Federal Practitioner

Precision medicine therapy proved feasible and superior to standard-of-care (SOC) chemotherapy in patients with acute myeloid leukemia in the Beat AML Master Clinical Trial.

The 30-day mortality rates were 3.7% versus 20.4% in 224 patients who enrolled in the Beat AML trial precision medicine substudies within 7 days of prospective genomic profiling and 103 who elected SOC chemotherapy, respectively, Amy Burd, PhD, vice president of research strategy for the Leukemia & Lymphoma Society, Rye Brook, N.Y. and her colleagues reported online in Nature Medicine.

Overall survival (OS) at a median of 7.1 months was also significantly longer with precision medicine than with SOC chemotherapy (median, 12.8 vs. 3.9 months), the investigators found.

In an additional 28 patients who selected an investigational therapy rather than a precision medicine strategy or SOC chemotherapy, median OS was not reached, and in 38 who chose palliative care, median OS was 0.6 months, they noted. Care type was unknown in two patients.

The results were similar after controlling for demographic, clinical, and molecular variables and did not change when patients with adverse events of special interest were excluded from the analysis or when only those with survival greater than 2 weeks were included in the analysis.

AML confers an adverse outcome in older adults and therefore is typically treated rapidly after diagnosis. This has precluded consideration of patients’ mutational profile for treatment decisions.

Beat AML, however, sought to prospectively assess the feasibility of quickly ascertaining cytogenetic and mutational data for the purpose of improving outcomes through targeted treatment.

“The study shows that delaying treatment up to 7 days is feasible and safe, and that patients who opted for the precision medicine approach experienced a lower early death rate and superior overall survival, compared with patients who opted for standard of care,” lead study author John C. Byrd, MD, the D. Warren Brown Chair of Leukemia Research of the Ohio State University, Columbus, noted in a press statement from the Leukemia & Lymphoma Society, which conducted the trial. “This patient-centric study shows that we can move away from chemotherapy treatment for patients who won’t respond or can’t withstand the harsh effects of the same chemotherapies we’ve been using for 40 years and match them with a treatment better suited for their individual cases.”

The ongoing Beat AML trial was launched by LLS in 2016 to assess various novel targeted therapies in newly diagnosed AML patients aged 60 years and older. Participants underwent next-generation genomic sequencing, were matched to the appropriate targeted therapy, and were given the option of enrolling on the relevant substudy or selecting an alternate treatment strategy. There are currently 11 substudies assessing novel therapies that have emerged in the wake of “significant progress in understanding the molecular pathogenesis of AML.”

The current findings represent outcomes in patients enrolled between Nov. 2016 and Jan. 2018. The patients had a mean age of 72 years, and those selecting precision medicine vs. SOC had similar demographic and genetic features, the authors noted.

LLS president and chief executive officer Louis J. DeGennaro, PhD, said the findings are practice changing and provide a template for studying precision medicine in other cancers.

“The study is changing significantly the way we look at treating patients with AML, showing that precision medicine ... can improve short- and long-term outcomes for patients with this deadly blood cancer,” he said in the LLS statement. “Further, BEAT AML has proven to be a viable model for other cancer clinical trials to emulate.”

In fact, the model has been applied to the recently launched Beat COVID trial, which looks at acalabrutinib in patients with hematologic cancers and COVID-19 infection, and other trials, including the LLS PedAL global precision medicine trial for children with relapsed acute leukemia, are planned.

“This study sets the path to establish the safety of precision medicine in AML and sets the stage to extend this same approach to younger patients with this disease and other cancers that are urgently treated as a single disease despite recognition of multiple subtypes, the authors concluded.

Dr. Burd is an employee of LLS, which received funding from AbbVie, Agios Pharmaceuticals, Alexion Pharmaceuticals, and a variety of other pharmaceutical and biotechnology companies. Dr. Byrd has received research support from Acerta Pharma, Genentech, Janssen Pharmaceutica, and Pharmacyclics and has served on the advisory board of Syndax Pharmaceuticals.

[email protected]

SOURCE: Burd A et al. Nature Medicine 2020 Oct 26. doi: 10.1038/s41591-020-1089-8.

Precision medicine therapy proved feasible and superior to standard-of-care (SOC) chemotherapy in patients with acute myeloid leukemia in the Beat AML Master Clinical Trial.

The 30-day mortality rates were 3.7% versus 20.4% in 224 patients who enrolled in the Beat AML trial precision medicine substudies within 7 days of prospective genomic profiling and 103 who elected SOC chemotherapy, respectively, Amy Burd, PhD, vice president of research strategy for the Leukemia & Lymphoma Society, Rye Brook, N.Y. and her colleagues reported online in Nature Medicine.

Overall survival (OS) at a median of 7.1 months was also significantly longer with precision medicine than with SOC chemotherapy (median, 12.8 vs. 3.9 months), the investigators found.

In an additional 28 patients who selected an investigational therapy rather than a precision medicine strategy or SOC chemotherapy, median OS was not reached, and in 38 who chose palliative care, median OS was 0.6 months, they noted. Care type was unknown in two patients.

The results were similar after controlling for demographic, clinical, and molecular variables and did not change when patients with adverse events of special interest were excluded from the analysis or when only those with survival greater than 2 weeks were included in the analysis.

AML confers an adverse outcome in older adults and therefore is typically treated rapidly after diagnosis. This has precluded consideration of patients’ mutational profile for treatment decisions.

Beat AML, however, sought to prospectively assess the feasibility of quickly ascertaining cytogenetic and mutational data for the purpose of improving outcomes through targeted treatment.

“The study shows that delaying treatment up to 7 days is feasible and safe, and that patients who opted for the precision medicine approach experienced a lower early death rate and superior overall survival, compared with patients who opted for standard of care,” lead study author John C. Byrd, MD, the D. Warren Brown Chair of Leukemia Research of the Ohio State University, Columbus, noted in a press statement from the Leukemia & Lymphoma Society, which conducted the trial. “This patient-centric study shows that we can move away from chemotherapy treatment for patients who won’t respond or can’t withstand the harsh effects of the same chemotherapies we’ve been using for 40 years and match them with a treatment better suited for their individual cases.”

The ongoing Beat AML trial was launched by LLS in 2016 to assess various novel targeted therapies in newly diagnosed AML patients aged 60 years and older. Participants underwent next-generation genomic sequencing, were matched to the appropriate targeted therapy, and were given the option of enrolling on the relevant substudy or selecting an alternate treatment strategy. There are currently 11 substudies assessing novel therapies that have emerged in the wake of “significant progress in understanding the molecular pathogenesis of AML.”

The current findings represent outcomes in patients enrolled between Nov. 2016 and Jan. 2018. The patients had a mean age of 72 years, and those selecting precision medicine vs. SOC had similar demographic and genetic features, the authors noted.

LLS president and chief executive officer Louis J. DeGennaro, PhD, said the findings are practice changing and provide a template for studying precision medicine in other cancers.

“The study is changing significantly the way we look at treating patients with AML, showing that precision medicine ... can improve short- and long-term outcomes for patients with this deadly blood cancer,” he said in the LLS statement. “Further, BEAT AML has proven to be a viable model for other cancer clinical trials to emulate.”

In fact, the model has been applied to the recently launched Beat COVID trial, which looks at acalabrutinib in patients with hematologic cancers and COVID-19 infection, and other trials, including the LLS PedAL global precision medicine trial for children with relapsed acute leukemia, are planned.

“This study sets the path to establish the safety of precision medicine in AML and sets the stage to extend this same approach to younger patients with this disease and other cancers that are urgently treated as a single disease despite recognition of multiple subtypes, the authors concluded.

Dr. Burd is an employee of LLS, which received funding from AbbVie, Agios Pharmaceuticals, Alexion Pharmaceuticals, and a variety of other pharmaceutical and biotechnology companies. Dr. Byrd has received research support from Acerta Pharma, Genentech, Janssen Pharmaceutica, and Pharmacyclics and has served on the advisory board of Syndax Pharmaceuticals.

[email protected]

SOURCE: Burd A et al. Nature Medicine 2020 Oct 26. doi: 10.1038/s41591-020-1089-8.

Precision medicine therapy proved feasible and superior to standard-of-care (SOC) chemotherapy in patients with acute myeloid leukemia in the Beat AML Master Clinical Trial.

The 30-day mortality rates were 3.7% versus 20.4% in 224 patients who enrolled in the Beat AML trial precision medicine substudies within 7 days of prospective genomic profiling and 103 who elected SOC chemotherapy, respectively, Amy Burd, PhD, vice president of research strategy for the Leukemia & Lymphoma Society, Rye Brook, N.Y. and her colleagues reported online in Nature Medicine.

Overall survival (OS) at a median of 7.1 months was also significantly longer with precision medicine than with SOC chemotherapy (median, 12.8 vs. 3.9 months), the investigators found.

In an additional 28 patients who selected an investigational therapy rather than a precision medicine strategy or SOC chemotherapy, median OS was not reached, and in 38 who chose palliative care, median OS was 0.6 months, they noted. Care type was unknown in two patients.

The results were similar after controlling for demographic, clinical, and molecular variables and did not change when patients with adverse events of special interest were excluded from the analysis or when only those with survival greater than 2 weeks were included in the analysis.

AML confers an adverse outcome in older adults and therefore is typically treated rapidly after diagnosis. This has precluded consideration of patients’ mutational profile for treatment decisions.

Beat AML, however, sought to prospectively assess the feasibility of quickly ascertaining cytogenetic and mutational data for the purpose of improving outcomes through targeted treatment.

“The study shows that delaying treatment up to 7 days is feasible and safe, and that patients who opted for the precision medicine approach experienced a lower early death rate and superior overall survival, compared with patients who opted for standard of care,” lead study author John C. Byrd, MD, the D. Warren Brown Chair of Leukemia Research of the Ohio State University, Columbus, noted in a press statement from the Leukemia & Lymphoma Society, which conducted the trial. “This patient-centric study shows that we can move away from chemotherapy treatment for patients who won’t respond or can’t withstand the harsh effects of the same chemotherapies we’ve been using for 40 years and match them with a treatment better suited for their individual cases.”

The ongoing Beat AML trial was launched by LLS in 2016 to assess various novel targeted therapies in newly diagnosed AML patients aged 60 years and older. Participants underwent next-generation genomic sequencing, were matched to the appropriate targeted therapy, and were given the option of enrolling on the relevant substudy or selecting an alternate treatment strategy. There are currently 11 substudies assessing novel therapies that have emerged in the wake of “significant progress in understanding the molecular pathogenesis of AML.”

The current findings represent outcomes in patients enrolled between Nov. 2016 and Jan. 2018. The patients had a mean age of 72 years, and those selecting precision medicine vs. SOC had similar demographic and genetic features, the authors noted.

LLS president and chief executive officer Louis J. DeGennaro, PhD, said the findings are practice changing and provide a template for studying precision medicine in other cancers.

“The study is changing significantly the way we look at treating patients with AML, showing that precision medicine ... can improve short- and long-term outcomes for patients with this deadly blood cancer,” he said in the LLS statement. “Further, BEAT AML has proven to be a viable model for other cancer clinical trials to emulate.”

In fact, the model has been applied to the recently launched Beat COVID trial, which looks at acalabrutinib in patients with hematologic cancers and COVID-19 infection, and other trials, including the LLS PedAL global precision medicine trial for children with relapsed acute leukemia, are planned.

“This study sets the path to establish the safety of precision medicine in AML and sets the stage to extend this same approach to younger patients with this disease and other cancers that are urgently treated as a single disease despite recognition of multiple subtypes, the authors concluded.

Dr. Burd is an employee of LLS, which received funding from AbbVie, Agios Pharmaceuticals, Alexion Pharmaceuticals, and a variety of other pharmaceutical and biotechnology companies. Dr. Byrd has received research support from Acerta Pharma, Genentech, Janssen Pharmaceutica, and Pharmacyclics and has served on the advisory board of Syndax Pharmaceuticals.

[email protected]

SOURCE: Burd A et al. Nature Medicine 2020 Oct 26. doi: 10.1038/s41591-020-1089-8.

Standardized template design is a useful tool to improve clinical documentation and reliable reporting of health care outcomes when constructed with clear objectives and with collaboration of key stakeholders. A standardized template should not only capture accurate diagnostic information, but also inform quality improvement (QI) measures and best practices.

Kang and colleagues showed that a correlation exists between organizational satisfaction and improved quality outcomes.¹ A new initiative should have a well-defined purpose reinforced by collaborative workgroups and engaged employees who understand their clinical care role with electronic health record (EHR) modifications.

Several studies have shown how the usefulness of templates achieve multipurpose goals, such as accurate documentation and improved care. Valluru and colleagues showed a significant increase in vaccination rates for patients with inflammatory bowel disease after implementing a standardized template.² By using a standardized template, Thaker and colleagues showed improved documentation regarding obesity and increased nutritional and physical activity counseling.³ Furthermore, Grogan and colleagues showed that templates are useful for house staff education on International Classification of Diseases (ICD) terminology and demonstrated improved documentation in the postintervention group.^4,5

This article discusses the US Department of Veterans Affairs (VA) North Florida/South Georgia Veterans Health System (NF/SGVHS) integrated informatics solutions within template design in the Veterans Health Administration (VHA) EHR system that was associated with an increase in its case severity index (CSI) through improved clinical documentation capture.

Methods

According to policy activities that constitute research at NF/SGVHS, institutional review board approval was not required as this work met the criteria for operational improvement activities exempt from ethics review.

NF/SGVHS includes 2 hospitals: Malcom Randall VA Medical Center (MRVAMC) in Gainesville, Florida, and Lake City VA Medical Center (LCVAMC) in Lake City, Florida. MRVAMC is a large, 1a, academic VA facility composed of rotating residents and fellows and includes multiple specialty care services. LCVAMC is a smaller, nonteaching facility.

Template Design Impact

CSI is a risk-adjusted formula developed by the Inpatient Evaluation Center within VHA. CSI is incorporated into the VHA quality metrics reporting system, Strategic Analytics for Improvement and Learning (SAIL). CSI risk-adjusts metrics such as length of stay and mortality before releasing SAIL reports. CSI is calculated separately for acute level of care (LOC) and for the intensive care unit (ICU). In fiscal year (FY) 2017, acute LOC preimplementation data for CSI at NF/SGVHS were 0.76 for MRVAMC and 0.81 for LCVAMC, which was significantly below the national VHA average of 0.96 (Table).

A below-average CSI conveys a less complicated case mix compared with most other VA facilities. Although smaller VA facilities may have a less complicated case mix, it is unusual for large, tertiary care 1a VA facilities to have a low CSI. This low CSI is usually due to inadequate documentation, which affects not only risk-adjusted quality metrics outcomes, but also potential reimbursement.⁶

An interdisciplinary team composed of attendings, residents, and a clinical document improvement specialist identified the below-average acute LOC CSI for MRVAMC and LCVAMC compared with that of the national VHA average. Further analysis by chart reviews showed inconsistencies with standardized documentation despite prior health care provider education on ICD terminology and specific groups of common comorbidities analyzed in administrative data reviews for risk-adjustment purposes, known as Elixhauser comorbidities.^5,7

A chart review showed lack of clarity regarding primary reason(s) for admission and chronic comorbidities within NF/SGVHS. Using Pareto chart analysis, the template team designed a standardized history and physical (H&P) medicine template based on NF/SGVHS common medicine admissions (Figure 1). A Pareto chart is a valuable QI tool that assists with identifying majority contributors to a problem(s) being analyzed when evaluating a large set of data points. Subsequently, this tool helps focus direction on QI efforts.⁸

In addition, data objects were created within the template that permitted the ability to retrieve information from the VHA EHR and insert specific data points of interest in the template; for example, body mass index to assess degree of obesity and estimated glomerular filtration rate to determine the stage of chronic kidney disease. This allowed users to easily reference data in one template in lieu of searching for data in multiple places in the EHR.⁹

Results

The standardized H&P medicine template was implemented at MRVAMC and LCVAMC in June 2018 (the final month of the third quarter of FY 2018). As clinical providers throughout NF/SGVHS used the standardized template, acute LOC postimplementation data for CSI significantly improved. Although the national VHA average slightly decreased from 0.96 in the first quarter of FY 2017 to 0.89, in the first quarter of FY 2019, MRVAMC acute LOC CSI improved from 0.76 to 0.97, and LCVAMC acute LOC CSI improved from 0.81 to 1.07 during the same period.

In addition, compliance also was monitored within MRVAMC and LCVAMC for about 1 year after standardized H&P medicine template implementation. Compliance was determined by how often the standardized H&P medicine template was used for inpatient medicine admissions to the acute care wards vs other H&P notes used (such as personalized templates).

Methodology for compliance analysis included acquisition of completed H&P medicine notes from June 18, 2018 to June 30, 2019, within the VHA Veterans Information Systems and Technology Architecture (VistA) clinical and business information system using the search strings: “H&P admission history and physical” and “history of present illness.”¹⁰

A review identified 10,845 completed medicine H&P notes. Nine hundred eighteen notes were excluded as their search function yielded a location not corresponding to MRVAMC or LCVAMC. Of the 9,927 notes remaining, 8,025 of these were completed medicine H&P notes at MRVAMC and 1,902 were completed medicine H&P notes at LCVAMC (Figure 2).

Discussion

Template design with clear objectives, strategic collaboration, and integrated informatics solutions has the potential to increase accuracy of documentation. As shown, the NF/SGVHS template design was associated with significant improvement in acute LOC CSI for both MRVAMC and LCVAMC due to more accurate documentation using the standardized H&P medicine template.

Numerous factors contributed to the success of this template design. First, a clear vision for application of the template was communicated with key stakeholders. In addition, the template design team was focused on specific goals rather than a one size fits all approach, which was crucial for sustainable execution. Although interdisciplinary teamwork has the potential to result in innovative practices, large multidisciplinary teams also may have difficulty establishing a shared vision that can result in barriers to achieving project goals.

Balancing standardization and customization was essential for user buy-in. As noted by Gardner and Pearce, inviting clinical providers to participate in template design and allowing for customization has the potential to increase acceptance and use of templates.¹¹ Although the original design for the standardized H&P medicine template started with the medicine service at NF/SGVHS, the design framework is applicable to numerous services where various clinical care elements can be customized.

Explaining the informatics tools built into the template allowed clinicians to see opportunities to improve clinical documentation and the impact it has on reporting health care outcomes. When improvement work involves integrating clinical care delivery and administrative expectations, it is essential that health care systems understand and strategically execute project initiatives at this critical juncture.

Finally, incorporation of a sustainability plan when process improvement strategies are implemented is vital. In addition to collaboration with the clinical providers during design and implementation of the standardized template, leadership buy-in was key. Compliance with standardized H&P medicine template use was monitored monthly and reviewed by the NF/SGVHS Chief of Staff.

As noted, LCVAMC postimplementation acute LOC CSI was higher than that of MRVAMC despite being a smaller facility. This might be due to the MRVAMC designation as a teaching institution. Medicine is the only inpatient service at LCVAMC staffed by hospitalists with limited specialists available for consultation, whereas MRVAMC is a tertiary care teaching facility with numerous inpatient services and subspecialties. As LCVAMC has more continuity, house staff rotating at MRVAMC require continued training/education on new templates and process changes.

Limitations

Although standardized template design was successful at NF/SGVHS, limitations should be noted. Our clinical documentation improvement (CDI) program also was expanded about the same time as the new templates were released. The expansion of the CDI program in addition to new template design likely had a synergistic effect on acute LOC CSI.

CSI is a complex, risk-adjusted model that includes numerous factors, including but not limited to diagnosis and comorbid conditions. Other factors include age, marital status, procedures, source of admission, specific laboratory values, medical or surgical diagnosis-related group, intensive care unit stays, and immunosuppressive status. CSI also includes operative and nonoperative components that average into an overall CSI. As the majority of CSI is composed of nonoperative constituents within NF/SGVHS, we do not believe this had any substantial impact on reporting of CSI improvements.

In addition, template entry into VHA EHR requires a location selection (such as a clinic name or ward name following an inpatient admission). Of the 10,845 completed H&P medicine notes identified in VistA, 918 notes were excluded from analysis as their search function yielded a location not corresponding to MRVAMC or LCVAMC. For the 918 notes excluded, we believe this was likely due to user error where locations not related to MRVAMC or LCVAMC were selected during standardized H&P medicine template entry.

Conclusions

After the NF/SGVHS implementation of a uniquely designed template embedded with informatics solutions within the VHA EHR, the CSI increased due to more accurate documentation.

Next steps include determining the impact of the NF/SGVHS template design on potential reimbursement and expanding template design into the outpatient setting where there are additional opportunities to improve clinical documentation and reliable reporting of health care outcomes.

Acknowledgments

The authors thank the following individuals for their experience and contribution: Beverley White is the Clinical Documentation Improvement Coordinator at North Florida/South Georgia Veterans Health System and provided expertise on documentation requirements. Russell Jacobitz and Susan Rozelle provided technical expertise on electronic health record system enhancements and implemented the template design. Jess Delaune, MD, and Robert Carroll, MD, provided additional physician input during template design. We also acknowledge the Inpatient Evaluation Center (IPEC) within the Veterans Health Administration (VHA). IPEC developed the case severity index, a risk-adjusted formula incorporated into the VHA quality metric reporting system, Strategic Analytics for Improvement and Learning (SAIL).

Standardized template design is a useful tool to improve clinical documentation and reliable reporting of health care outcomes when constructed with clear objectives and with collaboration of key stakeholders. A standardized template should not only capture accurate diagnostic information, but also inform quality improvement (QI) measures and best practices.

Kang and colleagues showed that a correlation exists between organizational satisfaction and improved quality outcomes.¹ A new initiative should have a well-defined purpose reinforced by collaborative workgroups and engaged employees who understand their clinical care role with electronic health record (EHR) modifications.

Several studies have shown how the usefulness of templates achieve multipurpose goals, such as accurate documentation and improved care. Valluru and colleagues showed a significant increase in vaccination rates for patients with inflammatory bowel disease after implementing a standardized template.² By using a standardized template, Thaker and colleagues showed improved documentation regarding obesity and increased nutritional and physical activity counseling.³ Furthermore, Grogan and colleagues showed that templates are useful for house staff education on International Classification of Diseases (ICD) terminology and demonstrated improved documentation in the postintervention group.^4,5

This article discusses the US Department of Veterans Affairs (VA) North Florida/South Georgia Veterans Health System (NF/SGVHS) integrated informatics solutions within template design in the Veterans Health Administration (VHA) EHR system that was associated with an increase in its case severity index (CSI) through improved clinical documentation capture.

Methods

According to policy activities that constitute research at NF/SGVHS, institutional review board approval was not required as this work met the criteria for operational improvement activities exempt from ethics review.

NF/SGVHS includes 2 hospitals: Malcom Randall VA Medical Center (MRVAMC) in Gainesville, Florida, and Lake City VA Medical Center (LCVAMC) in Lake City, Florida. MRVAMC is a large, 1a, academic VA facility composed of rotating residents and fellows and includes multiple specialty care services. LCVAMC is a smaller, nonteaching facility.

Template Design Impact

CSI is a risk-adjusted formula developed by the Inpatient Evaluation Center within VHA. CSI is incorporated into the VHA quality metrics reporting system, Strategic Analytics for Improvement and Learning (SAIL). CSI risk-adjusts metrics such as length of stay and mortality before releasing SAIL reports. CSI is calculated separately for acute level of care (LOC) and for the intensive care unit (ICU). In fiscal year (FY) 2017, acute LOC preimplementation data for CSI at NF/SGVHS were 0.76 for MRVAMC and 0.81 for LCVAMC, which was significantly below the national VHA average of 0.96 (Table).

A below-average CSI conveys a less complicated case mix compared with most other VA facilities. Although smaller VA facilities may have a less complicated case mix, it is unusual for large, tertiary care 1a VA facilities to have a low CSI. This low CSI is usually due to inadequate documentation, which affects not only risk-adjusted quality metrics outcomes, but also potential reimbursement.⁶

An interdisciplinary team composed of attendings, residents, and a clinical document improvement specialist identified the below-average acute LOC CSI for MRVAMC and LCVAMC compared with that of the national VHA average. Further analysis by chart reviews showed inconsistencies with standardized documentation despite prior health care provider education on ICD terminology and specific groups of common comorbidities analyzed in administrative data reviews for risk-adjustment purposes, known as Elixhauser comorbidities.^5,7

A chart review showed lack of clarity regarding primary reason(s) for admission and chronic comorbidities within NF/SGVHS. Using Pareto chart analysis, the template team designed a standardized history and physical (H&P) medicine template based on NF/SGVHS common medicine admissions (Figure 1). A Pareto chart is a valuable QI tool that assists with identifying majority contributors to a problem(s) being analyzed when evaluating a large set of data points. Subsequently, this tool helps focus direction on QI efforts.⁸

In addition, data objects were created within the template that permitted the ability to retrieve information from the VHA EHR and insert specific data points of interest in the template; for example, body mass index to assess degree of obesity and estimated glomerular filtration rate to determine the stage of chronic kidney disease. This allowed users to easily reference data in one template in lieu of searching for data in multiple places in the EHR.⁹

Results

The standardized H&P medicine template was implemented at MRVAMC and LCVAMC in June 2018 (the final month of the third quarter of FY 2018). As clinical providers throughout NF/SGVHS used the standardized template, acute LOC postimplementation data for CSI significantly improved. Although the national VHA average slightly decreased from 0.96 in the first quarter of FY 2017 to 0.89, in the first quarter of FY 2019, MRVAMC acute LOC CSI improved from 0.76 to 0.97, and LCVAMC acute LOC CSI improved from 0.81 to 1.07 during the same period.

In addition, compliance also was monitored within MRVAMC and LCVAMC for about 1 year after standardized H&P medicine template implementation. Compliance was determined by how often the standardized H&P medicine template was used for inpatient medicine admissions to the acute care wards vs other H&P notes used (such as personalized templates).

Methodology for compliance analysis included acquisition of completed H&P medicine notes from June 18, 2018 to June 30, 2019, within the VHA Veterans Information Systems and Technology Architecture (VistA) clinical and business information system using the search strings: “H&P admission history and physical” and “history of present illness.”¹⁰

A review identified 10,845 completed medicine H&P notes. Nine hundred eighteen notes were excluded as their search function yielded a location not corresponding to MRVAMC or LCVAMC. Of the 9,927 notes remaining, 8,025 of these were completed medicine H&P notes at MRVAMC and 1,902 were completed medicine H&P notes at LCVAMC (Figure 2).

Discussion

Template design with clear objectives, strategic collaboration, and integrated informatics solutions has the potential to increase accuracy of documentation. As shown, the NF/SGVHS template design was associated with significant improvement in acute LOC CSI for both MRVAMC and LCVAMC due to more accurate documentation using the standardized H&P medicine template.

Numerous factors contributed to the success of this template design. First, a clear vision for application of the template was communicated with key stakeholders. In addition, the template design team was focused on specific goals rather than a one size fits all approach, which was crucial for sustainable execution. Although interdisciplinary teamwork has the potential to result in innovative practices, large multidisciplinary teams also may have difficulty establishing a shared vision that can result in barriers to achieving project goals.

Balancing standardization and customization was essential for user buy-in. As noted by Gardner and Pearce, inviting clinical providers to participate in template design and allowing for customization has the potential to increase acceptance and use of templates.¹¹ Although the original design for the standardized H&P medicine template started with the medicine service at NF/SGVHS, the design framework is applicable to numerous services where various clinical care elements can be customized.

Explaining the informatics tools built into the template allowed clinicians to see opportunities to improve clinical documentation and the impact it has on reporting health care outcomes. When improvement work involves integrating clinical care delivery and administrative expectations, it is essential that health care systems understand and strategically execute project initiatives at this critical juncture.

Finally, incorporation of a sustainability plan when process improvement strategies are implemented is vital. In addition to collaboration with the clinical providers during design and implementation of the standardized template, leadership buy-in was key. Compliance with standardized H&P medicine template use was monitored monthly and reviewed by the NF/SGVHS Chief of Staff.

As noted, LCVAMC postimplementation acute LOC CSI was higher than that of MRVAMC despite being a smaller facility. This might be due to the MRVAMC designation as a teaching institution. Medicine is the only inpatient service at LCVAMC staffed by hospitalists with limited specialists available for consultation, whereas MRVAMC is a tertiary care teaching facility with numerous inpatient services and subspecialties. As LCVAMC has more continuity, house staff rotating at MRVAMC require continued training/education on new templates and process changes.

Limitations

Although standardized template design was successful at NF/SGVHS, limitations should be noted. Our clinical documentation improvement (CDI) program also was expanded about the same time as the new templates were released. The expansion of the CDI program in addition to new template design likely had a synergistic effect on acute LOC CSI.

CSI is a complex, risk-adjusted model that includes numerous factors, including but not limited to diagnosis and comorbid conditions. Other factors include age, marital status, procedures, source of admission, specific laboratory values, medical or surgical diagnosis-related group, intensive care unit stays, and immunosuppressive status. CSI also includes operative and nonoperative components that average into an overall CSI. As the majority of CSI is composed of nonoperative constituents within NF/SGVHS, we do not believe this had any substantial impact on reporting of CSI improvements.

In addition, template entry into VHA EHR requires a location selection (such as a clinic name or ward name following an inpatient admission). Of the 10,845 completed H&P medicine notes identified in VistA, 918 notes were excluded from analysis as their search function yielded a location not corresponding to MRVAMC or LCVAMC. For the 918 notes excluded, we believe this was likely due to user error where locations not related to MRVAMC or LCVAMC were selected during standardized H&P medicine template entry.

Conclusions

After the NF/SGVHS implementation of a uniquely designed template embedded with informatics solutions within the VHA EHR, the CSI increased due to more accurate documentation.

Next steps include determining the impact of the NF/SGVHS template design on potential reimbursement and expanding template design into the outpatient setting where there are additional opportunities to improve clinical documentation and reliable reporting of health care outcomes.

Acknowledgments

The authors thank the following individuals for their experience and contribution: Beverley White is the Clinical Documentation Improvement Coordinator at North Florida/South Georgia Veterans Health System and provided expertise on documentation requirements. Russell Jacobitz and Susan Rozelle provided technical expertise on electronic health record system enhancements and implemented the template design. Jess Delaune, MD, and Robert Carroll, MD, provided additional physician input during template design. We also acknowledge the Inpatient Evaluation Center (IPEC) within the Veterans Health Administration (VHA). IPEC developed the case severity index, a risk-adjusted formula incorporated into the VHA quality metric reporting system, Strategic Analytics for Improvement and Learning (SAIL).

Standardized template design is a useful tool to improve clinical documentation and reliable reporting of health care outcomes when constructed with clear objectives and with collaboration of key stakeholders. A standardized template should not only capture accurate diagnostic information, but also inform quality improvement (QI) measures and best practices.

Kang and colleagues showed that a correlation exists between organizational satisfaction and improved quality outcomes.¹ A new initiative should have a well-defined purpose reinforced by collaborative workgroups and engaged employees who understand their clinical care role with electronic health record (EHR) modifications.

Several studies have shown how the usefulness of templates achieve multipurpose goals, such as accurate documentation and improved care. Valluru and colleagues showed a significant increase in vaccination rates for patients with inflammatory bowel disease after implementing a standardized template.² By using a standardized template, Thaker and colleagues showed improved documentation regarding obesity and increased nutritional and physical activity counseling.³ Furthermore, Grogan and colleagues showed that templates are useful for house staff education on International Classification of Diseases (ICD) terminology and demonstrated improved documentation in the postintervention group.^4,5

This article discusses the US Department of Veterans Affairs (VA) North Florida/South Georgia Veterans Health System (NF/SGVHS) integrated informatics solutions within template design in the Veterans Health Administration (VHA) EHR system that was associated with an increase in its case severity index (CSI) through improved clinical documentation capture.

Methods

According to policy activities that constitute research at NF/SGVHS, institutional review board approval was not required as this work met the criteria for operational improvement activities exempt from ethics review.

NF/SGVHS includes 2 hospitals: Malcom Randall VA Medical Center (MRVAMC) in Gainesville, Florida, and Lake City VA Medical Center (LCVAMC) in Lake City, Florida. MRVAMC is a large, 1a, academic VA facility composed of rotating residents and fellows and includes multiple specialty care services. LCVAMC is a smaller, nonteaching facility.

Template Design Impact

CSI is a risk-adjusted formula developed by the Inpatient Evaluation Center within VHA. CSI is incorporated into the VHA quality metrics reporting system, Strategic Analytics for Improvement and Learning (SAIL). CSI risk-adjusts metrics such as length of stay and mortality before releasing SAIL reports. CSI is calculated separately for acute level of care (LOC) and for the intensive care unit (ICU). In fiscal year (FY) 2017, acute LOC preimplementation data for CSI at NF/SGVHS were 0.76 for MRVAMC and 0.81 for LCVAMC, which was significantly below the national VHA average of 0.96 (Table).

A below-average CSI conveys a less complicated case mix compared with most other VA facilities. Although smaller VA facilities may have a less complicated case mix, it is unusual for large, tertiary care 1a VA facilities to have a low CSI. This low CSI is usually due to inadequate documentation, which affects not only risk-adjusted quality metrics outcomes, but also potential reimbursement.⁶

An interdisciplinary team composed of attendings, residents, and a clinical document improvement specialist identified the below-average acute LOC CSI for MRVAMC and LCVAMC compared with that of the national VHA average. Further analysis by chart reviews showed inconsistencies with standardized documentation despite prior health care provider education on ICD terminology and specific groups of common comorbidities analyzed in administrative data reviews for risk-adjustment purposes, known as Elixhauser comorbidities.^5,7

A chart review showed lack of clarity regarding primary reason(s) for admission and chronic comorbidities within NF/SGVHS. Using Pareto chart analysis, the template team designed a standardized history and physical (H&P) medicine template based on NF/SGVHS common medicine admissions (Figure 1). A Pareto chart is a valuable QI tool that assists with identifying majority contributors to a problem(s) being analyzed when evaluating a large set of data points. Subsequently, this tool helps focus direction on QI efforts.⁸

In addition, data objects were created within the template that permitted the ability to retrieve information from the VHA EHR and insert specific data points of interest in the template; for example, body mass index to assess degree of obesity and estimated glomerular filtration rate to determine the stage of chronic kidney disease. This allowed users to easily reference data in one template in lieu of searching for data in multiple places in the EHR.⁹

Results

The standardized H&P medicine template was implemented at MRVAMC and LCVAMC in June 2018 (the final month of the third quarter of FY 2018). As clinical providers throughout NF/SGVHS used the standardized template, acute LOC postimplementation data for CSI significantly improved. Although the national VHA average slightly decreased from 0.96 in the first quarter of FY 2017 to 0.89, in the first quarter of FY 2019, MRVAMC acute LOC CSI improved from 0.76 to 0.97, and LCVAMC acute LOC CSI improved from 0.81 to 1.07 during the same period.

In addition, compliance also was monitored within MRVAMC and LCVAMC for about 1 year after standardized H&P medicine template implementation. Compliance was determined by how often the standardized H&P medicine template was used for inpatient medicine admissions to the acute care wards vs other H&P notes used (such as personalized templates).

Methodology for compliance analysis included acquisition of completed H&P medicine notes from June 18, 2018 to June 30, 2019, within the VHA Veterans Information Systems and Technology Architecture (VistA) clinical and business information system using the search strings: “H&P admission history and physical” and “history of present illness.”¹⁰

A review identified 10,845 completed medicine H&P notes. Nine hundred eighteen notes were excluded as their search function yielded a location not corresponding to MRVAMC or LCVAMC. Of the 9,927 notes remaining, 8,025 of these were completed medicine H&P notes at MRVAMC and 1,902 were completed medicine H&P notes at LCVAMC (Figure 2).

Discussion

Template design with clear objectives, strategic collaboration, and integrated informatics solutions has the potential to increase accuracy of documentation. As shown, the NF/SGVHS template design was associated with significant improvement in acute LOC CSI for both MRVAMC and LCVAMC due to more accurate documentation using the standardized H&P medicine template.

Numerous factors contributed to the success of this template design. First, a clear vision for application of the template was communicated with key stakeholders. In addition, the template design team was focused on specific goals rather than a one size fits all approach, which was crucial for sustainable execution. Although interdisciplinary teamwork has the potential to result in innovative practices, large multidisciplinary teams also may have difficulty establishing a shared vision that can result in barriers to achieving project goals.

Balancing standardization and customization was essential for user buy-in. As noted by Gardner and Pearce, inviting clinical providers to participate in template design and allowing for customization has the potential to increase acceptance and use of templates.¹¹ Although the original design for the standardized H&P medicine template started with the medicine service at NF/SGVHS, the design framework is applicable to numerous services where various clinical care elements can be customized.

Explaining the informatics tools built into the template allowed clinicians to see opportunities to improve clinical documentation and the impact it has on reporting health care outcomes. When improvement work involves integrating clinical care delivery and administrative expectations, it is essential that health care systems understand and strategically execute project initiatives at this critical juncture.

Finally, incorporation of a sustainability plan when process improvement strategies are implemented is vital. In addition to collaboration with the clinical providers during design and implementation of the standardized template, leadership buy-in was key. Compliance with standardized H&P medicine template use was monitored monthly and reviewed by the NF/SGVHS Chief of Staff.

As noted, LCVAMC postimplementation acute LOC CSI was higher than that of MRVAMC despite being a smaller facility. This might be due to the MRVAMC designation as a teaching institution. Medicine is the only inpatient service at LCVAMC staffed by hospitalists with limited specialists available for consultation, whereas MRVAMC is a tertiary care teaching facility with numerous inpatient services and subspecialties. As LCVAMC has more continuity, house staff rotating at MRVAMC require continued training/education on new templates and process changes.

Limitations

Although standardized template design was successful at NF/SGVHS, limitations should be noted. Our clinical documentation improvement (CDI) program also was expanded about the same time as the new templates were released. The expansion of the CDI program in addition to new template design likely had a synergistic effect on acute LOC CSI.

CSI is a complex, risk-adjusted model that includes numerous factors, including but not limited to diagnosis and comorbid conditions. Other factors include age, marital status, procedures, source of admission, specific laboratory values, medical or surgical diagnosis-related group, intensive care unit stays, and immunosuppressive status. CSI also includes operative and nonoperative components that average into an overall CSI. As the majority of CSI is composed of nonoperative constituents within NF/SGVHS, we do not believe this had any substantial impact on reporting of CSI improvements.

In addition, template entry into VHA EHR requires a location selection (such as a clinic name or ward name following an inpatient admission). Of the 10,845 completed H&P medicine notes identified in VistA, 918 notes were excluded from analysis as their search function yielded a location not corresponding to MRVAMC or LCVAMC. For the 918 notes excluded, we believe this was likely due to user error where locations not related to MRVAMC or LCVAMC were selected during standardized H&P medicine template entry.

Conclusions

After the NF/SGVHS implementation of a uniquely designed template embedded with informatics solutions within the VHA EHR, the CSI increased due to more accurate documentation.

Next steps include determining the impact of the NF/SGVHS template design on potential reimbursement and expanding template design into the outpatient setting where there are additional opportunities to improve clinical documentation and reliable reporting of health care outcomes.

Acknowledgments

The authors thank the following individuals for their experience and contribution: Beverley White is the Clinical Documentation Improvement Coordinator at North Florida/South Georgia Veterans Health System and provided expertise on documentation requirements. Russell Jacobitz and Susan Rozelle provided technical expertise on electronic health record system enhancements and implemented the template design. Jess Delaune, MD, and Robert Carroll, MD, provided additional physician input during template design. We also acknowledge the Inpatient Evaluation Center (IPEC) within the Veterans Health Administration (VHA). IPEC developed the case severity index, a risk-adjusted formula incorporated into the VHA quality metric reporting system, Strategic Analytics for Improvement and Learning (SAIL).

The Food and Drug Administration has cleared for marketing a smartphone app that can detect and interrupt nightmares in adults with posttraumatic stress disorder (PTSD).

The NightWare app, from Minneapolis-based NightWare Inc., runs on the Apple Watch and Apple iPhone.

During sleep, Apple Watch sensors monitor heart rate and body movement. These data are used to create a unique sleep profile using a proprietary algorithm.

When the NightWare app detects that a patient is experiencing a nightmare based on changes in heart rate and movement, it provides slight vibrations through the Apple Watch to arouse the patient and interrupt the nightmare, without fully awakening the patient, the company notes.

NightWare is available by prescription only and is intended for use in adults aged 22 years and older with PTSD.

“Sleep is an essential part of a person’s daily routine. However, certain adults who have a nightmare disorder or who experience nightmares from PTSD are not able to get the rest they need,” Carlos Peña, PhD, director, Office of Neurological and Physical Medicine Devices, Center for Devices and Radiological Health at the FDA, said in a news release.

This authorization “offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares,” said Dr. Peña.

NightWare was tested in a 30-day randomized, sham-controlled trial of 70 patients. Patients in the sham group wore the device, but no vibrations were provided.

Both the sham and active groups showed improvement in sleep on standard sleep scales, with the active group showing greater improvement than sham. “The evidence demonstrated the probable benefits outweighed the probable risks,” the FDA said in a statement.

NightWare is not a standalone therapy for PTSD and should be used in conjunction with prescribed medications for PTSD and other recommended therapies for PTSD-associated nightmares and nightmare disorder, the agency said.

NightWare was granted breakthrough device designation for the treatment of nightmares in patients with PTSD. The device reviewed through the de novo premarket pathway, a regulatory pathway for some low- to moderate-risk devices of a new type.

Along with this marketing authorization, the FDA is establishing “special controls” designed to provide a “reasonable assurance of safety and effectiveness for tests of this type,” the agency said.

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

The Food and Drug Administration has cleared for marketing a smartphone app that can detect and interrupt nightmares in adults with posttraumatic stress disorder (PTSD).

The NightWare app, from Minneapolis-based NightWare Inc., runs on the Apple Watch and Apple iPhone.

During sleep, Apple Watch sensors monitor heart rate and body movement. These data are used to create a unique sleep profile using a proprietary algorithm.

When the NightWare app detects that a patient is experiencing a nightmare based on changes in heart rate and movement, it provides slight vibrations through the Apple Watch to arouse the patient and interrupt the nightmare, without fully awakening the patient, the company notes.

NightWare is available by prescription only and is intended for use in adults aged 22 years and older with PTSD.

“Sleep is an essential part of a person’s daily routine. However, certain adults who have a nightmare disorder or who experience nightmares from PTSD are not able to get the rest they need,” Carlos Peña, PhD, director, Office of Neurological and Physical Medicine Devices, Center for Devices and Radiological Health at the FDA, said in a news release.

This authorization “offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares,” said Dr. Peña.

NightWare was tested in a 30-day randomized, sham-controlled trial of 70 patients. Patients in the sham group wore the device, but no vibrations were provided.

Both the sham and active groups showed improvement in sleep on standard sleep scales, with the active group showing greater improvement than sham. “The evidence demonstrated the probable benefits outweighed the probable risks,” the FDA said in a statement.

NightWare is not a standalone therapy for PTSD and should be used in conjunction with prescribed medications for PTSD and other recommended therapies for PTSD-associated nightmares and nightmare disorder, the agency said.

NightWare was granted breakthrough device designation for the treatment of nightmares in patients with PTSD. The device reviewed through the de novo premarket pathway, a regulatory pathway for some low- to moderate-risk devices of a new type.

Along with this marketing authorization, the FDA is establishing “special controls” designed to provide a “reasonable assurance of safety and effectiveness for tests of this type,” the agency said.

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

The Food and Drug Administration has cleared for marketing a smartphone app that can detect and interrupt nightmares in adults with posttraumatic stress disorder (PTSD).

The NightWare app, from Minneapolis-based NightWare Inc., runs on the Apple Watch and Apple iPhone.

During sleep, Apple Watch sensors monitor heart rate and body movement. These data are used to create a unique sleep profile using a proprietary algorithm.

When the NightWare app detects that a patient is experiencing a nightmare based on changes in heart rate and movement, it provides slight vibrations through the Apple Watch to arouse the patient and interrupt the nightmare, without fully awakening the patient, the company notes.

NightWare is available by prescription only and is intended for use in adults aged 22 years and older with PTSD.

“Sleep is an essential part of a person’s daily routine. However, certain adults who have a nightmare disorder or who experience nightmares from PTSD are not able to get the rest they need,” Carlos Peña, PhD, director, Office of Neurological and Physical Medicine Devices, Center for Devices and Radiological Health at the FDA, said in a news release.

This authorization “offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares,” said Dr. Peña.

NightWare was tested in a 30-day randomized, sham-controlled trial of 70 patients. Patients in the sham group wore the device, but no vibrations were provided.

Both the sham and active groups showed improvement in sleep on standard sleep scales, with the active group showing greater improvement than sham. “The evidence demonstrated the probable benefits outweighed the probable risks,” the FDA said in a statement.

NightWare is not a standalone therapy for PTSD and should be used in conjunction with prescribed medications for PTSD and other recommended therapies for PTSD-associated nightmares and nightmare disorder, the agency said.

NightWare was granted breakthrough device designation for the treatment of nightmares in patients with PTSD. The device reviewed through the de novo premarket pathway, a regulatory pathway for some low- to moderate-risk devices of a new type.

Along with this marketing authorization, the FDA is establishing “special controls” designed to provide a “reasonable assurance of safety and effectiveness for tests of this type,” the agency said.

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

A coauthor of the Great Barrington Declaration says that he and colleagues have never argued against using mitigation strategies to keep COVID-19 from spreading, and that critics have mischaracterized the document as a “let it rip” strategy.

Jay Bhattacharya, MD, PhD, a professor and public health policy expert in infectious diseases at Stanford University in California, spoke on a JAMA Livestream debate on November 6. Marc Lipsitch, MD, an epidemiology professor at the Harvard T.H. Chan School of Public Health in Boston, Massachusetts, represented the 6900 signatories of the John Snow Memorandum, a rebuttal to the Great Barrington document.

The Great Barrington approach of “Focused Protection” advocates isolation and protection of people who are most vulnerable to COVID-19 while avoiding what they characterize as lockdowns. “The most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk,” the document reads.

The Infectious Diseases Society of America (IDSA) and its HIV Medicine Association denounced the declaration, as reported by Medscape Medical News, and the World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus called the proposal “unethical.” But the idea has gained some traction at the White House, where Coronavirus Task Force Member and Stanford professor Scott Atlas, MD, has been advising President Donald J. Trump.

On the JAMA debate, Bhattacharya said, “I think all of the mitigation measures are really important,” listing social distancing, hand washing, and masks when distancing is not possible as chief among those strategies for the less vulnerable. “I don’t want to create infections intentionally, but I want us to allow people to go back to their lives as best they can, understanding of the risks they are taking when they do it,” he said, claiming that 99.95% of the population will survive infection.

“The harmful lockdowns are worse for many, many people,” Bhattacharya said.

“I think Jay is moving towards a middle ground which is not really what the Great Barrington Declaration seems to promote,” countered Lipsitch. The declaration does not say use masks or social distance, he said. “It just says we need to go back to a normal life.” 

Bhattacharya’s statements to JAMA mean that “maybe we are approaching some common ground,” Lipsitch said.
 

Definition of a lockdown

Both men were asked to give their definition of a “lockdown.” To Lipsitch, it means people are not allowed out except for essential services and that most businesses are closed, with exceptions for those deemed essential.

Bhattacharya, however, said he views that as a quarantine. Lockdowns “are what we’re currently doing,” he said. Schools, churches, businesses, and arts and culture organizations are shuttered, and “almost every aspect of society is restricted in some way,” Bhattacharya said.

He blamed these lockdowns for most of the excess deaths over and above the COVID-19 deaths and said they had failed to control the pandemic.

Lipsitch said that “it feels to me that Jay is describing as lockdown everything that causes harm, even when it’s not locked down.” He noted that the country was truly closed down for 2 months or so in the spring.

“All of these harms I agree are real,” said Lipsitch. “But they are because the normal life of our society is being interfered with by viral transmission and by people’s inability to live their normal lives.”

Closures and lockdowns are essential to delaying cases and deaths, said Lipsitch. “A case today is worse than a case tomorrow and a lot worse than a case 6 months from now,” he said, noting that a vaccine or improved therapeutics could evolve.

“Delay is not nothing,” Lipsitch added. “It’s actually the goal as I see it, and as the John Snow memo says, we want to keep the virus under control in such a way as that the vulnerable people are not at risk.”

He predicted that cases will continue to grow exponentially because the nation is “not even close to herd immunity.” And, if intensive care units fill up, “there will be a responsive lockdown,” he said, adding that he did not endorse that as a general matter or favor it as a default position.

Bhattacharya claimed that Sweden has tallied only 1800 excess deaths since the pandemic began. “That’s lockdown harm avoided,” he said, advocating a similar strategy for the United States. But, infections have been on the rise in Sweden, and the nation has a higher COVID-19 death rate — with 6000 deaths — than other Nordic countries.

“If we keep this policy of lockdown we will have the same kind of outcomes we’ve already had — high excess deaths and sort of indifferent control of COVID,” Bhattacharya said.

“We’re still going to have misery and death going forward until we reach a point where there’s sufficient immunity either though a vaccine or through natural infection,” he said.

This article first appeared on Medscape.com.

A coauthor of the Great Barrington Declaration says that he and colleagues have never argued against using mitigation strategies to keep COVID-19 from spreading, and that critics have mischaracterized the document as a “let it rip” strategy.

Jay Bhattacharya, MD, PhD, a professor and public health policy expert in infectious diseases at Stanford University in California, spoke on a JAMA Livestream debate on November 6. Marc Lipsitch, MD, an epidemiology professor at the Harvard T.H. Chan School of Public Health in Boston, Massachusetts, represented the 6900 signatories of the John Snow Memorandum, a rebuttal to the Great Barrington document.

The Great Barrington approach of “Focused Protection” advocates isolation and protection of people who are most vulnerable to COVID-19 while avoiding what they characterize as lockdowns. “The most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk,” the document reads.

The Infectious Diseases Society of America (IDSA) and its HIV Medicine Association denounced the declaration, as reported by Medscape Medical News, and the World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus called the proposal “unethical.” But the idea has gained some traction at the White House, where Coronavirus Task Force Member and Stanford professor Scott Atlas, MD, has been advising President Donald J. Trump.

On the JAMA debate, Bhattacharya said, “I think all of the mitigation measures are really important,” listing social distancing, hand washing, and masks when distancing is not possible as chief among those strategies for the less vulnerable. “I don’t want to create infections intentionally, but I want us to allow people to go back to their lives as best they can, understanding of the risks they are taking when they do it,” he said, claiming that 99.95% of the population will survive infection.

“The harmful lockdowns are worse for many, many people,” Bhattacharya said.

“I think Jay is moving towards a middle ground which is not really what the Great Barrington Declaration seems to promote,” countered Lipsitch. The declaration does not say use masks or social distance, he said. “It just says we need to go back to a normal life.” 

Bhattacharya’s statements to JAMA mean that “maybe we are approaching some common ground,” Lipsitch said.
 

Definition of a lockdown

Both men were asked to give their definition of a “lockdown.” To Lipsitch, it means people are not allowed out except for essential services and that most businesses are closed, with exceptions for those deemed essential.

Bhattacharya, however, said he views that as a quarantine. Lockdowns “are what we’re currently doing,” he said. Schools, churches, businesses, and arts and culture organizations are shuttered, and “almost every aspect of society is restricted in some way,” Bhattacharya said.

He blamed these lockdowns for most of the excess deaths over and above the COVID-19 deaths and said they had failed to control the pandemic.

Lipsitch said that “it feels to me that Jay is describing as lockdown everything that causes harm, even when it’s not locked down.” He noted that the country was truly closed down for 2 months or so in the spring.

“All of these harms I agree are real,” said Lipsitch. “But they are because the normal life of our society is being interfered with by viral transmission and by people’s inability to live their normal lives.”

Closures and lockdowns are essential to delaying cases and deaths, said Lipsitch. “A case today is worse than a case tomorrow and a lot worse than a case 6 months from now,” he said, noting that a vaccine or improved therapeutics could evolve.

“Delay is not nothing,” Lipsitch added. “It’s actually the goal as I see it, and as the John Snow memo says, we want to keep the virus under control in such a way as that the vulnerable people are not at risk.”

He predicted that cases will continue to grow exponentially because the nation is “not even close to herd immunity.” And, if intensive care units fill up, “there will be a responsive lockdown,” he said, adding that he did not endorse that as a general matter or favor it as a default position.

Bhattacharya claimed that Sweden has tallied only 1800 excess deaths since the pandemic began. “That’s lockdown harm avoided,” he said, advocating a similar strategy for the United States. But, infections have been on the rise in Sweden, and the nation has a higher COVID-19 death rate — with 6000 deaths — than other Nordic countries.

“If we keep this policy of lockdown we will have the same kind of outcomes we’ve already had — high excess deaths and sort of indifferent control of COVID,” Bhattacharya said.

“We’re still going to have misery and death going forward until we reach a point where there’s sufficient immunity either though a vaccine or through natural infection,” he said.

This article first appeared on Medscape.com.

A coauthor of the Great Barrington Declaration says that he and colleagues have never argued against using mitigation strategies to keep COVID-19 from spreading, and that critics have mischaracterized the document as a “let it rip” strategy.

Jay Bhattacharya, MD, PhD, a professor and public health policy expert in infectious diseases at Stanford University in California, spoke on a JAMA Livestream debate on November 6. Marc Lipsitch, MD, an epidemiology professor at the Harvard T.H. Chan School of Public Health in Boston, Massachusetts, represented the 6900 signatories of the John Snow Memorandum, a rebuttal to the Great Barrington document.

The Great Barrington approach of “Focused Protection” advocates isolation and protection of people who are most vulnerable to COVID-19 while avoiding what they characterize as lockdowns. “The most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk,” the document reads.

The Infectious Diseases Society of America (IDSA) and its HIV Medicine Association denounced the declaration, as reported by Medscape Medical News, and the World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus called the proposal “unethical.” But the idea has gained some traction at the White House, where Coronavirus Task Force Member and Stanford professor Scott Atlas, MD, has been advising President Donald J. Trump.

On the JAMA debate, Bhattacharya said, “I think all of the mitigation measures are really important,” listing social distancing, hand washing, and masks when distancing is not possible as chief among those strategies for the less vulnerable. “I don’t want to create infections intentionally, but I want us to allow people to go back to their lives as best they can, understanding of the risks they are taking when they do it,” he said, claiming that 99.95% of the population will survive infection.

“The harmful lockdowns are worse for many, many people,” Bhattacharya said.

“I think Jay is moving towards a middle ground which is not really what the Great Barrington Declaration seems to promote,” countered Lipsitch. The declaration does not say use masks or social distance, he said. “It just says we need to go back to a normal life.” 

Bhattacharya’s statements to JAMA mean that “maybe we are approaching some common ground,” Lipsitch said.
 

Definition of a lockdown

Both men were asked to give their definition of a “lockdown.” To Lipsitch, it means people are not allowed out except for essential services and that most businesses are closed, with exceptions for those deemed essential.

Bhattacharya, however, said he views that as a quarantine. Lockdowns “are what we’re currently doing,” he said. Schools, churches, businesses, and arts and culture organizations are shuttered, and “almost every aspect of society is restricted in some way,” Bhattacharya said.

He blamed these lockdowns for most of the excess deaths over and above the COVID-19 deaths and said they had failed to control the pandemic.

Lipsitch said that “it feels to me that Jay is describing as lockdown everything that causes harm, even when it’s not locked down.” He noted that the country was truly closed down for 2 months or so in the spring.

“All of these harms I agree are real,” said Lipsitch. “But they are because the normal life of our society is being interfered with by viral transmission and by people’s inability to live their normal lives.”

Closures and lockdowns are essential to delaying cases and deaths, said Lipsitch. “A case today is worse than a case tomorrow and a lot worse than a case 6 months from now,” he said, noting that a vaccine or improved therapeutics could evolve.

“Delay is not nothing,” Lipsitch added. “It’s actually the goal as I see it, and as the John Snow memo says, we want to keep the virus under control in such a way as that the vulnerable people are not at risk.”

He predicted that cases will continue to grow exponentially because the nation is “not even close to herd immunity.” And, if intensive care units fill up, “there will be a responsive lockdown,” he said, adding that he did not endorse that as a general matter or favor it as a default position.

Bhattacharya claimed that Sweden has tallied only 1800 excess deaths since the pandemic began. “That’s lockdown harm avoided,” he said, advocating a similar strategy for the United States. But, infections have been on the rise in Sweden, and the nation has a higher COVID-19 death rate — with 6000 deaths — than other Nordic countries.

“If we keep this policy of lockdown we will have the same kind of outcomes we’ve already had — high excess deaths and sort of indifferent control of COVID,” Bhattacharya said.

“We’re still going to have misery and death going forward until we reach a point where there’s sufficient immunity either though a vaccine or through natural infection,” he said.

This article first appeared on Medscape.com.

At first, when news spread of a 28-year-old doctor on the COVID-19 front lines in Brazil who died after receiving an experimental vaccine, doubts arose about the safety of one of the most promising coronavirus vaccine candidates. But then the story flipped. Although the vaccine maker wouldn’t confirm it, the doctor appeared to have been in the control group and had received a dose of an established meningitis vaccine. The danger came from exposure to the coronavirus itself.

That tragedy underscores the ongoing risk of COVID-19 to healthcare workers, who have been designated by US advisory panels as part of phase 1A – the first to receive doses of any approved vaccine. The Centers for Disease Control and Prevention (CDC) recently reported that 6% of adults hospitalized with COVID from March to May were healthcare workers. The report was based on surveillance data from 13 states. The average age of the patients was 49 years. The agency set a November 15 vaccination “readiness date” for jurisdictions, such as state health departments, even though a vaccine isn’t likely to be authorized by then.

As hospitals scramble to prepare, their watchword is flexibility. They don’t yet know how many initial doses they will get, of which vaccine, or in what time frame. They have a sophisticated infrastructure to deliver flu vaccines each fall, but that framework doesn’t align with the likely scenarios of limited supply, additional reporting requirements, two-dose regimens, and differing storage needs.

“Healthcare organizations have consistently risen to the challenge. I wholeheartedly believe in their potential to do this,” Anna Legreid Dopp, PharmD, senior director of quality improvement and guidelines for the American Society of Health-System Pharmacists, told Medscape Medical News.
 

Healthcare workers won’t face a vaccine mandate

Even after months of caring for COVID patients, most clinicians remain vulnerable to infection – at work and in their communities. That was what occupational medicine physician Kevin Smith, MD, realized when his health system, Toledo, Ohio–based ProMedica, offered antibody testing to all its 50,000 employees. About 2% of the 6933 tests given came back positive, he says.

Yet many physicians, nurses, and other healthcare workers share the public’s skepticism about the safety and effectiveness of a vaccine that receives swift US Food and Drug Administration (FDA) approval for emergency use. About half of nurses (47%) and almost 1 in 3 physicians (30%) say that they don’t want to get the vaccine when it first becomes available or that they’re unsure about vaccination, according to a Medscape survey.

Because vaccination of healthcare workers will set the stage for public acceptance of the vaccine, hospital epidemiologists are concerned. “We know that there will be some hesitancy in the healthcare workforce, just as there will be in the broader public,” said Marci Drees, MD, chief infection prevention officer and hospital epidemiologist for ChristianaCare in Newark, Delaware, and liaison from the Society for Healthcare Epidemiology of America to the CDC’s Advisory Committee on Immunization Practices.* “I do not think we can expect anyone to be vaccinated if we’re not willing to vaccinate ourselves.”

Healthcare workers are typically required to receive a range of vaccines, including measles, mumps, and rubella (MMR) and pertussis shots. Each year, close to half of US healthcare workers receive a flu vaccine under a workplace mandate. But COVID-19 will be different. The FDA requires anyone given products under an emergency use authorization (EUA) to receive information about risks and benefits and to have the option to decline. Hospitals instead will rely on education as they offer a novel vaccine (or more than one) that will have a minimum effectiveness of 50%.

ProMedica doesn’t require employees to be vaccinated against flu, but employees who decline must get a note from a doctor indicating that they have talked about the risks and benefits of the vaccine. A similar approach may be used with a COVID-19 vaccine, in which employees may be required to learn about the vaccine before they decline, Smith says. “I do believe some people will say they don’t want to get it,” he added.

Like colleagues across the country, Smith is identifying healthcare workers who are involved in direct care of COVID-19 patients and are at highest risk for exposure. Even within the top tier, those performing the riskiest tasks, such as respiratory therapists who provide breathing treatments that spread aerosols and droplets, will be tagged as a priority group, he says. Healthcare workers who spend the most time in proximity to COVID patients, such as nurses in a COVID unit, also are likely to get the first doses, he says.
 

Swirl, don’t shake, the vaccine

Hospitals are adept at ramping up vaccination campaigns. For example, last year, Vanderbilt University Medical Center, in Nashville, Tennessee, vaccinated nearly 16,000 employees against influenza in their 1-day “Flulapalooza” event. The medical center even earned a Guinness world record in 2011 at the first Flulapalooza for giving the most vaccinations ever within 8 hours.

The 10th anniversary of the event was canceled this year because of COVID restrictions. Instead, nurses, pharmacists, and other clinicians pitched in to vaccinate their coworkers against influenza. Now, plans for COVID-19 vaccination move forward amid uncertainty.

Instead of holding a mass event, “the delivery mechanisms will need to be more targeted and focused,” said Lori Rolando, MD, MPH, director of the Vanderbilt Occupational Health Clinic. In the CDC’s most recent version of its vaccination program “playbook,” the agency recommends giving the vaccines in an area that allows people to remain 6 feet apart and for them to wait for 15 minutes after receiving the shot to make sure they don’t faint, a potential risk common to almost all vaccines.

That’s the easy part. Planning becomes more complex, given the uncertainty as to which vaccines will receive approval and which one a hospital will receive.

If the Pfizer/BioNTech vaccine receives EUA in 2020, about 10 to 20 million doses could be available in November and 20 to 30 million doses in December. The ultracold containers used to ship the vaccines have to be replenished with dry ice within 24 hours of receipt and every 5 days thereafter. Hospitals will need temperature probes to monitor storage in the containers. The five-dose vials can be refrigerated before administering, but only for 5 days. The product must be diluted, and it then must be used within 6 hours.

The Moderna vaccine will be somewhat less plentiful at first. About 10 million doses are expected in November and 15 million doses by the end of December. The 10-dose vials are stored in a freezer. Once they are placed in a refrigerator to thaw, they have to be used within 7 days, and once they’re removed from the refrigerator, they have to be used within 12 hours. The pharmacist or other vaccinator must swirl – but not shake! – the vial before delivering a dose, according to the CDC playbook.

As more information emerges about the vaccines, instructions may change, and Smith is steeled for shifting scenarios. “These are all draft plans. We’re going to modify as we go along,” he says.

The Pfizer vaccine requires a second dose at 21 days, and the Moderna vaccine targets the second dose at 28 days. In addition to using information systems to track vaccinations and any adverse effects, hospitals will give employees a card indicating what vaccine they received, the date it was administered, and the date on which they need to return. (At this point, the time frame for the second dose doesn’t appear to be flexible.)

Regardless of the vaccine, one message stays the same: COVID precautions must continue. That means mask wearing, social distancing, and hand washing – practices that also must be followed by healthcare workers who test positive for naturally acquired antibodies.

“I don’t think anyone expects the COVID vaccine to be 100% effective at preventing COVID,” says Rolando. “So all of the other tools in our toolbox are going to need to be continued to be used as well.”
 

*Correction, 11/12/20: An earlier version of this article misstated the name of Dr. Drees' institution.

This article first appeared on Medscape.com.

At first, when news spread of a 28-year-old doctor on the COVID-19 front lines in Brazil who died after receiving an experimental vaccine, doubts arose about the safety of one of the most promising coronavirus vaccine candidates. But then the story flipped. Although the vaccine maker wouldn’t confirm it, the doctor appeared to have been in the control group and had received a dose of an established meningitis vaccine. The danger came from exposure to the coronavirus itself.

That tragedy underscores the ongoing risk of COVID-19 to healthcare workers, who have been designated by US advisory panels as part of phase 1A – the first to receive doses of any approved vaccine. The Centers for Disease Control and Prevention (CDC) recently reported that 6% of adults hospitalized with COVID from March to May were healthcare workers. The report was based on surveillance data from 13 states. The average age of the patients was 49 years. The agency set a November 15 vaccination “readiness date” for jurisdictions, such as state health departments, even though a vaccine isn’t likely to be authorized by then.

As hospitals scramble to prepare, their watchword is flexibility. They don’t yet know how many initial doses they will get, of which vaccine, or in what time frame. They have a sophisticated infrastructure to deliver flu vaccines each fall, but that framework doesn’t align with the likely scenarios of limited supply, additional reporting requirements, two-dose regimens, and differing storage needs.

“Healthcare organizations have consistently risen to the challenge. I wholeheartedly believe in their potential to do this,” Anna Legreid Dopp, PharmD, senior director of quality improvement and guidelines for the American Society of Health-System Pharmacists, told Medscape Medical News.
 

Healthcare workers won’t face a vaccine mandate

Even after months of caring for COVID patients, most clinicians remain vulnerable to infection – at work and in their communities. That was what occupational medicine physician Kevin Smith, MD, realized when his health system, Toledo, Ohio–based ProMedica, offered antibody testing to all its 50,000 employees. About 2% of the 6933 tests given came back positive, he says.

Yet many physicians, nurses, and other healthcare workers share the public’s skepticism about the safety and effectiveness of a vaccine that receives swift US Food and Drug Administration (FDA) approval for emergency use. About half of nurses (47%) and almost 1 in 3 physicians (30%) say that they don’t want to get the vaccine when it first becomes available or that they’re unsure about vaccination, according to a Medscape survey.

Because vaccination of healthcare workers will set the stage for public acceptance of the vaccine, hospital epidemiologists are concerned. “We know that there will be some hesitancy in the healthcare workforce, just as there will be in the broader public,” said Marci Drees, MD, chief infection prevention officer and hospital epidemiologist for ChristianaCare in Newark, Delaware, and liaison from the Society for Healthcare Epidemiology of America to the CDC’s Advisory Committee on Immunization Practices.* “I do not think we can expect anyone to be vaccinated if we’re not willing to vaccinate ourselves.”

Healthcare workers are typically required to receive a range of vaccines, including measles, mumps, and rubella (MMR) and pertussis shots. Each year, close to half of US healthcare workers receive a flu vaccine under a workplace mandate. But COVID-19 will be different. The FDA requires anyone given products under an emergency use authorization (EUA) to receive information about risks and benefits and to have the option to decline. Hospitals instead will rely on education as they offer a novel vaccine (or more than one) that will have a minimum effectiveness of 50%.

ProMedica doesn’t require employees to be vaccinated against flu, but employees who decline must get a note from a doctor indicating that they have talked about the risks and benefits of the vaccine. A similar approach may be used with a COVID-19 vaccine, in which employees may be required to learn about the vaccine before they decline, Smith says. “I do believe some people will say they don’t want to get it,” he added.

Like colleagues across the country, Smith is identifying healthcare workers who are involved in direct care of COVID-19 patients and are at highest risk for exposure. Even within the top tier, those performing the riskiest tasks, such as respiratory therapists who provide breathing treatments that spread aerosols and droplets, will be tagged as a priority group, he says. Healthcare workers who spend the most time in proximity to COVID patients, such as nurses in a COVID unit, also are likely to get the first doses, he says.
 

Swirl, don’t shake, the vaccine

Hospitals are adept at ramping up vaccination campaigns. For example, last year, Vanderbilt University Medical Center, in Nashville, Tennessee, vaccinated nearly 16,000 employees against influenza in their 1-day “Flulapalooza” event. The medical center even earned a Guinness world record in 2011 at the first Flulapalooza for giving the most vaccinations ever within 8 hours.

The 10th anniversary of the event was canceled this year because of COVID restrictions. Instead, nurses, pharmacists, and other clinicians pitched in to vaccinate their coworkers against influenza. Now, plans for COVID-19 vaccination move forward amid uncertainty.

Instead of holding a mass event, “the delivery mechanisms will need to be more targeted and focused,” said Lori Rolando, MD, MPH, director of the Vanderbilt Occupational Health Clinic. In the CDC’s most recent version of its vaccination program “playbook,” the agency recommends giving the vaccines in an area that allows people to remain 6 feet apart and for them to wait for 15 minutes after receiving the shot to make sure they don’t faint, a potential risk common to almost all vaccines.

That’s the easy part. Planning becomes more complex, given the uncertainty as to which vaccines will receive approval and which one a hospital will receive.

If the Pfizer/BioNTech vaccine receives EUA in 2020, about 10 to 20 million doses could be available in November and 20 to 30 million doses in December. The ultracold containers used to ship the vaccines have to be replenished with dry ice within 24 hours of receipt and every 5 days thereafter. Hospitals will need temperature probes to monitor storage in the containers. The five-dose vials can be refrigerated before administering, but only for 5 days. The product must be diluted, and it then must be used within 6 hours.

The Moderna vaccine will be somewhat less plentiful at first. About 10 million doses are expected in November and 15 million doses by the end of December. The 10-dose vials are stored in a freezer. Once they are placed in a refrigerator to thaw, they have to be used within 7 days, and once they’re removed from the refrigerator, they have to be used within 12 hours. The pharmacist or other vaccinator must swirl – but not shake! – the vial before delivering a dose, according to the CDC playbook.

As more information emerges about the vaccines, instructions may change, and Smith is steeled for shifting scenarios. “These are all draft plans. We’re going to modify as we go along,” he says.

The Pfizer vaccine requires a second dose at 21 days, and the Moderna vaccine targets the second dose at 28 days. In addition to using information systems to track vaccinations and any adverse effects, hospitals will give employees a card indicating what vaccine they received, the date it was administered, and the date on which they need to return. (At this point, the time frame for the second dose doesn’t appear to be flexible.)

Regardless of the vaccine, one message stays the same: COVID precautions must continue. That means mask wearing, social distancing, and hand washing – practices that also must be followed by healthcare workers who test positive for naturally acquired antibodies.

“I don’t think anyone expects the COVID vaccine to be 100% effective at preventing COVID,” says Rolando. “So all of the other tools in our toolbox are going to need to be continued to be used as well.”
 

*Correction, 11/12/20: An earlier version of this article misstated the name of Dr. Drees' institution.

This article first appeared on Medscape.com.

At first, when news spread of a 28-year-old doctor on the COVID-19 front lines in Brazil who died after receiving an experimental vaccine, doubts arose about the safety of one of the most promising coronavirus vaccine candidates. But then the story flipped. Although the vaccine maker wouldn’t confirm it, the doctor appeared to have been in the control group and had received a dose of an established meningitis vaccine. The danger came from exposure to the coronavirus itself.

That tragedy underscores the ongoing risk of COVID-19 to healthcare workers, who have been designated by US advisory panels as part of phase 1A – the first to receive doses of any approved vaccine. The Centers for Disease Control and Prevention (CDC) recently reported that 6% of adults hospitalized with COVID from March to May were healthcare workers. The report was based on surveillance data from 13 states. The average age of the patients was 49 years. The agency set a November 15 vaccination “readiness date” for jurisdictions, such as state health departments, even though a vaccine isn’t likely to be authorized by then.

As hospitals scramble to prepare, their watchword is flexibility. They don’t yet know how many initial doses they will get, of which vaccine, or in what time frame. They have a sophisticated infrastructure to deliver flu vaccines each fall, but that framework doesn’t align with the likely scenarios of limited supply, additional reporting requirements, two-dose regimens, and differing storage needs.

“Healthcare organizations have consistently risen to the challenge. I wholeheartedly believe in their potential to do this,” Anna Legreid Dopp, PharmD, senior director of quality improvement and guidelines for the American Society of Health-System Pharmacists, told Medscape Medical News.
 

Healthcare workers won’t face a vaccine mandate

Even after months of caring for COVID patients, most clinicians remain vulnerable to infection – at work and in their communities. That was what occupational medicine physician Kevin Smith, MD, realized when his health system, Toledo, Ohio–based ProMedica, offered antibody testing to all its 50,000 employees. About 2% of the 6933 tests given came back positive, he says.

Yet many physicians, nurses, and other healthcare workers share the public’s skepticism about the safety and effectiveness of a vaccine that receives swift US Food and Drug Administration (FDA) approval for emergency use. About half of nurses (47%) and almost 1 in 3 physicians (30%) say that they don’t want to get the vaccine when it first becomes available or that they’re unsure about vaccination, according to a Medscape survey.

Because vaccination of healthcare workers will set the stage for public acceptance of the vaccine, hospital epidemiologists are concerned. “We know that there will be some hesitancy in the healthcare workforce, just as there will be in the broader public,” said Marci Drees, MD, chief infection prevention officer and hospital epidemiologist for ChristianaCare in Newark, Delaware, and liaison from the Society for Healthcare Epidemiology of America to the CDC’s Advisory Committee on Immunization Practices.* “I do not think we can expect anyone to be vaccinated if we’re not willing to vaccinate ourselves.”

Healthcare workers are typically required to receive a range of vaccines, including measles, mumps, and rubella (MMR) and pertussis shots. Each year, close to half of US healthcare workers receive a flu vaccine under a workplace mandate. But COVID-19 will be different. The FDA requires anyone given products under an emergency use authorization (EUA) to receive information about risks and benefits and to have the option to decline. Hospitals instead will rely on education as they offer a novel vaccine (or more than one) that will have a minimum effectiveness of 50%.

ProMedica doesn’t require employees to be vaccinated against flu, but employees who decline must get a note from a doctor indicating that they have talked about the risks and benefits of the vaccine. A similar approach may be used with a COVID-19 vaccine, in which employees may be required to learn about the vaccine before they decline, Smith says. “I do believe some people will say they don’t want to get it,” he added.

Like colleagues across the country, Smith is identifying healthcare workers who are involved in direct care of COVID-19 patients and are at highest risk for exposure. Even within the top tier, those performing the riskiest tasks, such as respiratory therapists who provide breathing treatments that spread aerosols and droplets, will be tagged as a priority group, he says. Healthcare workers who spend the most time in proximity to COVID patients, such as nurses in a COVID unit, also are likely to get the first doses, he says.
 

Swirl, don’t shake, the vaccine

Hospitals are adept at ramping up vaccination campaigns. For example, last year, Vanderbilt University Medical Center, in Nashville, Tennessee, vaccinated nearly 16,000 employees against influenza in their 1-day “Flulapalooza” event. The medical center even earned a Guinness world record in 2011 at the first Flulapalooza for giving the most vaccinations ever within 8 hours.

The 10th anniversary of the event was canceled this year because of COVID restrictions. Instead, nurses, pharmacists, and other clinicians pitched in to vaccinate their coworkers against influenza. Now, plans for COVID-19 vaccination move forward amid uncertainty.

Instead of holding a mass event, “the delivery mechanisms will need to be more targeted and focused,” said Lori Rolando, MD, MPH, director of the Vanderbilt Occupational Health Clinic. In the CDC’s most recent version of its vaccination program “playbook,” the agency recommends giving the vaccines in an area that allows people to remain 6 feet apart and for them to wait for 15 minutes after receiving the shot to make sure they don’t faint, a potential risk common to almost all vaccines.

That’s the easy part. Planning becomes more complex, given the uncertainty as to which vaccines will receive approval and which one a hospital will receive.

If the Pfizer/BioNTech vaccine receives EUA in 2020, about 10 to 20 million doses could be available in November and 20 to 30 million doses in December. The ultracold containers used to ship the vaccines have to be replenished with dry ice within 24 hours of receipt and every 5 days thereafter. Hospitals will need temperature probes to monitor storage in the containers. The five-dose vials can be refrigerated before administering, but only for 5 days. The product must be diluted, and it then must be used within 6 hours.

The Moderna vaccine will be somewhat less plentiful at first. About 10 million doses are expected in November and 15 million doses by the end of December. The 10-dose vials are stored in a freezer. Once they are placed in a refrigerator to thaw, they have to be used within 7 days, and once they’re removed from the refrigerator, they have to be used within 12 hours. The pharmacist or other vaccinator must swirl – but not shake! – the vial before delivering a dose, according to the CDC playbook.

As more information emerges about the vaccines, instructions may change, and Smith is steeled for shifting scenarios. “These are all draft plans. We’re going to modify as we go along,” he says.

The Pfizer vaccine requires a second dose at 21 days, and the Moderna vaccine targets the second dose at 28 days. In addition to using information systems to track vaccinations and any adverse effects, hospitals will give employees a card indicating what vaccine they received, the date it was administered, and the date on which they need to return. (At this point, the time frame for the second dose doesn’t appear to be flexible.)

Regardless of the vaccine, one message stays the same: COVID precautions must continue. That means mask wearing, social distancing, and hand washing – practices that also must be followed by healthcare workers who test positive for naturally acquired antibodies.

“I don’t think anyone expects the COVID vaccine to be 100% effective at preventing COVID,” says Rolando. “So all of the other tools in our toolbox are going to need to be continued to be used as well.”
 

*Correction, 11/12/20: An earlier version of this article misstated the name of Dr. Drees' institution.

This article first appeared on Medscape.com.

You have a responsibility to screen families for food insecurity, intervene to help them, and advocate on behalf of those experiencing or at risk of food insecurity, according to Kofi Essel, MD, MPH, a pediatrician at Children’s National Hospital in Washington.

YES Market Media/Shutterstock

More than one in four adults are dealing with food access hardships during the pandemic, Dr. Essel said at the virtual annual meeting of the American Academy of Pediatrics. Food insecurity is often interchangeable with hunger and refers to limited or uncertain availability of foods that are nutritious and safe.

“Food insecurity is as much about the threat of deprivation as it is about deprivation itself: A food-insecure life means a life lived in fear of hunger, and the psychological toll that takes,” according to a 2020 New York Times photo feature on food insecurity by Brenda Ann Kenneally that Dr. Essel quoted.

The lived experience of food insecure households includes food anxiety, a preoccupation with being able to get enough food that takes up cognitive bandwidth and prevents people from being able to focus on other important things. Another feature of food-insecure homes is a monotony of diet, which often involves an increase in caloric density and decrease in nutritional quality. As food insecurity grows more dire, adults’ food intake decreases, and then children’s intake decreases as adults seek out any way to get food, including “socially unacceptable” ways, which can include food pantries and bartering for food.

Food insecurity is associated with a wide range of negative outcomes even after accounting for other confounders, including decreased overall health, mental health, and educational outcomes. It’s also associated with an increase in developmental delays, hospitalizations, iron deficiency, asthma, and birth defects, among other problems. Somewhat paradoxically, it’s associated with both an increase and a decrease in obesity in the research.

Megan J. Gray, MD, MPH, assistant professor of pediatrics and population health at Dell Medical School at the The University of Texas at Austin, attended Dr. Essel’s session because food insecurity during COVID-19 now affects about half her patients, according to screening research she’s conducted.

“I wanted to learn more about the nuances of screening and using language and talking points that are helpful with families and with staff in building a culture of discussing food insecurity in our clinics,” Dr. Gray said in an interview. “What I’ve learned in my clinic is that if we don’t ask about it, families aren’t telling us – food insecurity is hiding in plain sight.”

She particularly appreciated Dr. Essel’s slides on the progression of food insecurity and how they acknowledged the mental health burden of food insecurity among parents.

“Right now during COVID-19, I see more patients I would call ‘socially complex’ rather than ‘medically complex,’ ” she said. “We all need to get a crash course in social work and Dr. Essel’s presentation is a great starting place.”

Screening for food insecurity

Beginning in 2015, an AAP policy statement charged pediatricians to “screen and intervene” with regard to food insecurity and their patients, Dr. Essel said. The statement also called for pediatricians to advocate for programs and policies that end childhood food insecurity.

The policy statement recommended a validated two-question screening tool called the Hunger Vital Sign:

1. “Within the past 12 months, we worried whether our food would run out before we got money to buy more.”

2. “Within the past 12 months, the food that we bought just didn’t last and we didn’t have money to get more.”

But in screening, you need to be conscious of how dignity intersects with food insecurity concerns, Dr. Essel said.

“We need to create dignity for our families,” he said. “We need to create a safe environment for our families and use appropriate tools when necessary to be able to identify families that are struggling with food insecurity.”

That need is seen in research on food screening. The Hunger Vital Signs questions can be asked with a dichotomous variable, as a yes/no question, or on a Likert scale, though the latter is a more complex way to ask.

A 2017 study found, however, that asking with “yes/no” answers missed more than a quarter of at-risk families. In the AAP survey using “yes/no” answers, 31% of families screened positive for being at risk of food insecurity, compared with 46% when the same question was asked on a Likert scale. It seems the ability to answer with “sometimes” feels “safer” than answering “yes,” Dr. Essel said.

Another factor that potentially affects answers is how doctors ask. In a March 2020 study at a single primary care practice, 16% of families screened positive with yes/no responses to a food insecurity screen when the questions were written, compared with 10% of positive screens with verbal responses (P < .001).

Epidemiology of food insecurity

The most updated United States Department of Agriculture report on food insecurity released in September shows the United States finally reached prerecession levels in 2019, with 11% of families designated as “food insecure.” But 2019 data cannot show what has occurred since the pandemic.

Further, the numbers are higher in households with children: Fourteen percent, or one in seven households with children, are experiencing food insecurity. Racial and ethnic disparities in food insecurity have remained consistent over the past 2 decades, with about twice as many Black and Hispanic homes experiencing food insecurity as White homes.

More recent research using Census Household Pulse Surveys has found a tremendous increase in food insecurity for children in 2020. One in three Black children and one in four Hispanic children are food insecure, according to these surveys. The rates are one in six for Asian households and one in ten for White households.

“The disparity is consistent,” Dr. Essel said. “We see what COVID has done. We once may have described it as a great equalizer – everyone is touched in the same way – but the reality is, this is actually a great magnifier. It’s revealing to us and magnifying disparities that have existed for far too long and has really allowed us to see it in a new way.”

A big part of disparities in food insecurity is disparities in wealth, “the safety net or cushion for families when things go wrong,” Dr. Essel said. The median wealth of White Americans in 2016 was $171,000, compared to $20,700 among Latinx Americans and $17,600 among Black Americans, according to the Federal Reserve Board Survey of Consumer Finances.
 

Food insecurity interventions

Federal nutrition programs – such as Supplemental Nutrition Assistance Program (SNAP), the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), and school meal programs – are key to addressing food insecurity, Dr. Essel said.

“They have a long track record of rescuing families out of poverty, of rescuing families from food security and improving overall health of families,” he said.

But emergency food relief programs are important as well. Four in 10 families currently coming into food pantries are new recipients, and these resources have seen a 60% increase in clients, he said.

“This is utterly unreasonable for them to be able to manage,” he said. “Food pantries are essential but inadequate to compensate for large numbers of families,” even while they also may be the only option for families unable or unwilling to access federal programs. For example, for every one meal that food banks can provide, SNAP can provide nine meals, Dr. Essel said. Further, during times of economic downtown, every SNAP $1 spent generates $1.50 to $2 in economic activity.

Currently, the Pandemic Electronic Benefit Transfer (P-EBT) program provides benefits to families for school breakfast and lunch and has been extended through December 2021. Another federal pandemic response was to increase SNAP to the maximum household benefit for families, about $646 for a family of four, although 40% of households were already receiving the maximum benefit.
 

Food insecurity advocacy

You can advocate for any one of multiple pillars when it comes to food insecurity, Dr. Essel said. “Food cannot solve food insecurity by itself,” he said. “We have to think about root causes – systemic causes – and think about unemployment, livable wage, systemic racism, oppression, an inequitable food system. All of these things are pillars that any of you can advocate for when recognizing a family that is struggling with food insecurity.”

He offered several suggestions for advocacy:

• Join your local AAP chapter and prioritize food insecurity.
• Join a local antihunger task force.
• Make your clinical environment as safe as possible for families to respond to questions about food insecurity.
• Know what’s happening in your community immigrant populations.
• Provide up-to-date information to families about eligibility for federal programs.
• Share stories through op-eds and letters to the editor, and by contacting congressional representatives and providing expert testimony to school boards and city councils.
• Educate others about food insecurity through the above channels and on social media.

Jessica Lazerov, MD, a general pediatrician at Children’s National Anacostia and assistant professor of pediatrics at George Washington University, Washington, said the session was fantastic.

“Dr. Essel went beyond the basics of food insecurity, delving into the root causes, potential solutions, and important considerations when screening for food insecurity in practice,” Dr. Lazerov said in an interview. “I enjoyed his focus on advocacy, as well as the fact that he spent a bit of time reviewing how the COVID pandemic has affected food insecurity. I truly felt empowered to take my advocacy efforts a step further as Dr. Essel laid out concrete, actionable next steps, as well as a review of the most relevant and current information about food insecurity.”

Dr. Essel, Dr. Lazerov, and Dr. Gray have no relevant financial disclosures.

You have a responsibility to screen families for food insecurity, intervene to help them, and advocate on behalf of those experiencing or at risk of food insecurity, according to Kofi Essel, MD, MPH, a pediatrician at Children’s National Hospital in Washington.

YES Market Media/Shutterstock

More than one in four adults are dealing with food access hardships during the pandemic, Dr. Essel said at the virtual annual meeting of the American Academy of Pediatrics. Food insecurity is often interchangeable with hunger and refers to limited or uncertain availability of foods that are nutritious and safe.

“Food insecurity is as much about the threat of deprivation as it is about deprivation itself: A food-insecure life means a life lived in fear of hunger, and the psychological toll that takes,” according to a 2020 New York Times photo feature on food insecurity by Brenda Ann Kenneally that Dr. Essel quoted.

The lived experience of food insecure households includes food anxiety, a preoccupation with being able to get enough food that takes up cognitive bandwidth and prevents people from being able to focus on other important things. Another feature of food-insecure homes is a monotony of diet, which often involves an increase in caloric density and decrease in nutritional quality. As food insecurity grows more dire, adults’ food intake decreases, and then children’s intake decreases as adults seek out any way to get food, including “socially unacceptable” ways, which can include food pantries and bartering for food.

Food insecurity is associated with a wide range of negative outcomes even after accounting for other confounders, including decreased overall health, mental health, and educational outcomes. It’s also associated with an increase in developmental delays, hospitalizations, iron deficiency, asthma, and birth defects, among other problems. Somewhat paradoxically, it’s associated with both an increase and a decrease in obesity in the research.

Megan J. Gray, MD, MPH, assistant professor of pediatrics and population health at Dell Medical School at the The University of Texas at Austin, attended Dr. Essel’s session because food insecurity during COVID-19 now affects about half her patients, according to screening research she’s conducted.

“I wanted to learn more about the nuances of screening and using language and talking points that are helpful with families and with staff in building a culture of discussing food insecurity in our clinics,” Dr. Gray said in an interview. “What I’ve learned in my clinic is that if we don’t ask about it, families aren’t telling us – food insecurity is hiding in plain sight.”

She particularly appreciated Dr. Essel’s slides on the progression of food insecurity and how they acknowledged the mental health burden of food insecurity among parents.

“Right now during COVID-19, I see more patients I would call ‘socially complex’ rather than ‘medically complex,’ ” she said. “We all need to get a crash course in social work and Dr. Essel’s presentation is a great starting place.”

Screening for food insecurity

Beginning in 2015, an AAP policy statement charged pediatricians to “screen and intervene” with regard to food insecurity and their patients, Dr. Essel said. The statement also called for pediatricians to advocate for programs and policies that end childhood food insecurity.

The policy statement recommended a validated two-question screening tool called the Hunger Vital Sign:

1. “Within the past 12 months, we worried whether our food would run out before we got money to buy more.”

2. “Within the past 12 months, the food that we bought just didn’t last and we didn’t have money to get more.”

But in screening, you need to be conscious of how dignity intersects with food insecurity concerns, Dr. Essel said.

“We need to create dignity for our families,” he said. “We need to create a safe environment for our families and use appropriate tools when necessary to be able to identify families that are struggling with food insecurity.”

That need is seen in research on food screening. The Hunger Vital Signs questions can be asked with a dichotomous variable, as a yes/no question, or on a Likert scale, though the latter is a more complex way to ask.

A 2017 study found, however, that asking with “yes/no” answers missed more than a quarter of at-risk families. In the AAP survey using “yes/no” answers, 31% of families screened positive for being at risk of food insecurity, compared with 46% when the same question was asked on a Likert scale. It seems the ability to answer with “sometimes” feels “safer” than answering “yes,” Dr. Essel said.

Another factor that potentially affects answers is how doctors ask. In a March 2020 study at a single primary care practice, 16% of families screened positive with yes/no responses to a food insecurity screen when the questions were written, compared with 10% of positive screens with verbal responses (P < .001).

Epidemiology of food insecurity

The most updated United States Department of Agriculture report on food insecurity released in September shows the United States finally reached prerecession levels in 2019, with 11% of families designated as “food insecure.” But 2019 data cannot show what has occurred since the pandemic.

Further, the numbers are higher in households with children: Fourteen percent, or one in seven households with children, are experiencing food insecurity. Racial and ethnic disparities in food insecurity have remained consistent over the past 2 decades, with about twice as many Black and Hispanic homes experiencing food insecurity as White homes.

More recent research using Census Household Pulse Surveys has found a tremendous increase in food insecurity for children in 2020. One in three Black children and one in four Hispanic children are food insecure, according to these surveys. The rates are one in six for Asian households and one in ten for White households.

“The disparity is consistent,” Dr. Essel said. “We see what COVID has done. We once may have described it as a great equalizer – everyone is touched in the same way – but the reality is, this is actually a great magnifier. It’s revealing to us and magnifying disparities that have existed for far too long and has really allowed us to see it in a new way.”

A big part of disparities in food insecurity is disparities in wealth, “the safety net or cushion for families when things go wrong,” Dr. Essel said. The median wealth of White Americans in 2016 was $171,000, compared to $20,700 among Latinx Americans and $17,600 among Black Americans, according to the Federal Reserve Board Survey of Consumer Finances.
 

Food insecurity interventions

Federal nutrition programs – such as Supplemental Nutrition Assistance Program (SNAP), the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), and school meal programs – are key to addressing food insecurity, Dr. Essel said.

“They have a long track record of rescuing families out of poverty, of rescuing families from food security and improving overall health of families,” he said.

But emergency food relief programs are important as well. Four in 10 families currently coming into food pantries are new recipients, and these resources have seen a 60% increase in clients, he said.

“This is utterly unreasonable for them to be able to manage,” he said. “Food pantries are essential but inadequate to compensate for large numbers of families,” even while they also may be the only option for families unable or unwilling to access federal programs. For example, for every one meal that food banks can provide, SNAP can provide nine meals, Dr. Essel said. Further, during times of economic downtown, every SNAP $1 spent generates $1.50 to $2 in economic activity.

Currently, the Pandemic Electronic Benefit Transfer (P-EBT) program provides benefits to families for school breakfast and lunch and has been extended through December 2021. Another federal pandemic response was to increase SNAP to the maximum household benefit for families, about $646 for a family of four, although 40% of households were already receiving the maximum benefit.
 

Food insecurity advocacy

You can advocate for any one of multiple pillars when it comes to food insecurity, Dr. Essel said. “Food cannot solve food insecurity by itself,” he said. “We have to think about root causes – systemic causes – and think about unemployment, livable wage, systemic racism, oppression, an inequitable food system. All of these things are pillars that any of you can advocate for when recognizing a family that is struggling with food insecurity.”

He offered several suggestions for advocacy:

• Join your local AAP chapter and prioritize food insecurity.
• Join a local antihunger task force.
• Make your clinical environment as safe as possible for families to respond to questions about food insecurity.
• Know what’s happening in your community immigrant populations.
• Provide up-to-date information to families about eligibility for federal programs.
• Share stories through op-eds and letters to the editor, and by contacting congressional representatives and providing expert testimony to school boards and city councils.
• Educate others about food insecurity through the above channels and on social media.

Jessica Lazerov, MD, a general pediatrician at Children’s National Anacostia and assistant professor of pediatrics at George Washington University, Washington, said the session was fantastic.

“Dr. Essel went beyond the basics of food insecurity, delving into the root causes, potential solutions, and important considerations when screening for food insecurity in practice,” Dr. Lazerov said in an interview. “I enjoyed his focus on advocacy, as well as the fact that he spent a bit of time reviewing how the COVID pandemic has affected food insecurity. I truly felt empowered to take my advocacy efforts a step further as Dr. Essel laid out concrete, actionable next steps, as well as a review of the most relevant and current information about food insecurity.”

Dr. Essel, Dr. Lazerov, and Dr. Gray have no relevant financial disclosures.

You have a responsibility to screen families for food insecurity, intervene to help them, and advocate on behalf of those experiencing or at risk of food insecurity, according to Kofi Essel, MD, MPH, a pediatrician at Children’s National Hospital in Washington.

YES Market Media/Shutterstock

More than one in four adults are dealing with food access hardships during the pandemic, Dr. Essel said at the virtual annual meeting of the American Academy of Pediatrics. Food insecurity is often interchangeable with hunger and refers to limited or uncertain availability of foods that are nutritious and safe.

“Food insecurity is as much about the threat of deprivation as it is about deprivation itself: A food-insecure life means a life lived in fear of hunger, and the psychological toll that takes,” according to a 2020 New York Times photo feature on food insecurity by Brenda Ann Kenneally that Dr. Essel quoted.

The lived experience of food insecure households includes food anxiety, a preoccupation with being able to get enough food that takes up cognitive bandwidth and prevents people from being able to focus on other important things. Another feature of food-insecure homes is a monotony of diet, which often involves an increase in caloric density and decrease in nutritional quality. As food insecurity grows more dire, adults’ food intake decreases, and then children’s intake decreases as adults seek out any way to get food, including “socially unacceptable” ways, which can include food pantries and bartering for food.

Food insecurity is associated with a wide range of negative outcomes even after accounting for other confounders, including decreased overall health, mental health, and educational outcomes. It’s also associated with an increase in developmental delays, hospitalizations, iron deficiency, asthma, and birth defects, among other problems. Somewhat paradoxically, it’s associated with both an increase and a decrease in obesity in the research.

Megan J. Gray, MD, MPH, assistant professor of pediatrics and population health at Dell Medical School at the The University of Texas at Austin, attended Dr. Essel’s session because food insecurity during COVID-19 now affects about half her patients, according to screening research she’s conducted.

“I wanted to learn more about the nuances of screening and using language and talking points that are helpful with families and with staff in building a culture of discussing food insecurity in our clinics,” Dr. Gray said in an interview. “What I’ve learned in my clinic is that if we don’t ask about it, families aren’t telling us – food insecurity is hiding in plain sight.”

She particularly appreciated Dr. Essel’s slides on the progression of food insecurity and how they acknowledged the mental health burden of food insecurity among parents.

“Right now during COVID-19, I see more patients I would call ‘socially complex’ rather than ‘medically complex,’ ” she said. “We all need to get a crash course in social work and Dr. Essel’s presentation is a great starting place.”

Screening for food insecurity

Beginning in 2015, an AAP policy statement charged pediatricians to “screen and intervene” with regard to food insecurity and their patients, Dr. Essel said. The statement also called for pediatricians to advocate for programs and policies that end childhood food insecurity.

The policy statement recommended a validated two-question screening tool called the Hunger Vital Sign:

1. “Within the past 12 months, we worried whether our food would run out before we got money to buy more.”

2. “Within the past 12 months, the food that we bought just didn’t last and we didn’t have money to get more.”

But in screening, you need to be conscious of how dignity intersects with food insecurity concerns, Dr. Essel said.

“We need to create dignity for our families,” he said. “We need to create a safe environment for our families and use appropriate tools when necessary to be able to identify families that are struggling with food insecurity.”

That need is seen in research on food screening. The Hunger Vital Signs questions can be asked with a dichotomous variable, as a yes/no question, or on a Likert scale, though the latter is a more complex way to ask.

A 2017 study found, however, that asking with “yes/no” answers missed more than a quarter of at-risk families. In the AAP survey using “yes/no” answers, 31% of families screened positive for being at risk of food insecurity, compared with 46% when the same question was asked on a Likert scale. It seems the ability to answer with “sometimes” feels “safer” than answering “yes,” Dr. Essel said.

Another factor that potentially affects answers is how doctors ask. In a March 2020 study at a single primary care practice, 16% of families screened positive with yes/no responses to a food insecurity screen when the questions were written, compared with 10% of positive screens with verbal responses (P < .001).

Epidemiology of food insecurity

The most updated United States Department of Agriculture report on food insecurity released in September shows the United States finally reached prerecession levels in 2019, with 11% of families designated as “food insecure.” But 2019 data cannot show what has occurred since the pandemic.

Further, the numbers are higher in households with children: Fourteen percent, or one in seven households with children, are experiencing food insecurity. Racial and ethnic disparities in food insecurity have remained consistent over the past 2 decades, with about twice as many Black and Hispanic homes experiencing food insecurity as White homes.

More recent research using Census Household Pulse Surveys has found a tremendous increase in food insecurity for children in 2020. One in three Black children and one in four Hispanic children are food insecure, according to these surveys. The rates are one in six for Asian households and one in ten for White households.

“The disparity is consistent,” Dr. Essel said. “We see what COVID has done. We once may have described it as a great equalizer – everyone is touched in the same way – but the reality is, this is actually a great magnifier. It’s revealing to us and magnifying disparities that have existed for far too long and has really allowed us to see it in a new way.”

A big part of disparities in food insecurity is disparities in wealth, “the safety net or cushion for families when things go wrong,” Dr. Essel said. The median wealth of White Americans in 2016 was $171,000, compared to $20,700 among Latinx Americans and $17,600 among Black Americans, according to the Federal Reserve Board Survey of Consumer Finances.
 

Food insecurity interventions

Federal nutrition programs – such as Supplemental Nutrition Assistance Program (SNAP), the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), and school meal programs – are key to addressing food insecurity, Dr. Essel said.

“They have a long track record of rescuing families out of poverty, of rescuing families from food security and improving overall health of families,” he said.

But emergency food relief programs are important as well. Four in 10 families currently coming into food pantries are new recipients, and these resources have seen a 60% increase in clients, he said.

“This is utterly unreasonable for them to be able to manage,” he said. “Food pantries are essential but inadequate to compensate for large numbers of families,” even while they also may be the only option for families unable or unwilling to access federal programs. For example, for every one meal that food banks can provide, SNAP can provide nine meals, Dr. Essel said. Further, during times of economic downtown, every SNAP $1 spent generates $1.50 to $2 in economic activity.

Currently, the Pandemic Electronic Benefit Transfer (P-EBT) program provides benefits to families for school breakfast and lunch and has been extended through December 2021. Another federal pandemic response was to increase SNAP to the maximum household benefit for families, about $646 for a family of four, although 40% of households were already receiving the maximum benefit.
 

Food insecurity advocacy

You can advocate for any one of multiple pillars when it comes to food insecurity, Dr. Essel said. “Food cannot solve food insecurity by itself,” he said. “We have to think about root causes – systemic causes – and think about unemployment, livable wage, systemic racism, oppression, an inequitable food system. All of these things are pillars that any of you can advocate for when recognizing a family that is struggling with food insecurity.”

He offered several suggestions for advocacy:

• Join your local AAP chapter and prioritize food insecurity.
• Join a local antihunger task force.
• Make your clinical environment as safe as possible for families to respond to questions about food insecurity.
• Know what’s happening in your community immigrant populations.
• Provide up-to-date information to families about eligibility for federal programs.
• Share stories through op-eds and letters to the editor, and by contacting congressional representatives and providing expert testimony to school boards and city councils.
• Educate others about food insecurity through the above channels and on social media.

Jessica Lazerov, MD, a general pediatrician at Children’s National Anacostia and assistant professor of pediatrics at George Washington University, Washington, said the session was fantastic.

“Dr. Essel went beyond the basics of food insecurity, delving into the root causes, potential solutions, and important considerations when screening for food insecurity in practice,” Dr. Lazerov said in an interview. “I enjoyed his focus on advocacy, as well as the fact that he spent a bit of time reviewing how the COVID pandemic has affected food insecurity. I truly felt empowered to take my advocacy efforts a step further as Dr. Essel laid out concrete, actionable next steps, as well as a review of the most relevant and current information about food insecurity.”

Dr. Essel, Dr. Lazerov, and Dr. Gray have no relevant financial disclosures.

Dietary patterns with higher inflammatory potential were significantly associated with a higher incidence of cardiovascular disease (CVD) and stroke in a new pooled analysis of three prospective cohort studies.

The analysis included 210,145 U.S. women and men followed for up to 32 years in the Nurses’ Health Studies I and II and the Health Professionals Follow-up Study.

After adjustment for use of anti-inflammatory medications and CVD risk factors, those whose dietary pattern ranked in the highest quintile of inflammatory potential had a 38% higher risk of CVD (hazard ratio comparing highest with lowest quintiles, 1.38), a 46% higher risk of coronary heart disease (HR, 1.46), and a 28% higher risk of stroke (HR, 1.28) (all P for trend < .001).

Jun Li, MD, PhD, and colleagues at Harvard School of Public Health and Harvard Medical School, Boston, published the findings of their study in the Nov. 10 issue of the Journal of the American College of Cardiology.

The inflammatory potential of a diet was assessed using a food-based, dietary index called the “empirical dietary inflammatory pattern” or EDIP.

In an interview, Dr. Li explained that the EDIP was developed 4 years ago by many of the same authors involved with this study, including nutrition heavyweights Walter C. Willett, MD, DrPH, and Frank B. Hu, MD, PhD, both from Harvard.

“We summarized all the foods people eat into 39 defined food groups and did a reduced-rank regression analysis that looked at these 39 food groups and three inflammatory markers – interleukin-6, C-reactive protein, and tumor necrosis factor–alpha receptor 2. We found 18 food groups that are most predictive of these biomarkers, and the EDIP was calculated as the weighted sum of these 18 food groups.”

Individuals who had higher intakes of green-leafy vegetables (kale, spinach, arugula), dark-yellow vegetables (pumpkin, yellow peppers, carrots), whole grains, fruits, tea, coffee and wine had lower long-term CVD risk than those with higher intakes of red meat, processed meat, organ meat, refined carbohydrates, and sweetened beverages. 

The associations were consistent across cohorts and between sexes and remained significant in multiple sensitivity analysis that adjusted for alcohol consumption, smoking pack-years, use of lipid-lowering and antihypertensive medications, sodium intake, and blood pressure.

In a secondary analysis, diets with higher inflammatory potential were also associated with significantly higher biomarker levels indicative of more systemic, vascular, and metabolic inflammation, as well as less favorable lipid profiles.

“We wanted to be able to provide guidance on dietary patterns and food combinations,” said Dr. Li. “If you tell people to eat more polyunsaturated fats instead of saturated fat or trans fat, most people don’t know what foods are higher and lower in those nutrients. Also, many foods have different nutrients – some of which are good and some of which are bad – so we wanted to help people find the foods with the higher proportion of healthy nutrients rather than point out specific nutrients to avoid.”

Researchers used prospectively gathered data from the Nurses’ Health Studies I and II starting from 1984 and from the Health Professionals Follow-up Study. After excluding participants with missing diet information or previously diagnosed heart disease, stroke or cancer, over 210,000 participants were included in the analysis. Participants completed a survey every 4 years to ascertain dietary intake. 
 

Prevention, not treatment

In an editorial comment, Ramon Estruch, MD, PhD, from the Hospital Clinic in Barcelona, and colleagues suggested that it might be time for better dietary guidelines.

“A better knowledge of health protection provided by different foods and dietary patterns, mainly their anti-inflammatory properties, should provide the basis for designing even healthier dietary patterns to protect against heart disease,” the editorialists wrote.

They added extra-virgin olive oil, fatty fish, and tomatoes to the list of foods with “established anti-inflammatory activity.”

In a comment, Dr. Estruch said the findings of this new study are confirmatory of the PREDIMED trial, which showed a reduction in risk of major CV events in individuals at high cardiovascular risk assigned to an anti-inflammatory Mediterranean diet pattern supplemented with extra-virgin olive oil or nuts as compared with those assigned to a reduced-fat diet. 

“The study of Jun Li et al. confirms that an anti-inflammatory diet is useful to prevent cardiovascular events and, more important, that healthy dietary patterns may be even healthier if subjects increase consumption of foods with the highest anti-inflammatory potential,” he said, adding that “mechanistic explanations add plausibility to the results of observational studies.”

Dr. Estruch was the principal investigator of PREDIMED. This trial was originally published in 2013 and then retracted and republished in 2018, with some required corrections, but the results had not materially changed.

Dr. Li is supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and Boston Nutrition Obesity Research Center. Dr. Estruch disclosed no financial relationships relevant to the contents of this article.  

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

Dietary patterns with higher inflammatory potential were significantly associated with a higher incidence of cardiovascular disease (CVD) and stroke in a new pooled analysis of three prospective cohort studies.

The analysis included 210,145 U.S. women and men followed for up to 32 years in the Nurses’ Health Studies I and II and the Health Professionals Follow-up Study.

After adjustment for use of anti-inflammatory medications and CVD risk factors, those whose dietary pattern ranked in the highest quintile of inflammatory potential had a 38% higher risk of CVD (hazard ratio comparing highest with lowest quintiles, 1.38), a 46% higher risk of coronary heart disease (HR, 1.46), and a 28% higher risk of stroke (HR, 1.28) (all P for trend < .001).

Jun Li, MD, PhD, and colleagues at Harvard School of Public Health and Harvard Medical School, Boston, published the findings of their study in the Nov. 10 issue of the Journal of the American College of Cardiology.

The inflammatory potential of a diet was assessed using a food-based, dietary index called the “empirical dietary inflammatory pattern” or EDIP.

In an interview, Dr. Li explained that the EDIP was developed 4 years ago by many of the same authors involved with this study, including nutrition heavyweights Walter C. Willett, MD, DrPH, and Frank B. Hu, MD, PhD, both from Harvard.

“We summarized all the foods people eat into 39 defined food groups and did a reduced-rank regression analysis that looked at these 39 food groups and three inflammatory markers – interleukin-6, C-reactive protein, and tumor necrosis factor–alpha receptor 2. We found 18 food groups that are most predictive of these biomarkers, and the EDIP was calculated as the weighted sum of these 18 food groups.”

Individuals who had higher intakes of green-leafy vegetables (kale, spinach, arugula), dark-yellow vegetables (pumpkin, yellow peppers, carrots), whole grains, fruits, tea, coffee and wine had lower long-term CVD risk than those with higher intakes of red meat, processed meat, organ meat, refined carbohydrates, and sweetened beverages. 

The associations were consistent across cohorts and between sexes and remained significant in multiple sensitivity analysis that adjusted for alcohol consumption, smoking pack-years, use of lipid-lowering and antihypertensive medications, sodium intake, and blood pressure.

In a secondary analysis, diets with higher inflammatory potential were also associated with significantly higher biomarker levels indicative of more systemic, vascular, and metabolic inflammation, as well as less favorable lipid profiles.

“We wanted to be able to provide guidance on dietary patterns and food combinations,” said Dr. Li. “If you tell people to eat more polyunsaturated fats instead of saturated fat or trans fat, most people don’t know what foods are higher and lower in those nutrients. Also, many foods have different nutrients – some of which are good and some of which are bad – so we wanted to help people find the foods with the higher proportion of healthy nutrients rather than point out specific nutrients to avoid.”

Researchers used prospectively gathered data from the Nurses’ Health Studies I and II starting from 1984 and from the Health Professionals Follow-up Study. After excluding participants with missing diet information or previously diagnosed heart disease, stroke or cancer, over 210,000 participants were included in the analysis. Participants completed a survey every 4 years to ascertain dietary intake. 
 

Prevention, not treatment

In an editorial comment, Ramon Estruch, MD, PhD, from the Hospital Clinic in Barcelona, and colleagues suggested that it might be time for better dietary guidelines.

“A better knowledge of health protection provided by different foods and dietary patterns, mainly their anti-inflammatory properties, should provide the basis for designing even healthier dietary patterns to protect against heart disease,” the editorialists wrote.

They added extra-virgin olive oil, fatty fish, and tomatoes to the list of foods with “established anti-inflammatory activity.”

In a comment, Dr. Estruch said the findings of this new study are confirmatory of the PREDIMED trial, which showed a reduction in risk of major CV events in individuals at high cardiovascular risk assigned to an anti-inflammatory Mediterranean diet pattern supplemented with extra-virgin olive oil or nuts as compared with those assigned to a reduced-fat diet. 

“The study of Jun Li et al. confirms that an anti-inflammatory diet is useful to prevent cardiovascular events and, more important, that healthy dietary patterns may be even healthier if subjects increase consumption of foods with the highest anti-inflammatory potential,” he said, adding that “mechanistic explanations add plausibility to the results of observational studies.”

Dr. Estruch was the principal investigator of PREDIMED. This trial was originally published in 2013 and then retracted and republished in 2018, with some required corrections, but the results had not materially changed.

Dr. Li is supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and Boston Nutrition Obesity Research Center. Dr. Estruch disclosed no financial relationships relevant to the contents of this article.  

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

Dietary patterns with higher inflammatory potential were significantly associated with a higher incidence of cardiovascular disease (CVD) and stroke in a new pooled analysis of three prospective cohort studies.

The analysis included 210,145 U.S. women and men followed for up to 32 years in the Nurses’ Health Studies I and II and the Health Professionals Follow-up Study.

After adjustment for use of anti-inflammatory medications and CVD risk factors, those whose dietary pattern ranked in the highest quintile of inflammatory potential had a 38% higher risk of CVD (hazard ratio comparing highest with lowest quintiles, 1.38), a 46% higher risk of coronary heart disease (HR, 1.46), and a 28% higher risk of stroke (HR, 1.28) (all P for trend < .001).

Jun Li, MD, PhD, and colleagues at Harvard School of Public Health and Harvard Medical School, Boston, published the findings of their study in the Nov. 10 issue of the Journal of the American College of Cardiology.

The inflammatory potential of a diet was assessed using a food-based, dietary index called the “empirical dietary inflammatory pattern” or EDIP.

In an interview, Dr. Li explained that the EDIP was developed 4 years ago by many of the same authors involved with this study, including nutrition heavyweights Walter C. Willett, MD, DrPH, and Frank B. Hu, MD, PhD, both from Harvard.

“We summarized all the foods people eat into 39 defined food groups and did a reduced-rank regression analysis that looked at these 39 food groups and three inflammatory markers – interleukin-6, C-reactive protein, and tumor necrosis factor–alpha receptor 2. We found 18 food groups that are most predictive of these biomarkers, and the EDIP was calculated as the weighted sum of these 18 food groups.”

Individuals who had higher intakes of green-leafy vegetables (kale, spinach, arugula), dark-yellow vegetables (pumpkin, yellow peppers, carrots), whole grains, fruits, tea, coffee and wine had lower long-term CVD risk than those with higher intakes of red meat, processed meat, organ meat, refined carbohydrates, and sweetened beverages. 

The associations were consistent across cohorts and between sexes and remained significant in multiple sensitivity analysis that adjusted for alcohol consumption, smoking pack-years, use of lipid-lowering and antihypertensive medications, sodium intake, and blood pressure.

In a secondary analysis, diets with higher inflammatory potential were also associated with significantly higher biomarker levels indicative of more systemic, vascular, and metabolic inflammation, as well as less favorable lipid profiles.

“We wanted to be able to provide guidance on dietary patterns and food combinations,” said Dr. Li. “If you tell people to eat more polyunsaturated fats instead of saturated fat or trans fat, most people don’t know what foods are higher and lower in those nutrients. Also, many foods have different nutrients – some of which are good and some of which are bad – so we wanted to help people find the foods with the higher proportion of healthy nutrients rather than point out specific nutrients to avoid.”

Researchers used prospectively gathered data from the Nurses’ Health Studies I and II starting from 1984 and from the Health Professionals Follow-up Study. After excluding participants with missing diet information or previously diagnosed heart disease, stroke or cancer, over 210,000 participants were included in the analysis. Participants completed a survey every 4 years to ascertain dietary intake. 
 

Prevention, not treatment

In an editorial comment, Ramon Estruch, MD, PhD, from the Hospital Clinic in Barcelona, and colleagues suggested that it might be time for better dietary guidelines.

“A better knowledge of health protection provided by different foods and dietary patterns, mainly their anti-inflammatory properties, should provide the basis for designing even healthier dietary patterns to protect against heart disease,” the editorialists wrote.

They added extra-virgin olive oil, fatty fish, and tomatoes to the list of foods with “established anti-inflammatory activity.”

In a comment, Dr. Estruch said the findings of this new study are confirmatory of the PREDIMED trial, which showed a reduction in risk of major CV events in individuals at high cardiovascular risk assigned to an anti-inflammatory Mediterranean diet pattern supplemented with extra-virgin olive oil or nuts as compared with those assigned to a reduced-fat diet. 

“The study of Jun Li et al. confirms that an anti-inflammatory diet is useful to prevent cardiovascular events and, more important, that healthy dietary patterns may be even healthier if subjects increase consumption of foods with the highest anti-inflammatory potential,” he said, adding that “mechanistic explanations add plausibility to the results of observational studies.”

Dr. Estruch was the principal investigator of PREDIMED. This trial was originally published in 2013 and then retracted and republished in 2018, with some required corrections, but the results had not materially changed.

Dr. Li is supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and Boston Nutrition Obesity Research Center. Dr. Estruch disclosed no financial relationships relevant to the contents of this article.  

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