Clinical

U.S. prescribing data from 160,000 adults with type 2 diabetes and diabetic kidney disease showed a notable uptick in new prescriptions for sodium-glucose cotransporter 2 inhibitors and less dramatic gains for glucagonlike peptide–1 receptor agonists during 2019 and continuing into early 2020, compared with prior years, with usage levels of both classes during the first quarter of 2020 rivaling those of more traditional agents including metformin and insulin.

During the first 3 months of 2020, initiation of a SGLT2 inhibitor constituted 13% of all new starts of an antidiabetes drug among adults with type 2 diabetes and diabetic kidney disease (DKD). This compared with initiation rates during the same early 2020 period of 17% for GLP-1 receptor agonists, 19% for metformin, 16% for sulfonylureas, 15% for insulins, 14% for thiazolidinediones, and 6% for dipeptidyl peptidase–4 inhibitors, the seven drug classes examined in a study published in Diabetes Care.

Early 2020 was the first time that starts of a GLP-1 receptor agonist ranked second (behind only metformin) among these seven drug classes in the studied U.S. population, and early 2020 also marked an unprecedentedly high start rate for SGLT2 inhibitors that nearly tripled the roughly 5% rate in place as recently as 2018.
 

Rises are ‘what we expected’

The recent rise of SGLT2 inhibitors and GLP-1 receptor agonists in these patients “was what we expected,” given the evidence for both classes in slowing progression of DKD, said Julie M. Paik, MD, senior author on the study and a nephrologist and pharmacoepidemiologist at Brigham and Women’s Hospital in Boston.

“We’ve seen other beneficial drugs slow on the uptake, so it’s not surprising to see it here, and I’m optimistic” about further increases going forward, she said in an interview.

Both drug classes “were originally marketed as diabetes drugs,” and it is only since 2019, with the publication of trials showing dramatic renal benefits from canagliflozin (Invokana) in CREDENCE, and from dapagliflozin (Farxiga) in DAPA-CKD in 2020 that the evidence became truly compelling for SGLT2 inhibitors. This evidence also led to new renal-protection indications approved by the Food and Drug Administration for canagliflozin and for dapagliflozin, noted Dr. Paik.

Evidence for renal protection also emerged in 2017 for the GLP-1 receptor agonist liraglutide (Victoza) in the LEADER trial, and for dulaglutide (Trulicity) in the AWARD-7 trial, although neither drug has received a renal indication in its labeling.

By 2020, guidelines for managing patients with type 2 diabetes and chronic kidney disease from the influential Kidney Disease: Improving Global Outcomes organization had identified agents from the SGLT2 inhibitor class as top-tier options, along with metformin, for treating these patients, with agents from the GLP-1 receptor agonist class as the top third class to add in patients who require additional glycemic control.

Additional analyses Dr. Paik and associates ran showed how this played out in terms of which specialists prescribed these drugs during the full period studied beginning in 2013. Throughout this roughly 7-year span, about 70% of the prescriptions written for either SGLT2 inhibitors or for GLP-1 receptor agonists were from internal medicine physicians, followed by about 20% written by endocrinologists. Prescriptions from nephrologists, as well as from cardiologists, have hovered at about 5% each, but seem poised to start rising based on the recently added indications and newer treatment recommendations.

“It’s good to see the recent uptick in use since 2019,” Katherine R. Tuttle, MD, commented in an interview. It’s a positive development for U.S. public health, “but we need to do more to disseminate and implement these life-, kidney-, and heart-saving therapies.”

Future use could approach 80% of DKD patients

Dr. Tuttle estimated that “target” levels of use for SGLT2 inhibitors and for GLP-1 receptor agonists “could reasonably approach 80%” for patients with type 2 diabetes and diabetic kidney disease.

“We will likely move to combination therapy” with simultaneous use of agents from both classes in a targeted way using “precision phenotyping based on clinical characteristics, and eventually perhaps by biomarkers, kidney biopsies, or both.” Combined treatment with both an SGLT2 inhibitor and a GLP-1 receptor agonist may be especially suited to patients with type 2 diabetes, atherosclerotic cardiovascular disease, low estimated glomerular filtration rate, and need for better glycemic control and weight loss, a profile that is “pretty typical” in real-world practice, said Dr. Tuttle, a nephrologist and endocrinologist and executive director for research at Providence Healthcare in Spokane, Wash.
 

Study included patients with commercial or Medicare Advantage coverage

The study used information in an Optum database that included patients enrolled in either commercial or in Medicare Advantage health insurance plans from 2013 to the first quarter of 2020. This included 160,489 adults with type 2 diabetes and DKD who started during that period at least one agent from any of the seven included drug classes.

This focus may have biased the findings because, overall, U.S. coverage of the relatively expensive agents from the SGLT2 inhibitor and GLP-1 receptor agonist classes has often been problematic.

“There are issues of cost, coverage, and access” using these medications, as well as limited data on cost-effectiveness, Dr. Paik acknowledged. Additional issues that have helped generate prescribing lags include concerns about possible adverse effects, low familiarity by providers with these drugs early on, and limited trial experience using them in older patients. The process of clinicians growing more comfortable prescribing these new agents has depended on their “working through the evidence,” she explained.

The FDA’s approval in July 2021 of finerenone (Kerendia) for treating patients with type 2 diabetes and chronic kidney disease threw yet another new variable into the prescribing mix for these patients.

“SGLT2 inhibitors are here to stay as a new standard of care for patients with diabetic kidney disease, but combination with finerenone might be especially useful for patients with diabetic kidney disease and heart failure,” Dr. Tuttle suggested. A new generation of clinical trials will likely soon launch to test these combinations, she predicted.

Dr. Paik had no disclosures. Dr. Tuttle has been a consultant to AstraZeneca, Bayer, Boehringer Ingelheim, Gilead, Goldfinch Bio, Eli Lilly, and Novo Nordisk.

[email protected]

U.S. prescribing data from 160,000 adults with type 2 diabetes and diabetic kidney disease showed a notable uptick in new prescriptions for sodium-glucose cotransporter 2 inhibitors and less dramatic gains for glucagonlike peptide–1 receptor agonists during 2019 and continuing into early 2020, compared with prior years, with usage levels of both classes during the first quarter of 2020 rivaling those of more traditional agents including metformin and insulin.

During the first 3 months of 2020, initiation of a SGLT2 inhibitor constituted 13% of all new starts of an antidiabetes drug among adults with type 2 diabetes and diabetic kidney disease (DKD). This compared with initiation rates during the same early 2020 period of 17% for GLP-1 receptor agonists, 19% for metformin, 16% for sulfonylureas, 15% for insulins, 14% for thiazolidinediones, and 6% for dipeptidyl peptidase–4 inhibitors, the seven drug classes examined in a study published in Diabetes Care.

Early 2020 was the first time that starts of a GLP-1 receptor agonist ranked second (behind only metformin) among these seven drug classes in the studied U.S. population, and early 2020 also marked an unprecedentedly high start rate for SGLT2 inhibitors that nearly tripled the roughly 5% rate in place as recently as 2018.
 

Rises are ‘what we expected’

The recent rise of SGLT2 inhibitors and GLP-1 receptor agonists in these patients “was what we expected,” given the evidence for both classes in slowing progression of DKD, said Julie M. Paik, MD, senior author on the study and a nephrologist and pharmacoepidemiologist at Brigham and Women’s Hospital in Boston.

“We’ve seen other beneficial drugs slow on the uptake, so it’s not surprising to see it here, and I’m optimistic” about further increases going forward, she said in an interview.

Both drug classes “were originally marketed as diabetes drugs,” and it is only since 2019, with the publication of trials showing dramatic renal benefits from canagliflozin (Invokana) in CREDENCE, and from dapagliflozin (Farxiga) in DAPA-CKD in 2020 that the evidence became truly compelling for SGLT2 inhibitors. This evidence also led to new renal-protection indications approved by the Food and Drug Administration for canagliflozin and for dapagliflozin, noted Dr. Paik.

Evidence for renal protection also emerged in 2017 for the GLP-1 receptor agonist liraglutide (Victoza) in the LEADER trial, and for dulaglutide (Trulicity) in the AWARD-7 trial, although neither drug has received a renal indication in its labeling.

By 2020, guidelines for managing patients with type 2 diabetes and chronic kidney disease from the influential Kidney Disease: Improving Global Outcomes organization had identified agents from the SGLT2 inhibitor class as top-tier options, along with metformin, for treating these patients, with agents from the GLP-1 receptor agonist class as the top third class to add in patients who require additional glycemic control.

Additional analyses Dr. Paik and associates ran showed how this played out in terms of which specialists prescribed these drugs during the full period studied beginning in 2013. Throughout this roughly 7-year span, about 70% of the prescriptions written for either SGLT2 inhibitors or for GLP-1 receptor agonists were from internal medicine physicians, followed by about 20% written by endocrinologists. Prescriptions from nephrologists, as well as from cardiologists, have hovered at about 5% each, but seem poised to start rising based on the recently added indications and newer treatment recommendations.

“It’s good to see the recent uptick in use since 2019,” Katherine R. Tuttle, MD, commented in an interview. It’s a positive development for U.S. public health, “but we need to do more to disseminate and implement these life-, kidney-, and heart-saving therapies.”

Future use could approach 80% of DKD patients

Dr. Tuttle estimated that “target” levels of use for SGLT2 inhibitors and for GLP-1 receptor agonists “could reasonably approach 80%” for patients with type 2 diabetes and diabetic kidney disease.

“We will likely move to combination therapy” with simultaneous use of agents from both classes in a targeted way using “precision phenotyping based on clinical characteristics, and eventually perhaps by biomarkers, kidney biopsies, or both.” Combined treatment with both an SGLT2 inhibitor and a GLP-1 receptor agonist may be especially suited to patients with type 2 diabetes, atherosclerotic cardiovascular disease, low estimated glomerular filtration rate, and need for better glycemic control and weight loss, a profile that is “pretty typical” in real-world practice, said Dr. Tuttle, a nephrologist and endocrinologist and executive director for research at Providence Healthcare in Spokane, Wash.
 

Study included patients with commercial or Medicare Advantage coverage

The study used information in an Optum database that included patients enrolled in either commercial or in Medicare Advantage health insurance plans from 2013 to the first quarter of 2020. This included 160,489 adults with type 2 diabetes and DKD who started during that period at least one agent from any of the seven included drug classes.

This focus may have biased the findings because, overall, U.S. coverage of the relatively expensive agents from the SGLT2 inhibitor and GLP-1 receptor agonist classes has often been problematic.

“There are issues of cost, coverage, and access” using these medications, as well as limited data on cost-effectiveness, Dr. Paik acknowledged. Additional issues that have helped generate prescribing lags include concerns about possible adverse effects, low familiarity by providers with these drugs early on, and limited trial experience using them in older patients. The process of clinicians growing more comfortable prescribing these new agents has depended on their “working through the evidence,” she explained.

The FDA’s approval in July 2021 of finerenone (Kerendia) for treating patients with type 2 diabetes and chronic kidney disease threw yet another new variable into the prescribing mix for these patients.

“SGLT2 inhibitors are here to stay as a new standard of care for patients with diabetic kidney disease, but combination with finerenone might be especially useful for patients with diabetic kidney disease and heart failure,” Dr. Tuttle suggested. A new generation of clinical trials will likely soon launch to test these combinations, she predicted.

Dr. Paik had no disclosures. Dr. Tuttle has been a consultant to AstraZeneca, Bayer, Boehringer Ingelheim, Gilead, Goldfinch Bio, Eli Lilly, and Novo Nordisk.

[email protected]

U.S. prescribing data from 160,000 adults with type 2 diabetes and diabetic kidney disease showed a notable uptick in new prescriptions for sodium-glucose cotransporter 2 inhibitors and less dramatic gains for glucagonlike peptide–1 receptor agonists during 2019 and continuing into early 2020, compared with prior years, with usage levels of both classes during the first quarter of 2020 rivaling those of more traditional agents including metformin and insulin.

During the first 3 months of 2020, initiation of a SGLT2 inhibitor constituted 13% of all new starts of an antidiabetes drug among adults with type 2 diabetes and diabetic kidney disease (DKD). This compared with initiation rates during the same early 2020 period of 17% for GLP-1 receptor agonists, 19% for metformin, 16% for sulfonylureas, 15% for insulins, 14% for thiazolidinediones, and 6% for dipeptidyl peptidase–4 inhibitors, the seven drug classes examined in a study published in Diabetes Care.

Early 2020 was the first time that starts of a GLP-1 receptor agonist ranked second (behind only metformin) among these seven drug classes in the studied U.S. population, and early 2020 also marked an unprecedentedly high start rate for SGLT2 inhibitors that nearly tripled the roughly 5% rate in place as recently as 2018.
 

Rises are ‘what we expected’

The recent rise of SGLT2 inhibitors and GLP-1 receptor agonists in these patients “was what we expected,” given the evidence for both classes in slowing progression of DKD, said Julie M. Paik, MD, senior author on the study and a nephrologist and pharmacoepidemiologist at Brigham and Women’s Hospital in Boston.

“We’ve seen other beneficial drugs slow on the uptake, so it’s not surprising to see it here, and I’m optimistic” about further increases going forward, she said in an interview.

Both drug classes “were originally marketed as diabetes drugs,” and it is only since 2019, with the publication of trials showing dramatic renal benefits from canagliflozin (Invokana) in CREDENCE, and from dapagliflozin (Farxiga) in DAPA-CKD in 2020 that the evidence became truly compelling for SGLT2 inhibitors. This evidence also led to new renal-protection indications approved by the Food and Drug Administration for canagliflozin and for dapagliflozin, noted Dr. Paik.

Evidence for renal protection also emerged in 2017 for the GLP-1 receptor agonist liraglutide (Victoza) in the LEADER trial, and for dulaglutide (Trulicity) in the AWARD-7 trial, although neither drug has received a renal indication in its labeling.

By 2020, guidelines for managing patients with type 2 diabetes and chronic kidney disease from the influential Kidney Disease: Improving Global Outcomes organization had identified agents from the SGLT2 inhibitor class as top-tier options, along with metformin, for treating these patients, with agents from the GLP-1 receptor agonist class as the top third class to add in patients who require additional glycemic control.

Additional analyses Dr. Paik and associates ran showed how this played out in terms of which specialists prescribed these drugs during the full period studied beginning in 2013. Throughout this roughly 7-year span, about 70% of the prescriptions written for either SGLT2 inhibitors or for GLP-1 receptor agonists were from internal medicine physicians, followed by about 20% written by endocrinologists. Prescriptions from nephrologists, as well as from cardiologists, have hovered at about 5% each, but seem poised to start rising based on the recently added indications and newer treatment recommendations.

“It’s good to see the recent uptick in use since 2019,” Katherine R. Tuttle, MD, commented in an interview. It’s a positive development for U.S. public health, “but we need to do more to disseminate and implement these life-, kidney-, and heart-saving therapies.”

Future use could approach 80% of DKD patients

Dr. Tuttle estimated that “target” levels of use for SGLT2 inhibitors and for GLP-1 receptor agonists “could reasonably approach 80%” for patients with type 2 diabetes and diabetic kidney disease.

“We will likely move to combination therapy” with simultaneous use of agents from both classes in a targeted way using “precision phenotyping based on clinical characteristics, and eventually perhaps by biomarkers, kidney biopsies, or both.” Combined treatment with both an SGLT2 inhibitor and a GLP-1 receptor agonist may be especially suited to patients with type 2 diabetes, atherosclerotic cardiovascular disease, low estimated glomerular filtration rate, and need for better glycemic control and weight loss, a profile that is “pretty typical” in real-world practice, said Dr. Tuttle, a nephrologist and endocrinologist and executive director for research at Providence Healthcare in Spokane, Wash.
 

Study included patients with commercial or Medicare Advantage coverage

The study used information in an Optum database that included patients enrolled in either commercial or in Medicare Advantage health insurance plans from 2013 to the first quarter of 2020. This included 160,489 adults with type 2 diabetes and DKD who started during that period at least one agent from any of the seven included drug classes.

This focus may have biased the findings because, overall, U.S. coverage of the relatively expensive agents from the SGLT2 inhibitor and GLP-1 receptor agonist classes has often been problematic.

“There are issues of cost, coverage, and access” using these medications, as well as limited data on cost-effectiveness, Dr. Paik acknowledged. Additional issues that have helped generate prescribing lags include concerns about possible adverse effects, low familiarity by providers with these drugs early on, and limited trial experience using them in older patients. The process of clinicians growing more comfortable prescribing these new agents has depended on their “working through the evidence,” she explained.

The FDA’s approval in July 2021 of finerenone (Kerendia) for treating patients with type 2 diabetes and chronic kidney disease threw yet another new variable into the prescribing mix for these patients.

“SGLT2 inhibitors are here to stay as a new standard of care for patients with diabetic kidney disease, but combination with finerenone might be especially useful for patients with diabetic kidney disease and heart failure,” Dr. Tuttle suggested. A new generation of clinical trials will likely soon launch to test these combinations, she predicted.

Dr. Paik had no disclosures. Dr. Tuttle has been a consultant to AstraZeneca, Bayer, Boehringer Ingelheim, Gilead, Goldfinch Bio, Eli Lilly, and Novo Nordisk.

[email protected]

Background: Direct oral anticoagulants have proven to be more efficacious, safe, and easy to use, compared with warfarin, in patients with atrial fibrillation (Afib). An indirect comparison showed apixaban to be more effective and safer than rivaroxaban. But randomized controlled trials and head-to-head comparison data regarding the same have been lacking until now.

This observational study has several limitations including an inability to balance unmeasured confounding factors, both ICD-9 and ICD-10 codes being used for defined outcomes, an inability to account for time-varying confounders for stroke or bleeding, an inability to capture patients from locations other than primary internist and cardiologists, and a shorter follow-up period, compared with that of clinical trials.

Bottom line: In routine practice, apixaban is more effective and safer than rivaroxaban with a lower rate of strokes, systemic embolism, and major bleeding.

Citation: Fralick M et al. Effectiveness and safety of apixaban compared with rivaroxaban for patients with atrial fibrillation in routine practice: a cohort study. Ann Intern Med. 2020 Apr 7. doi: 10.7326/M19-2522.

Dr. Almagdub is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.

Background: Direct oral anticoagulants have proven to be more efficacious, safe, and easy to use, compared with warfarin, in patients with atrial fibrillation (Afib). An indirect comparison showed apixaban to be more effective and safer than rivaroxaban. But randomized controlled trials and head-to-head comparison data regarding the same have been lacking until now.

This observational study has several limitations including an inability to balance unmeasured confounding factors, both ICD-9 and ICD-10 codes being used for defined outcomes, an inability to account for time-varying confounders for stroke or bleeding, an inability to capture patients from locations other than primary internist and cardiologists, and a shorter follow-up period, compared with that of clinical trials.

Bottom line: In routine practice, apixaban is more effective and safer than rivaroxaban with a lower rate of strokes, systemic embolism, and major bleeding.

Citation: Fralick M et al. Effectiveness and safety of apixaban compared with rivaroxaban for patients with atrial fibrillation in routine practice: a cohort study. Ann Intern Med. 2020 Apr 7. doi: 10.7326/M19-2522.

Dr. Almagdub is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.

Background: Direct oral anticoagulants have proven to be more efficacious, safe, and easy to use, compared with warfarin, in patients with atrial fibrillation (Afib). An indirect comparison showed apixaban to be more effective and safer than rivaroxaban. But randomized controlled trials and head-to-head comparison data regarding the same have been lacking until now.

This observational study has several limitations including an inability to balance unmeasured confounding factors, both ICD-9 and ICD-10 codes being used for defined outcomes, an inability to account for time-varying confounders for stroke or bleeding, an inability to capture patients from locations other than primary internist and cardiologists, and a shorter follow-up period, compared with that of clinical trials.

Bottom line: In routine practice, apixaban is more effective and safer than rivaroxaban with a lower rate of strokes, systemic embolism, and major bleeding.

Citation: Fralick M et al. Effectiveness and safety of apixaban compared with rivaroxaban for patients with atrial fibrillation in routine practice: a cohort study. Ann Intern Med. 2020 Apr 7. doi: 10.7326/M19-2522.

Dr. Almagdub is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.

The Food and Drug Administration has granted a biological license application, more commonly known as “full approval,” to the Pfizer-BioNTech COVID-19 vaccine.

It is the first COVID-19 vaccine to be fully licensed in the United States. It will be marketed under the trade name Comirnaty. 

The approval applies to individuals ages 16 years and older. The vaccine is still available for emergency use for those ages 12-15.

The FDA’s stamp of approval is somewhat anticlimactic, following months of real-world use and millions of doses doled out to the general population. It comes after months of scrutiny by the agency of the clinical trial data.

Still, the approval puts the vaccines on firmer legal footing and is expected to spur a raft of new vaccination requirements by employers, schools, and universities. 

“The FDA approval is the gold standard,” President Joe Biden said from the White House. “Those who have been waiting for full approval should go and get your shot now.”

“It could save your life or the lives of those you love,” he said.

Biden also called on businesses to mandate COVID vaccines for their employees.

Indeed, soon after the approval was announced, Defense Secretary Lloyd Austin said the vaccines would be required for all 1.4 million active duty service members.

Public health advocates have seen full approval as an important tool to increase U.S. vaccination rates and had criticized the FDA for taking so long to grant the license. 

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

This article was updated on 8/24/21.

The Food and Drug Administration has granted a biological license application, more commonly known as “full approval,” to the Pfizer-BioNTech COVID-19 vaccine.

It is the first COVID-19 vaccine to be fully licensed in the United States. It will be marketed under the trade name Comirnaty. 

The approval applies to individuals ages 16 years and older. The vaccine is still available for emergency use for those ages 12-15.

The FDA’s stamp of approval is somewhat anticlimactic, following months of real-world use and millions of doses doled out to the general population. It comes after months of scrutiny by the agency of the clinical trial data.

Still, the approval puts the vaccines on firmer legal footing and is expected to spur a raft of new vaccination requirements by employers, schools, and universities. 

“The FDA approval is the gold standard,” President Joe Biden said from the White House. “Those who have been waiting for full approval should go and get your shot now.”

“It could save your life or the lives of those you love,” he said.

Biden also called on businesses to mandate COVID vaccines for their employees.

Indeed, soon after the approval was announced, Defense Secretary Lloyd Austin said the vaccines would be required for all 1.4 million active duty service members.

Public health advocates have seen full approval as an important tool to increase U.S. vaccination rates and had criticized the FDA for taking so long to grant the license. 

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

This article was updated on 8/24/21.

The Food and Drug Administration has granted a biological license application, more commonly known as “full approval,” to the Pfizer-BioNTech COVID-19 vaccine.

It is the first COVID-19 vaccine to be fully licensed in the United States. It will be marketed under the trade name Comirnaty. 

The approval applies to individuals ages 16 years and older. The vaccine is still available for emergency use for those ages 12-15.

The FDA’s stamp of approval is somewhat anticlimactic, following months of real-world use and millions of doses doled out to the general population. It comes after months of scrutiny by the agency of the clinical trial data.

Still, the approval puts the vaccines on firmer legal footing and is expected to spur a raft of new vaccination requirements by employers, schools, and universities. 

“The FDA approval is the gold standard,” President Joe Biden said from the White House. “Those who have been waiting for full approval should go and get your shot now.”

“It could save your life or the lives of those you love,” he said.

Biden also called on businesses to mandate COVID vaccines for their employees.

Indeed, soon after the approval was announced, Defense Secretary Lloyd Austin said the vaccines would be required for all 1.4 million active duty service members.

Public health advocates have seen full approval as an important tool to increase U.S. vaccination rates and had criticized the FDA for taking so long to grant the license. 

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

This article was updated on 8/24/21.

The COVID-19 pandemic has tested disaster preparedness in hospitals across the nation. The pandemic brought many unique disaster planning challenges not commonly seen with other emergencies disasters. These included an uncertain and prolonged time frame, the implementation of physical distancing, and the challenges of preserving the health care work force.

But how do we prepare for the next disaster when the health care system and staff are already stretched thin? Here, we discuss the concept of maintaining a state of preparedness through and beyond COVID-19, using a disaster preparedness cycle – including continuous assessments of vulnerabilities, dynamic staffing adjustments to support patient and hospital needs, and broadening of the pandemic response to incorporate planning for the next disaster.

Disaster preparedness and assessing ongoing needs

Disaster preparedness cycle and Hazard Vulnerability Assessment

The disaster preparedness cycle illustrates that disaster preparedness is continuous. Disaster preparedness is achieved with the non-stop cycle of planning, coordinating, and recognizing vulnerable areas.^1-5 Hazard vulnerability analysis (HVA) can play a critical role in recognizing areas in which a hospital system has strengths and weaknesses for different disaster scenarios. There are several tools available, but the overarching goal is to provide an objective and systematic approach to evaluate the potential damage and impact a disaster could have on the health care system and surrounding community.

The HVA can also be utilized to reassess system or personnel vulnerabilities that may have been exposed or highlighted during the pandemic.^6,7 These vulnerabilities must be addressed during preparations for the next disaster while concurrently “assuming the incident happens at the worst possible time.”⁷

Disaster preparedness staffing considerations

Management, communication, and staffing issues are critical to disaster response. Key leadership responses during COVID-19 included providing frequent and transparent communication, down-staffing for physical distancing during low census, and prioritizing staff well-being. These measures serve as a strong foundation moving into preparations for the next disaster.⁸

To ensure adequate staffing during an unexpected natural disaster, we recommend creating “ride-out” and “relief teams” as part of disaster staffing preparedness.^9,10 The ride-out team provides the initial care and these providers are expected to stay in the hospital during the primary impact of the event. Once the initial threat of disaster is over and it is deemed safe to travel, the relief team is activated and offers reprieve to the ride-out team. Leaders and backup leaders within these teams should be identified in the event teams are activated. These assignments should be made at the start of the year and updated yearly or more frequently, if needed.

Dynamic disaster response

Supporting patient and hospital needs

The next step in the disaster preparedness cycle is adjusting to changing needs during the disaster. The pediatric inpatient population was less affected initially by COVID-19, allowing hospitalists to support the unpredicted needs of the pandemic. A dynamic and flexible physician response is important to disaster preparedness.

As there has been a continued shift to telehealth during the pandemic, our group has engaged in telehealth calls related to COVID-19. Seizing these new opportunities not only provided additional services to our patients, but also strengthened community support, physician worth, and the hospital’s financial state. This is also an opportunity for higher-risk clinicians or quarantined faculty to offer patient care during the pandemic.

Cram et al. describe the importance of “unspecializing” during the COVID-19 pandemic.¹¹ Starting discussions early with adult and pediatric critical care colleagues is vital. Hospitalists take care of a broad patient population, and therefore, can adapt to where the clinical need may be. Optimizing and expanding our skill sets can bring value to the hospital system during uncertain times.

Hospitalists are also instrumental for patient flow during the pandemic. To address this, our group partnered with hospital leadership from many different areas including administration, nursing, emergency medicine, critical care, and ancillary services. By collaborating as one cohesive hospital unit, we were able to efficiently develop, implement, and update best clinical care guidelines and algorithms for COVID-19–related topics such as testing indications, admission criteria, infection control, and proper personal protective equipment use. Lastly, working with specialists to consolidate teams during a pandemic presents an opportunity for hospitalists to highlight expertise while bringing value to the hospital.
 

Unique staffing situations related to COVID-19

Different from other disasters, the COVID-19 pandemic affected older or immunocompromised staff in a unique way. Beauhaus et al. note that 20% of the physician workforce in the United Sates is between 55 and 64 years of age, and 9% are 65 years and older.¹² Hospitalist groups should focus on how to optimize and preserve their workforce, specifically those that are higher risk due to age or other health conditions.

We used a tiered guide to safely accommodate our physicians that were determined to be at higher-risk for complications of COVID-19; these recommendations included limiting exposure to patients with acute respiratory illnesses and shifting some providers to a different clinical environments with a lower exposure risk, such as telemedicine visits.

Other COVID-19 preparedness considerations that affected our group in particular include the changes in learner staffing. Similar to attending down-staffing to encourage physical distancing during low census, learners (residents, medical students, and physician assistant students) also experienced decreased hours or suspension of rotations. To maintain optimal patient care, adjusting to changing disaster needs may include assessing attendings’ capacity to assume responsibilities typically supported by learners.

Due to the ongoing nature of the pandemic, we have had to maintain a dynamic response while adjusting to changing and ongoing needs during recovery. Creating a measured and staggered approach helps facilitate a smooth transition back to nonemergent activities. The education of learners, academic and scholarly work, and administrative duties will resume, but likely in a different steady state. Also, awareness of physician burnout and fatigue is critical as an institution enters a phase of recovery.
 

Preparing for the next disaster during the pandemic

This brings us back to the beginning of the disaster preparedness cycle and the need to plan for the next disaster. Current disaster preparedness plans among physician groups and hospitals are likely focused on an individual disaster scenario, but adjusting current disaster plans to account for the uncertain time frame of an event like the COVID-19 pandemic is critical. Several articles in the national news posed similar questions, although these publications focused mainly on the Federal Emergency Management Agency and the governmental response to prepare for the next disaster when resources are already stretched.^13-15

How do we adequately plan, maintain a dynamic response, and continue to efficiently move through the disaster staffing cycle during an event like the COVID-19 pandemic? Being aware of current vulnerabilities and addressing gaps at the department and hospital level are vital to disaster preparedness. For example, we reassessed disaster (ride-out/relief) teams and the minimum number of staff needed to maintain safe and quality care, and what in-house arrangements would be needed (food, supplies, sleeping arrangements) while having to maintain physical distance.

Newman et al. explain “in disaster planning, having as many physicians as possible on hand may seem like an advantage, but being overstaffed in tight quarters was almost as bad as being understaffed.”⁹ This has been particularly true during the COVID-19 pandemic. It is crucial to have backup plans for faculty that are unable to serve ride-out duties from unexpected issues – such as availability, illnesses/quarantines, childcare/dependents. Also, it is important to be aware that some supply chains are already strained because of the pandemic and how this may play a role in the availability of certain supplies. Being aware and proactive about specific constraints allows for a better level of preparedness. Continued collaboration and communication with other services to provide care should be ongoing throughout the disaster preparedness cycle.
 

Conclusion

Providing and maintaining optimal and safe patient care should be the overarching goal throughout disaster preparedness. Being aware of group and institutional vulnerabilities, collaboration with hospital leadership, and remaining flexible as hospitalists are critical components for successful preparedness amid disasters. A dynamic and responsive disaster plan has been vital amid COVID-19, and for the next disasters we will certainly encounter.

Dr. Hadvani is assistant professor of pediatrics in the section of hospital medicine at Baylor College of Medicine, Texas Children’s Hospital. Dr. Uremovich is assistant professor of pediatrics in the section of hospital medicine at Baylor College of Medicine, Texas Children’s Hospital. Dr. Quinonez is associate professor of pediatrics and chief of pediatric hospital medicine at Baylor College of Medicine, Texas Children’s Hospital. Dr. Lopez is assistant professor of pediatrics in the section of hospital medicine at Baylor College of Medicine, Texas Children’s Hospital. Dr. Mothner is associate professor of pediatrics in the section of hospital medicine at Baylor College of Medicine, Texas Children’s Hospital and is the pediatric hospital medicine medical director for the main campus.

References

1. Malilay J et al. The role of applied epidemiology methods in the disaster management cycle. Am J Public Health. 2014;104(11):2092-102. doi: 10.2105/AJPH.2014.302010.

2. Federal Emergency Management Agency. Developing and maintaining emergency operations plans. 2010 Nov.

3. Federal Emergency Management Agency. National preparedness system. 2020 Jul 31.

4. Federal Emergency Management Agency. National preparedness goal. 2011 Sep.

5. Environmental health in emergencies and disasters: A practical guide. World Health Organization, Geneva. 2002:9-24. Edited by B. Wisner and J. Adams.

6. U.S. Department of Health and Human Services. Topic collection: Hazard vulnerability/risk assessment.

7. Hospital Association of Southern California. Hazard and vulnerability analysis.

8. Meier K et al. Pediatric hospital medicine management, staffing, and well-being in the face of COVID-19. J Hosp Med. 2020 May;15(5):308-10. doi: 10.12788/jhm.3435.

9. Newman B and Gallion C. Hurricane Harvey: Firsthand preparedness in graduate medical education. Acad Med. 2019 Sep;94(9):1267-69. doi: 10.1097/ACM.0000000000002696.

10. Brevard S et al. Analysis of disaster response plans and the aftermath of Hurricane Katrina: Lessons learned from a level I trauma center. J Trauma. 2008 Nov;65(5):1126-32. doi: 10.1097/TA.0b013e318188d6e5.

11. Cram P et al. All hands on deck learning to “un-specialize” in the COVID-19 pandemic. J Hosp Med. 2020 May;15(5):314-5. doi: 10.12788/jhm.3426.

12. Buerhaus P et al. Older clinicians and the surge in novel coronavirus disease 2019 (COVID-19). JAMA. 2020 May 12;323(18):1777-8. doi: 10.1001/jama.2020.4978.

13. VOX Media. Imagine Hurricane Katrina during a pandemic. The US needs to prepare for that – now. 2020 May 27.

14. The Hill. Democratic lawmakers ask how FEMA is planning to balance natural disasters, COVID-19 response. 2020 Apr 20.

15. The Atlantic. What happens if a ‘big one’ strikes during the pandemic? 2020 May 9.

The COVID-19 pandemic has tested disaster preparedness in hospitals across the nation. The pandemic brought many unique disaster planning challenges not commonly seen with other emergencies disasters. These included an uncertain and prolonged time frame, the implementation of physical distancing, and the challenges of preserving the health care work force.

But how do we prepare for the next disaster when the health care system and staff are already stretched thin? Here, we discuss the concept of maintaining a state of preparedness through and beyond COVID-19, using a disaster preparedness cycle – including continuous assessments of vulnerabilities, dynamic staffing adjustments to support patient and hospital needs, and broadening of the pandemic response to incorporate planning for the next disaster.

Disaster preparedness and assessing ongoing needs

Disaster preparedness cycle and Hazard Vulnerability Assessment

The disaster preparedness cycle illustrates that disaster preparedness is continuous. Disaster preparedness is achieved with the non-stop cycle of planning, coordinating, and recognizing vulnerable areas.^1-5 Hazard vulnerability analysis (HVA) can play a critical role in recognizing areas in which a hospital system has strengths and weaknesses for different disaster scenarios. There are several tools available, but the overarching goal is to provide an objective and systematic approach to evaluate the potential damage and impact a disaster could have on the health care system and surrounding community.

The HVA can also be utilized to reassess system or personnel vulnerabilities that may have been exposed or highlighted during the pandemic.^6,7 These vulnerabilities must be addressed during preparations for the next disaster while concurrently “assuming the incident happens at the worst possible time.”⁷

Disaster preparedness staffing considerations

Management, communication, and staffing issues are critical to disaster response. Key leadership responses during COVID-19 included providing frequent and transparent communication, down-staffing for physical distancing during low census, and prioritizing staff well-being. These measures serve as a strong foundation moving into preparations for the next disaster.⁸

To ensure adequate staffing during an unexpected natural disaster, we recommend creating “ride-out” and “relief teams” as part of disaster staffing preparedness.^9,10 The ride-out team provides the initial care and these providers are expected to stay in the hospital during the primary impact of the event. Once the initial threat of disaster is over and it is deemed safe to travel, the relief team is activated and offers reprieve to the ride-out team. Leaders and backup leaders within these teams should be identified in the event teams are activated. These assignments should be made at the start of the year and updated yearly or more frequently, if needed.

Dynamic disaster response

Supporting patient and hospital needs

The next step in the disaster preparedness cycle is adjusting to changing needs during the disaster. The pediatric inpatient population was less affected initially by COVID-19, allowing hospitalists to support the unpredicted needs of the pandemic. A dynamic and flexible physician response is important to disaster preparedness.

As there has been a continued shift to telehealth during the pandemic, our group has engaged in telehealth calls related to COVID-19. Seizing these new opportunities not only provided additional services to our patients, but also strengthened community support, physician worth, and the hospital’s financial state. This is also an opportunity for higher-risk clinicians or quarantined faculty to offer patient care during the pandemic.

Cram et al. describe the importance of “unspecializing” during the COVID-19 pandemic.¹¹ Starting discussions early with adult and pediatric critical care colleagues is vital. Hospitalists take care of a broad patient population, and therefore, can adapt to where the clinical need may be. Optimizing and expanding our skill sets can bring value to the hospital system during uncertain times.

Hospitalists are also instrumental for patient flow during the pandemic. To address this, our group partnered with hospital leadership from many different areas including administration, nursing, emergency medicine, critical care, and ancillary services. By collaborating as one cohesive hospital unit, we were able to efficiently develop, implement, and update best clinical care guidelines and algorithms for COVID-19–related topics such as testing indications, admission criteria, infection control, and proper personal protective equipment use. Lastly, working with specialists to consolidate teams during a pandemic presents an opportunity for hospitalists to highlight expertise while bringing value to the hospital.
 

Unique staffing situations related to COVID-19

Different from other disasters, the COVID-19 pandemic affected older or immunocompromised staff in a unique way. Beauhaus et al. note that 20% of the physician workforce in the United Sates is between 55 and 64 years of age, and 9% are 65 years and older.¹² Hospitalist groups should focus on how to optimize and preserve their workforce, specifically those that are higher risk due to age or other health conditions.

We used a tiered guide to safely accommodate our physicians that were determined to be at higher-risk for complications of COVID-19; these recommendations included limiting exposure to patients with acute respiratory illnesses and shifting some providers to a different clinical environments with a lower exposure risk, such as telemedicine visits.

Other COVID-19 preparedness considerations that affected our group in particular include the changes in learner staffing. Similar to attending down-staffing to encourage physical distancing during low census, learners (residents, medical students, and physician assistant students) also experienced decreased hours or suspension of rotations. To maintain optimal patient care, adjusting to changing disaster needs may include assessing attendings’ capacity to assume responsibilities typically supported by learners.

Due to the ongoing nature of the pandemic, we have had to maintain a dynamic response while adjusting to changing and ongoing needs during recovery. Creating a measured and staggered approach helps facilitate a smooth transition back to nonemergent activities. The education of learners, academic and scholarly work, and administrative duties will resume, but likely in a different steady state. Also, awareness of physician burnout and fatigue is critical as an institution enters a phase of recovery.
 

Preparing for the next disaster during the pandemic

This brings us back to the beginning of the disaster preparedness cycle and the need to plan for the next disaster. Current disaster preparedness plans among physician groups and hospitals are likely focused on an individual disaster scenario, but adjusting current disaster plans to account for the uncertain time frame of an event like the COVID-19 pandemic is critical. Several articles in the national news posed similar questions, although these publications focused mainly on the Federal Emergency Management Agency and the governmental response to prepare for the next disaster when resources are already stretched.^13-15

How do we adequately plan, maintain a dynamic response, and continue to efficiently move through the disaster staffing cycle during an event like the COVID-19 pandemic? Being aware of current vulnerabilities and addressing gaps at the department and hospital level are vital to disaster preparedness. For example, we reassessed disaster (ride-out/relief) teams and the minimum number of staff needed to maintain safe and quality care, and what in-house arrangements would be needed (food, supplies, sleeping arrangements) while having to maintain physical distance.

Newman et al. explain “in disaster planning, having as many physicians as possible on hand may seem like an advantage, but being overstaffed in tight quarters was almost as bad as being understaffed.”⁹ This has been particularly true during the COVID-19 pandemic. It is crucial to have backup plans for faculty that are unable to serve ride-out duties from unexpected issues – such as availability, illnesses/quarantines, childcare/dependents. Also, it is important to be aware that some supply chains are already strained because of the pandemic and how this may play a role in the availability of certain supplies. Being aware and proactive about specific constraints allows for a better level of preparedness. Continued collaboration and communication with other services to provide care should be ongoing throughout the disaster preparedness cycle.
 

Conclusion

Providing and maintaining optimal and safe patient care should be the overarching goal throughout disaster preparedness. Being aware of group and institutional vulnerabilities, collaboration with hospital leadership, and remaining flexible as hospitalists are critical components for successful preparedness amid disasters. A dynamic and responsive disaster plan has been vital amid COVID-19, and for the next disasters we will certainly encounter.

Dr. Hadvani is assistant professor of pediatrics in the section of hospital medicine at Baylor College of Medicine, Texas Children’s Hospital. Dr. Uremovich is assistant professor of pediatrics in the section of hospital medicine at Baylor College of Medicine, Texas Children’s Hospital. Dr. Quinonez is associate professor of pediatrics and chief of pediatric hospital medicine at Baylor College of Medicine, Texas Children’s Hospital. Dr. Lopez is assistant professor of pediatrics in the section of hospital medicine at Baylor College of Medicine, Texas Children’s Hospital. Dr. Mothner is associate professor of pediatrics in the section of hospital medicine at Baylor College of Medicine, Texas Children’s Hospital and is the pediatric hospital medicine medical director for the main campus.

References

1. Malilay J et al. The role of applied epidemiology methods in the disaster management cycle. Am J Public Health. 2014;104(11):2092-102. doi: 10.2105/AJPH.2014.302010.

2. Federal Emergency Management Agency. Developing and maintaining emergency operations plans. 2010 Nov.

3. Federal Emergency Management Agency. National preparedness system. 2020 Jul 31.

4. Federal Emergency Management Agency. National preparedness goal. 2011 Sep.

5. Environmental health in emergencies and disasters: A practical guide. World Health Organization, Geneva. 2002:9-24. Edited by B. Wisner and J. Adams.

6. U.S. Department of Health and Human Services. Topic collection: Hazard vulnerability/risk assessment.

7. Hospital Association of Southern California. Hazard and vulnerability analysis.

8. Meier K et al. Pediatric hospital medicine management, staffing, and well-being in the face of COVID-19. J Hosp Med. 2020 May;15(5):308-10. doi: 10.12788/jhm.3435.

9. Newman B and Gallion C. Hurricane Harvey: Firsthand preparedness in graduate medical education. Acad Med. 2019 Sep;94(9):1267-69. doi: 10.1097/ACM.0000000000002696.

10. Brevard S et al. Analysis of disaster response plans and the aftermath of Hurricane Katrina: Lessons learned from a level I trauma center. J Trauma. 2008 Nov;65(5):1126-32. doi: 10.1097/TA.0b013e318188d6e5.

11. Cram P et al. All hands on deck learning to “un-specialize” in the COVID-19 pandemic. J Hosp Med. 2020 May;15(5):314-5. doi: 10.12788/jhm.3426.

12. Buerhaus P et al. Older clinicians and the surge in novel coronavirus disease 2019 (COVID-19). JAMA. 2020 May 12;323(18):1777-8. doi: 10.1001/jama.2020.4978.

13. VOX Media. Imagine Hurricane Katrina during a pandemic. The US needs to prepare for that – now. 2020 May 27.

14. The Hill. Democratic lawmakers ask how FEMA is planning to balance natural disasters, COVID-19 response. 2020 Apr 20.

15. The Atlantic. What happens if a ‘big one’ strikes during the pandemic? 2020 May 9.

The COVID-19 pandemic has tested disaster preparedness in hospitals across the nation. The pandemic brought many unique disaster planning challenges not commonly seen with other emergencies disasters. These included an uncertain and prolonged time frame, the implementation of physical distancing, and the challenges of preserving the health care work force.

But how do we prepare for the next disaster when the health care system and staff are already stretched thin? Here, we discuss the concept of maintaining a state of preparedness through and beyond COVID-19, using a disaster preparedness cycle – including continuous assessments of vulnerabilities, dynamic staffing adjustments to support patient and hospital needs, and broadening of the pandemic response to incorporate planning for the next disaster.

Disaster preparedness and assessing ongoing needs

Disaster preparedness cycle and Hazard Vulnerability Assessment

The disaster preparedness cycle illustrates that disaster preparedness is continuous. Disaster preparedness is achieved with the non-stop cycle of planning, coordinating, and recognizing vulnerable areas.^1-5 Hazard vulnerability analysis (HVA) can play a critical role in recognizing areas in which a hospital system has strengths and weaknesses for different disaster scenarios. There are several tools available, but the overarching goal is to provide an objective and systematic approach to evaluate the potential damage and impact a disaster could have on the health care system and surrounding community.

The HVA can also be utilized to reassess system or personnel vulnerabilities that may have been exposed or highlighted during the pandemic.^6,7 These vulnerabilities must be addressed during preparations for the next disaster while concurrently “assuming the incident happens at the worst possible time.”⁷

Disaster preparedness staffing considerations

Management, communication, and staffing issues are critical to disaster response. Key leadership responses during COVID-19 included providing frequent and transparent communication, down-staffing for physical distancing during low census, and prioritizing staff well-being. These measures serve as a strong foundation moving into preparations for the next disaster.⁸

To ensure adequate staffing during an unexpected natural disaster, we recommend creating “ride-out” and “relief teams” as part of disaster staffing preparedness.^9,10 The ride-out team provides the initial care and these providers are expected to stay in the hospital during the primary impact of the event. Once the initial threat of disaster is over and it is deemed safe to travel, the relief team is activated and offers reprieve to the ride-out team. Leaders and backup leaders within these teams should be identified in the event teams are activated. These assignments should be made at the start of the year and updated yearly or more frequently, if needed.

Dynamic disaster response

Supporting patient and hospital needs

The next step in the disaster preparedness cycle is adjusting to changing needs during the disaster. The pediatric inpatient population was less affected initially by COVID-19, allowing hospitalists to support the unpredicted needs of the pandemic. A dynamic and flexible physician response is important to disaster preparedness.

As there has been a continued shift to telehealth during the pandemic, our group has engaged in telehealth calls related to COVID-19. Seizing these new opportunities not only provided additional services to our patients, but also strengthened community support, physician worth, and the hospital’s financial state. This is also an opportunity for higher-risk clinicians or quarantined faculty to offer patient care during the pandemic.

Cram et al. describe the importance of “unspecializing” during the COVID-19 pandemic.¹¹ Starting discussions early with adult and pediatric critical care colleagues is vital. Hospitalists take care of a broad patient population, and therefore, can adapt to where the clinical need may be. Optimizing and expanding our skill sets can bring value to the hospital system during uncertain times.

Hospitalists are also instrumental for patient flow during the pandemic. To address this, our group partnered with hospital leadership from many different areas including administration, nursing, emergency medicine, critical care, and ancillary services. By collaborating as one cohesive hospital unit, we were able to efficiently develop, implement, and update best clinical care guidelines and algorithms for COVID-19–related topics such as testing indications, admission criteria, infection control, and proper personal protective equipment use. Lastly, working with specialists to consolidate teams during a pandemic presents an opportunity for hospitalists to highlight expertise while bringing value to the hospital.
 

Unique staffing situations related to COVID-19

Different from other disasters, the COVID-19 pandemic affected older or immunocompromised staff in a unique way. Beauhaus et al. note that 20% of the physician workforce in the United Sates is between 55 and 64 years of age, and 9% are 65 years and older.¹² Hospitalist groups should focus on how to optimize and preserve their workforce, specifically those that are higher risk due to age or other health conditions.

We used a tiered guide to safely accommodate our physicians that were determined to be at higher-risk for complications of COVID-19; these recommendations included limiting exposure to patients with acute respiratory illnesses and shifting some providers to a different clinical environments with a lower exposure risk, such as telemedicine visits.

Other COVID-19 preparedness considerations that affected our group in particular include the changes in learner staffing. Similar to attending down-staffing to encourage physical distancing during low census, learners (residents, medical students, and physician assistant students) also experienced decreased hours or suspension of rotations. To maintain optimal patient care, adjusting to changing disaster needs may include assessing attendings’ capacity to assume responsibilities typically supported by learners.

Due to the ongoing nature of the pandemic, we have had to maintain a dynamic response while adjusting to changing and ongoing needs during recovery. Creating a measured and staggered approach helps facilitate a smooth transition back to nonemergent activities. The education of learners, academic and scholarly work, and administrative duties will resume, but likely in a different steady state. Also, awareness of physician burnout and fatigue is critical as an institution enters a phase of recovery.
 

Preparing for the next disaster during the pandemic

This brings us back to the beginning of the disaster preparedness cycle and the need to plan for the next disaster. Current disaster preparedness plans among physician groups and hospitals are likely focused on an individual disaster scenario, but adjusting current disaster plans to account for the uncertain time frame of an event like the COVID-19 pandemic is critical. Several articles in the national news posed similar questions, although these publications focused mainly on the Federal Emergency Management Agency and the governmental response to prepare for the next disaster when resources are already stretched.^13-15

How do we adequately plan, maintain a dynamic response, and continue to efficiently move through the disaster staffing cycle during an event like the COVID-19 pandemic? Being aware of current vulnerabilities and addressing gaps at the department and hospital level are vital to disaster preparedness. For example, we reassessed disaster (ride-out/relief) teams and the minimum number of staff needed to maintain safe and quality care, and what in-house arrangements would be needed (food, supplies, sleeping arrangements) while having to maintain physical distance.

Newman et al. explain “in disaster planning, having as many physicians as possible on hand may seem like an advantage, but being overstaffed in tight quarters was almost as bad as being understaffed.”⁹ This has been particularly true during the COVID-19 pandemic. It is crucial to have backup plans for faculty that are unable to serve ride-out duties from unexpected issues – such as availability, illnesses/quarantines, childcare/dependents. Also, it is important to be aware that some supply chains are already strained because of the pandemic and how this may play a role in the availability of certain supplies. Being aware and proactive about specific constraints allows for a better level of preparedness. Continued collaboration and communication with other services to provide care should be ongoing throughout the disaster preparedness cycle.
 

Conclusion

Providing and maintaining optimal and safe patient care should be the overarching goal throughout disaster preparedness. Being aware of group and institutional vulnerabilities, collaboration with hospital leadership, and remaining flexible as hospitalists are critical components for successful preparedness amid disasters. A dynamic and responsive disaster plan has been vital amid COVID-19, and for the next disasters we will certainly encounter.

Dr. Hadvani is assistant professor of pediatrics in the section of hospital medicine at Baylor College of Medicine, Texas Children’s Hospital. Dr. Uremovich is assistant professor of pediatrics in the section of hospital medicine at Baylor College of Medicine, Texas Children’s Hospital. Dr. Quinonez is associate professor of pediatrics and chief of pediatric hospital medicine at Baylor College of Medicine, Texas Children’s Hospital. Dr. Lopez is assistant professor of pediatrics in the section of hospital medicine at Baylor College of Medicine, Texas Children’s Hospital. Dr. Mothner is associate professor of pediatrics in the section of hospital medicine at Baylor College of Medicine, Texas Children’s Hospital and is the pediatric hospital medicine medical director for the main campus.

References

1. Malilay J et al. The role of applied epidemiology methods in the disaster management cycle. Am J Public Health. 2014;104(11):2092-102. doi: 10.2105/AJPH.2014.302010.

2. Federal Emergency Management Agency. Developing and maintaining emergency operations plans. 2010 Nov.

3. Federal Emergency Management Agency. National preparedness system. 2020 Jul 31.

4. Federal Emergency Management Agency. National preparedness goal. 2011 Sep.

5. Environmental health in emergencies and disasters: A practical guide. World Health Organization, Geneva. 2002:9-24. Edited by B. Wisner and J. Adams.

6. U.S. Department of Health and Human Services. Topic collection: Hazard vulnerability/risk assessment.

7. Hospital Association of Southern California. Hazard and vulnerability analysis.

8. Meier K et al. Pediatric hospital medicine management, staffing, and well-being in the face of COVID-19. J Hosp Med. 2020 May;15(5):308-10. doi: 10.12788/jhm.3435.

9. Newman B and Gallion C. Hurricane Harvey: Firsthand preparedness in graduate medical education. Acad Med. 2019 Sep;94(9):1267-69. doi: 10.1097/ACM.0000000000002696.

10. Brevard S et al. Analysis of disaster response plans and the aftermath of Hurricane Katrina: Lessons learned from a level I trauma center. J Trauma. 2008 Nov;65(5):1126-32. doi: 10.1097/TA.0b013e318188d6e5.

11. Cram P et al. All hands on deck learning to “un-specialize” in the COVID-19 pandemic. J Hosp Med. 2020 May;15(5):314-5. doi: 10.12788/jhm.3426.

12. Buerhaus P et al. Older clinicians and the surge in novel coronavirus disease 2019 (COVID-19). JAMA. 2020 May 12;323(18):1777-8. doi: 10.1001/jama.2020.4978.

13. VOX Media. Imagine Hurricane Katrina during a pandemic. The US needs to prepare for that – now. 2020 May 27.

14. The Hill. Democratic lawmakers ask how FEMA is planning to balance natural disasters, COVID-19 response. 2020 Apr 20.

15. The Atlantic. What happens if a ‘big one’ strikes during the pandemic? 2020 May 9.

With worldwide supplies of tocilizumab dwindling as the COVID-19 pandemic rages on, a shortage of the agent will persist “for at least the next several weeks,” according to Genentech, the Roche unit that manufactures tocilizumab under the trade name Actemra IV.

The World Health Organization and Unitaid have called on Genentech to guarantee equitable distribution of the biologic agent globally and to ease up on technology transfer restrictions to make the treatment more accessible.

At this point, supplies of tocilizumab for subcutaneous use to treat rheumatoid arthritis and its other approved indications for inflammatory conditions aren’t as dire, but Genentech is watching them as well, the company says.

In June, the Food and Drug Administration issued an emergency use authorization for intravenous tocilizumab for hospitalized COVID-19 patients. Since then, it has been included in the WHO Therapeutics and COVID-19: living guideline. And on the same day Genentech and Roche reported the tocilizumab shortage, the European Medicines Agency posted a statement that it had started evaluating RoActemra, the European brand name for tocilizumab, for hospitalized COVID-19 patients.

The FDA authorization has caused an unprecedented run on supplies for the biologic agent, which is FDA approved to treat RA, giant cell arteritis, systemic sclerosis–associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome. 
 

Depleted stocks

In the United States, stocks of the 200- and 400-mg units were unavailable, according to an FDA update in mid-August on its website, and the 80-mg/4-mL unit is available by drop ship only. Supplies of 80-mg units were expected to be depleted by the end of the third week in August, Genentech said in a press release.

The company expects to resupply stocks by the end of August. “However,” the Genentech statement added, “if the pandemic continues to spread at its current pace, we anticipate additional periods of stockout in the weeks and months ahead.”

For patients with RA or other approved indications taking the subcutaneous formulation – pens and prefilled syringes – supplies continue to be available, but, the company added, “the supply situation continues to evolve.” The subcutaneous formulations aren’t authorized for use in COVID-19 patients. However, the American Society of Health-System Pharmacists’ website lists the 162-mg/0.9-mL prefilled syringe as one of the products affected by the shortage.

In a separate statement, Roche said that demand for tocilizumab increased 300% in developing countries over prepandemic orders, and that U.S. demand spiked more than 400% in the first 2 weeks of August.

Roche laid out four reasons for the shortage: global manufacturing capacity limits; raw material shortages; the overall complex process of manufacturing biologic agents; and “the dynamically evolving nature of the pandemic.”

The Roche statement noted the company ramped up manufacturing of tocilizumab more than 100% over prepandemic capacity.

With regard to issues WHO and Unitaid raised in their statement, Roche stated that about 60% of its COVID-19 supplies have gone to developing countries, and that Roche and partner Chugai – both of whom hold tocilizumab-related patents – won’t assert any patents over its use for COVID-19 in low- and middle-income countries (LMICs) during the pandemic.

“Roche is in the midst of discussions with WHO and we are committed to support access in LMICs as much as we can,” a Roche spokesperson said in an interview.

Blair Solow, MD, chair of the American College of Rheumatology’s government affairs committee, said the organization supports the equitable distribution of tocilizumab. “We will work to ensure that our patients continue to have access to the medications they need,” she said. “We will continue to engage with the FDA and others to address shortages and ensure patient access to critical therapies.”

The ACR said that any health care professionals having difficulty getting tocilizumab IV or any other COVID-19-related issues can contact the organization at [email protected].

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

With worldwide supplies of tocilizumab dwindling as the COVID-19 pandemic rages on, a shortage of the agent will persist “for at least the next several weeks,” according to Genentech, the Roche unit that manufactures tocilizumab under the trade name Actemra IV.

The World Health Organization and Unitaid have called on Genentech to guarantee equitable distribution of the biologic agent globally and to ease up on technology transfer restrictions to make the treatment more accessible.

At this point, supplies of tocilizumab for subcutaneous use to treat rheumatoid arthritis and its other approved indications for inflammatory conditions aren’t as dire, but Genentech is watching them as well, the company says.

In June, the Food and Drug Administration issued an emergency use authorization for intravenous tocilizumab for hospitalized COVID-19 patients. Since then, it has been included in the WHO Therapeutics and COVID-19: living guideline. And on the same day Genentech and Roche reported the tocilizumab shortage, the European Medicines Agency posted a statement that it had started evaluating RoActemra, the European brand name for tocilizumab, for hospitalized COVID-19 patients.

The FDA authorization has caused an unprecedented run on supplies for the biologic agent, which is FDA approved to treat RA, giant cell arteritis, systemic sclerosis–associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome. 
 

Depleted stocks

In the United States, stocks of the 200- and 400-mg units were unavailable, according to an FDA update in mid-August on its website, and the 80-mg/4-mL unit is available by drop ship only. Supplies of 80-mg units were expected to be depleted by the end of the third week in August, Genentech said in a press release.

The company expects to resupply stocks by the end of August. “However,” the Genentech statement added, “if the pandemic continues to spread at its current pace, we anticipate additional periods of stockout in the weeks and months ahead.”

For patients with RA or other approved indications taking the subcutaneous formulation – pens and prefilled syringes – supplies continue to be available, but, the company added, “the supply situation continues to evolve.” The subcutaneous formulations aren’t authorized for use in COVID-19 patients. However, the American Society of Health-System Pharmacists’ website lists the 162-mg/0.9-mL prefilled syringe as one of the products affected by the shortage.

In a separate statement, Roche said that demand for tocilizumab increased 300% in developing countries over prepandemic orders, and that U.S. demand spiked more than 400% in the first 2 weeks of August.

Roche laid out four reasons for the shortage: global manufacturing capacity limits; raw material shortages; the overall complex process of manufacturing biologic agents; and “the dynamically evolving nature of the pandemic.”

The Roche statement noted the company ramped up manufacturing of tocilizumab more than 100% over prepandemic capacity.

With regard to issues WHO and Unitaid raised in their statement, Roche stated that about 60% of its COVID-19 supplies have gone to developing countries, and that Roche and partner Chugai – both of whom hold tocilizumab-related patents – won’t assert any patents over its use for COVID-19 in low- and middle-income countries (LMICs) during the pandemic.

“Roche is in the midst of discussions with WHO and we are committed to support access in LMICs as much as we can,” a Roche spokesperson said in an interview.

Blair Solow, MD, chair of the American College of Rheumatology’s government affairs committee, said the organization supports the equitable distribution of tocilizumab. “We will work to ensure that our patients continue to have access to the medications they need,” she said. “We will continue to engage with the FDA and others to address shortages and ensure patient access to critical therapies.”

The ACR said that any health care professionals having difficulty getting tocilizumab IV or any other COVID-19-related issues can contact the organization at [email protected].

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

With worldwide supplies of tocilizumab dwindling as the COVID-19 pandemic rages on, a shortage of the agent will persist “for at least the next several weeks,” according to Genentech, the Roche unit that manufactures tocilizumab under the trade name Actemra IV.

The World Health Organization and Unitaid have called on Genentech to guarantee equitable distribution of the biologic agent globally and to ease up on technology transfer restrictions to make the treatment more accessible.

At this point, supplies of tocilizumab for subcutaneous use to treat rheumatoid arthritis and its other approved indications for inflammatory conditions aren’t as dire, but Genentech is watching them as well, the company says.

In June, the Food and Drug Administration issued an emergency use authorization for intravenous tocilizumab for hospitalized COVID-19 patients. Since then, it has been included in the WHO Therapeutics and COVID-19: living guideline. And on the same day Genentech and Roche reported the tocilizumab shortage, the European Medicines Agency posted a statement that it had started evaluating RoActemra, the European brand name for tocilizumab, for hospitalized COVID-19 patients.

The FDA authorization has caused an unprecedented run on supplies for the biologic agent, which is FDA approved to treat RA, giant cell arteritis, systemic sclerosis–associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome. 
 

Depleted stocks

In the United States, stocks of the 200- and 400-mg units were unavailable, according to an FDA update in mid-August on its website, and the 80-mg/4-mL unit is available by drop ship only. Supplies of 80-mg units were expected to be depleted by the end of the third week in August, Genentech said in a press release.

The company expects to resupply stocks by the end of August. “However,” the Genentech statement added, “if the pandemic continues to spread at its current pace, we anticipate additional periods of stockout in the weeks and months ahead.”

For patients with RA or other approved indications taking the subcutaneous formulation – pens and prefilled syringes – supplies continue to be available, but, the company added, “the supply situation continues to evolve.” The subcutaneous formulations aren’t authorized for use in COVID-19 patients. However, the American Society of Health-System Pharmacists’ website lists the 162-mg/0.9-mL prefilled syringe as one of the products affected by the shortage.

In a separate statement, Roche said that demand for tocilizumab increased 300% in developing countries over prepandemic orders, and that U.S. demand spiked more than 400% in the first 2 weeks of August.

Roche laid out four reasons for the shortage: global manufacturing capacity limits; raw material shortages; the overall complex process of manufacturing biologic agents; and “the dynamically evolving nature of the pandemic.”

The Roche statement noted the company ramped up manufacturing of tocilizumab more than 100% over prepandemic capacity.

With regard to issues WHO and Unitaid raised in their statement, Roche stated that about 60% of its COVID-19 supplies have gone to developing countries, and that Roche and partner Chugai – both of whom hold tocilizumab-related patents – won’t assert any patents over its use for COVID-19 in low- and middle-income countries (LMICs) during the pandemic.

“Roche is in the midst of discussions with WHO and we are committed to support access in LMICs as much as we can,” a Roche spokesperson said in an interview.

Blair Solow, MD, chair of the American College of Rheumatology’s government affairs committee, said the organization supports the equitable distribution of tocilizumab. “We will work to ensure that our patients continue to have access to the medications they need,” she said. “We will continue to engage with the FDA and others to address shortages and ensure patient access to critical therapies.”

The ACR said that any health care professionals having difficulty getting tocilizumab IV or any other COVID-19-related issues can contact the organization at [email protected].

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

The U.S. Food and Drug Administration approved empagliflozin (Jardiance) as a treatment for adults with heart failure with reduced ejection fraction (HFrEF) regardless of whether patients have diabetes on Aug. 18, making it the second agent from the sodium-glucose transporter 2 inhibitor class to received this indication.

Empagliflozin first received FDA marketing approval in 2014 for improving glycemic control in patients with type 2 diabetes, and in 2016 the agency added a second indication of reducing cardiovascular death in patients with type 2 diabetes and cardiovascular disease. The newly granted indication for patients with HFrEF without regard to glycemic status was for reducing the risk for cardiovascular death and hospitalization for heart failure, according to a statement from Boehringer Ingelheim and Lilly, the two companies that together market empagliflozin.

The statement also said that the approval allowed for empagliflozin treatment in patients with HFrEF and an estimated glomerular filtration rate (eGFR) as low as 20 mL/min per 1.73 m², in contrast to its indication for improving glycemic control in patients with type 2 diabetes that limits use to patients with an eGFR of at least 30 mL per 1.73 m².


EMPEROR-Reduced results drive approval

The FDA based its decision on results from the EMPEROR-Reduced study, first reported in August 2020, that showed treatment of patients with HFrEF with empagliflozin on top of standard therapy for a median of 16 months cut the incidence of cardiovascular death or hospitalization for worsening heart failure by 25% relative to placebo, and by an absolute 5.3%, compared with placebo-treated patients.

Patients enrolled in EMPEROR-Reduced had chronic heart failure in New York Heart Association functional class II-IV and with a left ventricular ejection fraction of 40% or less, the standard ejection fraction criterion for defining HFrEF. Half the enrolled patients had diabetes, and analysis showed no heterogeneity in the primary outcome response based on diabetes status at enrollment.


Empagliflozin joins dapagliflozin for treating HFrEF

Dapagliflozin (Farxiga) was the first agent from the SGLT2 inhibitor class to receive an FDA indication, in 2020, for treating patients with HFrEF regardless of their diabetes status, a decision based on results from the DAPA-HF trial. Results from DAPA-HF showed that treatment with dapagliflozin in patients with HFrEF for a median of 18 months led to a 26% relative reduction in the incidence of cardiovascular death or worsening heart failure and a 4.9% absolute reduction, compared with placebo when added to standard treatment. DAPA-HF enrolled patients using similar criteria to EMPEROR-Reduced, and 42% of enrolled patients had diabetes with no heterogeneity in the primary outcome related to baseline diabetes status.

Subsequent to the report of results from the EMPEROR-Reduced trial nearly a year ago, heart failure experts declared that treatment with an agent from the SGLT2 inhibitor class had become a “new pillar of foundational therapy for HFrEF,” and they urged rapid initiation of an SGLT2 inhibitor (along with other appropriate medications) at the time of initial diagnosis of HFrEF.

[email protected]

The U.S. Food and Drug Administration approved empagliflozin (Jardiance) as a treatment for adults with heart failure with reduced ejection fraction (HFrEF) regardless of whether patients have diabetes on Aug. 18, making it the second agent from the sodium-glucose transporter 2 inhibitor class to received this indication.

Empagliflozin first received FDA marketing approval in 2014 for improving glycemic control in patients with type 2 diabetes, and in 2016 the agency added a second indication of reducing cardiovascular death in patients with type 2 diabetes and cardiovascular disease. The newly granted indication for patients with HFrEF without regard to glycemic status was for reducing the risk for cardiovascular death and hospitalization for heart failure, according to a statement from Boehringer Ingelheim and Lilly, the two companies that together market empagliflozin.

The statement also said that the approval allowed for empagliflozin treatment in patients with HFrEF and an estimated glomerular filtration rate (eGFR) as low as 20 mL/min per 1.73 m², in contrast to its indication for improving glycemic control in patients with type 2 diabetes that limits use to patients with an eGFR of at least 30 mL per 1.73 m².


EMPEROR-Reduced results drive approval

The FDA based its decision on results from the EMPEROR-Reduced study, first reported in August 2020, that showed treatment of patients with HFrEF with empagliflozin on top of standard therapy for a median of 16 months cut the incidence of cardiovascular death or hospitalization for worsening heart failure by 25% relative to placebo, and by an absolute 5.3%, compared with placebo-treated patients.

Patients enrolled in EMPEROR-Reduced had chronic heart failure in New York Heart Association functional class II-IV and with a left ventricular ejection fraction of 40% or less, the standard ejection fraction criterion for defining HFrEF. Half the enrolled patients had diabetes, and analysis showed no heterogeneity in the primary outcome response based on diabetes status at enrollment.


Empagliflozin joins dapagliflozin for treating HFrEF

Dapagliflozin (Farxiga) was the first agent from the SGLT2 inhibitor class to receive an FDA indication, in 2020, for treating patients with HFrEF regardless of their diabetes status, a decision based on results from the DAPA-HF trial. Results from DAPA-HF showed that treatment with dapagliflozin in patients with HFrEF for a median of 18 months led to a 26% relative reduction in the incidence of cardiovascular death or worsening heart failure and a 4.9% absolute reduction, compared with placebo when added to standard treatment. DAPA-HF enrolled patients using similar criteria to EMPEROR-Reduced, and 42% of enrolled patients had diabetes with no heterogeneity in the primary outcome related to baseline diabetes status.

Subsequent to the report of results from the EMPEROR-Reduced trial nearly a year ago, heart failure experts declared that treatment with an agent from the SGLT2 inhibitor class had become a “new pillar of foundational therapy for HFrEF,” and they urged rapid initiation of an SGLT2 inhibitor (along with other appropriate medications) at the time of initial diagnosis of HFrEF.

[email protected]

The U.S. Food and Drug Administration approved empagliflozin (Jardiance) as a treatment for adults with heart failure with reduced ejection fraction (HFrEF) regardless of whether patients have diabetes on Aug. 18, making it the second agent from the sodium-glucose transporter 2 inhibitor class to received this indication.

Empagliflozin first received FDA marketing approval in 2014 for improving glycemic control in patients with type 2 diabetes, and in 2016 the agency added a second indication of reducing cardiovascular death in patients with type 2 diabetes and cardiovascular disease. The newly granted indication for patients with HFrEF without regard to glycemic status was for reducing the risk for cardiovascular death and hospitalization for heart failure, according to a statement from Boehringer Ingelheim and Lilly, the two companies that together market empagliflozin.

The statement also said that the approval allowed for empagliflozin treatment in patients with HFrEF and an estimated glomerular filtration rate (eGFR) as low as 20 mL/min per 1.73 m², in contrast to its indication for improving glycemic control in patients with type 2 diabetes that limits use to patients with an eGFR of at least 30 mL per 1.73 m².


EMPEROR-Reduced results drive approval

The FDA based its decision on results from the EMPEROR-Reduced study, first reported in August 2020, that showed treatment of patients with HFrEF with empagliflozin on top of standard therapy for a median of 16 months cut the incidence of cardiovascular death or hospitalization for worsening heart failure by 25% relative to placebo, and by an absolute 5.3%, compared with placebo-treated patients.

Patients enrolled in EMPEROR-Reduced had chronic heart failure in New York Heart Association functional class II-IV and with a left ventricular ejection fraction of 40% or less, the standard ejection fraction criterion for defining HFrEF. Half the enrolled patients had diabetes, and analysis showed no heterogeneity in the primary outcome response based on diabetes status at enrollment.


Empagliflozin joins dapagliflozin for treating HFrEF

Dapagliflozin (Farxiga) was the first agent from the SGLT2 inhibitor class to receive an FDA indication, in 2020, for treating patients with HFrEF regardless of their diabetes status, a decision based on results from the DAPA-HF trial. Results from DAPA-HF showed that treatment with dapagliflozin in patients with HFrEF for a median of 18 months led to a 26% relative reduction in the incidence of cardiovascular death or worsening heart failure and a 4.9% absolute reduction, compared with placebo when added to standard treatment. DAPA-HF enrolled patients using similar criteria to EMPEROR-Reduced, and 42% of enrolled patients had diabetes with no heterogeneity in the primary outcome related to baseline diabetes status.

Subsequent to the report of results from the EMPEROR-Reduced trial nearly a year ago, heart failure experts declared that treatment with an agent from the SGLT2 inhibitor class had become a “new pillar of foundational therapy for HFrEF,” and they urged rapid initiation of an SGLT2 inhibitor (along with other appropriate medications) at the time of initial diagnosis of HFrEF.

[email protected]

Editor’s note: In this article, we present an archetypal ethics challenge in hospital medicine. The authors, members of the SHM’s Ethics Special Interest Group and clinical ethics consultants at their respective hospitals, will comment on the questions and practical approaches for hospitalists.

Ms. S, an 82-year-old woman with severe dementia, was initially hospitalized in the ICU with acute on chronic respiratory failure. Prior to admission, Ms. S lived with her daughter, who is her primary caregiver. Ms. S is able to say her daughter’s name, and answer “yes” and “no” to simple questions. She is bed bound, incontinent of urine and feces, and dependent on her daughter for all ADLs.

This admission, Ms. S has been re-intubated 4 times for recurrent respiratory failure. The nursing staff are distressed that she is suffering physically. Her daughter requests to continue all intensive, life-prolonging treatment including mechanical ventilation and artificial nutrition.

During sign out, your colleague remarks that his grandmother was in a similar situation and that his family chose to pursue comfort care. He questions whether Ms. S has any quality of life and asks if you think further intensive care is futile.

On your first day caring for Ms. S, you contact her primary care provider. Her PCP reports that Ms. S and her daughter completed an advance directive (AD) 10 years ago which documents a preference for all life prolonging treatment.
 

Question #1: What are the ethical challenges?

Dr. Chase: In caring for Ms. S, we face a common ethical challenge: how to respect the patient’s prior preferences (autonomy) when the currently requested treatments have diminishing benefits (beneficence) and escalating harms (non-maleficence). Life-prolonging care can have diminishing returns at the end of life. Ms. S’s loss of decision-making capacity adds a layer of complexity. Her AD was completed when she was able to consider decisions about her care, and she might make different decisions in her current state of health. Shared decision-making with a surrogate can be complicated by a surrogate’s anxiety with making life-altering decisions or their desire to avoid guilt or loneliness. Health care professionals face the limits of scientific knowledge in delivering accurate prognostic estimates, probabilities of recovery, and likelihood of benefit from interventions. In addition to the guideposts of ethical principles, some hospitals have policies which advise clinicians to avoid non-beneficial care.

Such situations are emotionally intense and can trigger distress among patients, families, caregivers and health care professionals. Conscious and unconscious bias about a patient’s perceived quality of life undermines equity and can play a role in our recommendations for patients of advanced age, with cognitive impairment, and those who live with a disability.
 

Question #2: How might you meet the patient’s medical needs in line with her goals?

Dr. Khawaja: In order to provide care consistent with the patient’s goals, the first step is to clarify these goals with Ms. S’s surrogate decision-maker, her daughter. In a previously autonomous but presently incapacitated patient, the previously expressed preferences in the form of a written AD should be respected. However, the AD is only a set of preferences completed at a particular time, not medical orders. The clinician and surrogate must consider how to apply the AD to the current clinical circumstances. The clinician should verify that the clinical circumstances specified in the AD have been met and evaluate if the patient’s preferences have changed since she originally completed the AD.

Surrogates are asked to use a Substituted Judgement Standard (i.e., what would the patient choose in this situation if known). This may differ from what the surrogate wants. If not known, surrogates are asked to use the Best Interest Standard (i.e., what would bring the most net benefit to the patient by weighing benefits and risks of treatment options). I often ask the surrogate, “Tell us about your loved one.” Or, “Knowing your loved one, what do you think would be the most important for her right now?”¹

I would also caution against bias in judging quality of life in patients with dementia, and using the term “futility,” as these concepts are inherently subjective. In general, when a colleague raises the issue of futility, I begin by asking, “…futile to achieve what goal?” That can help clarify some of the disagreement as some goals can be accomplished while others cannot.

Finally, I work to include other members of our team in these discussions. The distress of nurses, social workers, and others are important to acknowledge, validate, and involve in the problem-solving process.
 

Question #3: If you were Ms. S’s hospitalist, what would you do?

Dr. Khawaja: As the hospitalist caring for Ms. S, I would use the “four boxes” model as a helpful, clinically relevant and systematic approach to managing ethical concerns.²

This “four boxes” model gives us a practical framework to address these ethical principles by asking questions in four domains.

Medical indications: What is the nature of her current illness, and is it reversible or not? What is the probability of success of treatment options like mechanical ventilation? Are there adverse effects of treatment?

Patient preferences: Since Ms. S lacks capacity, does her daughter understand the benefits and burdens of treatment? What are the goals of treatment? Prolonging life? Minimizing discomfort? Spending time with loved ones? What burdens would the patient be willing to endure to reach her goals?

Quality of life: What would the patient’s quality of life be with and without the treatments?

Contextual features: My priorities would be building a relationship of trust with Ms. S’s daughter – by educating her about her mother’s clinical status, addressing her concerns and questions, and supporting her as we work through patient-centered decisions about what is best for her mother. Honest communication is a must, even if it means acknowledging uncertainties about the course of disease and prognosis.

These are not easy decisions for surrogates to make. They should be given time to process information and to make what they believe are the best decisions for their loved ones. It is critical for clinicians to provide honest and complete clinical information and to avoid value judgments, bias, or unreasonable time pressure. While one-on-one conversations are central, I find that multidisciplinary meetings allow all stakeholders to ask and answer vital questions and ideally to reach consensus in treatment planning.

Dr. Chase: In caring for Ms. S, I would use a structured approach to discussions with her daughter, such as the “SPIKES” protocol.³ Using open ended questions, I would ask about the patient’s and her daughter’s goals, values, and fears and provide support about the responsibility for shared-decision making and the difficulty of uncertainty. Reflecting statements can help in confirming understanding and showing attention (e.g. “I hear that avoiding discomfort would be important to your mother.”)

I find it helpful to emphasize my commitment to honesty and non-abandonment (a common fear among patients and families). By offering to provide recommendations about both disease-directed and palliative, comfort-focused interventions, the patient’s daughter has an opportunity to engage voluntarily in discussion. When asked about care that may have marginal benefit, I suggest time-limited trials.⁴ I do not offer non-beneficial treatments and if asked about such treatments, I note the underlying motive and why the treatment is not feasible (“I see that you are hoping that your mother will live longer, but I am concerned that tube feeding will not help because…”), offer preferable alternatives, and leave space for questions and emotions. It is important not to force a premature resolution of the situation through unilateral or coercive decisions⁵ (i.e., going off service does not mean I have to wrap up the existential crisis which is occurring.) A broader challenge is the grief and other emotions which accompany illness and death. I can neither prevent death nor grief, but I can offer my professional guidance and provide a supportive space for the patient and family to experience this transition. By acknowledging this, I center myself with the patient and family and we can work together toward a common goal of providing compassionate and ethical care.

Dr. Chase is associate professor, Department of Family and Community Medicine, University of California San Francisco; and co-chair, Ethics Committee, San Francisco General Hospital. Dr. Khawaja is assistant professor, Department of Internal Medicine, Baylor College of Medicine, Houston, and a member of the Ethics Committee of the Society of General Internal Medicine.

References

1. Sulmasy DP, Snyder L. Substituted interests and best judgments: an integrated model of surrogate decision making. JAMA. 2010 Nov 3;304(17):1946-7. doi: 10.1001/jama.2010.159.

2. Jonsen AR, Siegler M, Winslade WJ. Clinical ethics: A practical approach to ethical decisions in clinical medicine. 6th ed. New York: McGraw Hill Medical; 2006.

3. Baile WF, et al. SPIKES-A six-step protocol for delivering bad news: application to the patient with cancer. Oncologist. 2000;5(4):302–311. doi: 10.1634/theoncologist.5-4-302.

4. Chang DW, et al. Evaluation of time-limited trials among critically ill patients with advanced medical illnesses and reduction of nonbeneficial ICU treatments. JAMA Intern Med. 2021;181(6):786–794. doi: 10.1001/jamainternmed.2021.1000.

5. Sedig, L. What’s the role of autonomy in patient-and family-centered care when patients and family members don’t agree? AMA J Ethics. 2016;18(1):12-17. doi: 10.1001/journalofethics.2017.18.1.ecas2-1601.

Editor’s note: In this article, we present an archetypal ethics challenge in hospital medicine. The authors, members of the SHM’s Ethics Special Interest Group and clinical ethics consultants at their respective hospitals, will comment on the questions and practical approaches for hospitalists.

Ms. S, an 82-year-old woman with severe dementia, was initially hospitalized in the ICU with acute on chronic respiratory failure. Prior to admission, Ms. S lived with her daughter, who is her primary caregiver. Ms. S is able to say her daughter’s name, and answer “yes” and “no” to simple questions. She is bed bound, incontinent of urine and feces, and dependent on her daughter for all ADLs.

This admission, Ms. S has been re-intubated 4 times for recurrent respiratory failure. The nursing staff are distressed that she is suffering physically. Her daughter requests to continue all intensive, life-prolonging treatment including mechanical ventilation and artificial nutrition.

During sign out, your colleague remarks that his grandmother was in a similar situation and that his family chose to pursue comfort care. He questions whether Ms. S has any quality of life and asks if you think further intensive care is futile.

On your first day caring for Ms. S, you contact her primary care provider. Her PCP reports that Ms. S and her daughter completed an advance directive (AD) 10 years ago which documents a preference for all life prolonging treatment.
 

Question #1: What are the ethical challenges?

Dr. Chase: In caring for Ms. S, we face a common ethical challenge: how to respect the patient’s prior preferences (autonomy) when the currently requested treatments have diminishing benefits (beneficence) and escalating harms (non-maleficence). Life-prolonging care can have diminishing returns at the end of life. Ms. S’s loss of decision-making capacity adds a layer of complexity. Her AD was completed when she was able to consider decisions about her care, and she might make different decisions in her current state of health. Shared decision-making with a surrogate can be complicated by a surrogate’s anxiety with making life-altering decisions or their desire to avoid guilt or loneliness. Health care professionals face the limits of scientific knowledge in delivering accurate prognostic estimates, probabilities of recovery, and likelihood of benefit from interventions. In addition to the guideposts of ethical principles, some hospitals have policies which advise clinicians to avoid non-beneficial care.

Such situations are emotionally intense and can trigger distress among patients, families, caregivers and health care professionals. Conscious and unconscious bias about a patient’s perceived quality of life undermines equity and can play a role in our recommendations for patients of advanced age, with cognitive impairment, and those who live with a disability.
 

Question #2: How might you meet the patient’s medical needs in line with her goals?

Dr. Khawaja: In order to provide care consistent with the patient’s goals, the first step is to clarify these goals with Ms. S’s surrogate decision-maker, her daughter. In a previously autonomous but presently incapacitated patient, the previously expressed preferences in the form of a written AD should be respected. However, the AD is only a set of preferences completed at a particular time, not medical orders. The clinician and surrogate must consider how to apply the AD to the current clinical circumstances. The clinician should verify that the clinical circumstances specified in the AD have been met and evaluate if the patient’s preferences have changed since she originally completed the AD.

Surrogates are asked to use a Substituted Judgement Standard (i.e., what would the patient choose in this situation if known). This may differ from what the surrogate wants. If not known, surrogates are asked to use the Best Interest Standard (i.e., what would bring the most net benefit to the patient by weighing benefits and risks of treatment options). I often ask the surrogate, “Tell us about your loved one.” Or, “Knowing your loved one, what do you think would be the most important for her right now?”¹

I would also caution against bias in judging quality of life in patients with dementia, and using the term “futility,” as these concepts are inherently subjective. In general, when a colleague raises the issue of futility, I begin by asking, “…futile to achieve what goal?” That can help clarify some of the disagreement as some goals can be accomplished while others cannot.

Finally, I work to include other members of our team in these discussions. The distress of nurses, social workers, and others are important to acknowledge, validate, and involve in the problem-solving process.
 

Question #3: If you were Ms. S’s hospitalist, what would you do?

Dr. Khawaja: As the hospitalist caring for Ms. S, I would use the “four boxes” model as a helpful, clinically relevant and systematic approach to managing ethical concerns.²

This “four boxes” model gives us a practical framework to address these ethical principles by asking questions in four domains.

Medical indications: What is the nature of her current illness, and is it reversible or not? What is the probability of success of treatment options like mechanical ventilation? Are there adverse effects of treatment?

Patient preferences: Since Ms. S lacks capacity, does her daughter understand the benefits and burdens of treatment? What are the goals of treatment? Prolonging life? Minimizing discomfort? Spending time with loved ones? What burdens would the patient be willing to endure to reach her goals?

Quality of life: What would the patient’s quality of life be with and without the treatments?

Contextual features: My priorities would be building a relationship of trust with Ms. S’s daughter – by educating her about her mother’s clinical status, addressing her concerns and questions, and supporting her as we work through patient-centered decisions about what is best for her mother. Honest communication is a must, even if it means acknowledging uncertainties about the course of disease and prognosis.

These are not easy decisions for surrogates to make. They should be given time to process information and to make what they believe are the best decisions for their loved ones. It is critical for clinicians to provide honest and complete clinical information and to avoid value judgments, bias, or unreasonable time pressure. While one-on-one conversations are central, I find that multidisciplinary meetings allow all stakeholders to ask and answer vital questions and ideally to reach consensus in treatment planning.

Dr. Chase: In caring for Ms. S, I would use a structured approach to discussions with her daughter, such as the “SPIKES” protocol.³ Using open ended questions, I would ask about the patient’s and her daughter’s goals, values, and fears and provide support about the responsibility for shared-decision making and the difficulty of uncertainty. Reflecting statements can help in confirming understanding and showing attention (e.g. “I hear that avoiding discomfort would be important to your mother.”)

I find it helpful to emphasize my commitment to honesty and non-abandonment (a common fear among patients and families). By offering to provide recommendations about both disease-directed and palliative, comfort-focused interventions, the patient’s daughter has an opportunity to engage voluntarily in discussion. When asked about care that may have marginal benefit, I suggest time-limited trials.⁴ I do not offer non-beneficial treatments and if asked about such treatments, I note the underlying motive and why the treatment is not feasible (“I see that you are hoping that your mother will live longer, but I am concerned that tube feeding will not help because…”), offer preferable alternatives, and leave space for questions and emotions. It is important not to force a premature resolution of the situation through unilateral or coercive decisions⁵ (i.e., going off service does not mean I have to wrap up the existential crisis which is occurring.) A broader challenge is the grief and other emotions which accompany illness and death. I can neither prevent death nor grief, but I can offer my professional guidance and provide a supportive space for the patient and family to experience this transition. By acknowledging this, I center myself with the patient and family and we can work together toward a common goal of providing compassionate and ethical care.

Dr. Chase is associate professor, Department of Family and Community Medicine, University of California San Francisco; and co-chair, Ethics Committee, San Francisco General Hospital. Dr. Khawaja is assistant professor, Department of Internal Medicine, Baylor College of Medicine, Houston, and a member of the Ethics Committee of the Society of General Internal Medicine.

References

1. Sulmasy DP, Snyder L. Substituted interests and best judgments: an integrated model of surrogate decision making. JAMA. 2010 Nov 3;304(17):1946-7. doi: 10.1001/jama.2010.159.

2. Jonsen AR, Siegler M, Winslade WJ. Clinical ethics: A practical approach to ethical decisions in clinical medicine. 6th ed. New York: McGraw Hill Medical; 2006.

3. Baile WF, et al. SPIKES-A six-step protocol for delivering bad news: application to the patient with cancer. Oncologist. 2000;5(4):302–311. doi: 10.1634/theoncologist.5-4-302.

4. Chang DW, et al. Evaluation of time-limited trials among critically ill patients with advanced medical illnesses and reduction of nonbeneficial ICU treatments. JAMA Intern Med. 2021;181(6):786–794. doi: 10.1001/jamainternmed.2021.1000.

5. Sedig, L. What’s the role of autonomy in patient-and family-centered care when patients and family members don’t agree? AMA J Ethics. 2016;18(1):12-17. doi: 10.1001/journalofethics.2017.18.1.ecas2-1601.

Editor’s note: In this article, we present an archetypal ethics challenge in hospital medicine. The authors, members of the SHM’s Ethics Special Interest Group and clinical ethics consultants at their respective hospitals, will comment on the questions and practical approaches for hospitalists.

Ms. S, an 82-year-old woman with severe dementia, was initially hospitalized in the ICU with acute on chronic respiratory failure. Prior to admission, Ms. S lived with her daughter, who is her primary caregiver. Ms. S is able to say her daughter’s name, and answer “yes” and “no” to simple questions. She is bed bound, incontinent of urine and feces, and dependent on her daughter for all ADLs.

This admission, Ms. S has been re-intubated 4 times for recurrent respiratory failure. The nursing staff are distressed that she is suffering physically. Her daughter requests to continue all intensive, life-prolonging treatment including mechanical ventilation and artificial nutrition.

During sign out, your colleague remarks that his grandmother was in a similar situation and that his family chose to pursue comfort care. He questions whether Ms. S has any quality of life and asks if you think further intensive care is futile.

On your first day caring for Ms. S, you contact her primary care provider. Her PCP reports that Ms. S and her daughter completed an advance directive (AD) 10 years ago which documents a preference for all life prolonging treatment.
 

Question #1: What are the ethical challenges?

Dr. Chase: In caring for Ms. S, we face a common ethical challenge: how to respect the patient’s prior preferences (autonomy) when the currently requested treatments have diminishing benefits (beneficence) and escalating harms (non-maleficence). Life-prolonging care can have diminishing returns at the end of life. Ms. S’s loss of decision-making capacity adds a layer of complexity. Her AD was completed when she was able to consider decisions about her care, and she might make different decisions in her current state of health. Shared decision-making with a surrogate can be complicated by a surrogate’s anxiety with making life-altering decisions or their desire to avoid guilt or loneliness. Health care professionals face the limits of scientific knowledge in delivering accurate prognostic estimates, probabilities of recovery, and likelihood of benefit from interventions. In addition to the guideposts of ethical principles, some hospitals have policies which advise clinicians to avoid non-beneficial care.

Such situations are emotionally intense and can trigger distress among patients, families, caregivers and health care professionals. Conscious and unconscious bias about a patient’s perceived quality of life undermines equity and can play a role in our recommendations for patients of advanced age, with cognitive impairment, and those who live with a disability.
 

Question #2: How might you meet the patient’s medical needs in line with her goals?

Dr. Khawaja: In order to provide care consistent with the patient’s goals, the first step is to clarify these goals with Ms. S’s surrogate decision-maker, her daughter. In a previously autonomous but presently incapacitated patient, the previously expressed preferences in the form of a written AD should be respected. However, the AD is only a set of preferences completed at a particular time, not medical orders. The clinician and surrogate must consider how to apply the AD to the current clinical circumstances. The clinician should verify that the clinical circumstances specified in the AD have been met and evaluate if the patient’s preferences have changed since she originally completed the AD.

Surrogates are asked to use a Substituted Judgement Standard (i.e., what would the patient choose in this situation if known). This may differ from what the surrogate wants. If not known, surrogates are asked to use the Best Interest Standard (i.e., what would bring the most net benefit to the patient by weighing benefits and risks of treatment options). I often ask the surrogate, “Tell us about your loved one.” Or, “Knowing your loved one, what do you think would be the most important for her right now?”¹

I would also caution against bias in judging quality of life in patients with dementia, and using the term “futility,” as these concepts are inherently subjective. In general, when a colleague raises the issue of futility, I begin by asking, “…futile to achieve what goal?” That can help clarify some of the disagreement as some goals can be accomplished while others cannot.

Finally, I work to include other members of our team in these discussions. The distress of nurses, social workers, and others are important to acknowledge, validate, and involve in the problem-solving process.
 

Question #3: If you were Ms. S’s hospitalist, what would you do?

Dr. Khawaja: As the hospitalist caring for Ms. S, I would use the “four boxes” model as a helpful, clinically relevant and systematic approach to managing ethical concerns.²

This “four boxes” model gives us a practical framework to address these ethical principles by asking questions in four domains.

Medical indications: What is the nature of her current illness, and is it reversible or not? What is the probability of success of treatment options like mechanical ventilation? Are there adverse effects of treatment?

Patient preferences: Since Ms. S lacks capacity, does her daughter understand the benefits and burdens of treatment? What are the goals of treatment? Prolonging life? Minimizing discomfort? Spending time with loved ones? What burdens would the patient be willing to endure to reach her goals?

Quality of life: What would the patient’s quality of life be with and without the treatments?

Contextual features: My priorities would be building a relationship of trust with Ms. S’s daughter – by educating her about her mother’s clinical status, addressing her concerns and questions, and supporting her as we work through patient-centered decisions about what is best for her mother. Honest communication is a must, even if it means acknowledging uncertainties about the course of disease and prognosis.

These are not easy decisions for surrogates to make. They should be given time to process information and to make what they believe are the best decisions for their loved ones. It is critical for clinicians to provide honest and complete clinical information and to avoid value judgments, bias, or unreasonable time pressure. While one-on-one conversations are central, I find that multidisciplinary meetings allow all stakeholders to ask and answer vital questions and ideally to reach consensus in treatment planning.

Dr. Chase: In caring for Ms. S, I would use a structured approach to discussions with her daughter, such as the “SPIKES” protocol.³ Using open ended questions, I would ask about the patient’s and her daughter’s goals, values, and fears and provide support about the responsibility for shared-decision making and the difficulty of uncertainty. Reflecting statements can help in confirming understanding and showing attention (e.g. “I hear that avoiding discomfort would be important to your mother.”)

I find it helpful to emphasize my commitment to honesty and non-abandonment (a common fear among patients and families). By offering to provide recommendations about both disease-directed and palliative, comfort-focused interventions, the patient’s daughter has an opportunity to engage voluntarily in discussion. When asked about care that may have marginal benefit, I suggest time-limited trials.⁴ I do not offer non-beneficial treatments and if asked about such treatments, I note the underlying motive and why the treatment is not feasible (“I see that you are hoping that your mother will live longer, but I am concerned that tube feeding will not help because…”), offer preferable alternatives, and leave space for questions and emotions. It is important not to force a premature resolution of the situation through unilateral or coercive decisions⁵ (i.e., going off service does not mean I have to wrap up the existential crisis which is occurring.) A broader challenge is the grief and other emotions which accompany illness and death. I can neither prevent death nor grief, but I can offer my professional guidance and provide a supportive space for the patient and family to experience this transition. By acknowledging this, I center myself with the patient and family and we can work together toward a common goal of providing compassionate and ethical care.

Dr. Chase is associate professor, Department of Family and Community Medicine, University of California San Francisco; and co-chair, Ethics Committee, San Francisco General Hospital. Dr. Khawaja is assistant professor, Department of Internal Medicine, Baylor College of Medicine, Houston, and a member of the Ethics Committee of the Society of General Internal Medicine.

References

1. Sulmasy DP, Snyder L. Substituted interests and best judgments: an integrated model of surrogate decision making. JAMA. 2010 Nov 3;304(17):1946-7. doi: 10.1001/jama.2010.159.

2. Jonsen AR, Siegler M, Winslade WJ. Clinical ethics: A practical approach to ethical decisions in clinical medicine. 6th ed. New York: McGraw Hill Medical; 2006.

3. Baile WF, et al. SPIKES-A six-step protocol for delivering bad news: application to the patient with cancer. Oncologist. 2000;5(4):302–311. doi: 10.1634/theoncologist.5-4-302.

4. Chang DW, et al. Evaluation of time-limited trials among critically ill patients with advanced medical illnesses and reduction of nonbeneficial ICU treatments. JAMA Intern Med. 2021;181(6):786–794. doi: 10.1001/jamainternmed.2021.1000.

5. Sedig, L. What’s the role of autonomy in patient-and family-centered care when patients and family members don’t agree? AMA J Ethics. 2016;18(1):12-17. doi: 10.1001/journalofethics.2017.18.1.ecas2-1601.

Booster shots to ramp up protection against COVID-19 infection are slated to begin the week of Sept. 20, the Biden administration announced at a press briefing August 18.

Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.

“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”

The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.

“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”

Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.

At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.

“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
 

Data driving the plan

CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.

Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.

Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.

Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
 

Immunologic facts

Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.

“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”

A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
 

Booster details

“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.

The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
 

Big picture

Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”

Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”

Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”



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

Booster shots to ramp up protection against COVID-19 infection are slated to begin the week of Sept. 20, the Biden administration announced at a press briefing August 18.

Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.

“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”

The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.

“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”

Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.

At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.

“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
 

Data driving the plan

CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.

Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.

Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.

Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
 

Immunologic facts

Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.

“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”

A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
 

Booster details

“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.

The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
 

Big picture

Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”

Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”

Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”



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

Booster shots to ramp up protection against COVID-19 infection are slated to begin the week of Sept. 20, the Biden administration announced at a press briefing August 18.

Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.

“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”

The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.

“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”

Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.

At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.

“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
 

Data driving the plan

CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.

Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.

Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.

Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
 

Immunologic facts

Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.

“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”

A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
 

Booster details

“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.

The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
 

Big picture

Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”

Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”

Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”



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

Preliminary data from seven states suggests that breakthrough COVID-19 infections among vaccinated people may be on the rise because of the more contagious Delta variant.

Breakthrough cases accounted for about one in five newly diagnosed cases in six of the states, according to the New York Times. Hospitalizations and deaths among vaccinated people may be higher than previously thought as well.

“Remember when the early vaccine studies came out, it was like nobody gets hospitalized, nobody dies,” Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, said in an interview. “That clearly is not true.”

The New York Times analyzed data in seven states – California, Colorado, Massachusetts, Oregon, Utah, Vermont, and Virginia – that are tracking the most detailed information. The trends in these states may not reflect the numbers throughout the country, the newspaper reported.

Even still, the numbers back up the idea that vaccinated people may need booster shots this fall to support their earlier vaccine doses. Federal health officials are scheduled to approve the extra shots in coming weeks, potentially in September. The first people to receive booster shots will likely be health care workers and nursing home residents who took the first vaccines in December and January.

“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was, I think the case for boosters goes up pretty quickly,” Dr. Wachter said.

Previous analyses of breakthrough cases included data from June and earlier, the newspaper reported. But since July, COVID-19 cases have soared again because of the Delta variant, and the most recent numbers show an uptick among vaccinated people. In Los Angeles County, for instance, fully vaccinated people account for 20% of new COVID-19 cases, which is up from 11% in May, 5% in April, and 2% in March, according to a late July report from the Los Angeles County Department of Public Health.

What’s more, breakthrough infections in the seven states accounted for 12%-24% of COVID-19 hospitalizations in those states. About 8,000 breakthrough hospitalizations have been reported to the CDC. Still, the overall numbers remain low – in California, for instance, about 1,615 people have been hospitalized with breakthrough infections, which accounts for 0.007% of the state’s 22 million vaccinated people, the Times reported.

The breakthrough infections appear to be more severe among vaccinated people who are older or have weakened immune systems. About 74% of breakthrough cases are among adults 65 or older, the CDC reported.

The increase may shift how vaccinated people see their risks for infection and interact with loved ones. Public health officials have suggested that people follow some COVID-19 safety protocols again, such as wearing masks in public indoor spaces regardless of vaccination status.

As the Delta variant continues to circulate this fall, public health researchers will be researching more about breakthrough cases among vaccinated people, including whether they have prolonged symptoms and how easily they may pass the virus to others.

“I think some of us have been challenged by the numbers of clusters that we’ve seen,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told this news organization.

“I think that really needs to be examined more,” he said.

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

Preliminary data from seven states suggests that breakthrough COVID-19 infections among vaccinated people may be on the rise because of the more contagious Delta variant.

Breakthrough cases accounted for about one in five newly diagnosed cases in six of the states, according to the New York Times. Hospitalizations and deaths among vaccinated people may be higher than previously thought as well.

“Remember when the early vaccine studies came out, it was like nobody gets hospitalized, nobody dies,” Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, said in an interview. “That clearly is not true.”

The New York Times analyzed data in seven states – California, Colorado, Massachusetts, Oregon, Utah, Vermont, and Virginia – that are tracking the most detailed information. The trends in these states may not reflect the numbers throughout the country, the newspaper reported.

Even still, the numbers back up the idea that vaccinated people may need booster shots this fall to support their earlier vaccine doses. Federal health officials are scheduled to approve the extra shots in coming weeks, potentially in September. The first people to receive booster shots will likely be health care workers and nursing home residents who took the first vaccines in December and January.

“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was, I think the case for boosters goes up pretty quickly,” Dr. Wachter said.

Previous analyses of breakthrough cases included data from June and earlier, the newspaper reported. But since July, COVID-19 cases have soared again because of the Delta variant, and the most recent numbers show an uptick among vaccinated people. In Los Angeles County, for instance, fully vaccinated people account for 20% of new COVID-19 cases, which is up from 11% in May, 5% in April, and 2% in March, according to a late July report from the Los Angeles County Department of Public Health.

What’s more, breakthrough infections in the seven states accounted for 12%-24% of COVID-19 hospitalizations in those states. About 8,000 breakthrough hospitalizations have been reported to the CDC. Still, the overall numbers remain low – in California, for instance, about 1,615 people have been hospitalized with breakthrough infections, which accounts for 0.007% of the state’s 22 million vaccinated people, the Times reported.

The breakthrough infections appear to be more severe among vaccinated people who are older or have weakened immune systems. About 74% of breakthrough cases are among adults 65 or older, the CDC reported.

The increase may shift how vaccinated people see their risks for infection and interact with loved ones. Public health officials have suggested that people follow some COVID-19 safety protocols again, such as wearing masks in public indoor spaces regardless of vaccination status.

As the Delta variant continues to circulate this fall, public health researchers will be researching more about breakthrough cases among vaccinated people, including whether they have prolonged symptoms and how easily they may pass the virus to others.

“I think some of us have been challenged by the numbers of clusters that we’ve seen,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told this news organization.

“I think that really needs to be examined more,” he said.

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

Preliminary data from seven states suggests that breakthrough COVID-19 infections among vaccinated people may be on the rise because of the more contagious Delta variant.

Breakthrough cases accounted for about one in five newly diagnosed cases in six of the states, according to the New York Times. Hospitalizations and deaths among vaccinated people may be higher than previously thought as well.

“Remember when the early vaccine studies came out, it was like nobody gets hospitalized, nobody dies,” Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, said in an interview. “That clearly is not true.”

The New York Times analyzed data in seven states – California, Colorado, Massachusetts, Oregon, Utah, Vermont, and Virginia – that are tracking the most detailed information. The trends in these states may not reflect the numbers throughout the country, the newspaper reported.

Even still, the numbers back up the idea that vaccinated people may need booster shots this fall to support their earlier vaccine doses. Federal health officials are scheduled to approve the extra shots in coming weeks, potentially in September. The first people to receive booster shots will likely be health care workers and nursing home residents who took the first vaccines in December and January.

“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was, I think the case for boosters goes up pretty quickly,” Dr. Wachter said.

Previous analyses of breakthrough cases included data from June and earlier, the newspaper reported. But since July, COVID-19 cases have soared again because of the Delta variant, and the most recent numbers show an uptick among vaccinated people. In Los Angeles County, for instance, fully vaccinated people account for 20% of new COVID-19 cases, which is up from 11% in May, 5% in April, and 2% in March, according to a late July report from the Los Angeles County Department of Public Health.

What’s more, breakthrough infections in the seven states accounted for 12%-24% of COVID-19 hospitalizations in those states. About 8,000 breakthrough hospitalizations have been reported to the CDC. Still, the overall numbers remain low – in California, for instance, about 1,615 people have been hospitalized with breakthrough infections, which accounts for 0.007% of the state’s 22 million vaccinated people, the Times reported.

The breakthrough infections appear to be more severe among vaccinated people who are older or have weakened immune systems. About 74% of breakthrough cases are among adults 65 or older, the CDC reported.

The increase may shift how vaccinated people see their risks for infection and interact with loved ones. Public health officials have suggested that people follow some COVID-19 safety protocols again, such as wearing masks in public indoor spaces regardless of vaccination status.

As the Delta variant continues to circulate this fall, public health researchers will be researching more about breakthrough cases among vaccinated people, including whether they have prolonged symptoms and how easily they may pass the virus to others.

“I think some of us have been challenged by the numbers of clusters that we’ve seen,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told this news organization.

“I think that really needs to be examined more,” he said.

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

It is well known that survivors of critical care are at heightened risk of mental health disorders even months afterward they are discharged, but it’s less clear what factors might contribute to those outcomes. A new attempt to identify risk factors for post-ICU depression, anxiety, or posttraumatic stress disorder, as well as worse quality of life, paints a complex picture.

Age, mental preexisting mental health concerns, acute emotional stress at the time of critical care, and post-care physical impairment all may play a role, according to the multicenter, prospective cohort study conducted in Brazil, which was published in CHEST .

Previous systematic reviews have shown raised frequencies mental health disorders following ICU discharge, including anxiety (32%-40%), depression (29%-34%), and PTSD (16%-23%). Few studies have looked at the potential impact of preexisting conditions or post-ICU disability on these outcomes, yet that information is critical to key to designing effective prevention and rehabilitation interventions.

The results suggest that preexisting mental health and factors associated with the critical illness, which have gained attention as potential factors, aren’t sufficient to explain these outcomes. “Our data suggest that the network of potential risk factors for mental illness among patients who have been discharged from the ICU is much more complex and may involve risk factors from multiple domains. ... Long-term mental health disorders after critical illness may be the result of the interaction among stressors before ICU stay, during ICU stay, and after ICU stay, calling attention to the need for interdisciplinary and multifaceted strategies aimed at preventing and screening for mental health disorders after ICU discharge,” Cassiano Teixeira, MD, PhD, of the Postgraduation of Pulmonology–Federal University of Rio Grande do Sul, Brazil, and colleagues wrote.

The researchers also noted that some risk factors could be screened and may be modifiable, including anxiety and depression symptoms at ICU discharge, as well as reduced physical function status.
 

Complications or risk factors?

The findings are significant, though they may represent complications of emotional distress following ICU stays, rather than risk factors that predict it, according to an accompanying editorial. The author, O. Joseph Bienvenu III, MD, PhD, who is a professor of psychiatry and behavioral sciences at Johns Hopkins Medicine, Baltimore. He called for prospective studies to determine the predictive value of these factors. “If we are to improve long-term mental health after critical illnesses, this predictive information will be vital to selective prevention efforts.”

Dr. O. Joseph Bienvenu

Potential interventions could include psychological treatment in the ICU, ICU follow-up clinics, support groups, and cognitive-behavioral therapy, among others. Whichever approach is used, it should be targeted, according to Dr. Bienvenu, since patients who have greater emotional distress seem to gain the most benefit from such interventions.

The researchers examined outcomes among 579 adults who had spent at least 72 hours in the ICU. The median age was 61 years, and 47% were women.

Six months after release from the ICU, telephone assessments by trained researchers revealed that 48% had impairment in physical function, compared with the time preceding ICU admission. 36.2% of participants had a mental health disorder: 24.2% reported anxiety, 20.9% had depression, and 15.4% had PTSD.

Increasing numbers of psychiatric syndromes, from 0 to 3, was associated with worse scores on the mental dimension on the health-related quality of life (HRQoL) score, but there was no relationship with scores on the physical dimension.
 

Risks to mental health

Clinical characteristics associated with risk of anxiety at 6 months post discharge included being 65 years or older (prevalence ratio, 0.63; P = .009), a history of depression (PR, 1.52; P = .009), anxiety at discharge (PR, 1.65; P = .003), depression at discharge (HR, 1.44; P = .02), physical dependence (PR, 1.48; P = .01), and reduced physical functional status at 6 months post discharge (PR, 1.38; P = .04).

Characteristics associated with depression at 6 months post discharge included a history of depression (PR, 1.78; P = .001), symptoms of depression at discharge (PR, 3.04; P < .001), and reduced physical functional status at 6 months (PR, 1.53; P = .01).

Characteristics associated with PTSD at 6 months post discharge were depression symptoms at discharge (PR, 1.70; P = .01), physical dependence (PR, 1.79; P = .01), and reduced physical status at 6 months (PR, 1.62; P = .02).

Characteristics associated with any mental health disorder included higher education (PR, 0.74; P = .04), a history of depression (PR, 1.32; P = .02), anxiety symptoms at discharge (PR, 1.55; P = .001), depression symptoms at discharge (PR, 1.50; P = .001), and physical dependence at 6 months following discharge (PR, 1.66; P < .001).

“The lower HRQoL found in ICU survivors with mental health disorders in comparison with those without is a reason for concern. This finding, in association with the higher prevalence of psychiatric syndromes among ICU survivors, reinforces the importance of assessing anxiety, depression, and PTSD symptoms among ICU survivors, because these syndromes typically are long lasting and underdiagnosed, and their occurrence may affect quality of life, survival, and costs in the context of care after ICU discharge,” according to the researchers.

The authors of the study and Dr. Bienvenu have no relevant financial disclosures.

It is well known that survivors of critical care are at heightened risk of mental health disorders even months afterward they are discharged, but it’s less clear what factors might contribute to those outcomes. A new attempt to identify risk factors for post-ICU depression, anxiety, or posttraumatic stress disorder, as well as worse quality of life, paints a complex picture.

Age, mental preexisting mental health concerns, acute emotional stress at the time of critical care, and post-care physical impairment all may play a role, according to the multicenter, prospective cohort study conducted in Brazil, which was published in CHEST .

Previous systematic reviews have shown raised frequencies mental health disorders following ICU discharge, including anxiety (32%-40%), depression (29%-34%), and PTSD (16%-23%). Few studies have looked at the potential impact of preexisting conditions or post-ICU disability on these outcomes, yet that information is critical to key to designing effective prevention and rehabilitation interventions.

The results suggest that preexisting mental health and factors associated with the critical illness, which have gained attention as potential factors, aren’t sufficient to explain these outcomes. “Our data suggest that the network of potential risk factors for mental illness among patients who have been discharged from the ICU is much more complex and may involve risk factors from multiple domains. ... Long-term mental health disorders after critical illness may be the result of the interaction among stressors before ICU stay, during ICU stay, and after ICU stay, calling attention to the need for interdisciplinary and multifaceted strategies aimed at preventing and screening for mental health disorders after ICU discharge,” Cassiano Teixeira, MD, PhD, of the Postgraduation of Pulmonology–Federal University of Rio Grande do Sul, Brazil, and colleagues wrote.

The researchers also noted that some risk factors could be screened and may be modifiable, including anxiety and depression symptoms at ICU discharge, as well as reduced physical function status.
 

Complications or risk factors?

The findings are significant, though they may represent complications of emotional distress following ICU stays, rather than risk factors that predict it, according to an accompanying editorial. The author, O. Joseph Bienvenu III, MD, PhD, who is a professor of psychiatry and behavioral sciences at Johns Hopkins Medicine, Baltimore. He called for prospective studies to determine the predictive value of these factors. “If we are to improve long-term mental health after critical illnesses, this predictive information will be vital to selective prevention efforts.”

Dr. O. Joseph Bienvenu

Potential interventions could include psychological treatment in the ICU, ICU follow-up clinics, support groups, and cognitive-behavioral therapy, among others. Whichever approach is used, it should be targeted, according to Dr. Bienvenu, since patients who have greater emotional distress seem to gain the most benefit from such interventions.

The researchers examined outcomes among 579 adults who had spent at least 72 hours in the ICU. The median age was 61 years, and 47% were women.

Six months after release from the ICU, telephone assessments by trained researchers revealed that 48% had impairment in physical function, compared with the time preceding ICU admission. 36.2% of participants had a mental health disorder: 24.2% reported anxiety, 20.9% had depression, and 15.4% had PTSD.

Increasing numbers of psychiatric syndromes, from 0 to 3, was associated with worse scores on the mental dimension on the health-related quality of life (HRQoL) score, but there was no relationship with scores on the physical dimension.
 

Risks to mental health

Clinical characteristics associated with risk of anxiety at 6 months post discharge included being 65 years or older (prevalence ratio, 0.63; P = .009), a history of depression (PR, 1.52; P = .009), anxiety at discharge (PR, 1.65; P = .003), depression at discharge (HR, 1.44; P = .02), physical dependence (PR, 1.48; P = .01), and reduced physical functional status at 6 months post discharge (PR, 1.38; P = .04).

Characteristics associated with depression at 6 months post discharge included a history of depression (PR, 1.78; P = .001), symptoms of depression at discharge (PR, 3.04; P < .001), and reduced physical functional status at 6 months (PR, 1.53; P = .01).

Characteristics associated with PTSD at 6 months post discharge were depression symptoms at discharge (PR, 1.70; P = .01), physical dependence (PR, 1.79; P = .01), and reduced physical status at 6 months (PR, 1.62; P = .02).

Characteristics associated with any mental health disorder included higher education (PR, 0.74; P = .04), a history of depression (PR, 1.32; P = .02), anxiety symptoms at discharge (PR, 1.55; P = .001), depression symptoms at discharge (PR, 1.50; P = .001), and physical dependence at 6 months following discharge (PR, 1.66; P < .001).

“The lower HRQoL found in ICU survivors with mental health disorders in comparison with those without is a reason for concern. This finding, in association with the higher prevalence of psychiatric syndromes among ICU survivors, reinforces the importance of assessing anxiety, depression, and PTSD symptoms among ICU survivors, because these syndromes typically are long lasting and underdiagnosed, and their occurrence may affect quality of life, survival, and costs in the context of care after ICU discharge,” according to the researchers.

The authors of the study and Dr. Bienvenu have no relevant financial disclosures.

It is well known that survivors of critical care are at heightened risk of mental health disorders even months afterward they are discharged, but it’s less clear what factors might contribute to those outcomes. A new attempt to identify risk factors for post-ICU depression, anxiety, or posttraumatic stress disorder, as well as worse quality of life, paints a complex picture.

Age, mental preexisting mental health concerns, acute emotional stress at the time of critical care, and post-care physical impairment all may play a role, according to the multicenter, prospective cohort study conducted in Brazil, which was published in CHEST .

Previous systematic reviews have shown raised frequencies mental health disorders following ICU discharge, including anxiety (32%-40%), depression (29%-34%), and PTSD (16%-23%). Few studies have looked at the potential impact of preexisting conditions or post-ICU disability on these outcomes, yet that information is critical to key to designing effective prevention and rehabilitation interventions.

The results suggest that preexisting mental health and factors associated with the critical illness, which have gained attention as potential factors, aren’t sufficient to explain these outcomes. “Our data suggest that the network of potential risk factors for mental illness among patients who have been discharged from the ICU is much more complex and may involve risk factors from multiple domains. ... Long-term mental health disorders after critical illness may be the result of the interaction among stressors before ICU stay, during ICU stay, and after ICU stay, calling attention to the need for interdisciplinary and multifaceted strategies aimed at preventing and screening for mental health disorders after ICU discharge,” Cassiano Teixeira, MD, PhD, of the Postgraduation of Pulmonology–Federal University of Rio Grande do Sul, Brazil, and colleagues wrote.

The researchers also noted that some risk factors could be screened and may be modifiable, including anxiety and depression symptoms at ICU discharge, as well as reduced physical function status.
 

Complications or risk factors?

The findings are significant, though they may represent complications of emotional distress following ICU stays, rather than risk factors that predict it, according to an accompanying editorial. The author, O. Joseph Bienvenu III, MD, PhD, who is a professor of psychiatry and behavioral sciences at Johns Hopkins Medicine, Baltimore. He called for prospective studies to determine the predictive value of these factors. “If we are to improve long-term mental health after critical illnesses, this predictive information will be vital to selective prevention efforts.”

Dr. O. Joseph Bienvenu

Potential interventions could include psychological treatment in the ICU, ICU follow-up clinics, support groups, and cognitive-behavioral therapy, among others. Whichever approach is used, it should be targeted, according to Dr. Bienvenu, since patients who have greater emotional distress seem to gain the most benefit from such interventions.

The researchers examined outcomes among 579 adults who had spent at least 72 hours in the ICU. The median age was 61 years, and 47% were women.

Six months after release from the ICU, telephone assessments by trained researchers revealed that 48% had impairment in physical function, compared with the time preceding ICU admission. 36.2% of participants had a mental health disorder: 24.2% reported anxiety, 20.9% had depression, and 15.4% had PTSD.

Increasing numbers of psychiatric syndromes, from 0 to 3, was associated with worse scores on the mental dimension on the health-related quality of life (HRQoL) score, but there was no relationship with scores on the physical dimension.
 

Risks to mental health

Clinical characteristics associated with risk of anxiety at 6 months post discharge included being 65 years or older (prevalence ratio, 0.63; P = .009), a history of depression (PR, 1.52; P = .009), anxiety at discharge (PR, 1.65; P = .003), depression at discharge (HR, 1.44; P = .02), physical dependence (PR, 1.48; P = .01), and reduced physical functional status at 6 months post discharge (PR, 1.38; P = .04).

Characteristics associated with depression at 6 months post discharge included a history of depression (PR, 1.78; P = .001), symptoms of depression at discharge (PR, 3.04; P < .001), and reduced physical functional status at 6 months (PR, 1.53; P = .01).

Characteristics associated with PTSD at 6 months post discharge were depression symptoms at discharge (PR, 1.70; P = .01), physical dependence (PR, 1.79; P = .01), and reduced physical status at 6 months (PR, 1.62; P = .02).

Characteristics associated with any mental health disorder included higher education (PR, 0.74; P = .04), a history of depression (PR, 1.32; P = .02), anxiety symptoms at discharge (PR, 1.55; P = .001), depression symptoms at discharge (PR, 1.50; P = .001), and physical dependence at 6 months following discharge (PR, 1.66; P < .001).

“The lower HRQoL found in ICU survivors with mental health disorders in comparison with those without is a reason for concern. This finding, in association with the higher prevalence of psychiatric syndromes among ICU survivors, reinforces the importance of assessing anxiety, depression, and PTSD symptoms among ICU survivors, because these syndromes typically are long lasting and underdiagnosed, and their occurrence may affect quality of life, survival, and costs in the context of care after ICU discharge,” according to the researchers.

The authors of the study and Dr. Bienvenu have no relevant financial disclosures.