policies requiring everyone entering the facility to wear a cloth face covering (if tolerated) while in the building, regardless of symptoms.”7
It is our opinion, based on the CDC and IDSA recommendations, that both clinicians and patients should be required to wear masks when patients are seen in the office if possible. Many offices have instituted a policy that says, if a patient refuses to wear a mask during an office visit, then the patient will not be seen.
Eye protection
Many clinicians are uncertain about whether eye protection needs to be used when seeing asymptomatic patients. The IDSA acknowledges that there are not studies that have looked critically at eye protection, but the society also acknowledges “appropriate personal protective equipment includes, in addition to a mask or respirator, eye protection, gown and gloves.”1 In addition, the CDC recommends that, for healthcare workers located in areas with moderate or higher prevalence of COVID-19, HCPs should wear eye protection in addition to facemasks since they may encounter asymptomatic individuals with COVID-19.
Gowns and gloves
Gowns and gloves are recommended as a part of personal protective gear when caring for patients who have COVID-19. The IDSA guideline is clear in its recommendations, but does not cite evidence for having no gloves versus having gloves. Furthermore, they state that the evidence is insufficient to recommend double gloves, with the top glove used to take off a personal protective gown, and the inner glove discarded after the gown is removed. The CDC do not make recommendations for routine use of gloves in the care of patients who do not have COVID-19, even in areas where there may be asymptomatic COVID-19, and recommends standard precautions, specifically practicing hand hygiene before and after patient contact.8
The Bottom Line
When seeing patients with COVID-19, N-95 masks, goggles or face shields, gowns, and gloves should be used, with hand hygiene routinely practiced before and after seeing patients. For offices seeing patients not suspected of having COVID-19, the IDSA guideline clarifies that there is not a statistical difference in acquisition of infection with the use of surgical face masks vs N95 respirators. According to the CDC recommendations, eye protection in addition to facemasks should be used by the health care provider, and masks should be worn by patients. Hand hygiene should be used routinely before and after all patient contact. With use of these approaches, it should be safe for offices to reopen and see patients.
Neil Skolnik, MD, is professor of family and community medicine at the Thomas Jefferson University, Philadelphia, and associate director of the Family Medicine Residency Program at Abington (Pa.) Jefferson Health. Jeffrey Matthews, DO, is a second-year resident in the Family Medicine Residency at Abington Jefferson Health. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.
References
1. Lynch JB, Davitkov P, Anderson DJ, et al. COVID-19 Guideline, Part 2: Infection Prevention. IDSA Home. https://www.idsociety.org/practice-guideline/covid-19-guideline-infection-prevention/. April 27, 2020. Accessed June 10, 2020.
2. J Hosp Infect. 2020 May;105(1):104-5.
3. Lancet. 2003;361(9368):1519-20.
4. Influenza Other Respir Viruses. 2020 Apr 4. doi: 2020;10.1111/irv.12745.
5. J Hosp Infect. 2010;74(3):271-7.
6. Clin Infect Dis. 2016;63(8):999-1006.
7. Centers for Disease Control and Prevention. Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. Accessed Jun 16, 2020.
8. Centers for Disease Control and Prevention. Healthcare Infection Prevention and Control FAQs for COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-faq.html. Accessed June 15, 2020.
As we reopen our offices we are faced with the challenge of determining the best way to do it safely – protecting ourselves, our staff, and our patients.
In this column we will focus on selected details of the recommendations from IDSA and the CDC that may be helpful in primary care offices.
Face masks
Many clinicians have asked whether a physician should use a mask while seeing patients without COVID-19 in the office, and if yes, which type. The IDSA guideline states that mask usage is imperative for reducing the risk of health care workers contracting COVID-19.1 The evidence is derived from a number of sources, including a retrospective study from Wuhan (China) University that examined two groups of health care workers during the outbreak. The first group wore N95 masks and washed their hands frequently, while the second group did not wear masks and washed their hands less frequently. In the group that took greater actions to protect themselves, none of the 493 staff members contracted COVID-19, compared with 10 of 213 staff members in the other group. The decrease in infection rate occurred in the group that wore masks despite the fact that this group had 733% more exposure to COVID-19 patients.2 Further evidence came from a case-control study done in hospitals in Hong Kong during the 2003 SARS-CoV outbreak.3 This study showed that mask wearing was the most significant intervention for reducing infection, followed by gowning, and then handwashing. These findings make it clear that mask usage is a must for all health care providers who may be caring for patients who could have COVID-19.
The guideline also reviews evidence about the use of surgical masks versus N95 masks. On reviewing indirect evidence from the SARS-CoV epidemic, IDSA found that wearing any mask – surgical or N95 – led to a large reduction in the risk of developing an infection. In this systematic review of five observational studies in health care personnel, for those wearing surgical masks, the odds ratio for developing an infection was 0.13 (95% CI, 0.03-0.62), and for those wearing N95 masks, the odds ratio was 0.12 (95% CI, 0.06-0.26). There was not a significant difference between risk reductions for those who wore surgical masks and N95 masks, respectively.1,4 The IDSA guideline panel recommended “that health care personnel caring for patients with suspected or known COVID-19 use either a surgical mask or N95 respirator ... as part of appropriate PPE.” Since there is not a significant difference in outcomes between those who use surgical masks and those who use N95 respirators, and the IDSA guideline states either type of mask is considered appropriate when taking care of patients with suspected or known COVID-19, in our opinion, use of surgical masks rather than N95s is sufficient when performing low-risk activities. Such activities include seeing patients who do not have a high likelihood of COVID-19 in the office setting.
The IDSA recommendation also discusses universal masking, defined as both patients and clinicians wearing masks. The recommendation is supported by the findings of a study in which universal mask usage was used to prevent the spread of H1N 1 during the 2009 outbreak. In this study of staff members and patients exposed to H1N1 who all wore masks, only 0.48% of 836 acquired infection. In the same study, not wearing a mask by either the provider or patient increased the risk of infection.5 Also, in a prospective study of hematopoietic stem cell transplant patients, universal masking caused infection rates to drop from 10.3% to 4.4%.6
The IDSA guideline states the following: “There may be some, albeit uncertain, benefit to universal masking in the absence of resource constraints. However, the benefits of universal masking with surgical masks should be weighed against the risk of increasing the PPE burn rate and contextualized to the background COVID-19 prevalence rate for asymptomatic or minimally symptomatic HCPs [health care providers] and visitors.”1
The CDC’s guidance statement says the following: “Continued community transmission has increased the number of individuals potentially exposed to and infectious with SARS-CoV-2. Fever and symptom screening have proven to be relatively ineffective in identifying all infected individuals, including HCPs. Symptom screening also will not identify individuals who are infected but otherwise asymptomatic or pre-symptomatic; additional interventions are needed to limit the unrecognized introduction of SARS-CoV-2 into healthcare settings by these individuals. As part of aggressive source control measures, healthcare facilities should consider implementing policies requiring everyone entering the facility to wear a cloth face covering (if tolerated) while in the building, regardless of symptoms.”7
It is our opinion, based on the CDC and IDSA recommendations, that both clinicians and patients should be required to wear masks when patients are seen in the office if possible. Many offices have instituted a policy that says, if a patient refuses to wear a mask during an office visit, then the patient will not be seen.
Eye protection
Many clinicians are uncertain about whether eye protection needs to be used when seeing asymptomatic patients. The IDSA acknowledges that there are not studies that have looked critically at eye protection, but the society also acknowledges “appropriate personal protective equipment includes, in addition to a mask or respirator, eye protection, gown and gloves.”1 In addition, the CDC recommends that, for healthcare workers located in areas with moderate or higher prevalence of COVID-19, HCPs should wear eye protection in addition to facemasks since they may encounter asymptomatic individuals with COVID-19.
Gowns and gloves
Gowns and gloves are recommended as a part of personal protective gear when caring for patients who have COVID-19. The IDSA guideline is clear in its recommendations, but does not cite evidence for having no gloves versus having gloves. Furthermore, they state that the evidence is insufficient to recommend double gloves, with the top glove used to take off a personal protective gown, and the inner glove discarded after the gown is removed. The CDC do not make recommendations for routine use of gloves in the care of patients who do not have COVID-19, even in areas where there may be asymptomatic COVID-19, and recommends standard precautions, specifically practicing hand hygiene before and after patient contact.8
The Bottom Line
When seeing patients with COVID-19, N-95 masks, goggles or face shields, gowns, and gloves should be used, with hand hygiene routinely practiced before and after seeing patients. For offices seeing patients not suspected of having COVID-19, the IDSA guideline clarifies that there is not a statistical difference in acquisition of infection with the use of surgical face masks vs N95 respirators. According to the CDC recommendations, eye protection in addition to facemasks should be used by the health care provider, and masks should be worn by patients. Hand hygiene should be used routinely before and after all patient contact. With use of these approaches, it should be safe for offices to reopen and see patients.
Neil Skolnik, MD, is professor of family and community medicine at the Thomas Jefferson University, Philadelphia, and associate director of the Family Medicine Residency Program at Abington (Pa.) Jefferson Health. Jeffrey Matthews, DO, is a second-year resident in the Family Medicine Residency at Abington Jefferson Health. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.
References
1. Lynch JB, Davitkov P, Anderson DJ, et al. COVID-19 Guideline, Part 2: Infection Prevention. IDSA Home. https://www.idsociety.org/practice-guideline/covid-19-guideline-infection-prevention/. April 27, 2020. Accessed June 10, 2020.
2. J Hosp Infect. 2020 May;105(1):104-5.
3. Lancet. 2003;361(9368):1519-20.
4. Influenza Other Respir Viruses. 2020 Apr 4. doi: 2020;10.1111/irv.12745.
5. J Hosp Infect. 2010;74(3):271-7.
6. Clin Infect Dis. 2016;63(8):999-1006.
7. Centers for Disease Control and Prevention. Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. Accessed Jun 16, 2020.
8. Centers for Disease Control and Prevention. Healthcare Infection Prevention and Control FAQs for COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-faq.html. Accessed June 15, 2020.
Cortisol levels on COVID-19 admission may be a marker of severity
Patients with COVID-19 who have high levels of the steroid hormone cortisol on admission to hospital have a substantially increased risk of dying, U.K. researchers have discovered.
Waljit S. Dhillo, MBBS, PhD, head of the division of diabetes, endocrinology and metabolism at Imperial College London, and colleagues studied 535 patients admitted to major London hospitals. Their article was published online June 18 in Lancet Diabetes & Endocrinology.
“Our analyses show for the first time that patients with COVID-19 mount a marked and appropriate acute cortisol stress response,” said Dr. Dhillo and colleagues.
Moreover, “high cortisol concentrations were associated with increased mortality and a reduced median survival, probably because this is a marker of the severity of illness.”
So measuring cortisol on admission is potentially “another simple marker to use alongside oxygen saturation levels to help us identify which patients need to be admitted immediately, and which may not,” Dr. Dhillo noted in a statement from his institution.
“Having an early indicator of which patients may deteriorate more quickly will help us with providing the best level of care as quickly as possible. In addition, we can also take cortisol levels into account when we are working out how best to treat our patients,” he said.
However, it’s important to note that this means – particularly in the wake of the RECOVERY trial reported last week – that “in the early part of the disease you don’t need steroids,” he said.
In contrast to SARS, no adrenal insufficiency with COVID-19
Cortisol levels when healthy and resting are 100-200 nmol/L and nearly zero when sleeping, the researchers explained.
They decided to examine cortisol levels because, although physiological stress from critical illness normally increases levels of the hormone, the prior coronavirus, severe acute respiratory syndrome coronavirus (SARS-CoV), had the opposite effect and induced cortisol insufficiency in some patients.
“We would have said we’re not quite sure” what effect SARS-CoV-2 is having on cortisol levels, “so that’s why we collected the data,” Dr. Dhillo said in an interview.
The researchers studied patients admitted to three large London teaching hospitals between March 9 and April 22 with a clinical suspicion of SARS-CoV-2 infection. All patients had a standard set of blood tests, including full blood count, creatinine, C-reactive protein, D-dimer, and serum cortisol.
After exclusions, the team assessed 535 patients admitted over the study period who had baseline cortisol measured within 48 hours of admission.
Of these, 403 patients were diagnosed with COVID-19 based on a positive result on real-time polymerase chain reaction testing (88%) or a strong clinical and radiological suspicion, despite a negative test (12%).
In total, 132 (25%) individuals were not diagnosed with COVID-19.
Patients with COVID-19 were a mean age of 66.3 years, and 59.6% were men.
Mean cortisol concentrations in patients with COVID-19 were significantly higher than those not diagnosed with the virus (619 vs 519 nmol/L; P < .0001).
And by May 8, significantly more patients with COVID-19 died than those without (27.8% vs 6.8%; P < .0001).
Doubling of cortisol levels associated with 40% higher mortality
Multivariate analysis taking into account age, presence of comorbidities, and laboratory tests revealed that a doubling of cortisol concentrations among those with COVID-19 was associated with a significant increase in mortality, at a hazard ratio of 1.42 (P = .014).
And patients with COVID-19 whose baseline cortisol level was >744 nmol/L had a median survival of just 15 days, compared with those with a level ≤744 nmol/L, who had a median survival of 36 days (P < .0001).
The team notes that the cortisol stress responses in their patients with COVID-19 ranged up to 3,241 nmol/L, which is “a marked cortisol stress response, perhaps higher than is observed in patients undergoing major surgery.”
Of interest, there was no interaction between cortisol levels and ethnicity in their study; a subsequent analysis of the data stratified by black, Asian, and other minority ethnicities revealed no significant differences.
The team note that their results will need to be reproduced in other populations.
“Any potential role for cortisol measurement at baseline and later during an inpatient stay with COVID-19 as a prognostic biomarker, either by itself or in combination with other biomarkers, will require validation in a prospective study.”
Implications for treatment: Reserve dexamethasone for critically ill
Dr. Dhillo explained that, because their findings indicate that people initially infected with COVID-19 do mount an appropriate stress (cortisol) response, it is important that people properly understand this in the wake of the RECOVERY trial, reported last week.
The trial showed that the widely available steroid dexamethasone significantly reduced mortality among severely ill COVID-19 patients in the intensive care unit when given at a supraphysiologic dose of 6 mg.
But it would be hazardous for anyone to self-medicate with steroids at an early stage of COVID-19 because that would further increase cortisol levels and could suppress the immune system.
“For the average person on the street with COVID-19,” excess steroids will make their symptoms worse, Dr. Dhillo explained, adding this is important to emphasize because dexamethasone, and similar steroids, “are cheap and likely available on the Internet, and so misunderstanding of the RECOVERY trial could have serious implications.”
But once patients are very sick, with “inflammation in their lungs” and are in the intensive care unit, and often on ventilators – which is a very small subgroup of those with COVID-19 – it becomes a very different story, he stressed.
“RECOVERY shows clearly there seems to be a benefit once you need oxygen or are on a ventilator, and that makes sense because [dexamethasone] is going to be an anti-inflammatory,” in this instance when the “lungs are full of water.”
“But in the early days you definitely don’t need it and it could be harmful,” he reiterated.
The study is funded by the U.K. National Institute for Health Research and Medical Research Council. The authors have reported no relevant financial relationships.
This article first appeared on Medscape.com.
Patients with COVID-19 who have high levels of the steroid hormone cortisol on admission to hospital have a substantially increased risk of dying, U.K. researchers have discovered.
Waljit S. Dhillo, MBBS, PhD, head of the division of diabetes, endocrinology and metabolism at Imperial College London, and colleagues studied 535 patients admitted to major London hospitals. Their article was published online June 18 in Lancet Diabetes & Endocrinology.
“Our analyses show for the first time that patients with COVID-19 mount a marked and appropriate acute cortisol stress response,” said Dr. Dhillo and colleagues.
Moreover, “high cortisol concentrations were associated with increased mortality and a reduced median survival, probably because this is a marker of the severity of illness.”
So measuring cortisol on admission is potentially “another simple marker to use alongside oxygen saturation levels to help us identify which patients need to be admitted immediately, and which may not,” Dr. Dhillo noted in a statement from his institution.
“Having an early indicator of which patients may deteriorate more quickly will help us with providing the best level of care as quickly as possible. In addition, we can also take cortisol levels into account when we are working out how best to treat our patients,” he said.
However, it’s important to note that this means – particularly in the wake of the RECOVERY trial reported last week – that “in the early part of the disease you don’t need steroids,” he said.
In contrast to SARS, no adrenal insufficiency with COVID-19
Cortisol levels when healthy and resting are 100-200 nmol/L and nearly zero when sleeping, the researchers explained.
They decided to examine cortisol levels because, although physiological stress from critical illness normally increases levels of the hormone, the prior coronavirus, severe acute respiratory syndrome coronavirus (SARS-CoV), had the opposite effect and induced cortisol insufficiency in some patients.
“We would have said we’re not quite sure” what effect SARS-CoV-2 is having on cortisol levels, “so that’s why we collected the data,” Dr. Dhillo said in an interview.
The researchers studied patients admitted to three large London teaching hospitals between March 9 and April 22 with a clinical suspicion of SARS-CoV-2 infection. All patients had a standard set of blood tests, including full blood count, creatinine, C-reactive protein, D-dimer, and serum cortisol.
After exclusions, the team assessed 535 patients admitted over the study period who had baseline cortisol measured within 48 hours of admission.
Of these, 403 patients were diagnosed with COVID-19 based on a positive result on real-time polymerase chain reaction testing (88%) or a strong clinical and radiological suspicion, despite a negative test (12%).
In total, 132 (25%) individuals were not diagnosed with COVID-19.
Patients with COVID-19 were a mean age of 66.3 years, and 59.6% were men.
Mean cortisol concentrations in patients with COVID-19 were significantly higher than those not diagnosed with the virus (619 vs 519 nmol/L; P < .0001).
And by May 8, significantly more patients with COVID-19 died than those without (27.8% vs 6.8%; P < .0001).
Doubling of cortisol levels associated with 40% higher mortality
Multivariate analysis taking into account age, presence of comorbidities, and laboratory tests revealed that a doubling of cortisol concentrations among those with COVID-19 was associated with a significant increase in mortality, at a hazard ratio of 1.42 (P = .014).
And patients with COVID-19 whose baseline cortisol level was >744 nmol/L had a median survival of just 15 days, compared with those with a level ≤744 nmol/L, who had a median survival of 36 days (P < .0001).
The team notes that the cortisol stress responses in their patients with COVID-19 ranged up to 3,241 nmol/L, which is “a marked cortisol stress response, perhaps higher than is observed in patients undergoing major surgery.”
Of interest, there was no interaction between cortisol levels and ethnicity in their study; a subsequent analysis of the data stratified by black, Asian, and other minority ethnicities revealed no significant differences.
The team note that their results will need to be reproduced in other populations.
“Any potential role for cortisol measurement at baseline and later during an inpatient stay with COVID-19 as a prognostic biomarker, either by itself or in combination with other biomarkers, will require validation in a prospective study.”
Implications for treatment: Reserve dexamethasone for critically ill
Dr. Dhillo explained that, because their findings indicate that people initially infected with COVID-19 do mount an appropriate stress (cortisol) response, it is important that people properly understand this in the wake of the RECOVERY trial, reported last week.
The trial showed that the widely available steroid dexamethasone significantly reduced mortality among severely ill COVID-19 patients in the intensive care unit when given at a supraphysiologic dose of 6 mg.
But it would be hazardous for anyone to self-medicate with steroids at an early stage of COVID-19 because that would further increase cortisol levels and could suppress the immune system.
“For the average person on the street with COVID-19,” excess steroids will make their symptoms worse, Dr. Dhillo explained, adding this is important to emphasize because dexamethasone, and similar steroids, “are cheap and likely available on the Internet, and so misunderstanding of the RECOVERY trial could have serious implications.”
But once patients are very sick, with “inflammation in their lungs” and are in the intensive care unit, and often on ventilators – which is a very small subgroup of those with COVID-19 – it becomes a very different story, he stressed.
“RECOVERY shows clearly there seems to be a benefit once you need oxygen or are on a ventilator, and that makes sense because [dexamethasone] is going to be an anti-inflammatory,” in this instance when the “lungs are full of water.”
“But in the early days you definitely don’t need it and it could be harmful,” he reiterated.
The study is funded by the U.K. National Institute for Health Research and Medical Research Council. The authors have reported no relevant financial relationships.
This article first appeared on Medscape.com.
Patients with COVID-19 who have high levels of the steroid hormone cortisol on admission to hospital have a substantially increased risk of dying, U.K. researchers have discovered.
Waljit S. Dhillo, MBBS, PhD, head of the division of diabetes, endocrinology and metabolism at Imperial College London, and colleagues studied 535 patients admitted to major London hospitals. Their article was published online June 18 in Lancet Diabetes & Endocrinology.
“Our analyses show for the first time that patients with COVID-19 mount a marked and appropriate acute cortisol stress response,” said Dr. Dhillo and colleagues.
Moreover, “high cortisol concentrations were associated with increased mortality and a reduced median survival, probably because this is a marker of the severity of illness.”
So measuring cortisol on admission is potentially “another simple marker to use alongside oxygen saturation levels to help us identify which patients need to be admitted immediately, and which may not,” Dr. Dhillo noted in a statement from his institution.
“Having an early indicator of which patients may deteriorate more quickly will help us with providing the best level of care as quickly as possible. In addition, we can also take cortisol levels into account when we are working out how best to treat our patients,” he said.
However, it’s important to note that this means – particularly in the wake of the RECOVERY trial reported last week – that “in the early part of the disease you don’t need steroids,” he said.
In contrast to SARS, no adrenal insufficiency with COVID-19
Cortisol levels when healthy and resting are 100-200 nmol/L and nearly zero when sleeping, the researchers explained.
They decided to examine cortisol levels because, although physiological stress from critical illness normally increases levels of the hormone, the prior coronavirus, severe acute respiratory syndrome coronavirus (SARS-CoV), had the opposite effect and induced cortisol insufficiency in some patients.
“We would have said we’re not quite sure” what effect SARS-CoV-2 is having on cortisol levels, “so that’s why we collected the data,” Dr. Dhillo said in an interview.
The researchers studied patients admitted to three large London teaching hospitals between March 9 and April 22 with a clinical suspicion of SARS-CoV-2 infection. All patients had a standard set of blood tests, including full blood count, creatinine, C-reactive protein, D-dimer, and serum cortisol.
After exclusions, the team assessed 535 patients admitted over the study period who had baseline cortisol measured within 48 hours of admission.
Of these, 403 patients were diagnosed with COVID-19 based on a positive result on real-time polymerase chain reaction testing (88%) or a strong clinical and radiological suspicion, despite a negative test (12%).
In total, 132 (25%) individuals were not diagnosed with COVID-19.
Patients with COVID-19 were a mean age of 66.3 years, and 59.6% were men.
Mean cortisol concentrations in patients with COVID-19 were significantly higher than those not diagnosed with the virus (619 vs 519 nmol/L; P < .0001).
And by May 8, significantly more patients with COVID-19 died than those without (27.8% vs 6.8%; P < .0001).
Doubling of cortisol levels associated with 40% higher mortality
Multivariate analysis taking into account age, presence of comorbidities, and laboratory tests revealed that a doubling of cortisol concentrations among those with COVID-19 was associated with a significant increase in mortality, at a hazard ratio of 1.42 (P = .014).
And patients with COVID-19 whose baseline cortisol level was >744 nmol/L had a median survival of just 15 days, compared with those with a level ≤744 nmol/L, who had a median survival of 36 days (P < .0001).
The team notes that the cortisol stress responses in their patients with COVID-19 ranged up to 3,241 nmol/L, which is “a marked cortisol stress response, perhaps higher than is observed in patients undergoing major surgery.”
Of interest, there was no interaction between cortisol levels and ethnicity in their study; a subsequent analysis of the data stratified by black, Asian, and other minority ethnicities revealed no significant differences.
The team note that their results will need to be reproduced in other populations.
“Any potential role for cortisol measurement at baseline and later during an inpatient stay with COVID-19 as a prognostic biomarker, either by itself or in combination with other biomarkers, will require validation in a prospective study.”
Implications for treatment: Reserve dexamethasone for critically ill
Dr. Dhillo explained that, because their findings indicate that people initially infected with COVID-19 do mount an appropriate stress (cortisol) response, it is important that people properly understand this in the wake of the RECOVERY trial, reported last week.
The trial showed that the widely available steroid dexamethasone significantly reduced mortality among severely ill COVID-19 patients in the intensive care unit when given at a supraphysiologic dose of 6 mg.
But it would be hazardous for anyone to self-medicate with steroids at an early stage of COVID-19 because that would further increase cortisol levels and could suppress the immune system.
“For the average person on the street with COVID-19,” excess steroids will make their symptoms worse, Dr. Dhillo explained, adding this is important to emphasize because dexamethasone, and similar steroids, “are cheap and likely available on the Internet, and so misunderstanding of the RECOVERY trial could have serious implications.”
But once patients are very sick, with “inflammation in their lungs” and are in the intensive care unit, and often on ventilators – which is a very small subgroup of those with COVID-19 – it becomes a very different story, he stressed.
“RECOVERY shows clearly there seems to be a benefit once you need oxygen or are on a ventilator, and that makes sense because [dexamethasone] is going to be an anti-inflammatory,” in this instance when the “lungs are full of water.”
“But in the early days you definitely don’t need it and it could be harmful,” he reiterated.
The study is funded by the U.K. National Institute for Health Research and Medical Research Council. The authors have reported no relevant financial relationships.
This article first appeared on Medscape.com.
Experts publish imaging recommendations for pediatric COVID-19
A team of pulmonologists has synthesized the clinical and imaging characteristics of COVID-19 in children, and has devised recommendations for ordering imaging studies in suspected cases of the infection.
The review also included useful radiographic findings to help in the differential diagnosis of COVID-19 pneumonia from other respiratory infections. Alexandra M. Foust, DO, of Boston Children’s Hospital, and colleagues reported the summary of findings and recommendations in Pediatric Pulmonology.
“Pediatricians face numerous challenges created by increasing reports of severe COVID-19 related findings in affected children,” said Mary Cataletto, MD, of NYU Langone Health in Mineola, N.Y. “[The current review] represents a multinational collaboration to provide up to date information and key imaging findings to guide chest physicians caring for children with pneumonia symptoms during the COVID-19 pandemic.”
Clinical presentation in children
In general, pediatric patients infected with the virus show milder symptoms compared with adults, and based on the limited evidence reported to date, the most common clinical symptoms of COVID-19 in children are rhinorrhea and/or nasal congestion, fever and cough with sore throat, fatigue or dyspnea, and diarrhea.
As with other viral pneumonias in children, the laboratory parameters are usually nonspecific; however, while the complete blood count (CBC) is often normal, lymphopenia, thrombocytopenia, and neutropenia have been reported in some cases of pediatric COVID-19, the authors noted.
The current Centers for Disease Control and Prevention (CDC) recommendation for initial diagnosis of SARS-CoV-2 is obtaining a nasopharyngeal swab, followed by reverse transcription polymerase chain reaction (RT-PCR) testing, they explained.
Role of imaging in diagnosis
The researchers reported that current recommendations from the American College of Radiology (ACR) do not include chest computed tomography (CT) or chest radiography (CXR) as a upfront test to diagnose pediatric COVID-19, but they may still have a role in clinical monitoring, especially in patients with a moderate to severe disease course.
The potential benefits of utilizing radiologic evaluation, such as establishing a baseline for monitoring disease progression, must be balanced with potential drawbacks, which include radiation exposure, and reduced availability of imaging resources owing to necessary cleaning and air turnover time.
Recommendations for ordering imaging studies
Based on the most recent international guidelines for pediatric COVID-19 patient management, the authors developed an algorithm for performing imaging studies in suspected cases of COVID-19 pneumonia.
The purpose of the tool is to support clinical decision-making around the utilization of CXR and CT to evaluate pediatric COVID-19 pneumonia.
“The step by step algorithm addresses the selection, sequence and timing of imaging studies with multiple images illustrating key findings of COVID-19 pneumonia in the pediatric age group,” said Dr. Cataletto. “By synthesizing the available imaging case series and guidelines, this primer provides a useful tool for the practicing pulmonologist,” she explained.
Key recommendations: CXR
“For pediatric patients with suspected or known COVID-19 infection with moderate to severe clinical symptoms requiring hospitalization (i.e., hypoxia, moderate or severe dyspnea, signs of sepsis, shock, cardiovascular compromise, altered mentation), CXR is usually indicated to establish an imaging baseline and to assess for an alternative diagnosis,” they recommended.
“Sequential CXRs may be helpful to assess pediatric patients with COVID-19 who demonstrate worsening clinical symptoms or to assess response to supportive therapy,” they wrote.
Key recommendations: CT
“Due to the increased radiation sensitivity of pediatric patients, chest CT is not recommended as an initial diagnostic test for pediatric patients with known or suspected COVID-19 pneumonia,” they explained.
The guide also included several considerations around the differential diagnosis of COVID-19 pneumonia from other pediatric lung disorders, including immune-related conditions, infectious etiologies, hematological dyscrasias, and inhalation-related lung injury.
As best practice recommendations for COVID-19 continue to evolve, the availability of practical clinical decision-making tools becomes essential to ensure optimal patient care.
No funding sources or financial disclosures were reported in the manuscript.
SOURCE: Foust AM et al. Pediatr Pulmonol. 2020 May 28. doi: 10.1002/ppul.24870.
A team of pulmonologists has synthesized the clinical and imaging characteristics of COVID-19 in children, and has devised recommendations for ordering imaging studies in suspected cases of the infection.
The review also included useful radiographic findings to help in the differential diagnosis of COVID-19 pneumonia from other respiratory infections. Alexandra M. Foust, DO, of Boston Children’s Hospital, and colleagues reported the summary of findings and recommendations in Pediatric Pulmonology.
“Pediatricians face numerous challenges created by increasing reports of severe COVID-19 related findings in affected children,” said Mary Cataletto, MD, of NYU Langone Health in Mineola, N.Y. “[The current review] represents a multinational collaboration to provide up to date information and key imaging findings to guide chest physicians caring for children with pneumonia symptoms during the COVID-19 pandemic.”
Clinical presentation in children
In general, pediatric patients infected with the virus show milder symptoms compared with adults, and based on the limited evidence reported to date, the most common clinical symptoms of COVID-19 in children are rhinorrhea and/or nasal congestion, fever and cough with sore throat, fatigue or dyspnea, and diarrhea.
As with other viral pneumonias in children, the laboratory parameters are usually nonspecific; however, while the complete blood count (CBC) is often normal, lymphopenia, thrombocytopenia, and neutropenia have been reported in some cases of pediatric COVID-19, the authors noted.
The current Centers for Disease Control and Prevention (CDC) recommendation for initial diagnosis of SARS-CoV-2 is obtaining a nasopharyngeal swab, followed by reverse transcription polymerase chain reaction (RT-PCR) testing, they explained.
Role of imaging in diagnosis
The researchers reported that current recommendations from the American College of Radiology (ACR) do not include chest computed tomography (CT) or chest radiography (CXR) as a upfront test to diagnose pediatric COVID-19, but they may still have a role in clinical monitoring, especially in patients with a moderate to severe disease course.
The potential benefits of utilizing radiologic evaluation, such as establishing a baseline for monitoring disease progression, must be balanced with potential drawbacks, which include radiation exposure, and reduced availability of imaging resources owing to necessary cleaning and air turnover time.
Recommendations for ordering imaging studies
Based on the most recent international guidelines for pediatric COVID-19 patient management, the authors developed an algorithm for performing imaging studies in suspected cases of COVID-19 pneumonia.
The purpose of the tool is to support clinical decision-making around the utilization of CXR and CT to evaluate pediatric COVID-19 pneumonia.
“The step by step algorithm addresses the selection, sequence and timing of imaging studies with multiple images illustrating key findings of COVID-19 pneumonia in the pediatric age group,” said Dr. Cataletto. “By synthesizing the available imaging case series and guidelines, this primer provides a useful tool for the practicing pulmonologist,” she explained.
Key recommendations: CXR
“For pediatric patients with suspected or known COVID-19 infection with moderate to severe clinical symptoms requiring hospitalization (i.e., hypoxia, moderate or severe dyspnea, signs of sepsis, shock, cardiovascular compromise, altered mentation), CXR is usually indicated to establish an imaging baseline and to assess for an alternative diagnosis,” they recommended.
“Sequential CXRs may be helpful to assess pediatric patients with COVID-19 who demonstrate worsening clinical symptoms or to assess response to supportive therapy,” they wrote.
Key recommendations: CT
“Due to the increased radiation sensitivity of pediatric patients, chest CT is not recommended as an initial diagnostic test for pediatric patients with known or suspected COVID-19 pneumonia,” they explained.
The guide also included several considerations around the differential diagnosis of COVID-19 pneumonia from other pediatric lung disorders, including immune-related conditions, infectious etiologies, hematological dyscrasias, and inhalation-related lung injury.
As best practice recommendations for COVID-19 continue to evolve, the availability of practical clinical decision-making tools becomes essential to ensure optimal patient care.
No funding sources or financial disclosures were reported in the manuscript.
SOURCE: Foust AM et al. Pediatr Pulmonol. 2020 May 28. doi: 10.1002/ppul.24870.
A team of pulmonologists has synthesized the clinical and imaging characteristics of COVID-19 in children, and has devised recommendations for ordering imaging studies in suspected cases of the infection.
The review also included useful radiographic findings to help in the differential diagnosis of COVID-19 pneumonia from other respiratory infections. Alexandra M. Foust, DO, of Boston Children’s Hospital, and colleagues reported the summary of findings and recommendations in Pediatric Pulmonology.
“Pediatricians face numerous challenges created by increasing reports of severe COVID-19 related findings in affected children,” said Mary Cataletto, MD, of NYU Langone Health in Mineola, N.Y. “[The current review] represents a multinational collaboration to provide up to date information and key imaging findings to guide chest physicians caring for children with pneumonia symptoms during the COVID-19 pandemic.”
Clinical presentation in children
In general, pediatric patients infected with the virus show milder symptoms compared with adults, and based on the limited evidence reported to date, the most common clinical symptoms of COVID-19 in children are rhinorrhea and/or nasal congestion, fever and cough with sore throat, fatigue or dyspnea, and diarrhea.
As with other viral pneumonias in children, the laboratory parameters are usually nonspecific; however, while the complete blood count (CBC) is often normal, lymphopenia, thrombocytopenia, and neutropenia have been reported in some cases of pediatric COVID-19, the authors noted.
The current Centers for Disease Control and Prevention (CDC) recommendation for initial diagnosis of SARS-CoV-2 is obtaining a nasopharyngeal swab, followed by reverse transcription polymerase chain reaction (RT-PCR) testing, they explained.
Role of imaging in diagnosis
The researchers reported that current recommendations from the American College of Radiology (ACR) do not include chest computed tomography (CT) or chest radiography (CXR) as a upfront test to diagnose pediatric COVID-19, but they may still have a role in clinical monitoring, especially in patients with a moderate to severe disease course.
The potential benefits of utilizing radiologic evaluation, such as establishing a baseline for monitoring disease progression, must be balanced with potential drawbacks, which include radiation exposure, and reduced availability of imaging resources owing to necessary cleaning and air turnover time.
Recommendations for ordering imaging studies
Based on the most recent international guidelines for pediatric COVID-19 patient management, the authors developed an algorithm for performing imaging studies in suspected cases of COVID-19 pneumonia.
The purpose of the tool is to support clinical decision-making around the utilization of CXR and CT to evaluate pediatric COVID-19 pneumonia.
“The step by step algorithm addresses the selection, sequence and timing of imaging studies with multiple images illustrating key findings of COVID-19 pneumonia in the pediatric age group,” said Dr. Cataletto. “By synthesizing the available imaging case series and guidelines, this primer provides a useful tool for the practicing pulmonologist,” she explained.
Key recommendations: CXR
“For pediatric patients with suspected or known COVID-19 infection with moderate to severe clinical symptoms requiring hospitalization (i.e., hypoxia, moderate or severe dyspnea, signs of sepsis, shock, cardiovascular compromise, altered mentation), CXR is usually indicated to establish an imaging baseline and to assess for an alternative diagnosis,” they recommended.
“Sequential CXRs may be helpful to assess pediatric patients with COVID-19 who demonstrate worsening clinical symptoms or to assess response to supportive therapy,” they wrote.
Key recommendations: CT
“Due to the increased radiation sensitivity of pediatric patients, chest CT is not recommended as an initial diagnostic test for pediatric patients with known or suspected COVID-19 pneumonia,” they explained.
The guide also included several considerations around the differential diagnosis of COVID-19 pneumonia from other pediatric lung disorders, including immune-related conditions, infectious etiologies, hematological dyscrasias, and inhalation-related lung injury.
As best practice recommendations for COVID-19 continue to evolve, the availability of practical clinical decision-making tools becomes essential to ensure optimal patient care.
No funding sources or financial disclosures were reported in the manuscript.
SOURCE: Foust AM et al. Pediatr Pulmonol. 2020 May 28. doi: 10.1002/ppul.24870.
FROM PEDIATRIC PULMONOLOGY
ED visits for life-threatening conditions declined early in COVID-19 pandemic
ED visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency on March 13, according to the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23, Samantha J. Lange, MPH, and associates at the CDC reported June 22 in the Morbidity and Mortality Weekly Report.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” they wrote.
The largest decreases in the actual number of visits for MI occurred among both men (down by 2,114, –24%) and women (down by 1,459, –25%) aged 65-74 years. For stroke, men aged 65-74 years had 1,406 (–19%) fewer visits to the ED and women 75-84 years had 1,642 (–23%) fewer visits, the CDC researchers said.
For hypoglycemic crisis, the largest declines during the early pandemic period occurred among younger adults: ED visits for men and women aged 18-44 years were down, respectively, by 419 (–8%) and 775 (–16%), they reported based on data from the National Syndromic Surveillance Program.
“Decreases in ED visits for hyperglycemic crisis might be less striking because patient recognition of this crisis is typically augmented by home glucose monitoring and not reliant upon symptoms alone, as is the case for MI and stroke,” Ms. Lange and her associates noted.
Charting weekly visit numbers showed that the drop for all three conditions actually started the week before the emergency was declared and reached its nadir the week after (March 22) for MI and 2 weeks later (March 29) for stroke and hypoglycemic crisis.
Visits for hypoglycemic crisis have largely returned to normal since those low points, but MI and stroke visits “remain below prepandemic levels” despite gradual increases through April and May, they said.
It has been reported that “deaths not associated with confirmed or probable COVID-19 might have been directly or indirectly attributed to the pandemic. The striking decline in ED visits for acute life-threatening conditions might partially explain observed excess mortality not associated with COVID-19,” the investigators wrote.
ED visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency on March 13, according to the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23, Samantha J. Lange, MPH, and associates at the CDC reported June 22 in the Morbidity and Mortality Weekly Report.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” they wrote.
The largest decreases in the actual number of visits for MI occurred among both men (down by 2,114, –24%) and women (down by 1,459, –25%) aged 65-74 years. For stroke, men aged 65-74 years had 1,406 (–19%) fewer visits to the ED and women 75-84 years had 1,642 (–23%) fewer visits, the CDC researchers said.
For hypoglycemic crisis, the largest declines during the early pandemic period occurred among younger adults: ED visits for men and women aged 18-44 years were down, respectively, by 419 (–8%) and 775 (–16%), they reported based on data from the National Syndromic Surveillance Program.
“Decreases in ED visits for hyperglycemic crisis might be less striking because patient recognition of this crisis is typically augmented by home glucose monitoring and not reliant upon symptoms alone, as is the case for MI and stroke,” Ms. Lange and her associates noted.
Charting weekly visit numbers showed that the drop for all three conditions actually started the week before the emergency was declared and reached its nadir the week after (March 22) for MI and 2 weeks later (March 29) for stroke and hypoglycemic crisis.
Visits for hypoglycemic crisis have largely returned to normal since those low points, but MI and stroke visits “remain below prepandemic levels” despite gradual increases through April and May, they said.
It has been reported that “deaths not associated with confirmed or probable COVID-19 might have been directly or indirectly attributed to the pandemic. The striking decline in ED visits for acute life-threatening conditions might partially explain observed excess mortality not associated with COVID-19,” the investigators wrote.
ED visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency on March 13, according to the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23, Samantha J. Lange, MPH, and associates at the CDC reported June 22 in the Morbidity and Mortality Weekly Report.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” they wrote.
The largest decreases in the actual number of visits for MI occurred among both men (down by 2,114, –24%) and women (down by 1,459, –25%) aged 65-74 years. For stroke, men aged 65-74 years had 1,406 (–19%) fewer visits to the ED and women 75-84 years had 1,642 (–23%) fewer visits, the CDC researchers said.
For hypoglycemic crisis, the largest declines during the early pandemic period occurred among younger adults: ED visits for men and women aged 18-44 years were down, respectively, by 419 (–8%) and 775 (–16%), they reported based on data from the National Syndromic Surveillance Program.
“Decreases in ED visits for hyperglycemic crisis might be less striking because patient recognition of this crisis is typically augmented by home glucose monitoring and not reliant upon symptoms alone, as is the case for MI and stroke,” Ms. Lange and her associates noted.
Charting weekly visit numbers showed that the drop for all three conditions actually started the week before the emergency was declared and reached its nadir the week after (March 22) for MI and 2 weeks later (March 29) for stroke and hypoglycemic crisis.
Visits for hypoglycemic crisis have largely returned to normal since those low points, but MI and stroke visits “remain below prepandemic levels” despite gradual increases through April and May, they said.
It has been reported that “deaths not associated with confirmed or probable COVID-19 might have been directly or indirectly attributed to the pandemic. The striking decline in ED visits for acute life-threatening conditions might partially explain observed excess mortality not associated with COVID-19,” the investigators wrote.
FROM MMWR
Circadian rhythm changes linked to future Parkinson’s disease risk
Yue Leng, MD, University of California, San Francisco, said in an interview.
a new study suggests. “We found that men with abnormal circadian rhythms had three times the risk of developing Parkinson’s disease over an 11-year follow-up period,” lead author,“If confirmed to be a risk factor for Parkinson’s disease, then circadian rhythmicity could be a promising intervention target and will open new opportunities for the prevention and management of Parkinson’s disease,” the researchers concluded.
The study was published online in JAMA Neurology on June 15.
Circadian disruption is very common in neurodegenerative diseases such as Parkinson’s disease, but there isn’t much information on how it may predict the disease, Dr. Leng explained. “We wanted to see whether circadian abnormalities may predict Parkinson’s disease,” she said. “Parkinson’s disease has a long prodromal phase where brain changes have started to occur but no clinical symptoms have become evident. It would be useful to be able to identify these patients, and maybe changes in circadian rhythms may help us to do that,” she added.
For the study, the researchers analyzed data from 2,930 community-dwelling men aged 65 years or older (mean age, 76 years) who participated in the Osteoporotic Fractures in Men Study, in which they underwent comprehensive sleep and rest-activity rhythms assessment. “Patterns of rest and activity were measured with an actigraph device, which is worn on the wrist like a watch and captures movements which are translated into a rest-activity rhythm model – one of the most commonly used and evidence-based measures of circadian rhythm,” Dr. Leng said. Men were asked to wear the actigraphs continuously for a minimum of three 24-hour periods.
Results showed that 78 men (2.7%) developed Parkinson’s disease during the 11-year follow-up. After accounting for all covariates, the risk of Parkinson’s disease increased with decreasing circadian amplitude (strength of the rhythm) with an odds ratio of 1.77 per each decrease by one standard deviation; mesor (mean level of activity) with an odds ratio of 1.64; or robustness (how closely activity follows a 24-hour pattern) with an odds ratio of 1.54.
Those in the lowest quartile of amplitude, mesor, or robustness had approximately three times the risk of developing Parkinson’s disease compared with those in the highest quartile of amplitude. The association remained after further adjustment for nighttime sleep disturbances.
“It has previously been shown that daytime napping has been linked to risk of developing Parkinson’s disease. Now we have shown that abnormalities in the overall 24-hour circadian rest activity rhythm are also present in the prodromal phase of Parkinson’s disease, and this association was independent of several confounders, including nighttime sleep disturbances,” Dr. Leng said.
“This raises awareness of the importance of circadian rhythm in older individuals and changes in their 24-hour pattern of behavior could be an early signal of Parkinson’s disease,” she said.
“This study does not tell us whether these circadian changes are causal for Parkinson’s or not,” Dr. Leng noted.
Future studies are needed to explore underlying mechanisms and to determine whether circadian disruption itself might contribute to the development of Parkinson’s disease, the researchers said.
“If there is a causal link, then using techniques to improve circadian rhythm could help to prevent or slow the onset of Parkinson’s disease,” Dr. Leng suggested. There are many established therapies that act on circadian rhythm including bright light therapy, melatonin, and chronotherapy, she added.
Support for this study was provided by the National Institute on Aging (NIA); the National Institute of Arthritis and Musculoskeletal and Skin Diseases; the National Center for Advancing Translational Sciences; the National Heart, Lung, and Blood Institute; and the Weill Pilot Award. Dr. Leng reported grants from the NIA and the University of California, San Francisco, Weill Institute for Neurosciences during the conduct of the study; and grants from Global Brain Health Institute, the Alzheimer’s Association, and the Alzheimer’s Society outside the submitted work.
A version of this article originally appeared on Medscape.com.
Yue Leng, MD, University of California, San Francisco, said in an interview.
a new study suggests. “We found that men with abnormal circadian rhythms had three times the risk of developing Parkinson’s disease over an 11-year follow-up period,” lead author,“If confirmed to be a risk factor for Parkinson’s disease, then circadian rhythmicity could be a promising intervention target and will open new opportunities for the prevention and management of Parkinson’s disease,” the researchers concluded.
The study was published online in JAMA Neurology on June 15.
Circadian disruption is very common in neurodegenerative diseases such as Parkinson’s disease, but there isn’t much information on how it may predict the disease, Dr. Leng explained. “We wanted to see whether circadian abnormalities may predict Parkinson’s disease,” she said. “Parkinson’s disease has a long prodromal phase where brain changes have started to occur but no clinical symptoms have become evident. It would be useful to be able to identify these patients, and maybe changes in circadian rhythms may help us to do that,” she added.
For the study, the researchers analyzed data from 2,930 community-dwelling men aged 65 years or older (mean age, 76 years) who participated in the Osteoporotic Fractures in Men Study, in which they underwent comprehensive sleep and rest-activity rhythms assessment. “Patterns of rest and activity were measured with an actigraph device, which is worn on the wrist like a watch and captures movements which are translated into a rest-activity rhythm model – one of the most commonly used and evidence-based measures of circadian rhythm,” Dr. Leng said. Men were asked to wear the actigraphs continuously for a minimum of three 24-hour periods.
Results showed that 78 men (2.7%) developed Parkinson’s disease during the 11-year follow-up. After accounting for all covariates, the risk of Parkinson’s disease increased with decreasing circadian amplitude (strength of the rhythm) with an odds ratio of 1.77 per each decrease by one standard deviation; mesor (mean level of activity) with an odds ratio of 1.64; or robustness (how closely activity follows a 24-hour pattern) with an odds ratio of 1.54.
Those in the lowest quartile of amplitude, mesor, or robustness had approximately three times the risk of developing Parkinson’s disease compared with those in the highest quartile of amplitude. The association remained after further adjustment for nighttime sleep disturbances.
“It has previously been shown that daytime napping has been linked to risk of developing Parkinson’s disease. Now we have shown that abnormalities in the overall 24-hour circadian rest activity rhythm are also present in the prodromal phase of Parkinson’s disease, and this association was independent of several confounders, including nighttime sleep disturbances,” Dr. Leng said.
“This raises awareness of the importance of circadian rhythm in older individuals and changes in their 24-hour pattern of behavior could be an early signal of Parkinson’s disease,” she said.
“This study does not tell us whether these circadian changes are causal for Parkinson’s or not,” Dr. Leng noted.
Future studies are needed to explore underlying mechanisms and to determine whether circadian disruption itself might contribute to the development of Parkinson’s disease, the researchers said.
“If there is a causal link, then using techniques to improve circadian rhythm could help to prevent or slow the onset of Parkinson’s disease,” Dr. Leng suggested. There are many established therapies that act on circadian rhythm including bright light therapy, melatonin, and chronotherapy, she added.
Support for this study was provided by the National Institute on Aging (NIA); the National Institute of Arthritis and Musculoskeletal and Skin Diseases; the National Center for Advancing Translational Sciences; the National Heart, Lung, and Blood Institute; and the Weill Pilot Award. Dr. Leng reported grants from the NIA and the University of California, San Francisco, Weill Institute for Neurosciences during the conduct of the study; and grants from Global Brain Health Institute, the Alzheimer’s Association, and the Alzheimer’s Society outside the submitted work.
A version of this article originally appeared on Medscape.com.
Yue Leng, MD, University of California, San Francisco, said in an interview.
a new study suggests. “We found that men with abnormal circadian rhythms had three times the risk of developing Parkinson’s disease over an 11-year follow-up period,” lead author,“If confirmed to be a risk factor for Parkinson’s disease, then circadian rhythmicity could be a promising intervention target and will open new opportunities for the prevention and management of Parkinson’s disease,” the researchers concluded.
The study was published online in JAMA Neurology on June 15.
Circadian disruption is very common in neurodegenerative diseases such as Parkinson’s disease, but there isn’t much information on how it may predict the disease, Dr. Leng explained. “We wanted to see whether circadian abnormalities may predict Parkinson’s disease,” she said. “Parkinson’s disease has a long prodromal phase where brain changes have started to occur but no clinical symptoms have become evident. It would be useful to be able to identify these patients, and maybe changes in circadian rhythms may help us to do that,” she added.
For the study, the researchers analyzed data from 2,930 community-dwelling men aged 65 years or older (mean age, 76 years) who participated in the Osteoporotic Fractures in Men Study, in which they underwent comprehensive sleep and rest-activity rhythms assessment. “Patterns of rest and activity were measured with an actigraph device, which is worn on the wrist like a watch and captures movements which are translated into a rest-activity rhythm model – one of the most commonly used and evidence-based measures of circadian rhythm,” Dr. Leng said. Men were asked to wear the actigraphs continuously for a minimum of three 24-hour periods.
Results showed that 78 men (2.7%) developed Parkinson’s disease during the 11-year follow-up. After accounting for all covariates, the risk of Parkinson’s disease increased with decreasing circadian amplitude (strength of the rhythm) with an odds ratio of 1.77 per each decrease by one standard deviation; mesor (mean level of activity) with an odds ratio of 1.64; or robustness (how closely activity follows a 24-hour pattern) with an odds ratio of 1.54.
Those in the lowest quartile of amplitude, mesor, or robustness had approximately three times the risk of developing Parkinson’s disease compared with those in the highest quartile of amplitude. The association remained after further adjustment for nighttime sleep disturbances.
“It has previously been shown that daytime napping has been linked to risk of developing Parkinson’s disease. Now we have shown that abnormalities in the overall 24-hour circadian rest activity rhythm are also present in the prodromal phase of Parkinson’s disease, and this association was independent of several confounders, including nighttime sleep disturbances,” Dr. Leng said.
“This raises awareness of the importance of circadian rhythm in older individuals and changes in their 24-hour pattern of behavior could be an early signal of Parkinson’s disease,” she said.
“This study does not tell us whether these circadian changes are causal for Parkinson’s or not,” Dr. Leng noted.
Future studies are needed to explore underlying mechanisms and to determine whether circadian disruption itself might contribute to the development of Parkinson’s disease, the researchers said.
“If there is a causal link, then using techniques to improve circadian rhythm could help to prevent or slow the onset of Parkinson’s disease,” Dr. Leng suggested. There are many established therapies that act on circadian rhythm including bright light therapy, melatonin, and chronotherapy, she added.
Support for this study was provided by the National Institute on Aging (NIA); the National Institute of Arthritis and Musculoskeletal and Skin Diseases; the National Center for Advancing Translational Sciences; the National Heart, Lung, and Blood Institute; and the Weill Pilot Award. Dr. Leng reported grants from the NIA and the University of California, San Francisco, Weill Institute for Neurosciences during the conduct of the study; and grants from Global Brain Health Institute, the Alzheimer’s Association, and the Alzheimer’s Society outside the submitted work.
A version of this article originally appeared on Medscape.com.
FROM JAMA NEUROLOGY
Hashtag medicine: #ShareTheMicNowMed highlights Black female physicians on social media
Prominent female physicians are handing over their social media platforms today to black female physicians as part of a campaign called #ShareTheMicNowMed.
The social media event, which will play out on both Twitter and Instagram, is an offshoot of #ShareTheMicNow, held earlier this month. For that event, more than 90 women, including A-list celebrities like Ellen DeGeneres, Julia Roberts, and Senator Elizabeth Warren, swapped accounts with women of color, such as “I’m Still Here” author Austin Channing Brown, Olympic fencer Ibtihaj Muhammad, and #MeToo founder Tarana Burke.
The physician event will feature 10 teams of two, with one physician handing over her account to her black female counterpart for the day. The takeover will allow the black physician to share her thoughts about the successes and challenges she faces as a woman of color in medicine.
“It was such an honor to be contacted by Arghavan Salles, MD, PhD, to participate in an event that has a goal of connecting like-minded women from various backgrounds to share a diverse perspective with a different audience,” Minnesota family medicine physician Jay-Sheree Allen, MD, told Medscape Medical News. “This event is not only incredibly important but timely.”
Only about 5% of all active physicians in 2018 identified as Black or African American, according to a report by the Association of American Medical Colleges. And of those, just over a third are female, the report found.
“I think that as we hear those small numbers we often celebrate the success of those people without looking back and understanding where all of the barriers are that are limiting talented black women from entering medicine at every stage,” another campaign participant, Chicago pediatrician Rebekah Fenton, MD, told Medscape Medical News.
Allen says that, amid continuing worldwide protests over racial injustice, prompted by the death of George Floyd while in Minneapolis police custody last month, the online event is very timely and an important way to advocate for black lives and engage in a productive conversation.
“I believe that with the #ShareTheMicNowMed movement we will start to show people how they can become allies. I always say that a candle loses nothing by lighting another candle, and sharing that stage is one of the many ways you can support the Black Lives Matters movement by amplifying black voices,” she said.
Allen went on to add that women in medicine have many of the same experiences as any other doctor but do face some unique challenges. This is especially true for female physicians of color, she noted.
To join the conversation follow the hashtag #ShareTheMicNowMed all day on Monday, June 22, 2020.
This article originally appeared on Medscape.com.
Prominent female physicians are handing over their social media platforms today to black female physicians as part of a campaign called #ShareTheMicNowMed.
The social media event, which will play out on both Twitter and Instagram, is an offshoot of #ShareTheMicNow, held earlier this month. For that event, more than 90 women, including A-list celebrities like Ellen DeGeneres, Julia Roberts, and Senator Elizabeth Warren, swapped accounts with women of color, such as “I’m Still Here” author Austin Channing Brown, Olympic fencer Ibtihaj Muhammad, and #MeToo founder Tarana Burke.
The physician event will feature 10 teams of two, with one physician handing over her account to her black female counterpart for the day. The takeover will allow the black physician to share her thoughts about the successes and challenges she faces as a woman of color in medicine.
“It was such an honor to be contacted by Arghavan Salles, MD, PhD, to participate in an event that has a goal of connecting like-minded women from various backgrounds to share a diverse perspective with a different audience,” Minnesota family medicine physician Jay-Sheree Allen, MD, told Medscape Medical News. “This event is not only incredibly important but timely.”
Only about 5% of all active physicians in 2018 identified as Black or African American, according to a report by the Association of American Medical Colleges. And of those, just over a third are female, the report found.
“I think that as we hear those small numbers we often celebrate the success of those people without looking back and understanding where all of the barriers are that are limiting talented black women from entering medicine at every stage,” another campaign participant, Chicago pediatrician Rebekah Fenton, MD, told Medscape Medical News.
Allen says that, amid continuing worldwide protests over racial injustice, prompted by the death of George Floyd while in Minneapolis police custody last month, the online event is very timely and an important way to advocate for black lives and engage in a productive conversation.
“I believe that with the #ShareTheMicNowMed movement we will start to show people how they can become allies. I always say that a candle loses nothing by lighting another candle, and sharing that stage is one of the many ways you can support the Black Lives Matters movement by amplifying black voices,” she said.
Allen went on to add that women in medicine have many of the same experiences as any other doctor but do face some unique challenges. This is especially true for female physicians of color, she noted.
To join the conversation follow the hashtag #ShareTheMicNowMed all day on Monday, June 22, 2020.
This article originally appeared on Medscape.com.
Prominent female physicians are handing over their social media platforms today to black female physicians as part of a campaign called #ShareTheMicNowMed.
The social media event, which will play out on both Twitter and Instagram, is an offshoot of #ShareTheMicNow, held earlier this month. For that event, more than 90 women, including A-list celebrities like Ellen DeGeneres, Julia Roberts, and Senator Elizabeth Warren, swapped accounts with women of color, such as “I’m Still Here” author Austin Channing Brown, Olympic fencer Ibtihaj Muhammad, and #MeToo founder Tarana Burke.
The physician event will feature 10 teams of two, with one physician handing over her account to her black female counterpart for the day. The takeover will allow the black physician to share her thoughts about the successes and challenges she faces as a woman of color in medicine.
“It was such an honor to be contacted by Arghavan Salles, MD, PhD, to participate in an event that has a goal of connecting like-minded women from various backgrounds to share a diverse perspective with a different audience,” Minnesota family medicine physician Jay-Sheree Allen, MD, told Medscape Medical News. “This event is not only incredibly important but timely.”
Only about 5% of all active physicians in 2018 identified as Black or African American, according to a report by the Association of American Medical Colleges. And of those, just over a third are female, the report found.
“I think that as we hear those small numbers we often celebrate the success of those people without looking back and understanding where all of the barriers are that are limiting talented black women from entering medicine at every stage,” another campaign participant, Chicago pediatrician Rebekah Fenton, MD, told Medscape Medical News.
Allen says that, amid continuing worldwide protests over racial injustice, prompted by the death of George Floyd while in Minneapolis police custody last month, the online event is very timely and an important way to advocate for black lives and engage in a productive conversation.
“I believe that with the #ShareTheMicNowMed movement we will start to show people how they can become allies. I always say that a candle loses nothing by lighting another candle, and sharing that stage is one of the many ways you can support the Black Lives Matters movement by amplifying black voices,” she said.
Allen went on to add that women in medicine have many of the same experiences as any other doctor but do face some unique challenges. This is especially true for female physicians of color, she noted.
To join the conversation follow the hashtag #ShareTheMicNowMed all day on Monday, June 22, 2020.
This article originally appeared on Medscape.com.