Expanding suicide risk screening in primary care to identify patients at highest risk may help boost prevention efforts and make better use of health care resources, according to a new study.

Craig J. Bryan, PsyD, ABPP, with the department of psychiatry and behavioral health at Ohio State University Wexner Medical Center, Columbus, led the study, published online on Nov. 8, 2021, in Annals of Family Medicine.

The authors cited the urgency highlighted by statistics showing that, from 1999 to 2017, the U.S. suicide rate increased by more than 33% and was particularly high among military personnel and veterans.

Primary care offices are seen as a prime target for prevention efforts as nearly one-half of people who die by suicide in the United States visit a primary care office in the months before their deaths.

A common approach to screening for suicide risk has been to use the Patient Health Questionnaire–9 (PHQ-9). The first two questions assess the frequency of depressed mood and anhedonia in the past 2 weeks. If patients screen positive on those two questions, they are given the remaining seven questions.

A single item – question 9 – asks about how often a patient has “thoughts that you would be better off dead, or of hurting yourself in some way” during the past 2 weeks.

Yet, more that 95% of patients who screen positive on the PHQ-9 suicide risk question do not attempt or die by suicide, the authors noted.
 

Two methods tested for improving screening

Dr. Bryan and colleagues wanted to assess whether suicide risk screening could be improved in primary care and evaluated two methods.

One was to see whether using any of the other PHQ-9 items could be better than just using item 9 alone to identify the patients who were most likely to attempt suicide in the near future. Researchers found that method was not significantly beneficial. The second was to evaluate the performance of the 16 items on the Suicide Cognitions Scale (SCS), a questionnaire that asks patients to rate the extent to which they agree or disagree with statements that are commonly endorsed by suicidal people.

Patients who were eligible for medical treatment from the Department of Defense medical system were recruited from six large and small military primary care clinics across the United States from July 2015 to August 2018.

Patients answered questions on the PHQ-9 and 16 items from the SCS during routine primary care visits. Evaluators, who were blind to screening results, assessed postbaseline suicide attempts, interrupted attempts and aborted attempts by interviewing patients.

The study included 2,744 primary care patients, ranging from 18 to 89 years of age, with an average age of 40.
 

Adding at least one question may help

Researchers found that the accuracy of suicide risk screening using the PHQ-9 can be significantly improved by adding one or more questions from the SCS. Three items from SCS contributed most to meaningful improvements in identifying patients who went on to exhibit suicidal behaviors within 30-90 days of screening.

One question was item 16: “I don’t deserve to live another moment.”

Two SCS items improved specificity and positive predictive value without reducing sensitivity, the authors wrote. They are: “It is unbearable when I get this upset” (item 8) and “I can’t imagine anyone being able to withstand this kind of pain” (item 13).

“For example,” the authors wrote, “only 4.1% of patients who screened positive on the PHQ-9 suicide risk item 9 engaged in suicidal behavior within the next 30 days, but when the PHQ-9 suicide risk item 9 was combined with SCS item 13 (the best-performing SCS item), this percentage nearly doubled, to 7.6% of patients.”

Adding one of these SCS items to the PHQ-9 “could provide a simple, accessible, and low-cost method for more accurately identifying primary care patients who require more immediate clinical intervention,” the authors wrote.
 

Outside expert perspective

Meredith Williamson, PhD, a mental health diagnosis and psychotherapy expert and clinical assistant professor at Texas A&M University, Bryan, said that, though the SCS questions are valuable, neither they nor the PHQ-9 question get to the direct question of whether the person is likely to act on their thoughts and attempt or complete suicide.

“Someone with depression may have thought of wishing they were dead or wishing they weren’t here but that doesn’t always mean they necessarily want to kill themselves,” she said in an interview. “It’s our responsibility as providers to really clarify the meaning of that item.”

Dr. Williamson noted the PHQ-9 is a very accessible method to screen for depression in primary care settings and is a way to catch large numbers of people screening positive, but its shortcomings are well known and additional information is needed.

She said that, in her practice, if a patient screens positive on PHQ-9, clinicians ask more about their intentions, how frequently they occur and whether patients have developed a plan for killing themselves.

The challenge is that “we have yet to predict who is and who is not going to kill themselves.”

Dr. Williamson said she finds the Columbia-Suicide Severity Rating Scale a valuable tool used in research settings that looks at prior attempts and current desire to engage in an attempt in more detail.

“It doesn’t stop people from killing themselves, but helps to better understand their suicidal behavior,” she explained.

This project was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Defense Medical Research and Development Program. Dr. Williamson has no relevant financial disclosures. Dr. Bryan is a paid consultant to Oui Therapeutics and Neurostat Analytical Solutions. He is a principal of Anduril, which conducts training workshops and provides mental health consultation focused on suicide prevention and PTSD.

Expanding suicide risk screening in primary care to identify patients at highest risk may help boost prevention efforts and make better use of health care resources, according to a new study.

Craig J. Bryan, PsyD, ABPP, with the department of psychiatry and behavioral health at Ohio State University Wexner Medical Center, Columbus, led the study, published online on Nov. 8, 2021, in Annals of Family Medicine.

The authors cited the urgency highlighted by statistics showing that, from 1999 to 2017, the U.S. suicide rate increased by more than 33% and was particularly high among military personnel and veterans.

Primary care offices are seen as a prime target for prevention efforts as nearly one-half of people who die by suicide in the United States visit a primary care office in the months before their deaths.

A common approach to screening for suicide risk has been to use the Patient Health Questionnaire–9 (PHQ-9). The first two questions assess the frequency of depressed mood and anhedonia in the past 2 weeks. If patients screen positive on those two questions, they are given the remaining seven questions.

A single item – question 9 – asks about how often a patient has “thoughts that you would be better off dead, or of hurting yourself in some way” during the past 2 weeks.

Yet, more that 95% of patients who screen positive on the PHQ-9 suicide risk question do not attempt or die by suicide, the authors noted.
 

Two methods tested for improving screening

Dr. Bryan and colleagues wanted to assess whether suicide risk screening could be improved in primary care and evaluated two methods.

One was to see whether using any of the other PHQ-9 items could be better than just using item 9 alone to identify the patients who were most likely to attempt suicide in the near future. Researchers found that method was not significantly beneficial. The second was to evaluate the performance of the 16 items on the Suicide Cognitions Scale (SCS), a questionnaire that asks patients to rate the extent to which they agree or disagree with statements that are commonly endorsed by suicidal people.

Patients who were eligible for medical treatment from the Department of Defense medical system were recruited from six large and small military primary care clinics across the United States from July 2015 to August 2018.

Patients answered questions on the PHQ-9 and 16 items from the SCS during routine primary care visits. Evaluators, who were blind to screening results, assessed postbaseline suicide attempts, interrupted attempts and aborted attempts by interviewing patients.

The study included 2,744 primary care patients, ranging from 18 to 89 years of age, with an average age of 40.
 

Adding at least one question may help

Researchers found that the accuracy of suicide risk screening using the PHQ-9 can be significantly improved by adding one or more questions from the SCS. Three items from SCS contributed most to meaningful improvements in identifying patients who went on to exhibit suicidal behaviors within 30-90 days of screening.

One question was item 16: “I don’t deserve to live another moment.”

Two SCS items improved specificity and positive predictive value without reducing sensitivity, the authors wrote. They are: “It is unbearable when I get this upset” (item 8) and “I can’t imagine anyone being able to withstand this kind of pain” (item 13).

“For example,” the authors wrote, “only 4.1% of patients who screened positive on the PHQ-9 suicide risk item 9 engaged in suicidal behavior within the next 30 days, but when the PHQ-9 suicide risk item 9 was combined with SCS item 13 (the best-performing SCS item), this percentage nearly doubled, to 7.6% of patients.”

Adding one of these SCS items to the PHQ-9 “could provide a simple, accessible, and low-cost method for more accurately identifying primary care patients who require more immediate clinical intervention,” the authors wrote.
 

Outside expert perspective

Meredith Williamson, PhD, a mental health diagnosis and psychotherapy expert and clinical assistant professor at Texas A&M University, Bryan, said that, though the SCS questions are valuable, neither they nor the PHQ-9 question get to the direct question of whether the person is likely to act on their thoughts and attempt or complete suicide.

“Someone with depression may have thought of wishing they were dead or wishing they weren’t here but that doesn’t always mean they necessarily want to kill themselves,” she said in an interview. “It’s our responsibility as providers to really clarify the meaning of that item.”

Dr. Williamson noted the PHQ-9 is a very accessible method to screen for depression in primary care settings and is a way to catch large numbers of people screening positive, but its shortcomings are well known and additional information is needed.

She said that, in her practice, if a patient screens positive on PHQ-9, clinicians ask more about their intentions, how frequently they occur and whether patients have developed a plan for killing themselves.

The challenge is that “we have yet to predict who is and who is not going to kill themselves.”

Dr. Williamson said she finds the Columbia-Suicide Severity Rating Scale a valuable tool used in research settings that looks at prior attempts and current desire to engage in an attempt in more detail.

“It doesn’t stop people from killing themselves, but helps to better understand their suicidal behavior,” she explained.

This project was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Defense Medical Research and Development Program. Dr. Williamson has no relevant financial disclosures. Dr. Bryan is a paid consultant to Oui Therapeutics and Neurostat Analytical Solutions. He is a principal of Anduril, which conducts training workshops and provides mental health consultation focused on suicide prevention and PTSD.

Expanding suicide risk screening in primary care to identify patients at highest risk may help boost prevention efforts and make better use of health care resources, according to a new study.

Craig J. Bryan, PsyD, ABPP, with the department of psychiatry and behavioral health at Ohio State University Wexner Medical Center, Columbus, led the study, published online on Nov. 8, 2021, in Annals of Family Medicine.

The authors cited the urgency highlighted by statistics showing that, from 1999 to 2017, the U.S. suicide rate increased by more than 33% and was particularly high among military personnel and veterans.

Primary care offices are seen as a prime target for prevention efforts as nearly one-half of people who die by suicide in the United States visit a primary care office in the months before their deaths.

A common approach to screening for suicide risk has been to use the Patient Health Questionnaire–9 (PHQ-9). The first two questions assess the frequency of depressed mood and anhedonia in the past 2 weeks. If patients screen positive on those two questions, they are given the remaining seven questions.

A single item – question 9 – asks about how often a patient has “thoughts that you would be better off dead, or of hurting yourself in some way” during the past 2 weeks.

Yet, more that 95% of patients who screen positive on the PHQ-9 suicide risk question do not attempt or die by suicide, the authors noted.
 

Two methods tested for improving screening

Dr. Bryan and colleagues wanted to assess whether suicide risk screening could be improved in primary care and evaluated two methods.

One was to see whether using any of the other PHQ-9 items could be better than just using item 9 alone to identify the patients who were most likely to attempt suicide in the near future. Researchers found that method was not significantly beneficial. The second was to evaluate the performance of the 16 items on the Suicide Cognitions Scale (SCS), a questionnaire that asks patients to rate the extent to which they agree or disagree with statements that are commonly endorsed by suicidal people.

Patients who were eligible for medical treatment from the Department of Defense medical system were recruited from six large and small military primary care clinics across the United States from July 2015 to August 2018.

Patients answered questions on the PHQ-9 and 16 items from the SCS during routine primary care visits. Evaluators, who were blind to screening results, assessed postbaseline suicide attempts, interrupted attempts and aborted attempts by interviewing patients.

The study included 2,744 primary care patients, ranging from 18 to 89 years of age, with an average age of 40.
 

Adding at least one question may help

Researchers found that the accuracy of suicide risk screening using the PHQ-9 can be significantly improved by adding one or more questions from the SCS. Three items from SCS contributed most to meaningful improvements in identifying patients who went on to exhibit suicidal behaviors within 30-90 days of screening.

One question was item 16: “I don’t deserve to live another moment.”

Two SCS items improved specificity and positive predictive value without reducing sensitivity, the authors wrote. They are: “It is unbearable when I get this upset” (item 8) and “I can’t imagine anyone being able to withstand this kind of pain” (item 13).

“For example,” the authors wrote, “only 4.1% of patients who screened positive on the PHQ-9 suicide risk item 9 engaged in suicidal behavior within the next 30 days, but when the PHQ-9 suicide risk item 9 was combined with SCS item 13 (the best-performing SCS item), this percentage nearly doubled, to 7.6% of patients.”

Adding one of these SCS items to the PHQ-9 “could provide a simple, accessible, and low-cost method for more accurately identifying primary care patients who require more immediate clinical intervention,” the authors wrote.
 

Outside expert perspective

Meredith Williamson, PhD, a mental health diagnosis and psychotherapy expert and clinical assistant professor at Texas A&M University, Bryan, said that, though the SCS questions are valuable, neither they nor the PHQ-9 question get to the direct question of whether the person is likely to act on their thoughts and attempt or complete suicide.

“Someone with depression may have thought of wishing they were dead or wishing they weren’t here but that doesn’t always mean they necessarily want to kill themselves,” she said in an interview. “It’s our responsibility as providers to really clarify the meaning of that item.”

Dr. Williamson noted the PHQ-9 is a very accessible method to screen for depression in primary care settings and is a way to catch large numbers of people screening positive, but its shortcomings are well known and additional information is needed.

She said that, in her practice, if a patient screens positive on PHQ-9, clinicians ask more about their intentions, how frequently they occur and whether patients have developed a plan for killing themselves.

The challenge is that “we have yet to predict who is and who is not going to kill themselves.”

Dr. Williamson said she finds the Columbia-Suicide Severity Rating Scale a valuable tool used in research settings that looks at prior attempts and current desire to engage in an attempt in more detail.

“It doesn’t stop people from killing themselves, but helps to better understand their suicidal behavior,” she explained.

This project was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Defense Medical Research and Development Program. Dr. Williamson has no relevant financial disclosures. Dr. Bryan is a paid consultant to Oui Therapeutics and Neurostat Analytical Solutions. He is a principal of Anduril, which conducts training workshops and provides mental health consultation focused on suicide prevention and PTSD.

Editor’s note: Hospitalists told us about process changes that their teams have implemented during the COVID-19 pandemic.

Shyam Odeti, MD, SFHM

Ballad Health (Bristol, Tenn.)(Dr. Odeti was a hospitalist at Ballad Health during the period he describes below. He is currently chief of hospital medicine at Carilion Clinic, Roanoke, Va.)

Ballad Health is a 21-hospital health system serving 1.2 million population in 21 counties of rural Appalachia (northeast Tennessee, southwest Virginia, western North Carolina, and Kentucky). We saw a significant spike in COVID-19 numbers beginning in October 2020. We were at a 7.9% test positivity rate and 89 COVID-19 hospitalizations on Oct. 1, which rapidly increased to over 18% positivity rate and over 250 hospitalizations by mid-November. This alarming trend created concerns about handling the future inpatient volumes in an already strained health system.

There were some unique challenges to this region that were contributing to the increased hospitalizations. A significant part of the population we serve in this region has low health literacy, low socioeconomic status, and problems with transportation. Telehealth in an outpatient setting was rudimentary in parts of this region.

Ballad Health developed Safe At Home to identify lower-acuity COVID-19 patients and transition them to the home setting safely. This in turn would prevent their readmissions or return visits to the ED by implementing comprehensive oversight to their disease course. We achieved this through a collaborative approach of the existing teams, case management, telenurse team, primary care providers, and hospitalist-led transitional care. We leveraged the newly implemented EHR Epic and telehealth under the leadership of Ballad Health’s chief medical information officer, Dr. Mark Wilkinson.

Among the patients diagnosed with COVID-19 in ED and urgent care, low acuity cases were identified and enrolled into Safe At Home. Patients were provided with a pulse oximeter, thermometer, and incentive spirometer. They received phone calls the next 2 days from the telenurse team for a comprehensive interview, followed by daily phone calls during the first week. If no concerns were raised initially, then calls were spaced to every 3 days after that for up to 2 weeks. Any complaints or alarming symptoms would trigger a telehealth visit with primary care physicians, transitional care clinics, or a hospitalist.

The Safe At Home program was highly successful – in the past 5 months, over 1,500 patients were enrolled and hundreds of admissions were likely avoided. As we feared, the positivity rate in our region went close to 35% and inpatient COVID-19 census was over 350, with ICU utilization over 92%. If not for our innovative solution, this pandemic could have easily paralyzed health care in our region. Our patients also felt safe, as they were monitored daily and had help one call away, 24/7.

This innovation has brought solutions through technological advancements and process improvement. Safe At Home was also instrumental in breaking down silos and developing a culture of collaboration and cohesiveness among the inpatient, outpatient, and virtual teams of the health system. Lessons learned from this initiative can be easily replicated in the management of several chronic diseases to provide safe and affordable care to our patients in the comfort of their homes.
 

Vasundara Singh, MBBS

Mount Sinai West (New York)

At the onset of the pandemic in New York, our medium-sized midtown hospital used personal protective equipment briskly. One reason identified was the failure to cohort COVID-19 patients on a single floor. The other more important cause was that medicine teams in our hospital have patients scattered throughout the hospital in a nongeographic model across four different floors. Within 2 weeks, administration and hospital medicine leadership developed a geographic model. We started cohorting all COVID-19 positive patients on separate floors from negative patients. A geographic physician team model was also developed, which allowed physicians and nurses to don and doff at the entry and exit of each COVID-19 unit.

After the pandemic surge, hospital medicine and internal medicine residency program leadership made the collective decision to continue the geographic model for inpatient care. Care providers enjoyed working in a unit-based model, and noted increases in efficiency while rounding. Each of our four medicine floors has 36-40 beds, with variable occupancy. We restructured our resident teams and physician assistant teams by geography. Our outgoing chief residents led the change in May, designing a resident schedule to accommodate for a resident on each team to be available to admit and provide coverage until 8 p.m. each evening on their respective floors. The hospital medicine leadership put together a committee comprising representation of all stakeholders in this large transition of systems: attending hospitalists, physician assistants, chief residents, nurse managers, bed assignment, and administration. Since the transition and resumption of normal inpatient activity, we have encountered and addressed multiple concerns. Some notable hurdles in this transition included the high throughput on our telemetry team, movement of patients by bed board or nursing without involving the physicians in the decision, and variable nursing staffing that impacts teaching team caps because of geographic model.

This transition is very much still a work in progress, yet some benefits are already obvious. It has made bedside rounding more appealing and uncomplicated. Physicians in training learn very well at the bedside by role modeling. Greater acceptance of bedside rounding also affords the opportunity to teach physical exam skills, a dying art amongst newer generations of doctors. Another large gain is being able to involve nursing in bedside rounds, discussions, and decision-making. Finally, coordination with ancillary staff including social work and case management has become seamless as a result of having an entire floor to ourselves.

In summary, the silver lining of this pernicious pandemic at our hospital has been a transition to a geographic model for inpatient care. This is considered to be the gold standard for inpatient care across multiple health systems, and we hope to continue to refine this geographic model of care. Next steps would involve developing capabilities with flex acuity beds on each unit so that no matter what the patients need they can stay in one place.
 

Marina Farah, MD, MHA

Sound Physicians (Tacoma, Wash.)

With hospital programs in over 40 states, Sound Physicians has played an important role in the COVID-19 pandemic, treating approximately 6% of all COVID hospitalizations nationwide. To meet the needs of the crisis, Sound relied on innovation to expand coverage and improve outcomes at facilities across the country. Of one particular note, Sound Telemedicine partnered with the University of Maryland Medical System to open the state’s first COVID-only hospital. In March 2020, the UMMS needed to care for an emerging cohort of COVID-19 patients while maintaining high-quality care and minimizing exposure for non-COVID patients.

Sound collaborated with UMMS to rapidly reopen the University of Maryland Laurel Medical Center for COVID-only care, staffing the hospital with Sound’s telehospitalists. A model based on daily rounding delivered 100% by telemedicine providers and flexible staffing available 24/7 would let the program scale up or down to meet volume demands. Onsite physician support would be limited to one admitting doctor and a nocturnist. The COVID-only facility allowed a small group of doctors, nurses, and technicians to focus exclusively on an emerging disease, honing critical skills for treating COVID-19 patients.

Immediate benefits yielded big results. UMLMC’s capacity allowed UMMS to funnel COVID patients into fewer of their regional hospitals, limiting the risk of exposure. Rapid deployment got UMMS ahead of the surge, taking stress off other hospitals in the system and 24/7 telehospitalist coverage proved to be a successful long-term staffing strategy for UMLMC. Long-term benefits were recognized too. Sound’s staffing model and clinical processes significantly improved quality of care. Mortality rates dropped from 18% to 9% during the initial 60 days of the program. Vaccinations shifted COVID-19 needs, however, due to improvements in care and the flexibility offered, telemedicine remains an integral part of the UMMS’s long-term strategy
 

Emory Healthcare division of hospital medicine (Atlanta)

(Comments compiled by James Kim, MD, assistant professor in the division of hospital medicine) Ingrid Pinzon, MD, FACP Emory Johns Creek (Ga.) Hospital

When COVID-19 started, one of the things called to my attention was the disparity in education for the Hispanic population. Unfortunately, COVID showed how in our hospitals there is a lack of instructions and education in Spanish.

We started educating our Hispanic community with Facebook lives via the Latin American Association. I was also invited to the different Spanish news stations (Telemundo and Univision). I also educated this community through food drives, where I taught about the use of face masks, social distancing, and hand hygiene.

Reena Hemrajani, MD

Grady Memorial Hospital

At Grady, we transitioned our weekly educational conferences into virtual events, and this has increased our attendance, as more off-service people are likely to attend when they can log on remotely. This has also allowed us to record these sessions for later viewing by those were unable to make it in real time.

Yelena Burklin, MD, FHM

Emory University Hospital Midtown

In our Midtown group, we have started a few initiatives that we will continue post COVID. Hybrid didactic lectures have had great success with excellent attendance when our didactic sessions (lunch and learns, journal clubs, core lectures for step-down unit refresher series) have been conducted virtually.

During the pandemic’s height, when all resources were dedicated to COVID-19 patient care, there was a particular need to cognitively separate from “all things COVID” and provide additional topics to learn about, such as review of the management of different types of shock, chronic obstructive pulmonary disorder, sepsis, liver cirrhosis, etc. Attendance to these non–COVID-19 sessions was just as high.

We had a number of stressful and near-death experiences that tested our resilience, professional integrity, and overall wellness. These reflections prompted us to invite psychiatrists to one of the in-person–only sessions so that an informal conversation could be afforded in a safe space. Those hospitalists who felt the need to discuss their issues further received additional support and instructions from a subspecialist.

Ray Dantes, MD

Emory University Hospital Midtown

Post COVID, we will certainly utilize a hybrid approach to the didactic sessions when patient sensitive information is not being discussed. We will also preserve the continuity in addressing wellness and resilience, particularly, when our Midtown hospitalists had to work a lot of extra hours to cover the growing need at the time of pandemic, and need to emotionally decompress post pandemic. We are also taking infection control more seriously, and not coming to work with upper respiratory infections.

Rajasree Roy, MD

Emory Saint Joseph’s Hospital

At ESJH, we initiated a telemedicine pilot for our hospitalist team in order to sustain our service given census surge and physician illness.

Sara Millwee, DNP, APRN, FNP-BC

Emory chief of advanced practice providers

To help reduce exposure to COVID, our advanced practice providers (APPs) admitted patients from the ED (as they did pre-COVID) to the hospital medicine service, but the physicians administratively signed the note/orders. Emory Healthcare bylaws specify that patients are seen by a physician within 24 hours of admission. During the pandemic, at the time of admission, the APP discussed plan of care with the physician, but the patient was only seen by the APP upon initial evaluation/admission, as opposed to the physician and APP pre-COVID. This improved productivity, and facilitated communication and collaboration between APPs and physicians. This also fostered an environment where APPs were practicing at the top of their licenses and improved job satisfaction.

Additionally, across the hospital medicine division, several APPs were utilized from other divisions to assist with admissions and cross cover. As the volume was at incredibly high levels, this improved the workload and burden of the hospital medicine providers. The displaced APPs were utilized at several facilities and worked under the guidance and supervision of hospital medicine providers. Moving forward, this has prompted leadership to look at utilizing APPs from other divisions as “PRN” providers as well.

Editor’s note: Hospitalists told us about process changes that their teams have implemented during the COVID-19 pandemic.

Shyam Odeti, MD, SFHM

Ballad Health (Bristol, Tenn.)(Dr. Odeti was a hospitalist at Ballad Health during the period he describes below. He is currently chief of hospital medicine at Carilion Clinic, Roanoke, Va.)

Ballad Health is a 21-hospital health system serving 1.2 million population in 21 counties of rural Appalachia (northeast Tennessee, southwest Virginia, western North Carolina, and Kentucky). We saw a significant spike in COVID-19 numbers beginning in October 2020. We were at a 7.9% test positivity rate and 89 COVID-19 hospitalizations on Oct. 1, which rapidly increased to over 18% positivity rate and over 250 hospitalizations by mid-November. This alarming trend created concerns about handling the future inpatient volumes in an already strained health system.

There were some unique challenges to this region that were contributing to the increased hospitalizations. A significant part of the population we serve in this region has low health literacy, low socioeconomic status, and problems with transportation. Telehealth in an outpatient setting was rudimentary in parts of this region.

Ballad Health developed Safe At Home to identify lower-acuity COVID-19 patients and transition them to the home setting safely. This in turn would prevent their readmissions or return visits to the ED by implementing comprehensive oversight to their disease course. We achieved this through a collaborative approach of the existing teams, case management, telenurse team, primary care providers, and hospitalist-led transitional care. We leveraged the newly implemented EHR Epic and telehealth under the leadership of Ballad Health’s chief medical information officer, Dr. Mark Wilkinson.

Among the patients diagnosed with COVID-19 in ED and urgent care, low acuity cases were identified and enrolled into Safe At Home. Patients were provided with a pulse oximeter, thermometer, and incentive spirometer. They received phone calls the next 2 days from the telenurse team for a comprehensive interview, followed by daily phone calls during the first week. If no concerns were raised initially, then calls were spaced to every 3 days after that for up to 2 weeks. Any complaints or alarming symptoms would trigger a telehealth visit with primary care physicians, transitional care clinics, or a hospitalist.

The Safe At Home program was highly successful – in the past 5 months, over 1,500 patients were enrolled and hundreds of admissions were likely avoided. As we feared, the positivity rate in our region went close to 35% and inpatient COVID-19 census was over 350, with ICU utilization over 92%. If not for our innovative solution, this pandemic could have easily paralyzed health care in our region. Our patients also felt safe, as they were monitored daily and had help one call away, 24/7.

This innovation has brought solutions through technological advancements and process improvement. Safe At Home was also instrumental in breaking down silos and developing a culture of collaboration and cohesiveness among the inpatient, outpatient, and virtual teams of the health system. Lessons learned from this initiative can be easily replicated in the management of several chronic diseases to provide safe and affordable care to our patients in the comfort of their homes.
 

Vasundara Singh, MBBS

Mount Sinai West (New York)

At the onset of the pandemic in New York, our medium-sized midtown hospital used personal protective equipment briskly. One reason identified was the failure to cohort COVID-19 patients on a single floor. The other more important cause was that medicine teams in our hospital have patients scattered throughout the hospital in a nongeographic model across four different floors. Within 2 weeks, administration and hospital medicine leadership developed a geographic model. We started cohorting all COVID-19 positive patients on separate floors from negative patients. A geographic physician team model was also developed, which allowed physicians and nurses to don and doff at the entry and exit of each COVID-19 unit.

After the pandemic surge, hospital medicine and internal medicine residency program leadership made the collective decision to continue the geographic model for inpatient care. Care providers enjoyed working in a unit-based model, and noted increases in efficiency while rounding. Each of our four medicine floors has 36-40 beds, with variable occupancy. We restructured our resident teams and physician assistant teams by geography. Our outgoing chief residents led the change in May, designing a resident schedule to accommodate for a resident on each team to be available to admit and provide coverage until 8 p.m. each evening on their respective floors. The hospital medicine leadership put together a committee comprising representation of all stakeholders in this large transition of systems: attending hospitalists, physician assistants, chief residents, nurse managers, bed assignment, and administration. Since the transition and resumption of normal inpatient activity, we have encountered and addressed multiple concerns. Some notable hurdles in this transition included the high throughput on our telemetry team, movement of patients by bed board or nursing without involving the physicians in the decision, and variable nursing staffing that impacts teaching team caps because of geographic model.

This transition is very much still a work in progress, yet some benefits are already obvious. It has made bedside rounding more appealing and uncomplicated. Physicians in training learn very well at the bedside by role modeling. Greater acceptance of bedside rounding also affords the opportunity to teach physical exam skills, a dying art amongst newer generations of doctors. Another large gain is being able to involve nursing in bedside rounds, discussions, and decision-making. Finally, coordination with ancillary staff including social work and case management has become seamless as a result of having an entire floor to ourselves.

In summary, the silver lining of this pernicious pandemic at our hospital has been a transition to a geographic model for inpatient care. This is considered to be the gold standard for inpatient care across multiple health systems, and we hope to continue to refine this geographic model of care. Next steps would involve developing capabilities with flex acuity beds on each unit so that no matter what the patients need they can stay in one place.
 

Marina Farah, MD, MHA

Sound Physicians (Tacoma, Wash.)

With hospital programs in over 40 states, Sound Physicians has played an important role in the COVID-19 pandemic, treating approximately 6% of all COVID hospitalizations nationwide. To meet the needs of the crisis, Sound relied on innovation to expand coverage and improve outcomes at facilities across the country. Of one particular note, Sound Telemedicine partnered with the University of Maryland Medical System to open the state’s first COVID-only hospital. In March 2020, the UMMS needed to care for an emerging cohort of COVID-19 patients while maintaining high-quality care and minimizing exposure for non-COVID patients.

Sound collaborated with UMMS to rapidly reopen the University of Maryland Laurel Medical Center for COVID-only care, staffing the hospital with Sound’s telehospitalists. A model based on daily rounding delivered 100% by telemedicine providers and flexible staffing available 24/7 would let the program scale up or down to meet volume demands. Onsite physician support would be limited to one admitting doctor and a nocturnist. The COVID-only facility allowed a small group of doctors, nurses, and technicians to focus exclusively on an emerging disease, honing critical skills for treating COVID-19 patients.

Immediate benefits yielded big results. UMLMC’s capacity allowed UMMS to funnel COVID patients into fewer of their regional hospitals, limiting the risk of exposure. Rapid deployment got UMMS ahead of the surge, taking stress off other hospitals in the system and 24/7 telehospitalist coverage proved to be a successful long-term staffing strategy for UMLMC. Long-term benefits were recognized too. Sound’s staffing model and clinical processes significantly improved quality of care. Mortality rates dropped from 18% to 9% during the initial 60 days of the program. Vaccinations shifted COVID-19 needs, however, due to improvements in care and the flexibility offered, telemedicine remains an integral part of the UMMS’s long-term strategy
 

Emory Healthcare division of hospital medicine (Atlanta)

(Comments compiled by James Kim, MD, assistant professor in the division of hospital medicine) Ingrid Pinzon, MD, FACP Emory Johns Creek (Ga.) Hospital

When COVID-19 started, one of the things called to my attention was the disparity in education for the Hispanic population. Unfortunately, COVID showed how in our hospitals there is a lack of instructions and education in Spanish.

We started educating our Hispanic community with Facebook lives via the Latin American Association. I was also invited to the different Spanish news stations (Telemundo and Univision). I also educated this community through food drives, where I taught about the use of face masks, social distancing, and hand hygiene.

Reena Hemrajani, MD

Grady Memorial Hospital

At Grady, we transitioned our weekly educational conferences into virtual events, and this has increased our attendance, as more off-service people are likely to attend when they can log on remotely. This has also allowed us to record these sessions for later viewing by those were unable to make it in real time.

Yelena Burklin, MD, FHM

Emory University Hospital Midtown

In our Midtown group, we have started a few initiatives that we will continue post COVID. Hybrid didactic lectures have had great success with excellent attendance when our didactic sessions (lunch and learns, journal clubs, core lectures for step-down unit refresher series) have been conducted virtually.

During the pandemic’s height, when all resources were dedicated to COVID-19 patient care, there was a particular need to cognitively separate from “all things COVID” and provide additional topics to learn about, such as review of the management of different types of shock, chronic obstructive pulmonary disorder, sepsis, liver cirrhosis, etc. Attendance to these non–COVID-19 sessions was just as high.

We had a number of stressful and near-death experiences that tested our resilience, professional integrity, and overall wellness. These reflections prompted us to invite psychiatrists to one of the in-person–only sessions so that an informal conversation could be afforded in a safe space. Those hospitalists who felt the need to discuss their issues further received additional support and instructions from a subspecialist.

Ray Dantes, MD

Emory University Hospital Midtown

Post COVID, we will certainly utilize a hybrid approach to the didactic sessions when patient sensitive information is not being discussed. We will also preserve the continuity in addressing wellness and resilience, particularly, when our Midtown hospitalists had to work a lot of extra hours to cover the growing need at the time of pandemic, and need to emotionally decompress post pandemic. We are also taking infection control more seriously, and not coming to work with upper respiratory infections.

Rajasree Roy, MD

Emory Saint Joseph’s Hospital

At ESJH, we initiated a telemedicine pilot for our hospitalist team in order to sustain our service given census surge and physician illness.

Sara Millwee, DNP, APRN, FNP-BC

Emory chief of advanced practice providers

To help reduce exposure to COVID, our advanced practice providers (APPs) admitted patients from the ED (as they did pre-COVID) to the hospital medicine service, but the physicians administratively signed the note/orders. Emory Healthcare bylaws specify that patients are seen by a physician within 24 hours of admission. During the pandemic, at the time of admission, the APP discussed plan of care with the physician, but the patient was only seen by the APP upon initial evaluation/admission, as opposed to the physician and APP pre-COVID. This improved productivity, and facilitated communication and collaboration between APPs and physicians. This also fostered an environment where APPs were practicing at the top of their licenses and improved job satisfaction.

Additionally, across the hospital medicine division, several APPs were utilized from other divisions to assist with admissions and cross cover. As the volume was at incredibly high levels, this improved the workload and burden of the hospital medicine providers. The displaced APPs were utilized at several facilities and worked under the guidance and supervision of hospital medicine providers. Moving forward, this has prompted leadership to look at utilizing APPs from other divisions as “PRN” providers as well.

Editor’s note: Hospitalists told us about process changes that their teams have implemented during the COVID-19 pandemic.

Shyam Odeti, MD, SFHM

Ballad Health (Bristol, Tenn.)(Dr. Odeti was a hospitalist at Ballad Health during the period he describes below. He is currently chief of hospital medicine at Carilion Clinic, Roanoke, Va.)

Ballad Health is a 21-hospital health system serving 1.2 million population in 21 counties of rural Appalachia (northeast Tennessee, southwest Virginia, western North Carolina, and Kentucky). We saw a significant spike in COVID-19 numbers beginning in October 2020. We were at a 7.9% test positivity rate and 89 COVID-19 hospitalizations on Oct. 1, which rapidly increased to over 18% positivity rate and over 250 hospitalizations by mid-November. This alarming trend created concerns about handling the future inpatient volumes in an already strained health system.

There were some unique challenges to this region that were contributing to the increased hospitalizations. A significant part of the population we serve in this region has low health literacy, low socioeconomic status, and problems with transportation. Telehealth in an outpatient setting was rudimentary in parts of this region.

Ballad Health developed Safe At Home to identify lower-acuity COVID-19 patients and transition them to the home setting safely. This in turn would prevent their readmissions or return visits to the ED by implementing comprehensive oversight to their disease course. We achieved this through a collaborative approach of the existing teams, case management, telenurse team, primary care providers, and hospitalist-led transitional care. We leveraged the newly implemented EHR Epic and telehealth under the leadership of Ballad Health’s chief medical information officer, Dr. Mark Wilkinson.

Among the patients diagnosed with COVID-19 in ED and urgent care, low acuity cases were identified and enrolled into Safe At Home. Patients were provided with a pulse oximeter, thermometer, and incentive spirometer. They received phone calls the next 2 days from the telenurse team for a comprehensive interview, followed by daily phone calls during the first week. If no concerns were raised initially, then calls were spaced to every 3 days after that for up to 2 weeks. Any complaints or alarming symptoms would trigger a telehealth visit with primary care physicians, transitional care clinics, or a hospitalist.

The Safe At Home program was highly successful – in the past 5 months, over 1,500 patients were enrolled and hundreds of admissions were likely avoided. As we feared, the positivity rate in our region went close to 35% and inpatient COVID-19 census was over 350, with ICU utilization over 92%. If not for our innovative solution, this pandemic could have easily paralyzed health care in our region. Our patients also felt safe, as they were monitored daily and had help one call away, 24/7.

This innovation has brought solutions through technological advancements and process improvement. Safe At Home was also instrumental in breaking down silos and developing a culture of collaboration and cohesiveness among the inpatient, outpatient, and virtual teams of the health system. Lessons learned from this initiative can be easily replicated in the management of several chronic diseases to provide safe and affordable care to our patients in the comfort of their homes.
 

Vasundara Singh, MBBS

Mount Sinai West (New York)

At the onset of the pandemic in New York, our medium-sized midtown hospital used personal protective equipment briskly. One reason identified was the failure to cohort COVID-19 patients on a single floor. The other more important cause was that medicine teams in our hospital have patients scattered throughout the hospital in a nongeographic model across four different floors. Within 2 weeks, administration and hospital medicine leadership developed a geographic model. We started cohorting all COVID-19 positive patients on separate floors from negative patients. A geographic physician team model was also developed, which allowed physicians and nurses to don and doff at the entry and exit of each COVID-19 unit.

After the pandemic surge, hospital medicine and internal medicine residency program leadership made the collective decision to continue the geographic model for inpatient care. Care providers enjoyed working in a unit-based model, and noted increases in efficiency while rounding. Each of our four medicine floors has 36-40 beds, with variable occupancy. We restructured our resident teams and physician assistant teams by geography. Our outgoing chief residents led the change in May, designing a resident schedule to accommodate for a resident on each team to be available to admit and provide coverage until 8 p.m. each evening on their respective floors. The hospital medicine leadership put together a committee comprising representation of all stakeholders in this large transition of systems: attending hospitalists, physician assistants, chief residents, nurse managers, bed assignment, and administration. Since the transition and resumption of normal inpatient activity, we have encountered and addressed multiple concerns. Some notable hurdles in this transition included the high throughput on our telemetry team, movement of patients by bed board or nursing without involving the physicians in the decision, and variable nursing staffing that impacts teaching team caps because of geographic model.

This transition is very much still a work in progress, yet some benefits are already obvious. It has made bedside rounding more appealing and uncomplicated. Physicians in training learn very well at the bedside by role modeling. Greater acceptance of bedside rounding also affords the opportunity to teach physical exam skills, a dying art amongst newer generations of doctors. Another large gain is being able to involve nursing in bedside rounds, discussions, and decision-making. Finally, coordination with ancillary staff including social work and case management has become seamless as a result of having an entire floor to ourselves.

In summary, the silver lining of this pernicious pandemic at our hospital has been a transition to a geographic model for inpatient care. This is considered to be the gold standard for inpatient care across multiple health systems, and we hope to continue to refine this geographic model of care. Next steps would involve developing capabilities with flex acuity beds on each unit so that no matter what the patients need they can stay in one place.
 

Marina Farah, MD, MHA

Sound Physicians (Tacoma, Wash.)

With hospital programs in over 40 states, Sound Physicians has played an important role in the COVID-19 pandemic, treating approximately 6% of all COVID hospitalizations nationwide. To meet the needs of the crisis, Sound relied on innovation to expand coverage and improve outcomes at facilities across the country. Of one particular note, Sound Telemedicine partnered with the University of Maryland Medical System to open the state’s first COVID-only hospital. In March 2020, the UMMS needed to care for an emerging cohort of COVID-19 patients while maintaining high-quality care and minimizing exposure for non-COVID patients.

Sound collaborated with UMMS to rapidly reopen the University of Maryland Laurel Medical Center for COVID-only care, staffing the hospital with Sound’s telehospitalists. A model based on daily rounding delivered 100% by telemedicine providers and flexible staffing available 24/7 would let the program scale up or down to meet volume demands. Onsite physician support would be limited to one admitting doctor and a nocturnist. The COVID-only facility allowed a small group of doctors, nurses, and technicians to focus exclusively on an emerging disease, honing critical skills for treating COVID-19 patients.

Immediate benefits yielded big results. UMLMC’s capacity allowed UMMS to funnel COVID patients into fewer of their regional hospitals, limiting the risk of exposure. Rapid deployment got UMMS ahead of the surge, taking stress off other hospitals in the system and 24/7 telehospitalist coverage proved to be a successful long-term staffing strategy for UMLMC. Long-term benefits were recognized too. Sound’s staffing model and clinical processes significantly improved quality of care. Mortality rates dropped from 18% to 9% during the initial 60 days of the program. Vaccinations shifted COVID-19 needs, however, due to improvements in care and the flexibility offered, telemedicine remains an integral part of the UMMS’s long-term strategy
 

Emory Healthcare division of hospital medicine (Atlanta)

(Comments compiled by James Kim, MD, assistant professor in the division of hospital medicine) Ingrid Pinzon, MD, FACP Emory Johns Creek (Ga.) Hospital

When COVID-19 started, one of the things called to my attention was the disparity in education for the Hispanic population. Unfortunately, COVID showed how in our hospitals there is a lack of instructions and education in Spanish.

We started educating our Hispanic community with Facebook lives via the Latin American Association. I was also invited to the different Spanish news stations (Telemundo and Univision). I also educated this community through food drives, where I taught about the use of face masks, social distancing, and hand hygiene.

Reena Hemrajani, MD

Grady Memorial Hospital

At Grady, we transitioned our weekly educational conferences into virtual events, and this has increased our attendance, as more off-service people are likely to attend when they can log on remotely. This has also allowed us to record these sessions for later viewing by those were unable to make it in real time.

Yelena Burklin, MD, FHM

Emory University Hospital Midtown

In our Midtown group, we have started a few initiatives that we will continue post COVID. Hybrid didactic lectures have had great success with excellent attendance when our didactic sessions (lunch and learns, journal clubs, core lectures for step-down unit refresher series) have been conducted virtually.

During the pandemic’s height, when all resources were dedicated to COVID-19 patient care, there was a particular need to cognitively separate from “all things COVID” and provide additional topics to learn about, such as review of the management of different types of shock, chronic obstructive pulmonary disorder, sepsis, liver cirrhosis, etc. Attendance to these non–COVID-19 sessions was just as high.

We had a number of stressful and near-death experiences that tested our resilience, professional integrity, and overall wellness. These reflections prompted us to invite psychiatrists to one of the in-person–only sessions so that an informal conversation could be afforded in a safe space. Those hospitalists who felt the need to discuss their issues further received additional support and instructions from a subspecialist.

Ray Dantes, MD

Emory University Hospital Midtown

Post COVID, we will certainly utilize a hybrid approach to the didactic sessions when patient sensitive information is not being discussed. We will also preserve the continuity in addressing wellness and resilience, particularly, when our Midtown hospitalists had to work a lot of extra hours to cover the growing need at the time of pandemic, and need to emotionally decompress post pandemic. We are also taking infection control more seriously, and not coming to work with upper respiratory infections.

Rajasree Roy, MD

Emory Saint Joseph’s Hospital

At ESJH, we initiated a telemedicine pilot for our hospitalist team in order to sustain our service given census surge and physician illness.

Sara Millwee, DNP, APRN, FNP-BC

Emory chief of advanced practice providers

To help reduce exposure to COVID, our advanced practice providers (APPs) admitted patients from the ED (as they did pre-COVID) to the hospital medicine service, but the physicians administratively signed the note/orders. Emory Healthcare bylaws specify that patients are seen by a physician within 24 hours of admission. During the pandemic, at the time of admission, the APP discussed plan of care with the physician, but the patient was only seen by the APP upon initial evaluation/admission, as opposed to the physician and APP pre-COVID. This improved productivity, and facilitated communication and collaboration between APPs and physicians. This also fostered an environment where APPs were practicing at the top of their licenses and improved job satisfaction.

Additionally, across the hospital medicine division, several APPs were utilized from other divisions to assist with admissions and cross cover. As the volume was at incredibly high levels, this improved the workload and burden of the hospital medicine providers. The displaced APPs were utilized at several facilities and worked under the guidance and supervision of hospital medicine providers. Moving forward, this has prompted leadership to look at utilizing APPs from other divisions as “PRN” providers as well.

Doctors Hospital of Laredo, Texas, and the Laredo Physicians Group have filed a lawsuit against interventional cardiologist Ricardo Cigarroa, MD, alleging that he engaged in anticompetitive conduct over the availability of cardiologists in Laredo.

Also named in the lawsuit are Cigarroa Heart and Vascular Institute, Laredo Texas Hospital Company (doing business as Laredo Medical Center) and Laredo Physician Associates (LPA).

According to the complaint, in August 2020, Doctors Hospital and Laredo Physicians Group began actively recruiting cardiologists to the city of Laredo.

The complaint states that, with more than 260,000 residents, the city should have a minimum of 20 cardiologists. However, Laredo currently has only eight cardiologists and only six are interventional cardiologists. 

The lawsuit alleges that when Dr. Cigarroa got wind of these recruitment efforts, he entered into a conspiracy with the Cigarroa Institute (a cardiology outpatient clinic) and Laredo Medical Center, the largest acute-care hospital in the city, to engage in “anticompetitive and tortious behavior.

“Their conspiracy had a simple but pernicious goal: deprive Doctors Hospital and Physicians Group of the doctors and employees needed to compete and provide interventional cardiology services to the Laredo market,” the complaint reads. 

The alleged conspiracy unfolded in multiple steps, it notes, with Dr. Cigarroa issuing threats to Doctors Hospital, Laredo Physicians Group, and prospective interventional cardiologists being recruited.

Through threats and coercion, multiple qualified interventional cardiologists who were interested in joining Laredo Physicians Group, and to whom the group extended employment offers, decided not to join, the complaint states.

It further claims that Dr. Cigarroa, his son, and his nephew – who represent more than half of the interventional cardiologists in Laredo – informed Doctors Hospital that they would “no longer respond” to emergency calls at Doctors Hospital.

The complaint further alleges that after “scaring off competitors and further cementing their dominant market power and position,” the defendants targeted Arthur Santos, MD, Laredo’s only cardiovascular surgeon who was employed by Laredo Physicians Group.

“Defendants successfully induced Dr. Santos to agree to join Defendant Laredo Physicians Associates (LPA), breaching his enforceable noncompete contractual provision,” the complaint states.

The defendants then allegedly induced the cardiothoracic surgery technicians at Doctors Hospital to join Laredo Medical Center (LMC) and work with Dr. Cigarroa and Dr. Santos, the complaint says.

“The conspiracy to monopolize Laredo’s interventional cardiology market is a win-win-win for Defendants. Dr Cigarroa and the clinic avoid competition for interventional cardiological services, while LMC is left as the only provider of acute cardiology services in Laredo, gaining additional patients and corresponding increased revenue,” the complaint reads.

“Meanwhile, Doctors Hospital’s acute-care cardiology program will be threatened with extinction and, critically, Laredo patients are left with higher health care costs and greater health risks and without competitive market alternatives,” it states.
 

Dr. Cigarroa responds

According to the Laredo Times, in a statement responding to the anticompetitive conduct lawsuit, Dr. Cigarroa said: “This lawsuit is a dispute between a for-profit corporation and a physician who has demonstrated over 30 years of commitment to his patients and patient care in this community.

“It’s unfortunate that the executives [at] Doctors Hospital have chosen to put profit above the well-being of their patients and employees. Their actions confirm that they care more about their bottom line than they do about our residents and reaffirms how disconnected they are from our community,” Dr. Cigarroa said.

“My top priority continues to be the health of all Laredo residents. I will never stop caring for the patients that I love, and I will continue to help save lives,” Dr. Cigarroa said, according to the Times article.

“I am humbled to have received numerous calls of support from many Doctors Hospital employees. Their words of encouragement are a true testament to the strong relationships I have within the medical community,” Dr. Cigarroa added.

A version of this article first appeared on Medscape.com.

Doctors Hospital of Laredo, Texas, and the Laredo Physicians Group have filed a lawsuit against interventional cardiologist Ricardo Cigarroa, MD, alleging that he engaged in anticompetitive conduct over the availability of cardiologists in Laredo.

Also named in the lawsuit are Cigarroa Heart and Vascular Institute, Laredo Texas Hospital Company (doing business as Laredo Medical Center) and Laredo Physician Associates (LPA).

According to the complaint, in August 2020, Doctors Hospital and Laredo Physicians Group began actively recruiting cardiologists to the city of Laredo.

The complaint states that, with more than 260,000 residents, the city should have a minimum of 20 cardiologists. However, Laredo currently has only eight cardiologists and only six are interventional cardiologists. 

The lawsuit alleges that when Dr. Cigarroa got wind of these recruitment efforts, he entered into a conspiracy with the Cigarroa Institute (a cardiology outpatient clinic) and Laredo Medical Center, the largest acute-care hospital in the city, to engage in “anticompetitive and tortious behavior.

“Their conspiracy had a simple but pernicious goal: deprive Doctors Hospital and Physicians Group of the doctors and employees needed to compete and provide interventional cardiology services to the Laredo market,” the complaint reads. 

The alleged conspiracy unfolded in multiple steps, it notes, with Dr. Cigarroa issuing threats to Doctors Hospital, Laredo Physicians Group, and prospective interventional cardiologists being recruited.

Through threats and coercion, multiple qualified interventional cardiologists who were interested in joining Laredo Physicians Group, and to whom the group extended employment offers, decided not to join, the complaint states.

It further claims that Dr. Cigarroa, his son, and his nephew – who represent more than half of the interventional cardiologists in Laredo – informed Doctors Hospital that they would “no longer respond” to emergency calls at Doctors Hospital.

The complaint further alleges that after “scaring off competitors and further cementing their dominant market power and position,” the defendants targeted Arthur Santos, MD, Laredo’s only cardiovascular surgeon who was employed by Laredo Physicians Group.

“Defendants successfully induced Dr. Santos to agree to join Defendant Laredo Physicians Associates (LPA), breaching his enforceable noncompete contractual provision,” the complaint states.

The defendants then allegedly induced the cardiothoracic surgery technicians at Doctors Hospital to join Laredo Medical Center (LMC) and work with Dr. Cigarroa and Dr. Santos, the complaint says.

“The conspiracy to monopolize Laredo’s interventional cardiology market is a win-win-win for Defendants. Dr Cigarroa and the clinic avoid competition for interventional cardiological services, while LMC is left as the only provider of acute cardiology services in Laredo, gaining additional patients and corresponding increased revenue,” the complaint reads.

“Meanwhile, Doctors Hospital’s acute-care cardiology program will be threatened with extinction and, critically, Laredo patients are left with higher health care costs and greater health risks and without competitive market alternatives,” it states.
 

Dr. Cigarroa responds

According to the Laredo Times, in a statement responding to the anticompetitive conduct lawsuit, Dr. Cigarroa said: “This lawsuit is a dispute between a for-profit corporation and a physician who has demonstrated over 30 years of commitment to his patients and patient care in this community.

“It’s unfortunate that the executives [at] Doctors Hospital have chosen to put profit above the well-being of their patients and employees. Their actions confirm that they care more about their bottom line than they do about our residents and reaffirms how disconnected they are from our community,” Dr. Cigarroa said.

“My top priority continues to be the health of all Laredo residents. I will never stop caring for the patients that I love, and I will continue to help save lives,” Dr. Cigarroa said, according to the Times article.

“I am humbled to have received numerous calls of support from many Doctors Hospital employees. Their words of encouragement are a true testament to the strong relationships I have within the medical community,” Dr. Cigarroa added.

A version of this article first appeared on Medscape.com.

Doctors Hospital of Laredo, Texas, and the Laredo Physicians Group have filed a lawsuit against interventional cardiologist Ricardo Cigarroa, MD, alleging that he engaged in anticompetitive conduct over the availability of cardiologists in Laredo.

Also named in the lawsuit are Cigarroa Heart and Vascular Institute, Laredo Texas Hospital Company (doing business as Laredo Medical Center) and Laredo Physician Associates (LPA).

According to the complaint, in August 2020, Doctors Hospital and Laredo Physicians Group began actively recruiting cardiologists to the city of Laredo.

The complaint states that, with more than 260,000 residents, the city should have a minimum of 20 cardiologists. However, Laredo currently has only eight cardiologists and only six are interventional cardiologists. 

The lawsuit alleges that when Dr. Cigarroa got wind of these recruitment efforts, he entered into a conspiracy with the Cigarroa Institute (a cardiology outpatient clinic) and Laredo Medical Center, the largest acute-care hospital in the city, to engage in “anticompetitive and tortious behavior.

“Their conspiracy had a simple but pernicious goal: deprive Doctors Hospital and Physicians Group of the doctors and employees needed to compete and provide interventional cardiology services to the Laredo market,” the complaint reads. 

The alleged conspiracy unfolded in multiple steps, it notes, with Dr. Cigarroa issuing threats to Doctors Hospital, Laredo Physicians Group, and prospective interventional cardiologists being recruited.

Through threats and coercion, multiple qualified interventional cardiologists who were interested in joining Laredo Physicians Group, and to whom the group extended employment offers, decided not to join, the complaint states.

It further claims that Dr. Cigarroa, his son, and his nephew – who represent more than half of the interventional cardiologists in Laredo – informed Doctors Hospital that they would “no longer respond” to emergency calls at Doctors Hospital.

The complaint further alleges that after “scaring off competitors and further cementing their dominant market power and position,” the defendants targeted Arthur Santos, MD, Laredo’s only cardiovascular surgeon who was employed by Laredo Physicians Group.

“Defendants successfully induced Dr. Santos to agree to join Defendant Laredo Physicians Associates (LPA), breaching his enforceable noncompete contractual provision,” the complaint states.

The defendants then allegedly induced the cardiothoracic surgery technicians at Doctors Hospital to join Laredo Medical Center (LMC) and work with Dr. Cigarroa and Dr. Santos, the complaint says.

“The conspiracy to monopolize Laredo’s interventional cardiology market is a win-win-win for Defendants. Dr Cigarroa and the clinic avoid competition for interventional cardiological services, while LMC is left as the only provider of acute cardiology services in Laredo, gaining additional patients and corresponding increased revenue,” the complaint reads.

“Meanwhile, Doctors Hospital’s acute-care cardiology program will be threatened with extinction and, critically, Laredo patients are left with higher health care costs and greater health risks and without competitive market alternatives,” it states.
 

Dr. Cigarroa responds

According to the Laredo Times, in a statement responding to the anticompetitive conduct lawsuit, Dr. Cigarroa said: “This lawsuit is a dispute between a for-profit corporation and a physician who has demonstrated over 30 years of commitment to his patients and patient care in this community.

“It’s unfortunate that the executives [at] Doctors Hospital have chosen to put profit above the well-being of their patients and employees. Their actions confirm that they care more about their bottom line than they do about our residents and reaffirms how disconnected they are from our community,” Dr. Cigarroa said.

“My top priority continues to be the health of all Laredo residents. I will never stop caring for the patients that I love, and I will continue to help save lives,” Dr. Cigarroa said, according to the Times article.

“I am humbled to have received numerous calls of support from many Doctors Hospital employees. Their words of encouragement are a true testament to the strong relationships I have within the medical community,” Dr. Cigarroa added.

A version of this article first appeared on Medscape.com.

While COVID-19 vaccine mandates have sparked lawsuits and protests, the data shows that they’re working and increasing vaccination rates.

Some organizations have reported vaccination rates that jumped from less than 50% to more than 90%, according to ABC News. Workplace mandates have especially encouraged employees who were on the fence to get a shot.

“In general, vaccine mandates work,” James Colgrove, a public health professor at Columbia University’s Mailman School of Public Health, told ABC News.

For decades, the United States has monitored the effectiveness of vaccine mandates in schools, he noted, which have successfully required shots against measles, mumps, and other illnesses that used to be widespread. Certain employees, such as hospital workers, must take vaccines for their jobs, he said, and those requirements have also been effective over the years.

“The more normalized it becomes, the more people [know] someone else who is vaccinated, the more people will comply,” he said. “With any vaccine, the longer it’s been around, the more people get with it.”

With the widespread and contagious nature of COVID-19, workplaces have been forced to consider vaccine mandates to protect their employees and prevent worker shortages, Dr. Colgrove said.

Some companies began to issue vaccine rules this summer as the Delta variant caused a jump in cases, hospitalizations, and deaths. Major companies, including Google, Tyson Foods, United Airlines, and the Walt Disney Company, required in-person employees to get a shot. So far, the results from those mandates have been strong, ABC News reported.

For instance, Tyson announced a mandate in August, when less than half of its 140,000 employees were vaccinated. When the deadline came at the end of October, more than 60,000 additional employees had been vaccinated, and the vaccination rate was 96%.

“Has this made a difference in the health and safety of our team members? Absolutely. We’ve seen a significant decline in the number of active cases companywide,” Donnie King, CEO and president of Tyson Foods, said in a statement.

United Airlines has also shared that 99.7% of its 67,000 employees are vaccinated. Within 48 hours of announcing its mandate, the number of unvaccinated staffers fell from 593 to 320 people, ABC News reported.

Vaccine mandates appear to be working in the public sector as well. State health department officials in Washington told ABC News that the percentage of public employees who were vaccinated jumped from 49% in September to 96% by the vaccine mandate deadline in October.

Vaccination rates have also increased in New York City, where some employees in the fire, police, and sanitation departments protested the mandate. By the deadline, vaccination rates shifted from less than 75% to 82% in the fire department, 86% in the police department, and 91% of EMS personnel, ABC News reported.

Overall, vaccine mandates tend to reach groups who aren’t completely against the vaccine, medical experts told the news outlet. A small percentage of the population truly opposes the shot, and in most cases, unvaccinated people are on the fence or haven’t seen good enough messaging for it.

“When you look at vaccine resistance, the people who are the most opposed often make a very large amount of noise that is at odds with the actual numbers who are against vaccination,” Dr. Colgrove said.

A version of this article first appeared on WebMD.com.

While COVID-19 vaccine mandates have sparked lawsuits and protests, the data shows that they’re working and increasing vaccination rates.

Some organizations have reported vaccination rates that jumped from less than 50% to more than 90%, according to ABC News. Workplace mandates have especially encouraged employees who were on the fence to get a shot.

“In general, vaccine mandates work,” James Colgrove, a public health professor at Columbia University’s Mailman School of Public Health, told ABC News.

For decades, the United States has monitored the effectiveness of vaccine mandates in schools, he noted, which have successfully required shots against measles, mumps, and other illnesses that used to be widespread. Certain employees, such as hospital workers, must take vaccines for their jobs, he said, and those requirements have also been effective over the years.

“The more normalized it becomes, the more people [know] someone else who is vaccinated, the more people will comply,” he said. “With any vaccine, the longer it’s been around, the more people get with it.”

With the widespread and contagious nature of COVID-19, workplaces have been forced to consider vaccine mandates to protect their employees and prevent worker shortages, Dr. Colgrove said.

Some companies began to issue vaccine rules this summer as the Delta variant caused a jump in cases, hospitalizations, and deaths. Major companies, including Google, Tyson Foods, United Airlines, and the Walt Disney Company, required in-person employees to get a shot. So far, the results from those mandates have been strong, ABC News reported.

For instance, Tyson announced a mandate in August, when less than half of its 140,000 employees were vaccinated. When the deadline came at the end of October, more than 60,000 additional employees had been vaccinated, and the vaccination rate was 96%.

“Has this made a difference in the health and safety of our team members? Absolutely. We’ve seen a significant decline in the number of active cases companywide,” Donnie King, CEO and president of Tyson Foods, said in a statement.

United Airlines has also shared that 99.7% of its 67,000 employees are vaccinated. Within 48 hours of announcing its mandate, the number of unvaccinated staffers fell from 593 to 320 people, ABC News reported.

Vaccine mandates appear to be working in the public sector as well. State health department officials in Washington told ABC News that the percentage of public employees who were vaccinated jumped from 49% in September to 96% by the vaccine mandate deadline in October.

Vaccination rates have also increased in New York City, where some employees in the fire, police, and sanitation departments protested the mandate. By the deadline, vaccination rates shifted from less than 75% to 82% in the fire department, 86% in the police department, and 91% of EMS personnel, ABC News reported.

Overall, vaccine mandates tend to reach groups who aren’t completely against the vaccine, medical experts told the news outlet. A small percentage of the population truly opposes the shot, and in most cases, unvaccinated people are on the fence or haven’t seen good enough messaging for it.

“When you look at vaccine resistance, the people who are the most opposed often make a very large amount of noise that is at odds with the actual numbers who are against vaccination,” Dr. Colgrove said.

A version of this article first appeared on WebMD.com.

While COVID-19 vaccine mandates have sparked lawsuits and protests, the data shows that they’re working and increasing vaccination rates.

Some organizations have reported vaccination rates that jumped from less than 50% to more than 90%, according to ABC News. Workplace mandates have especially encouraged employees who were on the fence to get a shot.

“In general, vaccine mandates work,” James Colgrove, a public health professor at Columbia University’s Mailman School of Public Health, told ABC News.

For decades, the United States has monitored the effectiveness of vaccine mandates in schools, he noted, which have successfully required shots against measles, mumps, and other illnesses that used to be widespread. Certain employees, such as hospital workers, must take vaccines for their jobs, he said, and those requirements have also been effective over the years.

“The more normalized it becomes, the more people [know] someone else who is vaccinated, the more people will comply,” he said. “With any vaccine, the longer it’s been around, the more people get with it.”

With the widespread and contagious nature of COVID-19, workplaces have been forced to consider vaccine mandates to protect their employees and prevent worker shortages, Dr. Colgrove said.

Some companies began to issue vaccine rules this summer as the Delta variant caused a jump in cases, hospitalizations, and deaths. Major companies, including Google, Tyson Foods, United Airlines, and the Walt Disney Company, required in-person employees to get a shot. So far, the results from those mandates have been strong, ABC News reported.

For instance, Tyson announced a mandate in August, when less than half of its 140,000 employees were vaccinated. When the deadline came at the end of October, more than 60,000 additional employees had been vaccinated, and the vaccination rate was 96%.

“Has this made a difference in the health and safety of our team members? Absolutely. We’ve seen a significant decline in the number of active cases companywide,” Donnie King, CEO and president of Tyson Foods, said in a statement.

United Airlines has also shared that 99.7% of its 67,000 employees are vaccinated. Within 48 hours of announcing its mandate, the number of unvaccinated staffers fell from 593 to 320 people, ABC News reported.

Vaccine mandates appear to be working in the public sector as well. State health department officials in Washington told ABC News that the percentage of public employees who were vaccinated jumped from 49% in September to 96% by the vaccine mandate deadline in October.

Vaccination rates have also increased in New York City, where some employees in the fire, police, and sanitation departments protested the mandate. By the deadline, vaccination rates shifted from less than 75% to 82% in the fire department, 86% in the police department, and 91% of EMS personnel, ABC News reported.

Overall, vaccine mandates tend to reach groups who aren’t completely against the vaccine, medical experts told the news outlet. A small percentage of the population truly opposes the shot, and in most cases, unvaccinated people are on the fence or haven’t seen good enough messaging for it.

“When you look at vaccine resistance, the people who are the most opposed often make a very large amount of noise that is at odds with the actual numbers who are against vaccination,” Dr. Colgrove said.

A version of this article first appeared on WebMD.com.

The Department of Labor will likely need to rely on workplace whistleblowers when the Biden administration’s COVID-19 vaccine mandate for large companies goes into effect in January.

The Occupational Safety and Health Administration (OSHA) doesn’t have enough workplace safety inspectors to cover the nation, the Associated Press reported, so the agency will count on people within organizations to identify violations.

“There is no army of OSHA inspectors that is going to be knocking on employers’ doors or even calling them,” Debbie Berkowitz, a former OSHA chief of staff who is a fellow at Georgetown University, told the news service.

“They’re going to rely on workers and their union representatives to file complaints where the company is totally flouting the law,” she said.

Last week, OSHA published the details of the Biden administration’s vaccine mandate. Companies with more than 100 employees must require their workers to get vaccinated or undergo weekly testing. Companies that don’t comply could face fines of $14,000 for each “serious” violation. Repeat violators could face 10 times that amount.

Employees who are concerned about workplace safety, unvaccinated co-workers, or people not being tested as required may report their employers, according to Reuters.

Jim Frederick, the acting chief for OSHA, told reporters that the agency will focus on job sites “where workers need assistance to have a safe and healthy workplace.”

“That typically comes through in the form of a complaint,” he said.

OSHA has jurisdiction in 29 states, the AP reported. OSHA is tasked with addressing violations of the Occupational Safety and Health Act of 1970, which is meant to create safe workplaces, and the agency has updated its guidance about COVID-19 safety in the workplace throughout this year.

Other states, such as California and Michigan, have their own workplace safety agencies, which will have until February to adopt their own version of a vaccine mandate, according to the AP.

OSHA and state counterparts will be tasked with enforcing the mandate, and their agencies are already short-staffed. About 1,850 inspectors will oversee 130 million workers at 8 million job sites.

OSHA has encouraged workers to first report complaints to employers “if possible.” Otherwise, employees can file a confidential safety complaint with OSHA or file a case through a representative, such as a lawyer or union leader, the AP reported.

But workplace experts have voiced caution about the potential risks of reporting. Whistleblowers tend to face retaliation and OSHA can’t always offer protection in these cases.

“Technically, the law says that companies can’t retaliate against a worker for raising a health and safety issue or filing an OSHA complaint or even reporting an injury,” Ms. Berkowitz said. “But retaliation is rampant.”

OSHA has some jurisdiction to pursue employers who punish workers for reporting unsafe working conditions, the AP reported. Last month, the agency sued a luxury car dealer in Texas for firing an employee who warned co-workers about potential coronavirus hazards.

But at the same time, Ms. Berkowitz and the National Employment Law Project found that OSHA dismissed more than half of the COVID-related complaints of retaliation that it received from whistleblowers. About 2% of complaints were resolved during a 5-month period last year, according to their report.

As the vaccine mandate deadline approaches, most companies are expected to comply, experts told the AP. Some employers wanted to require the shot but didn’t want to create their own rule, and others have said they’ll follow OSHA regulations as they always do.

“Most employers, they’re law abiding,” David Michaels, a former OSHA chief who is a public health professor at George Washington University, told the AP.

“They’re trying to make sure that they meet the requirements of every law and regulation,” he said. “Now OSHA will follow up. They’ll respond to complaints. They’ll do spot checks. They’ll issue citations and fines, and they’ll make a big deal of those.”

A version of this article first appeared on WebMD.com.

The Department of Labor will likely need to rely on workplace whistleblowers when the Biden administration’s COVID-19 vaccine mandate for large companies goes into effect in January.

The Occupational Safety and Health Administration (OSHA) doesn’t have enough workplace safety inspectors to cover the nation, the Associated Press reported, so the agency will count on people within organizations to identify violations.

“There is no army of OSHA inspectors that is going to be knocking on employers’ doors or even calling them,” Debbie Berkowitz, a former OSHA chief of staff who is a fellow at Georgetown University, told the news service.

“They’re going to rely on workers and their union representatives to file complaints where the company is totally flouting the law,” she said.

Last week, OSHA published the details of the Biden administration’s vaccine mandate. Companies with more than 100 employees must require their workers to get vaccinated or undergo weekly testing. Companies that don’t comply could face fines of $14,000 for each “serious” violation. Repeat violators could face 10 times that amount.

Employees who are concerned about workplace safety, unvaccinated co-workers, or people not being tested as required may report their employers, according to Reuters.

Jim Frederick, the acting chief for OSHA, told reporters that the agency will focus on job sites “where workers need assistance to have a safe and healthy workplace.”

“That typically comes through in the form of a complaint,” he said.

OSHA has jurisdiction in 29 states, the AP reported. OSHA is tasked with addressing violations of the Occupational Safety and Health Act of 1970, which is meant to create safe workplaces, and the agency has updated its guidance about COVID-19 safety in the workplace throughout this year.

Other states, such as California and Michigan, have their own workplace safety agencies, which will have until February to adopt their own version of a vaccine mandate, according to the AP.

OSHA and state counterparts will be tasked with enforcing the mandate, and their agencies are already short-staffed. About 1,850 inspectors will oversee 130 million workers at 8 million job sites.

OSHA has encouraged workers to first report complaints to employers “if possible.” Otherwise, employees can file a confidential safety complaint with OSHA or file a case through a representative, such as a lawyer or union leader, the AP reported.

But workplace experts have voiced caution about the potential risks of reporting. Whistleblowers tend to face retaliation and OSHA can’t always offer protection in these cases.

“Technically, the law says that companies can’t retaliate against a worker for raising a health and safety issue or filing an OSHA complaint or even reporting an injury,” Ms. Berkowitz said. “But retaliation is rampant.”

OSHA has some jurisdiction to pursue employers who punish workers for reporting unsafe working conditions, the AP reported. Last month, the agency sued a luxury car dealer in Texas for firing an employee who warned co-workers about potential coronavirus hazards.

But at the same time, Ms. Berkowitz and the National Employment Law Project found that OSHA dismissed more than half of the COVID-related complaints of retaliation that it received from whistleblowers. About 2% of complaints were resolved during a 5-month period last year, according to their report.

As the vaccine mandate deadline approaches, most companies are expected to comply, experts told the AP. Some employers wanted to require the shot but didn’t want to create their own rule, and others have said they’ll follow OSHA regulations as they always do.

“Most employers, they’re law abiding,” David Michaels, a former OSHA chief who is a public health professor at George Washington University, told the AP.

“They’re trying to make sure that they meet the requirements of every law and regulation,” he said. “Now OSHA will follow up. They’ll respond to complaints. They’ll do spot checks. They’ll issue citations and fines, and they’ll make a big deal of those.”

A version of this article first appeared on WebMD.com.

The Department of Labor will likely need to rely on workplace whistleblowers when the Biden administration’s COVID-19 vaccine mandate for large companies goes into effect in January.

The Occupational Safety and Health Administration (OSHA) doesn’t have enough workplace safety inspectors to cover the nation, the Associated Press reported, so the agency will count on people within organizations to identify violations.

“There is no army of OSHA inspectors that is going to be knocking on employers’ doors or even calling them,” Debbie Berkowitz, a former OSHA chief of staff who is a fellow at Georgetown University, told the news service.

“They’re going to rely on workers and their union representatives to file complaints where the company is totally flouting the law,” she said.

Last week, OSHA published the details of the Biden administration’s vaccine mandate. Companies with more than 100 employees must require their workers to get vaccinated or undergo weekly testing. Companies that don’t comply could face fines of $14,000 for each “serious” violation. Repeat violators could face 10 times that amount.

Employees who are concerned about workplace safety, unvaccinated co-workers, or people not being tested as required may report their employers, according to Reuters.

Jim Frederick, the acting chief for OSHA, told reporters that the agency will focus on job sites “where workers need assistance to have a safe and healthy workplace.”

“That typically comes through in the form of a complaint,” he said.

OSHA has jurisdiction in 29 states, the AP reported. OSHA is tasked with addressing violations of the Occupational Safety and Health Act of 1970, which is meant to create safe workplaces, and the agency has updated its guidance about COVID-19 safety in the workplace throughout this year.

Other states, such as California and Michigan, have their own workplace safety agencies, which will have until February to adopt their own version of a vaccine mandate, according to the AP.

OSHA and state counterparts will be tasked with enforcing the mandate, and their agencies are already short-staffed. About 1,850 inspectors will oversee 130 million workers at 8 million job sites.

OSHA has encouraged workers to first report complaints to employers “if possible.” Otherwise, employees can file a confidential safety complaint with OSHA or file a case through a representative, such as a lawyer or union leader, the AP reported.

But workplace experts have voiced caution about the potential risks of reporting. Whistleblowers tend to face retaliation and OSHA can’t always offer protection in these cases.

“Technically, the law says that companies can’t retaliate against a worker for raising a health and safety issue or filing an OSHA complaint or even reporting an injury,” Ms. Berkowitz said. “But retaliation is rampant.”

OSHA has some jurisdiction to pursue employers who punish workers for reporting unsafe working conditions, the AP reported. Last month, the agency sued a luxury car dealer in Texas for firing an employee who warned co-workers about potential coronavirus hazards.

But at the same time, Ms. Berkowitz and the National Employment Law Project found that OSHA dismissed more than half of the COVID-related complaints of retaliation that it received from whistleblowers. About 2% of complaints were resolved during a 5-month period last year, according to their report.

As the vaccine mandate deadline approaches, most companies are expected to comply, experts told the AP. Some employers wanted to require the shot but didn’t want to create their own rule, and others have said they’ll follow OSHA regulations as they always do.

“Most employers, they’re law abiding,” David Michaels, a former OSHA chief who is a public health professor at George Washington University, told the AP.

“They’re trying to make sure that they meet the requirements of every law and regulation,” he said. “Now OSHA will follow up. They’ll respond to complaints. They’ll do spot checks. They’ll issue citations and fines, and they’ll make a big deal of those.”

A version of this article first appeared on WebMD.com.

Despite the clinical value of medical devices, there is a potential for these products to cause adverse skin reactions in some patients. Findings from a European retrospective study, published in the European Journal of Allergy and Clinical Immunology, show that nearly one-quarter of patients with suspected allergic contact dermatitis were referred for patch testing for contact allergies associated with medical devices, highlighting the possibility of a high prevalence of contact allergens in these devices.

“We found it important to publish these findings, because up until now no clear figures have been reported regarding this particular clinical problem,” said study author Olivier Aerts, MD, a researcher in the contact allergy unit at the University Hospital Antwerp, Belgium, in an interview with this news organization.

For the study, Dr. Aerts and colleagues conducted a retrospective analysis of medical device users with suspected allergic contact dermatitis. All patients had been patch tested at a tertiary European clinic between 2018 and 2020.

The cohort included patients who experienced suspected contact allergy from medical adhesives (n = 57), gloves (n = 38), topical and surface medical devices (n = 38), glucose sensors and insulin pumps (n = 74), and prostheses (n = 75). Other medical products associated with contact allergy in another 44 patients included surgical glues, face masks, compression stockings, condoms, and suture materials.

Overall, 326 patients had been patch-tested during the 30-month study period. Approximately 25.8% of all patients – including 299 adults and 27 children – were referred for contact allergy associated with medical devices.

Acrylates were the most frequently encountered contact allergens and were found in diabetes devices and medical adhesives. Potential skin sensitizers included colophonium-related substances, D-limonene, isothiazolinone derivatives, salicylates, and sulphites, all of which were identified across most products.

According to the investigators, many of the labels for the medical devices made no mention of the potential skin sensitizers, except in the cases of some topical and surface disinfectants. And many topical products are often marketed as medical devices rather than cosmetics, further complicating labeling issues, according to Dr. Aerts.

“What should be done to help any patient suffering from allergic contact due to medical devices is that these devices should be labeled with all their components, or at the very least with the potential skin sensitizers these may contain,” Dr. Aerts explained. He added that manufacturers should “establish more cooperation with physicians/dermatologists who evaluate such patients,” a cooperation that often exists with cosmetic companies.

Dr. Aerts noted that while it’s important for patch testers and dermatologists to be aware of the prevalence of allergic contact dermatitis in medical device users, companies producing these devices should also be aware of these potential issues. “Additionally, legislators/regulators should perhaps focus some more on the cutaneous side effects these products may provoke,” he said, “as this awareness may hopefully also serve as a stimulant to perform more clinical allergy research in this field.”

Leonard Bielory, MD, an allergist at Robert Wood Johnson University Hospital in Rahway, New Jersey, told this news organization that the findings are “alarming” and should heighten clinicians’ awareness of the possibility of allergic contact dermatitis among medical device users.

Dr. Bielory, who wasn’t involved in the research, noted that the findings from this study may not be entirely generalizable to the U.S., given the study was performed in Europe. “In contrast to other countries, the U.S. is very conscientious about allergic responses to items being used in hospitals,” he added, “or such that the issue here is that many of these things would be an adverse reaction, which you have to report.” He suggested that further research in this field is needed to determine the prevalence of possible skin sensitizers in products specifically developed and marketed in the U.S.

The study had no specific funding. Dr. Aerts and Dr. Bielory have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Despite the clinical value of medical devices, there is a potential for these products to cause adverse skin reactions in some patients. Findings from a European retrospective study, published in the European Journal of Allergy and Clinical Immunology, show that nearly one-quarter of patients with suspected allergic contact dermatitis were referred for patch testing for contact allergies associated with medical devices, highlighting the possibility of a high prevalence of contact allergens in these devices.

“We found it important to publish these findings, because up until now no clear figures have been reported regarding this particular clinical problem,” said study author Olivier Aerts, MD, a researcher in the contact allergy unit at the University Hospital Antwerp, Belgium, in an interview with this news organization.

For the study, Dr. Aerts and colleagues conducted a retrospective analysis of medical device users with suspected allergic contact dermatitis. All patients had been patch tested at a tertiary European clinic between 2018 and 2020.

The cohort included patients who experienced suspected contact allergy from medical adhesives (n = 57), gloves (n = 38), topical and surface medical devices (n = 38), glucose sensors and insulin pumps (n = 74), and prostheses (n = 75). Other medical products associated with contact allergy in another 44 patients included surgical glues, face masks, compression stockings, condoms, and suture materials.

Overall, 326 patients had been patch-tested during the 30-month study period. Approximately 25.8% of all patients – including 299 adults and 27 children – were referred for contact allergy associated with medical devices.

Acrylates were the most frequently encountered contact allergens and were found in diabetes devices and medical adhesives. Potential skin sensitizers included colophonium-related substances, D-limonene, isothiazolinone derivatives, salicylates, and sulphites, all of which were identified across most products.

According to the investigators, many of the labels for the medical devices made no mention of the potential skin sensitizers, except in the cases of some topical and surface disinfectants. And many topical products are often marketed as medical devices rather than cosmetics, further complicating labeling issues, according to Dr. Aerts.

“What should be done to help any patient suffering from allergic contact due to medical devices is that these devices should be labeled with all their components, or at the very least with the potential skin sensitizers these may contain,” Dr. Aerts explained. He added that manufacturers should “establish more cooperation with physicians/dermatologists who evaluate such patients,” a cooperation that often exists with cosmetic companies.

Dr. Aerts noted that while it’s important for patch testers and dermatologists to be aware of the prevalence of allergic contact dermatitis in medical device users, companies producing these devices should also be aware of these potential issues. “Additionally, legislators/regulators should perhaps focus some more on the cutaneous side effects these products may provoke,” he said, “as this awareness may hopefully also serve as a stimulant to perform more clinical allergy research in this field.”

Leonard Bielory, MD, an allergist at Robert Wood Johnson University Hospital in Rahway, New Jersey, told this news organization that the findings are “alarming” and should heighten clinicians’ awareness of the possibility of allergic contact dermatitis among medical device users.

Dr. Bielory, who wasn’t involved in the research, noted that the findings from this study may not be entirely generalizable to the U.S., given the study was performed in Europe. “In contrast to other countries, the U.S. is very conscientious about allergic responses to items being used in hospitals,” he added, “or such that the issue here is that many of these things would be an adverse reaction, which you have to report.” He suggested that further research in this field is needed to determine the prevalence of possible skin sensitizers in products specifically developed and marketed in the U.S.

The study had no specific funding. Dr. Aerts and Dr. Bielory have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Despite the clinical value of medical devices, there is a potential for these products to cause adverse skin reactions in some patients. Findings from a European retrospective study, published in the European Journal of Allergy and Clinical Immunology, show that nearly one-quarter of patients with suspected allergic contact dermatitis were referred for patch testing for contact allergies associated with medical devices, highlighting the possibility of a high prevalence of contact allergens in these devices.

“We found it important to publish these findings, because up until now no clear figures have been reported regarding this particular clinical problem,” said study author Olivier Aerts, MD, a researcher in the contact allergy unit at the University Hospital Antwerp, Belgium, in an interview with this news organization.

For the study, Dr. Aerts and colleagues conducted a retrospective analysis of medical device users with suspected allergic contact dermatitis. All patients had been patch tested at a tertiary European clinic between 2018 and 2020.

The cohort included patients who experienced suspected contact allergy from medical adhesives (n = 57), gloves (n = 38), topical and surface medical devices (n = 38), glucose sensors and insulin pumps (n = 74), and prostheses (n = 75). Other medical products associated with contact allergy in another 44 patients included surgical glues, face masks, compression stockings, condoms, and suture materials.

Overall, 326 patients had been patch-tested during the 30-month study period. Approximately 25.8% of all patients – including 299 adults and 27 children – were referred for contact allergy associated with medical devices.

Acrylates were the most frequently encountered contact allergens and were found in diabetes devices and medical adhesives. Potential skin sensitizers included colophonium-related substances, D-limonene, isothiazolinone derivatives, salicylates, and sulphites, all of which were identified across most products.

According to the investigators, many of the labels for the medical devices made no mention of the potential skin sensitizers, except in the cases of some topical and surface disinfectants. And many topical products are often marketed as medical devices rather than cosmetics, further complicating labeling issues, according to Dr. Aerts.

“What should be done to help any patient suffering from allergic contact due to medical devices is that these devices should be labeled with all their components, or at the very least with the potential skin sensitizers these may contain,” Dr. Aerts explained. He added that manufacturers should “establish more cooperation with physicians/dermatologists who evaluate such patients,” a cooperation that often exists with cosmetic companies.

Dr. Aerts noted that while it’s important for patch testers and dermatologists to be aware of the prevalence of allergic contact dermatitis in medical device users, companies producing these devices should also be aware of these potential issues. “Additionally, legislators/regulators should perhaps focus some more on the cutaneous side effects these products may provoke,” he said, “as this awareness may hopefully also serve as a stimulant to perform more clinical allergy research in this field.”

Leonard Bielory, MD, an allergist at Robert Wood Johnson University Hospital in Rahway, New Jersey, told this news organization that the findings are “alarming” and should heighten clinicians’ awareness of the possibility of allergic contact dermatitis among medical device users.

Dr. Bielory, who wasn’t involved in the research, noted that the findings from this study may not be entirely generalizable to the U.S., given the study was performed in Europe. “In contrast to other countries, the U.S. is very conscientious about allergic responses to items being used in hospitals,” he added, “or such that the issue here is that many of these things would be an adverse reaction, which you have to report.” He suggested that further research in this field is needed to determine the prevalence of possible skin sensitizers in products specifically developed and marketed in the U.S.

The study had no specific funding. Dr. Aerts and Dr. Bielory have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Cumulative annual revenue from cancer drug sales increased by 70% among the world’s largest pharmaceutical companies over the past decade, a retrospective analysis shows.

By comparison, revenues from other types of medications decreased by 18% during the same period.

“Cancer drugs now account for approximately 27% of new drug approvals in the United States, compared to 4% in the 1980s. During this period, there has also been a substantial increase in the price of cancer medicines,” Daniel E. Myers, MD, of the University of Calgary, Canada, and colleagues explain in their report, published online October 6 in Cancer.

To investigate the impact of these trends on pharmaceutical earnings, the investigators performed a retrospective analysis of the revenue generated from oncology drugs in comparison with total drug revenue among 10 large pharmaceutical companies between 2010 and 2019, using itemized product-sales data publicly available through company websites or annual filings.

The data, adjusted for inflation and converted to 2019 U.S. dollars, revealed that annual revenue for the 10 companies increased from $55.8 billion to $95.1 billion during the study period. Most of the growth in revenue occurred in the past 5 years. Over the decade, non-oncology drug revenue decreased by 18% – from $342.2 billion to $281.5 billion.

Overall, revenues from cancer drugs accounted for 25% of the net revenues generated by these companies in 2019, up from 14% in 2010. Roche had both the highest net revenue – $23.9 billion in 2010 and $27.7 billion in 2019 – and the greatest proportion of revenue from cancer drugs – 63.5% in 2016 and 57% in 2019.

Merck saw substantial growth in revenue from cancer drug sales, particularly between 2016 and 2019. In 2016, the company generated $2.4 billion from these medicines, representing 6% of total revenue. By 2019, that amount had grown to $12.3 billion, representing almost 30% of total revenue. This increase was driven largely by their drug pembrolizumab, which alone drew in about $11 billion in 2019, or 12% of total oncology revenue, the investigators note.

Sanofi and GSK had some of the lowest net revenues from cancer drugs during the study period. For instance, in 2019, GSK generated $300 million in revenue from oncology drugs, representing less than 1% of the company’s total revenue, down from 3% of its total revenue in 2010.

“With the cost of cancer drugs rapidly rising, further work is needed to understand how this [overall] increase in sales revenue reflects industry profit, and how this is linked (or not) to improvements in patient and population outcomes,” they conclude. Although data regarding how cancer drug development affects population mortality rates are limited, “there is a notion within biomedicine that rising corporate profitability may not translate into proportional societal gains.”

No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Cumulative annual revenue from cancer drug sales increased by 70% among the world’s largest pharmaceutical companies over the past decade, a retrospective analysis shows.

By comparison, revenues from other types of medications decreased by 18% during the same period.

“Cancer drugs now account for approximately 27% of new drug approvals in the United States, compared to 4% in the 1980s. During this period, there has also been a substantial increase in the price of cancer medicines,” Daniel E. Myers, MD, of the University of Calgary, Canada, and colleagues explain in their report, published online October 6 in Cancer.

To investigate the impact of these trends on pharmaceutical earnings, the investigators performed a retrospective analysis of the revenue generated from oncology drugs in comparison with total drug revenue among 10 large pharmaceutical companies between 2010 and 2019, using itemized product-sales data publicly available through company websites or annual filings.

The data, adjusted for inflation and converted to 2019 U.S. dollars, revealed that annual revenue for the 10 companies increased from $55.8 billion to $95.1 billion during the study period. Most of the growth in revenue occurred in the past 5 years. Over the decade, non-oncology drug revenue decreased by 18% – from $342.2 billion to $281.5 billion.

Overall, revenues from cancer drugs accounted for 25% of the net revenues generated by these companies in 2019, up from 14% in 2010. Roche had both the highest net revenue – $23.9 billion in 2010 and $27.7 billion in 2019 – and the greatest proportion of revenue from cancer drugs – 63.5% in 2016 and 57% in 2019.

Merck saw substantial growth in revenue from cancer drug sales, particularly between 2016 and 2019. In 2016, the company generated $2.4 billion from these medicines, representing 6% of total revenue. By 2019, that amount had grown to $12.3 billion, representing almost 30% of total revenue. This increase was driven largely by their drug pembrolizumab, which alone drew in about $11 billion in 2019, or 12% of total oncology revenue, the investigators note.

Sanofi and GSK had some of the lowest net revenues from cancer drugs during the study period. For instance, in 2019, GSK generated $300 million in revenue from oncology drugs, representing less than 1% of the company’s total revenue, down from 3% of its total revenue in 2010.

“With the cost of cancer drugs rapidly rising, further work is needed to understand how this [overall] increase in sales revenue reflects industry profit, and how this is linked (or not) to improvements in patient and population outcomes,” they conclude. Although data regarding how cancer drug development affects population mortality rates are limited, “there is a notion within biomedicine that rising corporate profitability may not translate into proportional societal gains.”

No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Cumulative annual revenue from cancer drug sales increased by 70% among the world’s largest pharmaceutical companies over the past decade, a retrospective analysis shows.

By comparison, revenues from other types of medications decreased by 18% during the same period.

“Cancer drugs now account for approximately 27% of new drug approvals in the United States, compared to 4% in the 1980s. During this period, there has also been a substantial increase in the price of cancer medicines,” Daniel E. Myers, MD, of the University of Calgary, Canada, and colleagues explain in their report, published online October 6 in Cancer.

To investigate the impact of these trends on pharmaceutical earnings, the investigators performed a retrospective analysis of the revenue generated from oncology drugs in comparison with total drug revenue among 10 large pharmaceutical companies between 2010 and 2019, using itemized product-sales data publicly available through company websites or annual filings.

The data, adjusted for inflation and converted to 2019 U.S. dollars, revealed that annual revenue for the 10 companies increased from $55.8 billion to $95.1 billion during the study period. Most of the growth in revenue occurred in the past 5 years. Over the decade, non-oncology drug revenue decreased by 18% – from $342.2 billion to $281.5 billion.

Overall, revenues from cancer drugs accounted for 25% of the net revenues generated by these companies in 2019, up from 14% in 2010. Roche had both the highest net revenue – $23.9 billion in 2010 and $27.7 billion in 2019 – and the greatest proportion of revenue from cancer drugs – 63.5% in 2016 and 57% in 2019.

Merck saw substantial growth in revenue from cancer drug sales, particularly between 2016 and 2019. In 2016, the company generated $2.4 billion from these medicines, representing 6% of total revenue. By 2019, that amount had grown to $12.3 billion, representing almost 30% of total revenue. This increase was driven largely by their drug pembrolizumab, which alone drew in about $11 billion in 2019, or 12% of total oncology revenue, the investigators note.

Sanofi and GSK had some of the lowest net revenues from cancer drugs during the study period. For instance, in 2019, GSK generated $300 million in revenue from oncology drugs, representing less than 1% of the company’s total revenue, down from 3% of its total revenue in 2010.

“With the cost of cancer drugs rapidly rising, further work is needed to understand how this [overall] increase in sales revenue reflects industry profit, and how this is linked (or not) to improvements in patient and population outcomes,” they conclude. Although data regarding how cancer drug development affects population mortality rates are limited, “there is a notion within biomedicine that rising corporate profitability may not translate into proportional societal gains.”

No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A potential new urine biomarker for prostate cancer not only spots the presence of aggressive tumors, it also indicates the amount of these tumors, according to a recent report.

In a study of biopsy and prostatectomy samples, researchers found that the multigene Prostate Urine Risk-4 (PUR-4) signature was strongly associated with the presence and amount of Gleason pattern 4 tumors, but not tumors of less aggressive histology.

Given that increased Gleason pattern 4 tumor burden is associated with disease progression in men at intermediate risk, the results suggest that “PUR can show us which men at intermediate risk may require treatment and which may instead be managed conservatively with surveillance,” said senior author Jeremy Clark, PhD, of the University of East Anglia, Norwich, England. “PUR will also be useful for monitoring disease in men that do not currently require treatment and flag up the emergence and expansion of aggressive disease.”

The study by Dr. Clark and colleagues was published online on Nov. 3, 2021, in Life.

Tests using the traditional blood-based biomarker for prostate cancer – prostate-specific antigen (PSA) – have limited sensitivity and specificity, leading to unnecessary biopsies and overtreatment.

The PUR biomarker, one of several emerging alternatives to PSA, is a four-group classifier based on 36 genes, Dr. Clark and colleagues explained. Its categories correspond to the probabilities of the presence of normal tissue (PUR-1), and D’Amico low-risk (PUR-2), intermediate-risk (PUR-3), and high-risk (PUR-4) prostate cancer.

Dr. Clark’s team found in earlier research that the PUR-4 signature was able to predict disease progression in men on active surveillance for prostate cancer up to 5 years after a single urine sample. For their latest study, they sought to understand the relationship between PUR-4 and the amount and grade of tumor.

On the basis of biopsy samples from 215 men with prostate cancer, the researchers found that PUR-4 signature values correlated significantly with increasing Gleason grade.

There was no significant difference in PSA level by tumor volume for Gleason grade 1, 2, or 3. The same was true for PUR-4 and Gleason grade 1 tumors, which only contain less clinically significant Gleason pattern 3 cancer. However, PUR-4 values in men with Gleason grade 2 tumors larger than the median were significantly greater than for smaller tumors. PUR-4 values for large Gleason grade 3 tumors were also greater than for smaller ones, although the difference did not reach statistical significance.

“Since [Gleason grade] 2 and [Gleason grade] 3 contain both Gleason pattern 3 and 4 cancer these observations suggest that Gleason Pattern 4 cancer may be contributing to PUR-4 status,” the authors wrote.

The researchers also examined radical-prostatectomy specimens from nine men – three with Gleason grade 1, four with Gleason grade 2, and two with Gleason grade 3 tumors, as determined on the basis of presurgical biopsy.

There was no significant correlation between PUR-4 and PSA levels, nor were PUR-4 values linked to total tumor area or Gleason pattern 3 tumor area. But the amount of Gleason pattern 4 tumors showed a strong correlation with PUR-4 values, which did not change after adjusting for total prostate size.

“Our study shows that the PUR test can assess the amount of Gleason pattern 4 without the need for a biopsy,” Dr. Clark said in an interview. “It could therefore be a very useful tool indeed for assessing a man’s risk of dying from prostate cancer.”

Jack Schalken, PhD, a professor of experimental urology at Radboud University Medical Center in Nijmegen, the Netherlands, called PUR “another test” for prostate cancer the performance of which is in the same range as that of existing products.

“In fact, several tests are commercially available, but the clinical use is surprisingly low,” he told this news organization. Dr. Schalken, who was not involved in the new study, has reviewed several biomarkers for prostate cancer.

The PUR test is now undergoing validation in an international study that is expected to last another 2 years, Dr. Clark said. If successful, the test would stand out for several reasons.

First, it is based on many genes, so it is able to spot malignancies that other tests, which rely on just a few genes, may not pick up. In addition, although it is sensitive to the amount of Gleason pattern 4 tumor, it does not seem to detect the clinically less significant Gleason pattern 3 cancers.

“We have an at-home collection kit – the men do not have to come to a hospital to provide a urine sample,” Dr. Clark said.

The study did not receive commercial funding. Dr. Clark and two coauthors have filed a patent application related to their research.
 

A version of this article first appeared on Medscape.com.

A potential new urine biomarker for prostate cancer not only spots the presence of aggressive tumors, it also indicates the amount of these tumors, according to a recent report.

In a study of biopsy and prostatectomy samples, researchers found that the multigene Prostate Urine Risk-4 (PUR-4) signature was strongly associated with the presence and amount of Gleason pattern 4 tumors, but not tumors of less aggressive histology.

Given that increased Gleason pattern 4 tumor burden is associated with disease progression in men at intermediate risk, the results suggest that “PUR can show us which men at intermediate risk may require treatment and which may instead be managed conservatively with surveillance,” said senior author Jeremy Clark, PhD, of the University of East Anglia, Norwich, England. “PUR will also be useful for monitoring disease in men that do not currently require treatment and flag up the emergence and expansion of aggressive disease.”

The study by Dr. Clark and colleagues was published online on Nov. 3, 2021, in Life.

Tests using the traditional blood-based biomarker for prostate cancer – prostate-specific antigen (PSA) – have limited sensitivity and specificity, leading to unnecessary biopsies and overtreatment.

The PUR biomarker, one of several emerging alternatives to PSA, is a four-group classifier based on 36 genes, Dr. Clark and colleagues explained. Its categories correspond to the probabilities of the presence of normal tissue (PUR-1), and D’Amico low-risk (PUR-2), intermediate-risk (PUR-3), and high-risk (PUR-4) prostate cancer.

Dr. Clark’s team found in earlier research that the PUR-4 signature was able to predict disease progression in men on active surveillance for prostate cancer up to 5 years after a single urine sample. For their latest study, they sought to understand the relationship between PUR-4 and the amount and grade of tumor.

On the basis of biopsy samples from 215 men with prostate cancer, the researchers found that PUR-4 signature values correlated significantly with increasing Gleason grade.

There was no significant difference in PSA level by tumor volume for Gleason grade 1, 2, or 3. The same was true for PUR-4 and Gleason grade 1 tumors, which only contain less clinically significant Gleason pattern 3 cancer. However, PUR-4 values in men with Gleason grade 2 tumors larger than the median were significantly greater than for smaller tumors. PUR-4 values for large Gleason grade 3 tumors were also greater than for smaller ones, although the difference did not reach statistical significance.

“Since [Gleason grade] 2 and [Gleason grade] 3 contain both Gleason pattern 3 and 4 cancer these observations suggest that Gleason Pattern 4 cancer may be contributing to PUR-4 status,” the authors wrote.

The researchers also examined radical-prostatectomy specimens from nine men – three with Gleason grade 1, four with Gleason grade 2, and two with Gleason grade 3 tumors, as determined on the basis of presurgical biopsy.

There was no significant correlation between PUR-4 and PSA levels, nor were PUR-4 values linked to total tumor area or Gleason pattern 3 tumor area. But the amount of Gleason pattern 4 tumors showed a strong correlation with PUR-4 values, which did not change after adjusting for total prostate size.

“Our study shows that the PUR test can assess the amount of Gleason pattern 4 without the need for a biopsy,” Dr. Clark said in an interview. “It could therefore be a very useful tool indeed for assessing a man’s risk of dying from prostate cancer.”

Jack Schalken, PhD, a professor of experimental urology at Radboud University Medical Center in Nijmegen, the Netherlands, called PUR “another test” for prostate cancer the performance of which is in the same range as that of existing products.

“In fact, several tests are commercially available, but the clinical use is surprisingly low,” he told this news organization. Dr. Schalken, who was not involved in the new study, has reviewed several biomarkers for prostate cancer.

The PUR test is now undergoing validation in an international study that is expected to last another 2 years, Dr. Clark said. If successful, the test would stand out for several reasons.

First, it is based on many genes, so it is able to spot malignancies that other tests, which rely on just a few genes, may not pick up. In addition, although it is sensitive to the amount of Gleason pattern 4 tumor, it does not seem to detect the clinically less significant Gleason pattern 3 cancers.

“We have an at-home collection kit – the men do not have to come to a hospital to provide a urine sample,” Dr. Clark said.

The study did not receive commercial funding. Dr. Clark and two coauthors have filed a patent application related to their research.
 

A version of this article first appeared on Medscape.com.

A potential new urine biomarker for prostate cancer not only spots the presence of aggressive tumors, it also indicates the amount of these tumors, according to a recent report.

In a study of biopsy and prostatectomy samples, researchers found that the multigene Prostate Urine Risk-4 (PUR-4) signature was strongly associated with the presence and amount of Gleason pattern 4 tumors, but not tumors of less aggressive histology.

Given that increased Gleason pattern 4 tumor burden is associated with disease progression in men at intermediate risk, the results suggest that “PUR can show us which men at intermediate risk may require treatment and which may instead be managed conservatively with surveillance,” said senior author Jeremy Clark, PhD, of the University of East Anglia, Norwich, England. “PUR will also be useful for monitoring disease in men that do not currently require treatment and flag up the emergence and expansion of aggressive disease.”

The study by Dr. Clark and colleagues was published online on Nov. 3, 2021, in Life.

Tests using the traditional blood-based biomarker for prostate cancer – prostate-specific antigen (PSA) – have limited sensitivity and specificity, leading to unnecessary biopsies and overtreatment.

The PUR biomarker, one of several emerging alternatives to PSA, is a four-group classifier based on 36 genes, Dr. Clark and colleagues explained. Its categories correspond to the probabilities of the presence of normal tissue (PUR-1), and D’Amico low-risk (PUR-2), intermediate-risk (PUR-3), and high-risk (PUR-4) prostate cancer.

Dr. Clark’s team found in earlier research that the PUR-4 signature was able to predict disease progression in men on active surveillance for prostate cancer up to 5 years after a single urine sample. For their latest study, they sought to understand the relationship between PUR-4 and the amount and grade of tumor.

On the basis of biopsy samples from 215 men with prostate cancer, the researchers found that PUR-4 signature values correlated significantly with increasing Gleason grade.

There was no significant difference in PSA level by tumor volume for Gleason grade 1, 2, or 3. The same was true for PUR-4 and Gleason grade 1 tumors, which only contain less clinically significant Gleason pattern 3 cancer. However, PUR-4 values in men with Gleason grade 2 tumors larger than the median were significantly greater than for smaller tumors. PUR-4 values for large Gleason grade 3 tumors were also greater than for smaller ones, although the difference did not reach statistical significance.

“Since [Gleason grade] 2 and [Gleason grade] 3 contain both Gleason pattern 3 and 4 cancer these observations suggest that Gleason Pattern 4 cancer may be contributing to PUR-4 status,” the authors wrote.

The researchers also examined radical-prostatectomy specimens from nine men – three with Gleason grade 1, four with Gleason grade 2, and two with Gleason grade 3 tumors, as determined on the basis of presurgical biopsy.

There was no significant correlation between PUR-4 and PSA levels, nor were PUR-4 values linked to total tumor area or Gleason pattern 3 tumor area. But the amount of Gleason pattern 4 tumors showed a strong correlation with PUR-4 values, which did not change after adjusting for total prostate size.

“Our study shows that the PUR test can assess the amount of Gleason pattern 4 without the need for a biopsy,” Dr. Clark said in an interview. “It could therefore be a very useful tool indeed for assessing a man’s risk of dying from prostate cancer.”

Jack Schalken, PhD, a professor of experimental urology at Radboud University Medical Center in Nijmegen, the Netherlands, called PUR “another test” for prostate cancer the performance of which is in the same range as that of existing products.

“In fact, several tests are commercially available, but the clinical use is surprisingly low,” he told this news organization. Dr. Schalken, who was not involved in the new study, has reviewed several biomarkers for prostate cancer.

The PUR test is now undergoing validation in an international study that is expected to last another 2 years, Dr. Clark said. If successful, the test would stand out for several reasons.

First, it is based on many genes, so it is able to spot malignancies that other tests, which rely on just a few genes, may not pick up. In addition, although it is sensitive to the amount of Gleason pattern 4 tumor, it does not seem to detect the clinically less significant Gleason pattern 3 cancers.

“We have an at-home collection kit – the men do not have to come to a hospital to provide a urine sample,” Dr. Clark said.

The study did not receive commercial funding. Dr. Clark and two coauthors have filed a patent application related to their research.
 

A version of this article first appeared on Medscape.com.

Recent research suggests that some pediatric patients who develop neuropsychiatric symptoms from COVID-19 may have intrathecal antineural SARS-CoV-2 autoantibodies, which may hint at central nervous system (CNS) autoimmunity in these patients.

“Overall, these findings indicate that severe neuropsychiatric symptoms can occur in the setting of pediatric COVID-19, including patients who lack many of the cardinal systemic features,” Christopher M. Bartley, MD, PhD, of the Weill Institute for Neurosciences at the University of California, San Francisco, and colleagues wrote in their study. “These data highlight the possibility of SARS-CoV-2 neuroinvasion and/or CNS autoimmunity in pediatric patients with COVID-19 and neuropsychiatric symptoms.”

In a case series published Oct. 25 in JAMA Neurology (doi: 10.1001/jamaneurol.2021.3821), Dr. Bartley and colleagues examined three pediatric patients who were infected with SARS-CoV-2 and, over a period of 5 months in 2020, were admitted to the hospital – where they received a neurology consultation for “subacute, functionally impairing behavioral changes.”

Patient 1 had a history of unspecified anxiety and depression, and was admitted for erratic behavior, paranoia-like fears, social withdrawal, and insomnia. The patient did not respond to treatment with risperidone and gabapentin, and was readmitted soon after discharge, then treated with olanzapine followed by a transition to valproate and lorazepam. It was found the patient had cerebrospinal fluid (CSF) abnormalities in the form of elevated protein levels, and an elevated IgG index, and was given intravenous immunoglobulin followed by IV methylprednisolone. While symptoms such as paranoia improved and the patient was able to better organize thoughts after 5 days, other symptoms such as delusions and hyperreflexia persisted for at least 1 month before resolving, and some symptoms, such as lability, did not resolve before discharge.

Patient 2 had a history of motor tics and anxiety, but showed signs of insomnia, mood lability, impaired concentration, difficulty finding words, and problems completing homework following a SARS-CoV-2 infection. The patient’s father previously had been diagnosed with COVID-19 and the patient developed respiratory symptoms and fever; an IgG serology test later confirmed a SARS-CoV-2 infection. The patient went on to experience internal preoccupation, aggression, and suicidal ideation. The patients was treated with aripiprazole and risperidone, but did not respond, and was admitted to the hospital. As with patient 1, patient 2 had CSF abnormalities in the form of elevated protein levels, and responded to IV methylprednisolone, with working memory and bradyphrenia improving. However, the patient developed insomnia, extreme anxiety, suicidal ideation, aggression, and sadness after discharge, and was readmitted. The patient was treated with IV immunoglobulin, and discharged with quetiapine and lithium.

“Six months later, although improved from initial presentation, the patient required academic accommodations and continued to endorse forgetfulness and attention difficulties. The patient’s chronic tics and anxiety were unchanged,” Dr. Bartley and colleagues wrote.

Patient 3 had no psychiatric history but started to demonstrate “odd behavior, including repetitive behaviors, anorexia, and insomnia” following a SARS-CoV-2 infection. After being hospitalized, the patient showed signs of “ideomotor apraxia, abulia, disorganized behavior, agitation, and diffusely brisk reflexes” and had a high white blood cell count, creatine kinase level, and C-reactive protein level. CSF was also abnormal for this patient, with three unique oligoclonal bands identified. The patient was treated with lorazepam and olanzapine, did not receive immunotherapy, and was discharged without psychiatric medications after 4 days.

When the researchers performed testing on each of the three patients, they found intrathecal anti–SARS-CoV-2 IgG and immunostained mouse brain tissue, and “a diverse set of candidate autoantigens by human phage immunoprecipitation sequencing” in patient 1 and patient 2. In comparison, patient 3 “neither appreciably immunostained nor enriched candidates by human phage immunoprecipitation sequencing,” the researchers said.

“These data motivate a systematic study of humoral immunity in the CSF of pediatric patients with COVID-19 and neuropsychiatric involvement and the potential for immunotherapy in some,” Dr. Bartley and colleagues concluded.
 

Potential of CNS autoimmunity

Evan J. Kyzar, MD, PhD, a resident physician in psychiatry at New York State Psychiatric Institute in New York Presbyterian–Columbia Campus, said in an interview that the results of the case series show some pediatric patients with neuropsychiatric symptoms can have anti-SARS-CoV-2 antibodies after viral clearance.

“Interestingly, some of the patients in this study also had antibodies in the CSF that targeted native proteins, demonstrating that COVID-19 may lead to autoimmunity directed at the brain,” he said. “This study increases our knowledge of how COVID-19 interacts with the nervous system and how autoimmune mechanisms might be contributing to at least a portion of patients with neuropsychiatric symptoms during acute infection, and possibly even after viral clearance.”

Dr. Kyzar noted that the immunological methods in the study were “cutting-edge” and the validation exploring the immune responses was detailed, but was limited because of the small sample size.

“[T]he researchers are using similar techniques to explore psychiatric disorders such as depression and schizophrenia to determine if some patients diagnosed with these conditions may have CNS-targeting autoantibodies that contribute to their symptoms and clinical presentation,” Dr. Kyzar said. “This work has the potential to discover novel neuroimmune mechanisms contributing to neuropsychiatric disease and offer possible pathways for the discovery of new treatments.”

The authors reported financial relationships with Allen & Company, the Chan Zuckerberg Initiative, National Institutes of Health, Novartis, Public Health Company, Roche/Genentech, Sandler Foundation, and Takeda in the form of grants and personal fees. They reported funding and/or support from the Brain Research Foundation, Hanna H. Gray Fellowship, Howard Hughes Medical Institute, John A. Watson Scholar Program, Latinx Center of Excellence, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, President’s Postdoctoral Fellowship Program, and Shared Instrumentation grant. Dr. Kyzar reported no relevant financial disclosures.

Recent research suggests that some pediatric patients who develop neuropsychiatric symptoms from COVID-19 may have intrathecal antineural SARS-CoV-2 autoantibodies, which may hint at central nervous system (CNS) autoimmunity in these patients.

“Overall, these findings indicate that severe neuropsychiatric symptoms can occur in the setting of pediatric COVID-19, including patients who lack many of the cardinal systemic features,” Christopher M. Bartley, MD, PhD, of the Weill Institute for Neurosciences at the University of California, San Francisco, and colleagues wrote in their study. “These data highlight the possibility of SARS-CoV-2 neuroinvasion and/or CNS autoimmunity in pediatric patients with COVID-19 and neuropsychiatric symptoms.”

In a case series published Oct. 25 in JAMA Neurology (doi: 10.1001/jamaneurol.2021.3821), Dr. Bartley and colleagues examined three pediatric patients who were infected with SARS-CoV-2 and, over a period of 5 months in 2020, were admitted to the hospital – where they received a neurology consultation for “subacute, functionally impairing behavioral changes.”

Patient 1 had a history of unspecified anxiety and depression, and was admitted for erratic behavior, paranoia-like fears, social withdrawal, and insomnia. The patient did not respond to treatment with risperidone and gabapentin, and was readmitted soon after discharge, then treated with olanzapine followed by a transition to valproate and lorazepam. It was found the patient had cerebrospinal fluid (CSF) abnormalities in the form of elevated protein levels, and an elevated IgG index, and was given intravenous immunoglobulin followed by IV methylprednisolone. While symptoms such as paranoia improved and the patient was able to better organize thoughts after 5 days, other symptoms such as delusions and hyperreflexia persisted for at least 1 month before resolving, and some symptoms, such as lability, did not resolve before discharge.

Patient 2 had a history of motor tics and anxiety, but showed signs of insomnia, mood lability, impaired concentration, difficulty finding words, and problems completing homework following a SARS-CoV-2 infection. The patient’s father previously had been diagnosed with COVID-19 and the patient developed respiratory symptoms and fever; an IgG serology test later confirmed a SARS-CoV-2 infection. The patient went on to experience internal preoccupation, aggression, and suicidal ideation. The patients was treated with aripiprazole and risperidone, but did not respond, and was admitted to the hospital. As with patient 1, patient 2 had CSF abnormalities in the form of elevated protein levels, and responded to IV methylprednisolone, with working memory and bradyphrenia improving. However, the patient developed insomnia, extreme anxiety, suicidal ideation, aggression, and sadness after discharge, and was readmitted. The patient was treated with IV immunoglobulin, and discharged with quetiapine and lithium.

“Six months later, although improved from initial presentation, the patient required academic accommodations and continued to endorse forgetfulness and attention difficulties. The patient’s chronic tics and anxiety were unchanged,” Dr. Bartley and colleagues wrote.

Patient 3 had no psychiatric history but started to demonstrate “odd behavior, including repetitive behaviors, anorexia, and insomnia” following a SARS-CoV-2 infection. After being hospitalized, the patient showed signs of “ideomotor apraxia, abulia, disorganized behavior, agitation, and diffusely brisk reflexes” and had a high white blood cell count, creatine kinase level, and C-reactive protein level. CSF was also abnormal for this patient, with three unique oligoclonal bands identified. The patient was treated with lorazepam and olanzapine, did not receive immunotherapy, and was discharged without psychiatric medications after 4 days.

When the researchers performed testing on each of the three patients, they found intrathecal anti–SARS-CoV-2 IgG and immunostained mouse brain tissue, and “a diverse set of candidate autoantigens by human phage immunoprecipitation sequencing” in patient 1 and patient 2. In comparison, patient 3 “neither appreciably immunostained nor enriched candidates by human phage immunoprecipitation sequencing,” the researchers said.

“These data motivate a systematic study of humoral immunity in the CSF of pediatric patients with COVID-19 and neuropsychiatric involvement and the potential for immunotherapy in some,” Dr. Bartley and colleagues concluded.
 

Potential of CNS autoimmunity

Evan J. Kyzar, MD, PhD, a resident physician in psychiatry at New York State Psychiatric Institute in New York Presbyterian–Columbia Campus, said in an interview that the results of the case series show some pediatric patients with neuropsychiatric symptoms can have anti-SARS-CoV-2 antibodies after viral clearance.

“Interestingly, some of the patients in this study also had antibodies in the CSF that targeted native proteins, demonstrating that COVID-19 may lead to autoimmunity directed at the brain,” he said. “This study increases our knowledge of how COVID-19 interacts with the nervous system and how autoimmune mechanisms might be contributing to at least a portion of patients with neuropsychiatric symptoms during acute infection, and possibly even after viral clearance.”

Dr. Kyzar noted that the immunological methods in the study were “cutting-edge” and the validation exploring the immune responses was detailed, but was limited because of the small sample size.

“[T]he researchers are using similar techniques to explore psychiatric disorders such as depression and schizophrenia to determine if some patients diagnosed with these conditions may have CNS-targeting autoantibodies that contribute to their symptoms and clinical presentation,” Dr. Kyzar said. “This work has the potential to discover novel neuroimmune mechanisms contributing to neuropsychiatric disease and offer possible pathways for the discovery of new treatments.”

The authors reported financial relationships with Allen & Company, the Chan Zuckerberg Initiative, National Institutes of Health, Novartis, Public Health Company, Roche/Genentech, Sandler Foundation, and Takeda in the form of grants and personal fees. They reported funding and/or support from the Brain Research Foundation, Hanna H. Gray Fellowship, Howard Hughes Medical Institute, John A. Watson Scholar Program, Latinx Center of Excellence, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, President’s Postdoctoral Fellowship Program, and Shared Instrumentation grant. Dr. Kyzar reported no relevant financial disclosures.

Recent research suggests that some pediatric patients who develop neuropsychiatric symptoms from COVID-19 may have intrathecal antineural SARS-CoV-2 autoantibodies, which may hint at central nervous system (CNS) autoimmunity in these patients.

“Overall, these findings indicate that severe neuropsychiatric symptoms can occur in the setting of pediatric COVID-19, including patients who lack many of the cardinal systemic features,” Christopher M. Bartley, MD, PhD, of the Weill Institute for Neurosciences at the University of California, San Francisco, and colleagues wrote in their study. “These data highlight the possibility of SARS-CoV-2 neuroinvasion and/or CNS autoimmunity in pediatric patients with COVID-19 and neuropsychiatric symptoms.”

In a case series published Oct. 25 in JAMA Neurology (doi: 10.1001/jamaneurol.2021.3821), Dr. Bartley and colleagues examined three pediatric patients who were infected with SARS-CoV-2 and, over a period of 5 months in 2020, were admitted to the hospital – where they received a neurology consultation for “subacute, functionally impairing behavioral changes.”

Patient 1 had a history of unspecified anxiety and depression, and was admitted for erratic behavior, paranoia-like fears, social withdrawal, and insomnia. The patient did not respond to treatment with risperidone and gabapentin, and was readmitted soon after discharge, then treated with olanzapine followed by a transition to valproate and lorazepam. It was found the patient had cerebrospinal fluid (CSF) abnormalities in the form of elevated protein levels, and an elevated IgG index, and was given intravenous immunoglobulin followed by IV methylprednisolone. While symptoms such as paranoia improved and the patient was able to better organize thoughts after 5 days, other symptoms such as delusions and hyperreflexia persisted for at least 1 month before resolving, and some symptoms, such as lability, did not resolve before discharge.

Patient 2 had a history of motor tics and anxiety, but showed signs of insomnia, mood lability, impaired concentration, difficulty finding words, and problems completing homework following a SARS-CoV-2 infection. The patient’s father previously had been diagnosed with COVID-19 and the patient developed respiratory symptoms and fever; an IgG serology test later confirmed a SARS-CoV-2 infection. The patient went on to experience internal preoccupation, aggression, and suicidal ideation. The patients was treated with aripiprazole and risperidone, but did not respond, and was admitted to the hospital. As with patient 1, patient 2 had CSF abnormalities in the form of elevated protein levels, and responded to IV methylprednisolone, with working memory and bradyphrenia improving. However, the patient developed insomnia, extreme anxiety, suicidal ideation, aggression, and sadness after discharge, and was readmitted. The patient was treated with IV immunoglobulin, and discharged with quetiapine and lithium.

“Six months later, although improved from initial presentation, the patient required academic accommodations and continued to endorse forgetfulness and attention difficulties. The patient’s chronic tics and anxiety were unchanged,” Dr. Bartley and colleagues wrote.

Patient 3 had no psychiatric history but started to demonstrate “odd behavior, including repetitive behaviors, anorexia, and insomnia” following a SARS-CoV-2 infection. After being hospitalized, the patient showed signs of “ideomotor apraxia, abulia, disorganized behavior, agitation, and diffusely brisk reflexes” and had a high white blood cell count, creatine kinase level, and C-reactive protein level. CSF was also abnormal for this patient, with three unique oligoclonal bands identified. The patient was treated with lorazepam and olanzapine, did not receive immunotherapy, and was discharged without psychiatric medications after 4 days.

When the researchers performed testing on each of the three patients, they found intrathecal anti–SARS-CoV-2 IgG and immunostained mouse brain tissue, and “a diverse set of candidate autoantigens by human phage immunoprecipitation sequencing” in patient 1 and patient 2. In comparison, patient 3 “neither appreciably immunostained nor enriched candidates by human phage immunoprecipitation sequencing,” the researchers said.

“These data motivate a systematic study of humoral immunity in the CSF of pediatric patients with COVID-19 and neuropsychiatric involvement and the potential for immunotherapy in some,” Dr. Bartley and colleagues concluded.
 

Potential of CNS autoimmunity

Evan J. Kyzar, MD, PhD, a resident physician in psychiatry at New York State Psychiatric Institute in New York Presbyterian–Columbia Campus, said in an interview that the results of the case series show some pediatric patients with neuropsychiatric symptoms can have anti-SARS-CoV-2 antibodies after viral clearance.

“Interestingly, some of the patients in this study also had antibodies in the CSF that targeted native proteins, demonstrating that COVID-19 may lead to autoimmunity directed at the brain,” he said. “This study increases our knowledge of how COVID-19 interacts with the nervous system and how autoimmune mechanisms might be contributing to at least a portion of patients with neuropsychiatric symptoms during acute infection, and possibly even after viral clearance.”

Dr. Kyzar noted that the immunological methods in the study were “cutting-edge” and the validation exploring the immune responses was detailed, but was limited because of the small sample size.

“[T]he researchers are using similar techniques to explore psychiatric disorders such as depression and schizophrenia to determine if some patients diagnosed with these conditions may have CNS-targeting autoantibodies that contribute to their symptoms and clinical presentation,” Dr. Kyzar said. “This work has the potential to discover novel neuroimmune mechanisms contributing to neuropsychiatric disease and offer possible pathways for the discovery of new treatments.”

The authors reported financial relationships with Allen & Company, the Chan Zuckerberg Initiative, National Institutes of Health, Novartis, Public Health Company, Roche/Genentech, Sandler Foundation, and Takeda in the form of grants and personal fees. They reported funding and/or support from the Brain Research Foundation, Hanna H. Gray Fellowship, Howard Hughes Medical Institute, John A. Watson Scholar Program, Latinx Center of Excellence, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, President’s Postdoctoral Fellowship Program, and Shared Instrumentation grant. Dr. Kyzar reported no relevant financial disclosures.

Treating elevated low-density lipoprotein cholesterol (LDL-C) in adults younger than 40 with statins is highly cost-effective in men, and intermediately cost-effective in women, a new report suggests.

Time to relax the age 40 threshold

The U.S. Preventive Services Task Force and the American College of Cardiology/American Heart Association should emphasize lifetime risk of elevated cholesterol, Paul A. Heidenreich, MD, MS, Stanford University School of Medicine, California, and colleagues write in an accompanying editorial.

“In addition to calculating 10-year risk, we should calculate years of life lost (or QALYs lost) from unhealthy LDL-C levels, and both lifestyle and pharmacologic treatment should be considered to treat high LDL-C in adults regardless of age. We also need to communicate that the mantra ‘lower is better’ applies not only to a single measurement but to lifetime exposure to LDL-C,” the editorialists write.

“I think treatment should be earlier than age 40,” Dr. Heidenreich said in an interview.

“Part of the reason that 40 was chosen as a threshold was because everyone looked at 10-year, or even 20-year risk, and thought there was no reason to worry until you get older. It’s interesting that we never accepted that with high blood pressure. But more and more, we are learning that it is a lifelong process,” he said.

“Statins are getting less and less expensive, and their safety is more and more established with every decade that goes by. I definitely agree with this paper that it would actually make sense to be starting much earlier for those with elevated CVD risk from their high cholesterol.”

The study was supported by the U.S. National Heart, Lung, and Blood Institute (NHLBI), the Medical Research Council, Swindon, U.K. Dr. Moran and Dr. Heidenreich have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Treating elevated low-density lipoprotein cholesterol (LDL-C) in adults younger than 40 with statins is highly cost-effective in men, and intermediately cost-effective in women, a new report suggests.

Time to relax the age 40 threshold

The U.S. Preventive Services Task Force and the American College of Cardiology/American Heart Association should emphasize lifetime risk of elevated cholesterol, Paul A. Heidenreich, MD, MS, Stanford University School of Medicine, California, and colleagues write in an accompanying editorial.

“In addition to calculating 10-year risk, we should calculate years of life lost (or QALYs lost) from unhealthy LDL-C levels, and both lifestyle and pharmacologic treatment should be considered to treat high LDL-C in adults regardless of age. We also need to communicate that the mantra ‘lower is better’ applies not only to a single measurement but to lifetime exposure to LDL-C,” the editorialists write.

“I think treatment should be earlier than age 40,” Dr. Heidenreich said in an interview.

“Part of the reason that 40 was chosen as a threshold was because everyone looked at 10-year, or even 20-year risk, and thought there was no reason to worry until you get older. It’s interesting that we never accepted that with high blood pressure. But more and more, we are learning that it is a lifelong process,” he said.

“Statins are getting less and less expensive, and their safety is more and more established with every decade that goes by. I definitely agree with this paper that it would actually make sense to be starting much earlier for those with elevated CVD risk from their high cholesterol.”

The study was supported by the U.S. National Heart, Lung, and Blood Institute (NHLBI), the Medical Research Council, Swindon, U.K. Dr. Moran and Dr. Heidenreich have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Treating elevated low-density lipoprotein cholesterol (LDL-C) in adults younger than 40 with statins is highly cost-effective in men, and intermediately cost-effective in women, a new report suggests.

Time to relax the age 40 threshold

The U.S. Preventive Services Task Force and the American College of Cardiology/American Heart Association should emphasize lifetime risk of elevated cholesterol, Paul A. Heidenreich, MD, MS, Stanford University School of Medicine, California, and colleagues write in an accompanying editorial.

“In addition to calculating 10-year risk, we should calculate years of life lost (or QALYs lost) from unhealthy LDL-C levels, and both lifestyle and pharmacologic treatment should be considered to treat high LDL-C in adults regardless of age. We also need to communicate that the mantra ‘lower is better’ applies not only to a single measurement but to lifetime exposure to LDL-C,” the editorialists write.

“I think treatment should be earlier than age 40,” Dr. Heidenreich said in an interview.

“Part of the reason that 40 was chosen as a threshold was because everyone looked at 10-year, or even 20-year risk, and thought there was no reason to worry until you get older. It’s interesting that we never accepted that with high blood pressure. But more and more, we are learning that it is a lifelong process,” he said.

“Statins are getting less and less expensive, and their safety is more and more established with every decade that goes by. I definitely agree with this paper that it would actually make sense to be starting much earlier for those with elevated CVD risk from their high cholesterol.”

The study was supported by the U.S. National Heart, Lung, and Blood Institute (NHLBI), the Medical Research Council, Swindon, U.K. Dr. Moran and Dr. Heidenreich have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.