The Hospitalist

Apixaban appears to be safer and more effective than rivaroxaban for reducing risk of venous thromboembolism and bleeding, based on new research.

Recurrent venous thromboembolism (VTE) – a composite of pulmonary embolism and deep vein thrombosis – was the primary effectiveness outcome in the retrospective analysis of new-user data from almost 40,000 patients, which was published in Annals of Internal Medicine. Safety was evaluated through a composite of intracranial and gastrointestinal bleeding.

After a median follow-up of 102 days in the apixaban group and 105 days in the rivaroxaban group, apixaban demonstrated superiority for both primary outcomes.

These real-world findings may guide selection of initial anticoagulant therapy, reported lead author Ghadeer K. Dawwas, PhD, MSc, MBA, of the University of Pennsylvania, Philadelphia, and colleagues.

“Randomized clinical trials comparing apixaban with rivaroxaban in patients with VTE are under way (for example, COBRRA (NCT03266783),” the investigators wrote. “Until the results from these trials become available (The estimated completion date for COBRRA is December 2023.), observational studies that use existing data can provide evidence on the effectiveness and safety of these alternatives to inform clinical practice.”

In the new research, apixaban was associated with a 23% lower rate of recurrent VTE (hazard ratio, 0.77; 95% confidence interval, 0.69-0.87), including a 15% lower rate of deep vein thrombosis and a 41% lower rate of pulmonary embolism. Apixaban was associated with 40% fewer bleeding events (HR, 0.60; 95% CI, 0.53-0.69]), including a 40% lower rate of GI bleeding and a 46% lower rate of intracranial bleeding.

The study involved 37,236 patients with VTE, all of whom were diagnosed in at least one inpatient encounter and initiated direct oral anticoagulant (DOAC) therapy within 30 days, according to Optum’s deidentified Clinformatics Data Mart Database. Patients were evenly split into apixaban and rivaroxaban groups, with 18,618 individuals in each. Propensity score matching was used to minimize differences in baseline characteristics.

Apixaban was associated with an absolute reduction in recurrent VTE of 0.6% and 1.1% over 2 and 6 months, respectively, as well as reductions in bleeding of 1.1% and 1.5% over the same respective time periods.

The investigators noted that these findings were maintained in various sensitivity and subgroup analyses, including a model in which patients with VTE who had transient risk factors were compared with VTE patients exhibiting chronic risk factors.

“These findings suggest that apixaban has superior effectiveness and safety, compared with rivaroxaban and may provide guidance to clinicians and patients regarding selection of an anticoagulant for treatment of VTE,” Dr. Dawwas and colleagues concluded.

Study may have missed some nuance in possible outcomes, according to vascular surgeon

Thomas Wakefield, MD, a vascular surgeon and a professor of surgery at the University of Michigan Health Frankel Cardiovascular Center, Ann Arbor, generally agreed with the investigators’ conclusion, although he noted that DOAC selection may also be influenced by other considerations.

Houghton_Damon_Rochester_MN_web.jpg

“The results of this study suggest that, when choosing an agent for an individual patient, apixaban does appear to have an advantage over rivaroxaban related to recurrent VTE and bleeding,” Dr. Wakefield said in an interview. “One must keep in mind that these are not the only factors that are considered when choosing an agent and these are not the only two DOACs available. For example, rivaroxaban is given once per day while apixaban is given twice per day, and rivaroxaban has been shown to be successful in the treatment of other thrombotic disorders.”

Dr. Wakefield also pointed out that the study may have missed some nuance in possible outcomes.

“The current study looked at severe outcomes that resulted in inpatient hospitalization, so the generalization to strictly outpatient treatment and less severe outcomes cannot be inferred,” he said.

Damon E. Houghton, MD, of the department of medicine and a consultant in the department of vascular medicine and hematology at Mayo Clinic, Rochester, Minn., called the study a “very nice analysis,” highlighting the large sample size.

“The results are not a reason to abandon rivaroxaban altogether, but do suggest that, when otherwise appropriate for a patient, apixaban should be the first choice,” Dr. Houghton said in a written comment. “Hopefully this analysis will encourage more payers to create financial incentives that facilitate the use of apixaban in more patients.”

Randomized trial needed, says hematologist

Colleen Edwards, MD, of the departments of medicine, hematology, and medical oncology, at the Icahn School of Medicine at Mount Sinai, New York, had a more guarded view of the findings than Dr. Wakefield and Dr. Houghton.

Edwards_Colleen_NYC_web.jpg

“[The investigators] certainly seem to be doing a lot of statistical gymnastics in this paper,” Dr. Edwards said in an interview. “They used all kinds of surrogates in place of real data that you would get from a randomized trial.”

For example, Dr. Edwards noted the use of prescription refills as a surrogate for medication adherence, and emphasized that inpatient observational data may not reflect outpatient therapy.

“Inpatients are constantly missing their medicines all the time,” she said. “They’re holding it for procedures, they’re NPO, they’re off the floor, so they missed their medicine. So it’s just a very different patient population than the outpatient population, which is where venous thromboembolism is treated now, by and large.”

Although Dr. Edwards suggested that the findings might guide treatment selection “a little bit,” she noted that insurance constraints and costs play a greater role, and ultimately concluded that a randomized trial is needed to materially alter clinical decision-making.

“I think we really have to wait for randomized trial before we abandon our other choices,” she said.

The investigators disclosed relationships with Merck, Celgene, UCB, and others. Dr. Wakefield reported awaiting disclosures. Dr. Houghton and Dr. Edwards reported no relevant conflicts of interest.

Apixaban appears to be safer and more effective than rivaroxaban for reducing risk of venous thromboembolism and bleeding, based on new research.

Recurrent venous thromboembolism (VTE) – a composite of pulmonary embolism and deep vein thrombosis – was the primary effectiveness outcome in the retrospective analysis of new-user data from almost 40,000 patients, which was published in Annals of Internal Medicine. Safety was evaluated through a composite of intracranial and gastrointestinal bleeding.

After a median follow-up of 102 days in the apixaban group and 105 days in the rivaroxaban group, apixaban demonstrated superiority for both primary outcomes.

These real-world findings may guide selection of initial anticoagulant therapy, reported lead author Ghadeer K. Dawwas, PhD, MSc, MBA, of the University of Pennsylvania, Philadelphia, and colleagues.

“Randomized clinical trials comparing apixaban with rivaroxaban in patients with VTE are under way (for example, COBRRA (NCT03266783),” the investigators wrote. “Until the results from these trials become available (The estimated completion date for COBRRA is December 2023.), observational studies that use existing data can provide evidence on the effectiveness and safety of these alternatives to inform clinical practice.”

In the new research, apixaban was associated with a 23% lower rate of recurrent VTE (hazard ratio, 0.77; 95% confidence interval, 0.69-0.87), including a 15% lower rate of deep vein thrombosis and a 41% lower rate of pulmonary embolism. Apixaban was associated with 40% fewer bleeding events (HR, 0.60; 95% CI, 0.53-0.69]), including a 40% lower rate of GI bleeding and a 46% lower rate of intracranial bleeding.

The study involved 37,236 patients with VTE, all of whom were diagnosed in at least one inpatient encounter and initiated direct oral anticoagulant (DOAC) therapy within 30 days, according to Optum’s deidentified Clinformatics Data Mart Database. Patients were evenly split into apixaban and rivaroxaban groups, with 18,618 individuals in each. Propensity score matching was used to minimize differences in baseline characteristics.

Apixaban was associated with an absolute reduction in recurrent VTE of 0.6% and 1.1% over 2 and 6 months, respectively, as well as reductions in bleeding of 1.1% and 1.5% over the same respective time periods.

The investigators noted that these findings were maintained in various sensitivity and subgroup analyses, including a model in which patients with VTE who had transient risk factors were compared with VTE patients exhibiting chronic risk factors.

“These findings suggest that apixaban has superior effectiveness and safety, compared with rivaroxaban and may provide guidance to clinicians and patients regarding selection of an anticoagulant for treatment of VTE,” Dr. Dawwas and colleagues concluded.

Study may have missed some nuance in possible outcomes, according to vascular surgeon

Thomas Wakefield, MD, a vascular surgeon and a professor of surgery at the University of Michigan Health Frankel Cardiovascular Center, Ann Arbor, generally agreed with the investigators’ conclusion, although he noted that DOAC selection may also be influenced by other considerations.

Houghton_Damon_Rochester_MN_web.jpg

“The results of this study suggest that, when choosing an agent for an individual patient, apixaban does appear to have an advantage over rivaroxaban related to recurrent VTE and bleeding,” Dr. Wakefield said in an interview. “One must keep in mind that these are not the only factors that are considered when choosing an agent and these are not the only two DOACs available. For example, rivaroxaban is given once per day while apixaban is given twice per day, and rivaroxaban has been shown to be successful in the treatment of other thrombotic disorders.”

Dr. Wakefield also pointed out that the study may have missed some nuance in possible outcomes.

“The current study looked at severe outcomes that resulted in inpatient hospitalization, so the generalization to strictly outpatient treatment and less severe outcomes cannot be inferred,” he said.

Damon E. Houghton, MD, of the department of medicine and a consultant in the department of vascular medicine and hematology at Mayo Clinic, Rochester, Minn., called the study a “very nice analysis,” highlighting the large sample size.

“The results are not a reason to abandon rivaroxaban altogether, but do suggest that, when otherwise appropriate for a patient, apixaban should be the first choice,” Dr. Houghton said in a written comment. “Hopefully this analysis will encourage more payers to create financial incentives that facilitate the use of apixaban in more patients.”

Randomized trial needed, says hematologist

Colleen Edwards, MD, of the departments of medicine, hematology, and medical oncology, at the Icahn School of Medicine at Mount Sinai, New York, had a more guarded view of the findings than Dr. Wakefield and Dr. Houghton.

Edwards_Colleen_NYC_web.jpg

“[The investigators] certainly seem to be doing a lot of statistical gymnastics in this paper,” Dr. Edwards said in an interview. “They used all kinds of surrogates in place of real data that you would get from a randomized trial.”

For example, Dr. Edwards noted the use of prescription refills as a surrogate for medication adherence, and emphasized that inpatient observational data may not reflect outpatient therapy.

“Inpatients are constantly missing their medicines all the time,” she said. “They’re holding it for procedures, they’re NPO, they’re off the floor, so they missed their medicine. So it’s just a very different patient population than the outpatient population, which is where venous thromboembolism is treated now, by and large.”

Although Dr. Edwards suggested that the findings might guide treatment selection “a little bit,” she noted that insurance constraints and costs play a greater role, and ultimately concluded that a randomized trial is needed to materially alter clinical decision-making.

“I think we really have to wait for randomized trial before we abandon our other choices,” she said.

The investigators disclosed relationships with Merck, Celgene, UCB, and others. Dr. Wakefield reported awaiting disclosures. Dr. Houghton and Dr. Edwards reported no relevant conflicts of interest.

Apixaban appears to be safer and more effective than rivaroxaban for reducing risk of venous thromboembolism and bleeding, based on new research.

Recurrent venous thromboembolism (VTE) – a composite of pulmonary embolism and deep vein thrombosis – was the primary effectiveness outcome in the retrospective analysis of new-user data from almost 40,000 patients, which was published in Annals of Internal Medicine. Safety was evaluated through a composite of intracranial and gastrointestinal bleeding.

After a median follow-up of 102 days in the apixaban group and 105 days in the rivaroxaban group, apixaban demonstrated superiority for both primary outcomes.

These real-world findings may guide selection of initial anticoagulant therapy, reported lead author Ghadeer K. Dawwas, PhD, MSc, MBA, of the University of Pennsylvania, Philadelphia, and colleagues.

“Randomized clinical trials comparing apixaban with rivaroxaban in patients with VTE are under way (for example, COBRRA (NCT03266783),” the investigators wrote. “Until the results from these trials become available (The estimated completion date for COBRRA is December 2023.), observational studies that use existing data can provide evidence on the effectiveness and safety of these alternatives to inform clinical practice.”

In the new research, apixaban was associated with a 23% lower rate of recurrent VTE (hazard ratio, 0.77; 95% confidence interval, 0.69-0.87), including a 15% lower rate of deep vein thrombosis and a 41% lower rate of pulmonary embolism. Apixaban was associated with 40% fewer bleeding events (HR, 0.60; 95% CI, 0.53-0.69]), including a 40% lower rate of GI bleeding and a 46% lower rate of intracranial bleeding.

The study involved 37,236 patients with VTE, all of whom were diagnosed in at least one inpatient encounter and initiated direct oral anticoagulant (DOAC) therapy within 30 days, according to Optum’s deidentified Clinformatics Data Mart Database. Patients were evenly split into apixaban and rivaroxaban groups, with 18,618 individuals in each. Propensity score matching was used to minimize differences in baseline characteristics.

Apixaban was associated with an absolute reduction in recurrent VTE of 0.6% and 1.1% over 2 and 6 months, respectively, as well as reductions in bleeding of 1.1% and 1.5% over the same respective time periods.

The investigators noted that these findings were maintained in various sensitivity and subgroup analyses, including a model in which patients with VTE who had transient risk factors were compared with VTE patients exhibiting chronic risk factors.

“These findings suggest that apixaban has superior effectiveness and safety, compared with rivaroxaban and may provide guidance to clinicians and patients regarding selection of an anticoagulant for treatment of VTE,” Dr. Dawwas and colleagues concluded.

Study may have missed some nuance in possible outcomes, according to vascular surgeon

Thomas Wakefield, MD, a vascular surgeon and a professor of surgery at the University of Michigan Health Frankel Cardiovascular Center, Ann Arbor, generally agreed with the investigators’ conclusion, although he noted that DOAC selection may also be influenced by other considerations.

Houghton_Damon_Rochester_MN_web.jpg

“The results of this study suggest that, when choosing an agent for an individual patient, apixaban does appear to have an advantage over rivaroxaban related to recurrent VTE and bleeding,” Dr. Wakefield said in an interview. “One must keep in mind that these are not the only factors that are considered when choosing an agent and these are not the only two DOACs available. For example, rivaroxaban is given once per day while apixaban is given twice per day, and rivaroxaban has been shown to be successful in the treatment of other thrombotic disorders.”

Dr. Wakefield also pointed out that the study may have missed some nuance in possible outcomes.

“The current study looked at severe outcomes that resulted in inpatient hospitalization, so the generalization to strictly outpatient treatment and less severe outcomes cannot be inferred,” he said.

Damon E. Houghton, MD, of the department of medicine and a consultant in the department of vascular medicine and hematology at Mayo Clinic, Rochester, Minn., called the study a “very nice analysis,” highlighting the large sample size.

“The results are not a reason to abandon rivaroxaban altogether, but do suggest that, when otherwise appropriate for a patient, apixaban should be the first choice,” Dr. Houghton said in a written comment. “Hopefully this analysis will encourage more payers to create financial incentives that facilitate the use of apixaban in more patients.”

Randomized trial needed, says hematologist

Colleen Edwards, MD, of the departments of medicine, hematology, and medical oncology, at the Icahn School of Medicine at Mount Sinai, New York, had a more guarded view of the findings than Dr. Wakefield and Dr. Houghton.

Edwards_Colleen_NYC_web.jpg

“[The investigators] certainly seem to be doing a lot of statistical gymnastics in this paper,” Dr. Edwards said in an interview. “They used all kinds of surrogates in place of real data that you would get from a randomized trial.”

For example, Dr. Edwards noted the use of prescription refills as a surrogate for medication adherence, and emphasized that inpatient observational data may not reflect outpatient therapy.

“Inpatients are constantly missing their medicines all the time,” she said. “They’re holding it for procedures, they’re NPO, they’re off the floor, so they missed their medicine. So it’s just a very different patient population than the outpatient population, which is where venous thromboembolism is treated now, by and large.”

Although Dr. Edwards suggested that the findings might guide treatment selection “a little bit,” she noted that insurance constraints and costs play a greater role, and ultimately concluded that a randomized trial is needed to materially alter clinical decision-making.

“I think we really have to wait for randomized trial before we abandon our other choices,” she said.

The investigators disclosed relationships with Merck, Celgene, UCB, and others. Dr. Wakefield reported awaiting disclosures. Dr. Houghton and Dr. Edwards reported no relevant conflicts of interest.

As the pandemic shows no signs of ending, primary care doctors may be reassured that delivering care via video teleconferencing can be as effective as usual in-person consultation for several common health conditions.

Albritton_Jordan_NC_web.jpg

This was a finding of a new study published in Annals of Internal Medicine involving a review of literature on video teleconferencing (VTC) visits, which was authored by Jordan Albritton, PhD, MPH and his colleagues.

The authors found generally comparable patient outcomes as well as no differences in health care use, patient satisfaction, and quality of life when visits conducted using VTC were compared with usual care.

While VTC may work best for monitoring patients with chronic conditions, it can also be effective for acute care, said Dr. Albritton, who is a research public health analyst at RTI International in Research Triangle Park, N.C., in an interview.

The investigators analyzed 20 randomized controlled trials of at least 50 patients and acceptable risk of bias in which VTC was used either for main or adjunct care delivery. Published from 2013 to 2019, these studies looked at care for diabetes and pain management, as well as some respiratory, neurologic, and cardiovascular conditions. Studies comparing VTC with usual care that did not involve any added in-person care were more likely to favor the VTC group, the investigators found.

“We excluded conditions such as substance use disorders, maternal care, and weight management for which there was sufficient prior evidence of the benefit of VTC,” Dr. Albritton said in an interview. “But I don’t think our results would have been substantially different if we had included these other diseases. We found general evidence in the literature that VTC is effective for a broader range of conditions.”

In some cases, such as if changes in a patient’s condition triggered an automatic virtual visit, the author said he thinks VTC may lead to even greater effectiveness.

“The doctor and patient could figure out on the spot what’s going on and perhaps change the medication,” Dr. Albritton explained.

In general agreement is Julia L. Frydman, MD, assistant professor in the Brookdale Department of Geriatric and Palliative Medicine at Icahn School of Medicine at Mount Sinai in New York, who was not involved in the RTI research.

Frydman_Julia_L_NYC_web.jpg

“Telemedicine has promise across many medical subspecialties, and what we need now are more studies to understand the perspectives of patients, caregivers, and clinicians as well as the impact of telemedicine on health outcomes and healthcare utilization.”

In acknowledgment of their utility, video visits are on the rise in the United States. A 2020 survey found that 22% of patients and 80% of physicians reported having participated in a video visit, three times the rate of the previous year. The authors noted that policy changes enacted to support telehealth strategies during the pandemic are expected to remain in place, and although patients are returning to in-person care, the virtual visit market will likely continue growing.
 

Increased telemedicine use by older adults

“We’ve seen an exciting expansion of telemedicine use among older adults, and we need to focus on continuing to meet their needs,” Dr. Frydman said.

In a recent study of televisits during the pandemic, Dr. Frydman’s group found a fivefold greater uptake of remote consultations by seniors – from 5% to 25%. Although in-person visits were far more common among older adults.

A specific advantage of video-based over audio-only telehealth, noted Dr. Albritton, is that physicians can directly observe patients in their home environment. Sharing that view is Deepa Iyengar, MBBS/MD,MPH, professor of family medicine at McGovern Medical School at The University of Texas Health Science Center at Houston, where, she said, “the pandemic has put VTC use into overdrive.”

Iyengar_Deepa_Houston_TX_web.jpg

According to Dr. Iyengar, who was not involved in the RTI research, the video component definitely represents value-added over phone calls. “You can pick up visual cues on video that you might not see if the patient came in and you can see what the home environment is like – whether there are a lot of loose rugs on the floor or broken or missing light bulbs,” she said in an interview.
 

‘VTC is here to stay’

In other parts of the country, doctors are finding virtual care useful – and more common. “VTC is here to stay, for sure – the horse is out of the barn,” said Cheryl L. Wilkes, MD, an internist at Northwestern Medicine and assistant professor of medicine at Northwestern University in Chicago. “The RTI study shows no harm from VTC and also shows it may even improve clinical outcomes.”

Wilkes_Cheryl_L_CHICAGO_web.jpg

Video visits can also save patients high parking fees at clinics and spare the sick or elderly from having to hire caregivers to bring them into the office or from having to walk blocks in dangerous weather conditions, she added. “And I can do a virtual visit on the fly or at night when a relative or caregiver is home from work to be there with the patient.”

In addition to being beneficial for following up with patients with chronic diseases such as hypertension or diabetes, VTC may be able to replace some visits that have traditionally required hands-on care, said Dr. Wilkes.

She said she knows a cardiologist who has refined a process whereby a patient – say, one who may have edema – is asked to perform a maneuver via VTC and then display the result to the doctor: The doctor says, “put your leg up and press on it hard for 10 seconds and then show me what it looks like,” according to Dr. Wilkes.

The key now is to identify the best persons across specialties from neurology to rheumatology to videotape ways they’ve created to help their patients participate virtually in consults traditionally done at the office, Dr. Wilkes noted.

But some conditions will always require palpation and the use of a stethoscope, according Dr. Iyengar.

“If someone has an ulcer, I have to be able to feel it,” she said.

And while some maternity care can be given virtually – for instance, if a mother-to be develops a bad cold – hands-on obstetrical care to check the position and health of the baby obviously has to be done in person. “So VTC is definitely going to be a welcome addition but not a replacement,” Dr. Iyengar said.

Gaps in research on VTC visits

Many questions remain regarding the overall usefulness of VTC visits for certain patient groups, according to the authors.

They highlighted, for example, the dearth of data on subgroups or on underserved and vulnerable populations, with no head-to-head studies identified in their review. In addition, they found no studies examining VTC versus usual care for patients with concurrent conditions or on its effect on health equity and disparities.

“It’s now our job to understand the ongoing barriers to telemedicine access, including the digital divide and the usability of telemedicine platforms, and design interventions that overcome them,” Dr. Frydman said. “At the same time, we need to make sure we’re understanding and respecting the preferences of older adults in terms of how they access health care.”

This study was supported by the Patient-Centered Outcomes Research Institute (PCORI). Dr. Albritton is employed by RTI International, the contractor responsible for conducting the research and developing the manuscript. Several coauthors disclosed support from or contracts with PCORI. One coauthor’s spouse holds stock in private health companies. Dr. Frydman, Dr. Iyengar, and Dr. Wilkes disclosed no competing interests relevant to their comments.

As the pandemic shows no signs of ending, primary care doctors may be reassured that delivering care via video teleconferencing can be as effective as usual in-person consultation for several common health conditions.

Albritton_Jordan_NC_web.jpg

This was a finding of a new study published in Annals of Internal Medicine involving a review of literature on video teleconferencing (VTC) visits, which was authored by Jordan Albritton, PhD, MPH and his colleagues.

The authors found generally comparable patient outcomes as well as no differences in health care use, patient satisfaction, and quality of life when visits conducted using VTC were compared with usual care.

While VTC may work best for monitoring patients with chronic conditions, it can also be effective for acute care, said Dr. Albritton, who is a research public health analyst at RTI International in Research Triangle Park, N.C., in an interview.

The investigators analyzed 20 randomized controlled trials of at least 50 patients and acceptable risk of bias in which VTC was used either for main or adjunct care delivery. Published from 2013 to 2019, these studies looked at care for diabetes and pain management, as well as some respiratory, neurologic, and cardiovascular conditions. Studies comparing VTC with usual care that did not involve any added in-person care were more likely to favor the VTC group, the investigators found.

“We excluded conditions such as substance use disorders, maternal care, and weight management for which there was sufficient prior evidence of the benefit of VTC,” Dr. Albritton said in an interview. “But I don’t think our results would have been substantially different if we had included these other diseases. We found general evidence in the literature that VTC is effective for a broader range of conditions.”

In some cases, such as if changes in a patient’s condition triggered an automatic virtual visit, the author said he thinks VTC may lead to even greater effectiveness.

“The doctor and patient could figure out on the spot what’s going on and perhaps change the medication,” Dr. Albritton explained.

In general agreement is Julia L. Frydman, MD, assistant professor in the Brookdale Department of Geriatric and Palliative Medicine at Icahn School of Medicine at Mount Sinai in New York, who was not involved in the RTI research.

Frydman_Julia_L_NYC_web.jpg

“Telemedicine has promise across many medical subspecialties, and what we need now are more studies to understand the perspectives of patients, caregivers, and clinicians as well as the impact of telemedicine on health outcomes and healthcare utilization.”

In acknowledgment of their utility, video visits are on the rise in the United States. A 2020 survey found that 22% of patients and 80% of physicians reported having participated in a video visit, three times the rate of the previous year. The authors noted that policy changes enacted to support telehealth strategies during the pandemic are expected to remain in place, and although patients are returning to in-person care, the virtual visit market will likely continue growing.
 

Increased telemedicine use by older adults

“We’ve seen an exciting expansion of telemedicine use among older adults, and we need to focus on continuing to meet their needs,” Dr. Frydman said.

In a recent study of televisits during the pandemic, Dr. Frydman’s group found a fivefold greater uptake of remote consultations by seniors – from 5% to 25%. Although in-person visits were far more common among older adults.

A specific advantage of video-based over audio-only telehealth, noted Dr. Albritton, is that physicians can directly observe patients in their home environment. Sharing that view is Deepa Iyengar, MBBS/MD,MPH, professor of family medicine at McGovern Medical School at The University of Texas Health Science Center at Houston, where, she said, “the pandemic has put VTC use into overdrive.”

Iyengar_Deepa_Houston_TX_web.jpg

According to Dr. Iyengar, who was not involved in the RTI research, the video component definitely represents value-added over phone calls. “You can pick up visual cues on video that you might not see if the patient came in and you can see what the home environment is like – whether there are a lot of loose rugs on the floor or broken or missing light bulbs,” she said in an interview.
 

‘VTC is here to stay’

In other parts of the country, doctors are finding virtual care useful – and more common. “VTC is here to stay, for sure – the horse is out of the barn,” said Cheryl L. Wilkes, MD, an internist at Northwestern Medicine and assistant professor of medicine at Northwestern University in Chicago. “The RTI study shows no harm from VTC and also shows it may even improve clinical outcomes.”

Wilkes_Cheryl_L_CHICAGO_web.jpg

Video visits can also save patients high parking fees at clinics and spare the sick or elderly from having to hire caregivers to bring them into the office or from having to walk blocks in dangerous weather conditions, she added. “And I can do a virtual visit on the fly or at night when a relative or caregiver is home from work to be there with the patient.”

In addition to being beneficial for following up with patients with chronic diseases such as hypertension or diabetes, VTC may be able to replace some visits that have traditionally required hands-on care, said Dr. Wilkes.

She said she knows a cardiologist who has refined a process whereby a patient – say, one who may have edema – is asked to perform a maneuver via VTC and then display the result to the doctor: The doctor says, “put your leg up and press on it hard for 10 seconds and then show me what it looks like,” according to Dr. Wilkes.

The key now is to identify the best persons across specialties from neurology to rheumatology to videotape ways they’ve created to help their patients participate virtually in consults traditionally done at the office, Dr. Wilkes noted.

But some conditions will always require palpation and the use of a stethoscope, according Dr. Iyengar.

“If someone has an ulcer, I have to be able to feel it,” she said.

And while some maternity care can be given virtually – for instance, if a mother-to be develops a bad cold – hands-on obstetrical care to check the position and health of the baby obviously has to be done in person. “So VTC is definitely going to be a welcome addition but not a replacement,” Dr. Iyengar said.

Gaps in research on VTC visits

Many questions remain regarding the overall usefulness of VTC visits for certain patient groups, according to the authors.

They highlighted, for example, the dearth of data on subgroups or on underserved and vulnerable populations, with no head-to-head studies identified in their review. In addition, they found no studies examining VTC versus usual care for patients with concurrent conditions or on its effect on health equity and disparities.

“It’s now our job to understand the ongoing barriers to telemedicine access, including the digital divide and the usability of telemedicine platforms, and design interventions that overcome them,” Dr. Frydman said. “At the same time, we need to make sure we’re understanding and respecting the preferences of older adults in terms of how they access health care.”

This study was supported by the Patient-Centered Outcomes Research Institute (PCORI). Dr. Albritton is employed by RTI International, the contractor responsible for conducting the research and developing the manuscript. Several coauthors disclosed support from or contracts with PCORI. One coauthor’s spouse holds stock in private health companies. Dr. Frydman, Dr. Iyengar, and Dr. Wilkes disclosed no competing interests relevant to their comments.

As the pandemic shows no signs of ending, primary care doctors may be reassured that delivering care via video teleconferencing can be as effective as usual in-person consultation for several common health conditions.

Albritton_Jordan_NC_web.jpg

This was a finding of a new study published in Annals of Internal Medicine involving a review of literature on video teleconferencing (VTC) visits, which was authored by Jordan Albritton, PhD, MPH and his colleagues.

The authors found generally comparable patient outcomes as well as no differences in health care use, patient satisfaction, and quality of life when visits conducted using VTC were compared with usual care.

While VTC may work best for monitoring patients with chronic conditions, it can also be effective for acute care, said Dr. Albritton, who is a research public health analyst at RTI International in Research Triangle Park, N.C., in an interview.

The investigators analyzed 20 randomized controlled trials of at least 50 patients and acceptable risk of bias in which VTC was used either for main or adjunct care delivery. Published from 2013 to 2019, these studies looked at care for diabetes and pain management, as well as some respiratory, neurologic, and cardiovascular conditions. Studies comparing VTC with usual care that did not involve any added in-person care were more likely to favor the VTC group, the investigators found.

“We excluded conditions such as substance use disorders, maternal care, and weight management for which there was sufficient prior evidence of the benefit of VTC,” Dr. Albritton said in an interview. “But I don’t think our results would have been substantially different if we had included these other diseases. We found general evidence in the literature that VTC is effective for a broader range of conditions.”

In some cases, such as if changes in a patient’s condition triggered an automatic virtual visit, the author said he thinks VTC may lead to even greater effectiveness.

“The doctor and patient could figure out on the spot what’s going on and perhaps change the medication,” Dr. Albritton explained.

In general agreement is Julia L. Frydman, MD, assistant professor in the Brookdale Department of Geriatric and Palliative Medicine at Icahn School of Medicine at Mount Sinai in New York, who was not involved in the RTI research.

Frydman_Julia_L_NYC_web.jpg

“Telemedicine has promise across many medical subspecialties, and what we need now are more studies to understand the perspectives of patients, caregivers, and clinicians as well as the impact of telemedicine on health outcomes and healthcare utilization.”

In acknowledgment of their utility, video visits are on the rise in the United States. A 2020 survey found that 22% of patients and 80% of physicians reported having participated in a video visit, three times the rate of the previous year. The authors noted that policy changes enacted to support telehealth strategies during the pandemic are expected to remain in place, and although patients are returning to in-person care, the virtual visit market will likely continue growing.
 

Increased telemedicine use by older adults

“We’ve seen an exciting expansion of telemedicine use among older adults, and we need to focus on continuing to meet their needs,” Dr. Frydman said.

In a recent study of televisits during the pandemic, Dr. Frydman’s group found a fivefold greater uptake of remote consultations by seniors – from 5% to 25%. Although in-person visits were far more common among older adults.

A specific advantage of video-based over audio-only telehealth, noted Dr. Albritton, is that physicians can directly observe patients in their home environment. Sharing that view is Deepa Iyengar, MBBS/MD,MPH, professor of family medicine at McGovern Medical School at The University of Texas Health Science Center at Houston, where, she said, “the pandemic has put VTC use into overdrive.”

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According to Dr. Iyengar, who was not involved in the RTI research, the video component definitely represents value-added over phone calls. “You can pick up visual cues on video that you might not see if the patient came in and you can see what the home environment is like – whether there are a lot of loose rugs on the floor or broken or missing light bulbs,” she said in an interview.
 

‘VTC is here to stay’

In other parts of the country, doctors are finding virtual care useful – and more common. “VTC is here to stay, for sure – the horse is out of the barn,” said Cheryl L. Wilkes, MD, an internist at Northwestern Medicine and assistant professor of medicine at Northwestern University in Chicago. “The RTI study shows no harm from VTC and also shows it may even improve clinical outcomes.”

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Video visits can also save patients high parking fees at clinics and spare the sick or elderly from having to hire caregivers to bring them into the office or from having to walk blocks in dangerous weather conditions, she added. “And I can do a virtual visit on the fly or at night when a relative or caregiver is home from work to be there with the patient.”

In addition to being beneficial for following up with patients with chronic diseases such as hypertension or diabetes, VTC may be able to replace some visits that have traditionally required hands-on care, said Dr. Wilkes.

She said she knows a cardiologist who has refined a process whereby a patient – say, one who may have edema – is asked to perform a maneuver via VTC and then display the result to the doctor: The doctor says, “put your leg up and press on it hard for 10 seconds and then show me what it looks like,” according to Dr. Wilkes.

The key now is to identify the best persons across specialties from neurology to rheumatology to videotape ways they’ve created to help their patients participate virtually in consults traditionally done at the office, Dr. Wilkes noted.

But some conditions will always require palpation and the use of a stethoscope, according Dr. Iyengar.

“If someone has an ulcer, I have to be able to feel it,” she said.

And while some maternity care can be given virtually – for instance, if a mother-to be develops a bad cold – hands-on obstetrical care to check the position and health of the baby obviously has to be done in person. “So VTC is definitely going to be a welcome addition but not a replacement,” Dr. Iyengar said.

Gaps in research on VTC visits

Many questions remain regarding the overall usefulness of VTC visits for certain patient groups, according to the authors.

They highlighted, for example, the dearth of data on subgroups or on underserved and vulnerable populations, with no head-to-head studies identified in their review. In addition, they found no studies examining VTC versus usual care for patients with concurrent conditions or on its effect on health equity and disparities.

“It’s now our job to understand the ongoing barriers to telemedicine access, including the digital divide and the usability of telemedicine platforms, and design interventions that overcome them,” Dr. Frydman said. “At the same time, we need to make sure we’re understanding and respecting the preferences of older adults in terms of how they access health care.”

This study was supported by the Patient-Centered Outcomes Research Institute (PCORI). Dr. Albritton is employed by RTI International, the contractor responsible for conducting the research and developing the manuscript. Several coauthors disclosed support from or contracts with PCORI. One coauthor’s spouse holds stock in private health companies. Dr. Frydman, Dr. Iyengar, and Dr. Wilkes disclosed no competing interests relevant to their comments.

TC-325, a bentonite-derived hemostatic powder, was not inferior to standard therapy for the endoscopic management of acute nonvariceal upper GI bleeding, according to a new study.

The findings from the study, lead investigator and study author James Y.W. Lau, MD, of the Prince of Wales Hospital in Hong Kong, said in an interview, suggest TC-325 could “be considered one of the primary endoscopic treatments to actively stop nonvariceal bleeding,” particularly in cases when other therapies prove unsuccessful. The study findings were published in Annals of Internal Medicine.

The study team noted that, after they first reported the use of TC-325 in active bleeding from gastroduodenal ulcers in 2011, there have been other studies of its use with acute nonvariceal upper GI bleeding, but to date there has been only two randomized controlled trials of it as a sole endoscopic treatment option for acute nonvariceal upper GI bleeding. To close this research gap, Dr. Lau and researchers enrolled 224 adult patients with acute bleeding from a nonvariceal source on upper GI endoscopy and randomly assigned these patients to receive either TC-325 (n = 111) or standard hemostatic treatment (n = 113). Standard endoscopic bleeding management consisted of contact thermocoagulation using a heater probe or bipolar probe, or hemoclipping with or without previously injected diluted epinephrine.

Success of assigned treatment was defined by the cessation of active bleeding as well as flattening of the protuberance or vessel with a heater or bipolar probe. For the primary outcome of the study, the investigators assessed the rate of bleeding control within 30 days following randomization. Additionally, the researchers compared the treatment groups to identify differences in the failure to control bleeding during the initial endoscopy and recurrent bleeding following hemostasis.

Treatment groups were even in regard to the proportions of patients with bleeding gastroduodenal ulcers (61.3% vs. 60.2%). A smaller proportion of patients in the TC-325 arm had a history of alcohol use (3.0% vs. 9.8%) and current use of NSAIDs (8.1% vs. 20.4%). The group assigned to TC-325 had more bleeding tumors (20.7% vs. 8.8%) and fewer Dieulafoy lesions (5.4% vs. 14.2%), compared with the standard treatment arm. Additionally, patients in the TC-325 group had a higher median Glasgow-Blatchford Score at hospital admission than the standard endoscopy management group (12 vs. 11, respectively; P < .05).

Although a greater proportion of patients assigned TC-325 had bleeding controlled within 30 days of randomization (90.1% vs. 81.4%; risk difference, 8.7 percentage points; 1-sided 95% CI, 0.95 percentage points), the researchers noted that the lower limit of the confidence interval for treatment difference “did not extend beyond the prespecified noninferiority margin of 10 percentage points, indicating that TC-325 is not inferior to standard treatment in the control of bleeding.”

Fewer failures of hemostasis were observed with TC-325 during index endoscopy (2.7% vs. 9.7%; odds ratio, 0.26; 95% CI, 0.07-0.95). After initial endoscopic control, recurrent bleeding was observed in 9 patients in the TC-325 arm and 10 patients in the standard treatment group.

The authors suggested that the low recurrent bleeding rate in the TC-325 arm may reflect enhanced responsiveness in the predominantly Asian study population, a group with lower parietal cell masses and higher rates of Helicobacter pylori infections. In an accompanying editorial published online in Annals of Internal Medicine, Alan N. Barkun, MD, McGill University and McGill University Health Centre in Montreal, and Ali Alali, MB BCh BAO, in the department of medicine at Kuwait University, Kuwait City, noted that “possible additional reasons for the enhanced effectiveness of TC-325 observed in the current trial may be its varied performance in the patients with nonulcer bleeding.”

No difference was found between the treatment strategies in terms of the need for additional interventions within 30 days. The need for further endoscopic treatment was reported in 7.2% of patients in the TC-325 groups versus 8.8% of patients assigned to standard treatment. In addition, further angiography was required in 1.8% and 3.5% of patients, while further surgery was required in 0.9% of patients treated with TC-325 versus none in the standard treatment group. Each group reported 14 deaths.

Dr. Lau noted that the study enrolled Asian patients who were more responsive to proton pump inhibitor therapy, which may limit the generalizability of the findings. “We also included patients with mixed etiologies,” he added. “Studies that focus on specific lesions would further inform our practice, and larger observational studies are required to understand failures with TC-325.”

Based on the study findings, corresponding editorial author Dr. Barkun wrote that “TC-325 can be used alone in nonvariceal upper gastrointestinal bleeding or as rescue therapy but should be reserved for patients with actively bleeding lesions” and suggests the treatment option “is likely one of the most effective modalities in achieving immediate hemostasis.”

The researchers reported no conflicts of interest with the pharmaceutical industry. The editorialists also reported no disclosures of interest.

TC-325, a bentonite-derived hemostatic powder, was not inferior to standard therapy for the endoscopic management of acute nonvariceal upper GI bleeding, according to a new study.

The findings from the study, lead investigator and study author James Y.W. Lau, MD, of the Prince of Wales Hospital in Hong Kong, said in an interview, suggest TC-325 could “be considered one of the primary endoscopic treatments to actively stop nonvariceal bleeding,” particularly in cases when other therapies prove unsuccessful. The study findings were published in Annals of Internal Medicine.

The study team noted that, after they first reported the use of TC-325 in active bleeding from gastroduodenal ulcers in 2011, there have been other studies of its use with acute nonvariceal upper GI bleeding, but to date there has been only two randomized controlled trials of it as a sole endoscopic treatment option for acute nonvariceal upper GI bleeding. To close this research gap, Dr. Lau and researchers enrolled 224 adult patients with acute bleeding from a nonvariceal source on upper GI endoscopy and randomly assigned these patients to receive either TC-325 (n = 111) or standard hemostatic treatment (n = 113). Standard endoscopic bleeding management consisted of contact thermocoagulation using a heater probe or bipolar probe, or hemoclipping with or without previously injected diluted epinephrine.

Success of assigned treatment was defined by the cessation of active bleeding as well as flattening of the protuberance or vessel with a heater or bipolar probe. For the primary outcome of the study, the investigators assessed the rate of bleeding control within 30 days following randomization. Additionally, the researchers compared the treatment groups to identify differences in the failure to control bleeding during the initial endoscopy and recurrent bleeding following hemostasis.

Treatment groups were even in regard to the proportions of patients with bleeding gastroduodenal ulcers (61.3% vs. 60.2%). A smaller proportion of patients in the TC-325 arm had a history of alcohol use (3.0% vs. 9.8%) and current use of NSAIDs (8.1% vs. 20.4%). The group assigned to TC-325 had more bleeding tumors (20.7% vs. 8.8%) and fewer Dieulafoy lesions (5.4% vs. 14.2%), compared with the standard treatment arm. Additionally, patients in the TC-325 group had a higher median Glasgow-Blatchford Score at hospital admission than the standard endoscopy management group (12 vs. 11, respectively; P < .05).

Although a greater proportion of patients assigned TC-325 had bleeding controlled within 30 days of randomization (90.1% vs. 81.4%; risk difference, 8.7 percentage points; 1-sided 95% CI, 0.95 percentage points), the researchers noted that the lower limit of the confidence interval for treatment difference “did not extend beyond the prespecified noninferiority margin of 10 percentage points, indicating that TC-325 is not inferior to standard treatment in the control of bleeding.”

Fewer failures of hemostasis were observed with TC-325 during index endoscopy (2.7% vs. 9.7%; odds ratio, 0.26; 95% CI, 0.07-0.95). After initial endoscopic control, recurrent bleeding was observed in 9 patients in the TC-325 arm and 10 patients in the standard treatment group.

The authors suggested that the low recurrent bleeding rate in the TC-325 arm may reflect enhanced responsiveness in the predominantly Asian study population, a group with lower parietal cell masses and higher rates of Helicobacter pylori infections. In an accompanying editorial published online in Annals of Internal Medicine, Alan N. Barkun, MD, McGill University and McGill University Health Centre in Montreal, and Ali Alali, MB BCh BAO, in the department of medicine at Kuwait University, Kuwait City, noted that “possible additional reasons for the enhanced effectiveness of TC-325 observed in the current trial may be its varied performance in the patients with nonulcer bleeding.”

No difference was found between the treatment strategies in terms of the need for additional interventions within 30 days. The need for further endoscopic treatment was reported in 7.2% of patients in the TC-325 groups versus 8.8% of patients assigned to standard treatment. In addition, further angiography was required in 1.8% and 3.5% of patients, while further surgery was required in 0.9% of patients treated with TC-325 versus none in the standard treatment group. Each group reported 14 deaths.

Dr. Lau noted that the study enrolled Asian patients who were more responsive to proton pump inhibitor therapy, which may limit the generalizability of the findings. “We also included patients with mixed etiologies,” he added. “Studies that focus on specific lesions would further inform our practice, and larger observational studies are required to understand failures with TC-325.”

Based on the study findings, corresponding editorial author Dr. Barkun wrote that “TC-325 can be used alone in nonvariceal upper gastrointestinal bleeding or as rescue therapy but should be reserved for patients with actively bleeding lesions” and suggests the treatment option “is likely one of the most effective modalities in achieving immediate hemostasis.”

The researchers reported no conflicts of interest with the pharmaceutical industry. The editorialists also reported no disclosures of interest.

TC-325, a bentonite-derived hemostatic powder, was not inferior to standard therapy for the endoscopic management of acute nonvariceal upper GI bleeding, according to a new study.

The findings from the study, lead investigator and study author James Y.W. Lau, MD, of the Prince of Wales Hospital in Hong Kong, said in an interview, suggest TC-325 could “be considered one of the primary endoscopic treatments to actively stop nonvariceal bleeding,” particularly in cases when other therapies prove unsuccessful. The study findings were published in Annals of Internal Medicine.

The study team noted that, after they first reported the use of TC-325 in active bleeding from gastroduodenal ulcers in 2011, there have been other studies of its use with acute nonvariceal upper GI bleeding, but to date there has been only two randomized controlled trials of it as a sole endoscopic treatment option for acute nonvariceal upper GI bleeding. To close this research gap, Dr. Lau and researchers enrolled 224 adult patients with acute bleeding from a nonvariceal source on upper GI endoscopy and randomly assigned these patients to receive either TC-325 (n = 111) or standard hemostatic treatment (n = 113). Standard endoscopic bleeding management consisted of contact thermocoagulation using a heater probe or bipolar probe, or hemoclipping with or without previously injected diluted epinephrine.

Success of assigned treatment was defined by the cessation of active bleeding as well as flattening of the protuberance or vessel with a heater or bipolar probe. For the primary outcome of the study, the investigators assessed the rate of bleeding control within 30 days following randomization. Additionally, the researchers compared the treatment groups to identify differences in the failure to control bleeding during the initial endoscopy and recurrent bleeding following hemostasis.

Treatment groups were even in regard to the proportions of patients with bleeding gastroduodenal ulcers (61.3% vs. 60.2%). A smaller proportion of patients in the TC-325 arm had a history of alcohol use (3.0% vs. 9.8%) and current use of NSAIDs (8.1% vs. 20.4%). The group assigned to TC-325 had more bleeding tumors (20.7% vs. 8.8%) and fewer Dieulafoy lesions (5.4% vs. 14.2%), compared with the standard treatment arm. Additionally, patients in the TC-325 group had a higher median Glasgow-Blatchford Score at hospital admission than the standard endoscopy management group (12 vs. 11, respectively; P < .05).

Although a greater proportion of patients assigned TC-325 had bleeding controlled within 30 days of randomization (90.1% vs. 81.4%; risk difference, 8.7 percentage points; 1-sided 95% CI, 0.95 percentage points), the researchers noted that the lower limit of the confidence interval for treatment difference “did not extend beyond the prespecified noninferiority margin of 10 percentage points, indicating that TC-325 is not inferior to standard treatment in the control of bleeding.”

Fewer failures of hemostasis were observed with TC-325 during index endoscopy (2.7% vs. 9.7%; odds ratio, 0.26; 95% CI, 0.07-0.95). After initial endoscopic control, recurrent bleeding was observed in 9 patients in the TC-325 arm and 10 patients in the standard treatment group.

The authors suggested that the low recurrent bleeding rate in the TC-325 arm may reflect enhanced responsiveness in the predominantly Asian study population, a group with lower parietal cell masses and higher rates of Helicobacter pylori infections. In an accompanying editorial published online in Annals of Internal Medicine, Alan N. Barkun, MD, McGill University and McGill University Health Centre in Montreal, and Ali Alali, MB BCh BAO, in the department of medicine at Kuwait University, Kuwait City, noted that “possible additional reasons for the enhanced effectiveness of TC-325 observed in the current trial may be its varied performance in the patients with nonulcer bleeding.”

No difference was found between the treatment strategies in terms of the need for additional interventions within 30 days. The need for further endoscopic treatment was reported in 7.2% of patients in the TC-325 groups versus 8.8% of patients assigned to standard treatment. In addition, further angiography was required in 1.8% and 3.5% of patients, while further surgery was required in 0.9% of patients treated with TC-325 versus none in the standard treatment group. Each group reported 14 deaths.

Dr. Lau noted that the study enrolled Asian patients who were more responsive to proton pump inhibitor therapy, which may limit the generalizability of the findings. “We also included patients with mixed etiologies,” he added. “Studies that focus on specific lesions would further inform our practice, and larger observational studies are required to understand failures with TC-325.”

Based on the study findings, corresponding editorial author Dr. Barkun wrote that “TC-325 can be used alone in nonvariceal upper gastrointestinal bleeding or as rescue therapy but should be reserved for patients with actively bleeding lesions” and suggests the treatment option “is likely one of the most effective modalities in achieving immediate hemostasis.”

The researchers reported no conflicts of interest with the pharmaceutical industry. The editorialists also reported no disclosures of interest.

Background: VTE is common in patients with cancer and can lead to serious complications and death. Relatively recently, the use of edoxaban or rivaroxaban was recommended by major guidelines for the treatment of cancer-associated VTE. Previous studies have demonstrated a higher risk of major bleeding when compared with low-molecular-weight heparin. Whether oral apixaban can be safely used in this setting is unknown.

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Dr. Hermansen is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: VTE is common in patients with cancer and can lead to serious complications and death. Relatively recently, the use of edoxaban or rivaroxaban was recommended by major guidelines for the treatment of cancer-associated VTE. Previous studies have demonstrated a higher risk of major bleeding when compared with low-molecular-weight heparin. Whether oral apixaban can be safely used in this setting is unknown.

Hermansen_Rex_NY_web.jpg

Dr. Hermansen is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: VTE is common in patients with cancer and can lead to serious complications and death. Relatively recently, the use of edoxaban or rivaroxaban was recommended by major guidelines for the treatment of cancer-associated VTE. Previous studies have demonstrated a higher risk of major bleeding when compared with low-molecular-weight heparin. Whether oral apixaban can be safely used in this setting is unknown.

Hermansen_Rex_NY_web.jpg

Dr. Hermansen is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: Antibiotic therapy is considered the standard of care for acute uncomplicated diverticulitis. Over the past decade, randomized clinical trials have suggested that treatment with antibiotics may be noninferior to observation with supportive care; however, there have not been any blinded, placebo-controlled trials to provide high-quality evidence.

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Notably, though this study was adequately powered to detect differences in length of stay, it was not powered to detect differences in clinical outcomes, including death or the need for surgery. The exclusion of patients with language barriers raises concerns regarding the generalizability of the results.

Bottom line: Antibiotic therapy does not decrease length of hospital stay when compared with placebo for patients with acute uncomplicated diverticulitis.

Citation: Jaung R et al. Antibiotics do not reduce length of hospital stay for uncomplicated diverticulitis in a pragmatic double-blind randomized trial. Clin Gastroenterol Hepatol. 2020 Mar;S1542-3565(20):30426-2. doi: 10.1016/j.cgh.2020.03.049.

Dr. Elyahu is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: Antibiotic therapy is considered the standard of care for acute uncomplicated diverticulitis. Over the past decade, randomized clinical trials have suggested that treatment with antibiotics may be noninferior to observation with supportive care; however, there have not been any blinded, placebo-controlled trials to provide high-quality evidence.

Elyahu_Ariel_Y_web.jpg

Notably, though this study was adequately powered to detect differences in length of stay, it was not powered to detect differences in clinical outcomes, including death or the need for surgery. The exclusion of patients with language barriers raises concerns regarding the generalizability of the results.

Bottom line: Antibiotic therapy does not decrease length of hospital stay when compared with placebo for patients with acute uncomplicated diverticulitis.

Citation: Jaung R et al. Antibiotics do not reduce length of hospital stay for uncomplicated diverticulitis in a pragmatic double-blind randomized trial. Clin Gastroenterol Hepatol. 2020 Mar;S1542-3565(20):30426-2. doi: 10.1016/j.cgh.2020.03.049.

Dr. Elyahu is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: Antibiotic therapy is considered the standard of care for acute uncomplicated diverticulitis. Over the past decade, randomized clinical trials have suggested that treatment with antibiotics may be noninferior to observation with supportive care; however, there have not been any blinded, placebo-controlled trials to provide high-quality evidence.

Elyahu_Ariel_Y_web.jpg

Notably, though this study was adequately powered to detect differences in length of stay, it was not powered to detect differences in clinical outcomes, including death or the need for surgery. The exclusion of patients with language barriers raises concerns regarding the generalizability of the results.

Bottom line: Antibiotic therapy does not decrease length of hospital stay when compared with placebo for patients with acute uncomplicated diverticulitis.

Citation: Jaung R et al. Antibiotics do not reduce length of hospital stay for uncomplicated diverticulitis in a pragmatic double-blind randomized trial. Clin Gastroenterol Hepatol. 2020 Mar;S1542-3565(20):30426-2. doi: 10.1016/j.cgh.2020.03.049.

Dr. Elyahu is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

It could be argued that hospital medicine in the United States was made vital by a major infectious disease epidemic – the HIV/AIDS crisis – said Emily Gottenborg, MD, a hospitalist and program director of hospitalist training at the University of Colorado at Denver, Aurora. Certainly, it was born out of the need for change, for physicians who could coordinate complex patient care plans and serve as the “quarterbacks” of the hospital. “As a result, we have always been very nimble and ready to embrace change,” said Dr. Gottenborg.

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That hospitalist-honed agility and penchant for innovation has proven to be invaluable during the current COVID-19 pandemic as hospital medicine–focused residency programs have been forced to pivot quickly and modify their agendas. From managing the pandemic’s impact on residents’ day-to-day experiences, to carefully balancing educational needs and goals, program leaders have worked tirelessly to ensure that residents continue to receive excellent training.

The overarching theme across U.S.-based residency programs is that the educational changes and challenges during the COVID-19 pandemic have often been one and the same.
 

Service versus education

At the beginning of the pandemic, trainees at the University of Pittsburgh Medical Center were limited in seeing COVID patients in order to curb exposure. But now that COVID appears to be the new normal, “I think the question becomes: ‘How do we incorporate our trainees to take care of COVID patients since it seems it will be staying around for a while?’ ” said Rachna Rawal, MD, a hospitalist and clinical assistant professor of medicine at UPMC.

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This dilemma highlights the conflict between service and education. Residents have been motivated and eager to help, which has been beneficial whenever there is a surge. “At the same time, you want to preserve their education, and it’s a very difficult balance at times,” said Dr. Rawal. It’s also challenging to figure out the safest way for residents to see patients, as well as how to include medical students, since interns and residents serve as important educational resources for them.

Keeping trainees involved with daily virtual conferences rather than in-person interactions raises the question of whether or not the engagement is equivalent. “It’s harder to keep them accountable when they’re not in person, but it’s also not worth the risk given the COVID numbers at times,” Dr. Rawal said. The goal has become to make sure residents stay safe while still feeling that they are getting a good education.
 

A balancing act

“I think early on, there was a lot of pride in what we were doing, that we were on the front line managing this thing that was emerging,” said Daniel Ricotta, MD, a hospitalist and associate program director of the internal medicine residency at Beth Israel Deaconess Medical Center and assistant professor of medicine at Harvard Medical School, both in Boston. “And now I think people are starting to feel a little bit weary.”

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It has been demanding trying to manage ongoing educational needs through this time. “At the end of the day, residents are still trainees and have to be trained and educated. They’re not just worker bees taking care of patients,” Dr. Ricotta said. Residents need a well-rounded clinical experience – “they can’t just take care of COVID patients and then be able to graduate as general internists,” he said – but that becomes onerous when the hospital is full of patients with COVID.

Along with balancing residents’ clinical immersion, Dr. Ricotta said there has been the challenge of doing “the content-based teaching from didactics that occur in the context of clinical work, but are somewhat separated when you need to limit the number of people in the rooms and try to keep as many people at home as possible when they’re not taking care of patients in order to limit their level of risk.” Adjusting and readjusting both of these aspects has had a major impact on residents’ day-to-day education.

“A big part of residency is community,” noted Dr. Ricotta, but the sense of community has been disrupted because some of the bonding experiences residents used to do outside the hospital to build that community have necessarily gone by the wayside. This particularly affects interns from around the country who are meeting each other for the first time. “We actually had a normal intern orientation this year, but last year, when everything was virtual, we were trying to find ways to bridge relationships in a way that was safe and socially distanced,” he said.
 

Improving quality

UC Denver is unique in that they have a 3-year program specifically for hospital medicine residents, said Dr. Gottenborg. Right away, “our residents rose to the challenge and wanted to be part of the workforce that helps care for this critical population of [COVID] patients.” The residents were able to run the ICUs and take care of COVID patients, but in exchange, they had to give up some of their elective rotation time.

One aspect of the UC Denver hospital medicine residency program is participation in projects that focus on how to improve the health care system. Over the past year, the residents worked on one project in particular that focused on restructuring the guidelines for consulting physical therapists. Since many patients end up needing a physical therapist for a variety of reasons, a full hospital puts increased strain on their workload, making their time more precious.

“[The project] forced us to think about the right criteria to consult them,” explained Dr. Gottenborg. “We cut down essentially all the inappropriate consults to PT, opening their time. That project was driven by how the residents were experiencing the pandemic in the hospital.”
 

Learning to adapt

“The training environment during this pandemic has been tumultuous for both our residents and medical students,” said Alan M. Hall, MD, associate professor of internal medicine and pediatrics and assistant dean of curriculum integration at the University of Kentucky, Lexington. Along with treating patients with COVID-19, he said trainees have also had to cope with anxiety about getting the virus themselves or inadvertently bringing it home to their families.

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Like most medical schools, University of Kentucky students were shifted away from clinical rotations and into alternative and online education for a time. When they returned to in-person education, the students were initially restricted from seeing patients with confirmed or suspected COVID-19 in order to reduce their personal risk and to conserve personal protective equipment.

This especially impacted certain rotations, such as pediatrics. Because respiratory symptoms are common in this population, students were greatly limited in the number of new patients they could see. Now they are given the option to see patients with COVID-19 if they want to.

“Our residents have had to adapt to seemingly endless changes during this pandemic,” Dr. Hall said. For example, at the beginning of the surge, the internal medicine residents trained for a completely new clinical model, though this ultimately never needed to be implemented. Then they had to adjust to extremely high census numbers that continue to have an effect on almost all of their rotations.

Conversely, the pediatrics residents saw far fewer inpatients last winter than they typically would. This made it more difficult for them to feel comfortable when census numbers increased with common diagnoses like bronchiolitis. “However, those respiratory viruses that were hibernating last winter caused an unusual and challenging summer surge,” Dr. Hall said.

The biggest challenge though “is knowing that there is not a perfect solution for this global pandemic’s effect on medical education,” said Dr. Hall. “We can’t possibly perfectly balance the safety of our learners and their families with the dangers of COVID-19.”
 

Leadership discussions

As a residency program leader, Dr. Ricotta said there are conversations about multiple topics, including maintaining a safe learning environment; providing important aspects of residency training; whether to go back to full in-person teaching, keep doing virtual teaching, or implement a hybrid model; and how to help residents understand the balance between their personal and professional lives, especially in terms of safety.

“They have to their lives outside of the hospital, but we also are trying to instill ... what their responsibility is to society, to their patients, and to each other,” said Dr. Ricotta.

A more recent discussion has been about how to manage the COVID vaccine boosters. “We can’t have everyone getting vaccines at the same time because they might have symptoms afterward, and then be out sick – you’re missing half your workforce,” Dr. Ricotta said. But staggering residents’ booster shots created yet another dilemma around deciding who received the booster sooner rather than later.

The biggest consideration for Dr. Gottenborg’s leadership team was deciding whether to use their residents to help with the COVID surges or keep them in a traditional residency experience. While the residents wanted to be part of the pandemic response, there were many factors to consider. Ultimately, they came up with a balance between the amount of time residents should spend taking care of COVID patients while also assuring that they leave the program with all the skills and experiences they need.

Though Dr. Hall works more closely with medical students than residents, he sees the challenges and effects as being similar. Creating harmony between a safe learning environment and students’ educational goals has been the topic of endless discussions. This includes decisions as to whether or not students should be involved in person in certain activities such as large classroom didactics, written exams, seeing patients in clinical settings, and small group discussions.
 

Recruitment effects

When it comes to recruiting during a global pandemic, the experiences and predictions are mixed. Dr. Hall believes virtual interviews are making recruitment easier, but in turn, the fact that they are virtual also makes it harder for the applicant to get a good feel for the program and the people involved in it.

Dr. Ricotta reported that recruitment numbers have been fairly steady at Beth Israel Deaconess over the last few years. “In addition to the critical care physicians, hospital medicine was really the front line of this pandemic and so in some ways, we gained some recognition that we may not have had otherwise,” said Dr. Ricotta. He believes this has the benefit of attracting some residents, but at the same time, it could potentially scare others away from what they perceive as a demanding, grueling job. “I think it has been mixed. It’s dependent on the person.”

At UC Denver, Dr. Gottenborg said they are seeing a rapid rise in the number of applications and interest in their programs. Still, “I think this could go both ways,” she acknowledged. With the focus on hospital medicine in the media, medical students are more aware of the specialty and what it involves. “I think the sense of mission is really exemplified and everyone is talking about it,” she said. This is evident in the arrival this summer of the first new class of interns since the pandemic. “They’re incredibly passionate about the work,” said Dr. Gottenborg.

However, there is also the notable increase in physician burnout since the pandemic started. That this has been regularly featured in the media leaves Dr. Gottenborg to wonder if prospective residents will shy away from hospital medicine because they believe it is an area that leads to burnout. “I hope that’s not the case,” she said.

“I would actually argue [recruitment] is easier,” said Dr. Rawal. Like Dr. Hall, she sees virtual interviews as a big benefit to prospective trainees because they don’t have to spend a large amount of money on travel, food, and other expenses like they did before, a welcome relief for residents with significant debt. “I think that is one very big positive from the pandemic,” she said. Her trainees were advised to make a final list and consider going to see the top two or three in person, but “at this point, there’s really no expectation to go see all 15 places that you look into.”

Dr. Rawal also pointed out that recruitment is affected by whether or not trainees are expected to see COVID patients. “I know in some places they aren’t and in some places they are, so it just depends on where you are and what you’re looking for,” she said.
 

Shifts in education

It remains to be seen if all the educational changes will be permanent, though it appears that many will remain. Dr. Hall hopes that virtual visits to provide care to patients who have difficulty getting to physical clinics will continue to be a focus for hospital medicine trainees. “For medical students, I think this will allow us to better assess what content can best be delivered in person, synchronously online, or asynchronously through recorded content,” he said.

Dr. Ricotta predicts that virtual conferences will become more pervasive as academic hospitals continue to acquire more community hospitals, especially for grand rounds. “The virtual teaching that occurred in the residency program because it’s required by the [Accreditation Council for Graduate Medical Education] has, I think, informed how academic centers do ongoing faculty development, professional development, and obviously education for the residents,” Dr. Ricotta said. “I think virtual teaching is here to stay.” This includes telehealth training, which had not been a widespread part of residency education before now.

Trainees have been given tools to handle high patient censuses and learned a whole new set of communication skills, thanks to the pandemic, said Dr. Rawal. There has been a focus on learning how to advocate for the vaccine, along with education on situations like how to have conversations with patients who don’t believe they have COVID, even when their tests are positive. “Learning to handle these situations and still be a physician and provide appropriate care regardless of the patient’s views is very important. This is not something I learned in my training because it never came up,” she said.

Dr. Gottenborg has been impressed by the resident workforce’s response across all specialties throughout these difficult days. “They were universally ready to dive in and work long hours and care for these very sick patients and ultimately share their experiences so that we could do it better as these patients continue to flow through our systems,” she said. “It has been very invigorating.”

The pandemic has also put a spotlight on the importance of being flexible, as well as various problems with how health care systems operate, “which, for people in our field, gets us both excited and gives us a lot of work to do,” said Dr. Gottenborg. “Our residents see that and feel that and will hopefully continue to hold that torch in hospital medicine.”

In spite of everything, Dr. Rawal believes this is an exhilarating time to be a trainee. “They’re getting an opportunity that none of us got. Usually, when policies are made, we really don’t see the immediate impact.” But with recent mandates like masks and social distancing, “the rate of change that they get to see things happen is exciting. They’re going to be a very exciting group of physicians.”

It could be argued that hospital medicine in the United States was made vital by a major infectious disease epidemic – the HIV/AIDS crisis – said Emily Gottenborg, MD, a hospitalist and program director of hospitalist training at the University of Colorado at Denver, Aurora. Certainly, it was born out of the need for change, for physicians who could coordinate complex patient care plans and serve as the “quarterbacks” of the hospital. “As a result, we have always been very nimble and ready to embrace change,” said Dr. Gottenborg.

Gottenborg_Emily_COLO_web.jpg

That hospitalist-honed agility and penchant for innovation has proven to be invaluable during the current COVID-19 pandemic as hospital medicine–focused residency programs have been forced to pivot quickly and modify their agendas. From managing the pandemic’s impact on residents’ day-to-day experiences, to carefully balancing educational needs and goals, program leaders have worked tirelessly to ensure that residents continue to receive excellent training.

The overarching theme across U.S.-based residency programs is that the educational changes and challenges during the COVID-19 pandemic have often been one and the same.
 

Service versus education

At the beginning of the pandemic, trainees at the University of Pittsburgh Medical Center were limited in seeing COVID patients in order to curb exposure. But now that COVID appears to be the new normal, “I think the question becomes: ‘How do we incorporate our trainees to take care of COVID patients since it seems it will be staying around for a while?’ ” said Rachna Rawal, MD, a hospitalist and clinical assistant professor of medicine at UPMC.

Rawal_Rachna_146_web.jpg

This dilemma highlights the conflict between service and education. Residents have been motivated and eager to help, which has been beneficial whenever there is a surge. “At the same time, you want to preserve their education, and it’s a very difficult balance at times,” said Dr. Rawal. It’s also challenging to figure out the safest way for residents to see patients, as well as how to include medical students, since interns and residents serve as important educational resources for them.

Keeping trainees involved with daily virtual conferences rather than in-person interactions raises the question of whether or not the engagement is equivalent. “It’s harder to keep them accountable when they’re not in person, but it’s also not worth the risk given the COVID numbers at times,” Dr. Rawal said. The goal has become to make sure residents stay safe while still feeling that they are getting a good education.
 

A balancing act

“I think early on, there was a lot of pride in what we were doing, that we were on the front line managing this thing that was emerging,” said Daniel Ricotta, MD, a hospitalist and associate program director of the internal medicine residency at Beth Israel Deaconess Medical Center and assistant professor of medicine at Harvard Medical School, both in Boston. “And now I think people are starting to feel a little bit weary.”

Ricotta_Daniel_MASS_web.jpg

It has been demanding trying to manage ongoing educational needs through this time. “At the end of the day, residents are still trainees and have to be trained and educated. They’re not just worker bees taking care of patients,” Dr. Ricotta said. Residents need a well-rounded clinical experience – “they can’t just take care of COVID patients and then be able to graduate as general internists,” he said – but that becomes onerous when the hospital is full of patients with COVID.

Along with balancing residents’ clinical immersion, Dr. Ricotta said there has been the challenge of doing “the content-based teaching from didactics that occur in the context of clinical work, but are somewhat separated when you need to limit the number of people in the rooms and try to keep as many people at home as possible when they’re not taking care of patients in order to limit their level of risk.” Adjusting and readjusting both of these aspects has had a major impact on residents’ day-to-day education.

“A big part of residency is community,” noted Dr. Ricotta, but the sense of community has been disrupted because some of the bonding experiences residents used to do outside the hospital to build that community have necessarily gone by the wayside. This particularly affects interns from around the country who are meeting each other for the first time. “We actually had a normal intern orientation this year, but last year, when everything was virtual, we were trying to find ways to bridge relationships in a way that was safe and socially distanced,” he said.
 

Improving quality

UC Denver is unique in that they have a 3-year program specifically for hospital medicine residents, said Dr. Gottenborg. Right away, “our residents rose to the challenge and wanted to be part of the workforce that helps care for this critical population of [COVID] patients.” The residents were able to run the ICUs and take care of COVID patients, but in exchange, they had to give up some of their elective rotation time.

One aspect of the UC Denver hospital medicine residency program is participation in projects that focus on how to improve the health care system. Over the past year, the residents worked on one project in particular that focused on restructuring the guidelines for consulting physical therapists. Since many patients end up needing a physical therapist for a variety of reasons, a full hospital puts increased strain on their workload, making their time more precious.

“[The project] forced us to think about the right criteria to consult them,” explained Dr. Gottenborg. “We cut down essentially all the inappropriate consults to PT, opening their time. That project was driven by how the residents were experiencing the pandemic in the hospital.”
 

Learning to adapt

“The training environment during this pandemic has been tumultuous for both our residents and medical students,” said Alan M. Hall, MD, associate professor of internal medicine and pediatrics and assistant dean of curriculum integration at the University of Kentucky, Lexington. Along with treating patients with COVID-19, he said trainees have also had to cope with anxiety about getting the virus themselves or inadvertently bringing it home to their families.

Hall_Alan_KY_web2.jpg

Like most medical schools, University of Kentucky students were shifted away from clinical rotations and into alternative and online education for a time. When they returned to in-person education, the students were initially restricted from seeing patients with confirmed or suspected COVID-19 in order to reduce their personal risk and to conserve personal protective equipment.

This especially impacted certain rotations, such as pediatrics. Because respiratory symptoms are common in this population, students were greatly limited in the number of new patients they could see. Now they are given the option to see patients with COVID-19 if they want to.

“Our residents have had to adapt to seemingly endless changes during this pandemic,” Dr. Hall said. For example, at the beginning of the surge, the internal medicine residents trained for a completely new clinical model, though this ultimately never needed to be implemented. Then they had to adjust to extremely high census numbers that continue to have an effect on almost all of their rotations.

Conversely, the pediatrics residents saw far fewer inpatients last winter than they typically would. This made it more difficult for them to feel comfortable when census numbers increased with common diagnoses like bronchiolitis. “However, those respiratory viruses that were hibernating last winter caused an unusual and challenging summer surge,” Dr. Hall said.

The biggest challenge though “is knowing that there is not a perfect solution for this global pandemic’s effect on medical education,” said Dr. Hall. “We can’t possibly perfectly balance the safety of our learners and their families with the dangers of COVID-19.”
 

Leadership discussions

As a residency program leader, Dr. Ricotta said there are conversations about multiple topics, including maintaining a safe learning environment; providing important aspects of residency training; whether to go back to full in-person teaching, keep doing virtual teaching, or implement a hybrid model; and how to help residents understand the balance between their personal and professional lives, especially in terms of safety.

“They have to their lives outside of the hospital, but we also are trying to instill ... what their responsibility is to society, to their patients, and to each other,” said Dr. Ricotta.

A more recent discussion has been about how to manage the COVID vaccine boosters. “We can’t have everyone getting vaccines at the same time because they might have symptoms afterward, and then be out sick – you’re missing half your workforce,” Dr. Ricotta said. But staggering residents’ booster shots created yet another dilemma around deciding who received the booster sooner rather than later.

The biggest consideration for Dr. Gottenborg’s leadership team was deciding whether to use their residents to help with the COVID surges or keep them in a traditional residency experience. While the residents wanted to be part of the pandemic response, there were many factors to consider. Ultimately, they came up with a balance between the amount of time residents should spend taking care of COVID patients while also assuring that they leave the program with all the skills and experiences they need.

Though Dr. Hall works more closely with medical students than residents, he sees the challenges and effects as being similar. Creating harmony between a safe learning environment and students’ educational goals has been the topic of endless discussions. This includes decisions as to whether or not students should be involved in person in certain activities such as large classroom didactics, written exams, seeing patients in clinical settings, and small group discussions.
 

Recruitment effects

When it comes to recruiting during a global pandemic, the experiences and predictions are mixed. Dr. Hall believes virtual interviews are making recruitment easier, but in turn, the fact that they are virtual also makes it harder for the applicant to get a good feel for the program and the people involved in it.

Dr. Ricotta reported that recruitment numbers have been fairly steady at Beth Israel Deaconess over the last few years. “In addition to the critical care physicians, hospital medicine was really the front line of this pandemic and so in some ways, we gained some recognition that we may not have had otherwise,” said Dr. Ricotta. He believes this has the benefit of attracting some residents, but at the same time, it could potentially scare others away from what they perceive as a demanding, grueling job. “I think it has been mixed. It’s dependent on the person.”

At UC Denver, Dr. Gottenborg said they are seeing a rapid rise in the number of applications and interest in their programs. Still, “I think this could go both ways,” she acknowledged. With the focus on hospital medicine in the media, medical students are more aware of the specialty and what it involves. “I think the sense of mission is really exemplified and everyone is talking about it,” she said. This is evident in the arrival this summer of the first new class of interns since the pandemic. “They’re incredibly passionate about the work,” said Dr. Gottenborg.

However, there is also the notable increase in physician burnout since the pandemic started. That this has been regularly featured in the media leaves Dr. Gottenborg to wonder if prospective residents will shy away from hospital medicine because they believe it is an area that leads to burnout. “I hope that’s not the case,” she said.

“I would actually argue [recruitment] is easier,” said Dr. Rawal. Like Dr. Hall, she sees virtual interviews as a big benefit to prospective trainees because they don’t have to spend a large amount of money on travel, food, and other expenses like they did before, a welcome relief for residents with significant debt. “I think that is one very big positive from the pandemic,” she said. Her trainees were advised to make a final list and consider going to see the top two or three in person, but “at this point, there’s really no expectation to go see all 15 places that you look into.”

Dr. Rawal also pointed out that recruitment is affected by whether or not trainees are expected to see COVID patients. “I know in some places they aren’t and in some places they are, so it just depends on where you are and what you’re looking for,” she said.
 

Shifts in education

It remains to be seen if all the educational changes will be permanent, though it appears that many will remain. Dr. Hall hopes that virtual visits to provide care to patients who have difficulty getting to physical clinics will continue to be a focus for hospital medicine trainees. “For medical students, I think this will allow us to better assess what content can best be delivered in person, synchronously online, or asynchronously through recorded content,” he said.

Dr. Ricotta predicts that virtual conferences will become more pervasive as academic hospitals continue to acquire more community hospitals, especially for grand rounds. “The virtual teaching that occurred in the residency program because it’s required by the [Accreditation Council for Graduate Medical Education] has, I think, informed how academic centers do ongoing faculty development, professional development, and obviously education for the residents,” Dr. Ricotta said. “I think virtual teaching is here to stay.” This includes telehealth training, which had not been a widespread part of residency education before now.

Trainees have been given tools to handle high patient censuses and learned a whole new set of communication skills, thanks to the pandemic, said Dr. Rawal. There has been a focus on learning how to advocate for the vaccine, along with education on situations like how to have conversations with patients who don’t believe they have COVID, even when their tests are positive. “Learning to handle these situations and still be a physician and provide appropriate care regardless of the patient’s views is very important. This is not something I learned in my training because it never came up,” she said.

Dr. Gottenborg has been impressed by the resident workforce’s response across all specialties throughout these difficult days. “They were universally ready to dive in and work long hours and care for these very sick patients and ultimately share their experiences so that we could do it better as these patients continue to flow through our systems,” she said. “It has been very invigorating.”

The pandemic has also put a spotlight on the importance of being flexible, as well as various problems with how health care systems operate, “which, for people in our field, gets us both excited and gives us a lot of work to do,” said Dr. Gottenborg. “Our residents see that and feel that and will hopefully continue to hold that torch in hospital medicine.”

In spite of everything, Dr. Rawal believes this is an exhilarating time to be a trainee. “They’re getting an opportunity that none of us got. Usually, when policies are made, we really don’t see the immediate impact.” But with recent mandates like masks and social distancing, “the rate of change that they get to see things happen is exciting. They’re going to be a very exciting group of physicians.”

It could be argued that hospital medicine in the United States was made vital by a major infectious disease epidemic – the HIV/AIDS crisis – said Emily Gottenborg, MD, a hospitalist and program director of hospitalist training at the University of Colorado at Denver, Aurora. Certainly, it was born out of the need for change, for physicians who could coordinate complex patient care plans and serve as the “quarterbacks” of the hospital. “As a result, we have always been very nimble and ready to embrace change,” said Dr. Gottenborg.

Gottenborg_Emily_COLO_web.jpg

That hospitalist-honed agility and penchant for innovation has proven to be invaluable during the current COVID-19 pandemic as hospital medicine–focused residency programs have been forced to pivot quickly and modify their agendas. From managing the pandemic’s impact on residents’ day-to-day experiences, to carefully balancing educational needs and goals, program leaders have worked tirelessly to ensure that residents continue to receive excellent training.

The overarching theme across U.S.-based residency programs is that the educational changes and challenges during the COVID-19 pandemic have often been one and the same.
 

Service versus education

At the beginning of the pandemic, trainees at the University of Pittsburgh Medical Center were limited in seeing COVID patients in order to curb exposure. But now that COVID appears to be the new normal, “I think the question becomes: ‘How do we incorporate our trainees to take care of COVID patients since it seems it will be staying around for a while?’ ” said Rachna Rawal, MD, a hospitalist and clinical assistant professor of medicine at UPMC.

Rawal_Rachna_146_web.jpg

This dilemma highlights the conflict between service and education. Residents have been motivated and eager to help, which has been beneficial whenever there is a surge. “At the same time, you want to preserve their education, and it’s a very difficult balance at times,” said Dr. Rawal. It’s also challenging to figure out the safest way for residents to see patients, as well as how to include medical students, since interns and residents serve as important educational resources for them.

Keeping trainees involved with daily virtual conferences rather than in-person interactions raises the question of whether or not the engagement is equivalent. “It’s harder to keep them accountable when they’re not in person, but it’s also not worth the risk given the COVID numbers at times,” Dr. Rawal said. The goal has become to make sure residents stay safe while still feeling that they are getting a good education.
 

A balancing act

“I think early on, there was a lot of pride in what we were doing, that we were on the front line managing this thing that was emerging,” said Daniel Ricotta, MD, a hospitalist and associate program director of the internal medicine residency at Beth Israel Deaconess Medical Center and assistant professor of medicine at Harvard Medical School, both in Boston. “And now I think people are starting to feel a little bit weary.”

Ricotta_Daniel_MASS_web.jpg

It has been demanding trying to manage ongoing educational needs through this time. “At the end of the day, residents are still trainees and have to be trained and educated. They’re not just worker bees taking care of patients,” Dr. Ricotta said. Residents need a well-rounded clinical experience – “they can’t just take care of COVID patients and then be able to graduate as general internists,” he said – but that becomes onerous when the hospital is full of patients with COVID.

Along with balancing residents’ clinical immersion, Dr. Ricotta said there has been the challenge of doing “the content-based teaching from didactics that occur in the context of clinical work, but are somewhat separated when you need to limit the number of people in the rooms and try to keep as many people at home as possible when they’re not taking care of patients in order to limit their level of risk.” Adjusting and readjusting both of these aspects has had a major impact on residents’ day-to-day education.

“A big part of residency is community,” noted Dr. Ricotta, but the sense of community has been disrupted because some of the bonding experiences residents used to do outside the hospital to build that community have necessarily gone by the wayside. This particularly affects interns from around the country who are meeting each other for the first time. “We actually had a normal intern orientation this year, but last year, when everything was virtual, we were trying to find ways to bridge relationships in a way that was safe and socially distanced,” he said.
 

Improving quality

UC Denver is unique in that they have a 3-year program specifically for hospital medicine residents, said Dr. Gottenborg. Right away, “our residents rose to the challenge and wanted to be part of the workforce that helps care for this critical population of [COVID] patients.” The residents were able to run the ICUs and take care of COVID patients, but in exchange, they had to give up some of their elective rotation time.

One aspect of the UC Denver hospital medicine residency program is participation in projects that focus on how to improve the health care system. Over the past year, the residents worked on one project in particular that focused on restructuring the guidelines for consulting physical therapists. Since many patients end up needing a physical therapist for a variety of reasons, a full hospital puts increased strain on their workload, making their time more precious.

“[The project] forced us to think about the right criteria to consult them,” explained Dr. Gottenborg. “We cut down essentially all the inappropriate consults to PT, opening their time. That project was driven by how the residents were experiencing the pandemic in the hospital.”
 

Learning to adapt

“The training environment during this pandemic has been tumultuous for both our residents and medical students,” said Alan M. Hall, MD, associate professor of internal medicine and pediatrics and assistant dean of curriculum integration at the University of Kentucky, Lexington. Along with treating patients with COVID-19, he said trainees have also had to cope with anxiety about getting the virus themselves or inadvertently bringing it home to their families.

Hall_Alan_KY_web2.jpg

Like most medical schools, University of Kentucky students were shifted away from clinical rotations and into alternative and online education for a time. When they returned to in-person education, the students were initially restricted from seeing patients with confirmed or suspected COVID-19 in order to reduce their personal risk and to conserve personal protective equipment.

This especially impacted certain rotations, such as pediatrics. Because respiratory symptoms are common in this population, students were greatly limited in the number of new patients they could see. Now they are given the option to see patients with COVID-19 if they want to.

“Our residents have had to adapt to seemingly endless changes during this pandemic,” Dr. Hall said. For example, at the beginning of the surge, the internal medicine residents trained for a completely new clinical model, though this ultimately never needed to be implemented. Then they had to adjust to extremely high census numbers that continue to have an effect on almost all of their rotations.

Conversely, the pediatrics residents saw far fewer inpatients last winter than they typically would. This made it more difficult for them to feel comfortable when census numbers increased with common diagnoses like bronchiolitis. “However, those respiratory viruses that were hibernating last winter caused an unusual and challenging summer surge,” Dr. Hall said.

The biggest challenge though “is knowing that there is not a perfect solution for this global pandemic’s effect on medical education,” said Dr. Hall. “We can’t possibly perfectly balance the safety of our learners and their families with the dangers of COVID-19.”
 

Leadership discussions

As a residency program leader, Dr. Ricotta said there are conversations about multiple topics, including maintaining a safe learning environment; providing important aspects of residency training; whether to go back to full in-person teaching, keep doing virtual teaching, or implement a hybrid model; and how to help residents understand the balance between their personal and professional lives, especially in terms of safety.

“They have to their lives outside of the hospital, but we also are trying to instill ... what their responsibility is to society, to their patients, and to each other,” said Dr. Ricotta.

A more recent discussion has been about how to manage the COVID vaccine boosters. “We can’t have everyone getting vaccines at the same time because they might have symptoms afterward, and then be out sick – you’re missing half your workforce,” Dr. Ricotta said. But staggering residents’ booster shots created yet another dilemma around deciding who received the booster sooner rather than later.

The biggest consideration for Dr. Gottenborg’s leadership team was deciding whether to use their residents to help with the COVID surges or keep them in a traditional residency experience. While the residents wanted to be part of the pandemic response, there were many factors to consider. Ultimately, they came up with a balance between the amount of time residents should spend taking care of COVID patients while also assuring that they leave the program with all the skills and experiences they need.

Though Dr. Hall works more closely with medical students than residents, he sees the challenges and effects as being similar. Creating harmony between a safe learning environment and students’ educational goals has been the topic of endless discussions. This includes decisions as to whether or not students should be involved in person in certain activities such as large classroom didactics, written exams, seeing patients in clinical settings, and small group discussions.
 

Recruitment effects

When it comes to recruiting during a global pandemic, the experiences and predictions are mixed. Dr. Hall believes virtual interviews are making recruitment easier, but in turn, the fact that they are virtual also makes it harder for the applicant to get a good feel for the program and the people involved in it.

Dr. Ricotta reported that recruitment numbers have been fairly steady at Beth Israel Deaconess over the last few years. “In addition to the critical care physicians, hospital medicine was really the front line of this pandemic and so in some ways, we gained some recognition that we may not have had otherwise,” said Dr. Ricotta. He believes this has the benefit of attracting some residents, but at the same time, it could potentially scare others away from what they perceive as a demanding, grueling job. “I think it has been mixed. It’s dependent on the person.”

At UC Denver, Dr. Gottenborg said they are seeing a rapid rise in the number of applications and interest in their programs. Still, “I think this could go both ways,” she acknowledged. With the focus on hospital medicine in the media, medical students are more aware of the specialty and what it involves. “I think the sense of mission is really exemplified and everyone is talking about it,” she said. This is evident in the arrival this summer of the first new class of interns since the pandemic. “They’re incredibly passionate about the work,” said Dr. Gottenborg.

However, there is also the notable increase in physician burnout since the pandemic started. That this has been regularly featured in the media leaves Dr. Gottenborg to wonder if prospective residents will shy away from hospital medicine because they believe it is an area that leads to burnout. “I hope that’s not the case,” she said.

“I would actually argue [recruitment] is easier,” said Dr. Rawal. Like Dr. Hall, she sees virtual interviews as a big benefit to prospective trainees because they don’t have to spend a large amount of money on travel, food, and other expenses like they did before, a welcome relief for residents with significant debt. “I think that is one very big positive from the pandemic,” she said. Her trainees were advised to make a final list and consider going to see the top two or three in person, but “at this point, there’s really no expectation to go see all 15 places that you look into.”

Dr. Rawal also pointed out that recruitment is affected by whether or not trainees are expected to see COVID patients. “I know in some places they aren’t and in some places they are, so it just depends on where you are and what you’re looking for,” she said.
 

Shifts in education

It remains to be seen if all the educational changes will be permanent, though it appears that many will remain. Dr. Hall hopes that virtual visits to provide care to patients who have difficulty getting to physical clinics will continue to be a focus for hospital medicine trainees. “For medical students, I think this will allow us to better assess what content can best be delivered in person, synchronously online, or asynchronously through recorded content,” he said.

Dr. Ricotta predicts that virtual conferences will become more pervasive as academic hospitals continue to acquire more community hospitals, especially for grand rounds. “The virtual teaching that occurred in the residency program because it’s required by the [Accreditation Council for Graduate Medical Education] has, I think, informed how academic centers do ongoing faculty development, professional development, and obviously education for the residents,” Dr. Ricotta said. “I think virtual teaching is here to stay.” This includes telehealth training, which had not been a widespread part of residency education before now.

Trainees have been given tools to handle high patient censuses and learned a whole new set of communication skills, thanks to the pandemic, said Dr. Rawal. There has been a focus on learning how to advocate for the vaccine, along with education on situations like how to have conversations with patients who don’t believe they have COVID, even when their tests are positive. “Learning to handle these situations and still be a physician and provide appropriate care regardless of the patient’s views is very important. This is not something I learned in my training because it never came up,” she said.

Dr. Gottenborg has been impressed by the resident workforce’s response across all specialties throughout these difficult days. “They were universally ready to dive in and work long hours and care for these very sick patients and ultimately share their experiences so that we could do it better as these patients continue to flow through our systems,” she said. “It has been very invigorating.”

The pandemic has also put a spotlight on the importance of being flexible, as well as various problems with how health care systems operate, “which, for people in our field, gets us both excited and gives us a lot of work to do,” said Dr. Gottenborg. “Our residents see that and feel that and will hopefully continue to hold that torch in hospital medicine.”

In spite of everything, Dr. Rawal believes this is an exhilarating time to be a trainee. “They’re getting an opportunity that none of us got. Usually, when policies are made, we really don’t see the immediate impact.” But with recent mandates like masks and social distancing, “the rate of change that they get to see things happen is exciting. They’re going to be a very exciting group of physicians.”

One Montana hospital went into lockdown and called police after a woman threatened violence because her relative was denied her request to be treated with ivermectin.

Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.

And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.

These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.

“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”

Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.

Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.

Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.

Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.

In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.

“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.

Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.

The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.

“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”

An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.

That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.

“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.

“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.

A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.

Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.

Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.

The report did not offer any conclusions or allegations of wrongdoing.

Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.

“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.

“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.

The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.

Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.

“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”

He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.

Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.

“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.

Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.

“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

One Montana hospital went into lockdown and called police after a woman threatened violence because her relative was denied her request to be treated with ivermectin.

Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.

And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.

These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.

“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”

Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.

Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.

Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.

Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.

In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.

“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.

Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.

The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.

“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”

An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.

That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.

“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.

“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.

A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.

Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.

Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.

The report did not offer any conclusions or allegations of wrongdoing.

Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.

“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.

“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.

The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.

Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.

“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”

He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.

Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.

“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.

Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.

“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

One Montana hospital went into lockdown and called police after a woman threatened violence because her relative was denied her request to be treated with ivermectin.

Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.

And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.

These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.

“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”

Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.

Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.

Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.

Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.

In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.

“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.

Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.

The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.

“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”

An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.

That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.

“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.

“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.

A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.

Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.

Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.

The report did not offer any conclusions or allegations of wrongdoing.

Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.

“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.

“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.

The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.

Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.

“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”

He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.

Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.

“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.

Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.

“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.

The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.

“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.

COVID_vaccine_senior_web.jpg

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

A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.

The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.

“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.

COVID_vaccine_senior_web.jpg

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

A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.

The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.

“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.

COVID_vaccine_senior_web.jpg

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

Early lab studies show that a COVID-19 antibody treatment developed by GlaxoSmithKline and Vir Biotechnology could be effective against the Omicron variant.

The companies said Dec. 2 that they tested the drug, called sotrovimab, against individual mutations found in the Omicron variant, according to The Wall Street Journal. The preliminary findings haven’t yet been peer-reviewed, and the drug will need to be tested against the whole spike protein on the virus to confirm results.

GlaxoSmithKline and Vir have previously tested sotrovimab against mutations on other variants, the newspaper reported. When the Omicron variant was identified, the companies looked at earlier research to find the tests they had done against mutations that are also found in Omicron.

Sotrovimab targets a spot on the spike protein that is found in other coronaviruses and is thought to be less likely to mutate, according to the newspaper. Omicron has at least two mutations that overlap with the drug’s target site, but researchers at the companies don’t think the mutations will affect the treatment’s ability to bind to the spike protein.

GlaxoSmithKline expects to see results from testing the drug against the full mutated spike protein in the next 2 to 3 weeks, the Journal reported.

Sotrovimab has been authorized in about a dozen countries, including the United States, which paid about $1 billion for hundreds of thousands of doses.

Other companies have also been testing their antibody treatments against the Omicron variant.

Regeneron announced Nov. 30 that its drug could be less effective, and it said further analyses will determine how much less effective by using the actual Omicron genetic sequence, according to Reuters.

Outside scientists have also said the antibody drug from Eli Lilly & Co. isn’t as effective against Omicron. The company told Reuters that it is still testing the treatment against the variant.

Another experimental antibody therapy developed by Adagio Therapeutics appears to work well against the new variant, the Journal reported, but the treatment is in late-stage clinical trials and isn’t yet authorized.

Antiviral drugs could also help prevent hospitalization and may be less vulnerable to new variants because they target a different part of the virus, the newspaper reported. Merck and Pfizer have developed antiviral pills, which still require FDA approval.

In addition, Gilead believes its approved IV therapy, called remdesivir, will continue to be effective against the variant, Reuters reported.

The FDA said Nov. 30 that it is looking at the effect that authorized COVID-19 vaccines can have on Omicron and expects to have more information in coming weeks, Reuters reported.

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

Early lab studies show that a COVID-19 antibody treatment developed by GlaxoSmithKline and Vir Biotechnology could be effective against the Omicron variant.

The companies said Dec. 2 that they tested the drug, called sotrovimab, against individual mutations found in the Omicron variant, according to The Wall Street Journal. The preliminary findings haven’t yet been peer-reviewed, and the drug will need to be tested against the whole spike protein on the virus to confirm results.

GlaxoSmithKline and Vir have previously tested sotrovimab against mutations on other variants, the newspaper reported. When the Omicron variant was identified, the companies looked at earlier research to find the tests they had done against mutations that are also found in Omicron.

Sotrovimab targets a spot on the spike protein that is found in other coronaviruses and is thought to be less likely to mutate, according to the newspaper. Omicron has at least two mutations that overlap with the drug’s target site, but researchers at the companies don’t think the mutations will affect the treatment’s ability to bind to the spike protein.

GlaxoSmithKline expects to see results from testing the drug against the full mutated spike protein in the next 2 to 3 weeks, the Journal reported.

Sotrovimab has been authorized in about a dozen countries, including the United States, which paid about $1 billion for hundreds of thousands of doses.

Other companies have also been testing their antibody treatments against the Omicron variant.

Regeneron announced Nov. 30 that its drug could be less effective, and it said further analyses will determine how much less effective by using the actual Omicron genetic sequence, according to Reuters.

Outside scientists have also said the antibody drug from Eli Lilly & Co. isn’t as effective against Omicron. The company told Reuters that it is still testing the treatment against the variant.

Another experimental antibody therapy developed by Adagio Therapeutics appears to work well against the new variant, the Journal reported, but the treatment is in late-stage clinical trials and isn’t yet authorized.

Antiviral drugs could also help prevent hospitalization and may be less vulnerable to new variants because they target a different part of the virus, the newspaper reported. Merck and Pfizer have developed antiviral pills, which still require FDA approval.

In addition, Gilead believes its approved IV therapy, called remdesivir, will continue to be effective against the variant, Reuters reported.

The FDA said Nov. 30 that it is looking at the effect that authorized COVID-19 vaccines can have on Omicron and expects to have more information in coming weeks, Reuters reported.

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

Early lab studies show that a COVID-19 antibody treatment developed by GlaxoSmithKline and Vir Biotechnology could be effective against the Omicron variant.

The companies said Dec. 2 that they tested the drug, called sotrovimab, against individual mutations found in the Omicron variant, according to The Wall Street Journal. The preliminary findings haven’t yet been peer-reviewed, and the drug will need to be tested against the whole spike protein on the virus to confirm results.

GlaxoSmithKline and Vir have previously tested sotrovimab against mutations on other variants, the newspaper reported. When the Omicron variant was identified, the companies looked at earlier research to find the tests they had done against mutations that are also found in Omicron.

Sotrovimab targets a spot on the spike protein that is found in other coronaviruses and is thought to be less likely to mutate, according to the newspaper. Omicron has at least two mutations that overlap with the drug’s target site, but researchers at the companies don’t think the mutations will affect the treatment’s ability to bind to the spike protein.

GlaxoSmithKline expects to see results from testing the drug against the full mutated spike protein in the next 2 to 3 weeks, the Journal reported.

Sotrovimab has been authorized in about a dozen countries, including the United States, which paid about $1 billion for hundreds of thousands of doses.

Other companies have also been testing their antibody treatments against the Omicron variant.

Regeneron announced Nov. 30 that its drug could be less effective, and it said further analyses will determine how much less effective by using the actual Omicron genetic sequence, according to Reuters.

Outside scientists have also said the antibody drug from Eli Lilly & Co. isn’t as effective against Omicron. The company told Reuters that it is still testing the treatment against the variant.

Another experimental antibody therapy developed by Adagio Therapeutics appears to work well against the new variant, the Journal reported, but the treatment is in late-stage clinical trials and isn’t yet authorized.

Antiviral drugs could also help prevent hospitalization and may be less vulnerable to new variants because they target a different part of the virus, the newspaper reported. Merck and Pfizer have developed antiviral pills, which still require FDA approval.

In addition, Gilead believes its approved IV therapy, called remdesivir, will continue to be effective against the variant, Reuters reported.

The FDA said Nov. 30 that it is looking at the effect that authorized COVID-19 vaccines can have on Omicron and expects to have more information in coming weeks, Reuters reported.

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

Background: TXA is an anti-fibrinolytic agent that decreases surgical bleeding and reduces death resulting from bleeding in trauma and postpartum hemorrhage. A 2012 Cochrane review suggested a reduction in mortality with use of TXA in patients with GI bleed, but previous trials were small with a high risk of bias.

Chung_Andrew_web.jpg

There was an increase in venous thromboembolism (VTE; deep vein thrombosis or pulmonary embolism) in the TXA group versus the placebo group (0.8% with TXA and 0.4% with placebo; RR, 1.85; 95% CI, 1.15-2.98), as well as an increase in seizure events (0.6% with TXA and 0.4% with placebo; RR, 1.73; 95% CI, 1.03–2.93).

Bottom line: TXA did not reduce mortality risk in patients with upper or lower GI bleeding and should not be used in the routine management of GI bleed.

Citation: Roberts I et al. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. Lancet. 2020;395(10241):1927-1936. doi: 10.1016/S0140-6736(20)30848-5.

Dr. Chung is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: TXA is an anti-fibrinolytic agent that decreases surgical bleeding and reduces death resulting from bleeding in trauma and postpartum hemorrhage. A 2012 Cochrane review suggested a reduction in mortality with use of TXA in patients with GI bleed, but previous trials were small with a high risk of bias.

Chung_Andrew_web.jpg

There was an increase in venous thromboembolism (VTE; deep vein thrombosis or pulmonary embolism) in the TXA group versus the placebo group (0.8% with TXA and 0.4% with placebo; RR, 1.85; 95% CI, 1.15-2.98), as well as an increase in seizure events (0.6% with TXA and 0.4% with placebo; RR, 1.73; 95% CI, 1.03–2.93).

Bottom line: TXA did not reduce mortality risk in patients with upper or lower GI bleeding and should not be used in the routine management of GI bleed.

Citation: Roberts I et al. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. Lancet. 2020;395(10241):1927-1936. doi: 10.1016/S0140-6736(20)30848-5.

Dr. Chung is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: TXA is an anti-fibrinolytic agent that decreases surgical bleeding and reduces death resulting from bleeding in trauma and postpartum hemorrhage. A 2012 Cochrane review suggested a reduction in mortality with use of TXA in patients with GI bleed, but previous trials were small with a high risk of bias.

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There was an increase in venous thromboembolism (VTE; deep vein thrombosis or pulmonary embolism) in the TXA group versus the placebo group (0.8% with TXA and 0.4% with placebo; RR, 1.85; 95% CI, 1.15-2.98), as well as an increase in seizure events (0.6% with TXA and 0.4% with placebo; RR, 1.73; 95% CI, 1.03–2.93).

Bottom line: TXA did not reduce mortality risk in patients with upper or lower GI bleeding and should not be used in the routine management of GI bleed.

Citation: Roberts I et al. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. Lancet. 2020;395(10241):1927-1936. doi: 10.1016/S0140-6736(20)30848-5.

Dr. Chung is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.