Federal Practitioner

The Food and Drug Administration has approved dexmedetomidine (Igalmi, BioXcel Therapeutics) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

This is the first FDA-approved, orally dissolving, self-administered sublingual treatment for this indication. With a demonstrated onset of action as early as 20 minutes, it shows a high response rate in patients at both 120-mcg and 180-mcg doses.

Olivier Le Moal/Getty Images

An estimated 7.3 million individuals in the United States are diagnosed with schizophrenia or bipolar disorders, and up to one-quarter of them experience episodes of agitation that can occur 10-17 times annually. These episodes represent a significant burden for patients, caregivers, and the health care system.

“There are large numbers of patients who experience agitation associated with schizophrenia and bipolar disorders, and this condition has been a long-standing challenge for health care professionals to treat,” said John Krystal, MD, the Robert L. McNeil Jr. Professor of Translational Research and chair of the department of psychiatry at Yale University, New Haven, Conn.

“The approval of Igalmi, a self-administered film with a desirable onset of action, represents a milestone moment. It provides health care teams with an innovative tool to help control agitation. As clinicians, we welcome this much-needed new oral treatment option,” he added.

“Igalmi is the first new acute treatment for schizophrenia or bipolar disorder–associated agitation in nearly a decade and represents a differentiated approach to helping patients manage this difficult and debilitating symptom,” said Vimal Mehta, PhD, CEO of BioXcel Therapeutics.

The FDA approval of Igalmi is based on data from two pivotal randomized, double-blinded, placebo-controlled, parallel-group, phase 3 trials that evaluated Igalmi for the acute treatment of agitation associated with schizophrenia (SERENITY I) or bipolar I or II disorder (SERENITY II).

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension. All adverse drug reactions were mild to moderate in severity. While Igalmi was not associated with any treatment-related serious adverse effects in phase 3 studies, it may cause notable side effects, including hypotension, orthostatic hypotension, bradycardia, QT interval prolongation, and somnolence.

As previously reported by this news organization, data from the phase 3 SERENITY II trial that evaluated Igalmi in bipolar disorders were published in JAMA.

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

The Food and Drug Administration has approved dexmedetomidine (Igalmi, BioXcel Therapeutics) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

This is the first FDA-approved, orally dissolving, self-administered sublingual treatment for this indication. With a demonstrated onset of action as early as 20 minutes, it shows a high response rate in patients at both 120-mcg and 180-mcg doses.

Olivier Le Moal/Getty Images

An estimated 7.3 million individuals in the United States are diagnosed with schizophrenia or bipolar disorders, and up to one-quarter of them experience episodes of agitation that can occur 10-17 times annually. These episodes represent a significant burden for patients, caregivers, and the health care system.

“There are large numbers of patients who experience agitation associated with schizophrenia and bipolar disorders, and this condition has been a long-standing challenge for health care professionals to treat,” said John Krystal, MD, the Robert L. McNeil Jr. Professor of Translational Research and chair of the department of psychiatry at Yale University, New Haven, Conn.

“The approval of Igalmi, a self-administered film with a desirable onset of action, represents a milestone moment. It provides health care teams with an innovative tool to help control agitation. As clinicians, we welcome this much-needed new oral treatment option,” he added.

“Igalmi is the first new acute treatment for schizophrenia or bipolar disorder–associated agitation in nearly a decade and represents a differentiated approach to helping patients manage this difficult and debilitating symptom,” said Vimal Mehta, PhD, CEO of BioXcel Therapeutics.

The FDA approval of Igalmi is based on data from two pivotal randomized, double-blinded, placebo-controlled, parallel-group, phase 3 trials that evaluated Igalmi for the acute treatment of agitation associated with schizophrenia (SERENITY I) or bipolar I or II disorder (SERENITY II).

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension. All adverse drug reactions were mild to moderate in severity. While Igalmi was not associated with any treatment-related serious adverse effects in phase 3 studies, it may cause notable side effects, including hypotension, orthostatic hypotension, bradycardia, QT interval prolongation, and somnolence.

As previously reported by this news organization, data from the phase 3 SERENITY II trial that evaluated Igalmi in bipolar disorders were published in JAMA.

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

The Food and Drug Administration has approved dexmedetomidine (Igalmi, BioXcel Therapeutics) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

This is the first FDA-approved, orally dissolving, self-administered sublingual treatment for this indication. With a demonstrated onset of action as early as 20 minutes, it shows a high response rate in patients at both 120-mcg and 180-mcg doses.

Olivier Le Moal/Getty Images

An estimated 7.3 million individuals in the United States are diagnosed with schizophrenia or bipolar disorders, and up to one-quarter of them experience episodes of agitation that can occur 10-17 times annually. These episodes represent a significant burden for patients, caregivers, and the health care system.

“There are large numbers of patients who experience agitation associated with schizophrenia and bipolar disorders, and this condition has been a long-standing challenge for health care professionals to treat,” said John Krystal, MD, the Robert L. McNeil Jr. Professor of Translational Research and chair of the department of psychiatry at Yale University, New Haven, Conn.

“The approval of Igalmi, a self-administered film with a desirable onset of action, represents a milestone moment. It provides health care teams with an innovative tool to help control agitation. As clinicians, we welcome this much-needed new oral treatment option,” he added.

“Igalmi is the first new acute treatment for schizophrenia or bipolar disorder–associated agitation in nearly a decade and represents a differentiated approach to helping patients manage this difficult and debilitating symptom,” said Vimal Mehta, PhD, CEO of BioXcel Therapeutics.

The FDA approval of Igalmi is based on data from two pivotal randomized, double-blinded, placebo-controlled, parallel-group, phase 3 trials that evaluated Igalmi for the acute treatment of agitation associated with schizophrenia (SERENITY I) or bipolar I or II disorder (SERENITY II).

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension. All adverse drug reactions were mild to moderate in severity. While Igalmi was not associated with any treatment-related serious adverse effects in phase 3 studies, it may cause notable side effects, including hypotension, orthostatic hypotension, bradycardia, QT interval prolongation, and somnolence.

As previously reported by this news organization, data from the phase 3 SERENITY II trial that evaluated Igalmi in bipolar disorders were published in JAMA.

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

Though overall COVID-19 case counts continue to drop nationally, that’s not the story in every U.S. state.

About half the states have reported increases in COVID cases fueled by the Omicron subvariant, Axios reported. Alaska, Vermont, and Rhode Island had the highest increases, with more than 20 new cases per 100,000 people.

Nationally, the statistics are encouraging, with the 7-day average of daily cases around 26,000 on April 6, down from around 41,000 on March 6, according to the Centers for Disease Control and Prevention. The number of deaths has dropped to an average of around 600 a day, down 34% from 2 weeks ago.

National health officials have said some spots would have a lot of COVID cases.

“Looking across the country, we see that 95% of counties are reporting low COVID-19 community levels, which represent over 97% of the U.S. population,” CDC Director Rochelle Walensky, MD, said April 5 at a White House news briefing.

“If we look more closely at the local level, we find a handful of counties where we are seeing increases in both cases and markers of more severe disease, like hospitalizations and in-patient bed capacity, which have resulted in an increased COVID-19 community level in some areas.”

Meanwhile, the Commonwealth Fund issued a report April 8 saying the U.S. vaccine program had prevented an estimated 2.2 million deaths and 17 million hospitalizations.

If the vaccine program didn’t exist, the United States would have had another 66 million COVID infections and spent about $900 billion more on health care, the foundation said.

The United States has reported about 982,000 COVID-related deaths so far with about 80 million COVID cases, according to the CDC.

“Our findings highlight the profound and ongoing impact of the vaccination program in reducing infections, hospitalizations, and deaths,” the Commonwealth Fund said.

“Investing in vaccination programs also has produced substantial cost savings – approximately the size of one-fifth of annual national health expenditures – by dramatically reducing the amount spent on COVID-19 hospitalizations.”

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

Though overall COVID-19 case counts continue to drop nationally, that’s not the story in every U.S. state.

About half the states have reported increases in COVID cases fueled by the Omicron subvariant, Axios reported. Alaska, Vermont, and Rhode Island had the highest increases, with more than 20 new cases per 100,000 people.

Nationally, the statistics are encouraging, with the 7-day average of daily cases around 26,000 on April 6, down from around 41,000 on March 6, according to the Centers for Disease Control and Prevention. The number of deaths has dropped to an average of around 600 a day, down 34% from 2 weeks ago.

National health officials have said some spots would have a lot of COVID cases.

“Looking across the country, we see that 95% of counties are reporting low COVID-19 community levels, which represent over 97% of the U.S. population,” CDC Director Rochelle Walensky, MD, said April 5 at a White House news briefing.

“If we look more closely at the local level, we find a handful of counties where we are seeing increases in both cases and markers of more severe disease, like hospitalizations and in-patient bed capacity, which have resulted in an increased COVID-19 community level in some areas.”

Meanwhile, the Commonwealth Fund issued a report April 8 saying the U.S. vaccine program had prevented an estimated 2.2 million deaths and 17 million hospitalizations.

If the vaccine program didn’t exist, the United States would have had another 66 million COVID infections and spent about $900 billion more on health care, the foundation said.

The United States has reported about 982,000 COVID-related deaths so far with about 80 million COVID cases, according to the CDC.

“Our findings highlight the profound and ongoing impact of the vaccination program in reducing infections, hospitalizations, and deaths,” the Commonwealth Fund said.

“Investing in vaccination programs also has produced substantial cost savings – approximately the size of one-fifth of annual national health expenditures – by dramatically reducing the amount spent on COVID-19 hospitalizations.”

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

Though overall COVID-19 case counts continue to drop nationally, that’s not the story in every U.S. state.

About half the states have reported increases in COVID cases fueled by the Omicron subvariant, Axios reported. Alaska, Vermont, and Rhode Island had the highest increases, with more than 20 new cases per 100,000 people.

Nationally, the statistics are encouraging, with the 7-day average of daily cases around 26,000 on April 6, down from around 41,000 on March 6, according to the Centers for Disease Control and Prevention. The number of deaths has dropped to an average of around 600 a day, down 34% from 2 weeks ago.

National health officials have said some spots would have a lot of COVID cases.

“Looking across the country, we see that 95% of counties are reporting low COVID-19 community levels, which represent over 97% of the U.S. population,” CDC Director Rochelle Walensky, MD, said April 5 at a White House news briefing.

“If we look more closely at the local level, we find a handful of counties where we are seeing increases in both cases and markers of more severe disease, like hospitalizations and in-patient bed capacity, which have resulted in an increased COVID-19 community level in some areas.”

Meanwhile, the Commonwealth Fund issued a report April 8 saying the U.S. vaccine program had prevented an estimated 2.2 million deaths and 17 million hospitalizations.

If the vaccine program didn’t exist, the United States would have had another 66 million COVID infections and spent about $900 billion more on health care, the foundation said.

The United States has reported about 982,000 COVID-related deaths so far with about 80 million COVID cases, according to the CDC.

“Our findings highlight the profound and ongoing impact of the vaccination program in reducing infections, hospitalizations, and deaths,” the Commonwealth Fund said.

“Investing in vaccination programs also has produced substantial cost savings – approximately the size of one-fifth of annual national health expenditures – by dramatically reducing the amount spent on COVID-19 hospitalizations.”

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

BOSTON – Among dermatology residents and attending dermatologists, rates of diagnostic accuracy and appropriate biopsy recommendations were significantly lower for patients with skin of color, compared with White patients, new research shows.

“Our findings suggest diagnostic biases based on skin color exist in dermatology practice,” lead author Loren Krueger, MD, assistant professor in the department of dermatology, Emory University School of Medicine, Atlanta, said at the Annual Skin of Color Society Scientific Symposium. “A lower likelihood of biopsy of malignancy in darker skin types could contribute to disparities in cutaneous malignancies,” she added.

Dr. Loren Krueger

The findings underscore that “for skin of color patients, you’re more likely to have a benign neoplasm biopsied, you’re less likely to have a malignant neoplasm biopsied, and more often, your etiology may be missed,” Dr. Krueger said at the meeting.

Of note, while 45% of respondents were dermatology residents or fellows, 20.4% had 1-5 years of experience, and about 28% had 10 to more than 25 years of experience.

And while 75% of the dermatology residents, fellows, and attendings were White, there was no difference in the probability of correctly identifying the underlying etiology in dark or light skin types based on the provider’s self-identified race.

Importantly, the patterns in the study of diagnostic discrepancies are reflected in broader dermatologic outcomes. The 5-year melanoma survival rate is 74.1% among Black patients and 92.9% among White patients. Dr. Krueger referred to data showing that only 52.6% of Black patients have stage I melanoma at diagnosis, whereas among White patients, the rate is much higher, at 75.9%.

“We know skin malignancy can be more aggressive and late-stage in skin of color populations, leading to increased morbidity and later stage at initial diagnosis,” Dr. Krueger told this news organization. “We routinely attribute this to limited access to care and lack of awareness on skin malignancy. However, we have no evidence on how we, as dermatologists, may be playing a role.”

Furthermore, the decision to perform biopsy or not can affect the size and stage at diagnosis of a cutaneous malignancy, she noted.

Key changes needed to prevent the disparities – and their implications – should start at the training level, she emphasized. “I would love to see increased photo representation in training materials – this is a great place to start,” Dr. Krueger said.

In addition, “encouraging medical students, residents, and dermatologists to learn from skin of color experts is vital,” she said. “We should also provide hands-on experience and training with diverse patient populations.”

The first step to addressing biases “is to acknowledge they exist,” Dr. Krueger added. “I am hopeful this inspires others to continue to investigate these biases, as well as how we can eliminate them.”

The study was funded by the Rudin Resident Research Award. The authors have disclosed no relevant financial relationships.

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

BOSTON – Among dermatology residents and attending dermatologists, rates of diagnostic accuracy and appropriate biopsy recommendations were significantly lower for patients with skin of color, compared with White patients, new research shows.

“Our findings suggest diagnostic biases based on skin color exist in dermatology practice,” lead author Loren Krueger, MD, assistant professor in the department of dermatology, Emory University School of Medicine, Atlanta, said at the Annual Skin of Color Society Scientific Symposium. “A lower likelihood of biopsy of malignancy in darker skin types could contribute to disparities in cutaneous malignancies,” she added.

Dr. Loren Krueger

The findings underscore that “for skin of color patients, you’re more likely to have a benign neoplasm biopsied, you’re less likely to have a malignant neoplasm biopsied, and more often, your etiology may be missed,” Dr. Krueger said at the meeting.

Of note, while 45% of respondents were dermatology residents or fellows, 20.4% had 1-5 years of experience, and about 28% had 10 to more than 25 years of experience.

And while 75% of the dermatology residents, fellows, and attendings were White, there was no difference in the probability of correctly identifying the underlying etiology in dark or light skin types based on the provider’s self-identified race.

Importantly, the patterns in the study of diagnostic discrepancies are reflected in broader dermatologic outcomes. The 5-year melanoma survival rate is 74.1% among Black patients and 92.9% among White patients. Dr. Krueger referred to data showing that only 52.6% of Black patients have stage I melanoma at diagnosis, whereas among White patients, the rate is much higher, at 75.9%.

“We know skin malignancy can be more aggressive and late-stage in skin of color populations, leading to increased morbidity and later stage at initial diagnosis,” Dr. Krueger told this news organization. “We routinely attribute this to limited access to care and lack of awareness on skin malignancy. However, we have no evidence on how we, as dermatologists, may be playing a role.”

Furthermore, the decision to perform biopsy or not can affect the size and stage at diagnosis of a cutaneous malignancy, she noted.

Key changes needed to prevent the disparities – and their implications – should start at the training level, she emphasized. “I would love to see increased photo representation in training materials – this is a great place to start,” Dr. Krueger said.

In addition, “encouraging medical students, residents, and dermatologists to learn from skin of color experts is vital,” she said. “We should also provide hands-on experience and training with diverse patient populations.”

The first step to addressing biases “is to acknowledge they exist,” Dr. Krueger added. “I am hopeful this inspires others to continue to investigate these biases, as well as how we can eliminate them.”

The study was funded by the Rudin Resident Research Award. The authors have disclosed no relevant financial relationships.

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

BOSTON – Among dermatology residents and attending dermatologists, rates of diagnostic accuracy and appropriate biopsy recommendations were significantly lower for patients with skin of color, compared with White patients, new research shows.

“Our findings suggest diagnostic biases based on skin color exist in dermatology practice,” lead author Loren Krueger, MD, assistant professor in the department of dermatology, Emory University School of Medicine, Atlanta, said at the Annual Skin of Color Society Scientific Symposium. “A lower likelihood of biopsy of malignancy in darker skin types could contribute to disparities in cutaneous malignancies,” she added.

Dr. Loren Krueger

The findings underscore that “for skin of color patients, you’re more likely to have a benign neoplasm biopsied, you’re less likely to have a malignant neoplasm biopsied, and more often, your etiology may be missed,” Dr. Krueger said at the meeting.

Of note, while 45% of respondents were dermatology residents or fellows, 20.4% had 1-5 years of experience, and about 28% had 10 to more than 25 years of experience.

And while 75% of the dermatology residents, fellows, and attendings were White, there was no difference in the probability of correctly identifying the underlying etiology in dark or light skin types based on the provider’s self-identified race.

Importantly, the patterns in the study of diagnostic discrepancies are reflected in broader dermatologic outcomes. The 5-year melanoma survival rate is 74.1% among Black patients and 92.9% among White patients. Dr. Krueger referred to data showing that only 52.6% of Black patients have stage I melanoma at diagnosis, whereas among White patients, the rate is much higher, at 75.9%.

“We know skin malignancy can be more aggressive and late-stage in skin of color populations, leading to increased morbidity and later stage at initial diagnosis,” Dr. Krueger told this news organization. “We routinely attribute this to limited access to care and lack of awareness on skin malignancy. However, we have no evidence on how we, as dermatologists, may be playing a role.”

Furthermore, the decision to perform biopsy or not can affect the size and stage at diagnosis of a cutaneous malignancy, she noted.

Key changes needed to prevent the disparities – and their implications – should start at the training level, she emphasized. “I would love to see increased photo representation in training materials – this is a great place to start,” Dr. Krueger said.

In addition, “encouraging medical students, residents, and dermatologists to learn from skin of color experts is vital,” she said. “We should also provide hands-on experience and training with diverse patient populations.”

The first step to addressing biases “is to acknowledge they exist,” Dr. Krueger added. “I am hopeful this inspires others to continue to investigate these biases, as well as how we can eliminate them.”

The study was funded by the Rudin Resident Research Award. The authors have disclosed no relevant financial relationships.

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

In recent years, patients with advanced lung cancer have benefited from the advent of immune therapies and genotype-directed therapies –both of which have led to improved survival rates. But what will lung cancer look like in 2030?

Pasi A. Janne, MD, PhD, of the Dana-Farber Cancer Institute, Boston, hopes to see improved access to tumor and blood-based genotyping.

Dr. Janne, who serves as director of the Lowe Center for Thoracic Oncology at Dana-Farber, gave a keynote presentation at the 2022 European Lung Cancer Congress, where he highlighted the need to broaden the scope of targeted therapies, make “great drugs work even better,” improve the ability to treat patients based on risk level, and expand the use of targeted therapies in the adjuvant and neoadjuvant setting to make significant progress in the treatment lung cancer treatment in coming years.

Genotyping is underutilized, he said. A 2019 multicenter study reported at the annual meeting of the American Society of Clinical Oncology showed that only 54% of 1,203 patients underwent testing for EGFR mutations, 22% were tested for EGFR, ALK, ROS1, and BRAF mutations, and only 7% were tested for all biomarkers recommended by National Comprehensive Cancer Network guidelines at the time.

That study also showed that only 45% of patients received biomarker-driven treatment, even when driver mutations were detected.

“Immunotherapy was often prescribed instead of targeted therapy, even when molecular results were available,” Dr. Janne said.

Another study, reported at the 2021 ASCO annual meeting, showed some improvement in testing rates, but still, only 37% of patients were tested for all biomarkers as recommended.

Racial disparities in testing have also been observed. Bruno and colleagues found that any next-generation sequencing was performed in 50.1% of White patients, compared with 39.8% of black patients, and NGS prior to first-line therapy was performed in 35.5% and 25.8%, respectively.

The study, also reported at ASCO in 2021, showed that trial participation was observed among 3.9% of White patients and 1.9% of Black patients.

“The studies really highlight the need for increased testing rates and appropriate utilization of testing results to deliver optimal care to our patients with advanced lung cancer. We have a long way to go. To live the promise and appreciate the promise of precision therapy ... we need to be able to offer this testing to all of our patients with lung cancer,” he said.

Dr. Janne reported relationships with numerous pharmaceutical companies, including consulting, research support and stock ownership. He also receives postmarketing royalties from Dana-Farber Cancer Institute–owned intellectual property on EGFR mutations.

In recent years, patients with advanced lung cancer have benefited from the advent of immune therapies and genotype-directed therapies –both of which have led to improved survival rates. But what will lung cancer look like in 2030?

Pasi A. Janne, MD, PhD, of the Dana-Farber Cancer Institute, Boston, hopes to see improved access to tumor and blood-based genotyping.

Dr. Janne, who serves as director of the Lowe Center for Thoracic Oncology at Dana-Farber, gave a keynote presentation at the 2022 European Lung Cancer Congress, where he highlighted the need to broaden the scope of targeted therapies, make “great drugs work even better,” improve the ability to treat patients based on risk level, and expand the use of targeted therapies in the adjuvant and neoadjuvant setting to make significant progress in the treatment lung cancer treatment in coming years.

Genotyping is underutilized, he said. A 2019 multicenter study reported at the annual meeting of the American Society of Clinical Oncology showed that only 54% of 1,203 patients underwent testing for EGFR mutations, 22% were tested for EGFR, ALK, ROS1, and BRAF mutations, and only 7% were tested for all biomarkers recommended by National Comprehensive Cancer Network guidelines at the time.

That study also showed that only 45% of patients received biomarker-driven treatment, even when driver mutations were detected.

“Immunotherapy was often prescribed instead of targeted therapy, even when molecular results were available,” Dr. Janne said.

Another study, reported at the 2021 ASCO annual meeting, showed some improvement in testing rates, but still, only 37% of patients were tested for all biomarkers as recommended.

Racial disparities in testing have also been observed. Bruno and colleagues found that any next-generation sequencing was performed in 50.1% of White patients, compared with 39.8% of black patients, and NGS prior to first-line therapy was performed in 35.5% and 25.8%, respectively.

The study, also reported at ASCO in 2021, showed that trial participation was observed among 3.9% of White patients and 1.9% of Black patients.

“The studies really highlight the need for increased testing rates and appropriate utilization of testing results to deliver optimal care to our patients with advanced lung cancer. We have a long way to go. To live the promise and appreciate the promise of precision therapy ... we need to be able to offer this testing to all of our patients with lung cancer,” he said.

Dr. Janne reported relationships with numerous pharmaceutical companies, including consulting, research support and stock ownership. He also receives postmarketing royalties from Dana-Farber Cancer Institute–owned intellectual property on EGFR mutations.

In recent years, patients with advanced lung cancer have benefited from the advent of immune therapies and genotype-directed therapies –both of which have led to improved survival rates. But what will lung cancer look like in 2030?

Pasi A. Janne, MD, PhD, of the Dana-Farber Cancer Institute, Boston, hopes to see improved access to tumor and blood-based genotyping.

Dr. Janne, who serves as director of the Lowe Center for Thoracic Oncology at Dana-Farber, gave a keynote presentation at the 2022 European Lung Cancer Congress, where he highlighted the need to broaden the scope of targeted therapies, make “great drugs work even better,” improve the ability to treat patients based on risk level, and expand the use of targeted therapies in the adjuvant and neoadjuvant setting to make significant progress in the treatment lung cancer treatment in coming years.

Genotyping is underutilized, he said. A 2019 multicenter study reported at the annual meeting of the American Society of Clinical Oncology showed that only 54% of 1,203 patients underwent testing for EGFR mutations, 22% were tested for EGFR, ALK, ROS1, and BRAF mutations, and only 7% were tested for all biomarkers recommended by National Comprehensive Cancer Network guidelines at the time.

That study also showed that only 45% of patients received biomarker-driven treatment, even when driver mutations were detected.

“Immunotherapy was often prescribed instead of targeted therapy, even when molecular results were available,” Dr. Janne said.

Another study, reported at the 2021 ASCO annual meeting, showed some improvement in testing rates, but still, only 37% of patients were tested for all biomarkers as recommended.

Racial disparities in testing have also been observed. Bruno and colleagues found that any next-generation sequencing was performed in 50.1% of White patients, compared with 39.8% of black patients, and NGS prior to first-line therapy was performed in 35.5% and 25.8%, respectively.

The study, also reported at ASCO in 2021, showed that trial participation was observed among 3.9% of White patients and 1.9% of Black patients.

“The studies really highlight the need for increased testing rates and appropriate utilization of testing results to deliver optimal care to our patients with advanced lung cancer. We have a long way to go. To live the promise and appreciate the promise of precision therapy ... we need to be able to offer this testing to all of our patients with lung cancer,” he said.

Dr. Janne reported relationships with numerous pharmaceutical companies, including consulting, research support and stock ownership. He also receives postmarketing royalties from Dana-Farber Cancer Institute–owned intellectual property on EGFR mutations.

Pathological response has emerged as a valuable endpoint and surrogate marker for overall survival in lung cancer studies, but much work remains to be done, said William D. Travis, MD, director of thoracic pathology at Memorial Sloan Kettering Cancer Center, New York.

In a keynote address at the 2022 European Lung Cancer Conference, Dr. Travis highlighted advances in the use of pathological response in this setting and outlined areas that need refinement. “Pathologic response after preoperative therapy is important because the extent of pathologic response strongly correlates with improved overall survival, and it is reflective of neoadjuvant therapy. The degree of response is associated with the degree of benefit in survival, and it’s being used as a surrogate for survival in phase 2 and 3 neoadjuvant clinical trials.”

In fact, multiple studies have demonstrated that non–small cell lung cancer patients with 10% or less viable residual tumor after treatment have improved overall survival and disease-free survival, compared with patients who have more residual tumor, he explained.

Recent studies have demonstrated the value of pathological response as an endpoint in the neoadjuvant therapy and molecular targeted therapy setting, he said, citing a study published in the Journal of Clinical Oncology that showed major pathological response rates of 14%-45% and pathological complete response rates up to 29% in patients treated with single-agent checkpoint inhibition.

In the CheckMate 816 trial, both major pathologic response and pathological complete response were significantly higher in patients treated with combination nivolumab and chemotherapy, compared with those treated with chemotherapy alone (37% vs. 8.9% and 24% vs. 2%, respectively).

“This high rate of responses with combined immunotherapy and chemotherapy is quite exciting,” he said.

Dr. Travis also stressed the importance of consulting the current International Association for the Study of Lung Cancer Recommendations for Pathologic Assessment of Lung Cancer Resection Specimens After Neoadjuvant Therapy.

He highlighted several key points regarding pathological response in lung cancer:

• Major pathological response (MPR) is calculated as the estimated size of viable tumor divided by the size of the tumor bed.
• Optimal cutoffs for determining MPR is currently 10%, but recent data suggest that in the conventional chemotherapy setting this may vary by tumor histology, with much higher cutoffs of about 65% for adenocarcinoma.
• Estimating the amount of viable tumor is “quite complicated and requires quite a number of steps,” and one the most important steps is “for the surgeon to the pathologist know that given specimen is from a patient who received neoadjuvant therapy.”
• Determining the border of the tumor bed can be challenging, therefore “resection specimens after neoadjuvant therapy should be sampled to optimize comprehensive gross and histologic assessment of the lung tumor bed for pathologic response ... as outlined in the guidelines.”
• The IASLC panel determined that having a single approach for estimating treatment effect would be best, despite the different therapy types and combinations used, but “it is recognized that there may be certain types of features that need to be addressed,” such as immune cell infiltrates in pats who received immunotherapy.
• The recommendations provide specific guidance for measuring tumor size for staging, including for special circumstances.

As for future direction, Dr. Travis said, “one question is how to assess treatment effect in lymph node samples.

“This is done for lymph nodes in breast cancer but not in lung cancer. We need system[s] for lung cancer.”

Good “infrastructure for pathology departments” is needed to support clinical trials, he said, noting that the team at Memorial Sloan Kettering Cancer Center includes physician assistants, tissue procurement staff, frozen section techs, research fellows, and research assistants.

Future work should also aim to standardize pathology assessment for clinical trials, improve the current recommendations, make use of new technology like artificial intelligence, optimize banking protocols and special techniques, and identify radiologic-pathological correlations, he said.

He added that “IASLC is promoting the design and implementation of an international database to collect uniformly clinical and pathologic information with the ultimate goal of fostering collaboration and to facilitate the identification of surrogate endpoints of long-term survival.”

Dr. Travis is a nonpaid pathology consultant for the LCMC3 and LCMC4 trials.

Pathological response has emerged as a valuable endpoint and surrogate marker for overall survival in lung cancer studies, but much work remains to be done, said William D. Travis, MD, director of thoracic pathology at Memorial Sloan Kettering Cancer Center, New York.

In a keynote address at the 2022 European Lung Cancer Conference, Dr. Travis highlighted advances in the use of pathological response in this setting and outlined areas that need refinement. “Pathologic response after preoperative therapy is important because the extent of pathologic response strongly correlates with improved overall survival, and it is reflective of neoadjuvant therapy. The degree of response is associated with the degree of benefit in survival, and it’s being used as a surrogate for survival in phase 2 and 3 neoadjuvant clinical trials.”

In fact, multiple studies have demonstrated that non–small cell lung cancer patients with 10% or less viable residual tumor after treatment have improved overall survival and disease-free survival, compared with patients who have more residual tumor, he explained.

Recent studies have demonstrated the value of pathological response as an endpoint in the neoadjuvant therapy and molecular targeted therapy setting, he said, citing a study published in the Journal of Clinical Oncology that showed major pathological response rates of 14%-45% and pathological complete response rates up to 29% in patients treated with single-agent checkpoint inhibition.

In the CheckMate 816 trial, both major pathologic response and pathological complete response were significantly higher in patients treated with combination nivolumab and chemotherapy, compared with those treated with chemotherapy alone (37% vs. 8.9% and 24% vs. 2%, respectively).

“This high rate of responses with combined immunotherapy and chemotherapy is quite exciting,” he said.

Dr. Travis also stressed the importance of consulting the current International Association for the Study of Lung Cancer Recommendations for Pathologic Assessment of Lung Cancer Resection Specimens After Neoadjuvant Therapy.

He highlighted several key points regarding pathological response in lung cancer:

• Major pathological response (MPR) is calculated as the estimated size of viable tumor divided by the size of the tumor bed.
• Optimal cutoffs for determining MPR is currently 10%, but recent data suggest that in the conventional chemotherapy setting this may vary by tumor histology, with much higher cutoffs of about 65% for adenocarcinoma.
• Estimating the amount of viable tumor is “quite complicated and requires quite a number of steps,” and one the most important steps is “for the surgeon to the pathologist know that given specimen is from a patient who received neoadjuvant therapy.”
• Determining the border of the tumor bed can be challenging, therefore “resection specimens after neoadjuvant therapy should be sampled to optimize comprehensive gross and histologic assessment of the lung tumor bed for pathologic response ... as outlined in the guidelines.”
• The IASLC panel determined that having a single approach for estimating treatment effect would be best, despite the different therapy types and combinations used, but “it is recognized that there may be certain types of features that need to be addressed,” such as immune cell infiltrates in pats who received immunotherapy.
• The recommendations provide specific guidance for measuring tumor size for staging, including for special circumstances.

As for future direction, Dr. Travis said, “one question is how to assess treatment effect in lymph node samples.

“This is done for lymph nodes in breast cancer but not in lung cancer. We need system[s] for lung cancer.”

Good “infrastructure for pathology departments” is needed to support clinical trials, he said, noting that the team at Memorial Sloan Kettering Cancer Center includes physician assistants, tissue procurement staff, frozen section techs, research fellows, and research assistants.

Future work should also aim to standardize pathology assessment for clinical trials, improve the current recommendations, make use of new technology like artificial intelligence, optimize banking protocols and special techniques, and identify radiologic-pathological correlations, he said.

He added that “IASLC is promoting the design and implementation of an international database to collect uniformly clinical and pathologic information with the ultimate goal of fostering collaboration and to facilitate the identification of surrogate endpoints of long-term survival.”

Dr. Travis is a nonpaid pathology consultant for the LCMC3 and LCMC4 trials.

Pathological response has emerged as a valuable endpoint and surrogate marker for overall survival in lung cancer studies, but much work remains to be done, said William D. Travis, MD, director of thoracic pathology at Memorial Sloan Kettering Cancer Center, New York.

In a keynote address at the 2022 European Lung Cancer Conference, Dr. Travis highlighted advances in the use of pathological response in this setting and outlined areas that need refinement. “Pathologic response after preoperative therapy is important because the extent of pathologic response strongly correlates with improved overall survival, and it is reflective of neoadjuvant therapy. The degree of response is associated with the degree of benefit in survival, and it’s being used as a surrogate for survival in phase 2 and 3 neoadjuvant clinical trials.”

In fact, multiple studies have demonstrated that non–small cell lung cancer patients with 10% or less viable residual tumor after treatment have improved overall survival and disease-free survival, compared with patients who have more residual tumor, he explained.

Recent studies have demonstrated the value of pathological response as an endpoint in the neoadjuvant therapy and molecular targeted therapy setting, he said, citing a study published in the Journal of Clinical Oncology that showed major pathological response rates of 14%-45% and pathological complete response rates up to 29% in patients treated with single-agent checkpoint inhibition.

In the CheckMate 816 trial, both major pathologic response and pathological complete response were significantly higher in patients treated with combination nivolumab and chemotherapy, compared with those treated with chemotherapy alone (37% vs. 8.9% and 24% vs. 2%, respectively).

“This high rate of responses with combined immunotherapy and chemotherapy is quite exciting,” he said.

Dr. Travis also stressed the importance of consulting the current International Association for the Study of Lung Cancer Recommendations for Pathologic Assessment of Lung Cancer Resection Specimens After Neoadjuvant Therapy.

He highlighted several key points regarding pathological response in lung cancer:

• Major pathological response (MPR) is calculated as the estimated size of viable tumor divided by the size of the tumor bed.
• Optimal cutoffs for determining MPR is currently 10%, but recent data suggest that in the conventional chemotherapy setting this may vary by tumor histology, with much higher cutoffs of about 65% for adenocarcinoma.
• Estimating the amount of viable tumor is “quite complicated and requires quite a number of steps,” and one the most important steps is “for the surgeon to the pathologist know that given specimen is from a patient who received neoadjuvant therapy.”
• Determining the border of the tumor bed can be challenging, therefore “resection specimens after neoadjuvant therapy should be sampled to optimize comprehensive gross and histologic assessment of the lung tumor bed for pathologic response ... as outlined in the guidelines.”
• The IASLC panel determined that having a single approach for estimating treatment effect would be best, despite the different therapy types and combinations used, but “it is recognized that there may be certain types of features that need to be addressed,” such as immune cell infiltrates in pats who received immunotherapy.
• The recommendations provide specific guidance for measuring tumor size for staging, including for special circumstances.

As for future direction, Dr. Travis said, “one question is how to assess treatment effect in lymph node samples.

“This is done for lymph nodes in breast cancer but not in lung cancer. We need system[s] for lung cancer.”

Good “infrastructure for pathology departments” is needed to support clinical trials, he said, noting that the team at Memorial Sloan Kettering Cancer Center includes physician assistants, tissue procurement staff, frozen section techs, research fellows, and research assistants.

Future work should also aim to standardize pathology assessment for clinical trials, improve the current recommendations, make use of new technology like artificial intelligence, optimize banking protocols and special techniques, and identify radiologic-pathological correlations, he said.

He added that “IASLC is promoting the design and implementation of an international database to collect uniformly clinical and pathologic information with the ultimate goal of fostering collaboration and to facilitate the identification of surrogate endpoints of long-term survival.”

Dr. Travis is a nonpaid pathology consultant for the LCMC3 and LCMC4 trials.

Once again, strawberries and spinach, along with kale and collard and mustard greens, top this year’s “Dirty Dozen” list, an annual and controversial ranking of nonorganic fruits and vegetables based on the amount of pesticides found in samples of the foods.

The yearly report comes from the Environmental Working Group, a nonprofit organization dedicated to improving human health and the environment, and also includes a “Clean 15” list of produce.

An industry group for growers of organic and nonorganic produce, along with some dietitians, make strong objections to the report, saying it raises unnecessary alarm and could discourage people from eating enough fruits and vegetables.

The report gives people valuable information, says the Environmental Working Group’s Alexis Temkin, PhD, a toxicologist, so they can make informed choices about the fruits and vegetables they buy.

Environmental Working Group researchers get data from the U.S. Department of Agriculture’s samplings of pesticide residue on produce done yearly or every 2 years, and from the Food and Drug Administration for honeydew melon, which the USDA doesn’t test for.
 

2022 results: Dirty Dozen

More than 70% of the conventionally grown produce had detectable pesticide residue, the Environmental Working Group found. These fruits and vegetables were found to have the most pesticide residues this year:

• 1. Strawberries
• 2. Spinach
• 3. Kale and collard and mustard greens
• 4. Nectarines
• 5. Apples
• 6. Grapes
• 7. Bell and hot peppers
• 8. Cherries
• 9. Peaches
• 10. Pears
• 11. Celery
• 12. Tomatoes

2022 results: Clean 15

Almost 70% of the Clean Fifteen fruit and vegetable samples had no detectable residues of pesticides, the Environmental Working Group found. Avocados and sweet corn were the cleanest, with less than 2% of samples showing any detectable pesticides.

• 1. Avocados
• 2. Sweet corn
• 3. Pineapple
• 4. Onions
• 5. Papaya
• 6. Sweet peas (frozen)
• 7. Asparagus
• 8. Honeydew melon
• 9. Kiwi
• 10. Cabbage
• 11. Mushrooms
• 12. Cantaloupe
• 13. Mangoes
• 14. Watermelon
• 15. Sweet potatoes

More on methods

To produce the report, the Environmental Working Group analyzed more than 44,000 samples taken by the FDA and USDA, which tests a subset of produce each year.

Before testing, USDA scientists prepare each fruit or vegetable the way people tend to do themselves, such as peeling those with inedible peels and rinsing produce with edible peels.

The Environmental Working Group takes six measures of pesticide contamination into account:

• Percent of samples tested with detectable pesticides
• Percent with two or more detectable pesticides
• Average number of pesticides in a single sample
• Average amount of pesticides, expressed in parts per million
• Maximum number of pesticides on a single sample
• Total number of pesticides found

Next, the Environmental Working Group researchers ranked the 46 fruits and vegetables analyzed, calculated a total score, and drew up the lists.
 

Industry criticism

The Alliance for Food and Farming, an industry group that represents organic and nonorganic farmers, growers, and shippers, takes strong issue with the annual report, noting that pesticide residues on conventional produce are low, if present at all.

“Ignore or discount the list,” says Teresa Thorne, executive director of the alliance. Like others, she fears that if an organic fruit or vegetable costs more, as they often do, consumers will bypass produce altogether, especially low-income consumers. “Pick what’s best for you and your family,” she says.

Temkin of the Environmental Working Group acknowledges that all the residues found were within legal limits set by the Environmental Protection Agency. “Although the levels are legal, that doesn’t necessarily mean they are safe,” she says.

The point of the rankings, she says, is to give people information so they can choose whether to buy organic or nonorganic produce. “Our recommendation is to buy the ones on the ‘Dirty Dozen’ list organic when available, or focus on the ‘Clean 15’ list.”

The Environmental Working Group depends on a broad base of support overall, according to information on its website, including companies that produce organic products such as Stonyfield Farms, Earthbound Farms, and Organic Valley.

But according to Iris Myers, an Environmental Working Group spokesperson, the Shopper’s Guide with the clean and dirty produce rankings “isn’t funded by any companies – only grants and individual donors. We don’t allow companies to sponsor any of our research reports.”

In the report, the Environmental Working Group also notes that the EPA has taken action to prohibit the pesticide chlorpyrifos in food, after the group and others spent years asking for the ban.
 

Dietitians weigh in

The report uses “fear-branded messages to steer people away from eating conventionally grown fruits and veggies,” says Christine Rosenbloom, PhD, a retired Georgia State University professor and an Atlanta nutrition consultant.

She reminds people that “both organic and conventional agriculture use pesticides to protect the crop. Organic famers use different pesticides that are described as ‘natural,’ but natural doesn’t mean safer, better, or chemical-free,” she says.

She refers people to the Pesticide Residue Calculator from toxicologists at the University of California, Riverside, posted on the consumer site the Alliance for Food and Farming.

The calculator helps reassure people that trace amounts of chemicals on conventionally grown produce are not a hazard to your health, Dr. Rosenbloom says. “Using myself as an example, I could eat 850 apples or 13,225 servings of blueberries in one day without any effect, even in the worst-case scenario of the fruit having the highest pesticide residue recorded by the USDA.”

“It’s one more example of putting good and bad food labels on foods when it isn’t deserved,” says Connie Diekman, a food and nutrition consultant in St. Louis and a former president of the Academy of Nutrition and Dietetics. “The amounts they are measuring are so much below the tolerance level set by the EPA.”

The report shouldn’t scare people, including parents worried about serving their children conventional produce, she says.

As for how much produce to eat, “the best advice is to have half your plate be fruits and vegetables,” Ms. Diekman says. Under current Dietary Guidelines for Americans, an intake of 2½ “cups equivalent” of vegetables and 2 “cups equivalent” of fruits is recommended daily for adults.

Ms. Diekman is on the Bayer LEAD Network, Leaders Engaged in Advancing Dialogue. Dr. Rosenbloom reports an honorarium from a bean industry group for developing a webinar on healthy aging.

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

Once again, strawberries and spinach, along with kale and collard and mustard greens, top this year’s “Dirty Dozen” list, an annual and controversial ranking of nonorganic fruits and vegetables based on the amount of pesticides found in samples of the foods.

The yearly report comes from the Environmental Working Group, a nonprofit organization dedicated to improving human health and the environment, and also includes a “Clean 15” list of produce.

An industry group for growers of organic and nonorganic produce, along with some dietitians, make strong objections to the report, saying it raises unnecessary alarm and could discourage people from eating enough fruits and vegetables.

The report gives people valuable information, says the Environmental Working Group’s Alexis Temkin, PhD, a toxicologist, so they can make informed choices about the fruits and vegetables they buy.

Environmental Working Group researchers get data from the U.S. Department of Agriculture’s samplings of pesticide residue on produce done yearly or every 2 years, and from the Food and Drug Administration for honeydew melon, which the USDA doesn’t test for.
 

2022 results: Dirty Dozen

More than 70% of the conventionally grown produce had detectable pesticide residue, the Environmental Working Group found. These fruits and vegetables were found to have the most pesticide residues this year:

• 1. Strawberries
• 2. Spinach
• 3. Kale and collard and mustard greens
• 4. Nectarines
• 5. Apples
• 6. Grapes
• 7. Bell and hot peppers
• 8. Cherries
• 9. Peaches
• 10. Pears
• 11. Celery
• 12. Tomatoes

2022 results: Clean 15

Almost 70% of the Clean Fifteen fruit and vegetable samples had no detectable residues of pesticides, the Environmental Working Group found. Avocados and sweet corn were the cleanest, with less than 2% of samples showing any detectable pesticides.

• 1. Avocados
• 2. Sweet corn
• 3. Pineapple
• 4. Onions
• 5. Papaya
• 6. Sweet peas (frozen)
• 7. Asparagus
• 8. Honeydew melon
• 9. Kiwi
• 10. Cabbage
• 11. Mushrooms
• 12. Cantaloupe
• 13. Mangoes
• 14. Watermelon
• 15. Sweet potatoes

More on methods

To produce the report, the Environmental Working Group analyzed more than 44,000 samples taken by the FDA and USDA, which tests a subset of produce each year.

Before testing, USDA scientists prepare each fruit or vegetable the way people tend to do themselves, such as peeling those with inedible peels and rinsing produce with edible peels.

The Environmental Working Group takes six measures of pesticide contamination into account:

• Percent of samples tested with detectable pesticides
• Percent with two or more detectable pesticides
• Average number of pesticides in a single sample
• Average amount of pesticides, expressed in parts per million
• Maximum number of pesticides on a single sample
• Total number of pesticides found

Next, the Environmental Working Group researchers ranked the 46 fruits and vegetables analyzed, calculated a total score, and drew up the lists.
 

Industry criticism

The Alliance for Food and Farming, an industry group that represents organic and nonorganic farmers, growers, and shippers, takes strong issue with the annual report, noting that pesticide residues on conventional produce are low, if present at all.

“Ignore or discount the list,” says Teresa Thorne, executive director of the alliance. Like others, she fears that if an organic fruit or vegetable costs more, as they often do, consumers will bypass produce altogether, especially low-income consumers. “Pick what’s best for you and your family,” she says.

Temkin of the Environmental Working Group acknowledges that all the residues found were within legal limits set by the Environmental Protection Agency. “Although the levels are legal, that doesn’t necessarily mean they are safe,” she says.

The point of the rankings, she says, is to give people information so they can choose whether to buy organic or nonorganic produce. “Our recommendation is to buy the ones on the ‘Dirty Dozen’ list organic when available, or focus on the ‘Clean 15’ list.”

The Environmental Working Group depends on a broad base of support overall, according to information on its website, including companies that produce organic products such as Stonyfield Farms, Earthbound Farms, and Organic Valley.

But according to Iris Myers, an Environmental Working Group spokesperson, the Shopper’s Guide with the clean and dirty produce rankings “isn’t funded by any companies – only grants and individual donors. We don’t allow companies to sponsor any of our research reports.”

In the report, the Environmental Working Group also notes that the EPA has taken action to prohibit the pesticide chlorpyrifos in food, after the group and others spent years asking for the ban.
 

Dietitians weigh in

The report uses “fear-branded messages to steer people away from eating conventionally grown fruits and veggies,” says Christine Rosenbloom, PhD, a retired Georgia State University professor and an Atlanta nutrition consultant.

She reminds people that “both organic and conventional agriculture use pesticides to protect the crop. Organic famers use different pesticides that are described as ‘natural,’ but natural doesn’t mean safer, better, or chemical-free,” she says.

She refers people to the Pesticide Residue Calculator from toxicologists at the University of California, Riverside, posted on the consumer site the Alliance for Food and Farming.

The calculator helps reassure people that trace amounts of chemicals on conventionally grown produce are not a hazard to your health, Dr. Rosenbloom says. “Using myself as an example, I could eat 850 apples or 13,225 servings of blueberries in one day without any effect, even in the worst-case scenario of the fruit having the highest pesticide residue recorded by the USDA.”

“It’s one more example of putting good and bad food labels on foods when it isn’t deserved,” says Connie Diekman, a food and nutrition consultant in St. Louis and a former president of the Academy of Nutrition and Dietetics. “The amounts they are measuring are so much below the tolerance level set by the EPA.”

The report shouldn’t scare people, including parents worried about serving their children conventional produce, she says.

As for how much produce to eat, “the best advice is to have half your plate be fruits and vegetables,” Ms. Diekman says. Under current Dietary Guidelines for Americans, an intake of 2½ “cups equivalent” of vegetables and 2 “cups equivalent” of fruits is recommended daily for adults.

Ms. Diekman is on the Bayer LEAD Network, Leaders Engaged in Advancing Dialogue. Dr. Rosenbloom reports an honorarium from a bean industry group for developing a webinar on healthy aging.

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

Once again, strawberries and spinach, along with kale and collard and mustard greens, top this year’s “Dirty Dozen” list, an annual and controversial ranking of nonorganic fruits and vegetables based on the amount of pesticides found in samples of the foods.

The yearly report comes from the Environmental Working Group, a nonprofit organization dedicated to improving human health and the environment, and also includes a “Clean 15” list of produce.

An industry group for growers of organic and nonorganic produce, along with some dietitians, make strong objections to the report, saying it raises unnecessary alarm and could discourage people from eating enough fruits and vegetables.

The report gives people valuable information, says the Environmental Working Group’s Alexis Temkin, PhD, a toxicologist, so they can make informed choices about the fruits and vegetables they buy.

Environmental Working Group researchers get data from the U.S. Department of Agriculture’s samplings of pesticide residue on produce done yearly or every 2 years, and from the Food and Drug Administration for honeydew melon, which the USDA doesn’t test for.
 

2022 results: Dirty Dozen

More than 70% of the conventionally grown produce had detectable pesticide residue, the Environmental Working Group found. These fruits and vegetables were found to have the most pesticide residues this year:

• 1. Strawberries
• 2. Spinach
• 3. Kale and collard and mustard greens
• 4. Nectarines
• 5. Apples
• 6. Grapes
• 7. Bell and hot peppers
• 8. Cherries
• 9. Peaches
• 10. Pears
• 11. Celery
• 12. Tomatoes

2022 results: Clean 15

Almost 70% of the Clean Fifteen fruit and vegetable samples had no detectable residues of pesticides, the Environmental Working Group found. Avocados and sweet corn were the cleanest, with less than 2% of samples showing any detectable pesticides.

• 1. Avocados
• 2. Sweet corn
• 3. Pineapple
• 4. Onions
• 5. Papaya
• 6. Sweet peas (frozen)
• 7. Asparagus
• 8. Honeydew melon
• 9. Kiwi
• 10. Cabbage
• 11. Mushrooms
• 12. Cantaloupe
• 13. Mangoes
• 14. Watermelon
• 15. Sweet potatoes

More on methods

To produce the report, the Environmental Working Group analyzed more than 44,000 samples taken by the FDA and USDA, which tests a subset of produce each year.

Before testing, USDA scientists prepare each fruit or vegetable the way people tend to do themselves, such as peeling those with inedible peels and rinsing produce with edible peels.

The Environmental Working Group takes six measures of pesticide contamination into account:

• Percent of samples tested with detectable pesticides
• Percent with two or more detectable pesticides
• Average number of pesticides in a single sample
• Average amount of pesticides, expressed in parts per million
• Maximum number of pesticides on a single sample
• Total number of pesticides found

Next, the Environmental Working Group researchers ranked the 46 fruits and vegetables analyzed, calculated a total score, and drew up the lists.
 

Industry criticism

The Alliance for Food and Farming, an industry group that represents organic and nonorganic farmers, growers, and shippers, takes strong issue with the annual report, noting that pesticide residues on conventional produce are low, if present at all.

“Ignore or discount the list,” says Teresa Thorne, executive director of the alliance. Like others, she fears that if an organic fruit or vegetable costs more, as they often do, consumers will bypass produce altogether, especially low-income consumers. “Pick what’s best for you and your family,” she says.

Temkin of the Environmental Working Group acknowledges that all the residues found were within legal limits set by the Environmental Protection Agency. “Although the levels are legal, that doesn’t necessarily mean they are safe,” she says.

The point of the rankings, she says, is to give people information so they can choose whether to buy organic or nonorganic produce. “Our recommendation is to buy the ones on the ‘Dirty Dozen’ list organic when available, or focus on the ‘Clean 15’ list.”

The Environmental Working Group depends on a broad base of support overall, according to information on its website, including companies that produce organic products such as Stonyfield Farms, Earthbound Farms, and Organic Valley.

But according to Iris Myers, an Environmental Working Group spokesperson, the Shopper’s Guide with the clean and dirty produce rankings “isn’t funded by any companies – only grants and individual donors. We don’t allow companies to sponsor any of our research reports.”

In the report, the Environmental Working Group also notes that the EPA has taken action to prohibit the pesticide chlorpyrifos in food, after the group and others spent years asking for the ban.
 

Dietitians weigh in

The report uses “fear-branded messages to steer people away from eating conventionally grown fruits and veggies,” says Christine Rosenbloom, PhD, a retired Georgia State University professor and an Atlanta nutrition consultant.

She reminds people that “both organic and conventional agriculture use pesticides to protect the crop. Organic famers use different pesticides that are described as ‘natural,’ but natural doesn’t mean safer, better, or chemical-free,” she says.

She refers people to the Pesticide Residue Calculator from toxicologists at the University of California, Riverside, posted on the consumer site the Alliance for Food and Farming.

The calculator helps reassure people that trace amounts of chemicals on conventionally grown produce are not a hazard to your health, Dr. Rosenbloom says. “Using myself as an example, I could eat 850 apples or 13,225 servings of blueberries in one day without any effect, even in the worst-case scenario of the fruit having the highest pesticide residue recorded by the USDA.”

“It’s one more example of putting good and bad food labels on foods when it isn’t deserved,” says Connie Diekman, a food and nutrition consultant in St. Louis and a former president of the Academy of Nutrition and Dietetics. “The amounts they are measuring are so much below the tolerance level set by the EPA.”

The report shouldn’t scare people, including parents worried about serving their children conventional produce, she says.

As for how much produce to eat, “the best advice is to have half your plate be fruits and vegetables,” Ms. Diekman says. Under current Dietary Guidelines for Americans, an intake of 2½ “cups equivalent” of vegetables and 2 “cups equivalent” of fruits is recommended daily for adults.

Ms. Diekman is on the Bayer LEAD Network, Leaders Engaged in Advancing Dialogue. Dr. Rosenbloom reports an honorarium from a bean industry group for developing a webinar on healthy aging.

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

Sepsis is life-threatening organ dysfunction caused by dysregulated host response to an infection that can progress to shock. Sepsis is a major cause of death in the United States, with > 1 million people developing sepsis and > 250,000 people dying from sepsis annually.¹ The Surviving Sepsis Campaign (SSC) guidelines recommend treating sepsis as an emergency with timely administration of fluids and antibiotics, as administering antibiotics within the first hour has been found to reduce mortality and disease progression. In addition, empiric antibiotic regimens should be chosen to target the most probable pathogens and dosing should be optimized. To achieve this, the SSC guidelines recommend that hospitals develop quality improvement (QI) programs developed by a multidisciplinary group to improve sepsis recognition and response using a protocolized approach.²

There are several studies describing efforts to improve the sepsis response at facilities, some of which have evaluated the addition of a pharmacist into the sepsis response, particularly in the emergency department (ED). Some studies found improved selection and decreased time to antibiotic administration with the addition of an ED pharmacist.^3-7 Despite this, ED pharmacists are not present in all hospitals, with a 2015 national survey reporting the presence of an ED pharmacist in 68.7% of respondents at 187 facilities. Even facilities with ED pharmacists often have limited hours of coverage, with at least 8 hours of coverage in 49.4% of facilities with an ED pharmacist and no weekend coverage at 34.8% of these facilities.⁸

While many hospitals do not routinely employ ED pharmacists, most hospitals have clinical staff pharmacists (CSPs), and many inpatient hospital pharmacies are staffed with CSPs 24 hours per day, 7 days per week. A 2017 survey conducted by the American Society of Health-System Pharmacists (ASHP) found 43% of all hospital pharmacy departments were staffed by a CSP around the clock, with the prevalence increasing to 56.7 to 100% in hospitals with > 100 beds.⁹ As a result, CSPs may be a useful resource to assist with the management of patients with sepsis in hospitals without an ED pharmacist.

Methods

Lexington VAHCS is a 94-bed hospital that provides services to veterans, including an ED, inpatient medical services, surgical services, acute mental health, progressive care, and intensive care units. This facility has 1 antimicrobial stewardship clinical pharmacy specialist, 2 critical care clinical pharmacy specialists, and 16 full-time CSPs with 24-hour CSP coverage. The annual ED volume at the time of this study was approximately 21,000 patients.

Consistent with the SSC guideline recommendation to develop multidisciplinary QI initiatives on sepsis recognition and response, an Interdisciplinary Sepsis Committee (ISC) was created in 2018 comprised of ED, pulmonary, critical care, and infectious diseases licensed independent practitioners (LIPs), ED nurses, and pharmacists. The ISC developed a comprehensive set of sepsis tools that included a sepsis screening tool used by ED triage nurses to provide early detection of sepsis and an updated electronic order set to decrease time to appropriate treatment. This order set included automatic orders for blood cultures and serum lactate, the initiation of IV crystalloids, as well as a Sepsis Alert order placed by ED LIPs which alerted CSPs to a patient with sepsis in the ED.

To ensure a protocol-based approach by the CSPs responding to the sepsis alert, an antibiotic algorithm and vancomycin dosing nomogram were developed by the ISC based on current guideline recommendations and the local antibiogram. These were subsequently approved by ED practitioners, the pharmacy and therapeutics committee, and the critical care committee. The antibiotic algorithm prompts CSPs to perform a chart review to identify β-lactam allergies, evaluate the severity of the allergy and which agents the patient has tolerated in the past, as well as determine whether the patient has a history of extended spectrum β-lactamase (ESBL)–producing organisms from previous cultures. A decision tree then guides CSPs toward the selection of 1 of 5 empiric antibiotic regimens to cover all likely pathogens. The medication orders are then entered by the CSPs as a telephone order from the ED LIP per protocol. Unless patients had a true vancomycin allergy, all patients received vancomycin as the empiric gram-positive backbone of the regimen. The vancomycin dosing nomogram was created to ensure an appropriate and consistent vancomycin weight-based loading dose was administered.

Results

Between December 3, 2018 and May 31, 2020, 160 sepsis alerts were ordered by ED practitioners. Of the 160 patients, 157 were included in the final data analysis. Two patients were excluded due to vancomycin allergy, and 1 patient because the physician ordered antibiotics prior to pharmacist order entry. The population was largely composed of male patients (98%) with a median age of 72 years (Table 2).

Of 157 sepsis alerts, the antibiotic selection algorithm was used appropriately in 154 (98%) instances (Table 3). Chart reviews were performed in instances of antimicrobial selection different from the algorithm. Of the 3 patients who received antibiotics not consistent with the algorithm, 1 patient without a history of ESBL-producing organisms in their culture history received meropenem instead of piperacillin/tazobactam. Another patient without a penicillin allergy received cefepime (plus metronidazole ordered separately from the ED practitioner) instead of piperacillin/tazobactam, and the third patient received piperacillin/tazobactam instead of meropenem despite a culture history of ESBL-producing organisms. Vancomycin dose was appropriate according to the weight-based nomogram in 147 cases (94%). The median time to administration of first dose antibiotics was 39 minutes after the sepsis alert order was placed and 96 minutes after initial ED presentation.

Discussion

This study found extremely high rates of accuracy among CSPs for both the antibiotic selection algorithm (98%) and the vancomycin dosing nomogram (94%). Moreover, analysis of the 3 patients who received antibiotics that were inconsistent with the algorithm revealed that 2 of these patients arguably still received adequate empiric coverage, increasing the percentage of patients receiving appropriate empiric antibiotics to 99.4%. Similarly, chart review of 10 patients who received vancomycin doses that deviated from the nomogram revealed that in at least 3 cases, patients were likely given correct vancomycin doses based on the patient’s last known weight. However, when actual current weights were recorded soon after admission, the updated weights rendered the initial vancomycin loading dose incorrect when this analysis was performed. Thus, the adherence to the vancomycin dosing nomogram is higher than it appears.

Median time to antibiotic administration from the sepsis alert was 39 minutes—well within SSC recommendations (60 minutes).² Previous internal analyses at Lexington VAHCS demonstrated the mean time to first dose of antibiotics in the ED has been 39 minutes since about 2015. Thus, this initiative did not necessarily make this process quicker; however it did remove 1 responsibility from LIPs so that they could focus their efforts on other components of sepsis management.

Further studies are needed to evaluate the effects of this initiative on other aspects of the sepsis bundle, such as volume of fluid administered and appropriateness of laboratory tests. It was noted that while the time to first-dose antibiotic administration was < 1 hour from order placement, the median time from ED presentation to antibiotic administration was 96 minutes. This suggests that another focus of the sepsis workgroup should be on speeding recognition of sepsis, triggering the sepsis alert even sooner, and evaluating the feasibility of storing first doses of antibiotics in the automatic dispensing cabinets in the ED.

Limitations

This descriptive study evaluating CSPs’ ability to accurately use the newly developed antibiotic selection algorithm and vancomycin dosing nomogram had no control group for outcome comparison. This study was not designed to evaluate clinical outcomes, such as mortality, so the impact of these interventions need to be further studied. In addition, as veterans receive most of their care at our facility, with their allergies and previous cultures readily available in our electronic health record, this process may not be feasible at other facilities where patients' care is divided among multiple facilities/systems.

Moreover, as the veteran population studied was predominately male patients aged > 60 years, implementation at other hospitals may require the dosing nomograms and treatment algorithms to be adapted for a broader population, such as children and pregnant women. In particular, the ISC chose to implement an algorithm that did not differentiate between suspected source of infections and included anti-Pseudomonal coverage in all regimens based on the most encountered diseases among our veteran population and our local antibiogram; implementation at other facilities would require a thoughtful evaluation of the most appropriate site-specific regimen. Finally, many of the CSPs at our facility are board certified and/or residency trained, so more staff development may be required prior to implementation at other facilities, depending on the experience and comfort level of the CSPs.

Strengths

This study describes an example of a protocolized and multidisciplinary approach to improve sepsis recognition and standardize the response, consistent with SSC guideline recommendations. To the best of our knowledge, this is the first study to demonstrate the incorporation of CSPs into the interdisciplinary sepsis response. This allows for CSPs to practice at the top of their license and contributes to their professional development. Although it was not formally assessed, anecdotally CSPs reported that this process presented a negligible addition to their workload (< 5 minutes was the most reported time requirement), and they expressed satisfaction with their involvement in the sepsis response. Overall, this presents a possible solution to improve the sepsis response in hospitals without a dedicated ED pharmacist.

Conclusions

This study describes the successful incorporation of CSPs into the sepsis response in the ED. As CSPs are more likely than ED pharmacists to be present at a facility, they are arguably an underused resource whose clinical skills can be used to optimize the treatment of patients with sepsis.

Sepsis is life-threatening organ dysfunction caused by dysregulated host response to an infection that can progress to shock. Sepsis is a major cause of death in the United States, with > 1 million people developing sepsis and > 250,000 people dying from sepsis annually.¹ The Surviving Sepsis Campaign (SSC) guidelines recommend treating sepsis as an emergency with timely administration of fluids and antibiotics, as administering antibiotics within the first hour has been found to reduce mortality and disease progression. In addition, empiric antibiotic regimens should be chosen to target the most probable pathogens and dosing should be optimized. To achieve this, the SSC guidelines recommend that hospitals develop quality improvement (QI) programs developed by a multidisciplinary group to improve sepsis recognition and response using a protocolized approach.²

There are several studies describing efforts to improve the sepsis response at facilities, some of which have evaluated the addition of a pharmacist into the sepsis response, particularly in the emergency department (ED). Some studies found improved selection and decreased time to antibiotic administration with the addition of an ED pharmacist.^3-7 Despite this, ED pharmacists are not present in all hospitals, with a 2015 national survey reporting the presence of an ED pharmacist in 68.7% of respondents at 187 facilities. Even facilities with ED pharmacists often have limited hours of coverage, with at least 8 hours of coverage in 49.4% of facilities with an ED pharmacist and no weekend coverage at 34.8% of these facilities.⁸

While many hospitals do not routinely employ ED pharmacists, most hospitals have clinical staff pharmacists (CSPs), and many inpatient hospital pharmacies are staffed with CSPs 24 hours per day, 7 days per week. A 2017 survey conducted by the American Society of Health-System Pharmacists (ASHP) found 43% of all hospital pharmacy departments were staffed by a CSP around the clock, with the prevalence increasing to 56.7 to 100% in hospitals with > 100 beds.⁹ As a result, CSPs may be a useful resource to assist with the management of patients with sepsis in hospitals without an ED pharmacist.

Methods

Lexington VAHCS is a 94-bed hospital that provides services to veterans, including an ED, inpatient medical services, surgical services, acute mental health, progressive care, and intensive care units. This facility has 1 antimicrobial stewardship clinical pharmacy specialist, 2 critical care clinical pharmacy specialists, and 16 full-time CSPs with 24-hour CSP coverage. The annual ED volume at the time of this study was approximately 21,000 patients.

Consistent with the SSC guideline recommendation to develop multidisciplinary QI initiatives on sepsis recognition and response, an Interdisciplinary Sepsis Committee (ISC) was created in 2018 comprised of ED, pulmonary, critical care, and infectious diseases licensed independent practitioners (LIPs), ED nurses, and pharmacists. The ISC developed a comprehensive set of sepsis tools that included a sepsis screening tool used by ED triage nurses to provide early detection of sepsis and an updated electronic order set to decrease time to appropriate treatment. This order set included automatic orders for blood cultures and serum lactate, the initiation of IV crystalloids, as well as a Sepsis Alert order placed by ED LIPs which alerted CSPs to a patient with sepsis in the ED.

To ensure a protocol-based approach by the CSPs responding to the sepsis alert, an antibiotic algorithm and vancomycin dosing nomogram were developed by the ISC based on current guideline recommendations and the local antibiogram. These were subsequently approved by ED practitioners, the pharmacy and therapeutics committee, and the critical care committee. The antibiotic algorithm prompts CSPs to perform a chart review to identify β-lactam allergies, evaluate the severity of the allergy and which agents the patient has tolerated in the past, as well as determine whether the patient has a history of extended spectrum β-lactamase (ESBL)–producing organisms from previous cultures. A decision tree then guides CSPs toward the selection of 1 of 5 empiric antibiotic regimens to cover all likely pathogens. The medication orders are then entered by the CSPs as a telephone order from the ED LIP per protocol. Unless patients had a true vancomycin allergy, all patients received vancomycin as the empiric gram-positive backbone of the regimen. The vancomycin dosing nomogram was created to ensure an appropriate and consistent vancomycin weight-based loading dose was administered.

Results

Between December 3, 2018 and May 31, 2020, 160 sepsis alerts were ordered by ED practitioners. Of the 160 patients, 157 were included in the final data analysis. Two patients were excluded due to vancomycin allergy, and 1 patient because the physician ordered antibiotics prior to pharmacist order entry. The population was largely composed of male patients (98%) with a median age of 72 years (Table 2).

Of 157 sepsis alerts, the antibiotic selection algorithm was used appropriately in 154 (98%) instances (Table 3). Chart reviews were performed in instances of antimicrobial selection different from the algorithm. Of the 3 patients who received antibiotics not consistent with the algorithm, 1 patient without a history of ESBL-producing organisms in their culture history received meropenem instead of piperacillin/tazobactam. Another patient without a penicillin allergy received cefepime (plus metronidazole ordered separately from the ED practitioner) instead of piperacillin/tazobactam, and the third patient received piperacillin/tazobactam instead of meropenem despite a culture history of ESBL-producing organisms. Vancomycin dose was appropriate according to the weight-based nomogram in 147 cases (94%). The median time to administration of first dose antibiotics was 39 minutes after the sepsis alert order was placed and 96 minutes after initial ED presentation.

Discussion

This study found extremely high rates of accuracy among CSPs for both the antibiotic selection algorithm (98%) and the vancomycin dosing nomogram (94%). Moreover, analysis of the 3 patients who received antibiotics that were inconsistent with the algorithm revealed that 2 of these patients arguably still received adequate empiric coverage, increasing the percentage of patients receiving appropriate empiric antibiotics to 99.4%. Similarly, chart review of 10 patients who received vancomycin doses that deviated from the nomogram revealed that in at least 3 cases, patients were likely given correct vancomycin doses based on the patient’s last known weight. However, when actual current weights were recorded soon after admission, the updated weights rendered the initial vancomycin loading dose incorrect when this analysis was performed. Thus, the adherence to the vancomycin dosing nomogram is higher than it appears.

Median time to antibiotic administration from the sepsis alert was 39 minutes—well within SSC recommendations (60 minutes).² Previous internal analyses at Lexington VAHCS demonstrated the mean time to first dose of antibiotics in the ED has been 39 minutes since about 2015. Thus, this initiative did not necessarily make this process quicker; however it did remove 1 responsibility from LIPs so that they could focus their efforts on other components of sepsis management.

Further studies are needed to evaluate the effects of this initiative on other aspects of the sepsis bundle, such as volume of fluid administered and appropriateness of laboratory tests. It was noted that while the time to first-dose antibiotic administration was < 1 hour from order placement, the median time from ED presentation to antibiotic administration was 96 minutes. This suggests that another focus of the sepsis workgroup should be on speeding recognition of sepsis, triggering the sepsis alert even sooner, and evaluating the feasibility of storing first doses of antibiotics in the automatic dispensing cabinets in the ED.

Limitations

This descriptive study evaluating CSPs’ ability to accurately use the newly developed antibiotic selection algorithm and vancomycin dosing nomogram had no control group for outcome comparison. This study was not designed to evaluate clinical outcomes, such as mortality, so the impact of these interventions need to be further studied. In addition, as veterans receive most of their care at our facility, with their allergies and previous cultures readily available in our electronic health record, this process may not be feasible at other facilities where patients' care is divided among multiple facilities/systems.

Moreover, as the veteran population studied was predominately male patients aged > 60 years, implementation at other hospitals may require the dosing nomograms and treatment algorithms to be adapted for a broader population, such as children and pregnant women. In particular, the ISC chose to implement an algorithm that did not differentiate between suspected source of infections and included anti-Pseudomonal coverage in all regimens based on the most encountered diseases among our veteran population and our local antibiogram; implementation at other facilities would require a thoughtful evaluation of the most appropriate site-specific regimen. Finally, many of the CSPs at our facility are board certified and/or residency trained, so more staff development may be required prior to implementation at other facilities, depending on the experience and comfort level of the CSPs.

Strengths

This study describes an example of a protocolized and multidisciplinary approach to improve sepsis recognition and standardize the response, consistent with SSC guideline recommendations. To the best of our knowledge, this is the first study to demonstrate the incorporation of CSPs into the interdisciplinary sepsis response. This allows for CSPs to practice at the top of their license and contributes to their professional development. Although it was not formally assessed, anecdotally CSPs reported that this process presented a negligible addition to their workload (< 5 minutes was the most reported time requirement), and they expressed satisfaction with their involvement in the sepsis response. Overall, this presents a possible solution to improve the sepsis response in hospitals without a dedicated ED pharmacist.

Conclusions

This study describes the successful incorporation of CSPs into the sepsis response in the ED. As CSPs are more likely than ED pharmacists to be present at a facility, they are arguably an underused resource whose clinical skills can be used to optimize the treatment of patients with sepsis.

Sepsis is life-threatening organ dysfunction caused by dysregulated host response to an infection that can progress to shock. Sepsis is a major cause of death in the United States, with > 1 million people developing sepsis and > 250,000 people dying from sepsis annually.¹ The Surviving Sepsis Campaign (SSC) guidelines recommend treating sepsis as an emergency with timely administration of fluids and antibiotics, as administering antibiotics within the first hour has been found to reduce mortality and disease progression. In addition, empiric antibiotic regimens should be chosen to target the most probable pathogens and dosing should be optimized. To achieve this, the SSC guidelines recommend that hospitals develop quality improvement (QI) programs developed by a multidisciplinary group to improve sepsis recognition and response using a protocolized approach.²

There are several studies describing efforts to improve the sepsis response at facilities, some of which have evaluated the addition of a pharmacist into the sepsis response, particularly in the emergency department (ED). Some studies found improved selection and decreased time to antibiotic administration with the addition of an ED pharmacist.^3-7 Despite this, ED pharmacists are not present in all hospitals, with a 2015 national survey reporting the presence of an ED pharmacist in 68.7% of respondents at 187 facilities. Even facilities with ED pharmacists often have limited hours of coverage, with at least 8 hours of coverage in 49.4% of facilities with an ED pharmacist and no weekend coverage at 34.8% of these facilities.⁸

While many hospitals do not routinely employ ED pharmacists, most hospitals have clinical staff pharmacists (CSPs), and many inpatient hospital pharmacies are staffed with CSPs 24 hours per day, 7 days per week. A 2017 survey conducted by the American Society of Health-System Pharmacists (ASHP) found 43% of all hospital pharmacy departments were staffed by a CSP around the clock, with the prevalence increasing to 56.7 to 100% in hospitals with > 100 beds.⁹ As a result, CSPs may be a useful resource to assist with the management of patients with sepsis in hospitals without an ED pharmacist.

Methods

Lexington VAHCS is a 94-bed hospital that provides services to veterans, including an ED, inpatient medical services, surgical services, acute mental health, progressive care, and intensive care units. This facility has 1 antimicrobial stewardship clinical pharmacy specialist, 2 critical care clinical pharmacy specialists, and 16 full-time CSPs with 24-hour CSP coverage. The annual ED volume at the time of this study was approximately 21,000 patients.

Consistent with the SSC guideline recommendation to develop multidisciplinary QI initiatives on sepsis recognition and response, an Interdisciplinary Sepsis Committee (ISC) was created in 2018 comprised of ED, pulmonary, critical care, and infectious diseases licensed independent practitioners (LIPs), ED nurses, and pharmacists. The ISC developed a comprehensive set of sepsis tools that included a sepsis screening tool used by ED triage nurses to provide early detection of sepsis and an updated electronic order set to decrease time to appropriate treatment. This order set included automatic orders for blood cultures and serum lactate, the initiation of IV crystalloids, as well as a Sepsis Alert order placed by ED LIPs which alerted CSPs to a patient with sepsis in the ED.

To ensure a protocol-based approach by the CSPs responding to the sepsis alert, an antibiotic algorithm and vancomycin dosing nomogram were developed by the ISC based on current guideline recommendations and the local antibiogram. These were subsequently approved by ED practitioners, the pharmacy and therapeutics committee, and the critical care committee. The antibiotic algorithm prompts CSPs to perform a chart review to identify β-lactam allergies, evaluate the severity of the allergy and which agents the patient has tolerated in the past, as well as determine whether the patient has a history of extended spectrum β-lactamase (ESBL)–producing organisms from previous cultures. A decision tree then guides CSPs toward the selection of 1 of 5 empiric antibiotic regimens to cover all likely pathogens. The medication orders are then entered by the CSPs as a telephone order from the ED LIP per protocol. Unless patients had a true vancomycin allergy, all patients received vancomycin as the empiric gram-positive backbone of the regimen. The vancomycin dosing nomogram was created to ensure an appropriate and consistent vancomycin weight-based loading dose was administered.

Results

Between December 3, 2018 and May 31, 2020, 160 sepsis alerts were ordered by ED practitioners. Of the 160 patients, 157 were included in the final data analysis. Two patients were excluded due to vancomycin allergy, and 1 patient because the physician ordered antibiotics prior to pharmacist order entry. The population was largely composed of male patients (98%) with a median age of 72 years (Table 2).

Of 157 sepsis alerts, the antibiotic selection algorithm was used appropriately in 154 (98%) instances (Table 3). Chart reviews were performed in instances of antimicrobial selection different from the algorithm. Of the 3 patients who received antibiotics not consistent with the algorithm, 1 patient without a history of ESBL-producing organisms in their culture history received meropenem instead of piperacillin/tazobactam. Another patient without a penicillin allergy received cefepime (plus metronidazole ordered separately from the ED practitioner) instead of piperacillin/tazobactam, and the third patient received piperacillin/tazobactam instead of meropenem despite a culture history of ESBL-producing organisms. Vancomycin dose was appropriate according to the weight-based nomogram in 147 cases (94%). The median time to administration of first dose antibiotics was 39 minutes after the sepsis alert order was placed and 96 minutes after initial ED presentation.

Discussion

This study found extremely high rates of accuracy among CSPs for both the antibiotic selection algorithm (98%) and the vancomycin dosing nomogram (94%). Moreover, analysis of the 3 patients who received antibiotics that were inconsistent with the algorithm revealed that 2 of these patients arguably still received adequate empiric coverage, increasing the percentage of patients receiving appropriate empiric antibiotics to 99.4%. Similarly, chart review of 10 patients who received vancomycin doses that deviated from the nomogram revealed that in at least 3 cases, patients were likely given correct vancomycin doses based on the patient’s last known weight. However, when actual current weights were recorded soon after admission, the updated weights rendered the initial vancomycin loading dose incorrect when this analysis was performed. Thus, the adherence to the vancomycin dosing nomogram is higher than it appears.

Median time to antibiotic administration from the sepsis alert was 39 minutes—well within SSC recommendations (60 minutes).² Previous internal analyses at Lexington VAHCS demonstrated the mean time to first dose of antibiotics in the ED has been 39 minutes since about 2015. Thus, this initiative did not necessarily make this process quicker; however it did remove 1 responsibility from LIPs so that they could focus their efforts on other components of sepsis management.

Further studies are needed to evaluate the effects of this initiative on other aspects of the sepsis bundle, such as volume of fluid administered and appropriateness of laboratory tests. It was noted that while the time to first-dose antibiotic administration was < 1 hour from order placement, the median time from ED presentation to antibiotic administration was 96 minutes. This suggests that another focus of the sepsis workgroup should be on speeding recognition of sepsis, triggering the sepsis alert even sooner, and evaluating the feasibility of storing first doses of antibiotics in the automatic dispensing cabinets in the ED.

Limitations

This descriptive study evaluating CSPs’ ability to accurately use the newly developed antibiotic selection algorithm and vancomycin dosing nomogram had no control group for outcome comparison. This study was not designed to evaluate clinical outcomes, such as mortality, so the impact of these interventions need to be further studied. In addition, as veterans receive most of their care at our facility, with their allergies and previous cultures readily available in our electronic health record, this process may not be feasible at other facilities where patients' care is divided among multiple facilities/systems.

Moreover, as the veteran population studied was predominately male patients aged > 60 years, implementation at other hospitals may require the dosing nomograms and treatment algorithms to be adapted for a broader population, such as children and pregnant women. In particular, the ISC chose to implement an algorithm that did not differentiate between suspected source of infections and included anti-Pseudomonal coverage in all regimens based on the most encountered diseases among our veteran population and our local antibiogram; implementation at other facilities would require a thoughtful evaluation of the most appropriate site-specific regimen. Finally, many of the CSPs at our facility are board certified and/or residency trained, so more staff development may be required prior to implementation at other facilities, depending on the experience and comfort level of the CSPs.

Strengths

This study describes an example of a protocolized and multidisciplinary approach to improve sepsis recognition and standardize the response, consistent with SSC guideline recommendations. To the best of our knowledge, this is the first study to demonstrate the incorporation of CSPs into the interdisciplinary sepsis response. This allows for CSPs to practice at the top of their license and contributes to their professional development. Although it was not formally assessed, anecdotally CSPs reported that this process presented a negligible addition to their workload (< 5 minutes was the most reported time requirement), and they expressed satisfaction with their involvement in the sepsis response. Overall, this presents a possible solution to improve the sepsis response in hospitals without a dedicated ED pharmacist.

Conclusions

This study describes the successful incorporation of CSPs into the sepsis response in the ED. As CSPs are more likely than ED pharmacists to be present at a facility, they are arguably an underused resource whose clinical skills can be used to optimize the treatment of patients with sepsis.

Chronic pain is persistent or recurring pain lasting more than 3 months past normal healing time. Primary care professionals usually refer patients experiencing chronic pain to pain specialists to better identify, treat, and manage the pain. Chronic noncancer-related pain affects more Americans than diabetes mellitus, cardiac disease, and cancer combined.¹ Veterans are no exception. The prevalence of severe pain was significantly higher in veterans compared with that of nonveterans who had back pain (21.6 vs 16.7%, respectively), jaw pain (37.5 vs 22.9%, respectively), severe headaches or migraine (26.4 vs 15.9%, respectively), and neck pain (27.7 vs 21.4%, respectively).² At an individual level, those who experience chronic pain can expect impaired functional capacity, reduced ability to work, sleep disturbance, reduced social interactions, and considerable psychological distress. At a societal level, the cost of treating chronic pain is exorbitant, exceeding $600 billion annually, yet treatment outcomes remain variable at best.³ Greater efforts are needed to improve and standardize patient outcomes.

Interventional pain procedures performed under fluoroscopic or ultrasound guidance by specialist physicians have shown mixed responses in previous studies. Past systematic reviews demonstrate reductions in pain scores after lumbar or caudal epidural steroid injections (ESIs) and radiofrequency ablation of nerves supplying lumbar and thoracic facet joints.^4-7 However, one review found insufficient evidence to support injection therapy for chronic low back pain.⁸ Unfortunately, the majority of the included studies evaluated outcomes using the visual analogue scale (VAS) or other limited factors, such as physical examination findings. Current biopsychosocial conceptualizations of chronic pain are beginning to recognize the complex nature of the experience of pain and highlighting the significance of multimodal management.⁹ It is vital that our assessment of chronic pain, like our treatment options, be multidimensional and reflect these underpinning principles.

The Pain Outcomes Questionnaire-For Veterans (POQ-VA) was developed within the Veterans Health Administration (VHA) by Clark and colleagues in 2003. It represents a brief but psychometrically sound pain outcomes instrument that assesses all key domains and meets accreditation body standards. The POQ-VA is valid and reliable for evaluating effectiveness of treatment of chronic noncancer pain in veterans in routine clinical practice.¹⁰ This review is the first study to use the POQ-VA to assess the impact of interventional pain procedures on veterans with chronic noncancer pain.

The aim of this study was to perform a retrospective review of POQ-VA scores before and after injection-based interventional treatment for chronic pain to determine whether the procedure affected patient outcomes. We hypothesized that POQ-VA scores would improve across multiple domains in the veteran population postprocedure. This study was approved by the Institutional Review Board (IRB-2018-053) at the Providence Veterans Affairs Medical Center (VAMC) in Rhode Island.

Methods

Using the Computerized Patient Record System, all adult veteran patients who had attended at least 2 appointments between April 1, 2009, and April 1, 2019 at the Providence VAMC interventional pain clinic were identified. POQ-VA reports were extracted provided the following criteria were met: (1) the veteran received an injection-based interventional treatment for chronic pain, including trigger point injections, ESIs, nerve blocks, and radiofrequency ablations; (2) the veteran completed POQ-VA both pre- and posttreatment; and (3) posttreatment POQ-VA reports were completed within 6 months of treatment. All patients who did not fit these criteria were excluded from the study.

After deidentification, 112 pre- and posttreatment POQ-VA reports were identified. All subsequent statistical analyses were conducted using Stata SE version 15. Descriptive statistics including mean, range, SD, and percent change were computed for POQ-VA domain—pain, mobility, activities of daily living (ADL), vitality, negative affect, fear, and total raw score—as well as for each POQ-VA question. Given that POQ-VA domain scores were found to be approximately normally distributed without outliers, domain scores were treated as continuous variables, and a paired samples t test was conducted to compare means among POQ-VA domains. Individual question responses were analyzed using nonparametric testing methods to account for the lack of normal distribution in each question, treating the range of 0 to 10 as an ordinal variable. A Wilcoxon matched-pairs signed-rank test was conducted to compare means among individual question responses before and after treatment.

Results

Of 112 included patients, 102 (91%) were male and 10 (9%) were female. The mean age was 62 years (range, 35-90). Diagnosis and procedures varied due to patient symptoms varying from muscle pain, nerve pain, degenerative disc disease, and osteoarthritis.

POQ-VA scores across all domains, including total raw score, showed statistically significant improvement after treatment (Table 1). Directionally, the POQ-VA scores for all 20 questions reflect a positive treatment response and 17 had statistically significant changes (P < .05) (Table 2). The changes in self-perceived energy level, safety, and feelings of tension were not statistically significant. Esteem had the greatest magnitude decrease, falling from 5.2 preprocedure to 3.8 postprocedure (P < .001). Other similarly significant magnitudes of improvement were seen from pre- to postprocedure in questions pertaining to grooming (2.2 to 1.6, P = .003) and the ability to use the bathroom (3.4 to 2.6, P < .001).

Discussion

The most important finding of this study was the ability of the POQ-VA to detect statistically significant positive responses to injection therapy across all domains. The largest improvements were in self-reported pain intensity, pain-related impairment in mobility and ADLs, and self-reported dysphoric effects. The single largest improvement posttreatment was a reduction in scores related to low self-esteem.

Chronic pain can be assessed in a variety of ways ranging from physical examination findings and subjective numerical ratings to extensive patient-reported questionnaires. The International Association for the Study of Pain acknowledges that pain is a complex experience and recommends assessment should be comprehensive.¹¹ Many patient-reported questionnaires are available to clinicians, including some that address pain in a specific body part, such as the Oswestry Low Back Pain Disability Questionnaire, or those that focus on depression or quality-of-life measures, such as the SF-36.^12,13

One major benefit of using the POQ-VA is its potential to demonstrate benefits across multiple domains, reflecting the complex nature of chronic pain. The POQ-VA also separates domain or scale scores, allowing clinicians to identify individuals with different patterns of dysfunction across domains.¹⁰ This separation also provides insight into which treatment options are best for chronic pain patients with predominant patterns or lower scores in certain domains. The use of a single summary score, as seen in other questionnaires such as the Roland-Morris Activity Scale, may conceal treatment-induced changes in specific outcome domains.¹⁴ Additionally, like many other similar instruments, the POQ-VA is easy to understand and use, requires no special training, takes little time to complete, and can be completed in person or over the phone.

As chronic pain has been studied further and its complexity recognized, more instruments have been developed and modified to reflect these new elements. There is no one scale applicable to all populations. A discussion about the strengths and weaknesses of each available assessment tool is outside the scope of this review. However, to date, the POQ-VA is the only instrument that has been validated to detect change following treatment of chronic pain in an exclusively veteran population.¹⁰ This validation emphasizes the importance of this study as it supports the use of this outcome measure to monitor treatment of pain in VA facilities.

One of the secondary findings indicated that injection therapy improved veterans’ physical activity levels and self-esteem and lowered pain scores as well as kinesiophobia and anxiety. The role of interventional procedures has been well established in the field of chronic pain, but their efficacy has been less clear. Injections are costly and not without risk, and these factors relegate them to fourth-line treatment options in most situations.¹⁵ Several meta-analyses have demonstrated small improvements in pain scores and patient-reported questionnaires after medial branch blocks, and lumbar or caudal ESIs for chronic back pain.^5-7 However, an updated Cochrane Review concluded that there was insufficient evidence to support the use of injection therapy in subacute and chronic low back pain.⁸ The review acknowledged the limited methodologic quality of the trials and could not definitively report that injection therapy did not have benefits for certain subgroups of patients. The ability of researchers to detect benefit from an intervention is intrinsically linked to how outcomes are determined. The most interesting finding of our study was the patient-reported improved self-esteem scores. Many trials included in the systematic reviews discussed used outcome measures that did not have the multidimensional scope to demonstrate such a potential benefit.

Limitations

Our relatively small sample size represents the main shortcoming of this study. Because many posttreatment questionnaires were never collected, unfortunately, much potential data was lost. Most procedures performed were corticosteroid injections for the treatment of low back pain. This represented a combination of lumbar ESI, caudal ESI, medial branch blocks, and sacroiliac joint injections. The limited numbers meant that a further regression analysis of each injection type was not possible. Since few interventions treated pain in other areas of the body, it is difficult to determine whether procedures such as hip joint injections and ilioinguinal nerve blocks provided overall benefit. In the same vein, there is an inability to comment on which injection for chronic low back pain was the most efficacious.

The veteran population, while similar to the general population experiencing chronic pain, is more likely to experience PTSD and other mental health conditions.² According to medical literature, no randomized controlled trials have been published examining pain interventions exclusively in veterans, so the applicability of these results needs further investigation. This study suggests there are potential benefits for the veteran population, not solely perhaps from receiving injection therapy, but to having access to an interventional pain clinic led by a pain physician within a network of other specialties. While limited by the inherent biases of a retrospective review, this study highlights the potential value in continuing to study this subgroup of patients, especially in the setting of an interdisciplinary approach.

Conclusions

The POQ-VA is the only instrument to date that has been validated to detect change following treatment of chronic pain in an exclusively veteran population. Our study is the first univariate analysis since the instrument’s validation in 2003. Our descriptive and inferential statistics suggest that the majority of veterans undergoing injection therapy for chronic pain had statistically significant improvements in POQ-VA measures within a 6-month period following treatment. In order to conduct more rigorous, multivariate studies, continued and more widespread use of the POQ-VA instrument is warranted.

Chronic pain is persistent or recurring pain lasting more than 3 months past normal healing time. Primary care professionals usually refer patients experiencing chronic pain to pain specialists to better identify, treat, and manage the pain. Chronic noncancer-related pain affects more Americans than diabetes mellitus, cardiac disease, and cancer combined.¹ Veterans are no exception. The prevalence of severe pain was significantly higher in veterans compared with that of nonveterans who had back pain (21.6 vs 16.7%, respectively), jaw pain (37.5 vs 22.9%, respectively), severe headaches or migraine (26.4 vs 15.9%, respectively), and neck pain (27.7 vs 21.4%, respectively).² At an individual level, those who experience chronic pain can expect impaired functional capacity, reduced ability to work, sleep disturbance, reduced social interactions, and considerable psychological distress. At a societal level, the cost of treating chronic pain is exorbitant, exceeding $600 billion annually, yet treatment outcomes remain variable at best.³ Greater efforts are needed to improve and standardize patient outcomes.

Interventional pain procedures performed under fluoroscopic or ultrasound guidance by specialist physicians have shown mixed responses in previous studies. Past systematic reviews demonstrate reductions in pain scores after lumbar or caudal epidural steroid injections (ESIs) and radiofrequency ablation of nerves supplying lumbar and thoracic facet joints.^4-7 However, one review found insufficient evidence to support injection therapy for chronic low back pain.⁸ Unfortunately, the majority of the included studies evaluated outcomes using the visual analogue scale (VAS) or other limited factors, such as physical examination findings. Current biopsychosocial conceptualizations of chronic pain are beginning to recognize the complex nature of the experience of pain and highlighting the significance of multimodal management.⁹ It is vital that our assessment of chronic pain, like our treatment options, be multidimensional and reflect these underpinning principles.

The Pain Outcomes Questionnaire-For Veterans (POQ-VA) was developed within the Veterans Health Administration (VHA) by Clark and colleagues in 2003. It represents a brief but psychometrically sound pain outcomes instrument that assesses all key domains and meets accreditation body standards. The POQ-VA is valid and reliable for evaluating effectiveness of treatment of chronic noncancer pain in veterans in routine clinical practice.¹⁰ This review is the first study to use the POQ-VA to assess the impact of interventional pain procedures on veterans with chronic noncancer pain.

The aim of this study was to perform a retrospective review of POQ-VA scores before and after injection-based interventional treatment for chronic pain to determine whether the procedure affected patient outcomes. We hypothesized that POQ-VA scores would improve across multiple domains in the veteran population postprocedure. This study was approved by the Institutional Review Board (IRB-2018-053) at the Providence Veterans Affairs Medical Center (VAMC) in Rhode Island.

Methods

Using the Computerized Patient Record System, all adult veteran patients who had attended at least 2 appointments between April 1, 2009, and April 1, 2019 at the Providence VAMC interventional pain clinic were identified. POQ-VA reports were extracted provided the following criteria were met: (1) the veteran received an injection-based interventional treatment for chronic pain, including trigger point injections, ESIs, nerve blocks, and radiofrequency ablations; (2) the veteran completed POQ-VA both pre- and posttreatment; and (3) posttreatment POQ-VA reports were completed within 6 months of treatment. All patients who did not fit these criteria were excluded from the study.

After deidentification, 112 pre- and posttreatment POQ-VA reports were identified. All subsequent statistical analyses were conducted using Stata SE version 15. Descriptive statistics including mean, range, SD, and percent change were computed for POQ-VA domain—pain, mobility, activities of daily living (ADL), vitality, negative affect, fear, and total raw score—as well as for each POQ-VA question. Given that POQ-VA domain scores were found to be approximately normally distributed without outliers, domain scores were treated as continuous variables, and a paired samples t test was conducted to compare means among POQ-VA domains. Individual question responses were analyzed using nonparametric testing methods to account for the lack of normal distribution in each question, treating the range of 0 to 10 as an ordinal variable. A Wilcoxon matched-pairs signed-rank test was conducted to compare means among individual question responses before and after treatment.

Results

Of 112 included patients, 102 (91%) were male and 10 (9%) were female. The mean age was 62 years (range, 35-90). Diagnosis and procedures varied due to patient symptoms varying from muscle pain, nerve pain, degenerative disc disease, and osteoarthritis.

POQ-VA scores across all domains, including total raw score, showed statistically significant improvement after treatment (Table 1). Directionally, the POQ-VA scores for all 20 questions reflect a positive treatment response and 17 had statistically significant changes (P < .05) (Table 2). The changes in self-perceived energy level, safety, and feelings of tension were not statistically significant. Esteem had the greatest magnitude decrease, falling from 5.2 preprocedure to 3.8 postprocedure (P < .001). Other similarly significant magnitudes of improvement were seen from pre- to postprocedure in questions pertaining to grooming (2.2 to 1.6, P = .003) and the ability to use the bathroom (3.4 to 2.6, P < .001).

Discussion

The most important finding of this study was the ability of the POQ-VA to detect statistically significant positive responses to injection therapy across all domains. The largest improvements were in self-reported pain intensity, pain-related impairment in mobility and ADLs, and self-reported dysphoric effects. The single largest improvement posttreatment was a reduction in scores related to low self-esteem.

Chronic pain can be assessed in a variety of ways ranging from physical examination findings and subjective numerical ratings to extensive patient-reported questionnaires. The International Association for the Study of Pain acknowledges that pain is a complex experience and recommends assessment should be comprehensive.¹¹ Many patient-reported questionnaires are available to clinicians, including some that address pain in a specific body part, such as the Oswestry Low Back Pain Disability Questionnaire, or those that focus on depression or quality-of-life measures, such as the SF-36.^12,13

One major benefit of using the POQ-VA is its potential to demonstrate benefits across multiple domains, reflecting the complex nature of chronic pain. The POQ-VA also separates domain or scale scores, allowing clinicians to identify individuals with different patterns of dysfunction across domains.¹⁰ This separation also provides insight into which treatment options are best for chronic pain patients with predominant patterns or lower scores in certain domains. The use of a single summary score, as seen in other questionnaires such as the Roland-Morris Activity Scale, may conceal treatment-induced changes in specific outcome domains.¹⁴ Additionally, like many other similar instruments, the POQ-VA is easy to understand and use, requires no special training, takes little time to complete, and can be completed in person or over the phone.

As chronic pain has been studied further and its complexity recognized, more instruments have been developed and modified to reflect these new elements. There is no one scale applicable to all populations. A discussion about the strengths and weaknesses of each available assessment tool is outside the scope of this review. However, to date, the POQ-VA is the only instrument that has been validated to detect change following treatment of chronic pain in an exclusively veteran population.¹⁰ This validation emphasizes the importance of this study as it supports the use of this outcome measure to monitor treatment of pain in VA facilities.

One of the secondary findings indicated that injection therapy improved veterans’ physical activity levels and self-esteem and lowered pain scores as well as kinesiophobia and anxiety. The role of interventional procedures has been well established in the field of chronic pain, but their efficacy has been less clear. Injections are costly and not without risk, and these factors relegate them to fourth-line treatment options in most situations.¹⁵ Several meta-analyses have demonstrated small improvements in pain scores and patient-reported questionnaires after medial branch blocks, and lumbar or caudal ESIs for chronic back pain.^5-7 However, an updated Cochrane Review concluded that there was insufficient evidence to support the use of injection therapy in subacute and chronic low back pain.⁸ The review acknowledged the limited methodologic quality of the trials and could not definitively report that injection therapy did not have benefits for certain subgroups of patients. The ability of researchers to detect benefit from an intervention is intrinsically linked to how outcomes are determined. The most interesting finding of our study was the patient-reported improved self-esteem scores. Many trials included in the systematic reviews discussed used outcome measures that did not have the multidimensional scope to demonstrate such a potential benefit.

Limitations

Our relatively small sample size represents the main shortcoming of this study. Because many posttreatment questionnaires were never collected, unfortunately, much potential data was lost. Most procedures performed were corticosteroid injections for the treatment of low back pain. This represented a combination of lumbar ESI, caudal ESI, medial branch blocks, and sacroiliac joint injections. The limited numbers meant that a further regression analysis of each injection type was not possible. Since few interventions treated pain in other areas of the body, it is difficult to determine whether procedures such as hip joint injections and ilioinguinal nerve blocks provided overall benefit. In the same vein, there is an inability to comment on which injection for chronic low back pain was the most efficacious.

The veteran population, while similar to the general population experiencing chronic pain, is more likely to experience PTSD and other mental health conditions.² According to medical literature, no randomized controlled trials have been published examining pain interventions exclusively in veterans, so the applicability of these results needs further investigation. This study suggests there are potential benefits for the veteran population, not solely perhaps from receiving injection therapy, but to having access to an interventional pain clinic led by a pain physician within a network of other specialties. While limited by the inherent biases of a retrospective review, this study highlights the potential value in continuing to study this subgroup of patients, especially in the setting of an interdisciplinary approach.

Conclusions

The POQ-VA is the only instrument to date that has been validated to detect change following treatment of chronic pain in an exclusively veteran population. Our study is the first univariate analysis since the instrument’s validation in 2003. Our descriptive and inferential statistics suggest that the majority of veterans undergoing injection therapy for chronic pain had statistically significant improvements in POQ-VA measures within a 6-month period following treatment. In order to conduct more rigorous, multivariate studies, continued and more widespread use of the POQ-VA instrument is warranted.

Chronic pain is persistent or recurring pain lasting more than 3 months past normal healing time. Primary care professionals usually refer patients experiencing chronic pain to pain specialists to better identify, treat, and manage the pain. Chronic noncancer-related pain affects more Americans than diabetes mellitus, cardiac disease, and cancer combined.¹ Veterans are no exception. The prevalence of severe pain was significantly higher in veterans compared with that of nonveterans who had back pain (21.6 vs 16.7%, respectively), jaw pain (37.5 vs 22.9%, respectively), severe headaches or migraine (26.4 vs 15.9%, respectively), and neck pain (27.7 vs 21.4%, respectively).² At an individual level, those who experience chronic pain can expect impaired functional capacity, reduced ability to work, sleep disturbance, reduced social interactions, and considerable psychological distress. At a societal level, the cost of treating chronic pain is exorbitant, exceeding $600 billion annually, yet treatment outcomes remain variable at best.³ Greater efforts are needed to improve and standardize patient outcomes.

Interventional pain procedures performed under fluoroscopic or ultrasound guidance by specialist physicians have shown mixed responses in previous studies. Past systematic reviews demonstrate reductions in pain scores after lumbar or caudal epidural steroid injections (ESIs) and radiofrequency ablation of nerves supplying lumbar and thoracic facet joints.^4-7 However, one review found insufficient evidence to support injection therapy for chronic low back pain.⁸ Unfortunately, the majority of the included studies evaluated outcomes using the visual analogue scale (VAS) or other limited factors, such as physical examination findings. Current biopsychosocial conceptualizations of chronic pain are beginning to recognize the complex nature of the experience of pain and highlighting the significance of multimodal management.⁹ It is vital that our assessment of chronic pain, like our treatment options, be multidimensional and reflect these underpinning principles.

The Pain Outcomes Questionnaire-For Veterans (POQ-VA) was developed within the Veterans Health Administration (VHA) by Clark and colleagues in 2003. It represents a brief but psychometrically sound pain outcomes instrument that assesses all key domains and meets accreditation body standards. The POQ-VA is valid and reliable for evaluating effectiveness of treatment of chronic noncancer pain in veterans in routine clinical practice.¹⁰ This review is the first study to use the POQ-VA to assess the impact of interventional pain procedures on veterans with chronic noncancer pain.

The aim of this study was to perform a retrospective review of POQ-VA scores before and after injection-based interventional treatment for chronic pain to determine whether the procedure affected patient outcomes. We hypothesized that POQ-VA scores would improve across multiple domains in the veteran population postprocedure. This study was approved by the Institutional Review Board (IRB-2018-053) at the Providence Veterans Affairs Medical Center (VAMC) in Rhode Island.

Methods

Using the Computerized Patient Record System, all adult veteran patients who had attended at least 2 appointments between April 1, 2009, and April 1, 2019 at the Providence VAMC interventional pain clinic were identified. POQ-VA reports were extracted provided the following criteria were met: (1) the veteran received an injection-based interventional treatment for chronic pain, including trigger point injections, ESIs, nerve blocks, and radiofrequency ablations; (2) the veteran completed POQ-VA both pre- and posttreatment; and (3) posttreatment POQ-VA reports were completed within 6 months of treatment. All patients who did not fit these criteria were excluded from the study.

After deidentification, 112 pre- and posttreatment POQ-VA reports were identified. All subsequent statistical analyses were conducted using Stata SE version 15. Descriptive statistics including mean, range, SD, and percent change were computed for POQ-VA domain—pain, mobility, activities of daily living (ADL), vitality, negative affect, fear, and total raw score—as well as for each POQ-VA question. Given that POQ-VA domain scores were found to be approximately normally distributed without outliers, domain scores were treated as continuous variables, and a paired samples t test was conducted to compare means among POQ-VA domains. Individual question responses were analyzed using nonparametric testing methods to account for the lack of normal distribution in each question, treating the range of 0 to 10 as an ordinal variable. A Wilcoxon matched-pairs signed-rank test was conducted to compare means among individual question responses before and after treatment.

Results

Of 112 included patients, 102 (91%) were male and 10 (9%) were female. The mean age was 62 years (range, 35-90). Diagnosis and procedures varied due to patient symptoms varying from muscle pain, nerve pain, degenerative disc disease, and osteoarthritis.

POQ-VA scores across all domains, including total raw score, showed statistically significant improvement after treatment (Table 1). Directionally, the POQ-VA scores for all 20 questions reflect a positive treatment response and 17 had statistically significant changes (P < .05) (Table 2). The changes in self-perceived energy level, safety, and feelings of tension were not statistically significant. Esteem had the greatest magnitude decrease, falling from 5.2 preprocedure to 3.8 postprocedure (P < .001). Other similarly significant magnitudes of improvement were seen from pre- to postprocedure in questions pertaining to grooming (2.2 to 1.6, P = .003) and the ability to use the bathroom (3.4 to 2.6, P < .001).

Discussion

The most important finding of this study was the ability of the POQ-VA to detect statistically significant positive responses to injection therapy across all domains. The largest improvements were in self-reported pain intensity, pain-related impairment in mobility and ADLs, and self-reported dysphoric effects. The single largest improvement posttreatment was a reduction in scores related to low self-esteem.

Chronic pain can be assessed in a variety of ways ranging from physical examination findings and subjective numerical ratings to extensive patient-reported questionnaires. The International Association for the Study of Pain acknowledges that pain is a complex experience and recommends assessment should be comprehensive.¹¹ Many patient-reported questionnaires are available to clinicians, including some that address pain in a specific body part, such as the Oswestry Low Back Pain Disability Questionnaire, or those that focus on depression or quality-of-life measures, such as the SF-36.^12,13

One major benefit of using the POQ-VA is its potential to demonstrate benefits across multiple domains, reflecting the complex nature of chronic pain. The POQ-VA also separates domain or scale scores, allowing clinicians to identify individuals with different patterns of dysfunction across domains.¹⁰ This separation also provides insight into which treatment options are best for chronic pain patients with predominant patterns or lower scores in certain domains. The use of a single summary score, as seen in other questionnaires such as the Roland-Morris Activity Scale, may conceal treatment-induced changes in specific outcome domains.¹⁴ Additionally, like many other similar instruments, the POQ-VA is easy to understand and use, requires no special training, takes little time to complete, and can be completed in person or over the phone.

As chronic pain has been studied further and its complexity recognized, more instruments have been developed and modified to reflect these new elements. There is no one scale applicable to all populations. A discussion about the strengths and weaknesses of each available assessment tool is outside the scope of this review. However, to date, the POQ-VA is the only instrument that has been validated to detect change following treatment of chronic pain in an exclusively veteran population.¹⁰ This validation emphasizes the importance of this study as it supports the use of this outcome measure to monitor treatment of pain in VA facilities.

One of the secondary findings indicated that injection therapy improved veterans’ physical activity levels and self-esteem and lowered pain scores as well as kinesiophobia and anxiety. The role of interventional procedures has been well established in the field of chronic pain, but their efficacy has been less clear. Injections are costly and not without risk, and these factors relegate them to fourth-line treatment options in most situations.¹⁵ Several meta-analyses have demonstrated small improvements in pain scores and patient-reported questionnaires after medial branch blocks, and lumbar or caudal ESIs for chronic back pain.^5-7 However, an updated Cochrane Review concluded that there was insufficient evidence to support the use of injection therapy in subacute and chronic low back pain.⁸ The review acknowledged the limited methodologic quality of the trials and could not definitively report that injection therapy did not have benefits for certain subgroups of patients. The ability of researchers to detect benefit from an intervention is intrinsically linked to how outcomes are determined. The most interesting finding of our study was the patient-reported improved self-esteem scores. Many trials included in the systematic reviews discussed used outcome measures that did not have the multidimensional scope to demonstrate such a potential benefit.

Limitations

Our relatively small sample size represents the main shortcoming of this study. Because many posttreatment questionnaires were never collected, unfortunately, much potential data was lost. Most procedures performed were corticosteroid injections for the treatment of low back pain. This represented a combination of lumbar ESI, caudal ESI, medial branch blocks, and sacroiliac joint injections. The limited numbers meant that a further regression analysis of each injection type was not possible. Since few interventions treated pain in other areas of the body, it is difficult to determine whether procedures such as hip joint injections and ilioinguinal nerve blocks provided overall benefit. In the same vein, there is an inability to comment on which injection for chronic low back pain was the most efficacious.

The veteran population, while similar to the general population experiencing chronic pain, is more likely to experience PTSD and other mental health conditions.² According to medical literature, no randomized controlled trials have been published examining pain interventions exclusively in veterans, so the applicability of these results needs further investigation. This study suggests there are potential benefits for the veteran population, not solely perhaps from receiving injection therapy, but to having access to an interventional pain clinic led by a pain physician within a network of other specialties. While limited by the inherent biases of a retrospective review, this study highlights the potential value in continuing to study this subgroup of patients, especially in the setting of an interdisciplinary approach.

Conclusions

The POQ-VA is the only instrument to date that has been validated to detect change following treatment of chronic pain in an exclusively veteran population. Our study is the first univariate analysis since the instrument’s validation in 2003. Our descriptive and inferential statistics suggest that the majority of veterans undergoing injection therapy for chronic pain had statistically significant improvements in POQ-VA measures within a 6-month period following treatment. In order to conduct more rigorous, multivariate studies, continued and more widespread use of the POQ-VA instrument is warranted.