People who have undergone bariatric surgery appear less likely to suffer an aortic dissection than other adults with obesity, researchers say.

The finding is the latest in a series of benefits researchers have linked to the surgery, not all of which appear to directly result from weight loss.

“It has an incredible impact on hyperlipidemia and hypertension,” said Luis Felipe Okida, MD, from Cleveland Clinic Florida, Weston. “Those are the main risk factors for aortic dissection.”

He presented the finding at the virtual American Congress of Surgeons Clinical Congress 2020. The study was also published online in the Journal of the American College of Surgeons.

Although uncommon, acute aortic dissection proves fatal to half the people it strikes if patients do not receive treatment within 72 hours, Dr. Okida said in an interview.

To learn whether there is an association between bariatric surgery and risk for aortic dissection, Dr. Okida and colleagues analyzed data from the National Inpatient Sample (NIS) database from 2010 to 2015. The NIS comprises about 20% of hospital inpatient admissions in the United States.

Among the patients in the sample, 296,041 adults had undergone bariatric surgery, and 2,004,804 adults had obesity (body mass index ≥35 kg/m²) but had never undergone bariatric surgery. This latter group represented the control group.

Among the control group, 1,411 patients (.070%) experienced aortic dissection; among the bariatric surgery group, 94 patients (0.032%) experienced aortic dissection. This was a statistically significant difference (P < .0001).

The groups differed significantly in many ways. The mean age of the patients in the control group was 54.4 years, which was a mean of 2.5 years older than the bariatric surgery group. Additionally, the control group included a higher percentage of women and a lower percentage of White persons.

Those in the control group were also more likely to have a history of tobacco use, hypertension (64.2% vs. 48.9% in the surgery group), hyperlipidemia (32.7% vs. 18.3%), diabetes, aortic aneurysm (20.6% vs. 12.0%), and bicuspid aortic valves but were less likely to have Marfan/Ehlers-Danlos syndrome.

A multivariate analysis showed that gender, age, history of tobacco use, hypertension, hyperlipidemia, and Marfan/Ehlers-Danlos syndrome were associated with an increased risk for aortic dissection. Diabetes was associated with a lower risk. All of these findings had previously been reported in the literature, Dr. Okida said, but the reasons for the negative association with diabetes is not well understood.

The association between the surgery and aortic dissection applied to younger patients as well as older ones.

“In elderly patients, the main risk factor for aortic dissection is hypertension, and in younger patients, below 40 years old, the main risk factors are diseases of the collagen and diseases of the aorta,” said Dr. Okida during his presentation. “But these younger patients still have a high prevalence of hypertension, and that’s why bariatric surgery is beneficial.”

Although the finding regarding risk for aortic dissection supports the value of bariatric surgery, it does not in itself provide justification for undergoing the procedure. “It’s not even one of the comorbidities that insurance companies would recognize as key in approving this procedure,” said senior author Emanuele Lo Menzo, MD, PhD, also from the Cleveland Clinic Florida.

“I don’t think a physician would ever recommend this procedure specifically to avoid aortic dissection,” he said in an interview. “It’s sort of an extended benefit.”

The study raises interesting questions about the effects of the surgery, said Shanu Kothari, MD, president-elect of the American Society for Metabolic and Bariatric Surgery.

“We’ve known for a long time that patients with chronic obesity who undergo weight-loss surgery live longer than those who don’t,” he said in an interview. “They have less cardiovascular disease and cancer. Is this one more reason that they live longer?”

Bariatric surgery produces benefits for people with diabetes the day after the surgery, long before patients lose weight as a result of the procedure, Dr. Kothari said.

The effects on metabolism are complex, he added. Besides caloric restriction, they include changes in bile salt absorption and the gut microbiome, which in turn can affect hormones and inflammation.

A key question is how long after the surgery the risk for aortic dissection starts to decline, said Dr. Kothari.

The study could not answer such questions, and Dr. Okida could not find any previous studies that explored the association. He also couldn’t find any study that examined whether weight loss by other means might also reduce the risk for aortic dissection.

Dr. Okida, Dr. Lo Menzo, and Dr. Kothari disclosed no relevant financial relationships.

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

People who have undergone bariatric surgery appear less likely to suffer an aortic dissection than other adults with obesity, researchers say.

The finding is the latest in a series of benefits researchers have linked to the surgery, not all of which appear to directly result from weight loss.

“It has an incredible impact on hyperlipidemia and hypertension,” said Luis Felipe Okida, MD, from Cleveland Clinic Florida, Weston. “Those are the main risk factors for aortic dissection.”

He presented the finding at the virtual American Congress of Surgeons Clinical Congress 2020. The study was also published online in the Journal of the American College of Surgeons.

Although uncommon, acute aortic dissection proves fatal to half the people it strikes if patients do not receive treatment within 72 hours, Dr. Okida said in an interview.

To learn whether there is an association between bariatric surgery and risk for aortic dissection, Dr. Okida and colleagues analyzed data from the National Inpatient Sample (NIS) database from 2010 to 2015. The NIS comprises about 20% of hospital inpatient admissions in the United States.

Among the patients in the sample, 296,041 adults had undergone bariatric surgery, and 2,004,804 adults had obesity (body mass index ≥35 kg/m²) but had never undergone bariatric surgery. This latter group represented the control group.

Among the control group, 1,411 patients (.070%) experienced aortic dissection; among the bariatric surgery group, 94 patients (0.032%) experienced aortic dissection. This was a statistically significant difference (P < .0001).

The groups differed significantly in many ways. The mean age of the patients in the control group was 54.4 years, which was a mean of 2.5 years older than the bariatric surgery group. Additionally, the control group included a higher percentage of women and a lower percentage of White persons.

Those in the control group were also more likely to have a history of tobacco use, hypertension (64.2% vs. 48.9% in the surgery group), hyperlipidemia (32.7% vs. 18.3%), diabetes, aortic aneurysm (20.6% vs. 12.0%), and bicuspid aortic valves but were less likely to have Marfan/Ehlers-Danlos syndrome.

A multivariate analysis showed that gender, age, history of tobacco use, hypertension, hyperlipidemia, and Marfan/Ehlers-Danlos syndrome were associated with an increased risk for aortic dissection. Diabetes was associated with a lower risk. All of these findings had previously been reported in the literature, Dr. Okida said, but the reasons for the negative association with diabetes is not well understood.

The association between the surgery and aortic dissection applied to younger patients as well as older ones.

“In elderly patients, the main risk factor for aortic dissection is hypertension, and in younger patients, below 40 years old, the main risk factors are diseases of the collagen and diseases of the aorta,” said Dr. Okida during his presentation. “But these younger patients still have a high prevalence of hypertension, and that’s why bariatric surgery is beneficial.”

Although the finding regarding risk for aortic dissection supports the value of bariatric surgery, it does not in itself provide justification for undergoing the procedure. “It’s not even one of the comorbidities that insurance companies would recognize as key in approving this procedure,” said senior author Emanuele Lo Menzo, MD, PhD, also from the Cleveland Clinic Florida.

“I don’t think a physician would ever recommend this procedure specifically to avoid aortic dissection,” he said in an interview. “It’s sort of an extended benefit.”

The study raises interesting questions about the effects of the surgery, said Shanu Kothari, MD, president-elect of the American Society for Metabolic and Bariatric Surgery.

“We’ve known for a long time that patients with chronic obesity who undergo weight-loss surgery live longer than those who don’t,” he said in an interview. “They have less cardiovascular disease and cancer. Is this one more reason that they live longer?”

Bariatric surgery produces benefits for people with diabetes the day after the surgery, long before patients lose weight as a result of the procedure, Dr. Kothari said.

The effects on metabolism are complex, he added. Besides caloric restriction, they include changes in bile salt absorption and the gut microbiome, which in turn can affect hormones and inflammation.

A key question is how long after the surgery the risk for aortic dissection starts to decline, said Dr. Kothari.

The study could not answer such questions, and Dr. Okida could not find any previous studies that explored the association. He also couldn’t find any study that examined whether weight loss by other means might also reduce the risk for aortic dissection.

Dr. Okida, Dr. Lo Menzo, and Dr. Kothari disclosed no relevant financial relationships.

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

People who have undergone bariatric surgery appear less likely to suffer an aortic dissection than other adults with obesity, researchers say.

The finding is the latest in a series of benefits researchers have linked to the surgery, not all of which appear to directly result from weight loss.

“It has an incredible impact on hyperlipidemia and hypertension,” said Luis Felipe Okida, MD, from Cleveland Clinic Florida, Weston. “Those are the main risk factors for aortic dissection.”

He presented the finding at the virtual American Congress of Surgeons Clinical Congress 2020. The study was also published online in the Journal of the American College of Surgeons.

Although uncommon, acute aortic dissection proves fatal to half the people it strikes if patients do not receive treatment within 72 hours, Dr. Okida said in an interview.

To learn whether there is an association between bariatric surgery and risk for aortic dissection, Dr. Okida and colleagues analyzed data from the National Inpatient Sample (NIS) database from 2010 to 2015. The NIS comprises about 20% of hospital inpatient admissions in the United States.

Among the patients in the sample, 296,041 adults had undergone bariatric surgery, and 2,004,804 adults had obesity (body mass index ≥35 kg/m²) but had never undergone bariatric surgery. This latter group represented the control group.

Among the control group, 1,411 patients (.070%) experienced aortic dissection; among the bariatric surgery group, 94 patients (0.032%) experienced aortic dissection. This was a statistically significant difference (P < .0001).

The groups differed significantly in many ways. The mean age of the patients in the control group was 54.4 years, which was a mean of 2.5 years older than the bariatric surgery group. Additionally, the control group included a higher percentage of women and a lower percentage of White persons.

Those in the control group were also more likely to have a history of tobacco use, hypertension (64.2% vs. 48.9% in the surgery group), hyperlipidemia (32.7% vs. 18.3%), diabetes, aortic aneurysm (20.6% vs. 12.0%), and bicuspid aortic valves but were less likely to have Marfan/Ehlers-Danlos syndrome.

A multivariate analysis showed that gender, age, history of tobacco use, hypertension, hyperlipidemia, and Marfan/Ehlers-Danlos syndrome were associated with an increased risk for aortic dissection. Diabetes was associated with a lower risk. All of these findings had previously been reported in the literature, Dr. Okida said, but the reasons for the negative association with diabetes is not well understood.

The association between the surgery and aortic dissection applied to younger patients as well as older ones.

“In elderly patients, the main risk factor for aortic dissection is hypertension, and in younger patients, below 40 years old, the main risk factors are diseases of the collagen and diseases of the aorta,” said Dr. Okida during his presentation. “But these younger patients still have a high prevalence of hypertension, and that’s why bariatric surgery is beneficial.”

Although the finding regarding risk for aortic dissection supports the value of bariatric surgery, it does not in itself provide justification for undergoing the procedure. “It’s not even one of the comorbidities that insurance companies would recognize as key in approving this procedure,” said senior author Emanuele Lo Menzo, MD, PhD, also from the Cleveland Clinic Florida.

“I don’t think a physician would ever recommend this procedure specifically to avoid aortic dissection,” he said in an interview. “It’s sort of an extended benefit.”

The study raises interesting questions about the effects of the surgery, said Shanu Kothari, MD, president-elect of the American Society for Metabolic and Bariatric Surgery.

“We’ve known for a long time that patients with chronic obesity who undergo weight-loss surgery live longer than those who don’t,” he said in an interview. “They have less cardiovascular disease and cancer. Is this one more reason that they live longer?”

Bariatric surgery produces benefits for people with diabetes the day after the surgery, long before patients lose weight as a result of the procedure, Dr. Kothari said.

The effects on metabolism are complex, he added. Besides caloric restriction, they include changes in bile salt absorption and the gut microbiome, which in turn can affect hormones and inflammation.

A key question is how long after the surgery the risk for aortic dissection starts to decline, said Dr. Kothari.

The study could not answer such questions, and Dr. Okida could not find any previous studies that explored the association. He also couldn’t find any study that examined whether weight loss by other means might also reduce the risk for aortic dissection.

Dr. Okida, Dr. Lo Menzo, and Dr. Kothari disclosed no relevant financial relationships.

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

An updated European Society for Medical Oncology (ESMO) clinical practice guidelines were released to provide key recommendations on the management of chronic lymphocytic leukemia (CLL).

The guidelines were developed by a multidisciplinary group of experts from different institutions and countries in Europe and provide levels of evidence and grades of recommendation where applicable for issues regarding prognosis and treatment decisions in CLL. Such decisions depend on genetic and clinical factors such as age, stage, and comorbidities. The guidelines also focus on new therapies targeting B-cell-receptor pathways or defect mechanism of apoptosis, which have been found to induce long-lasting remissions. The guidelines were endorsed by the European Hematology Association (EHA) through the Scientific Working Group on CLL/European Research Initiative on CLL (ERIC), according to the report published online the Annals of Oncology.

These clinical practice guidelines were developed in accordance with the ESMO standard operating procedures for clinical practice guidelines development with use of relevant literature selected by the expert authors. Statements without grading were considered justified as standard clinical practice by the experts and the ESMO faculty.

Below are some highlights of the guidelines, which cover a wide array of topics regarding the diagnosis, staging, treatment, and progression of CLL disease.
 

Diagnosis

The guidelines indicate that CLL diagnosis is usually possible by immunophenotyping of peripheral blood only and that lymph node (LN) biopsy and/or bone marrow biopsy may be helpful if immunophenotyping is not conclusive for the diagnosis of CLL, according to Barbara Eichhorst, MD, of the University of Cologne (Germany) and colleagues on behalf of the ESMO guidelines committee.

Staging and risk assessment

Early asymptomatic-stage disease does not need further risk assessment, but after the first year, when all patients should be seen at 3-monthly intervals, patients can be followed every 3-12 months. The interval would depend on burden and dynamics of the disease obtained by the using history and physical examinations, including a careful palpation of all LN areas, spleen, and liver, as well as assessing complete blood cell count and differential count, according to the report.

Advanced- and symptomatic-stage disease requires a broader examination including imaging, history and status of relevant infections, and fluorescent in situ hybridization (FISH) assays for the detection of deletion of the chromosome 17 (del[17p]) affecting the tumor protein p53 expression and, in the absence of del(17p), TP53 sequencing for detection of TP53 gene mutation, according to the authors.

Prognostication

Two clinical staging systems are typically used in CLL. Both Binet and Rai staging systems separate three groups of patients with different prognosis, although “as a consequence of more effective therapy, the overall survival (OS) of patients with advanced stage has improved and the relevance of the staging systems for prognostication has decreased,” according to the report.

The recent addition of genetic markers has also proved highly relevant to identifying patients with different prognoses and to guide treatment.
 

Therapy

Although CLL is an incurable disease, choice and application of treatment are strongly tied to the length of survival, according to the authors. The guidelines recommend Binet and Rai staging with clinical symptoms as relevant for treatment indication. In addition, the identification of del(17p), TP53 mutations, and IGHV status are relevant for choice of therapy and should be assessed prior to treatment.

The guidelines discuss specific treatment modalities for various stages of the disease, from early stages to relapse.

For frontline therapy, different treatment strategies are available including continuous treatment with Bruton tyrosine kinase (BTK)–inhibitors, such as ibrutinib, until progression or time-limited therapy with ChT backbone and CD20 antibodies. In addition, the Food and Drug Administration and European Medicines Agency have recently approved the combination of venetoclax plus obinutuzumab for first-line therapy of CLL.

Treatment decisions should include an assessment of IGHV and TP53 status, as well as patient-related factors such as comedication, comorbidities, preferences, drug availability, and potential of treatment adherence, according to the guidelines.

In case of symptomatic relapse within 3 years after fixed-duration therapy or nonresponse to therapy, the guidelines recommend that the therapeutic regimen should be changed, regardless of the type of first-line either to venetoclax plus rituximab for 24 months or to ibrutinib, acalabrutinib, or other BTK inhibitors (if available) as continuous therapy.

The guidelines also discuss the possible roles for hematopoietic stem cell transplantation and cellular therapies, as well as the treatment of the various complications that can arise in patients with CLL, and dealing with various aspects of disease progression.

No external funds were provided for the production of the guidelines. The authors of the report and members of the ESMO Guidelines Committee reported numerous disclosures regarding pharmaceutical and biotechnology companies.

[email protected]

SOURCE: Eichhorst B et al. Ann Oncol. 2020 Oct 19. doi: 10.1016/j.annonc.2020.09.019.

An updated European Society for Medical Oncology (ESMO) clinical practice guidelines were released to provide key recommendations on the management of chronic lymphocytic leukemia (CLL).

The guidelines were developed by a multidisciplinary group of experts from different institutions and countries in Europe and provide levels of evidence and grades of recommendation where applicable for issues regarding prognosis and treatment decisions in CLL. Such decisions depend on genetic and clinical factors such as age, stage, and comorbidities. The guidelines also focus on new therapies targeting B-cell-receptor pathways or defect mechanism of apoptosis, which have been found to induce long-lasting remissions. The guidelines were endorsed by the European Hematology Association (EHA) through the Scientific Working Group on CLL/European Research Initiative on CLL (ERIC), according to the report published online the Annals of Oncology.

These clinical practice guidelines were developed in accordance with the ESMO standard operating procedures for clinical practice guidelines development with use of relevant literature selected by the expert authors. Statements without grading were considered justified as standard clinical practice by the experts and the ESMO faculty.

Below are some highlights of the guidelines, which cover a wide array of topics regarding the diagnosis, staging, treatment, and progression of CLL disease.
 

Diagnosis

The guidelines indicate that CLL diagnosis is usually possible by immunophenotyping of peripheral blood only and that lymph node (LN) biopsy and/or bone marrow biopsy may be helpful if immunophenotyping is not conclusive for the diagnosis of CLL, according to Barbara Eichhorst, MD, of the University of Cologne (Germany) and colleagues on behalf of the ESMO guidelines committee.

Staging and risk assessment

Early asymptomatic-stage disease does not need further risk assessment, but after the first year, when all patients should be seen at 3-monthly intervals, patients can be followed every 3-12 months. The interval would depend on burden and dynamics of the disease obtained by the using history and physical examinations, including a careful palpation of all LN areas, spleen, and liver, as well as assessing complete blood cell count and differential count, according to the report.

Advanced- and symptomatic-stage disease requires a broader examination including imaging, history and status of relevant infections, and fluorescent in situ hybridization (FISH) assays for the detection of deletion of the chromosome 17 (del[17p]) affecting the tumor protein p53 expression and, in the absence of del(17p), TP53 sequencing for detection of TP53 gene mutation, according to the authors.

Prognostication

Two clinical staging systems are typically used in CLL. Both Binet and Rai staging systems separate three groups of patients with different prognosis, although “as a consequence of more effective therapy, the overall survival (OS) of patients with advanced stage has improved and the relevance of the staging systems for prognostication has decreased,” according to the report.

The recent addition of genetic markers has also proved highly relevant to identifying patients with different prognoses and to guide treatment.
 

Therapy

Although CLL is an incurable disease, choice and application of treatment are strongly tied to the length of survival, according to the authors. The guidelines recommend Binet and Rai staging with clinical symptoms as relevant for treatment indication. In addition, the identification of del(17p), TP53 mutations, and IGHV status are relevant for choice of therapy and should be assessed prior to treatment.

The guidelines discuss specific treatment modalities for various stages of the disease, from early stages to relapse.

For frontline therapy, different treatment strategies are available including continuous treatment with Bruton tyrosine kinase (BTK)–inhibitors, such as ibrutinib, until progression or time-limited therapy with ChT backbone and CD20 antibodies. In addition, the Food and Drug Administration and European Medicines Agency have recently approved the combination of venetoclax plus obinutuzumab for first-line therapy of CLL.

Treatment decisions should include an assessment of IGHV and TP53 status, as well as patient-related factors such as comedication, comorbidities, preferences, drug availability, and potential of treatment adherence, according to the guidelines.

In case of symptomatic relapse within 3 years after fixed-duration therapy or nonresponse to therapy, the guidelines recommend that the therapeutic regimen should be changed, regardless of the type of first-line either to venetoclax plus rituximab for 24 months or to ibrutinib, acalabrutinib, or other BTK inhibitors (if available) as continuous therapy.

The guidelines also discuss the possible roles for hematopoietic stem cell transplantation and cellular therapies, as well as the treatment of the various complications that can arise in patients with CLL, and dealing with various aspects of disease progression.

No external funds were provided for the production of the guidelines. The authors of the report and members of the ESMO Guidelines Committee reported numerous disclosures regarding pharmaceutical and biotechnology companies.

[email protected]

SOURCE: Eichhorst B et al. Ann Oncol. 2020 Oct 19. doi: 10.1016/j.annonc.2020.09.019.

An updated European Society for Medical Oncology (ESMO) clinical practice guidelines were released to provide key recommendations on the management of chronic lymphocytic leukemia (CLL).

The guidelines were developed by a multidisciplinary group of experts from different institutions and countries in Europe and provide levels of evidence and grades of recommendation where applicable for issues regarding prognosis and treatment decisions in CLL. Such decisions depend on genetic and clinical factors such as age, stage, and comorbidities. The guidelines also focus on new therapies targeting B-cell-receptor pathways or defect mechanism of apoptosis, which have been found to induce long-lasting remissions. The guidelines were endorsed by the European Hematology Association (EHA) through the Scientific Working Group on CLL/European Research Initiative on CLL (ERIC), according to the report published online the Annals of Oncology.

These clinical practice guidelines were developed in accordance with the ESMO standard operating procedures for clinical practice guidelines development with use of relevant literature selected by the expert authors. Statements without grading were considered justified as standard clinical practice by the experts and the ESMO faculty.

Below are some highlights of the guidelines, which cover a wide array of topics regarding the diagnosis, staging, treatment, and progression of CLL disease.
 

Diagnosis

The guidelines indicate that CLL diagnosis is usually possible by immunophenotyping of peripheral blood only and that lymph node (LN) biopsy and/or bone marrow biopsy may be helpful if immunophenotyping is not conclusive for the diagnosis of CLL, according to Barbara Eichhorst, MD, of the University of Cologne (Germany) and colleagues on behalf of the ESMO guidelines committee.

Staging and risk assessment

Early asymptomatic-stage disease does not need further risk assessment, but after the first year, when all patients should be seen at 3-monthly intervals, patients can be followed every 3-12 months. The interval would depend on burden and dynamics of the disease obtained by the using history and physical examinations, including a careful palpation of all LN areas, spleen, and liver, as well as assessing complete blood cell count and differential count, according to the report.

Advanced- and symptomatic-stage disease requires a broader examination including imaging, history and status of relevant infections, and fluorescent in situ hybridization (FISH) assays for the detection of deletion of the chromosome 17 (del[17p]) affecting the tumor protein p53 expression and, in the absence of del(17p), TP53 sequencing for detection of TP53 gene mutation, according to the authors.

Prognostication

Two clinical staging systems are typically used in CLL. Both Binet and Rai staging systems separate three groups of patients with different prognosis, although “as a consequence of more effective therapy, the overall survival (OS) of patients with advanced stage has improved and the relevance of the staging systems for prognostication has decreased,” according to the report.

The recent addition of genetic markers has also proved highly relevant to identifying patients with different prognoses and to guide treatment.
 

Therapy

Although CLL is an incurable disease, choice and application of treatment are strongly tied to the length of survival, according to the authors. The guidelines recommend Binet and Rai staging with clinical symptoms as relevant for treatment indication. In addition, the identification of del(17p), TP53 mutations, and IGHV status are relevant for choice of therapy and should be assessed prior to treatment.

The guidelines discuss specific treatment modalities for various stages of the disease, from early stages to relapse.

For frontline therapy, different treatment strategies are available including continuous treatment with Bruton tyrosine kinase (BTK)–inhibitors, such as ibrutinib, until progression or time-limited therapy with ChT backbone and CD20 antibodies. In addition, the Food and Drug Administration and European Medicines Agency have recently approved the combination of venetoclax plus obinutuzumab for first-line therapy of CLL.

Treatment decisions should include an assessment of IGHV and TP53 status, as well as patient-related factors such as comedication, comorbidities, preferences, drug availability, and potential of treatment adherence, according to the guidelines.

In case of symptomatic relapse within 3 years after fixed-duration therapy or nonresponse to therapy, the guidelines recommend that the therapeutic regimen should be changed, regardless of the type of first-line either to venetoclax plus rituximab for 24 months or to ibrutinib, acalabrutinib, or other BTK inhibitors (if available) as continuous therapy.

The guidelines also discuss the possible roles for hematopoietic stem cell transplantation and cellular therapies, as well as the treatment of the various complications that can arise in patients with CLL, and dealing with various aspects of disease progression.

No external funds were provided for the production of the guidelines. The authors of the report and members of the ESMO Guidelines Committee reported numerous disclosures regarding pharmaceutical and biotechnology companies.

[email protected]

SOURCE: Eichhorst B et al. Ann Oncol. 2020 Oct 19. doi: 10.1016/j.annonc.2020.09.019.

Have you ever done something where you’re not quite sure why you did it at the time, but later on you realize it was part of some larger cosmic purpose, and you go, “Ahhh, now I understand…that’s why!”? Call it a fortuitous coincidence. Or a subconscious act of anticipation. Maybe a little push from God.

Last summer, as SHM’s Practice Analysis Committee was planning the State of Hospital Medicine survey for 2020, we received a request from SHM’s Diversity, Equity & Inclusion (DEI) Special Interest Group (SIG) to include a series of questions related to hospitalist gender, race and ethnic distribution in the new survey. We’ve generally resisted doing things like this because the SoHM is designed to capture data at the group level, not the individual level – and honestly, it’s as much as a lot of groups can do to tell us reliably how many FTEs they have, much less provide details about individual providers. In addition, the survey is already really long, and we are always looking for ways to make it shorter and easier for participants while still collecting the information report users care most about.

But we wanted to take the asks from the DEI SIG seriously, and as we considered their request, we realized that though it wasn’t practical to collect this information for individual hospital medicine group (HMG) members, we could collect it for group leaders. Little did we know last summer that issues of gender and racial diversity and equity would be so front-and-center right now, as we prepare to release the 2020 SoHM Report in early September. Ahhh, now I understand…that’s why – with the prompting of the DEI SIG – we so fortuitously chose to include those questions this year!

Here’s a sneak preview of what we learned. Among SoHM respondents, 57.1% reported that the highest-ranking leader in their HMG is White, and 23.5% of highest-ranking leaders are Asian. Only 5.5% of HMG leaders were Black/African American. Ethnicity was a separate question, and only 2.2% of HMG leaders were reported as Hispanic/Latino.

I have been profoundly moved by the wretched deaths of George Floyd and other people of color at the hands of police in recent months, and by the subsequent protests and our growing national reckoning over issues of racial equity and justice. In my efforts to understand more about race in America, I have been challenged by my friend Ryan Brown, MD, specialty medical director for hospital medicine with Atrium Health in Charlotte, N.C., and others to go beyond just learning about these issues. I want to use my voice to advocate for change, and my actions to participate in effecting change, within the context of my sphere of influence.

So, what does that have to do with the SoHM data on HMG leader demographics? Well, it’s clear that Black and brown people are woefully underrepresented in the ranks of hospital medicine leadership.

• Create and sponsor a mentoring program in which hospitalists volunteer to mentor minority junior high and high school students and help them prepare to pursue a career in medicine.
• Develop a formal, structured advocacy or collaboration effort with organizations like AAMC and the Accreditation Council for Graduate Medical Education designed to promote meaningful increases in the proportion of medical school students and residents who are people of color, and in the proportion who choose primary care – and ultimately, hospital medicine.
• Work hard to collect reliable racial, ethnic and gender information about SHM members and consider collaborating with MGMA to incorporate demographic questions into its survey tool for individual hospitalist compensation and productivity data. Challenge us on the Practice Analysis Committee who are responsible for the SoHM survey to continue surveying leadership demographics, and to consider how we can expand our collection of DEI information in 2022.
• Undertake a public relations campaign to highlight to health systems and other employers the under-representation of Black and Latino hospitalists in leadership positions, and to promote conscious efforts to increase those ranks.
• Create scholarships for hospitalists from underrepresented racial and ethnic groups to attend SHM-sponsored leadership development programs such as Leadership Academy, Academic Hospitalist Academy, and Quality and Safety Educators Academy, with the goal of increasing their ranks in positions of influence throughout healthcare. A scholarship program might even include raising funds to help minority hospitalists pursue Master’s-level programs such as an MBA, MHA, or MMM.
• Develop an educational track, mentoring program, or other support initiative for early-career hospitalist leaders and those interested in developing leadership skills, and ensure it gives specific attention to strategies for increasing the proportion of hospitalists of color in leadership positions.
• Review and revise existing SHM documents such as The Key Principles and Characteristics of an Effective Hospital Medicine Group, the Core Competencies in Hospital Medicine, and various white papers and position statements to ensure they address diversity, equity and inclusion – both with regard to the hospital medicine workforce and leadership, and with regard to patient care and eliminating health disparities.

I’m sure there are plenty of other similar actions we can take that I haven’t thought of. But we need to start the conversation about concrete steps our Society, and the medical specialty we represent, can take to foster real change. And then, we need to follow our words up with actions.

Ms. Flores is a partner at Nelson Flores Hospital Medicine Consultants in La Quinta, Calif. She serves on SHM’s Practice Analysis and Annual Conference Committees and helps to coordinate SHM’s biannual State of Hospital Medicine survey.

Have you ever done something where you’re not quite sure why you did it at the time, but later on you realize it was part of some larger cosmic purpose, and you go, “Ahhh, now I understand…that’s why!”? Call it a fortuitous coincidence. Or a subconscious act of anticipation. Maybe a little push from God.

Last summer, as SHM’s Practice Analysis Committee was planning the State of Hospital Medicine survey for 2020, we received a request from SHM’s Diversity, Equity & Inclusion (DEI) Special Interest Group (SIG) to include a series of questions related to hospitalist gender, race and ethnic distribution in the new survey. We’ve generally resisted doing things like this because the SoHM is designed to capture data at the group level, not the individual level – and honestly, it’s as much as a lot of groups can do to tell us reliably how many FTEs they have, much less provide details about individual providers. In addition, the survey is already really long, and we are always looking for ways to make it shorter and easier for participants while still collecting the information report users care most about.

But we wanted to take the asks from the DEI SIG seriously, and as we considered their request, we realized that though it wasn’t practical to collect this information for individual hospital medicine group (HMG) members, we could collect it for group leaders. Little did we know last summer that issues of gender and racial diversity and equity would be so front-and-center right now, as we prepare to release the 2020 SoHM Report in early September. Ahhh, now I understand…that’s why – with the prompting of the DEI SIG – we so fortuitously chose to include those questions this year!

Here’s a sneak preview of what we learned. Among SoHM respondents, 57.1% reported that the highest-ranking leader in their HMG is White, and 23.5% of highest-ranking leaders are Asian. Only 5.5% of HMG leaders were Black/African American. Ethnicity was a separate question, and only 2.2% of HMG leaders were reported as Hispanic/Latino.

I have been profoundly moved by the wretched deaths of George Floyd and other people of color at the hands of police in recent months, and by the subsequent protests and our growing national reckoning over issues of racial equity and justice. In my efforts to understand more about race in America, I have been challenged by my friend Ryan Brown, MD, specialty medical director for hospital medicine with Atrium Health in Charlotte, N.C., and others to go beyond just learning about these issues. I want to use my voice to advocate for change, and my actions to participate in effecting change, within the context of my sphere of influence.

So, what does that have to do with the SoHM data on HMG leader demographics? Well, it’s clear that Black and brown people are woefully underrepresented in the ranks of hospital medicine leadership.

• Create and sponsor a mentoring program in which hospitalists volunteer to mentor minority junior high and high school students and help them prepare to pursue a career in medicine.
• Develop a formal, structured advocacy or collaboration effort with organizations like AAMC and the Accreditation Council for Graduate Medical Education designed to promote meaningful increases in the proportion of medical school students and residents who are people of color, and in the proportion who choose primary care – and ultimately, hospital medicine.
• Work hard to collect reliable racial, ethnic and gender information about SHM members and consider collaborating with MGMA to incorporate demographic questions into its survey tool for individual hospitalist compensation and productivity data. Challenge us on the Practice Analysis Committee who are responsible for the SoHM survey to continue surveying leadership demographics, and to consider how we can expand our collection of DEI information in 2022.
• Undertake a public relations campaign to highlight to health systems and other employers the under-representation of Black and Latino hospitalists in leadership positions, and to promote conscious efforts to increase those ranks.
• Create scholarships for hospitalists from underrepresented racial and ethnic groups to attend SHM-sponsored leadership development programs such as Leadership Academy, Academic Hospitalist Academy, and Quality and Safety Educators Academy, with the goal of increasing their ranks in positions of influence throughout healthcare. A scholarship program might even include raising funds to help minority hospitalists pursue Master’s-level programs such as an MBA, MHA, or MMM.
• Develop an educational track, mentoring program, or other support initiative for early-career hospitalist leaders and those interested in developing leadership skills, and ensure it gives specific attention to strategies for increasing the proportion of hospitalists of color in leadership positions.
• Review and revise existing SHM documents such as The Key Principles and Characteristics of an Effective Hospital Medicine Group, the Core Competencies in Hospital Medicine, and various white papers and position statements to ensure they address diversity, equity and inclusion – both with regard to the hospital medicine workforce and leadership, and with regard to patient care and eliminating health disparities.

I’m sure there are plenty of other similar actions we can take that I haven’t thought of. But we need to start the conversation about concrete steps our Society, and the medical specialty we represent, can take to foster real change. And then, we need to follow our words up with actions.

Ms. Flores is a partner at Nelson Flores Hospital Medicine Consultants in La Quinta, Calif. She serves on SHM’s Practice Analysis and Annual Conference Committees and helps to coordinate SHM’s biannual State of Hospital Medicine survey.

Have you ever done something where you’re not quite sure why you did it at the time, but later on you realize it was part of some larger cosmic purpose, and you go, “Ahhh, now I understand…that’s why!”? Call it a fortuitous coincidence. Or a subconscious act of anticipation. Maybe a little push from God.

Last summer, as SHM’s Practice Analysis Committee was planning the State of Hospital Medicine survey for 2020, we received a request from SHM’s Diversity, Equity & Inclusion (DEI) Special Interest Group (SIG) to include a series of questions related to hospitalist gender, race and ethnic distribution in the new survey. We’ve generally resisted doing things like this because the SoHM is designed to capture data at the group level, not the individual level – and honestly, it’s as much as a lot of groups can do to tell us reliably how many FTEs they have, much less provide details about individual providers. In addition, the survey is already really long, and we are always looking for ways to make it shorter and easier for participants while still collecting the information report users care most about.

But we wanted to take the asks from the DEI SIG seriously, and as we considered their request, we realized that though it wasn’t practical to collect this information for individual hospital medicine group (HMG) members, we could collect it for group leaders. Little did we know last summer that issues of gender and racial diversity and equity would be so front-and-center right now, as we prepare to release the 2020 SoHM Report in early September. Ahhh, now I understand…that’s why – with the prompting of the DEI SIG – we so fortuitously chose to include those questions this year!

Here’s a sneak preview of what we learned. Among SoHM respondents, 57.1% reported that the highest-ranking leader in their HMG is White, and 23.5% of highest-ranking leaders are Asian. Only 5.5% of HMG leaders were Black/African American. Ethnicity was a separate question, and only 2.2% of HMG leaders were reported as Hispanic/Latino.

I have been profoundly moved by the wretched deaths of George Floyd and other people of color at the hands of police in recent months, and by the subsequent protests and our growing national reckoning over issues of racial equity and justice. In my efforts to understand more about race in America, I have been challenged by my friend Ryan Brown, MD, specialty medical director for hospital medicine with Atrium Health in Charlotte, N.C., and others to go beyond just learning about these issues. I want to use my voice to advocate for change, and my actions to participate in effecting change, within the context of my sphere of influence.

So, what does that have to do with the SoHM data on HMG leader demographics? Well, it’s clear that Black and brown people are woefully underrepresented in the ranks of hospital medicine leadership.

• Create and sponsor a mentoring program in which hospitalists volunteer to mentor minority junior high and high school students and help them prepare to pursue a career in medicine.
• Develop a formal, structured advocacy or collaboration effort with organizations like AAMC and the Accreditation Council for Graduate Medical Education designed to promote meaningful increases in the proportion of medical school students and residents who are people of color, and in the proportion who choose primary care – and ultimately, hospital medicine.
• Work hard to collect reliable racial, ethnic and gender information about SHM members and consider collaborating with MGMA to incorporate demographic questions into its survey tool for individual hospitalist compensation and productivity data. Challenge us on the Practice Analysis Committee who are responsible for the SoHM survey to continue surveying leadership demographics, and to consider how we can expand our collection of DEI information in 2022.
• Undertake a public relations campaign to highlight to health systems and other employers the under-representation of Black and Latino hospitalists in leadership positions, and to promote conscious efforts to increase those ranks.
• Create scholarships for hospitalists from underrepresented racial and ethnic groups to attend SHM-sponsored leadership development programs such as Leadership Academy, Academic Hospitalist Academy, and Quality and Safety Educators Academy, with the goal of increasing their ranks in positions of influence throughout healthcare. A scholarship program might even include raising funds to help minority hospitalists pursue Master’s-level programs such as an MBA, MHA, or MMM.
• Develop an educational track, mentoring program, or other support initiative for early-career hospitalist leaders and those interested in developing leadership skills, and ensure it gives specific attention to strategies for increasing the proportion of hospitalists of color in leadership positions.
• Review and revise existing SHM documents such as The Key Principles and Characteristics of an Effective Hospital Medicine Group, the Core Competencies in Hospital Medicine, and various white papers and position statements to ensure they address diversity, equity and inclusion – both with regard to the hospital medicine workforce and leadership, and with regard to patient care and eliminating health disparities.

I’m sure there are plenty of other similar actions we can take that I haven’t thought of. But we need to start the conversation about concrete steps our Society, and the medical specialty we represent, can take to foster real change. And then, we need to follow our words up with actions.

Ms. Flores is a partner at Nelson Flores Hospital Medicine Consultants in La Quinta, Calif. She serves on SHM’s Practice Analysis and Annual Conference Committees and helps to coordinate SHM’s biannual State of Hospital Medicine survey.

Free CME Credit 

Hemolytic disease of the fetus and newborn (HDFN) is a rare condition with an estimated 3 to 80 cases per 100,000 persons annually in the United States. Nonetheless, the complexity and increased risk for adverse outcomes in such cases requires more targeted approaches to HDFN that minimize or negate the risks associated with intrauterine transfusion.
This article focuses on the pathophysiology underlying fetal/newborn allo- and autoimmune diseases, especially HDFN and the current/evolving diagnostic and treatment regimens for HDFN.

Click here to read the article.

CME CREDITS: .25 CREDITS
To receive CME credit, please read the articles and go to www.omniaeducation.com/HDFN to access the post-test and evaluation.

Free CME Credit 

Hemolytic disease of the fetus and newborn (HDFN) is a rare condition with an estimated 3 to 80 cases per 100,000 persons annually in the United States. Nonetheless, the complexity and increased risk for adverse outcomes in such cases requires more targeted approaches to HDFN that minimize or negate the risks associated with intrauterine transfusion.
This article focuses on the pathophysiology underlying fetal/newborn allo- and autoimmune diseases, especially HDFN and the current/evolving diagnostic and treatment regimens for HDFN.

Click here to read the article.

CME CREDITS: .25 CREDITS
To receive CME credit, please read the articles and go to www.omniaeducation.com/HDFN to access the post-test and evaluation.

Free CME Credit 

Hemolytic disease of the fetus and newborn (HDFN) is a rare condition with an estimated 3 to 80 cases per 100,000 persons annually in the United States. Nonetheless, the complexity and increased risk for adverse outcomes in such cases requires more targeted approaches to HDFN that minimize or negate the risks associated with intrauterine transfusion.
This article focuses on the pathophysiology underlying fetal/newborn allo- and autoimmune diseases, especially HDFN and the current/evolving diagnostic and treatment regimens for HDFN.

Click here to read the article.

CME CREDITS: .25 CREDITS
To receive CME credit, please read the articles and go to www.omniaeducation.com/HDFN to access the post-test and evaluation.

Rejuvenation of the lower face often involves treatment of the submentum and the jowls. Energy-based devices such as lasers, radiofrequency, radiofrequency microneedling, CoolSculpting, and ultrasound have been used in the tightening of the neck and jowls.

Lily Talakoub, MD

However, the only noninvasive injectable treatment approved for the reduction of submental fat is deoxycholic acid (Kybella). The mechanism of action of deoxycholic acid has been documented as adipocyte lysis, followed by a local tissue response with neutrophil infiltration, septal thickening, neocollagenesis, and neovascularization within the subcutaneous layer, with no adverse changes in the dermis or epidermis. This treatment, which has a dose-dependent response, is highly effective for submental fat reduction and jaw contouring.

In my practice, I have found that multiple consecutive treatments with deoxycholic acid (an off-label use) are effective in permanently reducing the jowl overhang with minimal adverse effects.

Jowl fat is a common cause of sagging of the jowls, and there are few alternatives to treatment with surgery or liposuction. Jowl overhang results from multiple factors related to aging, including skeletal resorption, subcutaneous atrophy, superior and inferior fat pad compartment displacement, or mandibular septum dehiscence, which allows for the accumulation of fat pockets to migrate into the neck.

A prospective study published earlier this year describes results in 66 adults with excess jowl fat, who were treated with 2 mg/cm² of deoxycholic acid. Injections were done in patients with “pinchable fat on the jawline” and “relatively” minimal skin laxity of 0.2 mL spaced approximately 1 cm apart or 0.1 mL spaced 0.5 cm-0.75 cm apart; the mean injection volume was 0.8 mL. After 6 months, 98% of the patients experienced improvement with a mean of 1.8 treatments. Common injection site adverse events included edema, numbness, tenderness, and bruising.

In my experience, injection volumes from 1.0 mL to 1.5 mL of deoxycholic acid can be used in each jowl with minimal adverse events if proper landmarks are followed. It is crucial that the correct patient is selected (one with minimal skin laxity), and that during injection, the fat and skin are pinched away from the underlying musculature and neurovascular structures to avoid injection near the marginal mandibular nerve. Volumes less than 1.0 mL have minimal visible improvements and will require more than 3-4 treatment sessions for optimal results.

Jowl contouring with deoxycholic acid (with or without treatment of the submental fat pads) should be considered in the treatment options for lower face rejuvenation. I often see a marked improvement in patients who present prominent marionette lines who have been unhappy with fillers in the lower face. Often, the marionette lines are a result of significant overhang from jowl fat and hyaluronic acid fillers are a temporary and often unsatisfactory treatment option. The use of deoxycholic acid in the treatment of the jowl fat is a highly effective option to minimize the appearance of marionette lines caused by displaced fat pockets in the aging lower face.
 

Dr. Talakoub and Dr. Wesley are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected] . They had no relevant disclosures.

Rejuvenation of the lower face often involves treatment of the submentum and the jowls. Energy-based devices such as lasers, radiofrequency, radiofrequency microneedling, CoolSculpting, and ultrasound have been used in the tightening of the neck and jowls.

Lily Talakoub, MD

However, the only noninvasive injectable treatment approved for the reduction of submental fat is deoxycholic acid (Kybella). The mechanism of action of deoxycholic acid has been documented as adipocyte lysis, followed by a local tissue response with neutrophil infiltration, septal thickening, neocollagenesis, and neovascularization within the subcutaneous layer, with no adverse changes in the dermis or epidermis. This treatment, which has a dose-dependent response, is highly effective for submental fat reduction and jaw contouring.

In my practice, I have found that multiple consecutive treatments with deoxycholic acid (an off-label use) are effective in permanently reducing the jowl overhang with minimal adverse effects.

Jowl fat is a common cause of sagging of the jowls, and there are few alternatives to treatment with surgery or liposuction. Jowl overhang results from multiple factors related to aging, including skeletal resorption, subcutaneous atrophy, superior and inferior fat pad compartment displacement, or mandibular septum dehiscence, which allows for the accumulation of fat pockets to migrate into the neck.

A prospective study published earlier this year describes results in 66 adults with excess jowl fat, who were treated with 2 mg/cm² of deoxycholic acid. Injections were done in patients with “pinchable fat on the jawline” and “relatively” minimal skin laxity of 0.2 mL spaced approximately 1 cm apart or 0.1 mL spaced 0.5 cm-0.75 cm apart; the mean injection volume was 0.8 mL. After 6 months, 98% of the patients experienced improvement with a mean of 1.8 treatments. Common injection site adverse events included edema, numbness, tenderness, and bruising.

In my experience, injection volumes from 1.0 mL to 1.5 mL of deoxycholic acid can be used in each jowl with minimal adverse events if proper landmarks are followed. It is crucial that the correct patient is selected (one with minimal skin laxity), and that during injection, the fat and skin are pinched away from the underlying musculature and neurovascular structures to avoid injection near the marginal mandibular nerve. Volumes less than 1.0 mL have minimal visible improvements and will require more than 3-4 treatment sessions for optimal results.

Jowl contouring with deoxycholic acid (with or without treatment of the submental fat pads) should be considered in the treatment options for lower face rejuvenation. I often see a marked improvement in patients who present prominent marionette lines who have been unhappy with fillers in the lower face. Often, the marionette lines are a result of significant overhang from jowl fat and hyaluronic acid fillers are a temporary and often unsatisfactory treatment option. The use of deoxycholic acid in the treatment of the jowl fat is a highly effective option to minimize the appearance of marionette lines caused by displaced fat pockets in the aging lower face.
 

Dr. Talakoub and Dr. Wesley are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected] . They had no relevant disclosures.

Rejuvenation of the lower face often involves treatment of the submentum and the jowls. Energy-based devices such as lasers, radiofrequency, radiofrequency microneedling, CoolSculpting, and ultrasound have been used in the tightening of the neck and jowls.

Lily Talakoub, MD

However, the only noninvasive injectable treatment approved for the reduction of submental fat is deoxycholic acid (Kybella). The mechanism of action of deoxycholic acid has been documented as adipocyte lysis, followed by a local tissue response with neutrophil infiltration, septal thickening, neocollagenesis, and neovascularization within the subcutaneous layer, with no adverse changes in the dermis or epidermis. This treatment, which has a dose-dependent response, is highly effective for submental fat reduction and jaw contouring.

In my practice, I have found that multiple consecutive treatments with deoxycholic acid (an off-label use) are effective in permanently reducing the jowl overhang with minimal adverse effects.

Jowl fat is a common cause of sagging of the jowls, and there are few alternatives to treatment with surgery or liposuction. Jowl overhang results from multiple factors related to aging, including skeletal resorption, subcutaneous atrophy, superior and inferior fat pad compartment displacement, or mandibular septum dehiscence, which allows for the accumulation of fat pockets to migrate into the neck.

A prospective study published earlier this year describes results in 66 adults with excess jowl fat, who were treated with 2 mg/cm² of deoxycholic acid. Injections were done in patients with “pinchable fat on the jawline” and “relatively” minimal skin laxity of 0.2 mL spaced approximately 1 cm apart or 0.1 mL spaced 0.5 cm-0.75 cm apart; the mean injection volume was 0.8 mL. After 6 months, 98% of the patients experienced improvement with a mean of 1.8 treatments. Common injection site adverse events included edema, numbness, tenderness, and bruising.

In my experience, injection volumes from 1.0 mL to 1.5 mL of deoxycholic acid can be used in each jowl with minimal adverse events if proper landmarks are followed. It is crucial that the correct patient is selected (one with minimal skin laxity), and that during injection, the fat and skin are pinched away from the underlying musculature and neurovascular structures to avoid injection near the marginal mandibular nerve. Volumes less than 1.0 mL have minimal visible improvements and will require more than 3-4 treatment sessions for optimal results.

Jowl contouring with deoxycholic acid (with or without treatment of the submental fat pads) should be considered in the treatment options for lower face rejuvenation. I often see a marked improvement in patients who present prominent marionette lines who have been unhappy with fillers in the lower face. Often, the marionette lines are a result of significant overhang from jowl fat and hyaluronic acid fillers are a temporary and often unsatisfactory treatment option. The use of deoxycholic acid in the treatment of the jowl fat is a highly effective option to minimize the appearance of marionette lines caused by displaced fat pockets in the aging lower face.
 

Dr. Talakoub and Dr. Wesley are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected] . They had no relevant disclosures.

Children with complex medical conditions are living longer, many with the help of interventions and technology, such as gastrostomy tubes, tracheostomies, ventilator support, and parenteral nutrition. Children with medical complexity and technology account for over 80% of hospital days in pediatric academic centers.¹

Hospitalists need communication skills and clinical information to guide discussions with patients and families about whether to pursue these measures. Tracheostomy discussions can be particularly challenging. Over 4,000 infants and children undergo tracheostomy each year, with related hospital charges of more than $2 billion, a 30-day readmission rate of 24.9%, and a median length of stay for pneumonia or tracheitis of 4 days.² There is limited research on prognosis, outcomes, decision-making, and effects on quality of life, especially in the population of children who have significant neurological impairment (NI) and/or progressive or deteriorating neurological conditions. Physician biases may also influence this discussion.

This article will examine the question: How can a hospitalist guide decision-making discussions with families about tracheostomy placement for children with NI? A literature search was performed on Medline and Web of Science using the key terms tracheostomy, prognosis, neurologically impaired children, and decision-making. Articles included were relevant to the clinical question and published in the last 5 years. One article was included outside this timeframe given the scarcity of data.

Indications for tracheostomy include airway obstruction and the need for prolonged ventilation support.³ The number of tracheostomies placed has been increasing over the last 30 years, especially at tertiary care centers.³ Primary indications for tracheostomy include prolonged ventilation particularly in the context of underlying conditions such as congenital or acquired respiratory disease, congenital or acquired neurologic disease, cardiopulmonary disease, and primary anatomic airway obstruction.^3,4 Children who undergo tracheostomy often have multiple medical conditions that impact their overall health and prognosis, with 41% having three or more complex chronic health conditions.⁵ This article will focus on children who have a primary indication of NI and in whom tracheostomy is often used as a life-prolonging measure.

Discussions about tracheostomy should include information about risks, benefits, and prognosis. Prognosis discussions can be challenging given that many children for whom this intervention is being considered have multiple and complex medical conditions with uncertain or even known poor prognoses. Mortality rates ranging from 3% to 11% have been reported during the initial tracheostomy admission, with NI increasing the risk for mortality during the tracheostomy admission.^5,6 Children with NI also have higher mortality beyond the initial hospital stay, lower decannulation rates, and more frequent admissions with longer lengths of stay than do children receiving a tracheostomy for upper airway obstruction (Table 1).^6,7

For most children in this population, prognosis is related more to the underlying disease process than to the risk of the surgery for tracheostomy placement itself. Discussions with families should include the anticipated prognosis of the underlying disease, as well as current available data on outcomes for children with neurological impairment who have undergone tracheostomy placement. Most patients who receive a tracheostomy are children with complex medical conditions who have an acute event that leads to airway compromise and respiratory failure underscoring the importance of advance care planning.⁵

Clinicians face challenges when initiating advance care planning discussions, including prognostic uncertainty, the perception that families may not want to engage in these discussions, and the complexity and time these discussions can take. In one study of more than 300 chronically ill children, only 17% of parents had discussed advance directives, although 49% reported they would like to create one for their child.⁹ A small study found that, although parents find these discussions difficult, they also find them important. They value a step by step approach with consideration for hope and nonmedical concerns.¹⁰ Advance care planning discussions should be viewed as a time out to clarify what the family sees as the best path forward before initiation of a tracheostomy discussion and decision.

Determining goals of care is a cornerstone of any discussion about tracheostomy placement, especially when a child has a condition that is life limiting. The decision to pursue tracheostomy should involve shared decision-making. This decision-making process is the preferred communication model when multiple options could be pursued, each with its own risks and benefits.¹⁰

In this model of decision-making, the family’s goals and values should be determined in the context of the medical intervention that is being pursued. Medical information such as prognosis, risk, benefits, and impact of the intervention on quality of life should all be shared with the family. Ideally, shared decision-making allows the practitioner and family to make a decision together that matches the family’s goals and values with the best option available. If the family’s goal is to prolong life and they feel their child has good quality of life, tracheostomy placement may be the most appropriate option. However, it is also possible that the family’s goals may align more with less invasive treatment options or a transition to comfort care.

Discussions regarding goals of care can be challenging, and involving an interdisciplinary team and a Palliative Care consultant can be helpful.

Research on what parents find helpful in discussions about tracheostomy is limited. One study of 56 caregivers found that parents did not feel they could make a “free choice” because the alternative to tracheostomy was death.¹¹ In interviews with caregivers following tracheostomy, this same study found several themes in caregiver perspectives on their decision for tracheostomy (Table 2); caregivers saw a benefit to “health and well-being” from tracheostomy even though they reported feeling unprepared for the caregiving aspect at home or the potential negative side effects. Half the children in this study had a neurologic diagnosis, and only families who chose tracheostomy placement were included. To this author’s knowledge, there are currently no studies that look at decisional themes, satisfaction, or outcomes for families that chose to not pursue tracheostomy.

There is limited literature about how providers discuss tracheostomy. One single-center study of practitioners found that providers focused more often on the benefits of tracheostomy rather than burdens (72% vs 28%).¹² A common benefit theme was the provider “suggesting life with a tracheostomy might not be as difficult as families fear in that the child may have the ability to regain speech, engage in normal activities, and have the tracheostomy reversed once the child’s health improved.” However, decannulation rates and recovery trajectories for children with NI do not support this general expectation (Table 1). These provider communication themes may help to explain the family’s perspective that they feel unprepared for the burdens of a tracheostomy or the intensity of home caregiving. Given the limited data, it is difficult to generalize. Comparing communication and decision-making themes side by side does draw attention to how providers might better communicate with families about this decision (Table 2).

The difficult aspects of caregiving deserve special attention. A study of 25 parents showed reduced parental quality of life after their child’s tracheostomy placement related to overwhelming medical care, fear of death of the child requiring constant vigilance, and financial and psychological stressors.¹³ Most (72%) families in this study reported decisional regret at 3 months.Resources and support for a child with this level of care varies based on the child’s community. Exploration and discussion of what is available for each family, including home nursing, respite, and/or a skilled nursing facility, should be completed prior to tracheostomy placement. Honest discussions about the potential effects of this intervention on the family’s life can help inform their decision.

Decision-making tools for tracheostomy could be valuable for both families and clinicians. These tools allow for a more systematic approach to the decision-making process that takes into account the multidimensional aspects of this decision. The “Child Tracheostomy Decision Guide,” published by the Winnipeg Regional Health Authority, is one available tool.¹⁴ This tool guides families through the factors that may affect their decision-making and includes thoughts about goals of care, quality of life, prognosis, care at home, and other options such as comfort care. The Courageous Parents Network has also developed parent videos giving the perspective of parents who have chosen or not chosen tracheostomy.¹⁵ Currently, there are no studies that examine the usefulness of decision-making tools.

A common theme throughout the literature is the lack of a unifying classification system for reporting outcomes data. Each study utilizes different primary indications for tracheostomy and often different definitions for NI. There is very little literature that focuses specifically on outcomes for children with NI who receive tracheostomy as a life-prolonging measure. These gaps present challenges for obtaining meaningful prognosis data to share with families. Outcomes data for children who do not receive tracheostomy is also lacking. Additional studies on how families make this decision and their decisional satisfaction could help inform the decision-making process for both parents and clinicians. Research regarding the helpfulness and outcomes with decision-making tools would be useful.

Although there are limited data on outcomes specific to the children with NI and tracheostomy, existing literature shows a higher mortality, lower decannulation rate, higher hospitalization rate, and longer length of stay than that for children who receive tracheostomy for other indications. Tracheostomy is often a life-prolonging measure for children with NI. Shared decision-making should be the preferred communication process and include defining goals of care, as well as anticipated prognosis with balanced information about risks and benefits. Further research about the decision-making process and communication would be beneficial.

Dr Shaw has nothing to disclose.

Children with complex medical conditions are living longer, many with the help of interventions and technology, such as gastrostomy tubes, tracheostomies, ventilator support, and parenteral nutrition. Children with medical complexity and technology account for over 80% of hospital days in pediatric academic centers.¹

Hospitalists need communication skills and clinical information to guide discussions with patients and families about whether to pursue these measures. Tracheostomy discussions can be particularly challenging. Over 4,000 infants and children undergo tracheostomy each year, with related hospital charges of more than $2 billion, a 30-day readmission rate of 24.9%, and a median length of stay for pneumonia or tracheitis of 4 days.² There is limited research on prognosis, outcomes, decision-making, and effects on quality of life, especially in the population of children who have significant neurological impairment (NI) and/or progressive or deteriorating neurological conditions. Physician biases may also influence this discussion.

This article will examine the question: How can a hospitalist guide decision-making discussions with families about tracheostomy placement for children with NI? A literature search was performed on Medline and Web of Science using the key terms tracheostomy, prognosis, neurologically impaired children, and decision-making. Articles included were relevant to the clinical question and published in the last 5 years. One article was included outside this timeframe given the scarcity of data.

Indications for tracheostomy include airway obstruction and the need for prolonged ventilation support.³ The number of tracheostomies placed has been increasing over the last 30 years, especially at tertiary care centers.³ Primary indications for tracheostomy include prolonged ventilation particularly in the context of underlying conditions such as congenital or acquired respiratory disease, congenital or acquired neurologic disease, cardiopulmonary disease, and primary anatomic airway obstruction.^3,4 Children who undergo tracheostomy often have multiple medical conditions that impact their overall health and prognosis, with 41% having three or more complex chronic health conditions.⁵ This article will focus on children who have a primary indication of NI and in whom tracheostomy is often used as a life-prolonging measure.

Discussions about tracheostomy should include information about risks, benefits, and prognosis. Prognosis discussions can be challenging given that many children for whom this intervention is being considered have multiple and complex medical conditions with uncertain or even known poor prognoses. Mortality rates ranging from 3% to 11% have been reported during the initial tracheostomy admission, with NI increasing the risk for mortality during the tracheostomy admission.^5,6 Children with NI also have higher mortality beyond the initial hospital stay, lower decannulation rates, and more frequent admissions with longer lengths of stay than do children receiving a tracheostomy for upper airway obstruction (Table 1).^6,7

For most children in this population, prognosis is related more to the underlying disease process than to the risk of the surgery for tracheostomy placement itself. Discussions with families should include the anticipated prognosis of the underlying disease, as well as current available data on outcomes for children with neurological impairment who have undergone tracheostomy placement. Most patients who receive a tracheostomy are children with complex medical conditions who have an acute event that leads to airway compromise and respiratory failure underscoring the importance of advance care planning.⁵

Clinicians face challenges when initiating advance care planning discussions, including prognostic uncertainty, the perception that families may not want to engage in these discussions, and the complexity and time these discussions can take. In one study of more than 300 chronically ill children, only 17% of parents had discussed advance directives, although 49% reported they would like to create one for their child.⁹ A small study found that, although parents find these discussions difficult, they also find them important. They value a step by step approach with consideration for hope and nonmedical concerns.¹⁰ Advance care planning discussions should be viewed as a time out to clarify what the family sees as the best path forward before initiation of a tracheostomy discussion and decision.

Determining goals of care is a cornerstone of any discussion about tracheostomy placement, especially when a child has a condition that is life limiting. The decision to pursue tracheostomy should involve shared decision-making. This decision-making process is the preferred communication model when multiple options could be pursued, each with its own risks and benefits.¹⁰

In this model of decision-making, the family’s goals and values should be determined in the context of the medical intervention that is being pursued. Medical information such as prognosis, risk, benefits, and impact of the intervention on quality of life should all be shared with the family. Ideally, shared decision-making allows the practitioner and family to make a decision together that matches the family’s goals and values with the best option available. If the family’s goal is to prolong life and they feel their child has good quality of life, tracheostomy placement may be the most appropriate option. However, it is also possible that the family’s goals may align more with less invasive treatment options or a transition to comfort care.

Discussions regarding goals of care can be challenging, and involving an interdisciplinary team and a Palliative Care consultant can be helpful.

Research on what parents find helpful in discussions about tracheostomy is limited. One study of 56 caregivers found that parents did not feel they could make a “free choice” because the alternative to tracheostomy was death.¹¹ In interviews with caregivers following tracheostomy, this same study found several themes in caregiver perspectives on their decision for tracheostomy (Table 2); caregivers saw a benefit to “health and well-being” from tracheostomy even though they reported feeling unprepared for the caregiving aspect at home or the potential negative side effects. Half the children in this study had a neurologic diagnosis, and only families who chose tracheostomy placement were included. To this author’s knowledge, there are currently no studies that look at decisional themes, satisfaction, or outcomes for families that chose to not pursue tracheostomy.

There is limited literature about how providers discuss tracheostomy. One single-center study of practitioners found that providers focused more often on the benefits of tracheostomy rather than burdens (72% vs 28%).¹² A common benefit theme was the provider “suggesting life with a tracheostomy might not be as difficult as families fear in that the child may have the ability to regain speech, engage in normal activities, and have the tracheostomy reversed once the child’s health improved.” However, decannulation rates and recovery trajectories for children with NI do not support this general expectation (Table 1). These provider communication themes may help to explain the family’s perspective that they feel unprepared for the burdens of a tracheostomy or the intensity of home caregiving. Given the limited data, it is difficult to generalize. Comparing communication and decision-making themes side by side does draw attention to how providers might better communicate with families about this decision (Table 2).

The difficult aspects of caregiving deserve special attention. A study of 25 parents showed reduced parental quality of life after their child’s tracheostomy placement related to overwhelming medical care, fear of death of the child requiring constant vigilance, and financial and psychological stressors.¹³ Most (72%) families in this study reported decisional regret at 3 months.Resources and support for a child with this level of care varies based on the child’s community. Exploration and discussion of what is available for each family, including home nursing, respite, and/or a skilled nursing facility, should be completed prior to tracheostomy placement. Honest discussions about the potential effects of this intervention on the family’s life can help inform their decision.

Decision-making tools for tracheostomy could be valuable for both families and clinicians. These tools allow for a more systematic approach to the decision-making process that takes into account the multidimensional aspects of this decision. The “Child Tracheostomy Decision Guide,” published by the Winnipeg Regional Health Authority, is one available tool.¹⁴ This tool guides families through the factors that may affect their decision-making and includes thoughts about goals of care, quality of life, prognosis, care at home, and other options such as comfort care. The Courageous Parents Network has also developed parent videos giving the perspective of parents who have chosen or not chosen tracheostomy.¹⁵ Currently, there are no studies that examine the usefulness of decision-making tools.

A common theme throughout the literature is the lack of a unifying classification system for reporting outcomes data. Each study utilizes different primary indications for tracheostomy and often different definitions for NI. There is very little literature that focuses specifically on outcomes for children with NI who receive tracheostomy as a life-prolonging measure. These gaps present challenges for obtaining meaningful prognosis data to share with families. Outcomes data for children who do not receive tracheostomy is also lacking. Additional studies on how families make this decision and their decisional satisfaction could help inform the decision-making process for both parents and clinicians. Research regarding the helpfulness and outcomes with decision-making tools would be useful.

Although there are limited data on outcomes specific to the children with NI and tracheostomy, existing literature shows a higher mortality, lower decannulation rate, higher hospitalization rate, and longer length of stay than that for children who receive tracheostomy for other indications. Tracheostomy is often a life-prolonging measure for children with NI. Shared decision-making should be the preferred communication process and include defining goals of care, as well as anticipated prognosis with balanced information about risks and benefits. Further research about the decision-making process and communication would be beneficial.

Dr Shaw has nothing to disclose.

Children with complex medical conditions are living longer, many with the help of interventions and technology, such as gastrostomy tubes, tracheostomies, ventilator support, and parenteral nutrition. Children with medical complexity and technology account for over 80% of hospital days in pediatric academic centers.¹

Hospitalists need communication skills and clinical information to guide discussions with patients and families about whether to pursue these measures. Tracheostomy discussions can be particularly challenging. Over 4,000 infants and children undergo tracheostomy each year, with related hospital charges of more than $2 billion, a 30-day readmission rate of 24.9%, and a median length of stay for pneumonia or tracheitis of 4 days.² There is limited research on prognosis, outcomes, decision-making, and effects on quality of life, especially in the population of children who have significant neurological impairment (NI) and/or progressive or deteriorating neurological conditions. Physician biases may also influence this discussion.

This article will examine the question: How can a hospitalist guide decision-making discussions with families about tracheostomy placement for children with NI? A literature search was performed on Medline and Web of Science using the key terms tracheostomy, prognosis, neurologically impaired children, and decision-making. Articles included were relevant to the clinical question and published in the last 5 years. One article was included outside this timeframe given the scarcity of data.

Indications for tracheostomy include airway obstruction and the need for prolonged ventilation support.³ The number of tracheostomies placed has been increasing over the last 30 years, especially at tertiary care centers.³ Primary indications for tracheostomy include prolonged ventilation particularly in the context of underlying conditions such as congenital or acquired respiratory disease, congenital or acquired neurologic disease, cardiopulmonary disease, and primary anatomic airway obstruction.^3,4 Children who undergo tracheostomy often have multiple medical conditions that impact their overall health and prognosis, with 41% having three or more complex chronic health conditions.⁵ This article will focus on children who have a primary indication of NI and in whom tracheostomy is often used as a life-prolonging measure.

Discussions about tracheostomy should include information about risks, benefits, and prognosis. Prognosis discussions can be challenging given that many children for whom this intervention is being considered have multiple and complex medical conditions with uncertain or even known poor prognoses. Mortality rates ranging from 3% to 11% have been reported during the initial tracheostomy admission, with NI increasing the risk for mortality during the tracheostomy admission.^5,6 Children with NI also have higher mortality beyond the initial hospital stay, lower decannulation rates, and more frequent admissions with longer lengths of stay than do children receiving a tracheostomy for upper airway obstruction (Table 1).^6,7

For most children in this population, prognosis is related more to the underlying disease process than to the risk of the surgery for tracheostomy placement itself. Discussions with families should include the anticipated prognosis of the underlying disease, as well as current available data on outcomes for children with neurological impairment who have undergone tracheostomy placement. Most patients who receive a tracheostomy are children with complex medical conditions who have an acute event that leads to airway compromise and respiratory failure underscoring the importance of advance care planning.⁵

Clinicians face challenges when initiating advance care planning discussions, including prognostic uncertainty, the perception that families may not want to engage in these discussions, and the complexity and time these discussions can take. In one study of more than 300 chronically ill children, only 17% of parents had discussed advance directives, although 49% reported they would like to create one for their child.⁹ A small study found that, although parents find these discussions difficult, they also find them important. They value a step by step approach with consideration for hope and nonmedical concerns.¹⁰ Advance care planning discussions should be viewed as a time out to clarify what the family sees as the best path forward before initiation of a tracheostomy discussion and decision.

Determining goals of care is a cornerstone of any discussion about tracheostomy placement, especially when a child has a condition that is life limiting. The decision to pursue tracheostomy should involve shared decision-making. This decision-making process is the preferred communication model when multiple options could be pursued, each with its own risks and benefits.¹⁰

In this model of decision-making, the family’s goals and values should be determined in the context of the medical intervention that is being pursued. Medical information such as prognosis, risk, benefits, and impact of the intervention on quality of life should all be shared with the family. Ideally, shared decision-making allows the practitioner and family to make a decision together that matches the family’s goals and values with the best option available. If the family’s goal is to prolong life and they feel their child has good quality of life, tracheostomy placement may be the most appropriate option. However, it is also possible that the family’s goals may align more with less invasive treatment options or a transition to comfort care.

Discussions regarding goals of care can be challenging, and involving an interdisciplinary team and a Palliative Care consultant can be helpful.

Research on what parents find helpful in discussions about tracheostomy is limited. One study of 56 caregivers found that parents did not feel they could make a “free choice” because the alternative to tracheostomy was death.¹¹ In interviews with caregivers following tracheostomy, this same study found several themes in caregiver perspectives on their decision for tracheostomy (Table 2); caregivers saw a benefit to “health and well-being” from tracheostomy even though they reported feeling unprepared for the caregiving aspect at home or the potential negative side effects. Half the children in this study had a neurologic diagnosis, and only families who chose tracheostomy placement were included. To this author’s knowledge, there are currently no studies that look at decisional themes, satisfaction, or outcomes for families that chose to not pursue tracheostomy.

There is limited literature about how providers discuss tracheostomy. One single-center study of practitioners found that providers focused more often on the benefits of tracheostomy rather than burdens (72% vs 28%).¹² A common benefit theme was the provider “suggesting life with a tracheostomy might not be as difficult as families fear in that the child may have the ability to regain speech, engage in normal activities, and have the tracheostomy reversed once the child’s health improved.” However, decannulation rates and recovery trajectories for children with NI do not support this general expectation (Table 1). These provider communication themes may help to explain the family’s perspective that they feel unprepared for the burdens of a tracheostomy or the intensity of home caregiving. Given the limited data, it is difficult to generalize. Comparing communication and decision-making themes side by side does draw attention to how providers might better communicate with families about this decision (Table 2).

The difficult aspects of caregiving deserve special attention. A study of 25 parents showed reduced parental quality of life after their child’s tracheostomy placement related to overwhelming medical care, fear of death of the child requiring constant vigilance, and financial and psychological stressors.¹³ Most (72%) families in this study reported decisional regret at 3 months.Resources and support for a child with this level of care varies based on the child’s community. Exploration and discussion of what is available for each family, including home nursing, respite, and/or a skilled nursing facility, should be completed prior to tracheostomy placement. Honest discussions about the potential effects of this intervention on the family’s life can help inform their decision.

Decision-making tools for tracheostomy could be valuable for both families and clinicians. These tools allow for a more systematic approach to the decision-making process that takes into account the multidimensional aspects of this decision. The “Child Tracheostomy Decision Guide,” published by the Winnipeg Regional Health Authority, is one available tool.¹⁴ This tool guides families through the factors that may affect their decision-making and includes thoughts about goals of care, quality of life, prognosis, care at home, and other options such as comfort care. The Courageous Parents Network has also developed parent videos giving the perspective of parents who have chosen or not chosen tracheostomy.¹⁵ Currently, there are no studies that examine the usefulness of decision-making tools.

A common theme throughout the literature is the lack of a unifying classification system for reporting outcomes data. Each study utilizes different primary indications for tracheostomy and often different definitions for NI. There is very little literature that focuses specifically on outcomes for children with NI who receive tracheostomy as a life-prolonging measure. These gaps present challenges for obtaining meaningful prognosis data to share with families. Outcomes data for children who do not receive tracheostomy is also lacking. Additional studies on how families make this decision and their decisional satisfaction could help inform the decision-making process for both parents and clinicians. Research regarding the helpfulness and outcomes with decision-making tools would be useful.

Although there are limited data on outcomes specific to the children with NI and tracheostomy, existing literature shows a higher mortality, lower decannulation rate, higher hospitalization rate, and longer length of stay than that for children who receive tracheostomy for other indications. Tracheostomy is often a life-prolonging measure for children with NI. Shared decision-making should be the preferred communication process and include defining goals of care, as well as anticipated prognosis with balanced information about risks and benefits. Further research about the decision-making process and communication would be beneficial.

Dr Shaw has nothing to disclose.

At the time this piece was written, 54 Florida hospitals reported no available intensive care unit (ICU) beds¹; hospitals in Miami-Dade County even started sending patients to neighboring Broward County for care despite Broward County also reporting a hospital bed shortage. Patients might even have needed to be transferred further north to Palm Beach County.² Miami-Dade County was diagnosing over 100 cases with SARS-CoV-2 per 100,000 residents per day at one point, with a test positivity rate of over 25% that suggests testing is inadequate and many more would-be positive tests are being missed.³ While certain parts of the United States seem to have gained some semblance of control over the novel coronavirus, Florida appears to be in a downward spiral of high infection rates and increasing hospitalizations.

It didn’t have to go this way.

According to Robert Redfield, MD, Director of the Centers for Disease Control and Prevention, wearing a mask significantly reduces SARS-CoV-2 transmission. If community masking were increased only modestly, disease transmission could be curtailed enough to prevent many stay-at-home orders and reduce losses of an estimated $1 trillion in gross domestic product⁴ while also providing incalculable improvements in morbidity and mortality. Some experts believe that, while wearing a mask can protect others, it can also protect the wearer.⁵

That masking should be universal has become the accepted public health sentiment during this pandemic. Yet at the time of writing this article, there was still no law mandating masks in Florida, perhaps due to a significant but vocal minority—those who have personal concerns about wearing a mask and little concern about transmitting the virus to other, more vulnerable populations. This was the reason that one of the authors (M.B.) campaigned tirelessly for mandatory masking at Palm Beach County Commission meetings, one of which made the international news because of the outrageous and seemingly heart-felt statements made by several antimask advocates.⁶

At the Palm Beach County Commission, organized antimask advocates arrived hours before the start of the meeting, coming in two buses. Because of social distancing guidelines and seating limitations, they were able to fill many of the open seats at the meeting, making it appear that the antimask advocates far outnumbered those in favor of mask laws. Despite their tactics of screaming and intimidation, a law mandating masks in the county passed unanimously, though medical exemptions for those with chronic obstructive pulmonary disease, asthma, or “other conditions that reduce breathing” and religious exemptions for “persons for whom wearing a facial covering conflicts with their religious beliefs or practices” were included.⁷ After the meeting, police escorts were required by those in favor of masks, while the county commissioners had to lock themselves behind chamber doors.

The antimask campaigners were already known to M.B., a teacher, from previous gatherings she had attended in support of firearm legislation aimed at reducing gun violence. The same antimask advocates at the County Commission meeting had previously gathered as counter-protesters at this prior event, heckling and threatening those advocating for improving gun safety through legislation such as background checks. While it should not be, mask wearing and the laws mandating it have become a question of politics rather than one based in scientific evidence.

The absence of mandatory masking laws in populations hesitant to wear them, combined with the rush to reopen businesses, resulted in increasing death rates in Florida, with 7-day averages continuing in an upward trajectory and over 7,000 deaths being reported as of August 3, 2020.⁸ A small glimmer of hope was raised on that day, when fewer than 100 deaths for the previous day were reported, although one wonders if the weekend’s Hurricane Isaias preparations may have delayed some reporting.

In the face of mounting death counts and increasingly stressed hospitals, Florida’s governor, Ron DeSantis, has not heeded calls to institute new regulations, instead deferring to localities. This is perhaps good news considering Georgia’s governor, Brian Kemp, has spoken out against local mask laws and has said that mandating wearing them, even at the local level, would be a “bridge too far.”⁹ Several Georgia municipalities defied the governor, passing mandatory masking for their populations anyway, prompting Governor Kemp to file a lawsuit against the city of Atlanta, which he subsequently dropped after a judge ordered the state and city into mediation.¹⁰

The idea that the state should create laws to regulate the health and safety of the population has been met with resistance in the past where there is a greater degree of libertarian and antipaternalistic thinking.¹¹ Campaigning against public health laws is not a new phenomenon. In the 1970s and 1980s, mandatory seat belt laws were met with significant resistance by a vocal minority, with the most common predictors for opposing these laws noted as holding beliefs that seat belts were ineffective, inconvenient, or uncomfortable¹²—the same arguments that have been made against masks. Additionally, having lower educational attainment, less income, and younger age were predictors of being against mandatory seat belt laws.¹²

In response to a vociferous and somewhat organized minority, which has, in many cases, intimidated state and local politicians into inaction, community organizers have put out the call for many more citizens to make their voices heard. This seemed to have had an impact on the Palm Beach County commissioners, one of whom tried to demonstrate that there was broad support for passing a mandatory masking law during the commission meeting by bringing a stack of printed-out communications he had received in favor of it. Community organizers and public health advocates generally have an easier time reaching local officials, whereas it can be more difficult to engage other government officials farther away in state capitals, especially in larger states such as Florida. The organizers can also appeal to the fact that the local officials must live in the communities they represent and do not want to suffer from the spread of SARS-CoV-2 and overflowing hospitals. While local officials may be ill equipped to handle a global pandemic, appealing to the community has been somewhat effective in putting pressure on these officials to get a patchwork of local laws, which hopefully will have an impact on Florida’s surge numbers.

In the absence of a statewide mandatory masking law in Florida, several municipalities have instituted their own restrictions. Counties with some of the largest cities, such as Miami, Fort Lauderdale, Tampa, and Orlando, have required that masks be worn in public since June or early July.¹³ These restrictions, however, were implemented later than states in the northeastern United States, which have required masks since April or May and before significant reopening of businesses took place, in contrast to the sequence observed in Florida.

In the absence of political leadership, Florida businesses are increasingly taking up the charge and mandating that employees work from home, while others are requiring that employees and customers wear masks. Following New York–based grocer Key Foods and national chains like Whole Foods, both of which have long required that Florida customers wear masks, Florida’s ubiquitous Publix Supermarkets mandated masks in over 800 of their stores beginning July 21.¹⁴

While individual businesses and localities should be commended for their efforts, unfortunately, this may not be enough to dampen the surge. A tool developed by Harvard-based researchers, has labeled Florida and several other neighboring states as having severe spread, necessitating the need for stay-at-home orders to be reinstated.¹⁵

Florida is currently a global epicenter for COVID-19 diagnoses, with the state reporting nearly 600,000 cases as of August 17,⁸ more than most countries with larger populations. Florida faces many barriers to gaining control over the virus, including a vocal and organized minority which has opposed public health measures, an unwilling state government and ill-equipped local officials, and an underfunded safety net if stay-at-home orders were to be issued. Appealing to the public and elected officials with science, sanity, and support for those who want to prevent the spread of COVID-19 may provide one solution for gaining some control over the pandemic.

The authors have nothing to disclose.

At the time this piece was written, 54 Florida hospitals reported no available intensive care unit (ICU) beds¹; hospitals in Miami-Dade County even started sending patients to neighboring Broward County for care despite Broward County also reporting a hospital bed shortage. Patients might even have needed to be transferred further north to Palm Beach County.² Miami-Dade County was diagnosing over 100 cases with SARS-CoV-2 per 100,000 residents per day at one point, with a test positivity rate of over 25% that suggests testing is inadequate and many more would-be positive tests are being missed.³ While certain parts of the United States seem to have gained some semblance of control over the novel coronavirus, Florida appears to be in a downward spiral of high infection rates and increasing hospitalizations.

It didn’t have to go this way.

According to Robert Redfield, MD, Director of the Centers for Disease Control and Prevention, wearing a mask significantly reduces SARS-CoV-2 transmission. If community masking were increased only modestly, disease transmission could be curtailed enough to prevent many stay-at-home orders and reduce losses of an estimated $1 trillion in gross domestic product⁴ while also providing incalculable improvements in morbidity and mortality. Some experts believe that, while wearing a mask can protect others, it can also protect the wearer.⁵

That masking should be universal has become the accepted public health sentiment during this pandemic. Yet at the time of writing this article, there was still no law mandating masks in Florida, perhaps due to a significant but vocal minority—those who have personal concerns about wearing a mask and little concern about transmitting the virus to other, more vulnerable populations. This was the reason that one of the authors (M.B.) campaigned tirelessly for mandatory masking at Palm Beach County Commission meetings, one of which made the international news because of the outrageous and seemingly heart-felt statements made by several antimask advocates.⁶

At the Palm Beach County Commission, organized antimask advocates arrived hours before the start of the meeting, coming in two buses. Because of social distancing guidelines and seating limitations, they were able to fill many of the open seats at the meeting, making it appear that the antimask advocates far outnumbered those in favor of mask laws. Despite their tactics of screaming and intimidation, a law mandating masks in the county passed unanimously, though medical exemptions for those with chronic obstructive pulmonary disease, asthma, or “other conditions that reduce breathing” and religious exemptions for “persons for whom wearing a facial covering conflicts with their religious beliefs or practices” were included.⁷ After the meeting, police escorts were required by those in favor of masks, while the county commissioners had to lock themselves behind chamber doors.

The antimask campaigners were already known to M.B., a teacher, from previous gatherings she had attended in support of firearm legislation aimed at reducing gun violence. The same antimask advocates at the County Commission meeting had previously gathered as counter-protesters at this prior event, heckling and threatening those advocating for improving gun safety through legislation such as background checks. While it should not be, mask wearing and the laws mandating it have become a question of politics rather than one based in scientific evidence.

The absence of mandatory masking laws in populations hesitant to wear them, combined with the rush to reopen businesses, resulted in increasing death rates in Florida, with 7-day averages continuing in an upward trajectory and over 7,000 deaths being reported as of August 3, 2020.⁸ A small glimmer of hope was raised on that day, when fewer than 100 deaths for the previous day were reported, although one wonders if the weekend’s Hurricane Isaias preparations may have delayed some reporting.

In the face of mounting death counts and increasingly stressed hospitals, Florida’s governor, Ron DeSantis, has not heeded calls to institute new regulations, instead deferring to localities. This is perhaps good news considering Georgia’s governor, Brian Kemp, has spoken out against local mask laws and has said that mandating wearing them, even at the local level, would be a “bridge too far.”⁹ Several Georgia municipalities defied the governor, passing mandatory masking for their populations anyway, prompting Governor Kemp to file a lawsuit against the city of Atlanta, which he subsequently dropped after a judge ordered the state and city into mediation.¹⁰

The idea that the state should create laws to regulate the health and safety of the population has been met with resistance in the past where there is a greater degree of libertarian and antipaternalistic thinking.¹¹ Campaigning against public health laws is not a new phenomenon. In the 1970s and 1980s, mandatory seat belt laws were met with significant resistance by a vocal minority, with the most common predictors for opposing these laws noted as holding beliefs that seat belts were ineffective, inconvenient, or uncomfortable¹²—the same arguments that have been made against masks. Additionally, having lower educational attainment, less income, and younger age were predictors of being against mandatory seat belt laws.¹²

In response to a vociferous and somewhat organized minority, which has, in many cases, intimidated state and local politicians into inaction, community organizers have put out the call for many more citizens to make their voices heard. This seemed to have had an impact on the Palm Beach County commissioners, one of whom tried to demonstrate that there was broad support for passing a mandatory masking law during the commission meeting by bringing a stack of printed-out communications he had received in favor of it. Community organizers and public health advocates generally have an easier time reaching local officials, whereas it can be more difficult to engage other government officials farther away in state capitals, especially in larger states such as Florida. The organizers can also appeal to the fact that the local officials must live in the communities they represent and do not want to suffer from the spread of SARS-CoV-2 and overflowing hospitals. While local officials may be ill equipped to handle a global pandemic, appealing to the community has been somewhat effective in putting pressure on these officials to get a patchwork of local laws, which hopefully will have an impact on Florida’s surge numbers.

In the absence of a statewide mandatory masking law in Florida, several municipalities have instituted their own restrictions. Counties with some of the largest cities, such as Miami, Fort Lauderdale, Tampa, and Orlando, have required that masks be worn in public since June or early July.¹³ These restrictions, however, were implemented later than states in the northeastern United States, which have required masks since April or May and before significant reopening of businesses took place, in contrast to the sequence observed in Florida.

In the absence of political leadership, Florida businesses are increasingly taking up the charge and mandating that employees work from home, while others are requiring that employees and customers wear masks. Following New York–based grocer Key Foods and national chains like Whole Foods, both of which have long required that Florida customers wear masks, Florida’s ubiquitous Publix Supermarkets mandated masks in over 800 of their stores beginning July 21.¹⁴

While individual businesses and localities should be commended for their efforts, unfortunately, this may not be enough to dampen the surge. A tool developed by Harvard-based researchers, has labeled Florida and several other neighboring states as having severe spread, necessitating the need for stay-at-home orders to be reinstated.¹⁵

Florida is currently a global epicenter for COVID-19 diagnoses, with the state reporting nearly 600,000 cases as of August 17,⁸ more than most countries with larger populations. Florida faces many barriers to gaining control over the virus, including a vocal and organized minority which has opposed public health measures, an unwilling state government and ill-equipped local officials, and an underfunded safety net if stay-at-home orders were to be issued. Appealing to the public and elected officials with science, sanity, and support for those who want to prevent the spread of COVID-19 may provide one solution for gaining some control over the pandemic.

The authors have nothing to disclose.

At the time this piece was written, 54 Florida hospitals reported no available intensive care unit (ICU) beds¹; hospitals in Miami-Dade County even started sending patients to neighboring Broward County for care despite Broward County also reporting a hospital bed shortage. Patients might even have needed to be transferred further north to Palm Beach County.² Miami-Dade County was diagnosing over 100 cases with SARS-CoV-2 per 100,000 residents per day at one point, with a test positivity rate of over 25% that suggests testing is inadequate and many more would-be positive tests are being missed.³ While certain parts of the United States seem to have gained some semblance of control over the novel coronavirus, Florida appears to be in a downward spiral of high infection rates and increasing hospitalizations.

It didn’t have to go this way.

According to Robert Redfield, MD, Director of the Centers for Disease Control and Prevention, wearing a mask significantly reduces SARS-CoV-2 transmission. If community masking were increased only modestly, disease transmission could be curtailed enough to prevent many stay-at-home orders and reduce losses of an estimated $1 trillion in gross domestic product⁴ while also providing incalculable improvements in morbidity and mortality. Some experts believe that, while wearing a mask can protect others, it can also protect the wearer.⁵

That masking should be universal has become the accepted public health sentiment during this pandemic. Yet at the time of writing this article, there was still no law mandating masks in Florida, perhaps due to a significant but vocal minority—those who have personal concerns about wearing a mask and little concern about transmitting the virus to other, more vulnerable populations. This was the reason that one of the authors (M.B.) campaigned tirelessly for mandatory masking at Palm Beach County Commission meetings, one of which made the international news because of the outrageous and seemingly heart-felt statements made by several antimask advocates.⁶

At the Palm Beach County Commission, organized antimask advocates arrived hours before the start of the meeting, coming in two buses. Because of social distancing guidelines and seating limitations, they were able to fill many of the open seats at the meeting, making it appear that the antimask advocates far outnumbered those in favor of mask laws. Despite their tactics of screaming and intimidation, a law mandating masks in the county passed unanimously, though medical exemptions for those with chronic obstructive pulmonary disease, asthma, or “other conditions that reduce breathing” and religious exemptions for “persons for whom wearing a facial covering conflicts with their religious beliefs or practices” were included.⁷ After the meeting, police escorts were required by those in favor of masks, while the county commissioners had to lock themselves behind chamber doors.

The antimask campaigners were already known to M.B., a teacher, from previous gatherings she had attended in support of firearm legislation aimed at reducing gun violence. The same antimask advocates at the County Commission meeting had previously gathered as counter-protesters at this prior event, heckling and threatening those advocating for improving gun safety through legislation such as background checks. While it should not be, mask wearing and the laws mandating it have become a question of politics rather than one based in scientific evidence.

The absence of mandatory masking laws in populations hesitant to wear them, combined with the rush to reopen businesses, resulted in increasing death rates in Florida, with 7-day averages continuing in an upward trajectory and over 7,000 deaths being reported as of August 3, 2020.⁸ A small glimmer of hope was raised on that day, when fewer than 100 deaths for the previous day were reported, although one wonders if the weekend’s Hurricane Isaias preparations may have delayed some reporting.

In the face of mounting death counts and increasingly stressed hospitals, Florida’s governor, Ron DeSantis, has not heeded calls to institute new regulations, instead deferring to localities. This is perhaps good news considering Georgia’s governor, Brian Kemp, has spoken out against local mask laws and has said that mandating wearing them, even at the local level, would be a “bridge too far.”⁹ Several Georgia municipalities defied the governor, passing mandatory masking for their populations anyway, prompting Governor Kemp to file a lawsuit against the city of Atlanta, which he subsequently dropped after a judge ordered the state and city into mediation.¹⁰

The idea that the state should create laws to regulate the health and safety of the population has been met with resistance in the past where there is a greater degree of libertarian and antipaternalistic thinking.¹¹ Campaigning against public health laws is not a new phenomenon. In the 1970s and 1980s, mandatory seat belt laws were met with significant resistance by a vocal minority, with the most common predictors for opposing these laws noted as holding beliefs that seat belts were ineffective, inconvenient, or uncomfortable¹²—the same arguments that have been made against masks. Additionally, having lower educational attainment, less income, and younger age were predictors of being against mandatory seat belt laws.¹²

In response to a vociferous and somewhat organized minority, which has, in many cases, intimidated state and local politicians into inaction, community organizers have put out the call for many more citizens to make their voices heard. This seemed to have had an impact on the Palm Beach County commissioners, one of whom tried to demonstrate that there was broad support for passing a mandatory masking law during the commission meeting by bringing a stack of printed-out communications he had received in favor of it. Community organizers and public health advocates generally have an easier time reaching local officials, whereas it can be more difficult to engage other government officials farther away in state capitals, especially in larger states such as Florida. The organizers can also appeal to the fact that the local officials must live in the communities they represent and do not want to suffer from the spread of SARS-CoV-2 and overflowing hospitals. While local officials may be ill equipped to handle a global pandemic, appealing to the community has been somewhat effective in putting pressure on these officials to get a patchwork of local laws, which hopefully will have an impact on Florida’s surge numbers.

In the absence of a statewide mandatory masking law in Florida, several municipalities have instituted their own restrictions. Counties with some of the largest cities, such as Miami, Fort Lauderdale, Tampa, and Orlando, have required that masks be worn in public since June or early July.¹³ These restrictions, however, were implemented later than states in the northeastern United States, which have required masks since April or May and before significant reopening of businesses took place, in contrast to the sequence observed in Florida.

In the absence of political leadership, Florida businesses are increasingly taking up the charge and mandating that employees work from home, while others are requiring that employees and customers wear masks. Following New York–based grocer Key Foods and national chains like Whole Foods, both of which have long required that Florida customers wear masks, Florida’s ubiquitous Publix Supermarkets mandated masks in over 800 of their stores beginning July 21.¹⁴

While individual businesses and localities should be commended for their efforts, unfortunately, this may not be enough to dampen the surge. A tool developed by Harvard-based researchers, has labeled Florida and several other neighboring states as having severe spread, necessitating the need for stay-at-home orders to be reinstated.¹⁵

Florida is currently a global epicenter for COVID-19 diagnoses, with the state reporting nearly 600,000 cases as of August 17,⁸ more than most countries with larger populations. Florida faces many barriers to gaining control over the virus, including a vocal and organized minority which has opposed public health measures, an unwilling state government and ill-equipped local officials, and an underfunded safety net if stay-at-home orders were to be issued. Appealing to the public and elected officials with science, sanity, and support for those who want to prevent the spread of COVID-19 may provide one solution for gaining some control over the pandemic.

The authors have nothing to disclose.

As of July 25, 2020, there had been 146,073 deaths from COVID-19 in the United States and 641,273 worldwide, with a disproportionate number of deaths occurring in historically disadvantaged minority groups, specifically African Americans.^1,2 The number of decedents will continue to increase over the coming months, even as the number of new COVID-19 cases decreases. Given that, for each death, five persons are believed to be significantly affected,³ the number of bereaved individuals whose loved ones died during the pandemic in the United States alone is likely to be in the millions.

COVID-19–related mortality has become a pressing public health issue, and as a result, support for bereaved family members, especially for minority populations, is also an important public health issue.⁴ It is likely that bereaved individuals are at greater risk of poor bereavement outcomes during the pandemic—irrespective of whether the death was a result of COVID-19—because of social isolation. This is particularly true if loved ones died in the hospital and, due to visitor restrictions, faced limited or no visitation. For many, bereavement will be affected by stay-at-home orders and social distancing restrictions that reduce access to emotional support and rituals, such as funerals, that usually provide comfort.⁵

Urgent attention is needed to support bereaved individuals, to flatten the curve of mental health disorders associated with the death of loved ones during the pandemic. Within a preventive model of care, we offer guidelines for how hospitals, longitudinal providers, and mental health clinicians can provide bereavement outreach to all individuals whose loved ones died during the COVID-19 pandemic.

The provision of bereavement care, including the assessment of risk for poor bereavement outcomes, is an essential component of high-quality end-of-life care endorsed by the hospice and palliative care movement.⁶ However, the development of standardized bereavement services has lagged behind that of other components of palliative care, varying greatly by institution and provider.⁷ Approximately 10% to 20% of bereaved individuals experience psychiatric difficulties following the death of a loved one, including prolonged grief disorder, posttraumatic stress disorder, and major depressive disorder.⁸ Risk factors include a hospital-based death, death in an intensive care unit (ICU), sudden death, not being able to say goodbye, and a history of psychiatric disorders.^8,9

One of the biggest barriers in providing standardized bereavement services is the lack of a systematic process to identify individuals at risk of poor bereavement outcomes.¹⁰ Aoun et al developed a public health model of bereavement support that comprises a three-tiered approach to risk and the corresponding need for support.¹¹ They propose that the low-risk group, approximately 60% of bereaved individuals, would primarily need support from family and friends, the moderate-risk group (30%) would need support from the wider community, and the high-risk group (10%) would need support from mental health providers.

It is reasonable to assume that many individuals whose loved ones died during the pandemic will fall into a high-risk group for poor bereavement outcomes, as identified by Aoun et al.¹¹ Given a higher than usual inpatient mortality due to COVID-19 for certain populations and that bereavement care is already underrecognized within healthcare systems, hospitals and other healthcare facilities and their providers need to fill this void.

We adopted an education, guidance, and support model of bereavement support in 2019.⁷ This model has been shown to positively affect the experience of bereaved individuals, especially because of condolences from providers and psycho-educational information about coping with grief.⁷ Each month, a list of deceased patients and family contacts is generated from a mortality review database,¹² and bereavement packets are mailed to family members; the packet includes a condolence letter from senior management, a psycho-educational grief guide, and a list of community-based resources. A social worker is also available to provide telephone support and to assist with mental health referrals. For patients who died in the COVID-19–specific units, social work also provides support and outreach to families.

Psycho-Education

During the early weeks of the pandemic, a tip sheet—”Grieving during a pandemic”¹³— was created to include in the bereavement packet and for distribution to community organizations within the hospital’s geographical area. This tip sheet offers strategies to facilitate coping based on the psychological model of cognitive-behavioral therapy (CBT).¹⁴ Topics addressed include understanding the nature of grief, self-care, adapting bereavement rituals in light of social distancing, challenging unhelpful thinking patterns that might lead to feelings of guilt especially regarding the death of the patient, and ways to obtain support during the pandemic. The tip sheet was made available in Spanish, French, Chinese, Haitian Creole, Portuguese, Arabic, and Russian given that our mortality data, consistent with preliminary findings from New York State, suggested higher death rates among Black/African American and Hispanic/Latino groups, compared with historical mortality statistics.¹⁵

Virtual Support

As part of our bereavement response during the COVID-19 crisis, we have launched virtual bereavement support for families impacted by the pandemic. It is challenging to identify the optimal type of support and timing, given the reliance on virtual outreach without in-person screening. With the increased distress and trauma associated with deaths during the pandemic, one clinical challenge is managing emotions in a virtual group without access to the usual tools that clinicians rely on, such as reading body language. Following a graded exposure approach, a form of behavioral therapy,¹⁴ we recommend offering a psycho-educational seminar first in which facilitators can control the content and limit exposure of sharing stories from participants. For support groups (eg, 6 to 8 sessions), we recommend that participants be screened prior to assess their risk factors and readiness and provide individual therapist referrals as needed.¹⁰

Community Outreach

Many diverse communities have been affected significantly by COVID-19 and faced high mortality rates.¹⁶ We recognized that proactive bereavement outreach to these communities was essential. Grief guides and tip sheets in various languages were made available as part of our community outreach programs, which included vans traveling to severely affected communities and providing testing, masks, alcohol-based hand sanitizer, and written materials.

Education About Bereavement

Many clinicians and staff express feelings of inadequacy about providing bereavement outreach. Such feelings are not uncommon, especially because clinicians tend to receive little training in dealing with the emotional toll of patient deaths and bereavement care.^17,18 These feelings are likely to be heightened during this pandemic given the increased exposure to patient deaths, concern for personal safety, and changed practices in providing care, including the need to socially distance. Providing support for clinicians to process their feelings about the death of patients is crucial.¹⁹ In addition to our Employee Assistance Program, psychosocial clinicians are facilitating weekly virtual support groups for providers to discuss the effects of the pandemic on their personal and professional lives.

Bereaved family members report they benefit from hearing from the clinical team and receiving condolences, which is seen as humanizing the physician-family relationship. This personal outreach is likely more important during this time because many providers will have interacted with family members virtually.^7,20,21 To help facilitate offers of condolences, we developed the TEARS acronym to describe the components of a condolence call that can also be adapted for writing condolence cards (Table).

We recommend that hospitals and other healthcare facilities that might not have well-established bereavement programs consider adopting a building block approach to provide basic outreach to families of their deceased patients.⁷ Tapping into existing resources, the major components are as follows: (1) a letter of condolence from leadership, (2) psycho-educational information about grief, (3) a list of community/online resources, including information about local hospice bereavement programs and bereavement camps or programs for children, (4) offers of condolences from individual providers/teams, and (5) mental health outreach as indicated.

The COVID-19–related mortality, particularly among already vulnerable populations, coupled with the existing underrecognition of bereavement has created an urgent public health issue that needs to be addressed. Given that few institutions offer standardized bereavement follow-up, we believe that hospital providers and mental health clinicians need to take a proactive approach to providing bereavement outreach to families affected by death during the pandemic.

The authors would like to acknowledge the Brigham Health Bereavement Committee and the staff of Care Continuum Management and the Department of Community Outreach at Brigham and Women’s Hospital.

No competing financial interests relevant to this article exist for Dr Morris, Ms Paterson, and Dr Mendu. Dr Morris receives royalties for two self-help books about grief published by Robinson and Dr Mendu provides consulting services for Bayer AG unrelated to the content of this article.

As of July 25, 2020, there had been 146,073 deaths from COVID-19 in the United States and 641,273 worldwide, with a disproportionate number of deaths occurring in historically disadvantaged minority groups, specifically African Americans.^1,2 The number of decedents will continue to increase over the coming months, even as the number of new COVID-19 cases decreases. Given that, for each death, five persons are believed to be significantly affected,³ the number of bereaved individuals whose loved ones died during the pandemic in the United States alone is likely to be in the millions.

COVID-19–related mortality has become a pressing public health issue, and as a result, support for bereaved family members, especially for minority populations, is also an important public health issue.⁴ It is likely that bereaved individuals are at greater risk of poor bereavement outcomes during the pandemic—irrespective of whether the death was a result of COVID-19—because of social isolation. This is particularly true if loved ones died in the hospital and, due to visitor restrictions, faced limited or no visitation. For many, bereavement will be affected by stay-at-home orders and social distancing restrictions that reduce access to emotional support and rituals, such as funerals, that usually provide comfort.⁵

Urgent attention is needed to support bereaved individuals, to flatten the curve of mental health disorders associated with the death of loved ones during the pandemic. Within a preventive model of care, we offer guidelines for how hospitals, longitudinal providers, and mental health clinicians can provide bereavement outreach to all individuals whose loved ones died during the COVID-19 pandemic.

The provision of bereavement care, including the assessment of risk for poor bereavement outcomes, is an essential component of high-quality end-of-life care endorsed by the hospice and palliative care movement.⁶ However, the development of standardized bereavement services has lagged behind that of other components of palliative care, varying greatly by institution and provider.⁷ Approximately 10% to 20% of bereaved individuals experience psychiatric difficulties following the death of a loved one, including prolonged grief disorder, posttraumatic stress disorder, and major depressive disorder.⁸ Risk factors include a hospital-based death, death in an intensive care unit (ICU), sudden death, not being able to say goodbye, and a history of psychiatric disorders.^8,9

One of the biggest barriers in providing standardized bereavement services is the lack of a systematic process to identify individuals at risk of poor bereavement outcomes.¹⁰ Aoun et al developed a public health model of bereavement support that comprises a three-tiered approach to risk and the corresponding need for support.¹¹ They propose that the low-risk group, approximately 60% of bereaved individuals, would primarily need support from family and friends, the moderate-risk group (30%) would need support from the wider community, and the high-risk group (10%) would need support from mental health providers.

It is reasonable to assume that many individuals whose loved ones died during the pandemic will fall into a high-risk group for poor bereavement outcomes, as identified by Aoun et al.¹¹ Given a higher than usual inpatient mortality due to COVID-19 for certain populations and that bereavement care is already underrecognized within healthcare systems, hospitals and other healthcare facilities and their providers need to fill this void.

We adopted an education, guidance, and support model of bereavement support in 2019.⁷ This model has been shown to positively affect the experience of bereaved individuals, especially because of condolences from providers and psycho-educational information about coping with grief.⁷ Each month, a list of deceased patients and family contacts is generated from a mortality review database,¹² and bereavement packets are mailed to family members; the packet includes a condolence letter from senior management, a psycho-educational grief guide, and a list of community-based resources. A social worker is also available to provide telephone support and to assist with mental health referrals. For patients who died in the COVID-19–specific units, social work also provides support and outreach to families.

Psycho-Education

During the early weeks of the pandemic, a tip sheet—”Grieving during a pandemic”¹³— was created to include in the bereavement packet and for distribution to community organizations within the hospital’s geographical area. This tip sheet offers strategies to facilitate coping based on the psychological model of cognitive-behavioral therapy (CBT).¹⁴ Topics addressed include understanding the nature of grief, self-care, adapting bereavement rituals in light of social distancing, challenging unhelpful thinking patterns that might lead to feelings of guilt especially regarding the death of the patient, and ways to obtain support during the pandemic. The tip sheet was made available in Spanish, French, Chinese, Haitian Creole, Portuguese, Arabic, and Russian given that our mortality data, consistent with preliminary findings from New York State, suggested higher death rates among Black/African American and Hispanic/Latino groups, compared with historical mortality statistics.¹⁵

Virtual Support

As part of our bereavement response during the COVID-19 crisis, we have launched virtual bereavement support for families impacted by the pandemic. It is challenging to identify the optimal type of support and timing, given the reliance on virtual outreach without in-person screening. With the increased distress and trauma associated with deaths during the pandemic, one clinical challenge is managing emotions in a virtual group without access to the usual tools that clinicians rely on, such as reading body language. Following a graded exposure approach, a form of behavioral therapy,¹⁴ we recommend offering a psycho-educational seminar first in which facilitators can control the content and limit exposure of sharing stories from participants. For support groups (eg, 6 to 8 sessions), we recommend that participants be screened prior to assess their risk factors and readiness and provide individual therapist referrals as needed.¹⁰

Community Outreach

Many diverse communities have been affected significantly by COVID-19 and faced high mortality rates.¹⁶ We recognized that proactive bereavement outreach to these communities was essential. Grief guides and tip sheets in various languages were made available as part of our community outreach programs, which included vans traveling to severely affected communities and providing testing, masks, alcohol-based hand sanitizer, and written materials.

Education About Bereavement

Many clinicians and staff express feelings of inadequacy about providing bereavement outreach. Such feelings are not uncommon, especially because clinicians tend to receive little training in dealing with the emotional toll of patient deaths and bereavement care.^17,18 These feelings are likely to be heightened during this pandemic given the increased exposure to patient deaths, concern for personal safety, and changed practices in providing care, including the need to socially distance. Providing support for clinicians to process their feelings about the death of patients is crucial.¹⁹ In addition to our Employee Assistance Program, psychosocial clinicians are facilitating weekly virtual support groups for providers to discuss the effects of the pandemic on their personal and professional lives.

Bereaved family members report they benefit from hearing from the clinical team and receiving condolences, which is seen as humanizing the physician-family relationship. This personal outreach is likely more important during this time because many providers will have interacted with family members virtually.^7,20,21 To help facilitate offers of condolences, we developed the TEARS acronym to describe the components of a condolence call that can also be adapted for writing condolence cards (Table).

We recommend that hospitals and other healthcare facilities that might not have well-established bereavement programs consider adopting a building block approach to provide basic outreach to families of their deceased patients.⁷ Tapping into existing resources, the major components are as follows: (1) a letter of condolence from leadership, (2) psycho-educational information about grief, (3) a list of community/online resources, including information about local hospice bereavement programs and bereavement camps or programs for children, (4) offers of condolences from individual providers/teams, and (5) mental health outreach as indicated.

The COVID-19–related mortality, particularly among already vulnerable populations, coupled with the existing underrecognition of bereavement has created an urgent public health issue that needs to be addressed. Given that few institutions offer standardized bereavement follow-up, we believe that hospital providers and mental health clinicians need to take a proactive approach to providing bereavement outreach to families affected by death during the pandemic.

The authors would like to acknowledge the Brigham Health Bereavement Committee and the staff of Care Continuum Management and the Department of Community Outreach at Brigham and Women’s Hospital.

No competing financial interests relevant to this article exist for Dr Morris, Ms Paterson, and Dr Mendu. Dr Morris receives royalties for two self-help books about grief published by Robinson and Dr Mendu provides consulting services for Bayer AG unrelated to the content of this article.

As of July 25, 2020, there had been 146,073 deaths from COVID-19 in the United States and 641,273 worldwide, with a disproportionate number of deaths occurring in historically disadvantaged minority groups, specifically African Americans.^1,2 The number of decedents will continue to increase over the coming months, even as the number of new COVID-19 cases decreases. Given that, for each death, five persons are believed to be significantly affected,³ the number of bereaved individuals whose loved ones died during the pandemic in the United States alone is likely to be in the millions.

COVID-19–related mortality has become a pressing public health issue, and as a result, support for bereaved family members, especially for minority populations, is also an important public health issue.⁴ It is likely that bereaved individuals are at greater risk of poor bereavement outcomes during the pandemic—irrespective of whether the death was a result of COVID-19—because of social isolation. This is particularly true if loved ones died in the hospital and, due to visitor restrictions, faced limited or no visitation. For many, bereavement will be affected by stay-at-home orders and social distancing restrictions that reduce access to emotional support and rituals, such as funerals, that usually provide comfort.⁵

Urgent attention is needed to support bereaved individuals, to flatten the curve of mental health disorders associated with the death of loved ones during the pandemic. Within a preventive model of care, we offer guidelines for how hospitals, longitudinal providers, and mental health clinicians can provide bereavement outreach to all individuals whose loved ones died during the COVID-19 pandemic.

The provision of bereavement care, including the assessment of risk for poor bereavement outcomes, is an essential component of high-quality end-of-life care endorsed by the hospice and palliative care movement.⁶ However, the development of standardized bereavement services has lagged behind that of other components of palliative care, varying greatly by institution and provider.⁷ Approximately 10% to 20% of bereaved individuals experience psychiatric difficulties following the death of a loved one, including prolonged grief disorder, posttraumatic stress disorder, and major depressive disorder.⁸ Risk factors include a hospital-based death, death in an intensive care unit (ICU), sudden death, not being able to say goodbye, and a history of psychiatric disorders.^8,9

One of the biggest barriers in providing standardized bereavement services is the lack of a systematic process to identify individuals at risk of poor bereavement outcomes.¹⁰ Aoun et al developed a public health model of bereavement support that comprises a three-tiered approach to risk and the corresponding need for support.¹¹ They propose that the low-risk group, approximately 60% of bereaved individuals, would primarily need support from family and friends, the moderate-risk group (30%) would need support from the wider community, and the high-risk group (10%) would need support from mental health providers.

It is reasonable to assume that many individuals whose loved ones died during the pandemic will fall into a high-risk group for poor bereavement outcomes, as identified by Aoun et al.¹¹ Given a higher than usual inpatient mortality due to COVID-19 for certain populations and that bereavement care is already underrecognized within healthcare systems, hospitals and other healthcare facilities and their providers need to fill this void.

We adopted an education, guidance, and support model of bereavement support in 2019.⁷ This model has been shown to positively affect the experience of bereaved individuals, especially because of condolences from providers and psycho-educational information about coping with grief.⁷ Each month, a list of deceased patients and family contacts is generated from a mortality review database,¹² and bereavement packets are mailed to family members; the packet includes a condolence letter from senior management, a psycho-educational grief guide, and a list of community-based resources. A social worker is also available to provide telephone support and to assist with mental health referrals. For patients who died in the COVID-19–specific units, social work also provides support and outreach to families.

Psycho-Education

During the early weeks of the pandemic, a tip sheet—”Grieving during a pandemic”¹³— was created to include in the bereavement packet and for distribution to community organizations within the hospital’s geographical area. This tip sheet offers strategies to facilitate coping based on the psychological model of cognitive-behavioral therapy (CBT).¹⁴ Topics addressed include understanding the nature of grief, self-care, adapting bereavement rituals in light of social distancing, challenging unhelpful thinking patterns that might lead to feelings of guilt especially regarding the death of the patient, and ways to obtain support during the pandemic. The tip sheet was made available in Spanish, French, Chinese, Haitian Creole, Portuguese, Arabic, and Russian given that our mortality data, consistent with preliminary findings from New York State, suggested higher death rates among Black/African American and Hispanic/Latino groups, compared with historical mortality statistics.¹⁵

Virtual Support

As part of our bereavement response during the COVID-19 crisis, we have launched virtual bereavement support for families impacted by the pandemic. It is challenging to identify the optimal type of support and timing, given the reliance on virtual outreach without in-person screening. With the increased distress and trauma associated with deaths during the pandemic, one clinical challenge is managing emotions in a virtual group without access to the usual tools that clinicians rely on, such as reading body language. Following a graded exposure approach, a form of behavioral therapy,¹⁴ we recommend offering a psycho-educational seminar first in which facilitators can control the content and limit exposure of sharing stories from participants. For support groups (eg, 6 to 8 sessions), we recommend that participants be screened prior to assess their risk factors and readiness and provide individual therapist referrals as needed.¹⁰

Community Outreach

Many diverse communities have been affected significantly by COVID-19 and faced high mortality rates.¹⁶ We recognized that proactive bereavement outreach to these communities was essential. Grief guides and tip sheets in various languages were made available as part of our community outreach programs, which included vans traveling to severely affected communities and providing testing, masks, alcohol-based hand sanitizer, and written materials.

Education About Bereavement

Many clinicians and staff express feelings of inadequacy about providing bereavement outreach. Such feelings are not uncommon, especially because clinicians tend to receive little training in dealing with the emotional toll of patient deaths and bereavement care.^17,18 These feelings are likely to be heightened during this pandemic given the increased exposure to patient deaths, concern for personal safety, and changed practices in providing care, including the need to socially distance. Providing support for clinicians to process their feelings about the death of patients is crucial.¹⁹ In addition to our Employee Assistance Program, psychosocial clinicians are facilitating weekly virtual support groups for providers to discuss the effects of the pandemic on their personal and professional lives.

Bereaved family members report they benefit from hearing from the clinical team and receiving condolences, which is seen as humanizing the physician-family relationship. This personal outreach is likely more important during this time because many providers will have interacted with family members virtually.^7,20,21 To help facilitate offers of condolences, we developed the TEARS acronym to describe the components of a condolence call that can also be adapted for writing condolence cards (Table).

We recommend that hospitals and other healthcare facilities that might not have well-established bereavement programs consider adopting a building block approach to provide basic outreach to families of their deceased patients.⁷ Tapping into existing resources, the major components are as follows: (1) a letter of condolence from leadership, (2) psycho-educational information about grief, (3) a list of community/online resources, including information about local hospice bereavement programs and bereavement camps or programs for children, (4) offers of condolences from individual providers/teams, and (5) mental health outreach as indicated.

The COVID-19–related mortality, particularly among already vulnerable populations, coupled with the existing underrecognition of bereavement has created an urgent public health issue that needs to be addressed. Given that few institutions offer standardized bereavement follow-up, we believe that hospital providers and mental health clinicians need to take a proactive approach to providing bereavement outreach to families affected by death during the pandemic.

The authors would like to acknowledge the Brigham Health Bereavement Committee and the staff of Care Continuum Management and the Department of Community Outreach at Brigham and Women’s Hospital.

No competing financial interests relevant to this article exist for Dr Morris, Ms Paterson, and Dr Mendu. Dr Morris receives royalties for two self-help books about grief published by Robinson and Dr Mendu provides consulting services for Bayer AG unrelated to the content of this article.

Febrile infants 60 days of age or younger pose a significant diagnostic challenge for clinicians. Most of these infants are well appearing and do not have localizing signs or symptoms of infection, yet they may have serious bacterial infections (SBI) such as urinary tract infection (UTI), bacteremia, and meningitis. While urinalysis is highly sensitive for predicting UTI,¹ older clinical decision rules and biomarkers such as white blood cell (WBC) count, absolute neutrophil count (ANC), and C-reactive protein (CRP) lack both appropriate sensitivity and specificity for identifying bacteremia and meningitis (ie, invasive bacterial infection [IBI]),^2,3 which affect approximately 2.4% and 0.9% of febrile infants during the first 2 months of life, respectively.⁴ The lack of accurate diagnostic markers can drive overuse of laboratory testing, antibiotics, and hospitalization despite the low rates of these infections. As a result, procalcitonin (PCT) has generated interest because of its potential to serve as a more accurate biomarker for bacterial infections. This review summarizes recent literature on the diagnostic utility of PCT in the identification of IBI in febrile young infants 60 days or younger.

Procalcitonin is undetectable in noninflammatory states but can be detected in the blood within 4 to 6 hours after initial bacterial infection.⁵ Its production is stimulated throughout various tissues of the body by cytokines such as interleukin-6 and tumor necrosis factor, which are produced in response to bacterial infections. Interferon-γ, which is produced in response to viral infections, attenuates PCT production. While these characteristics suggest promise for PCT as a more specific screening test for underlying bacterial infection, there are caveats. PCT levels are physiologically elevated in the first 48 hours of life and vary with gestational age, factors that should be considered when interpreting results.⁶ Additionally, PCT levels can rise in other inflammatory states such as autoimmune conditions and certain malignancies,⁵ though these states are unlikely to confound the evaluation of febrile young infants.

Because of PCT’s potential to be more specific than other commonly used biomarkers, multiple studies have evaluated its performance characteristics in febrile young infants. Gomez et al retrospectively evaluated 1,112 well-appearing infants younger than 3 months with fever without a source in seven European emergency departments (EDs).⁷ Overall, 23 infants (2.1%) had IBI (1 with meningitis). A PCT level of 0.5 ng/mL or greater was the only independent risk factor for IBI (adjusted odds ratio, 21.69; 95% CI, 7.93-59.28). Four infants with IBI had a PCT level less than 0.5 ng/mL, and none of these four had meningitis. PCT was superior to CRP, ANC, and WBC in detecting IBI (area under the curve [AUC], 0.825; 95% CI, 0.698-0.952). PCT was the also the best marker for identifying IBI among 451 infants with a normal urine dipstick and fever detected ≤6 hours before presentation (AUC, 0.819; 95% CI, 0.551-1.087).

In the largest prospective study to date evaluating the diagnostic accuracy of PCT in febrile young infants, Milcent et al studied 2,047 previously healthy infants aged 7-91 days admitted for fever from 15 French EDs.⁸ In total, 21 (1%) had an IBI (8 with meningitis). PCT performed better than CRP, ANC, and WBC for the detection of IBI with an AUC of 0.91 (95% CI, 0.83-0.99). In a multivariable model, a PCT level of 0.3 ng/mL or greater was the only independent risk factor for IBI with an adjusted odds ratio of 40.3 (95% CI, 5.0-332). Only one infant with IBI had a PCT level less than 0.3 ng/mL. This infant was 83 days old, had 4 hours of fever, and became afebrile spontaneously prior to the blood culture revealing Streptococcus pneumoniae. PCT also performed better than CRP in the detection of IBI in infants 7-30 days of age and those with fever for less than 6 hours, though both subgroups had small numbers of infants with IBI. The authors determined that a PCT level of 0.3 ng/mL was the optimal cutoff for ruling out IBI; this cutoff had a sensitivity of 90% and negative likelihood ratio (LR) of 0.1 (Table). In contrast, the more commonly studied PCT cutoff of 0.5 ng/mL increased the negative LR to 0.2. The authors suggested that PCT, when used in the context of history, exam, and tests such as urinalysis, could identify infants at low risk of IBI.

Gomez et al conducted a prospective, single-center study of well-appearing infants with fever without a source and negative urine dipsticks.⁹ They identified IBI in 9 of 196 infants (4.5%) 21 days or younger and 13 of 1,331 infants (1.0%) 22-90 days old. PCT was superior to CRP and ANC for IBI detection in both age groups. However, in infants 21 days or younger, both the positive and negative LRs for PCT levels of 0.5 ng/mL or greater were poor (Table). Differences in results from the prior two studies^7,8 may be related to smaller sample size and differences in patient population because this study included infants younger than 7 days and a higher proportion of infants presenting within 6 hours of fever.

PCT has also been incorporated into clinical decision rules for febrile young infants, primarily to identify those at low risk of either IBI or SBI. The Step-by-Step approach¹⁰ classified well-appearing febrile infants 90 days or younger as having a high risk of IBI if they were ill appearing, younger than 21 days old, had a positive urine dipstick or a PCT level of 0.5 ng/mL or greater, and classified them as intermediate risk if they had a CRP level greater than 20 mg/L or ANC level greater than 10,000/µL. The remaining infants were classified as low risk and could be managed as outpatients without lumbar puncture or empiric antibiotics. Of note, derivation of this rule excluded patients with respiratory signs or symptoms. In a prospective validation study with 2,185 infants from 11 European EDs, 87 (4.0%) had an IBI (10 with bacterial meningitis). Sequentially identifying patients as high risk using general appearance, age, and urine dipstick alone identified 80% of infants with IBI and 90% of those with bacterial meningitis. The remaining case of meningitis would have been detected by an elevated PCT. A total of 7 of 991 infants (0.7%) classified as low risk had an IBI and none had meningitis. Six of these infants had a fever duration of less than 2 hours, which would not be enough time for PCT to rise. The Step-by-Step approach, with a sensitivity of 92% and negative LR of 0.17, performed well in the ability to rule out IBI.

A clinical prediction rule developed by the Pediatric Emergency Care Applied Research Network (PECARN) found that urinalysis, ANC, and PCT performed well in identifying infants 60 days or younger at low risk for SBI and IBI.¹¹ This prospective observational study of 1,821 infants 60 days or younger in 26 US EDs found 170 (9.3%) with SBI and 30 (1.6%) with IBI; 10 had bacterial meningitis. Only one patient with IBI was classified as low risk, a 30-day-old whose blood culture grew Enterobacter cloacae and who had a negative repeat blood culture prior to antibiotic treatment. Together, a negative urinalysis, ANC of 4,090/µL or less, and PCT level of 1.71 ng/mL or less were excellent in predicting infants at low risk for both SBI and IBI, with a sensitivity of 97% and negative LR of 0.05 for the outcome of IBI. When applying these variables with “rounded cutoffs” of PCT levels less than 0.5 ng/mL (chosen by the authors because it is a more commonly used cutoff) and ANC of 4,000/µL or less to identify infants at low risk for SBI, their performance was similar to nonrounded cutoffs. Data for the rule with rounded cutoffs in identifying infants at low risk for IBI were not presented. The PECARN study was limited by the small numbers of infants with IBIs, and the authors recommended caution when applying the rule to infants 28 days or younger.

Older clinical decision rules without PCT, such as the Rochester and modified Philadelphia criteria, use clinical and laboratory features to assess risk of IBI.³ Recent studies have evaluated these criteria in cohorts with larger numbers of infants with IBI since the derivation studies included mostly infants with SBI and small numbers with IBI.³ Gomez et al demonstrated that the Rochester criteria had lower sensitivity and higher negative LR than the Step-by-Step approach in IBI detection.¹⁰ In a case-control study of 135 cases of IBI with 249 matched controls, Aronson et al reported that the modified Philadelphia criteria had higher sensitivity but lower specificity than the Rochester criteria for IBI detection.¹² The ability of the Rochester and modified Philadelphia criteria to rule out IBI, as demonstrated by the negative LR (range 0.2-0.4), was inferior to the negative LRs documented by Milcent et al⁸ (PCT cutoff value of 0.3 ng/mL), the Step-by-Step approach,¹⁰ and the PECARN rule¹¹ (range 0.05-0.17; Table). However, clinical decision rules with and without PCT suffer similar limitations in having poor specificity in identifying infants likely to have IBI.

Several key knowledge gaps around PCT use for diagnosing neonatal infections exist. First, the optimal use of PCT in context with other biomarkers and clinical decision rules remains uncertain. A meta-analysis of 28 studies involving over 2,600 infants that compared PCT level (with and without CRP) with isolated CRP and presepsin levels found that PCT in combination with CRP had greater diagnostic accuracy than either PCT or CRP alone, which highlights a potential opportunity for prospective study.¹³ Second, more data are needed on the use of PCT in the ≤ 28-day age group given the increased risk of both IBI and neonatal herpes simplex virus infection (HSV), compared with that in the second month of life. Neonatal HSV poses diagnostic challenges because half of infants will initially present as afebrile,¹⁴ and delays in initiating antiviral treatment dramatically increase the risk of permanent disability or death.¹⁵ There have been no prospective studies evaluating PCT use as part of neonatal HSV evaluations.

In summary, PCT can play an important adjunctive diagnostic role in the evaluation of febrile young infants, especially during the second month of life when outpatient management is more likely to be considered. PCT is superior to other inflammatory markers in identifying IBI, though the optimal cutoffs to maximize sensitivity and specificity are uncertain. Its performance characteristics, both alone and within clinical decision rules, can help clinicians better identify children at low risk for IBI when compared with clinical decision rules without PCT. PCT measurement can help clinicians miss fewer infants with IBI and identify infants for whom safely doing less is an appropriate option, which can ultimately reduce costs and hospitalizations. PCT may be particularly helpful when the clinical history is difficult to assess or when other diagnostic test results are missing or give conflicting results. Centers that use PCT will need to ensure that results are available within a short turnaround time (a few hours) in order to meaningfully affect care. Future studies of PCT in febrile infant evaluations should focus on identifying optimal strategies for incorporating this biomarker into risk assessments that present information to parents in a way that enables them to understand their child’s risk of a serious infection.

Febrile infants 60 days of age or younger pose a significant diagnostic challenge for clinicians. Most of these infants are well appearing and do not have localizing signs or symptoms of infection, yet they may have serious bacterial infections (SBI) such as urinary tract infection (UTI), bacteremia, and meningitis. While urinalysis is highly sensitive for predicting UTI,¹ older clinical decision rules and biomarkers such as white blood cell (WBC) count, absolute neutrophil count (ANC), and C-reactive protein (CRP) lack both appropriate sensitivity and specificity for identifying bacteremia and meningitis (ie, invasive bacterial infection [IBI]),^2,3 which affect approximately 2.4% and 0.9% of febrile infants during the first 2 months of life, respectively.⁴ The lack of accurate diagnostic markers can drive overuse of laboratory testing, antibiotics, and hospitalization despite the low rates of these infections. As a result, procalcitonin (PCT) has generated interest because of its potential to serve as a more accurate biomarker for bacterial infections. This review summarizes recent literature on the diagnostic utility of PCT in the identification of IBI in febrile young infants 60 days or younger.

Procalcitonin is undetectable in noninflammatory states but can be detected in the blood within 4 to 6 hours after initial bacterial infection.⁵ Its production is stimulated throughout various tissues of the body by cytokines such as interleukin-6 and tumor necrosis factor, which are produced in response to bacterial infections. Interferon-γ, which is produced in response to viral infections, attenuates PCT production. While these characteristics suggest promise for PCT as a more specific screening test for underlying bacterial infection, there are caveats. PCT levels are physiologically elevated in the first 48 hours of life and vary with gestational age, factors that should be considered when interpreting results.⁶ Additionally, PCT levels can rise in other inflammatory states such as autoimmune conditions and certain malignancies,⁵ though these states are unlikely to confound the evaluation of febrile young infants.

Because of PCT’s potential to be more specific than other commonly used biomarkers, multiple studies have evaluated its performance characteristics in febrile young infants. Gomez et al retrospectively evaluated 1,112 well-appearing infants younger than 3 months with fever without a source in seven European emergency departments (EDs).⁷ Overall, 23 infants (2.1%) had IBI (1 with meningitis). A PCT level of 0.5 ng/mL or greater was the only independent risk factor for IBI (adjusted odds ratio, 21.69; 95% CI, 7.93-59.28). Four infants with IBI had a PCT level less than 0.5 ng/mL, and none of these four had meningitis. PCT was superior to CRP, ANC, and WBC in detecting IBI (area under the curve [AUC], 0.825; 95% CI, 0.698-0.952). PCT was the also the best marker for identifying IBI among 451 infants with a normal urine dipstick and fever detected ≤6 hours before presentation (AUC, 0.819; 95% CI, 0.551-1.087).

In the largest prospective study to date evaluating the diagnostic accuracy of PCT in febrile young infants, Milcent et al studied 2,047 previously healthy infants aged 7-91 days admitted for fever from 15 French EDs.⁸ In total, 21 (1%) had an IBI (8 with meningitis). PCT performed better than CRP, ANC, and WBC for the detection of IBI with an AUC of 0.91 (95% CI, 0.83-0.99). In a multivariable model, a PCT level of 0.3 ng/mL or greater was the only independent risk factor for IBI with an adjusted odds ratio of 40.3 (95% CI, 5.0-332). Only one infant with IBI had a PCT level less than 0.3 ng/mL. This infant was 83 days old, had 4 hours of fever, and became afebrile spontaneously prior to the blood culture revealing Streptococcus pneumoniae. PCT also performed better than CRP in the detection of IBI in infants 7-30 days of age and those with fever for less than 6 hours, though both subgroups had small numbers of infants with IBI. The authors determined that a PCT level of 0.3 ng/mL was the optimal cutoff for ruling out IBI; this cutoff had a sensitivity of 90% and negative likelihood ratio (LR) of 0.1 (Table). In contrast, the more commonly studied PCT cutoff of 0.5 ng/mL increased the negative LR to 0.2. The authors suggested that PCT, when used in the context of history, exam, and tests such as urinalysis, could identify infants at low risk of IBI.

Gomez et al conducted a prospective, single-center study of well-appearing infants with fever without a source and negative urine dipsticks.⁹ They identified IBI in 9 of 196 infants (4.5%) 21 days or younger and 13 of 1,331 infants (1.0%) 22-90 days old. PCT was superior to CRP and ANC for IBI detection in both age groups. However, in infants 21 days or younger, both the positive and negative LRs for PCT levels of 0.5 ng/mL or greater were poor (Table). Differences in results from the prior two studies^7,8 may be related to smaller sample size and differences in patient population because this study included infants younger than 7 days and a higher proportion of infants presenting within 6 hours of fever.

PCT has also been incorporated into clinical decision rules for febrile young infants, primarily to identify those at low risk of either IBI or SBI. The Step-by-Step approach¹⁰ classified well-appearing febrile infants 90 days or younger as having a high risk of IBI if they were ill appearing, younger than 21 days old, had a positive urine dipstick or a PCT level of 0.5 ng/mL or greater, and classified them as intermediate risk if they had a CRP level greater than 20 mg/L or ANC level greater than 10,000/µL. The remaining infants were classified as low risk and could be managed as outpatients without lumbar puncture or empiric antibiotics. Of note, derivation of this rule excluded patients with respiratory signs or symptoms. In a prospective validation study with 2,185 infants from 11 European EDs, 87 (4.0%) had an IBI (10 with bacterial meningitis). Sequentially identifying patients as high risk using general appearance, age, and urine dipstick alone identified 80% of infants with IBI and 90% of those with bacterial meningitis. The remaining case of meningitis would have been detected by an elevated PCT. A total of 7 of 991 infants (0.7%) classified as low risk had an IBI and none had meningitis. Six of these infants had a fever duration of less than 2 hours, which would not be enough time for PCT to rise. The Step-by-Step approach, with a sensitivity of 92% and negative LR of 0.17, performed well in the ability to rule out IBI.

A clinical prediction rule developed by the Pediatric Emergency Care Applied Research Network (PECARN) found that urinalysis, ANC, and PCT performed well in identifying infants 60 days or younger at low risk for SBI and IBI.¹¹ This prospective observational study of 1,821 infants 60 days or younger in 26 US EDs found 170 (9.3%) with SBI and 30 (1.6%) with IBI; 10 had bacterial meningitis. Only one patient with IBI was classified as low risk, a 30-day-old whose blood culture grew Enterobacter cloacae and who had a negative repeat blood culture prior to antibiotic treatment. Together, a negative urinalysis, ANC of 4,090/µL or less, and PCT level of 1.71 ng/mL or less were excellent in predicting infants at low risk for both SBI and IBI, with a sensitivity of 97% and negative LR of 0.05 for the outcome of IBI. When applying these variables with “rounded cutoffs” of PCT levels less than 0.5 ng/mL (chosen by the authors because it is a more commonly used cutoff) and ANC of 4,000/µL or less to identify infants at low risk for SBI, their performance was similar to nonrounded cutoffs. Data for the rule with rounded cutoffs in identifying infants at low risk for IBI were not presented. The PECARN study was limited by the small numbers of infants with IBIs, and the authors recommended caution when applying the rule to infants 28 days or younger.

Older clinical decision rules without PCT, such as the Rochester and modified Philadelphia criteria, use clinical and laboratory features to assess risk of IBI.³ Recent studies have evaluated these criteria in cohorts with larger numbers of infants with IBI since the derivation studies included mostly infants with SBI and small numbers with IBI.³ Gomez et al demonstrated that the Rochester criteria had lower sensitivity and higher negative LR than the Step-by-Step approach in IBI detection.¹⁰ In a case-control study of 135 cases of IBI with 249 matched controls, Aronson et al reported that the modified Philadelphia criteria had higher sensitivity but lower specificity than the Rochester criteria for IBI detection.¹² The ability of the Rochester and modified Philadelphia criteria to rule out IBI, as demonstrated by the negative LR (range 0.2-0.4), was inferior to the negative LRs documented by Milcent et al⁸ (PCT cutoff value of 0.3 ng/mL), the Step-by-Step approach,¹⁰ and the PECARN rule¹¹ (range 0.05-0.17; Table). However, clinical decision rules with and without PCT suffer similar limitations in having poor specificity in identifying infants likely to have IBI.

Several key knowledge gaps around PCT use for diagnosing neonatal infections exist. First, the optimal use of PCT in context with other biomarkers and clinical decision rules remains uncertain. A meta-analysis of 28 studies involving over 2,600 infants that compared PCT level (with and without CRP) with isolated CRP and presepsin levels found that PCT in combination with CRP had greater diagnostic accuracy than either PCT or CRP alone, which highlights a potential opportunity for prospective study.¹³ Second, more data are needed on the use of PCT in the ≤ 28-day age group given the increased risk of both IBI and neonatal herpes simplex virus infection (HSV), compared with that in the second month of life. Neonatal HSV poses diagnostic challenges because half of infants will initially present as afebrile,¹⁴ and delays in initiating antiviral treatment dramatically increase the risk of permanent disability or death.¹⁵ There have been no prospective studies evaluating PCT use as part of neonatal HSV evaluations.

In summary, PCT can play an important adjunctive diagnostic role in the evaluation of febrile young infants, especially during the second month of life when outpatient management is more likely to be considered. PCT is superior to other inflammatory markers in identifying IBI, though the optimal cutoffs to maximize sensitivity and specificity are uncertain. Its performance characteristics, both alone and within clinical decision rules, can help clinicians better identify children at low risk for IBI when compared with clinical decision rules without PCT. PCT measurement can help clinicians miss fewer infants with IBI and identify infants for whom safely doing less is an appropriate option, which can ultimately reduce costs and hospitalizations. PCT may be particularly helpful when the clinical history is difficult to assess or when other diagnostic test results are missing or give conflicting results. Centers that use PCT will need to ensure that results are available within a short turnaround time (a few hours) in order to meaningfully affect care. Future studies of PCT in febrile infant evaluations should focus on identifying optimal strategies for incorporating this biomarker into risk assessments that present information to parents in a way that enables them to understand their child’s risk of a serious infection.

Febrile infants 60 days of age or younger pose a significant diagnostic challenge for clinicians. Most of these infants are well appearing and do not have localizing signs or symptoms of infection, yet they may have serious bacterial infections (SBI) such as urinary tract infection (UTI), bacteremia, and meningitis. While urinalysis is highly sensitive for predicting UTI,¹ older clinical decision rules and biomarkers such as white blood cell (WBC) count, absolute neutrophil count (ANC), and C-reactive protein (CRP) lack both appropriate sensitivity and specificity for identifying bacteremia and meningitis (ie, invasive bacterial infection [IBI]),^2,3 which affect approximately 2.4% and 0.9% of febrile infants during the first 2 months of life, respectively.⁴ The lack of accurate diagnostic markers can drive overuse of laboratory testing, antibiotics, and hospitalization despite the low rates of these infections. As a result, procalcitonin (PCT) has generated interest because of its potential to serve as a more accurate biomarker for bacterial infections. This review summarizes recent literature on the diagnostic utility of PCT in the identification of IBI in febrile young infants 60 days or younger.

Procalcitonin is undetectable in noninflammatory states but can be detected in the blood within 4 to 6 hours after initial bacterial infection.⁵ Its production is stimulated throughout various tissues of the body by cytokines such as interleukin-6 and tumor necrosis factor, which are produced in response to bacterial infections. Interferon-γ, which is produced in response to viral infections, attenuates PCT production. While these characteristics suggest promise for PCT as a more specific screening test for underlying bacterial infection, there are caveats. PCT levels are physiologically elevated in the first 48 hours of life and vary with gestational age, factors that should be considered when interpreting results.⁶ Additionally, PCT levels can rise in other inflammatory states such as autoimmune conditions and certain malignancies,⁵ though these states are unlikely to confound the evaluation of febrile young infants.

Because of PCT’s potential to be more specific than other commonly used biomarkers, multiple studies have evaluated its performance characteristics in febrile young infants. Gomez et al retrospectively evaluated 1,112 well-appearing infants younger than 3 months with fever without a source in seven European emergency departments (EDs).⁷ Overall, 23 infants (2.1%) had IBI (1 with meningitis). A PCT level of 0.5 ng/mL or greater was the only independent risk factor for IBI (adjusted odds ratio, 21.69; 95% CI, 7.93-59.28). Four infants with IBI had a PCT level less than 0.5 ng/mL, and none of these four had meningitis. PCT was superior to CRP, ANC, and WBC in detecting IBI (area under the curve [AUC], 0.825; 95% CI, 0.698-0.952). PCT was the also the best marker for identifying IBI among 451 infants with a normal urine dipstick and fever detected ≤6 hours before presentation (AUC, 0.819; 95% CI, 0.551-1.087).

In the largest prospective study to date evaluating the diagnostic accuracy of PCT in febrile young infants, Milcent et al studied 2,047 previously healthy infants aged 7-91 days admitted for fever from 15 French EDs.⁸ In total, 21 (1%) had an IBI (8 with meningitis). PCT performed better than CRP, ANC, and WBC for the detection of IBI with an AUC of 0.91 (95% CI, 0.83-0.99). In a multivariable model, a PCT level of 0.3 ng/mL or greater was the only independent risk factor for IBI with an adjusted odds ratio of 40.3 (95% CI, 5.0-332). Only one infant with IBI had a PCT level less than 0.3 ng/mL. This infant was 83 days old, had 4 hours of fever, and became afebrile spontaneously prior to the blood culture revealing Streptococcus pneumoniae. PCT also performed better than CRP in the detection of IBI in infants 7-30 days of age and those with fever for less than 6 hours, though both subgroups had small numbers of infants with IBI. The authors determined that a PCT level of 0.3 ng/mL was the optimal cutoff for ruling out IBI; this cutoff had a sensitivity of 90% and negative likelihood ratio (LR) of 0.1 (Table). In contrast, the more commonly studied PCT cutoff of 0.5 ng/mL increased the negative LR to 0.2. The authors suggested that PCT, when used in the context of history, exam, and tests such as urinalysis, could identify infants at low risk of IBI.

Gomez et al conducted a prospective, single-center study of well-appearing infants with fever without a source and negative urine dipsticks.⁹ They identified IBI in 9 of 196 infants (4.5%) 21 days or younger and 13 of 1,331 infants (1.0%) 22-90 days old. PCT was superior to CRP and ANC for IBI detection in both age groups. However, in infants 21 days or younger, both the positive and negative LRs for PCT levels of 0.5 ng/mL or greater were poor (Table). Differences in results from the prior two studies^7,8 may be related to smaller sample size and differences in patient population because this study included infants younger than 7 days and a higher proportion of infants presenting within 6 hours of fever.

PCT has also been incorporated into clinical decision rules for febrile young infants, primarily to identify those at low risk of either IBI or SBI. The Step-by-Step approach¹⁰ classified well-appearing febrile infants 90 days or younger as having a high risk of IBI if they were ill appearing, younger than 21 days old, had a positive urine dipstick or a PCT level of 0.5 ng/mL or greater, and classified them as intermediate risk if they had a CRP level greater than 20 mg/L or ANC level greater than 10,000/µL. The remaining infants were classified as low risk and could be managed as outpatients without lumbar puncture or empiric antibiotics. Of note, derivation of this rule excluded patients with respiratory signs or symptoms. In a prospective validation study with 2,185 infants from 11 European EDs, 87 (4.0%) had an IBI (10 with bacterial meningitis). Sequentially identifying patients as high risk using general appearance, age, and urine dipstick alone identified 80% of infants with IBI and 90% of those with bacterial meningitis. The remaining case of meningitis would have been detected by an elevated PCT. A total of 7 of 991 infants (0.7%) classified as low risk had an IBI and none had meningitis. Six of these infants had a fever duration of less than 2 hours, which would not be enough time for PCT to rise. The Step-by-Step approach, with a sensitivity of 92% and negative LR of 0.17, performed well in the ability to rule out IBI.

A clinical prediction rule developed by the Pediatric Emergency Care Applied Research Network (PECARN) found that urinalysis, ANC, and PCT performed well in identifying infants 60 days or younger at low risk for SBI and IBI.¹¹ This prospective observational study of 1,821 infants 60 days or younger in 26 US EDs found 170 (9.3%) with SBI and 30 (1.6%) with IBI; 10 had bacterial meningitis. Only one patient with IBI was classified as low risk, a 30-day-old whose blood culture grew Enterobacter cloacae and who had a negative repeat blood culture prior to antibiotic treatment. Together, a negative urinalysis, ANC of 4,090/µL or less, and PCT level of 1.71 ng/mL or less were excellent in predicting infants at low risk for both SBI and IBI, with a sensitivity of 97% and negative LR of 0.05 for the outcome of IBI. When applying these variables with “rounded cutoffs” of PCT levels less than 0.5 ng/mL (chosen by the authors because it is a more commonly used cutoff) and ANC of 4,000/µL or less to identify infants at low risk for SBI, their performance was similar to nonrounded cutoffs. Data for the rule with rounded cutoffs in identifying infants at low risk for IBI were not presented. The PECARN study was limited by the small numbers of infants with IBIs, and the authors recommended caution when applying the rule to infants 28 days or younger.

Older clinical decision rules without PCT, such as the Rochester and modified Philadelphia criteria, use clinical and laboratory features to assess risk of IBI.³ Recent studies have evaluated these criteria in cohorts with larger numbers of infants with IBI since the derivation studies included mostly infants with SBI and small numbers with IBI.³ Gomez et al demonstrated that the Rochester criteria had lower sensitivity and higher negative LR than the Step-by-Step approach in IBI detection.¹⁰ In a case-control study of 135 cases of IBI with 249 matched controls, Aronson et al reported that the modified Philadelphia criteria had higher sensitivity but lower specificity than the Rochester criteria for IBI detection.¹² The ability of the Rochester and modified Philadelphia criteria to rule out IBI, as demonstrated by the negative LR (range 0.2-0.4), was inferior to the negative LRs documented by Milcent et al⁸ (PCT cutoff value of 0.3 ng/mL), the Step-by-Step approach,¹⁰ and the PECARN rule¹¹ (range 0.05-0.17; Table). However, clinical decision rules with and without PCT suffer similar limitations in having poor specificity in identifying infants likely to have IBI.

Several key knowledge gaps around PCT use for diagnosing neonatal infections exist. First, the optimal use of PCT in context with other biomarkers and clinical decision rules remains uncertain. A meta-analysis of 28 studies involving over 2,600 infants that compared PCT level (with and without CRP) with isolated CRP and presepsin levels found that PCT in combination with CRP had greater diagnostic accuracy than either PCT or CRP alone, which highlights a potential opportunity for prospective study.¹³ Second, more data are needed on the use of PCT in the ≤ 28-day age group given the increased risk of both IBI and neonatal herpes simplex virus infection (HSV), compared with that in the second month of life. Neonatal HSV poses diagnostic challenges because half of infants will initially present as afebrile,¹⁴ and delays in initiating antiviral treatment dramatically increase the risk of permanent disability or death.¹⁵ There have been no prospective studies evaluating PCT use as part of neonatal HSV evaluations.

In summary, PCT can play an important adjunctive diagnostic role in the evaluation of febrile young infants, especially during the second month of life when outpatient management is more likely to be considered. PCT is superior to other inflammatory markers in identifying IBI, though the optimal cutoffs to maximize sensitivity and specificity are uncertain. Its performance characteristics, both alone and within clinical decision rules, can help clinicians better identify children at low risk for IBI when compared with clinical decision rules without PCT. PCT measurement can help clinicians miss fewer infants with IBI and identify infants for whom safely doing less is an appropriate option, which can ultimately reduce costs and hospitalizations. PCT may be particularly helpful when the clinical history is difficult to assess or when other diagnostic test results are missing or give conflicting results. Centers that use PCT will need to ensure that results are available within a short turnaround time (a few hours) in order to meaningfully affect care. Future studies of PCT in febrile infant evaluations should focus on identifying optimal strategies for incorporating this biomarker into risk assessments that present information to parents in a way that enables them to understand their child’s risk of a serious infection.

Continuous pulse oximetry monitoring in children with bronchiolitis who don’t require supplemental oxygen is discouraged by practice guidelines and is recognized as a form of medical overuse.^1-3 This practice can be associated with negative outcomes, including prolonged length of stay,^4-6 increased cost of hospitalization,⁷ and alarm fatigue among nurses.⁸ Despite initiatives to reduce continuous pulse oximetry monitoring in stable patients with bronchiolitis,^1,2 wide practice variation exists between hospitals.^9,10 Previous studies have shown that higher prevalence of inpatient bronchiolitis admissions is associated with decreased utilization of unnecessary interventions.¹¹ However, the relationship between pulse oximetry use and bronchiolitis prevalence has not been studied. The objective of this study is to test the hypothesis that hospital units with lower proportions of patients admitted for bronchiolitis and those with fewer general pediatrics patients relative to subspecialty patients would have higher rates of pulse oximetry overuse.

Study Design

We conducted a substudy of the Pediatric Research in Inpatient Settings (PRIS) Network’s Eliminating Monitoring Overuse (EMO) pulse oximetry study,^10,12 a 56-hospital cross-sectional study that used direct observation to measure the prevalence of continuous pulse oximetry monitoring in hospitalized infants with bronchiolitis who did not require supplemental oxygen between December 1, 2018, through March 31, 2019. This substudy was not included as part of the original aims of the project and was proposed as a separate analysis during data collection. For US sites, the Institutional Review Board (IRB) at Children’s Hospital of Philadelphia approved the study and served as the central IRB. The Research Ethics Board at University of Calgary also approved the study.

Site Selection

Hospitals with at least 60 observations were eligible for inclusion. Of the 32 hospitals that conducted the minimum observations, 25 agreed to participate (21 free-standing children’s hospitals, 3 children’s hospitals within general hospitals, and 1 community hospital).

Patient Population

The parent study included patients aged 8 weeks through 23 months with a primary diagnosis of bronchiolitis. Patients were included only if they were not receiving supplemental oxygen or nasal cannula flow at the time of data collection. The inclusion and exclusion criteria were for both the parent study and the substudy. Further inclusion and exclusion criteria have been described previously.^10,12

Data Collection

In order to ascertain continuous pulse oximetry monitoring status, staff at each hospital performed observational rounds by walking to the bedside of each patient who met inclusion criteria. Additional methodology for the parent study has been published elsewhere.^10,12

Bronchiolitis Admission Volume by Unit

Collaborators at each hospital gathered bronchiolitis census data from each unit that admitted patients with bronchiolitis. Units were identified prior to data collection and were characterized at the institution level based on previous local definitions. Each site was responsible for using institution-specific data collection methods for determining bronchiolitis and total admissions on each unit (eg, departmental reports or directly querying admissions data using International Classification of Diseases, Tenth Revision, diagnosis codes for bronchiolitis) over the same period as the parent study. Following data analysis, bronchiolitis admission burden was classified into five categories, based on less than 10%, 10% to less than 20%, 20% to less than 30%, 30% to less than 40%, or 40% or more of total admissions having a primary discharge diagnosis of bronchiolitis during the study period. This categorization allowed investigators to determine whether there was a dose-dependent response among categories.

Unit Composition

Site investigators also completed a survey identifying which patients were admitted to each unit (eg, general pediatrics only, medical subspecialty, surgical). Based on these results, units were further classified into seven types (Appendix Table). For the final analysis, units caring exclusively for general pediatrics patients were compared to all other unit types.

Analysis

Bronchiolitis admission burden and unit composition data were combined with observations of pulse oximetry monitoring use of patients not requiring supplemental oxygen from the parent study. We determined unadjusted observed monitoring proportions for each unit’s bronchiolitis admission burden category across all 25 hospitals. This was calculated as a simple proportion of the total number of observations during which patients were continuously monitored divided by the total number of observations performed within each unit’s admission category. We then calculated unadjusted odds ratios using the 40% and higher bronchiolitis admission burden category as a reference. We calculated similar proportions and odds ratios for the dichotomous unit composition variable. Next, we used mixed-effects logistic regression with a random intercept for each hospital to allow for differences in baseline monitoring rates, which varied widely between hospitals (2% to 92%),¹⁰ to calculate adjusted odds ratios for the unit’s admission category and unit’s composition. We also adjusted for the same covariates used in the primary study’s analysis (Table).¹⁰

We analyzed 2,366 observations of bronchiolitis patients from 25 hospitals. Most observations were concentrated in freestanding children’s hospitals (89%), and 50% were from hospitals with more than 250 pediatric beds. Observations were well distributed among the five categories of admit burden (Table).

In unadjusted regression, the relationship between admission burden and rate of pulse oximetry use did not appear to be dose-dependent, and 95% CIs were wide. We then analyzed the data accounting for baseline differences in hospital monitoring rates and adjusted for the covariates significantly associated with continuous pulse oximetry monitoring in the primary study’s analysis with use of a mixed-effects model. As shown in the Table, low-burden units in which bronchiolitis constituted less than 10% of total admissions had a 2.16-fold increased odds of unnecessary pulse oximetry monitoring compared to high-burden units in which bronchiolitis constituted 40% or more of total admissions (95% CI, 1.27-3.69; P = .01).

In examining the subspecialty unit composition, 596 observations (25.2%) were conducted on units exclusively caring for general pediatrics patients. In the mixed-effects model adjusted for bronchiolitis admission burden and the covariates used in the study’s primary analysis, units exclusively caring for general pediatrics patients did not have significantly different independent odds of pulse oximetry monitoring use compared to units with a mixed patient population (OR 1.01; 95% CI, 0.71-1.45; P = .95) (Appendix Table).

In this multicenter observational study of children hospitalized with bronchiolitis not concurrently receiving supplemental oxygen, units that only occasionally cared for bronchiolitis patients appeared to be more likely to overuse continuous pulse oximetry during bronchiolitis hospitalizations.

This finding was not immediately apparent when examining the raw data because of wide hospital-level variation in continuous pulse oximetry monitoring use. However, when the high degree of hospital-level variation in baseline overuse was accounted for with use of a random intercept for each hospital in the mixed-effects model, units that cared for higher proportions of bronchiolitis patients had significantly lower odds of continuous pulse oximetry monitoring use compared to units that cared for these infants infrequently.

As many institutions have subspecialized units to cultivate nursing expertise for care of certain diseases and patient populations, we hypothesized that units caring primarily for children on general pediatrics units would also have lower rates of monitoring overuse compared to mixed units. Interestingly, these units did not perform better, likely because potential cultural factors that might contribute to differences in monitoring are accounted for by bronchiolitis admission burden.

Our findings build on prior literature by demonstrating that unit-level, as well as hospital-level, factors appear to drive overuse in healthcare. A prior single-site retrospective cohort study demonstrated an association between higher prevalence of inpatient bronchiolitis and decreased use of unnecessary interventions such as laboratory and radiographic testing, as well as steroid and antibiotic administration.¹¹ Although study of the relationship between volume and quality is not new to healthcare, to our knowledge, this study is the first to examine the relationship between pulse oximetry overuse in bronchiolitis and unit-level factors like admission burden and subspecialty composition.

There are several limitations. First, because the study population included only children not receiving supplemental oxygen, both the parent study and this substudy assumed that all observed use of pulse oximetry monitoring was overuse. In some cases, however, there may have been other compelling clinical reasons, institutional policies, or differences in pulse oximetry availability that were not captured during data collection or in our adjusted model. Second, hospitals used convenience sampling. It is possible this resulted in samples that were not representative of each unit’s underlying patient population or monitoring practice. In addition, not all of the 32 eligible sites were able to provide data related to hospital admissions at the unit level and thus are not included in our analysis. This remains a potential source of hospital-level selection bias.

These findings demonstrate that high bronchiolitis admission burden correlates with lower rates of unnecessary pulse oximetry monitoring in bronchiolitis. We speculate that these outcomes might reflect differing degrees of nursing comfort, expertise, and unit-level norms in caring for bronchiolitis patients, although our study was not designed to establish underlying causes. Identification of operating principles that underpin low pulse oximetry monitoring on high-burden units will provide guidance for decreasing unnecessary monitoring and will inform future studies seeking ways to discourage continuous pulse oximetry monitoring in low-risk infants. Given the institutional variation in monitoring rates, future studies examining both institution-wide and unit-level interventions will be necessary to decrease unnecessary pulse oximetry monitoring in bronchiolitis. Furthermore, these findings may be relevant to studying care quality in other disease processes, with bronchiolitis serving as a model illness for overuse.

The authors acknowledge the National Heart, Lung, and Blood Institute of the National Institutes of Health scientists who contributed their expertise to this project as part of the U01 Cooperative Agreement funding mechanism as federal employees conducting their official job duties: Lora Reineck, MD, MS, Karen Bienstock, MS, and Cheryl Boyce, PhD. The authors thank the executive council of the Pediatric Research in Inpatient Settings Network for their contributions to the early scientific development of this project. The network assessed a Collaborative Support Fee for access to the hospitals and support of this project.

The authors thank the PRIS Network collaborators for their major contributions to data collection (see Appendix).

Continuous pulse oximetry monitoring in children with bronchiolitis who don’t require supplemental oxygen is discouraged by practice guidelines and is recognized as a form of medical overuse.^1-3 This practice can be associated with negative outcomes, including prolonged length of stay,^4-6 increased cost of hospitalization,⁷ and alarm fatigue among nurses.⁸ Despite initiatives to reduce continuous pulse oximetry monitoring in stable patients with bronchiolitis,^1,2 wide practice variation exists between hospitals.^9,10 Previous studies have shown that higher prevalence of inpatient bronchiolitis admissions is associated with decreased utilization of unnecessary interventions.¹¹ However, the relationship between pulse oximetry use and bronchiolitis prevalence has not been studied. The objective of this study is to test the hypothesis that hospital units with lower proportions of patients admitted for bronchiolitis and those with fewer general pediatrics patients relative to subspecialty patients would have higher rates of pulse oximetry overuse.

Study Design

We conducted a substudy of the Pediatric Research in Inpatient Settings (PRIS) Network’s Eliminating Monitoring Overuse (EMO) pulse oximetry study,^10,12 a 56-hospital cross-sectional study that used direct observation to measure the prevalence of continuous pulse oximetry monitoring in hospitalized infants with bronchiolitis who did not require supplemental oxygen between December 1, 2018, through March 31, 2019. This substudy was not included as part of the original aims of the project and was proposed as a separate analysis during data collection. For US sites, the Institutional Review Board (IRB) at Children’s Hospital of Philadelphia approved the study and served as the central IRB. The Research Ethics Board at University of Calgary also approved the study.

Site Selection

Hospitals with at least 60 observations were eligible for inclusion. Of the 32 hospitals that conducted the minimum observations, 25 agreed to participate (21 free-standing children’s hospitals, 3 children’s hospitals within general hospitals, and 1 community hospital).

Patient Population

The parent study included patients aged 8 weeks through 23 months with a primary diagnosis of bronchiolitis. Patients were included only if they were not receiving supplemental oxygen or nasal cannula flow at the time of data collection. The inclusion and exclusion criteria were for both the parent study and the substudy. Further inclusion and exclusion criteria have been described previously.^10,12

Data Collection

In order to ascertain continuous pulse oximetry monitoring status, staff at each hospital performed observational rounds by walking to the bedside of each patient who met inclusion criteria. Additional methodology for the parent study has been published elsewhere.^10,12

Bronchiolitis Admission Volume by Unit

Collaborators at each hospital gathered bronchiolitis census data from each unit that admitted patients with bronchiolitis. Units were identified prior to data collection and were characterized at the institution level based on previous local definitions. Each site was responsible for using institution-specific data collection methods for determining bronchiolitis and total admissions on each unit (eg, departmental reports or directly querying admissions data using International Classification of Diseases, Tenth Revision, diagnosis codes for bronchiolitis) over the same period as the parent study. Following data analysis, bronchiolitis admission burden was classified into five categories, based on less than 10%, 10% to less than 20%, 20% to less than 30%, 30% to less than 40%, or 40% or more of total admissions having a primary discharge diagnosis of bronchiolitis during the study period. This categorization allowed investigators to determine whether there was a dose-dependent response among categories.

Unit Composition

Site investigators also completed a survey identifying which patients were admitted to each unit (eg, general pediatrics only, medical subspecialty, surgical). Based on these results, units were further classified into seven types (Appendix Table). For the final analysis, units caring exclusively for general pediatrics patients were compared to all other unit types.

Analysis

Bronchiolitis admission burden and unit composition data were combined with observations of pulse oximetry monitoring use of patients not requiring supplemental oxygen from the parent study. We determined unadjusted observed monitoring proportions for each unit’s bronchiolitis admission burden category across all 25 hospitals. This was calculated as a simple proportion of the total number of observations during which patients were continuously monitored divided by the total number of observations performed within each unit’s admission category. We then calculated unadjusted odds ratios using the 40% and higher bronchiolitis admission burden category as a reference. We calculated similar proportions and odds ratios for the dichotomous unit composition variable. Next, we used mixed-effects logistic regression with a random intercept for each hospital to allow for differences in baseline monitoring rates, which varied widely between hospitals (2% to 92%),¹⁰ to calculate adjusted odds ratios for the unit’s admission category and unit’s composition. We also adjusted for the same covariates used in the primary study’s analysis (Table).¹⁰

We analyzed 2,366 observations of bronchiolitis patients from 25 hospitals. Most observations were concentrated in freestanding children’s hospitals (89%), and 50% were from hospitals with more than 250 pediatric beds. Observations were well distributed among the five categories of admit burden (Table).

In unadjusted regression, the relationship between admission burden and rate of pulse oximetry use did not appear to be dose-dependent, and 95% CIs were wide. We then analyzed the data accounting for baseline differences in hospital monitoring rates and adjusted for the covariates significantly associated with continuous pulse oximetry monitoring in the primary study’s analysis with use of a mixed-effects model. As shown in the Table, low-burden units in which bronchiolitis constituted less than 10% of total admissions had a 2.16-fold increased odds of unnecessary pulse oximetry monitoring compared to high-burden units in which bronchiolitis constituted 40% or more of total admissions (95% CI, 1.27-3.69; P = .01).

In examining the subspecialty unit composition, 596 observations (25.2%) were conducted on units exclusively caring for general pediatrics patients. In the mixed-effects model adjusted for bronchiolitis admission burden and the covariates used in the study’s primary analysis, units exclusively caring for general pediatrics patients did not have significantly different independent odds of pulse oximetry monitoring use compared to units with a mixed patient population (OR 1.01; 95% CI, 0.71-1.45; P = .95) (Appendix Table).

In this multicenter observational study of children hospitalized with bronchiolitis not concurrently receiving supplemental oxygen, units that only occasionally cared for bronchiolitis patients appeared to be more likely to overuse continuous pulse oximetry during bronchiolitis hospitalizations.

This finding was not immediately apparent when examining the raw data because of wide hospital-level variation in continuous pulse oximetry monitoring use. However, when the high degree of hospital-level variation in baseline overuse was accounted for with use of a random intercept for each hospital in the mixed-effects model, units that cared for higher proportions of bronchiolitis patients had significantly lower odds of continuous pulse oximetry monitoring use compared to units that cared for these infants infrequently.

As many institutions have subspecialized units to cultivate nursing expertise for care of certain diseases and patient populations, we hypothesized that units caring primarily for children on general pediatrics units would also have lower rates of monitoring overuse compared to mixed units. Interestingly, these units did not perform better, likely because potential cultural factors that might contribute to differences in monitoring are accounted for by bronchiolitis admission burden.

Our findings build on prior literature by demonstrating that unit-level, as well as hospital-level, factors appear to drive overuse in healthcare. A prior single-site retrospective cohort study demonstrated an association between higher prevalence of inpatient bronchiolitis and decreased use of unnecessary interventions such as laboratory and radiographic testing, as well as steroid and antibiotic administration.¹¹ Although study of the relationship between volume and quality is not new to healthcare, to our knowledge, this study is the first to examine the relationship between pulse oximetry overuse in bronchiolitis and unit-level factors like admission burden and subspecialty composition.

There are several limitations. First, because the study population included only children not receiving supplemental oxygen, both the parent study and this substudy assumed that all observed use of pulse oximetry monitoring was overuse. In some cases, however, there may have been other compelling clinical reasons, institutional policies, or differences in pulse oximetry availability that were not captured during data collection or in our adjusted model. Second, hospitals used convenience sampling. It is possible this resulted in samples that were not representative of each unit’s underlying patient population or monitoring practice. In addition, not all of the 32 eligible sites were able to provide data related to hospital admissions at the unit level and thus are not included in our analysis. This remains a potential source of hospital-level selection bias.

These findings demonstrate that high bronchiolitis admission burden correlates with lower rates of unnecessary pulse oximetry monitoring in bronchiolitis. We speculate that these outcomes might reflect differing degrees of nursing comfort, expertise, and unit-level norms in caring for bronchiolitis patients, although our study was not designed to establish underlying causes. Identification of operating principles that underpin low pulse oximetry monitoring on high-burden units will provide guidance for decreasing unnecessary monitoring and will inform future studies seeking ways to discourage continuous pulse oximetry monitoring in low-risk infants. Given the institutional variation in monitoring rates, future studies examining both institution-wide and unit-level interventions will be necessary to decrease unnecessary pulse oximetry monitoring in bronchiolitis. Furthermore, these findings may be relevant to studying care quality in other disease processes, with bronchiolitis serving as a model illness for overuse.

The authors acknowledge the National Heart, Lung, and Blood Institute of the National Institutes of Health scientists who contributed their expertise to this project as part of the U01 Cooperative Agreement funding mechanism as federal employees conducting their official job duties: Lora Reineck, MD, MS, Karen Bienstock, MS, and Cheryl Boyce, PhD. The authors thank the executive council of the Pediatric Research in Inpatient Settings Network for their contributions to the early scientific development of this project. The network assessed a Collaborative Support Fee for access to the hospitals and support of this project.

The authors thank the PRIS Network collaborators for their major contributions to data collection (see Appendix).

Continuous pulse oximetry monitoring in children with bronchiolitis who don’t require supplemental oxygen is discouraged by practice guidelines and is recognized as a form of medical overuse.^1-3 This practice can be associated with negative outcomes, including prolonged length of stay,^4-6 increased cost of hospitalization,⁷ and alarm fatigue among nurses.⁸ Despite initiatives to reduce continuous pulse oximetry monitoring in stable patients with bronchiolitis,^1,2 wide practice variation exists between hospitals.^9,10 Previous studies have shown that higher prevalence of inpatient bronchiolitis admissions is associated with decreased utilization of unnecessary interventions.¹¹ However, the relationship between pulse oximetry use and bronchiolitis prevalence has not been studied. The objective of this study is to test the hypothesis that hospital units with lower proportions of patients admitted for bronchiolitis and those with fewer general pediatrics patients relative to subspecialty patients would have higher rates of pulse oximetry overuse.

Study Design

We conducted a substudy of the Pediatric Research in Inpatient Settings (PRIS) Network’s Eliminating Monitoring Overuse (EMO) pulse oximetry study,^10,12 a 56-hospital cross-sectional study that used direct observation to measure the prevalence of continuous pulse oximetry monitoring in hospitalized infants with bronchiolitis who did not require supplemental oxygen between December 1, 2018, through March 31, 2019. This substudy was not included as part of the original aims of the project and was proposed as a separate analysis during data collection. For US sites, the Institutional Review Board (IRB) at Children’s Hospital of Philadelphia approved the study and served as the central IRB. The Research Ethics Board at University of Calgary also approved the study.

Site Selection

Hospitals with at least 60 observations were eligible for inclusion. Of the 32 hospitals that conducted the minimum observations, 25 agreed to participate (21 free-standing children’s hospitals, 3 children’s hospitals within general hospitals, and 1 community hospital).

Patient Population

The parent study included patients aged 8 weeks through 23 months with a primary diagnosis of bronchiolitis. Patients were included only if they were not receiving supplemental oxygen or nasal cannula flow at the time of data collection. The inclusion and exclusion criteria were for both the parent study and the substudy. Further inclusion and exclusion criteria have been described previously.^10,12

Data Collection

In order to ascertain continuous pulse oximetry monitoring status, staff at each hospital performed observational rounds by walking to the bedside of each patient who met inclusion criteria. Additional methodology for the parent study has been published elsewhere.^10,12

Bronchiolitis Admission Volume by Unit

Collaborators at each hospital gathered bronchiolitis census data from each unit that admitted patients with bronchiolitis. Units were identified prior to data collection and were characterized at the institution level based on previous local definitions. Each site was responsible for using institution-specific data collection methods for determining bronchiolitis and total admissions on each unit (eg, departmental reports or directly querying admissions data using International Classification of Diseases, Tenth Revision, diagnosis codes for bronchiolitis) over the same period as the parent study. Following data analysis, bronchiolitis admission burden was classified into five categories, based on less than 10%, 10% to less than 20%, 20% to less than 30%, 30% to less than 40%, or 40% or more of total admissions having a primary discharge diagnosis of bronchiolitis during the study period. This categorization allowed investigators to determine whether there was a dose-dependent response among categories.

Unit Composition

Site investigators also completed a survey identifying which patients were admitted to each unit (eg, general pediatrics only, medical subspecialty, surgical). Based on these results, units were further classified into seven types (Appendix Table). For the final analysis, units caring exclusively for general pediatrics patients were compared to all other unit types.

Analysis

Bronchiolitis admission burden and unit composition data were combined with observations of pulse oximetry monitoring use of patients not requiring supplemental oxygen from the parent study. We determined unadjusted observed monitoring proportions for each unit’s bronchiolitis admission burden category across all 25 hospitals. This was calculated as a simple proportion of the total number of observations during which patients were continuously monitored divided by the total number of observations performed within each unit’s admission category. We then calculated unadjusted odds ratios using the 40% and higher bronchiolitis admission burden category as a reference. We calculated similar proportions and odds ratios for the dichotomous unit composition variable. Next, we used mixed-effects logistic regression with a random intercept for each hospital to allow for differences in baseline monitoring rates, which varied widely between hospitals (2% to 92%),¹⁰ to calculate adjusted odds ratios for the unit’s admission category and unit’s composition. We also adjusted for the same covariates used in the primary study’s analysis (Table).¹⁰

We analyzed 2,366 observations of bronchiolitis patients from 25 hospitals. Most observations were concentrated in freestanding children’s hospitals (89%), and 50% were from hospitals with more than 250 pediatric beds. Observations were well distributed among the five categories of admit burden (Table).

In unadjusted regression, the relationship between admission burden and rate of pulse oximetry use did not appear to be dose-dependent, and 95% CIs were wide. We then analyzed the data accounting for baseline differences in hospital monitoring rates and adjusted for the covariates significantly associated with continuous pulse oximetry monitoring in the primary study’s analysis with use of a mixed-effects model. As shown in the Table, low-burden units in which bronchiolitis constituted less than 10% of total admissions had a 2.16-fold increased odds of unnecessary pulse oximetry monitoring compared to high-burden units in which bronchiolitis constituted 40% or more of total admissions (95% CI, 1.27-3.69; P = .01).

In examining the subspecialty unit composition, 596 observations (25.2%) were conducted on units exclusively caring for general pediatrics patients. In the mixed-effects model adjusted for bronchiolitis admission burden and the covariates used in the study’s primary analysis, units exclusively caring for general pediatrics patients did not have significantly different independent odds of pulse oximetry monitoring use compared to units with a mixed patient population (OR 1.01; 95% CI, 0.71-1.45; P = .95) (Appendix Table).

In this multicenter observational study of children hospitalized with bronchiolitis not concurrently receiving supplemental oxygen, units that only occasionally cared for bronchiolitis patients appeared to be more likely to overuse continuous pulse oximetry during bronchiolitis hospitalizations.

This finding was not immediately apparent when examining the raw data because of wide hospital-level variation in continuous pulse oximetry monitoring use. However, when the high degree of hospital-level variation in baseline overuse was accounted for with use of a random intercept for each hospital in the mixed-effects model, units that cared for higher proportions of bronchiolitis patients had significantly lower odds of continuous pulse oximetry monitoring use compared to units that cared for these infants infrequently.

As many institutions have subspecialized units to cultivate nursing expertise for care of certain diseases and patient populations, we hypothesized that units caring primarily for children on general pediatrics units would also have lower rates of monitoring overuse compared to mixed units. Interestingly, these units did not perform better, likely because potential cultural factors that might contribute to differences in monitoring are accounted for by bronchiolitis admission burden.

Our findings build on prior literature by demonstrating that unit-level, as well as hospital-level, factors appear to drive overuse in healthcare. A prior single-site retrospective cohort study demonstrated an association between higher prevalence of inpatient bronchiolitis and decreased use of unnecessary interventions such as laboratory and radiographic testing, as well as steroid and antibiotic administration.¹¹ Although study of the relationship between volume and quality is not new to healthcare, to our knowledge, this study is the first to examine the relationship between pulse oximetry overuse in bronchiolitis and unit-level factors like admission burden and subspecialty composition.

There are several limitations. First, because the study population included only children not receiving supplemental oxygen, both the parent study and this substudy assumed that all observed use of pulse oximetry monitoring was overuse. In some cases, however, there may have been other compelling clinical reasons, institutional policies, or differences in pulse oximetry availability that were not captured during data collection or in our adjusted model. Second, hospitals used convenience sampling. It is possible this resulted in samples that were not representative of each unit’s underlying patient population or monitoring practice. In addition, not all of the 32 eligible sites were able to provide data related to hospital admissions at the unit level and thus are not included in our analysis. This remains a potential source of hospital-level selection bias.

These findings demonstrate that high bronchiolitis admission burden correlates with lower rates of unnecessary pulse oximetry monitoring in bronchiolitis. We speculate that these outcomes might reflect differing degrees of nursing comfort, expertise, and unit-level norms in caring for bronchiolitis patients, although our study was not designed to establish underlying causes. Identification of operating principles that underpin low pulse oximetry monitoring on high-burden units will provide guidance for decreasing unnecessary monitoring and will inform future studies seeking ways to discourage continuous pulse oximetry monitoring in low-risk infants. Given the institutional variation in monitoring rates, future studies examining both institution-wide and unit-level interventions will be necessary to decrease unnecessary pulse oximetry monitoring in bronchiolitis. Furthermore, these findings may be relevant to studying care quality in other disease processes, with bronchiolitis serving as a model illness for overuse.

The authors acknowledge the National Heart, Lung, and Blood Institute of the National Institutes of Health scientists who contributed their expertise to this project as part of the U01 Cooperative Agreement funding mechanism as federal employees conducting their official job duties: Lora Reineck, MD, MS, Karen Bienstock, MS, and Cheryl Boyce, PhD. The authors thank the executive council of the Pediatric Research in Inpatient Settings Network for their contributions to the early scientific development of this project. The network assessed a Collaborative Support Fee for access to the hospitals and support of this project.

The authors thank the PRIS Network collaborators for their major contributions to data collection (see Appendix).