Point-of-care ultrasound (POCUS) is increasingly being used by critical care physicians to augment the physical examination and guide clinical decision making, and several protocols have been established to standardize the POCUS evaluation.¹ During the COVID-19 pandemic, POCUS has been a valuable tool as standard imaging techniques were used judiciously to minimize exposure of personnel and use of personal protective equipment (PPE).²

In the US Department of Veterans Affairs (VA) New York Harbor Healthcare System (VANYHHS) intensive care unit (ICU) on initial clinical examination included POCUS, which was helpful to examine deep vein thromboses, cardiac function, and the presence and extent of pneumonia. An international expert consensus on the use of POCUS for COVID-19 published in December 2020 called for further studies defining the role of lung and cardiac ultrasound in risk stratification, outcomes, and clinical management.³

The objective of this study was to review POCUS findings and correlate them with severity of illness and 30-day outcomes in critically ill patients with COVID-19.

Methods

The study was submitted to and reviewed by the VANYHHS Research and Development committee and study approval and informed consent waiver was granted. The study was a retrospective chart review of patients admitted to the VANYHHS ICU between March and April 2020, a tertiary health care center designated as a COVID-19 hospital.

Patients admitted to the ICU aged > 18 years with a diagnosis of acute hypoxemic respiratory failure, diagnosis of COVID-19, and documentation of POCUS findings in the chart were included in the study. A patient was considered to have a COVID-19 diagnosis following a positive SARS-CoV-2 polymerase chain reaction test documented in the electronic health record (EHR). Acute respiratory failure was defined as hypoxemia < 94% and the need for either supplemental oxygen by nasal cannula > 2 L/min, high flow nasal cannula, noninvasive ventilation, or mechanical ventilation.

To minimize personnel exposure, initial patient evaluations and POCUS examinations were performed by the most senior personnel (ie, fellowship trained, board-certified pulmonary critical care attending physicians or pulmonary and critical care fellowship trainees). Three members of the team had certification in advanced critical care echocardiography by the National Board of Echocardiography and oversaw POCUS imaging. POCUS examinations were performed with a GE Heathcare Venue POCUS or handheld unit. After use, ultrasound probes and ultrasound units were disinfected with wipes designated by the manufacturer and US Environmental Protection Agency for use during the COVID-19 pandemic.

The POCUS protocol used by members of the team was as follows: POCUS lung—at least 2 anterior fields and 1 posterior/lateral field looking at the costophrenic angle on each hemithorax with a phased array or curvilinear probe. A linear probe was used to look for subpleural changes per physician discretion.^4,5 Lung ultrasound findings in anterior lung fields were documented as A lines, B lines (as defined by the bedside lung ultrasound in emergency [BLUE] protocol)anterior pleural abnormalities or consolidations.^4,5 The costophrenic point findings were documented as presence of consolidation or pleural effusion.

The POCUS cardiac examination consisted of parasternal long and short axis views, apical 4 chamber view, subcostal and inferior vena cava (IVC) view. Left ventricular (LV) ejection fraction was visually estimated as reduced or normal. Right ventricular (RV) dilation was considered present if RV size approached or exceeded LV size in the apical 4 chamber view. RV dysfunction was considered present if in addition there was flattening of interventricular septum, RV free wall hypokinesis or reduced tricuspid annular plane systolic excursion (TAPSE).⁶ IVC was documented as collapsible or plethoric by size and respirophasic variability (2 cm and 50%). Other POCUS examinations including venous compression were done at the discretion of the treating physician.⁷ POCUS was also used for the placement of central and arterial lines and to guide fluid management.⁸

The VA EHR and Venue image local archives were reviewed for patient demographics, laboratory findings, imaging studies and outcomes. All ICU attending physician and fellow notes were reviewed for POCUS lung, cardiac and vascular findings. The chart was also reviewed for management changes as a result of POCUS findings. Patients who had at minimum a POCUS lung or cardiac examination documented in the EHR were included in the study. For patients with serial POCUS the most severe findings were included.

Patients were divided into 2 groups based on 30-day outcome: discharge home vs mortality for comparison. POCUS findings were also compared by need for mechanical ventilation. Patients still hospitalized or transferred to other facilities were excluded from the analysis. A Student t test was used for comparison between the groups for continuous normally distributed variables. Linear and stepwise regression models were used to evaluate univariate and multivariate associations of baseline characteristics, biomarker, and ultrasound findings with patient outcomes. Analyses were performed using R 4.0.2 statistical software.

Results

Eighty-two patients were admitted to the VANYHHS ICU in March and April 2020, including 12 nonveterans. Sixty-four had COVID-19 and acute respiratory failure. POCUS findings were documented in 43 (67%) patients. Thirty-nine patients had documented lung examinations, and 25 patients had documented cardiac examinations. Patients were divided into 2 groups by 30-day outcome (discharge home vs mortality) for statistical analysis. Five patients who were either still hospitalized or had been transferred to another facility were excluded.

Baseline characteristics of patients included in the study stratified by 30-day outcomes are shown in Table 1. The study group was predominantly male (95%). Patients with poor 30-day outcomes were older, had higher white blood cell counts, more severe hypoxemia, higher rates of mechanical ventilation and RV dilation (Figures 1, 2, 3, 4, and 5). RV dilation was an independent predictor of mortality (odds ratio [OR], 12.0; P = .048).

Discussion

POCUS identified both lung and cardiac features that were associated with worse outcomes. While lung ultrasound abnormalities were very prevalent and associated with worse PaO₂ to FiO₂ ratios, the presence of RV dilation was associated most clearly with mortality and poor 30-day outcomes in the critical care setting.

Lung ultrasound abnormalities were pervasive in patients with acute respiratory failure and COVID-19. On linear regression we found that presence with bilateral B lines and pleural thickening was predictive of a lower PaO₂/FiO₂ (coefficient, -70; P = .005). Our study found that B lines with pleural irregularities, otherwise known as a B’ profile per the BLUE protocol, was seen in patients with severe COVID-19. Thus severe acute respiratory failure secondary to COVID-19 has similar lung ultrasound findings as non-COVID-19 acute respiratory distress syndrome (ARDS).^4,5 Based on prior lung ultrasound studies in ARDS, lung ultrasound findings can be used as an alternate to chest radiography for the diagnosis of ARDS in COVID-19 and predict the severity of ARDS.⁹ This has particular implications in overwhelmed and resource poor health care settings.

We found no difference in 30-day mortality based on lung ultrasound findings or profile, probably because of small sample size or because the findings were tabulated as profiles and not differentiated further with lung ultrasound scores.^10,11 However, there was a significant difference in RV dilation between the 2 groups by 30 days and its presence was found to be a predictor of mortality even when controlled for hypertension and diabetes mellitus (P = .048) with an OR of 12. RV dysfunction in patients with ARDS on mechanical ventilation ranges from 22 to 25% and is typically associated with high driving pressures.^12-14 The mechanism is thought to be multifactorial including hypoxemic vasoconstriction in the pulmonary vasculature in addition to the increased transpulmonary pressure.¹⁵ While all of the above are at play in COVID-19 infection, there is reported damage to the pulmonary vascular endothelium and resultant hypercoagulability and thrombosis that further increases the RV afterload.¹⁶

While RV strain and dysfunction indices done by an echocardiographer would be ideal, given the surge in infections and hospitalizations and strain on health care resources, POCUS by the treating or examining clinician was considered the only feasible way to screen a large number of patients.¹⁷ Identification of RV dilation could influence clinical management including workup for venous thromboembolic disease and optimization of lung protective strategies. Further studies are needed to understand the particular etiology and pathophysiology of COVID-19 associated RV dilation. Given increased thrombosis events in COVID-19 infection we believe a POCUS vascular examination should be included as part of evaluation especially in the presence of increased D-dimers and has been discussed above for its important role in working up RV dilation.¹⁸

Limitations

Our study has several limitations. It was retrospective in nature and involved a small group of individuals. There was some variation in POCUS examinations done at the discretion of the examining physician. We did not have a blinded observer independently review all images. Since RV dilation was documented only when RV size approached or exceeded LV size in the apical 4 chamber view representing moderate or severe dilation, we may be underreporting the prevalence in critically ill patients.

Conclusions

POCUS is an invaluable adjunct to clinical evaluation and procedures in patients with severe COVID-19 with the ability to identity patients at risk for worse outcomes. B lines with pleural thickening is a sign of severe ARDS and RV dilatation is predictive of mortality. POCUS should be made available to the treating physician for monitoring and risk stratification and can be incorporated into management algorithms.

Additional point-of-care ultrasound videos.

Acknowledgments

We thank frontline healthcare workers and intensive care unit staff of the US Department of Veterans Affairs New York Harbor Healthcare System (NYHHS) for their dedication to the care of veterans and civilians during the COVID-19 pandemic in New York City. The authors acknowledge the NYHHS research and development committee and administration for their support.

Point-of-care ultrasound (POCUS) is increasingly being used by critical care physicians to augment the physical examination and guide clinical decision making, and several protocols have been established to standardize the POCUS evaluation.¹ During the COVID-19 pandemic, POCUS has been a valuable tool as standard imaging techniques were used judiciously to minimize exposure of personnel and use of personal protective equipment (PPE).²

In the US Department of Veterans Affairs (VA) New York Harbor Healthcare System (VANYHHS) intensive care unit (ICU) on initial clinical examination included POCUS, which was helpful to examine deep vein thromboses, cardiac function, and the presence and extent of pneumonia. An international expert consensus on the use of POCUS for COVID-19 published in December 2020 called for further studies defining the role of lung and cardiac ultrasound in risk stratification, outcomes, and clinical management.³

The objective of this study was to review POCUS findings and correlate them with severity of illness and 30-day outcomes in critically ill patients with COVID-19.

Methods

The study was submitted to and reviewed by the VANYHHS Research and Development committee and study approval and informed consent waiver was granted. The study was a retrospective chart review of patients admitted to the VANYHHS ICU between March and April 2020, a tertiary health care center designated as a COVID-19 hospital.

Patients admitted to the ICU aged > 18 years with a diagnosis of acute hypoxemic respiratory failure, diagnosis of COVID-19, and documentation of POCUS findings in the chart were included in the study. A patient was considered to have a COVID-19 diagnosis following a positive SARS-CoV-2 polymerase chain reaction test documented in the electronic health record (EHR). Acute respiratory failure was defined as hypoxemia < 94% and the need for either supplemental oxygen by nasal cannula > 2 L/min, high flow nasal cannula, noninvasive ventilation, or mechanical ventilation.

To minimize personnel exposure, initial patient evaluations and POCUS examinations were performed by the most senior personnel (ie, fellowship trained, board-certified pulmonary critical care attending physicians or pulmonary and critical care fellowship trainees). Three members of the team had certification in advanced critical care echocardiography by the National Board of Echocardiography and oversaw POCUS imaging. POCUS examinations were performed with a GE Heathcare Venue POCUS or handheld unit. After use, ultrasound probes and ultrasound units were disinfected with wipes designated by the manufacturer and US Environmental Protection Agency for use during the COVID-19 pandemic.

The POCUS protocol used by members of the team was as follows: POCUS lung—at least 2 anterior fields and 1 posterior/lateral field looking at the costophrenic angle on each hemithorax with a phased array or curvilinear probe. A linear probe was used to look for subpleural changes per physician discretion.^4,5 Lung ultrasound findings in anterior lung fields were documented as A lines, B lines (as defined by the bedside lung ultrasound in emergency [BLUE] protocol)anterior pleural abnormalities or consolidations.^4,5 The costophrenic point findings were documented as presence of consolidation or pleural effusion.

The POCUS cardiac examination consisted of parasternal long and short axis views, apical 4 chamber view, subcostal and inferior vena cava (IVC) view. Left ventricular (LV) ejection fraction was visually estimated as reduced or normal. Right ventricular (RV) dilation was considered present if RV size approached or exceeded LV size in the apical 4 chamber view. RV dysfunction was considered present if in addition there was flattening of interventricular septum, RV free wall hypokinesis or reduced tricuspid annular plane systolic excursion (TAPSE).⁶ IVC was documented as collapsible or plethoric by size and respirophasic variability (2 cm and 50%). Other POCUS examinations including venous compression were done at the discretion of the treating physician.⁷ POCUS was also used for the placement of central and arterial lines and to guide fluid management.⁸

The VA EHR and Venue image local archives were reviewed for patient demographics, laboratory findings, imaging studies and outcomes. All ICU attending physician and fellow notes were reviewed for POCUS lung, cardiac and vascular findings. The chart was also reviewed for management changes as a result of POCUS findings. Patients who had at minimum a POCUS lung or cardiac examination documented in the EHR were included in the study. For patients with serial POCUS the most severe findings were included.

Patients were divided into 2 groups based on 30-day outcome: discharge home vs mortality for comparison. POCUS findings were also compared by need for mechanical ventilation. Patients still hospitalized or transferred to other facilities were excluded from the analysis. A Student t test was used for comparison between the groups for continuous normally distributed variables. Linear and stepwise regression models were used to evaluate univariate and multivariate associations of baseline characteristics, biomarker, and ultrasound findings with patient outcomes. Analyses were performed using R 4.0.2 statistical software.

Results

Eighty-two patients were admitted to the VANYHHS ICU in March and April 2020, including 12 nonveterans. Sixty-four had COVID-19 and acute respiratory failure. POCUS findings were documented in 43 (67%) patients. Thirty-nine patients had documented lung examinations, and 25 patients had documented cardiac examinations. Patients were divided into 2 groups by 30-day outcome (discharge home vs mortality) for statistical analysis. Five patients who were either still hospitalized or had been transferred to another facility were excluded.

Baseline characteristics of patients included in the study stratified by 30-day outcomes are shown in Table 1. The study group was predominantly male (95%). Patients with poor 30-day outcomes were older, had higher white blood cell counts, more severe hypoxemia, higher rates of mechanical ventilation and RV dilation (Figures 1, 2, 3, 4, and 5). RV dilation was an independent predictor of mortality (odds ratio [OR], 12.0; P = .048).

Discussion

POCUS identified both lung and cardiac features that were associated with worse outcomes. While lung ultrasound abnormalities were very prevalent and associated with worse PaO₂ to FiO₂ ratios, the presence of RV dilation was associated most clearly with mortality and poor 30-day outcomes in the critical care setting.

Lung ultrasound abnormalities were pervasive in patients with acute respiratory failure and COVID-19. On linear regression we found that presence with bilateral B lines and pleural thickening was predictive of a lower PaO₂/FiO₂ (coefficient, -70; P = .005). Our study found that B lines with pleural irregularities, otherwise known as a B’ profile per the BLUE protocol, was seen in patients with severe COVID-19. Thus severe acute respiratory failure secondary to COVID-19 has similar lung ultrasound findings as non-COVID-19 acute respiratory distress syndrome (ARDS).^4,5 Based on prior lung ultrasound studies in ARDS, lung ultrasound findings can be used as an alternate to chest radiography for the diagnosis of ARDS in COVID-19 and predict the severity of ARDS.⁹ This has particular implications in overwhelmed and resource poor health care settings.

We found no difference in 30-day mortality based on lung ultrasound findings or profile, probably because of small sample size or because the findings were tabulated as profiles and not differentiated further with lung ultrasound scores.^10,11 However, there was a significant difference in RV dilation between the 2 groups by 30 days and its presence was found to be a predictor of mortality even when controlled for hypertension and diabetes mellitus (P = .048) with an OR of 12. RV dysfunction in patients with ARDS on mechanical ventilation ranges from 22 to 25% and is typically associated with high driving pressures.^12-14 The mechanism is thought to be multifactorial including hypoxemic vasoconstriction in the pulmonary vasculature in addition to the increased transpulmonary pressure.¹⁵ While all of the above are at play in COVID-19 infection, there is reported damage to the pulmonary vascular endothelium and resultant hypercoagulability and thrombosis that further increases the RV afterload.¹⁶

While RV strain and dysfunction indices done by an echocardiographer would be ideal, given the surge in infections and hospitalizations and strain on health care resources, POCUS by the treating or examining clinician was considered the only feasible way to screen a large number of patients.¹⁷ Identification of RV dilation could influence clinical management including workup for venous thromboembolic disease and optimization of lung protective strategies. Further studies are needed to understand the particular etiology and pathophysiology of COVID-19 associated RV dilation. Given increased thrombosis events in COVID-19 infection we believe a POCUS vascular examination should be included as part of evaluation especially in the presence of increased D-dimers and has been discussed above for its important role in working up RV dilation.¹⁸

Limitations

Our study has several limitations. It was retrospective in nature and involved a small group of individuals. There was some variation in POCUS examinations done at the discretion of the examining physician. We did not have a blinded observer independently review all images. Since RV dilation was documented only when RV size approached or exceeded LV size in the apical 4 chamber view representing moderate or severe dilation, we may be underreporting the prevalence in critically ill patients.

Conclusions

POCUS is an invaluable adjunct to clinical evaluation and procedures in patients with severe COVID-19 with the ability to identity patients at risk for worse outcomes. B lines with pleural thickening is a sign of severe ARDS and RV dilatation is predictive of mortality. POCUS should be made available to the treating physician for monitoring and risk stratification and can be incorporated into management algorithms.

Additional point-of-care ultrasound videos.

Acknowledgments

We thank frontline healthcare workers and intensive care unit staff of the US Department of Veterans Affairs New York Harbor Healthcare System (NYHHS) for their dedication to the care of veterans and civilians during the COVID-19 pandemic in New York City. The authors acknowledge the NYHHS research and development committee and administration for their support.

Point-of-care ultrasound (POCUS) is increasingly being used by critical care physicians to augment the physical examination and guide clinical decision making, and several protocols have been established to standardize the POCUS evaluation.¹ During the COVID-19 pandemic, POCUS has been a valuable tool as standard imaging techniques were used judiciously to minimize exposure of personnel and use of personal protective equipment (PPE).²

In the US Department of Veterans Affairs (VA) New York Harbor Healthcare System (VANYHHS) intensive care unit (ICU) on initial clinical examination included POCUS, which was helpful to examine deep vein thromboses, cardiac function, and the presence and extent of pneumonia. An international expert consensus on the use of POCUS for COVID-19 published in December 2020 called for further studies defining the role of lung and cardiac ultrasound in risk stratification, outcomes, and clinical management.³

The objective of this study was to review POCUS findings and correlate them with severity of illness and 30-day outcomes in critically ill patients with COVID-19.

Methods

The study was submitted to and reviewed by the VANYHHS Research and Development committee and study approval and informed consent waiver was granted. The study was a retrospective chart review of patients admitted to the VANYHHS ICU between March and April 2020, a tertiary health care center designated as a COVID-19 hospital.

Patients admitted to the ICU aged > 18 years with a diagnosis of acute hypoxemic respiratory failure, diagnosis of COVID-19, and documentation of POCUS findings in the chart were included in the study. A patient was considered to have a COVID-19 diagnosis following a positive SARS-CoV-2 polymerase chain reaction test documented in the electronic health record (EHR). Acute respiratory failure was defined as hypoxemia < 94% and the need for either supplemental oxygen by nasal cannula > 2 L/min, high flow nasal cannula, noninvasive ventilation, or mechanical ventilation.

To minimize personnel exposure, initial patient evaluations and POCUS examinations were performed by the most senior personnel (ie, fellowship trained, board-certified pulmonary critical care attending physicians or pulmonary and critical care fellowship trainees). Three members of the team had certification in advanced critical care echocardiography by the National Board of Echocardiography and oversaw POCUS imaging. POCUS examinations were performed with a GE Heathcare Venue POCUS or handheld unit. After use, ultrasound probes and ultrasound units were disinfected with wipes designated by the manufacturer and US Environmental Protection Agency for use during the COVID-19 pandemic.

The POCUS protocol used by members of the team was as follows: POCUS lung—at least 2 anterior fields and 1 posterior/lateral field looking at the costophrenic angle on each hemithorax with a phased array or curvilinear probe. A linear probe was used to look for subpleural changes per physician discretion.^4,5 Lung ultrasound findings in anterior lung fields were documented as A lines, B lines (as defined by the bedside lung ultrasound in emergency [BLUE] protocol)anterior pleural abnormalities or consolidations.^4,5 The costophrenic point findings were documented as presence of consolidation or pleural effusion.

The POCUS cardiac examination consisted of parasternal long and short axis views, apical 4 chamber view, subcostal and inferior vena cava (IVC) view. Left ventricular (LV) ejection fraction was visually estimated as reduced or normal. Right ventricular (RV) dilation was considered present if RV size approached or exceeded LV size in the apical 4 chamber view. RV dysfunction was considered present if in addition there was flattening of interventricular septum, RV free wall hypokinesis or reduced tricuspid annular plane systolic excursion (TAPSE).⁶ IVC was documented as collapsible or plethoric by size and respirophasic variability (2 cm and 50%). Other POCUS examinations including venous compression were done at the discretion of the treating physician.⁷ POCUS was also used for the placement of central and arterial lines and to guide fluid management.⁸

The VA EHR and Venue image local archives were reviewed for patient demographics, laboratory findings, imaging studies and outcomes. All ICU attending physician and fellow notes were reviewed for POCUS lung, cardiac and vascular findings. The chart was also reviewed for management changes as a result of POCUS findings. Patients who had at minimum a POCUS lung or cardiac examination documented in the EHR were included in the study. For patients with serial POCUS the most severe findings were included.

Patients were divided into 2 groups based on 30-day outcome: discharge home vs mortality for comparison. POCUS findings were also compared by need for mechanical ventilation. Patients still hospitalized or transferred to other facilities were excluded from the analysis. A Student t test was used for comparison between the groups for continuous normally distributed variables. Linear and stepwise regression models were used to evaluate univariate and multivariate associations of baseline characteristics, biomarker, and ultrasound findings with patient outcomes. Analyses were performed using R 4.0.2 statistical software.

Results

Eighty-two patients were admitted to the VANYHHS ICU in March and April 2020, including 12 nonveterans. Sixty-four had COVID-19 and acute respiratory failure. POCUS findings were documented in 43 (67%) patients. Thirty-nine patients had documented lung examinations, and 25 patients had documented cardiac examinations. Patients were divided into 2 groups by 30-day outcome (discharge home vs mortality) for statistical analysis. Five patients who were either still hospitalized or had been transferred to another facility were excluded.

Baseline characteristics of patients included in the study stratified by 30-day outcomes are shown in Table 1. The study group was predominantly male (95%). Patients with poor 30-day outcomes were older, had higher white blood cell counts, more severe hypoxemia, higher rates of mechanical ventilation and RV dilation (Figures 1, 2, 3, 4, and 5). RV dilation was an independent predictor of mortality (odds ratio [OR], 12.0; P = .048).

Discussion

POCUS identified both lung and cardiac features that were associated with worse outcomes. While lung ultrasound abnormalities were very prevalent and associated with worse PaO₂ to FiO₂ ratios, the presence of RV dilation was associated most clearly with mortality and poor 30-day outcomes in the critical care setting.

Lung ultrasound abnormalities were pervasive in patients with acute respiratory failure and COVID-19. On linear regression we found that presence with bilateral B lines and pleural thickening was predictive of a lower PaO₂/FiO₂ (coefficient, -70; P = .005). Our study found that B lines with pleural irregularities, otherwise known as a B’ profile per the BLUE protocol, was seen in patients with severe COVID-19. Thus severe acute respiratory failure secondary to COVID-19 has similar lung ultrasound findings as non-COVID-19 acute respiratory distress syndrome (ARDS).^4,5 Based on prior lung ultrasound studies in ARDS, lung ultrasound findings can be used as an alternate to chest radiography for the diagnosis of ARDS in COVID-19 and predict the severity of ARDS.⁹ This has particular implications in overwhelmed and resource poor health care settings.

We found no difference in 30-day mortality based on lung ultrasound findings or profile, probably because of small sample size or because the findings were tabulated as profiles and not differentiated further with lung ultrasound scores.^10,11 However, there was a significant difference in RV dilation between the 2 groups by 30 days and its presence was found to be a predictor of mortality even when controlled for hypertension and diabetes mellitus (P = .048) with an OR of 12. RV dysfunction in patients with ARDS on mechanical ventilation ranges from 22 to 25% and is typically associated with high driving pressures.^12-14 The mechanism is thought to be multifactorial including hypoxemic vasoconstriction in the pulmonary vasculature in addition to the increased transpulmonary pressure.¹⁵ While all of the above are at play in COVID-19 infection, there is reported damage to the pulmonary vascular endothelium and resultant hypercoagulability and thrombosis that further increases the RV afterload.¹⁶

While RV strain and dysfunction indices done by an echocardiographer would be ideal, given the surge in infections and hospitalizations and strain on health care resources, POCUS by the treating or examining clinician was considered the only feasible way to screen a large number of patients.¹⁷ Identification of RV dilation could influence clinical management including workup for venous thromboembolic disease and optimization of lung protective strategies. Further studies are needed to understand the particular etiology and pathophysiology of COVID-19 associated RV dilation. Given increased thrombosis events in COVID-19 infection we believe a POCUS vascular examination should be included as part of evaluation especially in the presence of increased D-dimers and has been discussed above for its important role in working up RV dilation.¹⁸

Limitations

Our study has several limitations. It was retrospective in nature and involved a small group of individuals. There was some variation in POCUS examinations done at the discretion of the examining physician. We did not have a blinded observer independently review all images. Since RV dilation was documented only when RV size approached or exceeded LV size in the apical 4 chamber view representing moderate or severe dilation, we may be underreporting the prevalence in critically ill patients.

Conclusions

POCUS is an invaluable adjunct to clinical evaluation and procedures in patients with severe COVID-19 with the ability to identity patients at risk for worse outcomes. B lines with pleural thickening is a sign of severe ARDS and RV dilatation is predictive of mortality. POCUS should be made available to the treating physician for monitoring and risk stratification and can be incorporated into management algorithms.

Additional point-of-care ultrasound videos.

Acknowledgments

We thank frontline healthcare workers and intensive care unit staff of the US Department of Veterans Affairs New York Harbor Healthcare System (NYHHS) for their dedication to the care of veterans and civilians during the COVID-19 pandemic in New York City. The authors acknowledge the NYHHS research and development committee and administration for their support.

The United States is facing an opioid crisis in which approximately 10 million people have misused opioids in the past year, and an estimated 2 million people have an opioid use disorder (OUD).¹ Compared with the general population, veterans treated in the Veterans Health Administration (VHA) facilities are at nearly twice the risk for accidental opioid overdose.² The implementation of opioid safety measures in VHA facilities across all care settings is a priority in addressing this public health crisis. Hence, VHA leadership is working to minimize veteran risk of fatal opioid overdoses and to increase veteran access to medication-assisted treatments (MAT) for OUD.³

Since the administration of our survey, the VHA has shifted to using the term medication for opioid use disorder (MOUD) instead of MAT for OUD. However, for consistency with the survey we distributed, we use MAT in this analysis.

Acute care settings represent an opportunity to offer appropriate opioid care and treatment options to patients at risk for OUD or opioid-related overdose. VHA facilities offer 2 outpatient acute care settings for emergent ambulatory care: emergency departments (EDs) and urgent care centers (UCCs). Annually, these settings see an estimated 2.5 million patients each year, making EDs and UCCs critical access points of OUD care for veterans. Partnering with key national VHA stakeholders from Pharmacy Benefits Management (PBM), the Office of Emergency Medicine, and Academic Detailing Services (ADS), we developed the Emergency Department Opioid Safety Initiative (ED OSI) aimed at implementing and evaluating opioid safety measures in VHA outpatient acute care settings.

The US Department of Veterans Affairs (VA)/Department of Defense (DoD) Clinical Practice Guidelines for Opioid Therapy for Chronic Pain (CPG) makes recommendations for the initiation and continuation of opioids, risk mitigation, taper of opioids, and opioid therapy for acute pain in VHA facilities.⁴ Using these recommendations, we developed the broad aims of the ED OSI quality improvement (QI) program. The CPG is clear about the prioritization of safe opioid prescribing practices. New opioid prescriptions written in the ED have been associated with continued and chronic opioid use.⁵ At the time of prescription, patients not currently and chronically on opioids who receive more than a 3-day supply are at increased risk of becoming long-term opioid users.⁶ Given the annual volume of patients seen, VHA ED/UCCs are a crucial area for implementing better opioid prescribing practices.

The CPG also includes recommendations for the prescribing or coprescribing of naloxone rescue kits. The administration of naloxone following opioid overdose has been found to be an effective measure against fatal overdose. Increasing provider awareness of common risk factors for opioid-related overdose (eg, frequent ED visits or hospitalizations) helps facilitate a discussion on naloxone prescribing at discharge. Prior studies provide evidence that naloxone distribution and accompanying education also are effective in reducing opioid overdose mortalityand ED visits related to adverse opioid-related events.^7,8

Similarly, the guidelines provide recommendations for the use of MAT for veterans with OUD. MAT for OUD is considered a first-line treatment option for patients with moderate-to-severe OUD. When used to treat patients with unsafe opioid use, this treatment helps alleviate symptoms of withdrawal, which can increase opioid taper adherence and has a protective effect against opioid overdose mortality.⁹ MAT initiated in the ED can increase patient engagement to addiction services.¹⁰

These 3 CPG recommendations serve as the basis for the broad goals of the ED OSI program. We aim to develop, implement, and evaluate programs and initiatives to (aim 1) reduce inappropriate opioid prescribing from VHA EDs; (aim 2) increase naloxone distribution from VHA EDs; and (aim 3) increase access to MAT initiation from VHA EDs through the implementation of ED-based MAT-initiation programs with EDs across the VHA. Aim 1 was a focused and strategic QI effort to implement an ED-based program to reduce inappropriate opioid prescribing. The ED OSI prescribing program offered a 4-step bundled approach: (1) sharing of opioid prescribing dashboard data with ED medical director and academic detailer; (2) education of ED providers and implementation of toolkit resources; (3) academic detailers conduct audit and feedback session(s) with highest prescribers; and (4) quarterly reports of opioid prescribing data to ED providers.

Results from the pilot suggested that our program was associated with accelerating the rate at which ED prescribing rates decreased.¹¹ In addition, the pilot found that ED-based QI initiatives in VHA facilities are a feasible practice. As we work to develop and implement the next 2 phases of the QI program, a major consideration is to identify facilitators and address any existing barriers to the implementation of naloxone distribution (aim 2) and MAT-initiation (aim 3) programs for treatment-naïve patients from VHA EDs. To date, there have been no recent published studies examining the barriers and facilitators to use or implementation of MAT initiation or naloxone distribution in VHA facilities or, more specifically, from VHA EDs.¹² As part of our QI program, we set out to better understand VHA ED provider perceptions of barriers and facilitators to implementation of programs aimed at increasing naloxone distribution and initiation of MAT for treatment-naïve patients in the ED.

Methods 

This project received a QI designation from the Office of PBM Academic Detailing Service Institutional Review Board at the Edward Hines, Jr. Veterans Affairs Hospital VA Medical Center (VAMC). This designation was reviewed and approved by the Rocky Mountain Regional VAMC Research and Development service. In addition, we received national union approval to disseminate this survey nationally across all VA Integrated Service Networks (VISNs).

Survey

We worked with VHA subject matter experts, key stakeholders, and the VA Collaborative Evaluation Center (VACE) to develop the survey. Subject matter experts and stakeholders included VHA emergency medicine leadership, ADS leadership, and mental health and substance treatment providers. VACE is an interdisciplinary group of mixed-method researchers. The survey questions aimed to capture perceptions and experiences regarding naloxone distribution and new MAT initiation of VHA ED/UCC providers.

We used a variety of survey question formats. Close-ended questions with a predefined list of answer options were used to capture discrete domains, such as demographic information, comfort level, and experience level. To capture health care provider (HCP) perceptions on barriers and facilitators, we used multiple-answer multiple-choice questions. Built into this question format was a free-response option, which allowed respondents to offer additional barriers or facilitators. Respondents also had the option of not answering individual questions.

We identified physicians, nurse practitioners (NPs), and physician assistants (PAs) who saw at least 100 patients in the ED or UCC in at least one 3-month period in the prior year and obtained an email address for each. In total, 2228 ED or UCC providers across 132 facilities were emailed a survey; 1883 (84.5%) were ED providers and 345 (15.5%) were UCC providers.

We used Research Electronic Data Capture (REDCap) software to build and disseminate the survey via email. Surveys were initially disseminated in late January 2019. During the 3-month survey period, recipients received 3 automated email reminders from REDCap to complete the survey. Survey data were exported from REDCap. Results were analyzed using descriptive statistics analyses with Microsoft Excel.

Results 

One respondent received the survey in error and was excluded from the analysis. The survey response rate was 16.7%: 372 responses from 103 unique facilities. Each VISN had a mean 20 respondents. The majority of respondents (n = 286, 76.9%) worked in highly complex level 1 facilities characterized by high patient volume and more high-risk patients and were teaching and research facilities. Respondents were asked to describe their most recent ED or UCC role. While 281 respondents (75.5%) were medical doctors, 61 respondents (16.4%) were NPs, 30 (8.1%) were PAs, and 26 (7.0%) were ED/UCC chiefs or medical directors (Table 1). Most respondents (80.4%) reported at least 10 years of health care experience.

The majority of respondents (72.9%) believed that HCPs at their VHA facility should be prescribing naloxone. When asked to specify which HCPs should be prescribing naloxone, most HCP respondents selected pharmacists (76.4%) and substance abuse providers (71.6%). Less than half of respondents (45.0%) felt that VA ED/UCC providers also should be prescribing naloxone. However, 58.1% of most HCP respondents reported being comfortable or very comfortable with prescribing naloxone to a patient in the ED or UCC who already had an existing prescription of opioids. Similarly, 52.7% of respondents reported being comfortable or very comfortable with coprescribing naloxone when discharging a patient with an opioid prescription from the ED/UCC. Notably, while 36.7% of PAs reported being comfortable/very comfortable coprescribing naloxone, 46.7% reported being comfortable/very comfortable prescribing naloxone to a patient with an existing opioid prescription. Physicians and NPs expressed similar levels of comfort with coprescribing and prescribing naloxone.

Respondents across provider types indicated a number of barriers to prescribing naloxone to medically appropriate patients (Table 2). Many respondents indicated prescribing naloxone was beyond the ED/UCC provider scope of practice (35.2%), followed by the perceived stigma associated with naloxone (33.3%), time required to prescribe naloxone (23.9%), and concern with patient’s ability to use naloxone (22.8%).

Discussion

To the best of our knowledge, there have not been any studies examining HCP perceptions of the barriers and facilitators to naloxone distribution or the initiation of MAT in VHA ED and UCCs. Veterans are at an increased risk of overdose when compared with the general population, and increasing access to opioid safety measures (eg, safer prescribing practices, naloxone distribution) and treatment with MAT for OUD across all clinical settings has been a VHA priority.³

National guidance from VHA leadership, the Centers for Disease Control and Prevention (CDC), the US Surgeon General, and the US Department of Health and Human Services (HHS) call for an all-hands-on-deck approach to combatting opioid overdose with naloxone distribution or MAT (such as buprenorphine) initiation.¹³ VHA ED and UCC settings provide acute outpatient care to patients with medical or psychiatric illnesses or injuries that the patient believes requires emergent or immediate medical attention or for which there is a critical need for treatment to prevent deterioration of the condition or the possible impairment of recovery.¹⁴ However, ED and UCC environments are often regarded as settings meant to stabilize a patient until they can be seen by a primary care or long-term care provider.

A major barrier identified by HCPs was that MAT for OUD was outside their ED/UCC scope of practice, which suggests a need for a top-down or peer-to-peer reexamination of the role of HCPs in ED/UCC settings. Any naloxone distribution and/or MAT-initiation program in VHA ED/UCCs should consider education about the role of ED/UCC HCPs in opioid safety and treatment. According to a VHA Support Service Center (VSSC) employee report database, in fiscal year 2018, per diem/fee-basis and contract HCPs comprised nearly 40% of clinical emergency medicine physician full-time equivalent employees, which presents a unique barrier to HCP education. Fee-basis and per diem HCPs may be less aware of, engaged in, or committed to VHA goals. Additionally, short-term HCPs may have fewer opportunities for training and education regarding naloxone or MAT use.

Only 25.3% of HCPs reported that their facility leadership was supportive or very supportive of MAT prescribing. This suggests that facility leadership should be engaged in any efforts to implement a MAT-initiation program in the facility’s ED. Engaging leadership in efforts to implement ED-based MAT programs will allow for a better understanding of leadership goals as related to opioid safety and an opportunity to address concerns regarding prescribing MAT in the ED. We recommend engaging facility leadership early in MAT implementation efforts. Respectively, 12.4% and 28.2% of HCP respondents reported discomfort prescribing naloxone or using MAT, suggesting a need for more education. Similarly, only 6.8% of HCPs reported comfort with using MAT.

A consideration for implementing ED/UCC-based MAT should be the inclusion of a training component. An evidence-based clinical treatment pathway that is appropriate to the ED/UCC setting and facility on the administration of MAT also could be beneficial. A clinical treatment pathway that includes ED/UCC-initiated discharge recommendations would address HCP concerns of unclear follow-up plans and system for referral of care. To this end, a key implementation task is coordinating with other outpatient services (eg, pain management clinic, substance use disorder treatment clinic) equipped for long-term patient follow-up to develop a system for referral of care. For example, as part of the clinical treatment pathway, an ED can develop a system of referral for patients initiated on MAT in the ED in which patients are referred for follow-up at the facility’s substance use disorder treatment clinic to be seen within 72 hours to continue the administration of MAT (such as buprenorphine).

In addition to HCP education, results suggest that patient/veteran education regarding naloxone and/or MAT should be considered. HCPs indicated that having help from a pharmacist to educate the patient about the medications would be a facilitator to naloxone distribution and MAT initiation. Similarly, patient knowledge of the medications also was endorsed as a facilitator. As such, a consideration for any future ED/UCC-based naloxone distribution or MAT-initiation programs in the VHA should be patient education whether by a clinically trained professional or an educational campaign for veterans.

Expanded naloxone distribution and initiation of MAT for OUD for EDs/UCCs across the VHA could impact the lives of veterans on long-term opioid therapy, with OUD, or who are otherwise at risk for opioid overdose. Steps taken to address the barriers and leverage the facilitators identified by HCP respondents can greatly reduce current obstacles to widespread implementation of ED/UCC-based naloxone distribution and MAT initiation nationally within the VHA.

Limitations

This survey had a low response rate (16.7%). One potential explanation for the low response rate is that when the survey was deployed, many of the VHA ED/UCC physicians were per-diem employees. Per-diem physicians may be less engaged and aware of site facilitators or barriers to naloxone and MAT prescribing. This, too, may have potentially skewed the collected data. However, the survey did not ask HCPs to disclose their employment status; thus, exact rates of per diem respondents are unknown.

We aimed to capture only self-perceived barriers to prescribing naloxone and MAT in the ED, but we did not capture or measure HCP respondent’s actual prescribing rates of MAT or naloxone. Understanding HCP perceptions of naloxone distribution and MAT initiation in the ED may have been further informed by comparing HCP responses to their actual clinical practice as related to their prescribing of these medications. In future research, we will link HCPs with the actual numbers of naloxone and MAT medications prescribed. Additionally, we do not know how many of these barriers or proposed facilitators will impact clinical practice.

Conclusions

A key aim for VHA leadership is to increase veteran access to naloxone distribution and MAT for OUD across clinical areas. The present study aimed to identify HCP perceptions of barriers and facilitators to the naloxone distribution and MAT-initiation programs in VHA ED/UCCs to inform the development of a targeted QI program to implement these opioid safety measures. Although the survey yielded a low response rate, results allowed us to identify important action items for our QI program, such as the development of clear protocols, follow-up plans, and systems for referral of care and HCP educational materials related to MAT and naloxone. We hope this work will serve as the basis for ED/UCC-tailored programs that can provide customized educational programs for HCPs designed to overcome known barriers to naloxone and MAT initiation.

Acknowledgments
This work was supported by the VA Office of Specialty Care Services 10P11 and through funding provided by the Comprehensive Addiction and Recovery Act (CARA).

The United States is facing an opioid crisis in which approximately 10 million people have misused opioids in the past year, and an estimated 2 million people have an opioid use disorder (OUD).¹ Compared with the general population, veterans treated in the Veterans Health Administration (VHA) facilities are at nearly twice the risk for accidental opioid overdose.² The implementation of opioid safety measures in VHA facilities across all care settings is a priority in addressing this public health crisis. Hence, VHA leadership is working to minimize veteran risk of fatal opioid overdoses and to increase veteran access to medication-assisted treatments (MAT) for OUD.³

Since the administration of our survey, the VHA has shifted to using the term medication for opioid use disorder (MOUD) instead of MAT for OUD. However, for consistency with the survey we distributed, we use MAT in this analysis.

Acute care settings represent an opportunity to offer appropriate opioid care and treatment options to patients at risk for OUD or opioid-related overdose. VHA facilities offer 2 outpatient acute care settings for emergent ambulatory care: emergency departments (EDs) and urgent care centers (UCCs). Annually, these settings see an estimated 2.5 million patients each year, making EDs and UCCs critical access points of OUD care for veterans. Partnering with key national VHA stakeholders from Pharmacy Benefits Management (PBM), the Office of Emergency Medicine, and Academic Detailing Services (ADS), we developed the Emergency Department Opioid Safety Initiative (ED OSI) aimed at implementing and evaluating opioid safety measures in VHA outpatient acute care settings.

The US Department of Veterans Affairs (VA)/Department of Defense (DoD) Clinical Practice Guidelines for Opioid Therapy for Chronic Pain (CPG) makes recommendations for the initiation and continuation of opioids, risk mitigation, taper of opioids, and opioid therapy for acute pain in VHA facilities.⁴ Using these recommendations, we developed the broad aims of the ED OSI quality improvement (QI) program. The CPG is clear about the prioritization of safe opioid prescribing practices. New opioid prescriptions written in the ED have been associated with continued and chronic opioid use.⁵ At the time of prescription, patients not currently and chronically on opioids who receive more than a 3-day supply are at increased risk of becoming long-term opioid users.⁶ Given the annual volume of patients seen, VHA ED/UCCs are a crucial area for implementing better opioid prescribing practices.

The CPG also includes recommendations for the prescribing or coprescribing of naloxone rescue kits. The administration of naloxone following opioid overdose has been found to be an effective measure against fatal overdose. Increasing provider awareness of common risk factors for opioid-related overdose (eg, frequent ED visits or hospitalizations) helps facilitate a discussion on naloxone prescribing at discharge. Prior studies provide evidence that naloxone distribution and accompanying education also are effective in reducing opioid overdose mortalityand ED visits related to adverse opioid-related events.^7,8

Similarly, the guidelines provide recommendations for the use of MAT for veterans with OUD. MAT for OUD is considered a first-line treatment option for patients with moderate-to-severe OUD. When used to treat patients with unsafe opioid use, this treatment helps alleviate symptoms of withdrawal, which can increase opioid taper adherence and has a protective effect against opioid overdose mortality.⁹ MAT initiated in the ED can increase patient engagement to addiction services.¹⁰

These 3 CPG recommendations serve as the basis for the broad goals of the ED OSI program. We aim to develop, implement, and evaluate programs and initiatives to (aim 1) reduce inappropriate opioid prescribing from VHA EDs; (aim 2) increase naloxone distribution from VHA EDs; and (aim 3) increase access to MAT initiation from VHA EDs through the implementation of ED-based MAT-initiation programs with EDs across the VHA. Aim 1 was a focused and strategic QI effort to implement an ED-based program to reduce inappropriate opioid prescribing. The ED OSI prescribing program offered a 4-step bundled approach: (1) sharing of opioid prescribing dashboard data with ED medical director and academic detailer; (2) education of ED providers and implementation of toolkit resources; (3) academic detailers conduct audit and feedback session(s) with highest prescribers; and (4) quarterly reports of opioid prescribing data to ED providers.

Results from the pilot suggested that our program was associated with accelerating the rate at which ED prescribing rates decreased.¹¹ In addition, the pilot found that ED-based QI initiatives in VHA facilities are a feasible practice. As we work to develop and implement the next 2 phases of the QI program, a major consideration is to identify facilitators and address any existing barriers to the implementation of naloxone distribution (aim 2) and MAT-initiation (aim 3) programs for treatment-naïve patients from VHA EDs. To date, there have been no recent published studies examining the barriers and facilitators to use or implementation of MAT initiation or naloxone distribution in VHA facilities or, more specifically, from VHA EDs.¹² As part of our QI program, we set out to better understand VHA ED provider perceptions of barriers and facilitators to implementation of programs aimed at increasing naloxone distribution and initiation of MAT for treatment-naïve patients in the ED.

Methods 

This project received a QI designation from the Office of PBM Academic Detailing Service Institutional Review Board at the Edward Hines, Jr. Veterans Affairs Hospital VA Medical Center (VAMC). This designation was reviewed and approved by the Rocky Mountain Regional VAMC Research and Development service. In addition, we received national union approval to disseminate this survey nationally across all VA Integrated Service Networks (VISNs).

Survey

We worked with VHA subject matter experts, key stakeholders, and the VA Collaborative Evaluation Center (VACE) to develop the survey. Subject matter experts and stakeholders included VHA emergency medicine leadership, ADS leadership, and mental health and substance treatment providers. VACE is an interdisciplinary group of mixed-method researchers. The survey questions aimed to capture perceptions and experiences regarding naloxone distribution and new MAT initiation of VHA ED/UCC providers.

We used a variety of survey question formats. Close-ended questions with a predefined list of answer options were used to capture discrete domains, such as demographic information, comfort level, and experience level. To capture health care provider (HCP) perceptions on barriers and facilitators, we used multiple-answer multiple-choice questions. Built into this question format was a free-response option, which allowed respondents to offer additional barriers or facilitators. Respondents also had the option of not answering individual questions.

We identified physicians, nurse practitioners (NPs), and physician assistants (PAs) who saw at least 100 patients in the ED or UCC in at least one 3-month period in the prior year and obtained an email address for each. In total, 2228 ED or UCC providers across 132 facilities were emailed a survey; 1883 (84.5%) were ED providers and 345 (15.5%) were UCC providers.

We used Research Electronic Data Capture (REDCap) software to build and disseminate the survey via email. Surveys were initially disseminated in late January 2019. During the 3-month survey period, recipients received 3 automated email reminders from REDCap to complete the survey. Survey data were exported from REDCap. Results were analyzed using descriptive statistics analyses with Microsoft Excel.

Results 

One respondent received the survey in error and was excluded from the analysis. The survey response rate was 16.7%: 372 responses from 103 unique facilities. Each VISN had a mean 20 respondents. The majority of respondents (n = 286, 76.9%) worked in highly complex level 1 facilities characterized by high patient volume and more high-risk patients and were teaching and research facilities. Respondents were asked to describe their most recent ED or UCC role. While 281 respondents (75.5%) were medical doctors, 61 respondents (16.4%) were NPs, 30 (8.1%) were PAs, and 26 (7.0%) were ED/UCC chiefs or medical directors (Table 1). Most respondents (80.4%) reported at least 10 years of health care experience.

The majority of respondents (72.9%) believed that HCPs at their VHA facility should be prescribing naloxone. When asked to specify which HCPs should be prescribing naloxone, most HCP respondents selected pharmacists (76.4%) and substance abuse providers (71.6%). Less than half of respondents (45.0%) felt that VA ED/UCC providers also should be prescribing naloxone. However, 58.1% of most HCP respondents reported being comfortable or very comfortable with prescribing naloxone to a patient in the ED or UCC who already had an existing prescription of opioids. Similarly, 52.7% of respondents reported being comfortable or very comfortable with coprescribing naloxone when discharging a patient with an opioid prescription from the ED/UCC. Notably, while 36.7% of PAs reported being comfortable/very comfortable coprescribing naloxone, 46.7% reported being comfortable/very comfortable prescribing naloxone to a patient with an existing opioid prescription. Physicians and NPs expressed similar levels of comfort with coprescribing and prescribing naloxone.

Respondents across provider types indicated a number of barriers to prescribing naloxone to medically appropriate patients (Table 2). Many respondents indicated prescribing naloxone was beyond the ED/UCC provider scope of practice (35.2%), followed by the perceived stigma associated with naloxone (33.3%), time required to prescribe naloxone (23.9%), and concern with patient’s ability to use naloxone (22.8%).

Discussion

To the best of our knowledge, there have not been any studies examining HCP perceptions of the barriers and facilitators to naloxone distribution or the initiation of MAT in VHA ED and UCCs. Veterans are at an increased risk of overdose when compared with the general population, and increasing access to opioid safety measures (eg, safer prescribing practices, naloxone distribution) and treatment with MAT for OUD across all clinical settings has been a VHA priority.³

National guidance from VHA leadership, the Centers for Disease Control and Prevention (CDC), the US Surgeon General, and the US Department of Health and Human Services (HHS) call for an all-hands-on-deck approach to combatting opioid overdose with naloxone distribution or MAT (such as buprenorphine) initiation.¹³ VHA ED and UCC settings provide acute outpatient care to patients with medical or psychiatric illnesses or injuries that the patient believes requires emergent or immediate medical attention or for which there is a critical need for treatment to prevent deterioration of the condition or the possible impairment of recovery.¹⁴ However, ED and UCC environments are often regarded as settings meant to stabilize a patient until they can be seen by a primary care or long-term care provider.

A major barrier identified by HCPs was that MAT for OUD was outside their ED/UCC scope of practice, which suggests a need for a top-down or peer-to-peer reexamination of the role of HCPs in ED/UCC settings. Any naloxone distribution and/or MAT-initiation program in VHA ED/UCCs should consider education about the role of ED/UCC HCPs in opioid safety and treatment. According to a VHA Support Service Center (VSSC) employee report database, in fiscal year 2018, per diem/fee-basis and contract HCPs comprised nearly 40% of clinical emergency medicine physician full-time equivalent employees, which presents a unique barrier to HCP education. Fee-basis and per diem HCPs may be less aware of, engaged in, or committed to VHA goals. Additionally, short-term HCPs may have fewer opportunities for training and education regarding naloxone or MAT use.

Only 25.3% of HCPs reported that their facility leadership was supportive or very supportive of MAT prescribing. This suggests that facility leadership should be engaged in any efforts to implement a MAT-initiation program in the facility’s ED. Engaging leadership in efforts to implement ED-based MAT programs will allow for a better understanding of leadership goals as related to opioid safety and an opportunity to address concerns regarding prescribing MAT in the ED. We recommend engaging facility leadership early in MAT implementation efforts. Respectively, 12.4% and 28.2% of HCP respondents reported discomfort prescribing naloxone or using MAT, suggesting a need for more education. Similarly, only 6.8% of HCPs reported comfort with using MAT.

A consideration for implementing ED/UCC-based MAT should be the inclusion of a training component. An evidence-based clinical treatment pathway that is appropriate to the ED/UCC setting and facility on the administration of MAT also could be beneficial. A clinical treatment pathway that includes ED/UCC-initiated discharge recommendations would address HCP concerns of unclear follow-up plans and system for referral of care. To this end, a key implementation task is coordinating with other outpatient services (eg, pain management clinic, substance use disorder treatment clinic) equipped for long-term patient follow-up to develop a system for referral of care. For example, as part of the clinical treatment pathway, an ED can develop a system of referral for patients initiated on MAT in the ED in which patients are referred for follow-up at the facility’s substance use disorder treatment clinic to be seen within 72 hours to continue the administration of MAT (such as buprenorphine).

In addition to HCP education, results suggest that patient/veteran education regarding naloxone and/or MAT should be considered. HCPs indicated that having help from a pharmacist to educate the patient about the medications would be a facilitator to naloxone distribution and MAT initiation. Similarly, patient knowledge of the medications also was endorsed as a facilitator. As such, a consideration for any future ED/UCC-based naloxone distribution or MAT-initiation programs in the VHA should be patient education whether by a clinically trained professional or an educational campaign for veterans.

Expanded naloxone distribution and initiation of MAT for OUD for EDs/UCCs across the VHA could impact the lives of veterans on long-term opioid therapy, with OUD, or who are otherwise at risk for opioid overdose. Steps taken to address the barriers and leverage the facilitators identified by HCP respondents can greatly reduce current obstacles to widespread implementation of ED/UCC-based naloxone distribution and MAT initiation nationally within the VHA.

Limitations

This survey had a low response rate (16.7%). One potential explanation for the low response rate is that when the survey was deployed, many of the VHA ED/UCC physicians were per-diem employees. Per-diem physicians may be less engaged and aware of site facilitators or barriers to naloxone and MAT prescribing. This, too, may have potentially skewed the collected data. However, the survey did not ask HCPs to disclose their employment status; thus, exact rates of per diem respondents are unknown.

We aimed to capture only self-perceived barriers to prescribing naloxone and MAT in the ED, but we did not capture or measure HCP respondent’s actual prescribing rates of MAT or naloxone. Understanding HCP perceptions of naloxone distribution and MAT initiation in the ED may have been further informed by comparing HCP responses to their actual clinical practice as related to their prescribing of these medications. In future research, we will link HCPs with the actual numbers of naloxone and MAT medications prescribed. Additionally, we do not know how many of these barriers or proposed facilitators will impact clinical practice.

Conclusions

A key aim for VHA leadership is to increase veteran access to naloxone distribution and MAT for OUD across clinical areas. The present study aimed to identify HCP perceptions of barriers and facilitators to the naloxone distribution and MAT-initiation programs in VHA ED/UCCs to inform the development of a targeted QI program to implement these opioid safety measures. Although the survey yielded a low response rate, results allowed us to identify important action items for our QI program, such as the development of clear protocols, follow-up plans, and systems for referral of care and HCP educational materials related to MAT and naloxone. We hope this work will serve as the basis for ED/UCC-tailored programs that can provide customized educational programs for HCPs designed to overcome known barriers to naloxone and MAT initiation.

Acknowledgments
This work was supported by the VA Office of Specialty Care Services 10P11 and through funding provided by the Comprehensive Addiction and Recovery Act (CARA).

The United States is facing an opioid crisis in which approximately 10 million people have misused opioids in the past year, and an estimated 2 million people have an opioid use disorder (OUD).¹ Compared with the general population, veterans treated in the Veterans Health Administration (VHA) facilities are at nearly twice the risk for accidental opioid overdose.² The implementation of opioid safety measures in VHA facilities across all care settings is a priority in addressing this public health crisis. Hence, VHA leadership is working to minimize veteran risk of fatal opioid overdoses and to increase veteran access to medication-assisted treatments (MAT) for OUD.³

Since the administration of our survey, the VHA has shifted to using the term medication for opioid use disorder (MOUD) instead of MAT for OUD. However, for consistency with the survey we distributed, we use MAT in this analysis.

Acute care settings represent an opportunity to offer appropriate opioid care and treatment options to patients at risk for OUD or opioid-related overdose. VHA facilities offer 2 outpatient acute care settings for emergent ambulatory care: emergency departments (EDs) and urgent care centers (UCCs). Annually, these settings see an estimated 2.5 million patients each year, making EDs and UCCs critical access points of OUD care for veterans. Partnering with key national VHA stakeholders from Pharmacy Benefits Management (PBM), the Office of Emergency Medicine, and Academic Detailing Services (ADS), we developed the Emergency Department Opioid Safety Initiative (ED OSI) aimed at implementing and evaluating opioid safety measures in VHA outpatient acute care settings.

The US Department of Veterans Affairs (VA)/Department of Defense (DoD) Clinical Practice Guidelines for Opioid Therapy for Chronic Pain (CPG) makes recommendations for the initiation and continuation of opioids, risk mitigation, taper of opioids, and opioid therapy for acute pain in VHA facilities.⁴ Using these recommendations, we developed the broad aims of the ED OSI quality improvement (QI) program. The CPG is clear about the prioritization of safe opioid prescribing practices. New opioid prescriptions written in the ED have been associated with continued and chronic opioid use.⁵ At the time of prescription, patients not currently and chronically on opioids who receive more than a 3-day supply are at increased risk of becoming long-term opioid users.⁶ Given the annual volume of patients seen, VHA ED/UCCs are a crucial area for implementing better opioid prescribing practices.

The CPG also includes recommendations for the prescribing or coprescribing of naloxone rescue kits. The administration of naloxone following opioid overdose has been found to be an effective measure against fatal overdose. Increasing provider awareness of common risk factors for opioid-related overdose (eg, frequent ED visits or hospitalizations) helps facilitate a discussion on naloxone prescribing at discharge. Prior studies provide evidence that naloxone distribution and accompanying education also are effective in reducing opioid overdose mortalityand ED visits related to adverse opioid-related events.^7,8

Similarly, the guidelines provide recommendations for the use of MAT for veterans with OUD. MAT for OUD is considered a first-line treatment option for patients with moderate-to-severe OUD. When used to treat patients with unsafe opioid use, this treatment helps alleviate symptoms of withdrawal, which can increase opioid taper adherence and has a protective effect against opioid overdose mortality.⁹ MAT initiated in the ED can increase patient engagement to addiction services.¹⁰

These 3 CPG recommendations serve as the basis for the broad goals of the ED OSI program. We aim to develop, implement, and evaluate programs and initiatives to (aim 1) reduce inappropriate opioid prescribing from VHA EDs; (aim 2) increase naloxone distribution from VHA EDs; and (aim 3) increase access to MAT initiation from VHA EDs through the implementation of ED-based MAT-initiation programs with EDs across the VHA. Aim 1 was a focused and strategic QI effort to implement an ED-based program to reduce inappropriate opioid prescribing. The ED OSI prescribing program offered a 4-step bundled approach: (1) sharing of opioid prescribing dashboard data with ED medical director and academic detailer; (2) education of ED providers and implementation of toolkit resources; (3) academic detailers conduct audit and feedback session(s) with highest prescribers; and (4) quarterly reports of opioid prescribing data to ED providers.

Results from the pilot suggested that our program was associated with accelerating the rate at which ED prescribing rates decreased.¹¹ In addition, the pilot found that ED-based QI initiatives in VHA facilities are a feasible practice. As we work to develop and implement the next 2 phases of the QI program, a major consideration is to identify facilitators and address any existing barriers to the implementation of naloxone distribution (aim 2) and MAT-initiation (aim 3) programs for treatment-naïve patients from VHA EDs. To date, there have been no recent published studies examining the barriers and facilitators to use or implementation of MAT initiation or naloxone distribution in VHA facilities or, more specifically, from VHA EDs.¹² As part of our QI program, we set out to better understand VHA ED provider perceptions of barriers and facilitators to implementation of programs aimed at increasing naloxone distribution and initiation of MAT for treatment-naïve patients in the ED.

Methods 

This project received a QI designation from the Office of PBM Academic Detailing Service Institutional Review Board at the Edward Hines, Jr. Veterans Affairs Hospital VA Medical Center (VAMC). This designation was reviewed and approved by the Rocky Mountain Regional VAMC Research and Development service. In addition, we received national union approval to disseminate this survey nationally across all VA Integrated Service Networks (VISNs).

Survey

We worked with VHA subject matter experts, key stakeholders, and the VA Collaborative Evaluation Center (VACE) to develop the survey. Subject matter experts and stakeholders included VHA emergency medicine leadership, ADS leadership, and mental health and substance treatment providers. VACE is an interdisciplinary group of mixed-method researchers. The survey questions aimed to capture perceptions and experiences regarding naloxone distribution and new MAT initiation of VHA ED/UCC providers.

We used a variety of survey question formats. Close-ended questions with a predefined list of answer options were used to capture discrete domains, such as demographic information, comfort level, and experience level. To capture health care provider (HCP) perceptions on barriers and facilitators, we used multiple-answer multiple-choice questions. Built into this question format was a free-response option, which allowed respondents to offer additional barriers or facilitators. Respondents also had the option of not answering individual questions.

We identified physicians, nurse practitioners (NPs), and physician assistants (PAs) who saw at least 100 patients in the ED or UCC in at least one 3-month period in the prior year and obtained an email address for each. In total, 2228 ED or UCC providers across 132 facilities were emailed a survey; 1883 (84.5%) were ED providers and 345 (15.5%) were UCC providers.

We used Research Electronic Data Capture (REDCap) software to build and disseminate the survey via email. Surveys were initially disseminated in late January 2019. During the 3-month survey period, recipients received 3 automated email reminders from REDCap to complete the survey. Survey data were exported from REDCap. Results were analyzed using descriptive statistics analyses with Microsoft Excel.

Results 

One respondent received the survey in error and was excluded from the analysis. The survey response rate was 16.7%: 372 responses from 103 unique facilities. Each VISN had a mean 20 respondents. The majority of respondents (n = 286, 76.9%) worked in highly complex level 1 facilities characterized by high patient volume and more high-risk patients and were teaching and research facilities. Respondents were asked to describe their most recent ED or UCC role. While 281 respondents (75.5%) were medical doctors, 61 respondents (16.4%) were NPs, 30 (8.1%) were PAs, and 26 (7.0%) were ED/UCC chiefs or medical directors (Table 1). Most respondents (80.4%) reported at least 10 years of health care experience.

The majority of respondents (72.9%) believed that HCPs at their VHA facility should be prescribing naloxone. When asked to specify which HCPs should be prescribing naloxone, most HCP respondents selected pharmacists (76.4%) and substance abuse providers (71.6%). Less than half of respondents (45.0%) felt that VA ED/UCC providers also should be prescribing naloxone. However, 58.1% of most HCP respondents reported being comfortable or very comfortable with prescribing naloxone to a patient in the ED or UCC who already had an existing prescription of opioids. Similarly, 52.7% of respondents reported being comfortable or very comfortable with coprescribing naloxone when discharging a patient with an opioid prescription from the ED/UCC. Notably, while 36.7% of PAs reported being comfortable/very comfortable coprescribing naloxone, 46.7% reported being comfortable/very comfortable prescribing naloxone to a patient with an existing opioid prescription. Physicians and NPs expressed similar levels of comfort with coprescribing and prescribing naloxone.

Respondents across provider types indicated a number of barriers to prescribing naloxone to medically appropriate patients (Table 2). Many respondents indicated prescribing naloxone was beyond the ED/UCC provider scope of practice (35.2%), followed by the perceived stigma associated with naloxone (33.3%), time required to prescribe naloxone (23.9%), and concern with patient’s ability to use naloxone (22.8%).

Discussion

To the best of our knowledge, there have not been any studies examining HCP perceptions of the barriers and facilitators to naloxone distribution or the initiation of MAT in VHA ED and UCCs. Veterans are at an increased risk of overdose when compared with the general population, and increasing access to opioid safety measures (eg, safer prescribing practices, naloxone distribution) and treatment with MAT for OUD across all clinical settings has been a VHA priority.³

National guidance from VHA leadership, the Centers for Disease Control and Prevention (CDC), the US Surgeon General, and the US Department of Health and Human Services (HHS) call for an all-hands-on-deck approach to combatting opioid overdose with naloxone distribution or MAT (such as buprenorphine) initiation.¹³ VHA ED and UCC settings provide acute outpatient care to patients with medical or psychiatric illnesses or injuries that the patient believes requires emergent or immediate medical attention or for which there is a critical need for treatment to prevent deterioration of the condition or the possible impairment of recovery.¹⁴ However, ED and UCC environments are often regarded as settings meant to stabilize a patient until they can be seen by a primary care or long-term care provider.

A major barrier identified by HCPs was that MAT for OUD was outside their ED/UCC scope of practice, which suggests a need for a top-down or peer-to-peer reexamination of the role of HCPs in ED/UCC settings. Any naloxone distribution and/or MAT-initiation program in VHA ED/UCCs should consider education about the role of ED/UCC HCPs in opioid safety and treatment. According to a VHA Support Service Center (VSSC) employee report database, in fiscal year 2018, per diem/fee-basis and contract HCPs comprised nearly 40% of clinical emergency medicine physician full-time equivalent employees, which presents a unique barrier to HCP education. Fee-basis and per diem HCPs may be less aware of, engaged in, or committed to VHA goals. Additionally, short-term HCPs may have fewer opportunities for training and education regarding naloxone or MAT use.

Only 25.3% of HCPs reported that their facility leadership was supportive or very supportive of MAT prescribing. This suggests that facility leadership should be engaged in any efforts to implement a MAT-initiation program in the facility’s ED. Engaging leadership in efforts to implement ED-based MAT programs will allow for a better understanding of leadership goals as related to opioid safety and an opportunity to address concerns regarding prescribing MAT in the ED. We recommend engaging facility leadership early in MAT implementation efforts. Respectively, 12.4% and 28.2% of HCP respondents reported discomfort prescribing naloxone or using MAT, suggesting a need for more education. Similarly, only 6.8% of HCPs reported comfort with using MAT.

A consideration for implementing ED/UCC-based MAT should be the inclusion of a training component. An evidence-based clinical treatment pathway that is appropriate to the ED/UCC setting and facility on the administration of MAT also could be beneficial. A clinical treatment pathway that includes ED/UCC-initiated discharge recommendations would address HCP concerns of unclear follow-up plans and system for referral of care. To this end, a key implementation task is coordinating with other outpatient services (eg, pain management clinic, substance use disorder treatment clinic) equipped for long-term patient follow-up to develop a system for referral of care. For example, as part of the clinical treatment pathway, an ED can develop a system of referral for patients initiated on MAT in the ED in which patients are referred for follow-up at the facility’s substance use disorder treatment clinic to be seen within 72 hours to continue the administration of MAT (such as buprenorphine).

In addition to HCP education, results suggest that patient/veteran education regarding naloxone and/or MAT should be considered. HCPs indicated that having help from a pharmacist to educate the patient about the medications would be a facilitator to naloxone distribution and MAT initiation. Similarly, patient knowledge of the medications also was endorsed as a facilitator. As such, a consideration for any future ED/UCC-based naloxone distribution or MAT-initiation programs in the VHA should be patient education whether by a clinically trained professional or an educational campaign for veterans.

Expanded naloxone distribution and initiation of MAT for OUD for EDs/UCCs across the VHA could impact the lives of veterans on long-term opioid therapy, with OUD, or who are otherwise at risk for opioid overdose. Steps taken to address the barriers and leverage the facilitators identified by HCP respondents can greatly reduce current obstacles to widespread implementation of ED/UCC-based naloxone distribution and MAT initiation nationally within the VHA.

Limitations

This survey had a low response rate (16.7%). One potential explanation for the low response rate is that when the survey was deployed, many of the VHA ED/UCC physicians were per-diem employees. Per-diem physicians may be less engaged and aware of site facilitators or barriers to naloxone and MAT prescribing. This, too, may have potentially skewed the collected data. However, the survey did not ask HCPs to disclose their employment status; thus, exact rates of per diem respondents are unknown.

We aimed to capture only self-perceived barriers to prescribing naloxone and MAT in the ED, but we did not capture or measure HCP respondent’s actual prescribing rates of MAT or naloxone. Understanding HCP perceptions of naloxone distribution and MAT initiation in the ED may have been further informed by comparing HCP responses to their actual clinical practice as related to their prescribing of these medications. In future research, we will link HCPs with the actual numbers of naloxone and MAT medications prescribed. Additionally, we do not know how many of these barriers or proposed facilitators will impact clinical practice.

Conclusions

A key aim for VHA leadership is to increase veteran access to naloxone distribution and MAT for OUD across clinical areas. The present study aimed to identify HCP perceptions of barriers and facilitators to the naloxone distribution and MAT-initiation programs in VHA ED/UCCs to inform the development of a targeted QI program to implement these opioid safety measures. Although the survey yielded a low response rate, results allowed us to identify important action items for our QI program, such as the development of clear protocols, follow-up plans, and systems for referral of care and HCP educational materials related to MAT and naloxone. We hope this work will serve as the basis for ED/UCC-tailored programs that can provide customized educational programs for HCPs designed to overcome known barriers to naloxone and MAT initiation.

Acknowledgments
This work was supported by the VA Office of Specialty Care Services 10P11 and through funding provided by the Comprehensive Addiction and Recovery Act (CARA).

Patients can now receive their COVID-19 vaccine and flu shot during the same visit, according to updated recommendations by the Centers for Disease Control and Prevention.

Esben H/iStock/Getty Images

Previously, the CDC recommended that people receive their COVID-19 vaccinations alone and schedule any other vaccinations at least 2 weeks before or after their COVID-19 immunization. “This was out of an abundance of caution during a period when these vaccines were new and not due to any known safety or immunogenicity concerns,” the CDC guidance states. “However, substantial data have now been collected regarding the safety of COVID-19 vaccines currently approved or authorized by FDA.”

The guidance allowing for coadministration of COVID-19 vaccines with other immunizations, including the flu shot, was issued in mid-May 2021, and was restated in influenza vaccine recommendations released Aug. 27. The American Academy of Pediatrics soon followed suit, announcing that, for children eligible for the COVID-19 vaccine (age 12 and older), AAP recommendations allow for both the influenza and COVID-19 vaccines to be administered during the same visit.

Although there is limited data around giving COVID-19 vaccines with other vaccines, “extensive experience with non–COVID-19 vaccines has demonstrated that immunogenicity and adverse-event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone,” the recommendations state. If administering other immunizations along with COVID-19 vaccines, providers should separate injection sites by at least 1 inch, the CDC recommends, and influenza vaccines that are more likely to cause a local reaction, like high-dose or the adjuvanted inactivated flu vaccine, should be administered in different limbs, if possible.

Whether someone should get their flu vaccine at the same time or separate from a COVID-19 vaccination or booster is a matter of personal preference as well as convenience, Susan Coffin, MD, MPH, an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia, said in an interview. “It basically boils down to: Will you be able to get your flu shot without any difficulty in 2 weeks’ time?” she said. “We don’t want inconvenience or difficulties in access to get the way of people getting their flu shot this year.”

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

Patients can now receive their COVID-19 vaccine and flu shot during the same visit, according to updated recommendations by the Centers for Disease Control and Prevention.

Esben H/iStock/Getty Images

Previously, the CDC recommended that people receive their COVID-19 vaccinations alone and schedule any other vaccinations at least 2 weeks before or after their COVID-19 immunization. “This was out of an abundance of caution during a period when these vaccines were new and not due to any known safety or immunogenicity concerns,” the CDC guidance states. “However, substantial data have now been collected regarding the safety of COVID-19 vaccines currently approved or authorized by FDA.”

The guidance allowing for coadministration of COVID-19 vaccines with other immunizations, including the flu shot, was issued in mid-May 2021, and was restated in influenza vaccine recommendations released Aug. 27. The American Academy of Pediatrics soon followed suit, announcing that, for children eligible for the COVID-19 vaccine (age 12 and older), AAP recommendations allow for both the influenza and COVID-19 vaccines to be administered during the same visit.

Although there is limited data around giving COVID-19 vaccines with other vaccines, “extensive experience with non–COVID-19 vaccines has demonstrated that immunogenicity and adverse-event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone,” the recommendations state. If administering other immunizations along with COVID-19 vaccines, providers should separate injection sites by at least 1 inch, the CDC recommends, and influenza vaccines that are more likely to cause a local reaction, like high-dose or the adjuvanted inactivated flu vaccine, should be administered in different limbs, if possible.

Whether someone should get their flu vaccine at the same time or separate from a COVID-19 vaccination or booster is a matter of personal preference as well as convenience, Susan Coffin, MD, MPH, an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia, said in an interview. “It basically boils down to: Will you be able to get your flu shot without any difficulty in 2 weeks’ time?” she said. “We don’t want inconvenience or difficulties in access to get the way of people getting their flu shot this year.”

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

Patients can now receive their COVID-19 vaccine and flu shot during the same visit, according to updated recommendations by the Centers for Disease Control and Prevention.

Esben H/iStock/Getty Images

Previously, the CDC recommended that people receive their COVID-19 vaccinations alone and schedule any other vaccinations at least 2 weeks before or after their COVID-19 immunization. “This was out of an abundance of caution during a period when these vaccines were new and not due to any known safety or immunogenicity concerns,” the CDC guidance states. “However, substantial data have now been collected regarding the safety of COVID-19 vaccines currently approved or authorized by FDA.”

The guidance allowing for coadministration of COVID-19 vaccines with other immunizations, including the flu shot, was issued in mid-May 2021, and was restated in influenza vaccine recommendations released Aug. 27. The American Academy of Pediatrics soon followed suit, announcing that, for children eligible for the COVID-19 vaccine (age 12 and older), AAP recommendations allow for both the influenza and COVID-19 vaccines to be administered during the same visit.

Although there is limited data around giving COVID-19 vaccines with other vaccines, “extensive experience with non–COVID-19 vaccines has demonstrated that immunogenicity and adverse-event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone,” the recommendations state. If administering other immunizations along with COVID-19 vaccines, providers should separate injection sites by at least 1 inch, the CDC recommends, and influenza vaccines that are more likely to cause a local reaction, like high-dose or the adjuvanted inactivated flu vaccine, should be administered in different limbs, if possible.

Whether someone should get their flu vaccine at the same time or separate from a COVID-19 vaccination or booster is a matter of personal preference as well as convenience, Susan Coffin, MD, MPH, an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia, said in an interview. “It basically boils down to: Will you be able to get your flu shot without any difficulty in 2 weeks’ time?” she said. “We don’t want inconvenience or difficulties in access to get the way of people getting their flu shot this year.”

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

Increasing antibiotic resistance is an urgent threat to public health and establishing a review service for antibiotics could alleviate this problem. As use of antibiotics escalates, the risk of resistance becomes increasingly important. Each year, approximately 269 million antibiotics are dispensed and at least 30% are prescribed inappropriately.¹ In addition to inappropriate prescribing, increased antibiotic resistance can be caused by patients not completing an antibiotic course as recommended or inherent bacterial mutations. According to the Centers for Disease Control and Prevention, each year approximately 3 million individuals contract an antibiotic-resistant infection.² By 2050, it is projected that drug-resistant conditions could cause 300 million deaths and might be as disastrous to the economy as the 2008 global financial crisis.³ Ensuring appropriate use of antibiotic therapy through antimicrobial stewardship can help combat this significant public health issue.

Antimicrobial stewardship promotes appropriate use of antimicrobials to improve patient outcomes, reduce health care costs, and decrease antimicrobial resistance. One study found that nearly 50% of patients discharged from the emergency department with antibiotics required therapy modification after culture and susceptibility results were returned.⁴ Both the Infectious Disease Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) support incorporating a clinical pharmacist into culture reviews.³ Several institutions have implemented a pharmacist-led culture review service to improve antibiotic usage, which has shown positive results. A retrospective case-control study at University of Rochester Medical Center showed reduced time to positive culture review and to patient or health care provider (HCP) notification when emergency medicine pharmacists were involved in culture review.⁵ A retrospective study at Carolinas Medical Center-Northeast showed 12% decreased readmission rate using pharmacist-implemented culture review compared with HCP review.⁶ Results from previous studies showed an overall improvement in patient safety through decreased use of inappropriate agents and reduced time on inappropriate antibiotic therapy.

Establishing a pharmacist-led culture review service at the Carl Vinson Veterans Affairs Medical Center (CVVAMC) in Dublin, Georgia, could decrease the time to review of positive culture results, time to patient or HCP notification, and readmission rates. CVVAMC provides outpatient primary care services to about 30,000 veterans in the central and southern regions of Georgia. Our facility has executed an antimicrobial stewardship program based on guidelines published in 2016 by IDSA and SHEA to guide optimal use of antibiotics. Clinical pharmacists play an active role in antimicrobial stewardship throughout the facility. Clinical responsibilities of the antimicrobial stewardship pharmacist include assessing therapy for inappropriate dual anaerobic coverage, evaluating inpatient culture results within 48 hours, dosing and monitoring antibiotic therapy, including vancomycin and aminoglycosides, and implementing IV to by-mouth conversions for appropriate patients. HCPs involved with antimicrobial stewardship could order an array of tests to assess a veteran’s condition, including cultures, when an infection is suspected.

Culture results take about 3 to 5 days, then HCPs evaluate the result to ensure current antibiotic therapy is appropriate. Patients might not receive timely follow-up because HCPs often have many laboratory alerts to sift through every day, and a protocol is not in place for pharmacists to adjust outpatient antimicrobial regimens based on culture results. Before implementing this project, there was no outpatient service for pharmacists to impact culture and susceptibility review. This project was initiated because a lead physician identified difficulty reviewing culture and susceptibility results. HCPs often work on rotating schedules, and there was a concern about possible delay in follow-up of results if a HCP was not scheduled to work for a period of time.

The purpose of this project was to implement an outpatient, pharmacist-managed culture and susceptibility review service to improve patient outcomes, including decreasing and preventing inappropriate antibiotic use. The primary objective was to design and implement a pharmacist-led review service to intervene in cases of mismatched antibiotic bacteria combinations. Secondary objectives included identifying most common culture types and organisms encountered and intervened on at our facility.

Quality Improvement Project

This quality improvement project was approved by the CVVAMC Pharmacy and Therapeutics Committee. Members of the medical review board signed a care coordination agreement between pharmacy and outpatient HCPs to permit pharmacist interventions involving optimization of antibiotic therapy. This agreement allowed pharmacists to make changes to existing antimicrobial regimens within their scope of practice (SOP) without requiring discussion with HCPs. A protocol was also developed to guide pharmacist modification of antimicrobial therapy based on current antimicrobial guidelines.⁷ This protocol was based on commonly isolated organisms and local resistance patterns and provided guidance for antibiotic treatment based on culture type (ie, skin and soft tissue infection, urine, etc). Computerized Patient Record System (CPRS) note templates were also developed for interventions performed, and patient follow-up after antibiotic regimens were completed (eAppendix 1 

Program Inclusion

Veterans were included in this project if they presented to primary care or urgent care clinics for therapy; had positive culture and sensitivity results; and were prescribed an empiric antibiotic. Veterans were not eligible for this project if they were not receiving antibiotic therapy, with or without pending or resulted culture results shown in CPRS.

Implementation

Data gathered through a CPRS dashboard from August 2019 to February 2020 identified patients with pending or completed culture results in urgent care and primary care settings (eAppendix 4). The dashboard was created specifically for this project to show patient details that included initial antibiotic(s) prescribed and preliminary and final culture results. After a mismatched combination was identified, pharmacists contacted patients and assessed symptoms. If a patient was still symptomatic, the pharmacist changed the antibiotic regimen and educated the patient about this change. The pharmacist documented an intervention note in CPRS and added the HCP as a signer so he or she would be aware of the change. The clinical pharmacist followed up after regimens were complete. At this time, the pharmacist assessed patients to ensure the medication was taken as directed (eg, number of days of therapy, how many tablets per day, etc), to discuss any reported adverse effects, and to assess resolution of symptoms. If a patient still had symptoms, the pharmacist contacted the patient’s primary care provider. If the veteran could not be contacted after 3 consecutive attempts via phone, a certified letter was mailed. If patients were asymptomatic at the time of the call, the pharmacist documented the lack of symptoms and added the HCP as a signer for awareness purposes. HCPs continued to practice as usual while this service was implemented.

Observations

Using the culture and susceptibility dashboard, the pharmacist identified 675 patients as having a pending culture (Table 1). Among these patients, 320 results were positive, and were taking antibiotics empirically. Out of the 320 patients who met inclusion criteria, 10 required pharmacist intervention. After contacting the veterans, 7 required regimen changes because their current antibiotic was not susceptible to the isolated organism. Three additional patients were contacted because of a mismatch between the empiric antibiotic and culture result. Antibiotic therapy was not modified because these patients were asymptomatic at the time the clinical pharmacist contacted them. These patient cases were discussed with the HCP before documenting the intervention to prevent initiation of unwarranted antibiotics.

Most of the modified antimicrobial regimens were found in urine cultures from symptomatic patients (Table 2). Of the 7 patients requiring therapy change because of a mismatch antibiotic–bacteria combination, 4 were empirically prescribed fluoroquinolones, 2 received levofloxacin, and 2 were prescribed ciprofloxacin. According to the most recent antibiogram at our facility, some organisms are resistant to fluoroquinolones, specifically Proteus mirabilis (P mirabilis) and Escherichia coli (E coli). These pathogens were the cause of urinary tract infections in 3 of 4 patients with fluoroquinolone prescriptions.

Through the CPRS dashboard, the pharmacist inadvertently identified 4 patients with positive culture results who were not on antibiotic therapy. These patients were contacted by telephone, and antibiotics were initiated for symptomatic patients after consultation with the HCP. The primary culture type intervened on was urine in 12 of 14 cases (86%). The other 2 culture types included oropharynx culture (7%) positive for an acute bacterial respiratory tract infection caused by group C Streptococcus and a stool culture (7%) positive for Pseudomonas aeruginosa (P aeruginosa). E coli (36%) was isolated in 5 cases and was the most commonly isolated organism. P aeruginosa (29%) was identified in 4 cases. Other organisms included P mirabilis (14%) in 2 patients and streptococcus species (14%) in 2 cases. Enterococcus faecium (7%) was isolated in 1 case.

Discussion

This project was an innovative antimicrobial stewardship endeavor that helped initiate antibiotic interventions quickly and improve patient outcomes. The antimicrobial stewardship pharmacist independently performed interventions for patients without requiring HCP consultation, therefore decreasing HCP burden and possibly reducing time to assessment of culture results.

Limitations

The study results were limited due to its small sample size of antimicrobial interventions. The clinical pharmacist did not contact the patient when the antibiotic prescribed empirically by the HCP was appropriate for the isolated organism. Among the patients contacted, 3 were asymptomatic, did not require further antibiotic therapy, and no intervention was made. Provider education was deemed successful because HCPs did not request further information about the service. However, not all HCPs were provided education because of different shifts and inability to attend educational sessions. Closely working with lead physicians within the facility provided an alternate method for information dissemination.

The care coordination agreement allowed the pharmacist to make changes if patients had a current prescription for an antibiotic. In addition to the changes to antibiotics, this project improved HCP awareness of culture results even in cases of symptomatic patients who were not prescribed therapy. When this occurred, the pharmacist contacted the patient to assess symptoms and then notified the HCP if the patient was symptomatic.

Future Directions

Future endeavors regarding this project include modifying the scope of the service to allow pharmacists to prescribe antibiotics for patients with positive cultures and symptoms without empiric antibiotics in addition to continuing to modify empiric therapy. Additionally, improving dashboard efficiency through changes to include only isolated antibiotic mismatches rather than all antibiotics prescribed and all available cultures would reduce the pharmacists’ time commitment. Expanding to other parts of the medical center, including long-term care facilities and other outpatient clinics, would allow this service to reach more veterans. Integrating this service throughout the medical center will require continued HCP education and modifying care coordination agreements to include these facilities.

On a typical day, 60 to 90 minutes were spent navigating the dashboard and implementing this service. The CPRS dashboard should be modified to streamline patients identified to decrease the daily time commitment. Re-education of HCPs about resistance rates of fluoroquinolones and empirically prescribing these agents also will be completed based on empiric antibiotic interventions made with these agents throughout this project. Discussing HCP viewpoints on this service would be beneficial to ensure HCP satisfaction.

Conclusions

This pharmacy service and antimicrobial stewardship program reduced time patients were on inappropriate antibiotics. Pharmacists reviewed the dashboard daily under the scope of this project, which expedited needed changes and decreased provider burden because pharmacists were able to make changes without interrupting HCPs’ daily tasks, including patient care.

This program may also reduce readmissions. Patients who were still symptomatic were contacted could be given revised medication regimens without the patient returning to the facility for follow-up treatment. An interesting conclusion not included in the current scope of this service was possible reduced time to therapy initiation in cases of positive cultures and symptomatic patients without antibiotic therapy. If this occurred on the dashboard, patient’s symptoms could be assessed, and if symptoms were ongoing, the pharmacist contacted the HCP with a recommended antimicrobial therapy. In these cases, we were able to mail the antibiotic quickly, and many times, on the same day as this intervention through overnight mail. Implementation of a pharmacist-led antimicrobial review service has provided positive results overall for CVVAMC.

Acknowledgment
This material is the result of work supported with resources and the use of the facilities at the Carl Vinson VA Medical Center.

Increasing antibiotic resistance is an urgent threat to public health and establishing a review service for antibiotics could alleviate this problem. As use of antibiotics escalates, the risk of resistance becomes increasingly important. Each year, approximately 269 million antibiotics are dispensed and at least 30% are prescribed inappropriately.¹ In addition to inappropriate prescribing, increased antibiotic resistance can be caused by patients not completing an antibiotic course as recommended or inherent bacterial mutations. According to the Centers for Disease Control and Prevention, each year approximately 3 million individuals contract an antibiotic-resistant infection.² By 2050, it is projected that drug-resistant conditions could cause 300 million deaths and might be as disastrous to the economy as the 2008 global financial crisis.³ Ensuring appropriate use of antibiotic therapy through antimicrobial stewardship can help combat this significant public health issue.

Antimicrobial stewardship promotes appropriate use of antimicrobials to improve patient outcomes, reduce health care costs, and decrease antimicrobial resistance. One study found that nearly 50% of patients discharged from the emergency department with antibiotics required therapy modification after culture and susceptibility results were returned.⁴ Both the Infectious Disease Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) support incorporating a clinical pharmacist into culture reviews.³ Several institutions have implemented a pharmacist-led culture review service to improve antibiotic usage, which has shown positive results. A retrospective case-control study at University of Rochester Medical Center showed reduced time to positive culture review and to patient or health care provider (HCP) notification when emergency medicine pharmacists were involved in culture review.⁵ A retrospective study at Carolinas Medical Center-Northeast showed 12% decreased readmission rate using pharmacist-implemented culture review compared with HCP review.⁶ Results from previous studies showed an overall improvement in patient safety through decreased use of inappropriate agents and reduced time on inappropriate antibiotic therapy.

Establishing a pharmacist-led culture review service at the Carl Vinson Veterans Affairs Medical Center (CVVAMC) in Dublin, Georgia, could decrease the time to review of positive culture results, time to patient or HCP notification, and readmission rates. CVVAMC provides outpatient primary care services to about 30,000 veterans in the central and southern regions of Georgia. Our facility has executed an antimicrobial stewardship program based on guidelines published in 2016 by IDSA and SHEA to guide optimal use of antibiotics. Clinical pharmacists play an active role in antimicrobial stewardship throughout the facility. Clinical responsibilities of the antimicrobial stewardship pharmacist include assessing therapy for inappropriate dual anaerobic coverage, evaluating inpatient culture results within 48 hours, dosing and monitoring antibiotic therapy, including vancomycin and aminoglycosides, and implementing IV to by-mouth conversions for appropriate patients. HCPs involved with antimicrobial stewardship could order an array of tests to assess a veteran’s condition, including cultures, when an infection is suspected.

Culture results take about 3 to 5 days, then HCPs evaluate the result to ensure current antibiotic therapy is appropriate. Patients might not receive timely follow-up because HCPs often have many laboratory alerts to sift through every day, and a protocol is not in place for pharmacists to adjust outpatient antimicrobial regimens based on culture results. Before implementing this project, there was no outpatient service for pharmacists to impact culture and susceptibility review. This project was initiated because a lead physician identified difficulty reviewing culture and susceptibility results. HCPs often work on rotating schedules, and there was a concern about possible delay in follow-up of results if a HCP was not scheduled to work for a period of time.

The purpose of this project was to implement an outpatient, pharmacist-managed culture and susceptibility review service to improve patient outcomes, including decreasing and preventing inappropriate antibiotic use. The primary objective was to design and implement a pharmacist-led review service to intervene in cases of mismatched antibiotic bacteria combinations. Secondary objectives included identifying most common culture types and organisms encountered and intervened on at our facility.

Quality Improvement Project

This quality improvement project was approved by the CVVAMC Pharmacy and Therapeutics Committee. Members of the medical review board signed a care coordination agreement between pharmacy and outpatient HCPs to permit pharmacist interventions involving optimization of antibiotic therapy. This agreement allowed pharmacists to make changes to existing antimicrobial regimens within their scope of practice (SOP) without requiring discussion with HCPs. A protocol was also developed to guide pharmacist modification of antimicrobial therapy based on current antimicrobial guidelines.⁷ This protocol was based on commonly isolated organisms and local resistance patterns and provided guidance for antibiotic treatment based on culture type (ie, skin and soft tissue infection, urine, etc). Computerized Patient Record System (CPRS) note templates were also developed for interventions performed, and patient follow-up after antibiotic regimens were completed (eAppendix 1 

Program Inclusion

Veterans were included in this project if they presented to primary care or urgent care clinics for therapy; had positive culture and sensitivity results; and were prescribed an empiric antibiotic. Veterans were not eligible for this project if they were not receiving antibiotic therapy, with or without pending or resulted culture results shown in CPRS.

Implementation

Data gathered through a CPRS dashboard from August 2019 to February 2020 identified patients with pending or completed culture results in urgent care and primary care settings (eAppendix 4). The dashboard was created specifically for this project to show patient details that included initial antibiotic(s) prescribed and preliminary and final culture results. After a mismatched combination was identified, pharmacists contacted patients and assessed symptoms. If a patient was still symptomatic, the pharmacist changed the antibiotic regimen and educated the patient about this change. The pharmacist documented an intervention note in CPRS and added the HCP as a signer so he or she would be aware of the change. The clinical pharmacist followed up after regimens were complete. At this time, the pharmacist assessed patients to ensure the medication was taken as directed (eg, number of days of therapy, how many tablets per day, etc), to discuss any reported adverse effects, and to assess resolution of symptoms. If a patient still had symptoms, the pharmacist contacted the patient’s primary care provider. If the veteran could not be contacted after 3 consecutive attempts via phone, a certified letter was mailed. If patients were asymptomatic at the time of the call, the pharmacist documented the lack of symptoms and added the HCP as a signer for awareness purposes. HCPs continued to practice as usual while this service was implemented.

Observations

Using the culture and susceptibility dashboard, the pharmacist identified 675 patients as having a pending culture (Table 1). Among these patients, 320 results were positive, and were taking antibiotics empirically. Out of the 320 patients who met inclusion criteria, 10 required pharmacist intervention. After contacting the veterans, 7 required regimen changes because their current antibiotic was not susceptible to the isolated organism. Three additional patients were contacted because of a mismatch between the empiric antibiotic and culture result. Antibiotic therapy was not modified because these patients were asymptomatic at the time the clinical pharmacist contacted them. These patient cases were discussed with the HCP before documenting the intervention to prevent initiation of unwarranted antibiotics.

Most of the modified antimicrobial regimens were found in urine cultures from symptomatic patients (Table 2). Of the 7 patients requiring therapy change because of a mismatch antibiotic–bacteria combination, 4 were empirically prescribed fluoroquinolones, 2 received levofloxacin, and 2 were prescribed ciprofloxacin. According to the most recent antibiogram at our facility, some organisms are resistant to fluoroquinolones, specifically Proteus mirabilis (P mirabilis) and Escherichia coli (E coli). These pathogens were the cause of urinary tract infections in 3 of 4 patients with fluoroquinolone prescriptions.

Through the CPRS dashboard, the pharmacist inadvertently identified 4 patients with positive culture results who were not on antibiotic therapy. These patients were contacted by telephone, and antibiotics were initiated for symptomatic patients after consultation with the HCP. The primary culture type intervened on was urine in 12 of 14 cases (86%). The other 2 culture types included oropharynx culture (7%) positive for an acute bacterial respiratory tract infection caused by group C Streptococcus and a stool culture (7%) positive for Pseudomonas aeruginosa (P aeruginosa). E coli (36%) was isolated in 5 cases and was the most commonly isolated organism. P aeruginosa (29%) was identified in 4 cases. Other organisms included P mirabilis (14%) in 2 patients and streptococcus species (14%) in 2 cases. Enterococcus faecium (7%) was isolated in 1 case.

Discussion

This project was an innovative antimicrobial stewardship endeavor that helped initiate antibiotic interventions quickly and improve patient outcomes. The antimicrobial stewardship pharmacist independently performed interventions for patients without requiring HCP consultation, therefore decreasing HCP burden and possibly reducing time to assessment of culture results.

Limitations

The study results were limited due to its small sample size of antimicrobial interventions. The clinical pharmacist did not contact the patient when the antibiotic prescribed empirically by the HCP was appropriate for the isolated organism. Among the patients contacted, 3 were asymptomatic, did not require further antibiotic therapy, and no intervention was made. Provider education was deemed successful because HCPs did not request further information about the service. However, not all HCPs were provided education because of different shifts and inability to attend educational sessions. Closely working with lead physicians within the facility provided an alternate method for information dissemination.

The care coordination agreement allowed the pharmacist to make changes if patients had a current prescription for an antibiotic. In addition to the changes to antibiotics, this project improved HCP awareness of culture results even in cases of symptomatic patients who were not prescribed therapy. When this occurred, the pharmacist contacted the patient to assess symptoms and then notified the HCP if the patient was symptomatic.

Future Directions

Future endeavors regarding this project include modifying the scope of the service to allow pharmacists to prescribe antibiotics for patients with positive cultures and symptoms without empiric antibiotics in addition to continuing to modify empiric therapy. Additionally, improving dashboard efficiency through changes to include only isolated antibiotic mismatches rather than all antibiotics prescribed and all available cultures would reduce the pharmacists’ time commitment. Expanding to other parts of the medical center, including long-term care facilities and other outpatient clinics, would allow this service to reach more veterans. Integrating this service throughout the medical center will require continued HCP education and modifying care coordination agreements to include these facilities.

On a typical day, 60 to 90 minutes were spent navigating the dashboard and implementing this service. The CPRS dashboard should be modified to streamline patients identified to decrease the daily time commitment. Re-education of HCPs about resistance rates of fluoroquinolones and empirically prescribing these agents also will be completed based on empiric antibiotic interventions made with these agents throughout this project. Discussing HCP viewpoints on this service would be beneficial to ensure HCP satisfaction.

Conclusions

This pharmacy service and antimicrobial stewardship program reduced time patients were on inappropriate antibiotics. Pharmacists reviewed the dashboard daily under the scope of this project, which expedited needed changes and decreased provider burden because pharmacists were able to make changes without interrupting HCPs’ daily tasks, including patient care.

This program may also reduce readmissions. Patients who were still symptomatic were contacted could be given revised medication regimens without the patient returning to the facility for follow-up treatment. An interesting conclusion not included in the current scope of this service was possible reduced time to therapy initiation in cases of positive cultures and symptomatic patients without antibiotic therapy. If this occurred on the dashboard, patient’s symptoms could be assessed, and if symptoms were ongoing, the pharmacist contacted the HCP with a recommended antimicrobial therapy. In these cases, we were able to mail the antibiotic quickly, and many times, on the same day as this intervention through overnight mail. Implementation of a pharmacist-led antimicrobial review service has provided positive results overall for CVVAMC.

Acknowledgment
This material is the result of work supported with resources and the use of the facilities at the Carl Vinson VA Medical Center.

Increasing antibiotic resistance is an urgent threat to public health and establishing a review service for antibiotics could alleviate this problem. As use of antibiotics escalates, the risk of resistance becomes increasingly important. Each year, approximately 269 million antibiotics are dispensed and at least 30% are prescribed inappropriately.¹ In addition to inappropriate prescribing, increased antibiotic resistance can be caused by patients not completing an antibiotic course as recommended or inherent bacterial mutations. According to the Centers for Disease Control and Prevention, each year approximately 3 million individuals contract an antibiotic-resistant infection.² By 2050, it is projected that drug-resistant conditions could cause 300 million deaths and might be as disastrous to the economy as the 2008 global financial crisis.³ Ensuring appropriate use of antibiotic therapy through antimicrobial stewardship can help combat this significant public health issue.

Antimicrobial stewardship promotes appropriate use of antimicrobials to improve patient outcomes, reduce health care costs, and decrease antimicrobial resistance. One study found that nearly 50% of patients discharged from the emergency department with antibiotics required therapy modification after culture and susceptibility results were returned.⁴ Both the Infectious Disease Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) support incorporating a clinical pharmacist into culture reviews.³ Several institutions have implemented a pharmacist-led culture review service to improve antibiotic usage, which has shown positive results. A retrospective case-control study at University of Rochester Medical Center showed reduced time to positive culture review and to patient or health care provider (HCP) notification when emergency medicine pharmacists were involved in culture review.⁵ A retrospective study at Carolinas Medical Center-Northeast showed 12% decreased readmission rate using pharmacist-implemented culture review compared with HCP review.⁶ Results from previous studies showed an overall improvement in patient safety through decreased use of inappropriate agents and reduced time on inappropriate antibiotic therapy.

Establishing a pharmacist-led culture review service at the Carl Vinson Veterans Affairs Medical Center (CVVAMC) in Dublin, Georgia, could decrease the time to review of positive culture results, time to patient or HCP notification, and readmission rates. CVVAMC provides outpatient primary care services to about 30,000 veterans in the central and southern regions of Georgia. Our facility has executed an antimicrobial stewardship program based on guidelines published in 2016 by IDSA and SHEA to guide optimal use of antibiotics. Clinical pharmacists play an active role in antimicrobial stewardship throughout the facility. Clinical responsibilities of the antimicrobial stewardship pharmacist include assessing therapy for inappropriate dual anaerobic coverage, evaluating inpatient culture results within 48 hours, dosing and monitoring antibiotic therapy, including vancomycin and aminoglycosides, and implementing IV to by-mouth conversions for appropriate patients. HCPs involved with antimicrobial stewardship could order an array of tests to assess a veteran’s condition, including cultures, when an infection is suspected.

Culture results take about 3 to 5 days, then HCPs evaluate the result to ensure current antibiotic therapy is appropriate. Patients might not receive timely follow-up because HCPs often have many laboratory alerts to sift through every day, and a protocol is not in place for pharmacists to adjust outpatient antimicrobial regimens based on culture results. Before implementing this project, there was no outpatient service for pharmacists to impact culture and susceptibility review. This project was initiated because a lead physician identified difficulty reviewing culture and susceptibility results. HCPs often work on rotating schedules, and there was a concern about possible delay in follow-up of results if a HCP was not scheduled to work for a period of time.

The purpose of this project was to implement an outpatient, pharmacist-managed culture and susceptibility review service to improve patient outcomes, including decreasing and preventing inappropriate antibiotic use. The primary objective was to design and implement a pharmacist-led review service to intervene in cases of mismatched antibiotic bacteria combinations. Secondary objectives included identifying most common culture types and organisms encountered and intervened on at our facility.

Quality Improvement Project

This quality improvement project was approved by the CVVAMC Pharmacy and Therapeutics Committee. Members of the medical review board signed a care coordination agreement between pharmacy and outpatient HCPs to permit pharmacist interventions involving optimization of antibiotic therapy. This agreement allowed pharmacists to make changes to existing antimicrobial regimens within their scope of practice (SOP) without requiring discussion with HCPs. A protocol was also developed to guide pharmacist modification of antimicrobial therapy based on current antimicrobial guidelines.⁷ This protocol was based on commonly isolated organisms and local resistance patterns and provided guidance for antibiotic treatment based on culture type (ie, skin and soft tissue infection, urine, etc). Computerized Patient Record System (CPRS) note templates were also developed for interventions performed, and patient follow-up after antibiotic regimens were completed (eAppendix 1 

Program Inclusion

Veterans were included in this project if they presented to primary care or urgent care clinics for therapy; had positive culture and sensitivity results; and were prescribed an empiric antibiotic. Veterans were not eligible for this project if they were not receiving antibiotic therapy, with or without pending or resulted culture results shown in CPRS.

Implementation

Data gathered through a CPRS dashboard from August 2019 to February 2020 identified patients with pending or completed culture results in urgent care and primary care settings (eAppendix 4). The dashboard was created specifically for this project to show patient details that included initial antibiotic(s) prescribed and preliminary and final culture results. After a mismatched combination was identified, pharmacists contacted patients and assessed symptoms. If a patient was still symptomatic, the pharmacist changed the antibiotic regimen and educated the patient about this change. The pharmacist documented an intervention note in CPRS and added the HCP as a signer so he or she would be aware of the change. The clinical pharmacist followed up after regimens were complete. At this time, the pharmacist assessed patients to ensure the medication was taken as directed (eg, number of days of therapy, how many tablets per day, etc), to discuss any reported adverse effects, and to assess resolution of symptoms. If a patient still had symptoms, the pharmacist contacted the patient’s primary care provider. If the veteran could not be contacted after 3 consecutive attempts via phone, a certified letter was mailed. If patients were asymptomatic at the time of the call, the pharmacist documented the lack of symptoms and added the HCP as a signer for awareness purposes. HCPs continued to practice as usual while this service was implemented.

Observations

Using the culture and susceptibility dashboard, the pharmacist identified 675 patients as having a pending culture (Table 1). Among these patients, 320 results were positive, and were taking antibiotics empirically. Out of the 320 patients who met inclusion criteria, 10 required pharmacist intervention. After contacting the veterans, 7 required regimen changes because their current antibiotic was not susceptible to the isolated organism. Three additional patients were contacted because of a mismatch between the empiric antibiotic and culture result. Antibiotic therapy was not modified because these patients were asymptomatic at the time the clinical pharmacist contacted them. These patient cases were discussed with the HCP before documenting the intervention to prevent initiation of unwarranted antibiotics.

Most of the modified antimicrobial regimens were found in urine cultures from symptomatic patients (Table 2). Of the 7 patients requiring therapy change because of a mismatch antibiotic–bacteria combination, 4 were empirically prescribed fluoroquinolones, 2 received levofloxacin, and 2 were prescribed ciprofloxacin. According to the most recent antibiogram at our facility, some organisms are resistant to fluoroquinolones, specifically Proteus mirabilis (P mirabilis) and Escherichia coli (E coli). These pathogens were the cause of urinary tract infections in 3 of 4 patients with fluoroquinolone prescriptions.

Through the CPRS dashboard, the pharmacist inadvertently identified 4 patients with positive culture results who were not on antibiotic therapy. These patients were contacted by telephone, and antibiotics were initiated for symptomatic patients after consultation with the HCP. The primary culture type intervened on was urine in 12 of 14 cases (86%). The other 2 culture types included oropharynx culture (7%) positive for an acute bacterial respiratory tract infection caused by group C Streptococcus and a stool culture (7%) positive for Pseudomonas aeruginosa (P aeruginosa). E coli (36%) was isolated in 5 cases and was the most commonly isolated organism. P aeruginosa (29%) was identified in 4 cases. Other organisms included P mirabilis (14%) in 2 patients and streptococcus species (14%) in 2 cases. Enterococcus faecium (7%) was isolated in 1 case.

Discussion

This project was an innovative antimicrobial stewardship endeavor that helped initiate antibiotic interventions quickly and improve patient outcomes. The antimicrobial stewardship pharmacist independently performed interventions for patients without requiring HCP consultation, therefore decreasing HCP burden and possibly reducing time to assessment of culture results.

Limitations

The study results were limited due to its small sample size of antimicrobial interventions. The clinical pharmacist did not contact the patient when the antibiotic prescribed empirically by the HCP was appropriate for the isolated organism. Among the patients contacted, 3 were asymptomatic, did not require further antibiotic therapy, and no intervention was made. Provider education was deemed successful because HCPs did not request further information about the service. However, not all HCPs were provided education because of different shifts and inability to attend educational sessions. Closely working with lead physicians within the facility provided an alternate method for information dissemination.

The care coordination agreement allowed the pharmacist to make changes if patients had a current prescription for an antibiotic. In addition to the changes to antibiotics, this project improved HCP awareness of culture results even in cases of symptomatic patients who were not prescribed therapy. When this occurred, the pharmacist contacted the patient to assess symptoms and then notified the HCP if the patient was symptomatic.

Future Directions

Future endeavors regarding this project include modifying the scope of the service to allow pharmacists to prescribe antibiotics for patients with positive cultures and symptoms without empiric antibiotics in addition to continuing to modify empiric therapy. Additionally, improving dashboard efficiency through changes to include only isolated antibiotic mismatches rather than all antibiotics prescribed and all available cultures would reduce the pharmacists’ time commitment. Expanding to other parts of the medical center, including long-term care facilities and other outpatient clinics, would allow this service to reach more veterans. Integrating this service throughout the medical center will require continued HCP education and modifying care coordination agreements to include these facilities.

On a typical day, 60 to 90 minutes were spent navigating the dashboard and implementing this service. The CPRS dashboard should be modified to streamline patients identified to decrease the daily time commitment. Re-education of HCPs about resistance rates of fluoroquinolones and empirically prescribing these agents also will be completed based on empiric antibiotic interventions made with these agents throughout this project. Discussing HCP viewpoints on this service would be beneficial to ensure HCP satisfaction.

Conclusions

This pharmacy service and antimicrobial stewardship program reduced time patients were on inappropriate antibiotics. Pharmacists reviewed the dashboard daily under the scope of this project, which expedited needed changes and decreased provider burden because pharmacists were able to make changes without interrupting HCPs’ daily tasks, including patient care.

This program may also reduce readmissions. Patients who were still symptomatic were contacted could be given revised medication regimens without the patient returning to the facility for follow-up treatment. An interesting conclusion not included in the current scope of this service was possible reduced time to therapy initiation in cases of positive cultures and symptomatic patients without antibiotic therapy. If this occurred on the dashboard, patient’s symptoms could be assessed, and if symptoms were ongoing, the pharmacist contacted the HCP with a recommended antimicrobial therapy. In these cases, we were able to mail the antibiotic quickly, and many times, on the same day as this intervention through overnight mail. Implementation of a pharmacist-led antimicrobial review service has provided positive results overall for CVVAMC.

Acknowledgment
This material is the result of work supported with resources and the use of the facilities at the Carl Vinson VA Medical Center.

We present a case of an orbital varix masquerading as an orbital lymphoma. Our case underscores the importance of clinical correlation and thorough study of the ordered films by the ordering health care provider.

Case Presentation

An 84-year-old female veteran presented to the Bay Pines Veterans Affairs Healthcare System emergency department. She had a past ocular history of nonproliferative diabetic retinopathy in both eyes (OU) and senile cataracts OU. She had a complicated medical history most notable for congestive heart failure and Stage IV B cell follicular lymphoma, having received 6 rounds of chemotherapy, and has since been on rituximab maintenance therapy for the past few years.

The patient reported dyspnea on exertion, 30-pound weight gain, and ocular pain in her right eye (OD), more so than her left eye (OS) that was severe enough to wake her from sleep. She endorsed an associated headache but reported no visual loss or any other ocular symptoms other than conjunctival injection. On examination, the patient demonstrated jugular venous distension. X-ray imaging obtained in the emergency department demonstrated bilateral pleural effusions. Our patient was admitted subsequently for an exacerbation of congestive heart failure. She was monitored for euvolemia and discharged 4 days later.

During admission, imaging of the orbits was obtained. Computed tomography (CT) of the head without contrast demonstrated at least 4 intraorbital masses in the right orbit, measuring up to 22 mm in maximum diameter and at least 3 intraorbital masses in the left orbit, measuring up to 16 mm in diameter (Figure 1). Magnetic resonance imaging (MRI) with contrast of the brain and orbits was ordered, which demonstrated multiple bilateral uniformly enhancing, primarily extraconal masses present in both orbits, the largest of which occupied the superomedial aspect of the right orbit and measured 12 x 18 x 20 mm. Further, the ophthalmic veins were noted to be engorged. The cavernous did not demonstrate any thrombosis. No other ocular structures were compromised, although there was compression of the extraocular muscles in both orbits (Figures 2, 3, 4, 5, and 6). At that time, the reading radiologist suggested the most likely diagnosis was metastatic orbital lymphoma given the clinical history, which became the working diagnosis.

Discussion

In a study of 242 patients, Bacorn and colleagues found that a clinician’s preoperative assessment correlated with histopathologic diagnosis in 75.7% of cases, whereas the radiology report was correct in only 52.4% of cases.¹ Retrospective analysis identified clues that could have been used to more rapidly elucidate the true diagnosis for our patient.

In regard to symptomatology, orbital varices present with intermittent proptosis, vision loss, and rarely, periorbital pain unless thrombosed.^2,3 The severity of periorbital pain experienced by our patient is atypical of an orbital varix especially in the absence of a phlebolith. A specific feature of orbital varix is enlargement with the Valsalva maneuver.³ Although the patient did not report the notedsymptoms, more pointed questioning may have helped elucidate our patient’s true diagnosis sooner.

Radiologically, the presence of a partial flow void (decreased signal on T2) is useful for confirming the vascular nature of a lesion as was present in our case. Specific to the radiologic evaluation of orbital varices, it is recommended to obtain imaging with and without the Valsalva maneuver.⁴ Ultrasound is a superb tool in our armamentarium to image orbital lesions. B-scan ultrasound with and without Valsalva should be able to demonstrate variation in size when standing (minimal distension) vs lying flat with Valsalva (maximal distension).⁴ Further, Doppler ultrasound would be able to demonstrate changes in flow within the lesion when comparing previously mentioned maneuvers.⁴ Orbital lymphoma would not demonstrate this variation.

The size change of an orbital varix lesion may be further demonstrated on head CT with contrast. On CT, an orbital varix will demonstrate isodensity to other venous structures, whereas orbital lymphomas will be hyperdense when compared to extraocular muscles.^4,5 Further, a head CT without contrast may demonstrate phleboliths within an orbital varix.⁴ MRI should be performed with the Valsalva maneuver. On T1 and T2 studies, orbital varices demonstrate hypointensity when compared to extraocular muscles (EOMs).⁴ Lymphomas demonstrate a very specific radiologic pattern on MRI. On T1, they demonstrate isointensity to hypointensity when compared to EOMS, and on T2, they demonstrate iso- to hyperintensity when compared to EOMs.⁵ With respect to fluorodeoxyglucose (FDG) positron emission tomography (PET), our patient’s orbital lesion did not demonstrate FDG uptake. In patients where lymphoma previously demonstrated FDG PET uptake, the absence of such uptake strongly argues against malignant nature of the lesion (Figure 7).

Conclusions

We present a case of an orbital varix masquerading as an orbital lymphoma. While the ruling out of a diagnosis that might portend a poor prognosis is always of paramount importance, proper use of investigative studies and a thorough history could have helped elucidate the true diagnosis sooner: In this case an orbital varix masquerading as an orbital lymphoma. Mainly, the use of the Valsalva maneuver during the physical examination (resulting in proptosis) and during radiologic studies might have obviated the need for formal biopsy. Furthermore, orbital pain may be a presenting symptom of fluid overload in patients with a history of orbital varices.

We present a case of an orbital varix masquerading as an orbital lymphoma. Our case underscores the importance of clinical correlation and thorough study of the ordered films by the ordering health care provider.

Case Presentation

An 84-year-old female veteran presented to the Bay Pines Veterans Affairs Healthcare System emergency department. She had a past ocular history of nonproliferative diabetic retinopathy in both eyes (OU) and senile cataracts OU. She had a complicated medical history most notable for congestive heart failure and Stage IV B cell follicular lymphoma, having received 6 rounds of chemotherapy, and has since been on rituximab maintenance therapy for the past few years.

The patient reported dyspnea on exertion, 30-pound weight gain, and ocular pain in her right eye (OD), more so than her left eye (OS) that was severe enough to wake her from sleep. She endorsed an associated headache but reported no visual loss or any other ocular symptoms other than conjunctival injection. On examination, the patient demonstrated jugular venous distension. X-ray imaging obtained in the emergency department demonstrated bilateral pleural effusions. Our patient was admitted subsequently for an exacerbation of congestive heart failure. She was monitored for euvolemia and discharged 4 days later.

During admission, imaging of the orbits was obtained. Computed tomography (CT) of the head without contrast demonstrated at least 4 intraorbital masses in the right orbit, measuring up to 22 mm in maximum diameter and at least 3 intraorbital masses in the left orbit, measuring up to 16 mm in diameter (Figure 1). Magnetic resonance imaging (MRI) with contrast of the brain and orbits was ordered, which demonstrated multiple bilateral uniformly enhancing, primarily extraconal masses present in both orbits, the largest of which occupied the superomedial aspect of the right orbit and measured 12 x 18 x 20 mm. Further, the ophthalmic veins were noted to be engorged. The cavernous did not demonstrate any thrombosis. No other ocular structures were compromised, although there was compression of the extraocular muscles in both orbits (Figures 2, 3, 4, 5, and 6). At that time, the reading radiologist suggested the most likely diagnosis was metastatic orbital lymphoma given the clinical history, which became the working diagnosis.

Discussion

In a study of 242 patients, Bacorn and colleagues found that a clinician’s preoperative assessment correlated with histopathologic diagnosis in 75.7% of cases, whereas the radiology report was correct in only 52.4% of cases.¹ Retrospective analysis identified clues that could have been used to more rapidly elucidate the true diagnosis for our patient.

In regard to symptomatology, orbital varices present with intermittent proptosis, vision loss, and rarely, periorbital pain unless thrombosed.^2,3 The severity of periorbital pain experienced by our patient is atypical of an orbital varix especially in the absence of a phlebolith. A specific feature of orbital varix is enlargement with the Valsalva maneuver.³ Although the patient did not report the notedsymptoms, more pointed questioning may have helped elucidate our patient’s true diagnosis sooner.

Radiologically, the presence of a partial flow void (decreased signal on T2) is useful for confirming the vascular nature of a lesion as was present in our case. Specific to the radiologic evaluation of orbital varices, it is recommended to obtain imaging with and without the Valsalva maneuver.⁴ Ultrasound is a superb tool in our armamentarium to image orbital lesions. B-scan ultrasound with and without Valsalva should be able to demonstrate variation in size when standing (minimal distension) vs lying flat with Valsalva (maximal distension).⁴ Further, Doppler ultrasound would be able to demonstrate changes in flow within the lesion when comparing previously mentioned maneuvers.⁴ Orbital lymphoma would not demonstrate this variation.

The size change of an orbital varix lesion may be further demonstrated on head CT with contrast. On CT, an orbital varix will demonstrate isodensity to other venous structures, whereas orbital lymphomas will be hyperdense when compared to extraocular muscles.^4,5 Further, a head CT without contrast may demonstrate phleboliths within an orbital varix.⁴ MRI should be performed with the Valsalva maneuver. On T1 and T2 studies, orbital varices demonstrate hypointensity when compared to extraocular muscles (EOMs).⁴ Lymphomas demonstrate a very specific radiologic pattern on MRI. On T1, they demonstrate isointensity to hypointensity when compared to EOMS, and on T2, they demonstrate iso- to hyperintensity when compared to EOMs.⁵ With respect to fluorodeoxyglucose (FDG) positron emission tomography (PET), our patient’s orbital lesion did not demonstrate FDG uptake. In patients where lymphoma previously demonstrated FDG PET uptake, the absence of such uptake strongly argues against malignant nature of the lesion (Figure 7).

Conclusions

We present a case of an orbital varix masquerading as an orbital lymphoma. While the ruling out of a diagnosis that might portend a poor prognosis is always of paramount importance, proper use of investigative studies and a thorough history could have helped elucidate the true diagnosis sooner: In this case an orbital varix masquerading as an orbital lymphoma. Mainly, the use of the Valsalva maneuver during the physical examination (resulting in proptosis) and during radiologic studies might have obviated the need for formal biopsy. Furthermore, orbital pain may be a presenting symptom of fluid overload in patients with a history of orbital varices.

We present a case of an orbital varix masquerading as an orbital lymphoma. Our case underscores the importance of clinical correlation and thorough study of the ordered films by the ordering health care provider.

Case Presentation

An 84-year-old female veteran presented to the Bay Pines Veterans Affairs Healthcare System emergency department. She had a past ocular history of nonproliferative diabetic retinopathy in both eyes (OU) and senile cataracts OU. She had a complicated medical history most notable for congestive heart failure and Stage IV B cell follicular lymphoma, having received 6 rounds of chemotherapy, and has since been on rituximab maintenance therapy for the past few years.

The patient reported dyspnea on exertion, 30-pound weight gain, and ocular pain in her right eye (OD), more so than her left eye (OS) that was severe enough to wake her from sleep. She endorsed an associated headache but reported no visual loss or any other ocular symptoms other than conjunctival injection. On examination, the patient demonstrated jugular venous distension. X-ray imaging obtained in the emergency department demonstrated bilateral pleural effusions. Our patient was admitted subsequently for an exacerbation of congestive heart failure. She was monitored for euvolemia and discharged 4 days later.

During admission, imaging of the orbits was obtained. Computed tomography (CT) of the head without contrast demonstrated at least 4 intraorbital masses in the right orbit, measuring up to 22 mm in maximum diameter and at least 3 intraorbital masses in the left orbit, measuring up to 16 mm in diameter (Figure 1). Magnetic resonance imaging (MRI) with contrast of the brain and orbits was ordered, which demonstrated multiple bilateral uniformly enhancing, primarily extraconal masses present in both orbits, the largest of which occupied the superomedial aspect of the right orbit and measured 12 x 18 x 20 mm. Further, the ophthalmic veins were noted to be engorged. The cavernous did not demonstrate any thrombosis. No other ocular structures were compromised, although there was compression of the extraocular muscles in both orbits (Figures 2, 3, 4, 5, and 6). At that time, the reading radiologist suggested the most likely diagnosis was metastatic orbital lymphoma given the clinical history, which became the working diagnosis.

Discussion

In a study of 242 patients, Bacorn and colleagues found that a clinician’s preoperative assessment correlated with histopathologic diagnosis in 75.7% of cases, whereas the radiology report was correct in only 52.4% of cases.¹ Retrospective analysis identified clues that could have been used to more rapidly elucidate the true diagnosis for our patient.

In regard to symptomatology, orbital varices present with intermittent proptosis, vision loss, and rarely, periorbital pain unless thrombosed.^2,3 The severity of periorbital pain experienced by our patient is atypical of an orbital varix especially in the absence of a phlebolith. A specific feature of orbital varix is enlargement with the Valsalva maneuver.³ Although the patient did not report the notedsymptoms, more pointed questioning may have helped elucidate our patient’s true diagnosis sooner.

Radiologically, the presence of a partial flow void (decreased signal on T2) is useful for confirming the vascular nature of a lesion as was present in our case. Specific to the radiologic evaluation of orbital varices, it is recommended to obtain imaging with and without the Valsalva maneuver.⁴ Ultrasound is a superb tool in our armamentarium to image orbital lesions. B-scan ultrasound with and without Valsalva should be able to demonstrate variation in size when standing (minimal distension) vs lying flat with Valsalva (maximal distension).⁴ Further, Doppler ultrasound would be able to demonstrate changes in flow within the lesion when comparing previously mentioned maneuvers.⁴ Orbital lymphoma would not demonstrate this variation.

The size change of an orbital varix lesion may be further demonstrated on head CT with contrast. On CT, an orbital varix will demonstrate isodensity to other venous structures, whereas orbital lymphomas will be hyperdense when compared to extraocular muscles.^4,5 Further, a head CT without contrast may demonstrate phleboliths within an orbital varix.⁴ MRI should be performed with the Valsalva maneuver. On T1 and T2 studies, orbital varices demonstrate hypointensity when compared to extraocular muscles (EOMs).⁴ Lymphomas demonstrate a very specific radiologic pattern on MRI. On T1, they demonstrate isointensity to hypointensity when compared to EOMS, and on T2, they demonstrate iso- to hyperintensity when compared to EOMs.⁵ With respect to fluorodeoxyglucose (FDG) positron emission tomography (PET), our patient’s orbital lesion did not demonstrate FDG uptake. In patients where lymphoma previously demonstrated FDG PET uptake, the absence of such uptake strongly argues against malignant nature of the lesion (Figure 7).

Conclusions

We present a case of an orbital varix masquerading as an orbital lymphoma. While the ruling out of a diagnosis that might portend a poor prognosis is always of paramount importance, proper use of investigative studies and a thorough history could have helped elucidate the true diagnosis sooner: In this case an orbital varix masquerading as an orbital lymphoma. Mainly, the use of the Valsalva maneuver during the physical examination (resulting in proptosis) and during radiologic studies might have obviated the need for formal biopsy. Furthermore, orbital pain may be a presenting symptom of fluid overload in patients with a history of orbital varices.

Friday, July 16, 2021, marked the end of a week on duty in the hospital, and it was time to celebrate with a nice dinner out with my wife, since COVID-19 masking requirements had been lifted in our part of California for people like us who were fully vaccinated.

We always loved a nice dinner out and missed it so much during the pandemic. Unlike 6 months earlier, when I was administering dexamethasone, remdesivir, and high-flow oxygen to half of the patients on my panel, not a single patient was diagnosed with COVID-19, much less treated for it, during the previous week. We were doing so well in Sacramento that the hospital visitation rules had been relaxed and vaccinated patients were not required to have a negative COVID-19 test prior to hospital admission.

Saturday was game 5 of the NBA finals, so we had two couples join us for the game at our house; no masks because we were all vaccinated. On Sunday, we visited our neighbors who had just had a new baby boy and made them the gift of some baby books. The new mom had struggled with the decision of whether to get vaccinated during her pregnancy, but eventually decided to complete the vaccination cycle prior to delivery. She was fully immune at the time of the baby’s birth, wisely wanting the baby to have passive immunity through her. We kept an appropriate distance, and never touched baby or mom, but since masking guidelines had been lifted for the vaccinated,we didn’t bother with them.

On Monday, I felt a little something in my nose but still pursued my usual workout. Interestingly, my performance wasn’t up to my usual standards. There was a meeting that evening that I had to prepare for, when all of a sudden I felt very fatigued. I lay down and slept for a good hour, which disrupted my preparation. I warned the participants that I was feeling a little under the weather, but they wanted to proceed. At this point, I decided it was time to start wearing a mask again.

More meetings on Tuesday morning, but I made sure that I was fully masked. That little thing in my nose had blown up into a full-scale rhinitis, requiring Kleenex and decongestants. Plus, the fatigue was hitting me very hard. “Dang!” I thought. “I haven’t had a cold since 2019. All those COVID-19 precautions not only worked against COVID-19 (which I never got) but also worked against the common cold, which I had now.”

I finished up my meetings and laid down for a good hour and a half. As the father of two, I had plenty of experience with the common cold, and I knew that plenty of rest and hydration was the key to kicking this thing. Besides, my 55th birthday was coming up, and I wanted to make sure I was fully recovered for the festivities my wife was planning for me. Nonetheless, I scheduled myself for a COVID-19 test. I knew this couldn’t be COVID-19 because I was fully vaccinated, but it was hitting me so hard. It had to be a virus that my body had never seen before; maybe the human metapneumovirus. That was my line of reasoning, anyway.

Wednesday was another day on the couch because of continued severe fatigue and myalgias. I figured another good day of rest would help me kick this cold in time for my birthday celebration. Then the COVID-19 results came back positive. “How could this be? I was vaccinated?!” Admittedly I had been more relaxed with masking, per the CDC and county guidelines, but I always wore a mask when I was seeing patients in the hospital. Yeah, I wasn’t wearing an N95 anymore, and I had given up my goggles months ago, but we just weren’t seeing much COVID-19 anymore, so a plain surgical mask was all that was required and seemed sufficient. I had been reading articles about the new Delta variant that was becoming dominant across the country, and reports were that the vaccine was still effective against the Delta variant. However, I was experiencing the COVID-19 vaccine breakthrough infection because of the remarkable talent the Delta variant has for replicating and producing high levels of viremia.

My first thoughts were for my family, of course. As my illness unfolded, I had kept checking in with them to see if they had any of these “cold” symptoms I had; none of them did. When my test came back positive, we all went into quarantine immediately and they went to get tested; all of them were negative. Next, I contacted the people I had been meeting with that week and warned them that I had tested positive. Despite my mask, and their fully vaccinated status, they needed to get tested. They did, and they were negative. I realized that I was probably contagious, though asymptomatic, on Saturday night when we had friends over to watch the NBA finals. Yeah, everyone was vaccinated, but if I could get sick from this new Delta variant, they could too. The public health department sent me a survey when they found out about my positive test, and they pinpointed Saturday as the day I started to be contagious. I told my friends that I was probably contagious when they were over for the game, and that they should get tested. They did, and everyone came back negative for COVID-19.

Wait a minute; what about Sunday night? The newborn baby and the sleep-deprived mom. Oh no! I was contagious then as well. We kept our distance, and were only there for about 10 minutes, but if I felt bad from COVID-19, I felt worse for exposing them to the virus.

I am no Anthony Fauci, and I am grateful that we have had levelheaded scientists like him to lead us through this terrible experience. I am sure there will be many papers written about COVID-19 breakthrough infections in the future, but I have many thoughts from this experience. First, my practice of wearing an N95 and goggles for all patients, not just COVID-19 patients, during the height of the pandemic was effective. Prior to getting vaccinated, my antibody tests were negative, so I never contracted the illness when I stuck to this regimen. Second, we all want to get back to something that looks like “normal,” but because there are large unvaccinated populations in the community the virus will continue to propagate and evolve, and hence everyone is at risk. While the guidelines said it was okay to ease up on our restrictions, because so many people are not vaccinated, we all must continue to keep our guard up. Third, would a booster shot have saved me from this fate? Because I was on the front lines of the pandemic as a hospitalist, I was also among the first members of my community to get vaccinated, receiving my second shot on Jan. 14, 2021. My wife was not in any risk group, was not on any vaccine priority list, and didn’t complete the series until early April. If I was going to give the infection to anyone, it would have been her. Not only did she never develop symptoms, but she also repeatedly tested negative, as did everyone else that I was in contact with when I was most contagious. The thing that was different about me from everyone else was that I had gotten the vaccine well ahead of them. Had my immunity waned over the months?

The good news is that, while I wouldn’t characterize what I had as “mild,” it certainly wasn’t protracted. Yes, I was a good boy, and did the basics: stay hydrated and get plenty of sleep. I was really bad off for about 3 days, and I hate to think what it would have been like if I had coexisting conditions such as asthma or diabetes. We all know what a bad case of COVID-19 looks like in the unvaccinated, with months in the hospital, intravenous infusions, and high-flow oxygen for the lucky ones. I had nothing remotely like that. The dominant symptom I had was incapacitating fatigue and significant body aches. The second night I had some major chills, sweats, and wild dreams. From a respiratory standpoint, I had bad rhinitis and a wicked cough for a while that tapered off. My oxygen saturations dropped into the mid 90’s, but never below 94%. But if I had been ten times sicker, I doubt I would have survived. I was on quarantine for 10 days but I highly doubt I was at all contagious by day 5, based on my symptoms and the fact that nobody around me turned COVID positive with repeat testing.

I was so relieved that none of my contacts when I was most contagious turned positive for COVID-19. Though not scientific, I find that illustrative. While I should have canceled my meetings on Monday and Tuesday, everybody knew I had a “cold” and nobody wanted to cancel. Nobody thought it possible that I had COVID-19, especially me. The Delta variant is notorious for generating high levels of viremia, yet I didn’t get anybody sick, not even my wife. That suggests to me that, while the vaccine doesn’t eliminate the risk of infection – which we already knew – it probably significantly reduced my infectivity. For that I am very grateful. Now that I can say that I had the COVID-19 experience, I can tell you it feels terrible. But I would have felt much worse if I had gotten others ill. My personal belief is that while the vaccine didn’t save me from disease, it dramatically truncated my illness, and significantly reduced my risk of passing the virus on to my friends and family.

So where did I contract the virus? We were unmasked at dinner on Friday night, which was acceptable in Yolo County at that time. By the way, I actually live in Yolo County, not YOLO (you only live once) county. You can imagine the latter would be a bit more loosey-goosey with the masking requirements. That notwithstanding, I don’t think the dinner was where I picked it up because it was too short of an incubation period. My wife and I obviously reacted differently, as I discussed, but we were both at the restaurant. She didn’t get COVID-19 and I did. I think that I probably picked it up at the hospital, because, while I was wearing a mask there, I was only wearing a surgical mask, not an N95. And I wasn’t wearing goggles anymore. While none of my patients were officially diagnosed with COVID-19, I was encountering a lot of people, getting in relatively close contact, and guidelines were being relaxed, including preadmission COVID-19 testing.

I was an outlier, as I have pointed out; none of my other close contacts contracted COVID-19. A lot of politics and public opinion is driven by outlier cases, and even pure fabrications these days; we certainly can’t create public health policy based on an outlier. I am not suggesting that my experience is any basis for rewriting the rules of COVID-19. The experience has given me pause to think through many facets of this horrible illness we have had to deal with in so many ways, however. And I have also reexamined my own practice for protecting myself in the hospital. Clearly what I was doing in the height of the pandemic was effective, and my more relaxed recent practices were not. Now that I am fully recovered after a relatively unique encounter with the condition, I look forward to seeing what the scientists and public policy makers do with COVID-19 vaccine breakthrough cases. So, between us hospitalist friends and colleagues, regardless of the policy guidelines, I say we keep on masking.

Dr. McIlraith is the founding chairman of the hospital medicine department at Mercy Medical Group in Sacramento. He received the SHM Award for Outstanding Service in Hospital Medicine in 2016.

Friday, July 16, 2021, marked the end of a week on duty in the hospital, and it was time to celebrate with a nice dinner out with my wife, since COVID-19 masking requirements had been lifted in our part of California for people like us who were fully vaccinated.

We always loved a nice dinner out and missed it so much during the pandemic. Unlike 6 months earlier, when I was administering dexamethasone, remdesivir, and high-flow oxygen to half of the patients on my panel, not a single patient was diagnosed with COVID-19, much less treated for it, during the previous week. We were doing so well in Sacramento that the hospital visitation rules had been relaxed and vaccinated patients were not required to have a negative COVID-19 test prior to hospital admission.

Saturday was game 5 of the NBA finals, so we had two couples join us for the game at our house; no masks because we were all vaccinated. On Sunday, we visited our neighbors who had just had a new baby boy and made them the gift of some baby books. The new mom had struggled with the decision of whether to get vaccinated during her pregnancy, but eventually decided to complete the vaccination cycle prior to delivery. She was fully immune at the time of the baby’s birth, wisely wanting the baby to have passive immunity through her. We kept an appropriate distance, and never touched baby or mom, but since masking guidelines had been lifted for the vaccinated,we didn’t bother with them.

On Monday, I felt a little something in my nose but still pursued my usual workout. Interestingly, my performance wasn’t up to my usual standards. There was a meeting that evening that I had to prepare for, when all of a sudden I felt very fatigued. I lay down and slept for a good hour, which disrupted my preparation. I warned the participants that I was feeling a little under the weather, but they wanted to proceed. At this point, I decided it was time to start wearing a mask again.

More meetings on Tuesday morning, but I made sure that I was fully masked. That little thing in my nose had blown up into a full-scale rhinitis, requiring Kleenex and decongestants. Plus, the fatigue was hitting me very hard. “Dang!” I thought. “I haven’t had a cold since 2019. All those COVID-19 precautions not only worked against COVID-19 (which I never got) but also worked against the common cold, which I had now.”

I finished up my meetings and laid down for a good hour and a half. As the father of two, I had plenty of experience with the common cold, and I knew that plenty of rest and hydration was the key to kicking this thing. Besides, my 55th birthday was coming up, and I wanted to make sure I was fully recovered for the festivities my wife was planning for me. Nonetheless, I scheduled myself for a COVID-19 test. I knew this couldn’t be COVID-19 because I was fully vaccinated, but it was hitting me so hard. It had to be a virus that my body had never seen before; maybe the human metapneumovirus. That was my line of reasoning, anyway.

Wednesday was another day on the couch because of continued severe fatigue and myalgias. I figured another good day of rest would help me kick this cold in time for my birthday celebration. Then the COVID-19 results came back positive. “How could this be? I was vaccinated?!” Admittedly I had been more relaxed with masking, per the CDC and county guidelines, but I always wore a mask when I was seeing patients in the hospital. Yeah, I wasn’t wearing an N95 anymore, and I had given up my goggles months ago, but we just weren’t seeing much COVID-19 anymore, so a plain surgical mask was all that was required and seemed sufficient. I had been reading articles about the new Delta variant that was becoming dominant across the country, and reports were that the vaccine was still effective against the Delta variant. However, I was experiencing the COVID-19 vaccine breakthrough infection because of the remarkable talent the Delta variant has for replicating and producing high levels of viremia.

My first thoughts were for my family, of course. As my illness unfolded, I had kept checking in with them to see if they had any of these “cold” symptoms I had; none of them did. When my test came back positive, we all went into quarantine immediately and they went to get tested; all of them were negative. Next, I contacted the people I had been meeting with that week and warned them that I had tested positive. Despite my mask, and their fully vaccinated status, they needed to get tested. They did, and they were negative. I realized that I was probably contagious, though asymptomatic, on Saturday night when we had friends over to watch the NBA finals. Yeah, everyone was vaccinated, but if I could get sick from this new Delta variant, they could too. The public health department sent me a survey when they found out about my positive test, and they pinpointed Saturday as the day I started to be contagious. I told my friends that I was probably contagious when they were over for the game, and that they should get tested. They did, and everyone came back negative for COVID-19.

Wait a minute; what about Sunday night? The newborn baby and the sleep-deprived mom. Oh no! I was contagious then as well. We kept our distance, and were only there for about 10 minutes, but if I felt bad from COVID-19, I felt worse for exposing them to the virus.

I am no Anthony Fauci, and I am grateful that we have had levelheaded scientists like him to lead us through this terrible experience. I am sure there will be many papers written about COVID-19 breakthrough infections in the future, but I have many thoughts from this experience. First, my practice of wearing an N95 and goggles for all patients, not just COVID-19 patients, during the height of the pandemic was effective. Prior to getting vaccinated, my antibody tests were negative, so I never contracted the illness when I stuck to this regimen. Second, we all want to get back to something that looks like “normal,” but because there are large unvaccinated populations in the community the virus will continue to propagate and evolve, and hence everyone is at risk. While the guidelines said it was okay to ease up on our restrictions, because so many people are not vaccinated, we all must continue to keep our guard up. Third, would a booster shot have saved me from this fate? Because I was on the front lines of the pandemic as a hospitalist, I was also among the first members of my community to get vaccinated, receiving my second shot on Jan. 14, 2021. My wife was not in any risk group, was not on any vaccine priority list, and didn’t complete the series until early April. If I was going to give the infection to anyone, it would have been her. Not only did she never develop symptoms, but she also repeatedly tested negative, as did everyone else that I was in contact with when I was most contagious. The thing that was different about me from everyone else was that I had gotten the vaccine well ahead of them. Had my immunity waned over the months?

The good news is that, while I wouldn’t characterize what I had as “mild,” it certainly wasn’t protracted. Yes, I was a good boy, and did the basics: stay hydrated and get plenty of sleep. I was really bad off for about 3 days, and I hate to think what it would have been like if I had coexisting conditions such as asthma or diabetes. We all know what a bad case of COVID-19 looks like in the unvaccinated, with months in the hospital, intravenous infusions, and high-flow oxygen for the lucky ones. I had nothing remotely like that. The dominant symptom I had was incapacitating fatigue and significant body aches. The second night I had some major chills, sweats, and wild dreams. From a respiratory standpoint, I had bad rhinitis and a wicked cough for a while that tapered off. My oxygen saturations dropped into the mid 90’s, but never below 94%. But if I had been ten times sicker, I doubt I would have survived. I was on quarantine for 10 days but I highly doubt I was at all contagious by day 5, based on my symptoms and the fact that nobody around me turned COVID positive with repeat testing.

I was so relieved that none of my contacts when I was most contagious turned positive for COVID-19. Though not scientific, I find that illustrative. While I should have canceled my meetings on Monday and Tuesday, everybody knew I had a “cold” and nobody wanted to cancel. Nobody thought it possible that I had COVID-19, especially me. The Delta variant is notorious for generating high levels of viremia, yet I didn’t get anybody sick, not even my wife. That suggests to me that, while the vaccine doesn’t eliminate the risk of infection – which we already knew – it probably significantly reduced my infectivity. For that I am very grateful. Now that I can say that I had the COVID-19 experience, I can tell you it feels terrible. But I would have felt much worse if I had gotten others ill. My personal belief is that while the vaccine didn’t save me from disease, it dramatically truncated my illness, and significantly reduced my risk of passing the virus on to my friends and family.

So where did I contract the virus? We were unmasked at dinner on Friday night, which was acceptable in Yolo County at that time. By the way, I actually live in Yolo County, not YOLO (you only live once) county. You can imagine the latter would be a bit more loosey-goosey with the masking requirements. That notwithstanding, I don’t think the dinner was where I picked it up because it was too short of an incubation period. My wife and I obviously reacted differently, as I discussed, but we were both at the restaurant. She didn’t get COVID-19 and I did. I think that I probably picked it up at the hospital, because, while I was wearing a mask there, I was only wearing a surgical mask, not an N95. And I wasn’t wearing goggles anymore. While none of my patients were officially diagnosed with COVID-19, I was encountering a lot of people, getting in relatively close contact, and guidelines were being relaxed, including preadmission COVID-19 testing.

I was an outlier, as I have pointed out; none of my other close contacts contracted COVID-19. A lot of politics and public opinion is driven by outlier cases, and even pure fabrications these days; we certainly can’t create public health policy based on an outlier. I am not suggesting that my experience is any basis for rewriting the rules of COVID-19. The experience has given me pause to think through many facets of this horrible illness we have had to deal with in so many ways, however. And I have also reexamined my own practice for protecting myself in the hospital. Clearly what I was doing in the height of the pandemic was effective, and my more relaxed recent practices were not. Now that I am fully recovered after a relatively unique encounter with the condition, I look forward to seeing what the scientists and public policy makers do with COVID-19 vaccine breakthrough cases. So, between us hospitalist friends and colleagues, regardless of the policy guidelines, I say we keep on masking.

Dr. McIlraith is the founding chairman of the hospital medicine department at Mercy Medical Group in Sacramento. He received the SHM Award for Outstanding Service in Hospital Medicine in 2016.

Friday, July 16, 2021, marked the end of a week on duty in the hospital, and it was time to celebrate with a nice dinner out with my wife, since COVID-19 masking requirements had been lifted in our part of California for people like us who were fully vaccinated.

We always loved a nice dinner out and missed it so much during the pandemic. Unlike 6 months earlier, when I was administering dexamethasone, remdesivir, and high-flow oxygen to half of the patients on my panel, not a single patient was diagnosed with COVID-19, much less treated for it, during the previous week. We were doing so well in Sacramento that the hospital visitation rules had been relaxed and vaccinated patients were not required to have a negative COVID-19 test prior to hospital admission.

Saturday was game 5 of the NBA finals, so we had two couples join us for the game at our house; no masks because we were all vaccinated. On Sunday, we visited our neighbors who had just had a new baby boy and made them the gift of some baby books. The new mom had struggled with the decision of whether to get vaccinated during her pregnancy, but eventually decided to complete the vaccination cycle prior to delivery. She was fully immune at the time of the baby’s birth, wisely wanting the baby to have passive immunity through her. We kept an appropriate distance, and never touched baby or mom, but since masking guidelines had been lifted for the vaccinated,we didn’t bother with them.

On Monday, I felt a little something in my nose but still pursued my usual workout. Interestingly, my performance wasn’t up to my usual standards. There was a meeting that evening that I had to prepare for, when all of a sudden I felt very fatigued. I lay down and slept for a good hour, which disrupted my preparation. I warned the participants that I was feeling a little under the weather, but they wanted to proceed. At this point, I decided it was time to start wearing a mask again.

More meetings on Tuesday morning, but I made sure that I was fully masked. That little thing in my nose had blown up into a full-scale rhinitis, requiring Kleenex and decongestants. Plus, the fatigue was hitting me very hard. “Dang!” I thought. “I haven’t had a cold since 2019. All those COVID-19 precautions not only worked against COVID-19 (which I never got) but also worked against the common cold, which I had now.”

I finished up my meetings and laid down for a good hour and a half. As the father of two, I had plenty of experience with the common cold, and I knew that plenty of rest and hydration was the key to kicking this thing. Besides, my 55th birthday was coming up, and I wanted to make sure I was fully recovered for the festivities my wife was planning for me. Nonetheless, I scheduled myself for a COVID-19 test. I knew this couldn’t be COVID-19 because I was fully vaccinated, but it was hitting me so hard. It had to be a virus that my body had never seen before; maybe the human metapneumovirus. That was my line of reasoning, anyway.

Wednesday was another day on the couch because of continued severe fatigue and myalgias. I figured another good day of rest would help me kick this cold in time for my birthday celebration. Then the COVID-19 results came back positive. “How could this be? I was vaccinated?!” Admittedly I had been more relaxed with masking, per the CDC and county guidelines, but I always wore a mask when I was seeing patients in the hospital. Yeah, I wasn’t wearing an N95 anymore, and I had given up my goggles months ago, but we just weren’t seeing much COVID-19 anymore, so a plain surgical mask was all that was required and seemed sufficient. I had been reading articles about the new Delta variant that was becoming dominant across the country, and reports were that the vaccine was still effective against the Delta variant. However, I was experiencing the COVID-19 vaccine breakthrough infection because of the remarkable talent the Delta variant has for replicating and producing high levels of viremia.

My first thoughts were for my family, of course. As my illness unfolded, I had kept checking in with them to see if they had any of these “cold” symptoms I had; none of them did. When my test came back positive, we all went into quarantine immediately and they went to get tested; all of them were negative. Next, I contacted the people I had been meeting with that week and warned them that I had tested positive. Despite my mask, and their fully vaccinated status, they needed to get tested. They did, and they were negative. I realized that I was probably contagious, though asymptomatic, on Saturday night when we had friends over to watch the NBA finals. Yeah, everyone was vaccinated, but if I could get sick from this new Delta variant, they could too. The public health department sent me a survey when they found out about my positive test, and they pinpointed Saturday as the day I started to be contagious. I told my friends that I was probably contagious when they were over for the game, and that they should get tested. They did, and everyone came back negative for COVID-19.

Wait a minute; what about Sunday night? The newborn baby and the sleep-deprived mom. Oh no! I was contagious then as well. We kept our distance, and were only there for about 10 minutes, but if I felt bad from COVID-19, I felt worse for exposing them to the virus.

I am no Anthony Fauci, and I am grateful that we have had levelheaded scientists like him to lead us through this terrible experience. I am sure there will be many papers written about COVID-19 breakthrough infections in the future, but I have many thoughts from this experience. First, my practice of wearing an N95 and goggles for all patients, not just COVID-19 patients, during the height of the pandemic was effective. Prior to getting vaccinated, my antibody tests were negative, so I never contracted the illness when I stuck to this regimen. Second, we all want to get back to something that looks like “normal,” but because there are large unvaccinated populations in the community the virus will continue to propagate and evolve, and hence everyone is at risk. While the guidelines said it was okay to ease up on our restrictions, because so many people are not vaccinated, we all must continue to keep our guard up. Third, would a booster shot have saved me from this fate? Because I was on the front lines of the pandemic as a hospitalist, I was also among the first members of my community to get vaccinated, receiving my second shot on Jan. 14, 2021. My wife was not in any risk group, was not on any vaccine priority list, and didn’t complete the series until early April. If I was going to give the infection to anyone, it would have been her. Not only did she never develop symptoms, but she also repeatedly tested negative, as did everyone else that I was in contact with when I was most contagious. The thing that was different about me from everyone else was that I had gotten the vaccine well ahead of them. Had my immunity waned over the months?

The good news is that, while I wouldn’t characterize what I had as “mild,” it certainly wasn’t protracted. Yes, I was a good boy, and did the basics: stay hydrated and get plenty of sleep. I was really bad off for about 3 days, and I hate to think what it would have been like if I had coexisting conditions such as asthma or diabetes. We all know what a bad case of COVID-19 looks like in the unvaccinated, with months in the hospital, intravenous infusions, and high-flow oxygen for the lucky ones. I had nothing remotely like that. The dominant symptom I had was incapacitating fatigue and significant body aches. The second night I had some major chills, sweats, and wild dreams. From a respiratory standpoint, I had bad rhinitis and a wicked cough for a while that tapered off. My oxygen saturations dropped into the mid 90’s, but never below 94%. But if I had been ten times sicker, I doubt I would have survived. I was on quarantine for 10 days but I highly doubt I was at all contagious by day 5, based on my symptoms and the fact that nobody around me turned COVID positive with repeat testing.

I was so relieved that none of my contacts when I was most contagious turned positive for COVID-19. Though not scientific, I find that illustrative. While I should have canceled my meetings on Monday and Tuesday, everybody knew I had a “cold” and nobody wanted to cancel. Nobody thought it possible that I had COVID-19, especially me. The Delta variant is notorious for generating high levels of viremia, yet I didn’t get anybody sick, not even my wife. That suggests to me that, while the vaccine doesn’t eliminate the risk of infection – which we already knew – it probably significantly reduced my infectivity. For that I am very grateful. Now that I can say that I had the COVID-19 experience, I can tell you it feels terrible. But I would have felt much worse if I had gotten others ill. My personal belief is that while the vaccine didn’t save me from disease, it dramatically truncated my illness, and significantly reduced my risk of passing the virus on to my friends and family.

So where did I contract the virus? We were unmasked at dinner on Friday night, which was acceptable in Yolo County at that time. By the way, I actually live in Yolo County, not YOLO (you only live once) county. You can imagine the latter would be a bit more loosey-goosey with the masking requirements. That notwithstanding, I don’t think the dinner was where I picked it up because it was too short of an incubation period. My wife and I obviously reacted differently, as I discussed, but we were both at the restaurant. She didn’t get COVID-19 and I did. I think that I probably picked it up at the hospital, because, while I was wearing a mask there, I was only wearing a surgical mask, not an N95. And I wasn’t wearing goggles anymore. While none of my patients were officially diagnosed with COVID-19, I was encountering a lot of people, getting in relatively close contact, and guidelines were being relaxed, including preadmission COVID-19 testing.

I was an outlier, as I have pointed out; none of my other close contacts contracted COVID-19. A lot of politics and public opinion is driven by outlier cases, and even pure fabrications these days; we certainly can’t create public health policy based on an outlier. I am not suggesting that my experience is any basis for rewriting the rules of COVID-19. The experience has given me pause to think through many facets of this horrible illness we have had to deal with in so many ways, however. And I have also reexamined my own practice for protecting myself in the hospital. Clearly what I was doing in the height of the pandemic was effective, and my more relaxed recent practices were not. Now that I am fully recovered after a relatively unique encounter with the condition, I look forward to seeing what the scientists and public policy makers do with COVID-19 vaccine breakthrough cases. So, between us hospitalist friends and colleagues, regardless of the policy guidelines, I say we keep on masking.

Dr. McIlraith is the founding chairman of the hospital medicine department at Mercy Medical Group in Sacramento. He received the SHM Award for Outstanding Service in Hospital Medicine in 2016.

After Russell Jordan sent a stool sample through the mail to the microbiome company Viome, his idea of what he should eat shifted. The gym owner in Sacramento, had always consumed large quantities of leafy greens. But the results from the test – which sequenced and analyzed the microbes in a pea-sized stool sample – recommended he steer clear of spinach, kale, and broccoli.

“Things I’ve been eating for the better part of 30 years,” said Mr. Jordan, 31. “And it worked.” Soon, his mild indigestion subsided. He recommended the product to his girlfriend.

She took the test in late February, when the company – which sells its “Gut Intelligence” test for $129 and a more extensive “Health Intelligence” test, which requires a blood sample, for $199 – began experiencing hiccups. Viome had promised results within 4 weeks once the sample arrived at a testing facility, but Mr. Jordan said his girlfriend has been waiting more than 5 months and has submitted fresh blood and stool samples – twice.

Other Viome customers have flocked to social media to complain about similar problems: stool samples lost in the mail, months-long waits with no communication from the company, samples being rejected because of shipping or lab-processing snafus. (I, too, have a stool sample lost in transit, which I mailed after a first vial was rejected because it “leaked.”) The company’s CEO, Naveen Jain, took to Facebook to apologize in late July.

Viome’s troubles provide a cautionary tale for consumers in the wild west of microbiome startups, which have been alternately hailed for health breakthroughs and indicted for fraud.

The nascent industry offers individualized diet regimens based on analyzing gut bacteria – collectively known as the gut microbiome. Consumers pay hundreds of dollars for tests not covered by insurance, hoping to get answers to health problems ranging from irritable bowel syndrome to obesity.

Venture capitalists pumped $1 billion into these kinds of startups from 2015 to 2020, according to Crunchbase, buoyed by promising research and consumers’ embrace of at-home testing. PitchBook has identified more than a dozen direct-to-consumer gut health providers.

But not all the startups are equal. Some are supported by peer-reviewed studies. Others are peddling murky science – and not just because poop samples are getting lost in the mail.

“A lot of companies are interested in the space, but they don’t have the research to show that it’s actually working,” said Christopher Lynch, acting director of the National Institutes of Health Office of Nutrition Research. “And the research is really expensive.”

With nearly $160 million in government funding, the NIH Common Fund’s Nutrition for Precision Health research program, expected to launch by early 2022, seeks to enroll 1 million people to study the interactions among diet, the microbiome, genes, metabolism and other factors.

The gut microbiome is a complex community of trillions of bacteria. Research over the past 15 years has determined that these microbes, both good and bad, are an integral part of human biology, and that altering a person’s gut microbes can fundamentally change their metabolism, immune function – and, potentially, cure diseases, explained Justin Sonnenburg, PhD, a microbiology and immunology associate professor at Stanford (Calif.) University.

Metagenomic sequencing, which identifies the unique set of bugs in someone’s gut (similar to what 23andMe does with its saliva test), has also improved dramatically, making the process cheaper for companies to reproduce.

“It’s seen as one of the exciting areas of precision health,” said Dr. Sonnenburg, who recently coauthored a study that found a fermented food diet increases microbiome diversity – which is considered positive – and reduces markers of inflammation. That includes foods like yogurt, kefir, and kimchi.

“The difficulty for the consumer is to differentiate which of these companies is based on solid science versus overreaching the current limits of the field,” he added via email. “And for those companies based on solid science, what are the limits of what they should be recommending?”

San Francisco–based uBiome, founded in 2012, was one of the first to offer fecal sample testing.

But as uBiome began marketing its tests as “clinical” – and seeking reimbursement from insurers for up to nearly $3,000 – its business tactics came under scrutiny. The company was raided by the FBI and later filed for bankruptcy. Earlier this year, its cofounders were indicted for defrauding insurers into paying for tests that “were not validated and not medically necessary” in order to please investors, the Department of Justice alleges.

But for Tim Spector, a professor of genetic epidemiology at King’s College London and cofounder of the startup Zoe, being associated with uBiome is insulting.

Zoe has spent more than 2 years conducting trials, which have included dietary assessments, standardized meals, testing glycemic responses and gut microbiome profiling on thousands of participants. In January, the findings were published in Nature Medicine.

The company offers a $354 test that requires a stool sample, a completed questionnaire, and then a blood sample after eating muffins designed to test blood fat and sugar levels. Customers can also opt in to a 2-week, continuous glucose monitoring test.

The results are run through the company’s algorithm to create a customized library of foods and meals – and how customers are likely to respond to those foods.

DayTwo, a Walnut Creek, Calif., company that recently raised $37 million to expand its precision nutrition program, focuses on people with prediabetes or diabetes. It sells to large employers – and, soon, to health insurance plans – rather than directly to consumers, charging “a few thousand dollars” per person, said Jan Berger, MD, chief clinical strategist.

Based on a decade of research, DayTwo has worked with nearly 75,000 people. It sends participants a testing kit and survey, and arranges for them to chat with a dietitian while their stool sample is processing. Then, when the results come in, it makes recommendations, Dr. Berger said.

“I can still eat two scoops of ice cream, but I need to add walnuts in it to regulate my blood sugar,” she offered as an example.

Viome says it has tested more than 200,000 customers and has published its methodology for analyzing stool samples, which is different from other gut health companies. But the paper does not address Viome’s larger claims of connecting the microbiome to dietary advice, and researcher Elisabeth Bik called the claims “far fetched” in a 2019 review of the preprint version.

Viome makes additional money by selling supplements, probiotics and prebiotics based on consumers’ test results. It has also rebranded as Viome Life Sciences, expanding into precision diagnostics and therapeutics, such as saliva tests to detect throat cancer. Meanwhile, its gut health program has been mired in logistical missteps.

One customer who posted on Facebook tracked her sample through the U.S. Postal Service as it boomeranged between Los Alamos, N.M., and Bothell, Wash., where it was supposed to be picked up. Another fought for a refund after waiting 6 weeks to hear her sample was not viable and learning a second attempt had expired after spending too long in transit. The company’s expected lab processing time jumped from 4 weeks in February, when Mr. Jordan said his girlfriend took her first test, to 6 in summer. (Three weeks after I mailed my second sample in July, it still hadn’t made it to the lab, so I called it quits and asked for a refund.)

In Mr. Jain’s July apology posted to the private Facebook group for Viome users, he said the company recently moved its lab from New Mexico to Washington state, close to its headquarters, which prompted a mail-forwarding fiasco. It bought new robotics that “refused to cooperate,” he wrote. “Many things didn’t go as planned during the move.”

Spokesperson Kendall Donohue said Viome has been working on the problems but laid much of the blame on the Postal Service.

She also said Viome has been notifying customers – even though many (including myself) had not been contacted.

It is Viome’s “top priority right now to ensure complete customer satisfaction, but unfortunately USPS needs to sort the issue internally for further action to be taken,” she said.

She also offered me a free “Health Intelligence” test. I declined.

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

After Russell Jordan sent a stool sample through the mail to the microbiome company Viome, his idea of what he should eat shifted. The gym owner in Sacramento, had always consumed large quantities of leafy greens. But the results from the test – which sequenced and analyzed the microbes in a pea-sized stool sample – recommended he steer clear of spinach, kale, and broccoli.

“Things I’ve been eating for the better part of 30 years,” said Mr. Jordan, 31. “And it worked.” Soon, his mild indigestion subsided. He recommended the product to his girlfriend.

She took the test in late February, when the company – which sells its “Gut Intelligence” test for $129 and a more extensive “Health Intelligence” test, which requires a blood sample, for $199 – began experiencing hiccups. Viome had promised results within 4 weeks once the sample arrived at a testing facility, but Mr. Jordan said his girlfriend has been waiting more than 5 months and has submitted fresh blood and stool samples – twice.

Other Viome customers have flocked to social media to complain about similar problems: stool samples lost in the mail, months-long waits with no communication from the company, samples being rejected because of shipping or lab-processing snafus. (I, too, have a stool sample lost in transit, which I mailed after a first vial was rejected because it “leaked.”) The company’s CEO, Naveen Jain, took to Facebook to apologize in late July.

Viome’s troubles provide a cautionary tale for consumers in the wild west of microbiome startups, which have been alternately hailed for health breakthroughs and indicted for fraud.

The nascent industry offers individualized diet regimens based on analyzing gut bacteria – collectively known as the gut microbiome. Consumers pay hundreds of dollars for tests not covered by insurance, hoping to get answers to health problems ranging from irritable bowel syndrome to obesity.

Venture capitalists pumped $1 billion into these kinds of startups from 2015 to 2020, according to Crunchbase, buoyed by promising research and consumers’ embrace of at-home testing. PitchBook has identified more than a dozen direct-to-consumer gut health providers.

But not all the startups are equal. Some are supported by peer-reviewed studies. Others are peddling murky science – and not just because poop samples are getting lost in the mail.

“A lot of companies are interested in the space, but they don’t have the research to show that it’s actually working,” said Christopher Lynch, acting director of the National Institutes of Health Office of Nutrition Research. “And the research is really expensive.”

With nearly $160 million in government funding, the NIH Common Fund’s Nutrition for Precision Health research program, expected to launch by early 2022, seeks to enroll 1 million people to study the interactions among diet, the microbiome, genes, metabolism and other factors.

The gut microbiome is a complex community of trillions of bacteria. Research over the past 15 years has determined that these microbes, both good and bad, are an integral part of human biology, and that altering a person’s gut microbes can fundamentally change their metabolism, immune function – and, potentially, cure diseases, explained Justin Sonnenburg, PhD, a microbiology and immunology associate professor at Stanford (Calif.) University.

Metagenomic sequencing, which identifies the unique set of bugs in someone’s gut (similar to what 23andMe does with its saliva test), has also improved dramatically, making the process cheaper for companies to reproduce.

“It’s seen as one of the exciting areas of precision health,” said Dr. Sonnenburg, who recently coauthored a study that found a fermented food diet increases microbiome diversity – which is considered positive – and reduces markers of inflammation. That includes foods like yogurt, kefir, and kimchi.

“The difficulty for the consumer is to differentiate which of these companies is based on solid science versus overreaching the current limits of the field,” he added via email. “And for those companies based on solid science, what are the limits of what they should be recommending?”

San Francisco–based uBiome, founded in 2012, was one of the first to offer fecal sample testing.

But as uBiome began marketing its tests as “clinical” – and seeking reimbursement from insurers for up to nearly $3,000 – its business tactics came under scrutiny. The company was raided by the FBI and later filed for bankruptcy. Earlier this year, its cofounders were indicted for defrauding insurers into paying for tests that “were not validated and not medically necessary” in order to please investors, the Department of Justice alleges.

But for Tim Spector, a professor of genetic epidemiology at King’s College London and cofounder of the startup Zoe, being associated with uBiome is insulting.

Zoe has spent more than 2 years conducting trials, which have included dietary assessments, standardized meals, testing glycemic responses and gut microbiome profiling on thousands of participants. In January, the findings were published in Nature Medicine.

The company offers a $354 test that requires a stool sample, a completed questionnaire, and then a blood sample after eating muffins designed to test blood fat and sugar levels. Customers can also opt in to a 2-week, continuous glucose monitoring test.

The results are run through the company’s algorithm to create a customized library of foods and meals – and how customers are likely to respond to those foods.

DayTwo, a Walnut Creek, Calif., company that recently raised $37 million to expand its precision nutrition program, focuses on people with prediabetes or diabetes. It sells to large employers – and, soon, to health insurance plans – rather than directly to consumers, charging “a few thousand dollars” per person, said Jan Berger, MD, chief clinical strategist.

Based on a decade of research, DayTwo has worked with nearly 75,000 people. It sends participants a testing kit and survey, and arranges for them to chat with a dietitian while their stool sample is processing. Then, when the results come in, it makes recommendations, Dr. Berger said.

“I can still eat two scoops of ice cream, but I need to add walnuts in it to regulate my blood sugar,” she offered as an example.

Viome says it has tested more than 200,000 customers and has published its methodology for analyzing stool samples, which is different from other gut health companies. But the paper does not address Viome’s larger claims of connecting the microbiome to dietary advice, and researcher Elisabeth Bik called the claims “far fetched” in a 2019 review of the preprint version.

Viome makes additional money by selling supplements, probiotics and prebiotics based on consumers’ test results. It has also rebranded as Viome Life Sciences, expanding into precision diagnostics and therapeutics, such as saliva tests to detect throat cancer. Meanwhile, its gut health program has been mired in logistical missteps.

One customer who posted on Facebook tracked her sample through the U.S. Postal Service as it boomeranged between Los Alamos, N.M., and Bothell, Wash., where it was supposed to be picked up. Another fought for a refund after waiting 6 weeks to hear her sample was not viable and learning a second attempt had expired after spending too long in transit. The company’s expected lab processing time jumped from 4 weeks in February, when Mr. Jordan said his girlfriend took her first test, to 6 in summer. (Three weeks after I mailed my second sample in July, it still hadn’t made it to the lab, so I called it quits and asked for a refund.)

In Mr. Jain’s July apology posted to the private Facebook group for Viome users, he said the company recently moved its lab from New Mexico to Washington state, close to its headquarters, which prompted a mail-forwarding fiasco. It bought new robotics that “refused to cooperate,” he wrote. “Many things didn’t go as planned during the move.”

Spokesperson Kendall Donohue said Viome has been working on the problems but laid much of the blame on the Postal Service.

She also said Viome has been notifying customers – even though many (including myself) had not been contacted.

It is Viome’s “top priority right now to ensure complete customer satisfaction, but unfortunately USPS needs to sort the issue internally for further action to be taken,” she said.

She also offered me a free “Health Intelligence” test. I declined.

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

After Russell Jordan sent a stool sample through the mail to the microbiome company Viome, his idea of what he should eat shifted. The gym owner in Sacramento, had always consumed large quantities of leafy greens. But the results from the test – which sequenced and analyzed the microbes in a pea-sized stool sample – recommended he steer clear of spinach, kale, and broccoli.

“Things I’ve been eating for the better part of 30 years,” said Mr. Jordan, 31. “And it worked.” Soon, his mild indigestion subsided. He recommended the product to his girlfriend.

She took the test in late February, when the company – which sells its “Gut Intelligence” test for $129 and a more extensive “Health Intelligence” test, which requires a blood sample, for $199 – began experiencing hiccups. Viome had promised results within 4 weeks once the sample arrived at a testing facility, but Mr. Jordan said his girlfriend has been waiting more than 5 months and has submitted fresh blood and stool samples – twice.

Other Viome customers have flocked to social media to complain about similar problems: stool samples lost in the mail, months-long waits with no communication from the company, samples being rejected because of shipping or lab-processing snafus. (I, too, have a stool sample lost in transit, which I mailed after a first vial was rejected because it “leaked.”) The company’s CEO, Naveen Jain, took to Facebook to apologize in late July.

Viome’s troubles provide a cautionary tale for consumers in the wild west of microbiome startups, which have been alternately hailed for health breakthroughs and indicted for fraud.

The nascent industry offers individualized diet regimens based on analyzing gut bacteria – collectively known as the gut microbiome. Consumers pay hundreds of dollars for tests not covered by insurance, hoping to get answers to health problems ranging from irritable bowel syndrome to obesity.

Venture capitalists pumped $1 billion into these kinds of startups from 2015 to 2020, according to Crunchbase, buoyed by promising research and consumers’ embrace of at-home testing. PitchBook has identified more than a dozen direct-to-consumer gut health providers.

But not all the startups are equal. Some are supported by peer-reviewed studies. Others are peddling murky science – and not just because poop samples are getting lost in the mail.

“A lot of companies are interested in the space, but they don’t have the research to show that it’s actually working,” said Christopher Lynch, acting director of the National Institutes of Health Office of Nutrition Research. “And the research is really expensive.”

With nearly $160 million in government funding, the NIH Common Fund’s Nutrition for Precision Health research program, expected to launch by early 2022, seeks to enroll 1 million people to study the interactions among diet, the microbiome, genes, metabolism and other factors.

The gut microbiome is a complex community of trillions of bacteria. Research over the past 15 years has determined that these microbes, both good and bad, are an integral part of human biology, and that altering a person’s gut microbes can fundamentally change their metabolism, immune function – and, potentially, cure diseases, explained Justin Sonnenburg, PhD, a microbiology and immunology associate professor at Stanford (Calif.) University.

Metagenomic sequencing, which identifies the unique set of bugs in someone’s gut (similar to what 23andMe does with its saliva test), has also improved dramatically, making the process cheaper for companies to reproduce.

“It’s seen as one of the exciting areas of precision health,” said Dr. Sonnenburg, who recently coauthored a study that found a fermented food diet increases microbiome diversity – which is considered positive – and reduces markers of inflammation. That includes foods like yogurt, kefir, and kimchi.

“The difficulty for the consumer is to differentiate which of these companies is based on solid science versus overreaching the current limits of the field,” he added via email. “And for those companies based on solid science, what are the limits of what they should be recommending?”

San Francisco–based uBiome, founded in 2012, was one of the first to offer fecal sample testing.

But as uBiome began marketing its tests as “clinical” – and seeking reimbursement from insurers for up to nearly $3,000 – its business tactics came under scrutiny. The company was raided by the FBI and later filed for bankruptcy. Earlier this year, its cofounders were indicted for defrauding insurers into paying for tests that “were not validated and not medically necessary” in order to please investors, the Department of Justice alleges.

But for Tim Spector, a professor of genetic epidemiology at King’s College London and cofounder of the startup Zoe, being associated with uBiome is insulting.

Zoe has spent more than 2 years conducting trials, which have included dietary assessments, standardized meals, testing glycemic responses and gut microbiome profiling on thousands of participants. In January, the findings were published in Nature Medicine.

The company offers a $354 test that requires a stool sample, a completed questionnaire, and then a blood sample after eating muffins designed to test blood fat and sugar levels. Customers can also opt in to a 2-week, continuous glucose monitoring test.

The results are run through the company’s algorithm to create a customized library of foods and meals – and how customers are likely to respond to those foods.

DayTwo, a Walnut Creek, Calif., company that recently raised $37 million to expand its precision nutrition program, focuses on people with prediabetes or diabetes. It sells to large employers – and, soon, to health insurance plans – rather than directly to consumers, charging “a few thousand dollars” per person, said Jan Berger, MD, chief clinical strategist.

Based on a decade of research, DayTwo has worked with nearly 75,000 people. It sends participants a testing kit and survey, and arranges for them to chat with a dietitian while their stool sample is processing. Then, when the results come in, it makes recommendations, Dr. Berger said.

“I can still eat two scoops of ice cream, but I need to add walnuts in it to regulate my blood sugar,” she offered as an example.

Viome says it has tested more than 200,000 customers and has published its methodology for analyzing stool samples, which is different from other gut health companies. But the paper does not address Viome’s larger claims of connecting the microbiome to dietary advice, and researcher Elisabeth Bik called the claims “far fetched” in a 2019 review of the preprint version.

Viome makes additional money by selling supplements, probiotics and prebiotics based on consumers’ test results. It has also rebranded as Viome Life Sciences, expanding into precision diagnostics and therapeutics, such as saliva tests to detect throat cancer. Meanwhile, its gut health program has been mired in logistical missteps.

One customer who posted on Facebook tracked her sample through the U.S. Postal Service as it boomeranged between Los Alamos, N.M., and Bothell, Wash., where it was supposed to be picked up. Another fought for a refund after waiting 6 weeks to hear her sample was not viable and learning a second attempt had expired after spending too long in transit. The company’s expected lab processing time jumped from 4 weeks in February, when Mr. Jordan said his girlfriend took her first test, to 6 in summer. (Three weeks after I mailed my second sample in July, it still hadn’t made it to the lab, so I called it quits and asked for a refund.)

In Mr. Jain’s July apology posted to the private Facebook group for Viome users, he said the company recently moved its lab from New Mexico to Washington state, close to its headquarters, which prompted a mail-forwarding fiasco. It bought new robotics that “refused to cooperate,” he wrote. “Many things didn’t go as planned during the move.”

Spokesperson Kendall Donohue said Viome has been working on the problems but laid much of the blame on the Postal Service.

She also said Viome has been notifying customers – even though many (including myself) had not been contacted.

It is Viome’s “top priority right now to ensure complete customer satisfaction, but unfortunately USPS needs to sort the issue internally for further action to be taken,” she said.

She also offered me a free “Health Intelligence” test. I declined.

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

Although breakthrough COVID-19 infections appear to be infrequent in people with inflammatory rheumatic and musculoskeletal diseases (iRMDs), these patients’ comparatively low antibodies after their initial vaccine series validate the recommendation that booster doses could reinforce their immune responses. These findings were highlighted in three letters recently published in Annals of the Rheumatic Diseases.

In the first letter, the researchers assessed breakthrough COVID-19 infections among vaccinated patients with iRMDs who were treated within the Mass General Brigham health care system in the Boston area. Of the 340 COVID-19 infections in patients with iRMDs after vaccinations were approved by the Food and Drug Administration for emergency use, 16 (4.7%) were breakthrough infections. All but one of the breakthrough infections were symptomatic, and six of the patients were hospitalized.

Patients who had breakthrough infections took disease-modifying antirheumatic drugs (DMARDs) that included rituximab and glucocorticoids (five patients each), mycophenolate mofetil or mycophenolic acid (four patients), and methotrexate (three patients). Two of the patients died, both of whom were on rituximab and had interstitial lung disease.

“Some DMARD users may require alternative risk-mitigation strategies, including passive immunity or booster vaccines, and may need to continue shielding practices,” the authors wrote.

“Honestly, it’s hard to know what to make of that rate of breakthrough infections,” Camille Kotton, MD, clinical director of transplant and immunocompromised host infectious diseases in the infectious diseases division at Massachusetts General Hospital in Boston, said in an interview. “People who are immunocompromised were strongly advised to change behavior so as to avoid infection, which probably greatly alters their risk of breakthrough infection. It’s thus hard to evaluate vaccine efficacy.

“Also, 93% were symptomatic, which is fairly high,” she added. “I’m not sure if these patients were more likely to be symptomatic or if there was some bias in testing based on symptoms.”

In the second letter, the researchers assessed postvaccination COVID-19 infections in European patients with iRMDs. Two COVID-19 registries with thousands of patients were reviewed, with less than 1% of patients in each deemed eligible for this study. Of the 34 patients who were ultimately analyzed with available COVID-19 outcomes – 10 were fully vaccinated and 24 were partially vaccinated – 28 fully recovered, 3 recovered with ongoing sequelae, and 3 patients died. The three patients who died were all over 70 years old and had been treated with glucocorticoids and mycophenolate mofetil, glucocorticoids, and rituximab, respectively.

The medications most frequently used by the iRMDs patients with breakthrough cases included glucocorticoids (32%), methotrexate (26%), and tumor necrosis factor inhibitors (26%).

“Overall, the low numbers of SARS-CoV-2 infection post vaccination in both registries are encouraging,” the authors wrote, adding that “all three deceased patients were treated with medications that are potential negative influences on postvaccination SARS-CoV-2 immunogenicity in the RMD population.”
 

Patients with RMDs: Consider COVID-19 booster shots

In the third letter, the researchers investigated booster doses of COVID-19 vaccine in patients with autoimmune diseases. Of the 18 participants who received a booster dose, 14 were on antimetabolite therapy and 8 of those were on mycophenolate. At a median of 29 days after completion of their initial vaccine series, antispike antibodies were negative in 10 of the participants and low positive in 6 others, with a median antispike antibody level of less than 0.4 U/mL (interquartile range, <0.4-222 U/mL).

Booster doses were administered at a median of 77 days after completion of the initial series. At a median of 30 days after booster dose, 89% of the participants had an augmented humoral response, with a median antispike antibody level of 2,500 (IQR, 885-2,500 U/mL). Of the 10 participants who had negative anti-spike antibodies after the initial series, 80% were positive after the booster.

“I think this study supports the wealth of evidence that contributed to the [Centers for Disease Control and Prevention]’s and the FDA’s recommendation to get the third dose of the COVID vaccination,” coauthor Julie J. Paik, MD, of Johns Hopkins University, Baltimore, said in an interview. “Our patients are a very vulnerable group, including lupus patients or myositis patients, both of whom can get severe COVID if they were to contract it. They think they’re protected after a two-dose series, but in reality they’re not.

“We were just happy that they had a response,” she added. “Most of them had absolutely no response whatsoever after the first series.”

One other recently published case report in Arthritis & Rheumatology describes booster vaccination with the viral vector Johnson & Johnson vaccine in a man with seropositive RA who had previously received both doses of the Moderna mRNA-1273 vaccine. The 74-year-old man, who had low disease activity over the past 5 years on hydroxychloroquine, etanercept, and leflunomide, received the booster dose of his own accord after undergoing testing that showed a semiquantitative spike protein receptor binding domain (RBD) antibody level of 53.9 U/mL (reference range, 0-2,500 U/mL) and a negative SARS-CoV-2 antispike (S1/RBD) IgG test, as well as less than 10% blocking activity on an assay designed to detect blocking of the interaction between the SARS-CoV-2 spike protein RBD and the human ACE2 receptor and a negative interferon-gamma release assay detecting SARS-CoV-2–specific T cells. Several weeks after the booster dose, a repeat semiquantitative spike protein RBD antibody level was 2,455.0 U/mL and the S1/RBD IgG level was positive. An ACE2 blocking assay demonstrated 90%-100% blocking activity, but the interferon-gamma release assay remained negative.

“I would recommend abiding by the CDC guidelines regarding boosters for immunocompromised patients,” Dr. Kotton stated. “Patients with rheumatologic disease generally fit into the last category on that list. We don’t have an antibody titer that ensures protection, and as per CDC guidance, we don’t recommend checking antibody titers. Furthermore, boosters were given for this study before the CDC recommendation came out.”

Dr. Paik and coauthors acknowledged their study’s limitations, including a small, inhomogeneous sample and a lack of data on memory B-cell and T-cell response. They also echoed Dr. Kotton’s thoughts by noting that, although this subset of patients had notably limited antibody responses, “no antibody titer has been defined to correlate with protection.”

“Of course, the humoral response isn’t the whole story,” Dr. Paik said. “Some studies are showing that some vaccine recipients may not have the antibodies but their T-cell response may still be intact; it just takes time, and we’re not picking it up. Even if the antibody test is coming up negative, there may be some immunogenicity to the vaccine that we’re not detecting.

“Hopefully at some point, we’ll have more T-cell immunophenotyping to provide better insight into the full vaccine response.”

The Boston-area breakthrough study and the booster shot study were both funded primarily by grants from various institutes within the National Institutes of Health. The European study was financially supported by the European Alliance of Associations for Rheumatology.

Although breakthrough COVID-19 infections appear to be infrequent in people with inflammatory rheumatic and musculoskeletal diseases (iRMDs), these patients’ comparatively low antibodies after their initial vaccine series validate the recommendation that booster doses could reinforce their immune responses. These findings were highlighted in three letters recently published in Annals of the Rheumatic Diseases.

In the first letter, the researchers assessed breakthrough COVID-19 infections among vaccinated patients with iRMDs who were treated within the Mass General Brigham health care system in the Boston area. Of the 340 COVID-19 infections in patients with iRMDs after vaccinations were approved by the Food and Drug Administration for emergency use, 16 (4.7%) were breakthrough infections. All but one of the breakthrough infections were symptomatic, and six of the patients were hospitalized.

Patients who had breakthrough infections took disease-modifying antirheumatic drugs (DMARDs) that included rituximab and glucocorticoids (five patients each), mycophenolate mofetil or mycophenolic acid (four patients), and methotrexate (three patients). Two of the patients died, both of whom were on rituximab and had interstitial lung disease.

“Some DMARD users may require alternative risk-mitigation strategies, including passive immunity or booster vaccines, and may need to continue shielding practices,” the authors wrote.

“Honestly, it’s hard to know what to make of that rate of breakthrough infections,” Camille Kotton, MD, clinical director of transplant and immunocompromised host infectious diseases in the infectious diseases division at Massachusetts General Hospital in Boston, said in an interview. “People who are immunocompromised were strongly advised to change behavior so as to avoid infection, which probably greatly alters their risk of breakthrough infection. It’s thus hard to evaluate vaccine efficacy.

“Also, 93% were symptomatic, which is fairly high,” she added. “I’m not sure if these patients were more likely to be symptomatic or if there was some bias in testing based on symptoms.”

In the second letter, the researchers assessed postvaccination COVID-19 infections in European patients with iRMDs. Two COVID-19 registries with thousands of patients were reviewed, with less than 1% of patients in each deemed eligible for this study. Of the 34 patients who were ultimately analyzed with available COVID-19 outcomes – 10 were fully vaccinated and 24 were partially vaccinated – 28 fully recovered, 3 recovered with ongoing sequelae, and 3 patients died. The three patients who died were all over 70 years old and had been treated with glucocorticoids and mycophenolate mofetil, glucocorticoids, and rituximab, respectively.

The medications most frequently used by the iRMDs patients with breakthrough cases included glucocorticoids (32%), methotrexate (26%), and tumor necrosis factor inhibitors (26%).

“Overall, the low numbers of SARS-CoV-2 infection post vaccination in both registries are encouraging,” the authors wrote, adding that “all three deceased patients were treated with medications that are potential negative influences on postvaccination SARS-CoV-2 immunogenicity in the RMD population.”
 

Patients with RMDs: Consider COVID-19 booster shots

In the third letter, the researchers investigated booster doses of COVID-19 vaccine in patients with autoimmune diseases. Of the 18 participants who received a booster dose, 14 were on antimetabolite therapy and 8 of those were on mycophenolate. At a median of 29 days after completion of their initial vaccine series, antispike antibodies were negative in 10 of the participants and low positive in 6 others, with a median antispike antibody level of less than 0.4 U/mL (interquartile range, <0.4-222 U/mL).

Booster doses were administered at a median of 77 days after completion of the initial series. At a median of 30 days after booster dose, 89% of the participants had an augmented humoral response, with a median antispike antibody level of 2,500 (IQR, 885-2,500 U/mL). Of the 10 participants who had negative anti-spike antibodies after the initial series, 80% were positive after the booster.

“I think this study supports the wealth of evidence that contributed to the [Centers for Disease Control and Prevention]’s and the FDA’s recommendation to get the third dose of the COVID vaccination,” coauthor Julie J. Paik, MD, of Johns Hopkins University, Baltimore, said in an interview. “Our patients are a very vulnerable group, including lupus patients or myositis patients, both of whom can get severe COVID if they were to contract it. They think they’re protected after a two-dose series, but in reality they’re not.

“We were just happy that they had a response,” she added. “Most of them had absolutely no response whatsoever after the first series.”

One other recently published case report in Arthritis & Rheumatology describes booster vaccination with the viral vector Johnson & Johnson vaccine in a man with seropositive RA who had previously received both doses of the Moderna mRNA-1273 vaccine. The 74-year-old man, who had low disease activity over the past 5 years on hydroxychloroquine, etanercept, and leflunomide, received the booster dose of his own accord after undergoing testing that showed a semiquantitative spike protein receptor binding domain (RBD) antibody level of 53.9 U/mL (reference range, 0-2,500 U/mL) and a negative SARS-CoV-2 antispike (S1/RBD) IgG test, as well as less than 10% blocking activity on an assay designed to detect blocking of the interaction between the SARS-CoV-2 spike protein RBD and the human ACE2 receptor and a negative interferon-gamma release assay detecting SARS-CoV-2–specific T cells. Several weeks after the booster dose, a repeat semiquantitative spike protein RBD antibody level was 2,455.0 U/mL and the S1/RBD IgG level was positive. An ACE2 blocking assay demonstrated 90%-100% blocking activity, but the interferon-gamma release assay remained negative.

“I would recommend abiding by the CDC guidelines regarding boosters for immunocompromised patients,” Dr. Kotton stated. “Patients with rheumatologic disease generally fit into the last category on that list. We don’t have an antibody titer that ensures protection, and as per CDC guidance, we don’t recommend checking antibody titers. Furthermore, boosters were given for this study before the CDC recommendation came out.”

Dr. Paik and coauthors acknowledged their study’s limitations, including a small, inhomogeneous sample and a lack of data on memory B-cell and T-cell response. They also echoed Dr. Kotton’s thoughts by noting that, although this subset of patients had notably limited antibody responses, “no antibody titer has been defined to correlate with protection.”

“Of course, the humoral response isn’t the whole story,” Dr. Paik said. “Some studies are showing that some vaccine recipients may not have the antibodies but their T-cell response may still be intact; it just takes time, and we’re not picking it up. Even if the antibody test is coming up negative, there may be some immunogenicity to the vaccine that we’re not detecting.

“Hopefully at some point, we’ll have more T-cell immunophenotyping to provide better insight into the full vaccine response.”

The Boston-area breakthrough study and the booster shot study were both funded primarily by grants from various institutes within the National Institutes of Health. The European study was financially supported by the European Alliance of Associations for Rheumatology.

Although breakthrough COVID-19 infections appear to be infrequent in people with inflammatory rheumatic and musculoskeletal diseases (iRMDs), these patients’ comparatively low antibodies after their initial vaccine series validate the recommendation that booster doses could reinforce their immune responses. These findings were highlighted in three letters recently published in Annals of the Rheumatic Diseases.

In the first letter, the researchers assessed breakthrough COVID-19 infections among vaccinated patients with iRMDs who were treated within the Mass General Brigham health care system in the Boston area. Of the 340 COVID-19 infections in patients with iRMDs after vaccinations were approved by the Food and Drug Administration for emergency use, 16 (4.7%) were breakthrough infections. All but one of the breakthrough infections were symptomatic, and six of the patients were hospitalized.

Patients who had breakthrough infections took disease-modifying antirheumatic drugs (DMARDs) that included rituximab and glucocorticoids (five patients each), mycophenolate mofetil or mycophenolic acid (four patients), and methotrexate (three patients). Two of the patients died, both of whom were on rituximab and had interstitial lung disease.

“Some DMARD users may require alternative risk-mitigation strategies, including passive immunity or booster vaccines, and may need to continue shielding practices,” the authors wrote.

“Honestly, it’s hard to know what to make of that rate of breakthrough infections,” Camille Kotton, MD, clinical director of transplant and immunocompromised host infectious diseases in the infectious diseases division at Massachusetts General Hospital in Boston, said in an interview. “People who are immunocompromised were strongly advised to change behavior so as to avoid infection, which probably greatly alters their risk of breakthrough infection. It’s thus hard to evaluate vaccine efficacy.

“Also, 93% were symptomatic, which is fairly high,” she added. “I’m not sure if these patients were more likely to be symptomatic or if there was some bias in testing based on symptoms.”

In the second letter, the researchers assessed postvaccination COVID-19 infections in European patients with iRMDs. Two COVID-19 registries with thousands of patients were reviewed, with less than 1% of patients in each deemed eligible for this study. Of the 34 patients who were ultimately analyzed with available COVID-19 outcomes – 10 were fully vaccinated and 24 were partially vaccinated – 28 fully recovered, 3 recovered with ongoing sequelae, and 3 patients died. The three patients who died were all over 70 years old and had been treated with glucocorticoids and mycophenolate mofetil, glucocorticoids, and rituximab, respectively.

The medications most frequently used by the iRMDs patients with breakthrough cases included glucocorticoids (32%), methotrexate (26%), and tumor necrosis factor inhibitors (26%).

“Overall, the low numbers of SARS-CoV-2 infection post vaccination in both registries are encouraging,” the authors wrote, adding that “all three deceased patients were treated with medications that are potential negative influences on postvaccination SARS-CoV-2 immunogenicity in the RMD population.”
 

Patients with RMDs: Consider COVID-19 booster shots

In the third letter, the researchers investigated booster doses of COVID-19 vaccine in patients with autoimmune diseases. Of the 18 participants who received a booster dose, 14 were on antimetabolite therapy and 8 of those were on mycophenolate. At a median of 29 days after completion of their initial vaccine series, antispike antibodies were negative in 10 of the participants and low positive in 6 others, with a median antispike antibody level of less than 0.4 U/mL (interquartile range, <0.4-222 U/mL).

Booster doses were administered at a median of 77 days after completion of the initial series. At a median of 30 days after booster dose, 89% of the participants had an augmented humoral response, with a median antispike antibody level of 2,500 (IQR, 885-2,500 U/mL). Of the 10 participants who had negative anti-spike antibodies after the initial series, 80% were positive after the booster.

“I think this study supports the wealth of evidence that contributed to the [Centers for Disease Control and Prevention]’s and the FDA’s recommendation to get the third dose of the COVID vaccination,” coauthor Julie J. Paik, MD, of Johns Hopkins University, Baltimore, said in an interview. “Our patients are a very vulnerable group, including lupus patients or myositis patients, both of whom can get severe COVID if they were to contract it. They think they’re protected after a two-dose series, but in reality they’re not.

“We were just happy that they had a response,” she added. “Most of them had absolutely no response whatsoever after the first series.”

One other recently published case report in Arthritis & Rheumatology describes booster vaccination with the viral vector Johnson & Johnson vaccine in a man with seropositive RA who had previously received both doses of the Moderna mRNA-1273 vaccine. The 74-year-old man, who had low disease activity over the past 5 years on hydroxychloroquine, etanercept, and leflunomide, received the booster dose of his own accord after undergoing testing that showed a semiquantitative spike protein receptor binding domain (RBD) antibody level of 53.9 U/mL (reference range, 0-2,500 U/mL) and a negative SARS-CoV-2 antispike (S1/RBD) IgG test, as well as less than 10% blocking activity on an assay designed to detect blocking of the interaction between the SARS-CoV-2 spike protein RBD and the human ACE2 receptor and a negative interferon-gamma release assay detecting SARS-CoV-2–specific T cells. Several weeks after the booster dose, a repeat semiquantitative spike protein RBD antibody level was 2,455.0 U/mL and the S1/RBD IgG level was positive. An ACE2 blocking assay demonstrated 90%-100% blocking activity, but the interferon-gamma release assay remained negative.

“I would recommend abiding by the CDC guidelines regarding boosters for immunocompromised patients,” Dr. Kotton stated. “Patients with rheumatologic disease generally fit into the last category on that list. We don’t have an antibody titer that ensures protection, and as per CDC guidance, we don’t recommend checking antibody titers. Furthermore, boosters were given for this study before the CDC recommendation came out.”

Dr. Paik and coauthors acknowledged their study’s limitations, including a small, inhomogeneous sample and a lack of data on memory B-cell and T-cell response. They also echoed Dr. Kotton’s thoughts by noting that, although this subset of patients had notably limited antibody responses, “no antibody titer has been defined to correlate with protection.”

“Of course, the humoral response isn’t the whole story,” Dr. Paik said. “Some studies are showing that some vaccine recipients may not have the antibodies but their T-cell response may still be intact; it just takes time, and we’re not picking it up. Even if the antibody test is coming up negative, there may be some immunogenicity to the vaccine that we’re not detecting.

“Hopefully at some point, we’ll have more T-cell immunophenotyping to provide better insight into the full vaccine response.”

The Boston-area breakthrough study and the booster shot study were both funded primarily by grants from various institutes within the National Institutes of Health. The European study was financially supported by the European Alliance of Associations for Rheumatology.

Telehealth can be effective for delivering cognitive-behavioral therapy for insomnia (CBT-I) – and is not inferior to in-person treatment, new research suggests.

Results from a study of 60 adults with insomnia disorder showed no significant between-group difference at 3-month follow-up between those assigned to receive in-person CBT-I and those assigned to telehealth CBT-I in regard to change in score on the Insomnia Severity Index (ISI).

In addition, both groups showed significant change compared with a wait-list group, indicating that telehealth was not inferior to the in-person mode of delivery, the investigators note.

Telehealth ‘explosion’

Although CBT-I is the recommended intervention for insomnia, “widespread implementation of CBT-I is limited by the lack of clinicians who are trained in this treatment,” the investigators note. There is a “need for strategies to increase access, particularly for patients in areas with few health care providers.”

Telehealth is a promising technology for providing treatment, without the necessity of having the patient and the practitioner in the same place. There has been an “explosion” in its use because of restrictions necessitated by the COVID-19 pandemic. However, the “rapid deployment of telehealth interventions did not allow time to assess this approach in a controlled manner,” so it is possible that this type of communication might reduce treatment efficacy, the investigators note.

Previous research suggests that telehealth psychotherapeutic treatments in general are not inferior to in-person treatments. One study showed that CBT-I delivered via telehealth was noninferior to in-person delivery. However, that study did not include a control group.

“I have been doing telehealth clinical work for about 10 years – so way before the pandemic pushed everything virtual,” Dr. Gehrman said. “But when I would talk about my telehealth work to other providers, I would frequently get asked whether the advantages of telehealth (greater access to care, reduced travel costs) came at a price of lower efficacy.”

Dr. Gehrman said he suspected that telehealth treatment was just as effective and wanted to formally test this impression to see whether he was correct.

The investigators randomly assigned 60 adults (mean age, 32.72 years; mean ISI score, 17.0; 65% women) with insomnia disorder to in-person CBT-I (n = 20), telehealth-delivered CBT-I (n = 21), or to a wait-list control group (n = 19). For the study, insomnia disorder was determined on the basis of DSM-5 criteria.

Most participants had completed college or postgraduate school (43% and 37%, respectively) and did not have many comorbidities.

The primary outcome was change on the ISI. Other assessments included measures of depression, anxiety, work and social adjustment, fatigue, and medical outcomes. Participants also completed a home unattended sleep study using a portable monitor to screen participants for obstructive sleep apnea.

Both types of CBT-I were delivered over 6 to 8 weekly sessions, with 2-week and 3-month post-treatment follow-ups.

An a priori margin of -3.0 points was used in the noninferiority analysis, and all analyses were conducted using mixed-effects models, the authors explain.
 

Necessary evil?

In the primary noninferiority analyses, the mean change in ISI score from baseline to 3-month follow-up was -7.8 points for in-person CBT-I, -7.5 points for telehealth, and -1.6 for wait list.

The difference between the CBT-I groups was not statistically significant (t 28 = -0.98, P = .33).

“The lower confidence limit of this between-group difference in the mean ISI changes was greater than the a priori margin of -3.0 points, indicating that telehealth treatment was not inferior to in-person treatment,” the investigators write.

Although there were significant improvements on most secondary outcome measures related to mood/anxiety and daytime functioning, the investigators found no group differences.

The findings suggest that the benefits of telehealth, including increased access and reduced travel time, “do not come with a cost of reduced efficacy,” the researchers write.

The study was conducted prior to the COVID-19 pandemic, the investigators note. However, the results “underscore that the use of telehealth during the pandemic is not a ‘necessary evil,’ but rather a means of providing high quality care while reducing risks of exposure,” they write.
 

Benefits, fidelity maintained

Commenting on the study, J. Todd Arnedt, PhD, professor of psychiatry and neurology and co-director of the Sleep and Circadian Research Laboratory, Michigan Medicine, University of Michigan, Ann Arbor, said it is “one of the first studies to clearly demonstrate that the benefits and fidelity of CBT for insomnia, which is most commonly delivered in-person, can be maintained with telehealth delivery.”

Dr. Arnedt is also director of the Behavioral Sleep Medicine Program and was not involved in the study. He said the findings “support the use of this modality by providers to expand access to this highly effective but underutilized insomnia treatment.”

Additionally, telehealth delivery of CBT-I “offers a safe and effective alternative to in-person care for improving insomnia and associated daytime consequences and has the potential to reduce health care disparities by increasing availability to underserved communities,” Dr. Arnedt said.

However, the investigators point out that the utility of this approach for underserved communities needs further investigation. A study limitation was that the participants were “generally healthy and well educated.”

In addition, further research is needed to see whether the findings can be generalized to individuals who have “more complicated health or socioeconomic difficulties,” they write.

The study was funded by a grant from the American Sleep Medicine Foundation and the Doris Duke Charitable Foundation Clinical Scientist Development Award. Dr. Gehrman has received research funding from Merck, is a consultant to WW, and serves on the scientific advisory board of Eight Sleep. The other authors’ disclosures are listed in the original article. Dr. Arnedt reports no relevant financial relationships but notes that he was the principal investigator of a similar study run in parallel to this one that was also funded by the American Academy of Sleep Medicine Foundation at the same time.

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

Telehealth can be effective for delivering cognitive-behavioral therapy for insomnia (CBT-I) – and is not inferior to in-person treatment, new research suggests.

Results from a study of 60 adults with insomnia disorder showed no significant between-group difference at 3-month follow-up between those assigned to receive in-person CBT-I and those assigned to telehealth CBT-I in regard to change in score on the Insomnia Severity Index (ISI).

In addition, both groups showed significant change compared with a wait-list group, indicating that telehealth was not inferior to the in-person mode of delivery, the investigators note.

Telehealth ‘explosion’

Although CBT-I is the recommended intervention for insomnia, “widespread implementation of CBT-I is limited by the lack of clinicians who are trained in this treatment,” the investigators note. There is a “need for strategies to increase access, particularly for patients in areas with few health care providers.”

Telehealth is a promising technology for providing treatment, without the necessity of having the patient and the practitioner in the same place. There has been an “explosion” in its use because of restrictions necessitated by the COVID-19 pandemic. However, the “rapid deployment of telehealth interventions did not allow time to assess this approach in a controlled manner,” so it is possible that this type of communication might reduce treatment efficacy, the investigators note.

Previous research suggests that telehealth psychotherapeutic treatments in general are not inferior to in-person treatments. One study showed that CBT-I delivered via telehealth was noninferior to in-person delivery. However, that study did not include a control group.

“I have been doing telehealth clinical work for about 10 years – so way before the pandemic pushed everything virtual,” Dr. Gehrman said. “But when I would talk about my telehealth work to other providers, I would frequently get asked whether the advantages of telehealth (greater access to care, reduced travel costs) came at a price of lower efficacy.”

Dr. Gehrman said he suspected that telehealth treatment was just as effective and wanted to formally test this impression to see whether he was correct.

The investigators randomly assigned 60 adults (mean age, 32.72 years; mean ISI score, 17.0; 65% women) with insomnia disorder to in-person CBT-I (n = 20), telehealth-delivered CBT-I (n = 21), or to a wait-list control group (n = 19). For the study, insomnia disorder was determined on the basis of DSM-5 criteria.

Most participants had completed college or postgraduate school (43% and 37%, respectively) and did not have many comorbidities.

The primary outcome was change on the ISI. Other assessments included measures of depression, anxiety, work and social adjustment, fatigue, and medical outcomes. Participants also completed a home unattended sleep study using a portable monitor to screen participants for obstructive sleep apnea.

Both types of CBT-I were delivered over 6 to 8 weekly sessions, with 2-week and 3-month post-treatment follow-ups.

An a priori margin of -3.0 points was used in the noninferiority analysis, and all analyses were conducted using mixed-effects models, the authors explain.
 

Necessary evil?

In the primary noninferiority analyses, the mean change in ISI score from baseline to 3-month follow-up was -7.8 points for in-person CBT-I, -7.5 points for telehealth, and -1.6 for wait list.

The difference between the CBT-I groups was not statistically significant (t 28 = -0.98, P = .33).

“The lower confidence limit of this between-group difference in the mean ISI changes was greater than the a priori margin of -3.0 points, indicating that telehealth treatment was not inferior to in-person treatment,” the investigators write.

Although there were significant improvements on most secondary outcome measures related to mood/anxiety and daytime functioning, the investigators found no group differences.

The findings suggest that the benefits of telehealth, including increased access and reduced travel time, “do not come with a cost of reduced efficacy,” the researchers write.

The study was conducted prior to the COVID-19 pandemic, the investigators note. However, the results “underscore that the use of telehealth during the pandemic is not a ‘necessary evil,’ but rather a means of providing high quality care while reducing risks of exposure,” they write.
 

Benefits, fidelity maintained

Commenting on the study, J. Todd Arnedt, PhD, professor of psychiatry and neurology and co-director of the Sleep and Circadian Research Laboratory, Michigan Medicine, University of Michigan, Ann Arbor, said it is “one of the first studies to clearly demonstrate that the benefits and fidelity of CBT for insomnia, which is most commonly delivered in-person, can be maintained with telehealth delivery.”

Dr. Arnedt is also director of the Behavioral Sleep Medicine Program and was not involved in the study. He said the findings “support the use of this modality by providers to expand access to this highly effective but underutilized insomnia treatment.”

Additionally, telehealth delivery of CBT-I “offers a safe and effective alternative to in-person care for improving insomnia and associated daytime consequences and has the potential to reduce health care disparities by increasing availability to underserved communities,” Dr. Arnedt said.

However, the investigators point out that the utility of this approach for underserved communities needs further investigation. A study limitation was that the participants were “generally healthy and well educated.”

In addition, further research is needed to see whether the findings can be generalized to individuals who have “more complicated health or socioeconomic difficulties,” they write.

The study was funded by a grant from the American Sleep Medicine Foundation and the Doris Duke Charitable Foundation Clinical Scientist Development Award. Dr. Gehrman has received research funding from Merck, is a consultant to WW, and serves on the scientific advisory board of Eight Sleep. The other authors’ disclosures are listed in the original article. Dr. Arnedt reports no relevant financial relationships but notes that he was the principal investigator of a similar study run in parallel to this one that was also funded by the American Academy of Sleep Medicine Foundation at the same time.

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

Telehealth can be effective for delivering cognitive-behavioral therapy for insomnia (CBT-I) – and is not inferior to in-person treatment, new research suggests.

Results from a study of 60 adults with insomnia disorder showed no significant between-group difference at 3-month follow-up between those assigned to receive in-person CBT-I and those assigned to telehealth CBT-I in regard to change in score on the Insomnia Severity Index (ISI).

In addition, both groups showed significant change compared with a wait-list group, indicating that telehealth was not inferior to the in-person mode of delivery, the investigators note.

Telehealth ‘explosion’

Although CBT-I is the recommended intervention for insomnia, “widespread implementation of CBT-I is limited by the lack of clinicians who are trained in this treatment,” the investigators note. There is a “need for strategies to increase access, particularly for patients in areas with few health care providers.”

Telehealth is a promising technology for providing treatment, without the necessity of having the patient and the practitioner in the same place. There has been an “explosion” in its use because of restrictions necessitated by the COVID-19 pandemic. However, the “rapid deployment of telehealth interventions did not allow time to assess this approach in a controlled manner,” so it is possible that this type of communication might reduce treatment efficacy, the investigators note.

Previous research suggests that telehealth psychotherapeutic treatments in general are not inferior to in-person treatments. One study showed that CBT-I delivered via telehealth was noninferior to in-person delivery. However, that study did not include a control group.

“I have been doing telehealth clinical work for about 10 years – so way before the pandemic pushed everything virtual,” Dr. Gehrman said. “But when I would talk about my telehealth work to other providers, I would frequently get asked whether the advantages of telehealth (greater access to care, reduced travel costs) came at a price of lower efficacy.”

Dr. Gehrman said he suspected that telehealth treatment was just as effective and wanted to formally test this impression to see whether he was correct.

The investigators randomly assigned 60 adults (mean age, 32.72 years; mean ISI score, 17.0; 65% women) with insomnia disorder to in-person CBT-I (n = 20), telehealth-delivered CBT-I (n = 21), or to a wait-list control group (n = 19). For the study, insomnia disorder was determined on the basis of DSM-5 criteria.

Most participants had completed college or postgraduate school (43% and 37%, respectively) and did not have many comorbidities.

The primary outcome was change on the ISI. Other assessments included measures of depression, anxiety, work and social adjustment, fatigue, and medical outcomes. Participants also completed a home unattended sleep study using a portable monitor to screen participants for obstructive sleep apnea.

Both types of CBT-I were delivered over 6 to 8 weekly sessions, with 2-week and 3-month post-treatment follow-ups.

An a priori margin of -3.0 points was used in the noninferiority analysis, and all analyses were conducted using mixed-effects models, the authors explain.
 

Necessary evil?

In the primary noninferiority analyses, the mean change in ISI score from baseline to 3-month follow-up was -7.8 points for in-person CBT-I, -7.5 points for telehealth, and -1.6 for wait list.

The difference between the CBT-I groups was not statistically significant (t 28 = -0.98, P = .33).

“The lower confidence limit of this between-group difference in the mean ISI changes was greater than the a priori margin of -3.0 points, indicating that telehealth treatment was not inferior to in-person treatment,” the investigators write.

Although there were significant improvements on most secondary outcome measures related to mood/anxiety and daytime functioning, the investigators found no group differences.

The findings suggest that the benefits of telehealth, including increased access and reduced travel time, “do not come with a cost of reduced efficacy,” the researchers write.

The study was conducted prior to the COVID-19 pandemic, the investigators note. However, the results “underscore that the use of telehealth during the pandemic is not a ‘necessary evil,’ but rather a means of providing high quality care while reducing risks of exposure,” they write.
 

Benefits, fidelity maintained

Commenting on the study, J. Todd Arnedt, PhD, professor of psychiatry and neurology and co-director of the Sleep and Circadian Research Laboratory, Michigan Medicine, University of Michigan, Ann Arbor, said it is “one of the first studies to clearly demonstrate that the benefits and fidelity of CBT for insomnia, which is most commonly delivered in-person, can be maintained with telehealth delivery.”

Dr. Arnedt is also director of the Behavioral Sleep Medicine Program and was not involved in the study. He said the findings “support the use of this modality by providers to expand access to this highly effective but underutilized insomnia treatment.”

Additionally, telehealth delivery of CBT-I “offers a safe and effective alternative to in-person care for improving insomnia and associated daytime consequences and has the potential to reduce health care disparities by increasing availability to underserved communities,” Dr. Arnedt said.

However, the investigators point out that the utility of this approach for underserved communities needs further investigation. A study limitation was that the participants were “generally healthy and well educated.”

In addition, further research is needed to see whether the findings can be generalized to individuals who have “more complicated health or socioeconomic difficulties,” they write.

The study was funded by a grant from the American Sleep Medicine Foundation and the Doris Duke Charitable Foundation Clinical Scientist Development Award. Dr. Gehrman has received research funding from Merck, is a consultant to WW, and serves on the scientific advisory board of Eight Sleep. The other authors’ disclosures are listed in the original article. Dr. Arnedt reports no relevant financial relationships but notes that he was the principal investigator of a similar study run in parallel to this one that was also funded by the American Academy of Sleep Medicine Foundation at the same time.

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

Lung function in early infancy may be influenced by the mother’s level of physical activity during pregnancy, results of a study from Sweden suggest.

Low-lung function at 3 months of age, as measured by the ratio of time to peak tidal expiratory flow to expiratory time (tPTEF/tE), was more frequent among children whose mothers were physically inactive during the first half of pregnancy compared with those who exercised either moderately or strenuously, reported Hrefna Katrin Gudmundsdottir, MD, a pediatrician and PhD candidate at the University of Oslo, Norway. The results were based on a prospective observational study of 841 mother-child pairs.

“The potential link between maternal inactivity and low lung function in infancy adds to the importance of advising pregnant women and women of childbearing age on physical activity,” she said in an oral abstract presented during the virtual European Respiratory Society (ERS) International Congress.

Jonathan Grigg, MD, professor of pediatric respiratory and environmental medicine at Queen Mary University of London, who was not involved in the study, commented that it “offers a fascinating hint that increased physical activity of mothers is associated with better lung function in their babies and, therefore, possibly their health in later life. More research is needed to confirm this link, but it is important that women feel supported by their health care providers to be active in a way that is comfortable and accessible to them.”

Impaired lung function in infancy is associated with wheezing and asthma in childhood, and lower lung function later in life, Dr. Gudmundsdottir said. She also noted that impaired lung function begins in utero and is related to fetal and infant size, family history of asthma, and/or maternal smoking.

Physical activity during pregnancy has been demonstrated to reduce the risk of preterm birth and cesarean birth and of children being born either abnormally small or abnormally large for their gestational age, she explained.

To see where physical inactivity in the first half of pregnancy is associated with lower lung function in otherwise healthy 3-month old infants, Dr. Gudmundsdottir and colleagues looked at data on a mother-child cohort from the prospective population-based PreventADALL study, which was designed to study prevention of atopic dermatitis and allergies in children in Norway and Sweden.

A total of 814 infants (49% female) had available measures of tidal flow volume in the awake state at 3 months, as well as mother-reported data on physical activity at 18 weeks of pregnancy.

The investigators categorized the mothers as inactive, with either no or only low-intensity physical activity, “fairly” active, or “very” active based on self reporting.

The average tPTEF/tE value among all infants in the study was 0.391. The average value for 290 infants born to inactive mothers was 0.387, compared with 0.394 for 299 infants born to very active mothers, a difference that was not statistically significant.

Maternal physical activity level was not significantly associated with continuous tPTEF/tE, but the investigators did find that the offspring of inactive mothers were significantly more likely than the children of fairly or very active mothers to have a tPTEF/tE below 0.25 in both univariate analysis (odds ratio, 2.15; P = .011), and in multivariate analysis controlling for maternal age, education, parity, prepregnancy body-mass index, parental atopy, and in-utero exposure to nicotine (OR, 2.18; P = .013).

In univariate but not multivariate analysis, children of inactive mothers were significantly more likely than infants of more active mothers to have tPTEF/tE values below the 50th percentile (OR, 1.35; P = .042).

“We observed a trend that adds to the importance of advising women of childbearing age and pregnant women about physical activity. However, there may be factors that affect both maternal physical activity and lung function in offspring that we have not accounted for and could affect the results, so more research is needed,” Dr. Gudmundsdottir said in a statement.

Dr. Grigg pointed out that “it’s also worth keeping in mind that the single most important thing that mothers can do for their own health and that of their baby is to ensure that they do not smoke or use other tobacco products before, during, and after pregnancy. A smoke-free home has the biggest impact on lung function and health in childhood and later life.”

The study was supported by the University of Oslo. Dr. Gudmundsdottir and Dr. Grigg have disclosed no relevant financial relationships.

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

Lung function in early infancy may be influenced by the mother’s level of physical activity during pregnancy, results of a study from Sweden suggest.

Low-lung function at 3 months of age, as measured by the ratio of time to peak tidal expiratory flow to expiratory time (tPTEF/tE), was more frequent among children whose mothers were physically inactive during the first half of pregnancy compared with those who exercised either moderately or strenuously, reported Hrefna Katrin Gudmundsdottir, MD, a pediatrician and PhD candidate at the University of Oslo, Norway. The results were based on a prospective observational study of 841 mother-child pairs.

“The potential link between maternal inactivity and low lung function in infancy adds to the importance of advising pregnant women and women of childbearing age on physical activity,” she said in an oral abstract presented during the virtual European Respiratory Society (ERS) International Congress.

Jonathan Grigg, MD, professor of pediatric respiratory and environmental medicine at Queen Mary University of London, who was not involved in the study, commented that it “offers a fascinating hint that increased physical activity of mothers is associated with better lung function in their babies and, therefore, possibly their health in later life. More research is needed to confirm this link, but it is important that women feel supported by their health care providers to be active in a way that is comfortable and accessible to them.”

Impaired lung function in infancy is associated with wheezing and asthma in childhood, and lower lung function later in life, Dr. Gudmundsdottir said. She also noted that impaired lung function begins in utero and is related to fetal and infant size, family history of asthma, and/or maternal smoking.

Physical activity during pregnancy has been demonstrated to reduce the risk of preterm birth and cesarean birth and of children being born either abnormally small or abnormally large for their gestational age, she explained.

To see where physical inactivity in the first half of pregnancy is associated with lower lung function in otherwise healthy 3-month old infants, Dr. Gudmundsdottir and colleagues looked at data on a mother-child cohort from the prospective population-based PreventADALL study, which was designed to study prevention of atopic dermatitis and allergies in children in Norway and Sweden.

A total of 814 infants (49% female) had available measures of tidal flow volume in the awake state at 3 months, as well as mother-reported data on physical activity at 18 weeks of pregnancy.

The investigators categorized the mothers as inactive, with either no or only low-intensity physical activity, “fairly” active, or “very” active based on self reporting.

The average tPTEF/tE value among all infants in the study was 0.391. The average value for 290 infants born to inactive mothers was 0.387, compared with 0.394 for 299 infants born to very active mothers, a difference that was not statistically significant.

Maternal physical activity level was not significantly associated with continuous tPTEF/tE, but the investigators did find that the offspring of inactive mothers were significantly more likely than the children of fairly or very active mothers to have a tPTEF/tE below 0.25 in both univariate analysis (odds ratio, 2.15; P = .011), and in multivariate analysis controlling for maternal age, education, parity, prepregnancy body-mass index, parental atopy, and in-utero exposure to nicotine (OR, 2.18; P = .013).

In univariate but not multivariate analysis, children of inactive mothers were significantly more likely than infants of more active mothers to have tPTEF/tE values below the 50th percentile (OR, 1.35; P = .042).

“We observed a trend that adds to the importance of advising women of childbearing age and pregnant women about physical activity. However, there may be factors that affect both maternal physical activity and lung function in offspring that we have not accounted for and could affect the results, so more research is needed,” Dr. Gudmundsdottir said in a statement.

Dr. Grigg pointed out that “it’s also worth keeping in mind that the single most important thing that mothers can do for their own health and that of their baby is to ensure that they do not smoke or use other tobacco products before, during, and after pregnancy. A smoke-free home has the biggest impact on lung function and health in childhood and later life.”

The study was supported by the University of Oslo. Dr. Gudmundsdottir and Dr. Grigg have disclosed no relevant financial relationships.

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

Lung function in early infancy may be influenced by the mother’s level of physical activity during pregnancy, results of a study from Sweden suggest.

Low-lung function at 3 months of age, as measured by the ratio of time to peak tidal expiratory flow to expiratory time (tPTEF/tE), was more frequent among children whose mothers were physically inactive during the first half of pregnancy compared with those who exercised either moderately or strenuously, reported Hrefna Katrin Gudmundsdottir, MD, a pediatrician and PhD candidate at the University of Oslo, Norway. The results were based on a prospective observational study of 841 mother-child pairs.

“The potential link between maternal inactivity and low lung function in infancy adds to the importance of advising pregnant women and women of childbearing age on physical activity,” she said in an oral abstract presented during the virtual European Respiratory Society (ERS) International Congress.

Jonathan Grigg, MD, professor of pediatric respiratory and environmental medicine at Queen Mary University of London, who was not involved in the study, commented that it “offers a fascinating hint that increased physical activity of mothers is associated with better lung function in their babies and, therefore, possibly their health in later life. More research is needed to confirm this link, but it is important that women feel supported by their health care providers to be active in a way that is comfortable and accessible to them.”

Impaired lung function in infancy is associated with wheezing and asthma in childhood, and lower lung function later in life, Dr. Gudmundsdottir said. She also noted that impaired lung function begins in utero and is related to fetal and infant size, family history of asthma, and/or maternal smoking.

Physical activity during pregnancy has been demonstrated to reduce the risk of preterm birth and cesarean birth and of children being born either abnormally small or abnormally large for their gestational age, she explained.

To see where physical inactivity in the first half of pregnancy is associated with lower lung function in otherwise healthy 3-month old infants, Dr. Gudmundsdottir and colleagues looked at data on a mother-child cohort from the prospective population-based PreventADALL study, which was designed to study prevention of atopic dermatitis and allergies in children in Norway and Sweden.

A total of 814 infants (49% female) had available measures of tidal flow volume in the awake state at 3 months, as well as mother-reported data on physical activity at 18 weeks of pregnancy.

The investigators categorized the mothers as inactive, with either no or only low-intensity physical activity, “fairly” active, or “very” active based on self reporting.

The average tPTEF/tE value among all infants in the study was 0.391. The average value for 290 infants born to inactive mothers was 0.387, compared with 0.394 for 299 infants born to very active mothers, a difference that was not statistically significant.

Maternal physical activity level was not significantly associated with continuous tPTEF/tE, but the investigators did find that the offspring of inactive mothers were significantly more likely than the children of fairly or very active mothers to have a tPTEF/tE below 0.25 in both univariate analysis (odds ratio, 2.15; P = .011), and in multivariate analysis controlling for maternal age, education, parity, prepregnancy body-mass index, parental atopy, and in-utero exposure to nicotine (OR, 2.18; P = .013).

In univariate but not multivariate analysis, children of inactive mothers were significantly more likely than infants of more active mothers to have tPTEF/tE values below the 50th percentile (OR, 1.35; P = .042).

“We observed a trend that adds to the importance of advising women of childbearing age and pregnant women about physical activity. However, there may be factors that affect both maternal physical activity and lung function in offspring that we have not accounted for and could affect the results, so more research is needed,” Dr. Gudmundsdottir said in a statement.

Dr. Grigg pointed out that “it’s also worth keeping in mind that the single most important thing that mothers can do for their own health and that of their baby is to ensure that they do not smoke or use other tobacco products before, during, and after pregnancy. A smoke-free home has the biggest impact on lung function and health in childhood and later life.”

The study was supported by the University of Oslo. Dr. Gudmundsdottir and Dr. Grigg have disclosed no relevant financial relationships.

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