Bernard Maria, MD, MBA, Director of the Division of Child Neurology and Developmental Medicine at Goryeb Children’s Hospital in Morristown, NJ, part of the Atlantic Health System, has been recognized with the 2018 Hower Award, the highest recognition from the Child Neurology Society. This prestigious award is given yearly to one member of the Child Neurology Society who is highly regarded by peers as an outstanding teacher and scholar. There is a particular emphasis on contributions to child neurology at national and international levels.

“I am deeply humbled by this award, and the opportunity to honor two of my mentors that were past Hower recipients, Drs. John Menkes and John Freeman,” Dr. Maria said. “I am so grateful to all the children, families, students, and colleagues I have served.”

Dr. Maria has been instrumental in developing specialty services within the Atlantic Health System for children with neurologic and neuromuscular disorders including: autism and development, brain and spinal tumors, concussion, epilepsy, headache and migraine, muscle and nerve diseases, and other neurologic problems. In addition to providing care and shaping future research directions, Dr. Maria has lectured on these topics nationally and internationally. Dr. Maria also is a member of the Neurology Reviews Editorial Advisory Board.

“The Hower Award is the Child Neurology Society’s highest honor, given annually to a child neurologist in recognition for sustained and outstanding contributions to the field of Child Neurology and to the Child Neurology Society,” said Dr. Jonathan W. Mink, MD PhD, President of the Child Neurology Society. “We congratulate Dr. Maria on being the 2018 recipient of this honor and look forward to his presentation at our next annual meeting.”

Dr. Maria received his MD from the Université de Sherbrooke in Sherbrooke, Québec, Canada, and subsequently earned his MBA from the University of Florida. He completed his pediatrics residency at McGill University and pediatric neurology residency at the Johns Hopkins Hospital, where he also served as chief resident. He completed his fellowship in pediatric neuro-oncology at the MD Anderson Cancer Center. He is a diplomate of the American Board of Pediatrics, and American Board of Psychiatry and Neurology (with a special qualification in child neurology).

Dr. Maria is a Fellow of the American Academy of Pediatrics, Fellow of the American Academy of Neurology, Elected Active Member of the Society for Pediatric Research and the American Pediatric Society, the oldest medical society in America. He has been continuously funded by the National Institutes of Health since 2001 for the Neurobiology of Disease in Children (neurobiologyofdisease.com) conferences, and he has been named to national top/best doctors lists multiple times.

Dr. Maria has held a number of professorial roles over his tenure, including Professor of Pediatrics, Neurology, and Neurosciences (with tenure), at the Medical University of South Carolina, Distinguished Chair and Professor of Pediatrics; Professor of Pediatrics, Neurology, and Neurosurgery (with tenure) at the Medical College of Georgia—Georgia Regents University, and currently serves as Professor of Pediatrics and Neurology, Sidney Kimmel Medical College of Thomas Jefferson University in Philadelphia. He has chaired two departments of pediatrics and was founding director of the largest pediatric research institute in the Carolinas, the Charles P. Darby Children’s Research Institute.

Bernard Maria, MD, MBA, Director of the Division of Child Neurology and Developmental Medicine at Goryeb Children’s Hospital in Morristown, NJ, part of the Atlantic Health System, has been recognized with the 2018 Hower Award, the highest recognition from the Child Neurology Society. This prestigious award is given yearly to one member of the Child Neurology Society who is highly regarded by peers as an outstanding teacher and scholar. There is a particular emphasis on contributions to child neurology at national and international levels.

“I am deeply humbled by this award, and the opportunity to honor two of my mentors that were past Hower recipients, Drs. John Menkes and John Freeman,” Dr. Maria said. “I am so grateful to all the children, families, students, and colleagues I have served.”

Dr. Maria has been instrumental in developing specialty services within the Atlantic Health System for children with neurologic and neuromuscular disorders including: autism and development, brain and spinal tumors, concussion, epilepsy, headache and migraine, muscle and nerve diseases, and other neurologic problems. In addition to providing care and shaping future research directions, Dr. Maria has lectured on these topics nationally and internationally. Dr. Maria also is a member of the Neurology Reviews Editorial Advisory Board.

“The Hower Award is the Child Neurology Society’s highest honor, given annually to a child neurologist in recognition for sustained and outstanding contributions to the field of Child Neurology and to the Child Neurology Society,” said Dr. Jonathan W. Mink, MD PhD, President of the Child Neurology Society. “We congratulate Dr. Maria on being the 2018 recipient of this honor and look forward to his presentation at our next annual meeting.”

Dr. Maria received his MD from the Université de Sherbrooke in Sherbrooke, Québec, Canada, and subsequently earned his MBA from the University of Florida. He completed his pediatrics residency at McGill University and pediatric neurology residency at the Johns Hopkins Hospital, where he also served as chief resident. He completed his fellowship in pediatric neuro-oncology at the MD Anderson Cancer Center. He is a diplomate of the American Board of Pediatrics, and American Board of Psychiatry and Neurology (with a special qualification in child neurology).

Dr. Maria is a Fellow of the American Academy of Pediatrics, Fellow of the American Academy of Neurology, Elected Active Member of the Society for Pediatric Research and the American Pediatric Society, the oldest medical society in America. He has been continuously funded by the National Institutes of Health since 2001 for the Neurobiology of Disease in Children (neurobiologyofdisease.com) conferences, and he has been named to national top/best doctors lists multiple times.

Dr. Maria has held a number of professorial roles over his tenure, including Professor of Pediatrics, Neurology, and Neurosciences (with tenure), at the Medical University of South Carolina, Distinguished Chair and Professor of Pediatrics; Professor of Pediatrics, Neurology, and Neurosurgery (with tenure) at the Medical College of Georgia—Georgia Regents University, and currently serves as Professor of Pediatrics and Neurology, Sidney Kimmel Medical College of Thomas Jefferson University in Philadelphia. He has chaired two departments of pediatrics and was founding director of the largest pediatric research institute in the Carolinas, the Charles P. Darby Children’s Research Institute.

Bernard Maria, MD, MBA, Director of the Division of Child Neurology and Developmental Medicine at Goryeb Children’s Hospital in Morristown, NJ, part of the Atlantic Health System, has been recognized with the 2018 Hower Award, the highest recognition from the Child Neurology Society. This prestigious award is given yearly to one member of the Child Neurology Society who is highly regarded by peers as an outstanding teacher and scholar. There is a particular emphasis on contributions to child neurology at national and international levels.

“I am deeply humbled by this award, and the opportunity to honor two of my mentors that were past Hower recipients, Drs. John Menkes and John Freeman,” Dr. Maria said. “I am so grateful to all the children, families, students, and colleagues I have served.”

Dr. Maria has been instrumental in developing specialty services within the Atlantic Health System for children with neurologic and neuromuscular disorders including: autism and development, brain and spinal tumors, concussion, epilepsy, headache and migraine, muscle and nerve diseases, and other neurologic problems. In addition to providing care and shaping future research directions, Dr. Maria has lectured on these topics nationally and internationally. Dr. Maria also is a member of the Neurology Reviews Editorial Advisory Board.

“The Hower Award is the Child Neurology Society’s highest honor, given annually to a child neurologist in recognition for sustained and outstanding contributions to the field of Child Neurology and to the Child Neurology Society,” said Dr. Jonathan W. Mink, MD PhD, President of the Child Neurology Society. “We congratulate Dr. Maria on being the 2018 recipient of this honor and look forward to his presentation at our next annual meeting.”

Dr. Maria received his MD from the Université de Sherbrooke in Sherbrooke, Québec, Canada, and subsequently earned his MBA from the University of Florida. He completed his pediatrics residency at McGill University and pediatric neurology residency at the Johns Hopkins Hospital, where he also served as chief resident. He completed his fellowship in pediatric neuro-oncology at the MD Anderson Cancer Center. He is a diplomate of the American Board of Pediatrics, and American Board of Psychiatry and Neurology (with a special qualification in child neurology).

Dr. Maria is a Fellow of the American Academy of Pediatrics, Fellow of the American Academy of Neurology, Elected Active Member of the Society for Pediatric Research and the American Pediatric Society, the oldest medical society in America. He has been continuously funded by the National Institutes of Health since 2001 for the Neurobiology of Disease in Children (neurobiologyofdisease.com) conferences, and he has been named to national top/best doctors lists multiple times.

Dr. Maria has held a number of professorial roles over his tenure, including Professor of Pediatrics, Neurology, and Neurosciences (with tenure), at the Medical University of South Carolina, Distinguished Chair and Professor of Pediatrics; Professor of Pediatrics, Neurology, and Neurosurgery (with tenure) at the Medical College of Georgia—Georgia Regents University, and currently serves as Professor of Pediatrics and Neurology, Sidney Kimmel Medical College of Thomas Jefferson University in Philadelphia. He has chaired two departments of pediatrics and was founding director of the largest pediatric research institute in the Carolinas, the Charles P. Darby Children’s Research Institute.

If the hospital or clinic where you work is anything like my medical center, the looming deadline of October 1 is anything but a contemplative occasion. There are encounters to close, budgets to prepare, a flurry of e-mails—either pleading or threatening—to complete consults, mandatory training to finish, and on and on with protean tasks in the parlance of bureaucracy. For many it is the nadir of the mundane, mindless drudgery we slog through all year in pursuit of those transcendent moments when we feel morally certain we have made things better for a real human being.

What is the origin and rationale for the federal New Year beginning on October 1? In 1974, Congress passed the Congressional Budget and Impoundment Act. The act shifted the beginning of the fiscal year—for our purposes the date of the federal New Year—from the first of July to October 1. Shifting the end of the fiscal year 3 months later enabled Congress to have additional time to study and prepare to receive the annual budget from the executive office and productively engage in the subsequent negotiations regarding federal spending priorities.¹

For all of us who practice in a federal health care system, our New Year is fast approaching and will indeed be past when most of you read this editorial. While January 1 may be the date for parades and football for the rest of the country, the federal government is not alone in selecting a different day on which to begin the New Year. In fact, were we to look at most of the world, we would find a variety of dates chosen for reasons both symbolic and functional to be the end of an annum. Let’s look at a few of them to see whether we can glean any hints about how we might sublimate what often seem to be meaningless demands into something more personal and profound.

Currently, we are in the last quarter of the Chinese New Year of the earth dog, which began on February 16^, using a lunar calendar. In the modern era China has adopted January 1 as the official New Year, but the traditional Chinese festival remains among the most popular holidays in China—and for good reason. Historically, the New Year in China was a period of turning away from work to focus on the honoring of family both living and dead, those in heaven and on earth joining in one timeless community. The family home was often thoroughly cleaned to purge any residual bad luck from the prior cycle and to welcome the good fortune sought for the coming year.²

Several weeks before the writing of this column, the Jewish people celebrated Rosh Hashanah (literally, “head of the year” in Hebrew), one of the holiest days of the Jewish liturgical calendar. It is a commemoration of both creation and judgment. Rosh Hashanah ushers in a period of introspection and repentance, of taking responsibility for past actions, and of committing to do better in the future.

There are some common themes in all these celebrations, religious or secular, and among the most prominent is preparation. Too often, preparing in federal service is a word associated with resentment and apprehension. The US Department of Veterans Affairs prepares for the next investigation, the US Public Health Service for the next inspection, and the military, sadly, for the next war. Our thoughts are perforce focused on funding and finances: Will the president and Congress agree on a timely and sufficient allocation of resources for all of us to do our work well and without excessive worry and wear?

With the exception of the most powerful among us, these negotiations are far beyond our ken or dominion, and the new fiscal year becomes yet another imposed burden. I suggest that we all take back some of that power and purpose, not literally but psychologically. No, I am not advocating either sedition or a new Hallmark holiday with “Happy Federal New Year” cards and parties. Instead I am inviting all of us to consider how we can reset as we do with our computers.

Management experts tell us that cleaning our desk can have positive mental and even physical health benefits. I am not there, but I am willing to try to be more organized if you are. Combat veteran and psychologist Dr. Brett Moore offers “tips to police your workspace” as a means to fight against stress.³ Organizing your desk is a way to unclutter your mind so it can regain the attitudinal agility that is key to resilience.

Another New Year’s theme is remembering as a way of consolidating lessons learned and rededicating yourself to continue personal and professional growth in the months ahead. Invent your own rituals to commemorate another year of working for federal health care, even if that custom is to mark your calendar another year closer to retirement! Fall is beautiful in many parts of the country: Go outside for a few minutes a couple of times a week. Find somewhere quiet to sit and look around at the leaves turning and reflect. Reflection is literally, “return of light or sound from a surface.” It does not have to be formal meditation but simply mindfully looking back on the year to see what fruitful images and ideas return to you.

Reflection and preparation prime us for the third theme, which is a rekindling of motivation to be better and the commitment to do things differently, however that is expressed in the unique struggles and rewards of each individual’s career. New Year’s resolutions have become a trite cliché for stores to advertise exercise clothing and the Internet to feature fad diets. The ancient history of resolutions reveals their more spiritual nature as a celebration of the renewal of life.⁴

Virtue ethics tells us to look to walk in the steps of those we admire to know how to stay on the higher moral road: Who in your unit or clinic or office inspires you to aspire? There are a multitude of opportunities to recreate your work personae to be more like those you would emulate, the colleagues who are often able to solve the “impossible” problem, to stand up to the bully, and to find the ethical values in even the most ridiculous or demoralizing rule. Songwriter and performer Bob Dylan was right when he wrote, “You’re gonna have to serve somebody, yes indeed.”⁵ But no matter how oppressive we experience that mastery, we must hold tight and recognize that these forces are external.

No one can stop us from the small acts of compassion toward ourselves and one another that keep us free. Pick up the phone or walk over to see someone you know or used to work with and ask how they are doing. Volunteer for a new committee or service project to feel as though your work is more than your job. Repair a torn relationship or mend a departmental fence so you leave work with less emotional baggage than you carried in with you that morning. The next time you want to say something sarcastic or critical, challenge yourself to be silent instead or say something kind or affirming. As a priest I knew once told me, when someone cuts in front of you on the road, instead of raging “bless them before you start cursing.”

After you read this column, take a few minutes to ask yourself how you can cast off the shadows that gather around us from the media and government and find a new way of letting sunlight into your work life. Happy Fiscal Year 2019 from the Editor-in-Chief.

If the hospital or clinic where you work is anything like my medical center, the looming deadline of October 1 is anything but a contemplative occasion. There are encounters to close, budgets to prepare, a flurry of e-mails—either pleading or threatening—to complete consults, mandatory training to finish, and on and on with protean tasks in the parlance of bureaucracy. For many it is the nadir of the mundane, mindless drudgery we slog through all year in pursuit of those transcendent moments when we feel morally certain we have made things better for a real human being.

What is the origin and rationale for the federal New Year beginning on October 1? In 1974, Congress passed the Congressional Budget and Impoundment Act. The act shifted the beginning of the fiscal year—for our purposes the date of the federal New Year—from the first of July to October 1. Shifting the end of the fiscal year 3 months later enabled Congress to have additional time to study and prepare to receive the annual budget from the executive office and productively engage in the subsequent negotiations regarding federal spending priorities.¹

For all of us who practice in a federal health care system, our New Year is fast approaching and will indeed be past when most of you read this editorial. While January 1 may be the date for parades and football for the rest of the country, the federal government is not alone in selecting a different day on which to begin the New Year. In fact, were we to look at most of the world, we would find a variety of dates chosen for reasons both symbolic and functional to be the end of an annum. Let’s look at a few of them to see whether we can glean any hints about how we might sublimate what often seem to be meaningless demands into something more personal and profound.

Currently, we are in the last quarter of the Chinese New Year of the earth dog, which began on February 16^, using a lunar calendar. In the modern era China has adopted January 1 as the official New Year, but the traditional Chinese festival remains among the most popular holidays in China—and for good reason. Historically, the New Year in China was a period of turning away from work to focus on the honoring of family both living and dead, those in heaven and on earth joining in one timeless community. The family home was often thoroughly cleaned to purge any residual bad luck from the prior cycle and to welcome the good fortune sought for the coming year.²

Several weeks before the writing of this column, the Jewish people celebrated Rosh Hashanah (literally, “head of the year” in Hebrew), one of the holiest days of the Jewish liturgical calendar. It is a commemoration of both creation and judgment. Rosh Hashanah ushers in a period of introspection and repentance, of taking responsibility for past actions, and of committing to do better in the future.

There are some common themes in all these celebrations, religious or secular, and among the most prominent is preparation. Too often, preparing in federal service is a word associated with resentment and apprehension. The US Department of Veterans Affairs prepares for the next investigation, the US Public Health Service for the next inspection, and the military, sadly, for the next war. Our thoughts are perforce focused on funding and finances: Will the president and Congress agree on a timely and sufficient allocation of resources for all of us to do our work well and without excessive worry and wear?

With the exception of the most powerful among us, these negotiations are far beyond our ken or dominion, and the new fiscal year becomes yet another imposed burden. I suggest that we all take back some of that power and purpose, not literally but psychologically. No, I am not advocating either sedition or a new Hallmark holiday with “Happy Federal New Year” cards and parties. Instead I am inviting all of us to consider how we can reset as we do with our computers.

Management experts tell us that cleaning our desk can have positive mental and even physical health benefits. I am not there, but I am willing to try to be more organized if you are. Combat veteran and psychologist Dr. Brett Moore offers “tips to police your workspace” as a means to fight against stress.³ Organizing your desk is a way to unclutter your mind so it can regain the attitudinal agility that is key to resilience.

Another New Year’s theme is remembering as a way of consolidating lessons learned and rededicating yourself to continue personal and professional growth in the months ahead. Invent your own rituals to commemorate another year of working for federal health care, even if that custom is to mark your calendar another year closer to retirement! Fall is beautiful in many parts of the country: Go outside for a few minutes a couple of times a week. Find somewhere quiet to sit and look around at the leaves turning and reflect. Reflection is literally, “return of light or sound from a surface.” It does not have to be formal meditation but simply mindfully looking back on the year to see what fruitful images and ideas return to you.

Reflection and preparation prime us for the third theme, which is a rekindling of motivation to be better and the commitment to do things differently, however that is expressed in the unique struggles and rewards of each individual’s career. New Year’s resolutions have become a trite cliché for stores to advertise exercise clothing and the Internet to feature fad diets. The ancient history of resolutions reveals their more spiritual nature as a celebration of the renewal of life.⁴

Virtue ethics tells us to look to walk in the steps of those we admire to know how to stay on the higher moral road: Who in your unit or clinic or office inspires you to aspire? There are a multitude of opportunities to recreate your work personae to be more like those you would emulate, the colleagues who are often able to solve the “impossible” problem, to stand up to the bully, and to find the ethical values in even the most ridiculous or demoralizing rule. Songwriter and performer Bob Dylan was right when he wrote, “You’re gonna have to serve somebody, yes indeed.”⁵ But no matter how oppressive we experience that mastery, we must hold tight and recognize that these forces are external.

No one can stop us from the small acts of compassion toward ourselves and one another that keep us free. Pick up the phone or walk over to see someone you know or used to work with and ask how they are doing. Volunteer for a new committee or service project to feel as though your work is more than your job. Repair a torn relationship or mend a departmental fence so you leave work with less emotional baggage than you carried in with you that morning. The next time you want to say something sarcastic or critical, challenge yourself to be silent instead or say something kind or affirming. As a priest I knew once told me, when someone cuts in front of you on the road, instead of raging “bless them before you start cursing.”

After you read this column, take a few minutes to ask yourself how you can cast off the shadows that gather around us from the media and government and find a new way of letting sunlight into your work life. Happy Fiscal Year 2019 from the Editor-in-Chief.

If the hospital or clinic where you work is anything like my medical center, the looming deadline of October 1 is anything but a contemplative occasion. There are encounters to close, budgets to prepare, a flurry of e-mails—either pleading or threatening—to complete consults, mandatory training to finish, and on and on with protean tasks in the parlance of bureaucracy. For many it is the nadir of the mundane, mindless drudgery we slog through all year in pursuit of those transcendent moments when we feel morally certain we have made things better for a real human being.

What is the origin and rationale for the federal New Year beginning on October 1? In 1974, Congress passed the Congressional Budget and Impoundment Act. The act shifted the beginning of the fiscal year—for our purposes the date of the federal New Year—from the first of July to October 1. Shifting the end of the fiscal year 3 months later enabled Congress to have additional time to study and prepare to receive the annual budget from the executive office and productively engage in the subsequent negotiations regarding federal spending priorities.¹

For all of us who practice in a federal health care system, our New Year is fast approaching and will indeed be past when most of you read this editorial. While January 1 may be the date for parades and football for the rest of the country, the federal government is not alone in selecting a different day on which to begin the New Year. In fact, were we to look at most of the world, we would find a variety of dates chosen for reasons both symbolic and functional to be the end of an annum. Let’s look at a few of them to see whether we can glean any hints about how we might sublimate what often seem to be meaningless demands into something more personal and profound.

Currently, we are in the last quarter of the Chinese New Year of the earth dog, which began on February 16^, using a lunar calendar. In the modern era China has adopted January 1 as the official New Year, but the traditional Chinese festival remains among the most popular holidays in China—and for good reason. Historically, the New Year in China was a period of turning away from work to focus on the honoring of family both living and dead, those in heaven and on earth joining in one timeless community. The family home was often thoroughly cleaned to purge any residual bad luck from the prior cycle and to welcome the good fortune sought for the coming year.²

Several weeks before the writing of this column, the Jewish people celebrated Rosh Hashanah (literally, “head of the year” in Hebrew), one of the holiest days of the Jewish liturgical calendar. It is a commemoration of both creation and judgment. Rosh Hashanah ushers in a period of introspection and repentance, of taking responsibility for past actions, and of committing to do better in the future.

There are some common themes in all these celebrations, religious or secular, and among the most prominent is preparation. Too often, preparing in federal service is a word associated with resentment and apprehension. The US Department of Veterans Affairs prepares for the next investigation, the US Public Health Service for the next inspection, and the military, sadly, for the next war. Our thoughts are perforce focused on funding and finances: Will the president and Congress agree on a timely and sufficient allocation of resources for all of us to do our work well and without excessive worry and wear?

With the exception of the most powerful among us, these negotiations are far beyond our ken or dominion, and the new fiscal year becomes yet another imposed burden. I suggest that we all take back some of that power and purpose, not literally but psychologically. No, I am not advocating either sedition or a new Hallmark holiday with “Happy Federal New Year” cards and parties. Instead I am inviting all of us to consider how we can reset as we do with our computers.

Management experts tell us that cleaning our desk can have positive mental and even physical health benefits. I am not there, but I am willing to try to be more organized if you are. Combat veteran and psychologist Dr. Brett Moore offers “tips to police your workspace” as a means to fight against stress.³ Organizing your desk is a way to unclutter your mind so it can regain the attitudinal agility that is key to resilience.

Another New Year’s theme is remembering as a way of consolidating lessons learned and rededicating yourself to continue personal and professional growth in the months ahead. Invent your own rituals to commemorate another year of working for federal health care, even if that custom is to mark your calendar another year closer to retirement! Fall is beautiful in many parts of the country: Go outside for a few minutes a couple of times a week. Find somewhere quiet to sit and look around at the leaves turning and reflect. Reflection is literally, “return of light or sound from a surface.” It does not have to be formal meditation but simply mindfully looking back on the year to see what fruitful images and ideas return to you.

Reflection and preparation prime us for the third theme, which is a rekindling of motivation to be better and the commitment to do things differently, however that is expressed in the unique struggles and rewards of each individual’s career. New Year’s resolutions have become a trite cliché for stores to advertise exercise clothing and the Internet to feature fad diets. The ancient history of resolutions reveals their more spiritual nature as a celebration of the renewal of life.⁴

Virtue ethics tells us to look to walk in the steps of those we admire to know how to stay on the higher moral road: Who in your unit or clinic or office inspires you to aspire? There are a multitude of opportunities to recreate your work personae to be more like those you would emulate, the colleagues who are often able to solve the “impossible” problem, to stand up to the bully, and to find the ethical values in even the most ridiculous or demoralizing rule. Songwriter and performer Bob Dylan was right when he wrote, “You’re gonna have to serve somebody, yes indeed.”⁵ But no matter how oppressive we experience that mastery, we must hold tight and recognize that these forces are external.

No one can stop us from the small acts of compassion toward ourselves and one another that keep us free. Pick up the phone or walk over to see someone you know or used to work with and ask how they are doing. Volunteer for a new committee or service project to feel as though your work is more than your job. Repair a torn relationship or mend a departmental fence so you leave work with less emotional baggage than you carried in with you that morning. The next time you want to say something sarcastic or critical, challenge yourself to be silent instead or say something kind or affirming. As a priest I knew once told me, when someone cuts in front of you on the road, instead of raging “bless them before you start cursing.”

After you read this column, take a few minutes to ask yourself how you can cast off the shadows that gather around us from the media and government and find a new way of letting sunlight into your work life. Happy Fiscal Year 2019 from the Editor-in-Chief.

The Centers for Disease Control and Prevention lists cardiovascular-related diseases as a leading cause of mortality.¹ The medication class of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, more commonly known as statins, is first-line therapy to prevent negative cardiovascular outcomes and reduce premature death.² Additional hyperlipidemia medications, such as fish oil, can be added for potential cardiovascular benefit.

Yokoyama and colleagues demonstrated that fish oil is a promising treatment for the prevention of major coronary events in patients with hypercholesterolemia.³ Furthermore, Macchia and colleagues found reductions in cardiovascular outcomes and all-cause mortality in postmyocardial infarction patients treated with fish oil and statin combination therapy.⁴ In contrast, the Outcomes Reduction with an Initial Glargine Intervention (ORIGIN) trial found glucose intolerant and patients with diabetes mellitus did not have improved cardiovascular outcomes with fish oil therapy.⁵ Likewise The Risk and Prevention Study Collaborative Group found fish oil supplementation provided no benefit for primary prevention in patients with multiple cardiovascular risk factors.⁶ These studies demonstrate fish oil therapy can cause diverse cardiovascular outcomes in different patient populations.

Currently, there are no studies examining the impact of fish oil and statin combination therapy on the US veteran population. The research of Yokoyama, Macchia, and The Risk and Prevention Study Collaborative Group took place in Japanese and Italian populations, which impacts their external validity.^3,4,6 Furthermore, these studies had higher rates of female subjects when compared with the US veteran population. For example, 68% of female subjects in the Yokoyama study received fish oil therapy.³ Also, the ORIGIN trial subjects were restricted to patients with diabetes mellitus or who were glucose intolerant, which is not reflective of the entire veteran population.⁵ These differences can make it difficult to define the role of fish oil and statin combination therapy in treating cardiovascular disease and reducing mortality in the veteran population.

This study aims to help the US Department of Veterans Affairs (VA) primary care providers and clinical pharmacists address the role of fish oil and statin combination therapy in the prevention of cardiovascular disease and all-cause mortality in the veteran population. The addition of fish oil to statin therapy was compared with an established standard of care, statin monotherapy, in veterans at the Fargo Veterans Affairs Health Care System (FVAHCS).

Methods

A retrospective chart review was conducted using the FVAHCS Computerized Patient Record System (CPRS). The institution’s review board and VA medical center approved the study. Eligible veterans with prescriptions for fish oil or statin therapy between January 1, 2000 and September 30, 2015 were randomly selected, reviewed, and sorted based on inclusion and exclusion criteria. 

The primary outcome was time to aggregate cardiovascular events, specifically myocardial infarction (MI), stroke, transient ischemic attack, coronary artery bypass graft, and percutaneous intervention. Adverse cardiovascular event data were obtained from the veterans’ International Classification of Disease (ICD) 9 codes. Furthermore, the secondary outcome—time to all-cause mortality—was gathered by death records in CPRS. Time to these events was compared in veterans on fish oil and statin combination therapy or statin monotherapy. The date of the cardiovascular event or death was recorded for each outcome and was obtained by reviewing provider notes that documented the incidence. If a specific day or month of incidence was not documented, July 1 was selected as the default date for the adverse cardiovascular event.

Demographics, medication adherence, diagnoses, lab values within 90 days of initiation of therapy, and primary and secondary outcomes were collected. Demographics that included age, race, and sex all were obtained via chart review. Diagnoses were gathered using ICD 9 codes. Refill history was retrieved to assess adherence. Adherence was calculated by the total days of medication therapy divided by the total days within the study. Total days in the study was calculated by the duration of therapy days between therapy initiation date and a terminating factor. Terminating factors included an adverse cardiovascular event, death, or the study termination date.

Statistics

Demographic and other cohort characterization variables were compared either by a t test, rank sum test, or Fisher exact test given the character of the variable. Kaplan Meier analysis was used to evaluate time to aggregate cardiovascular events and all-cause mortality. VA Informatics and Computing Infrastructure (VINCI) R 3.4.3 was used for data analysis. One of the few combination studies by Macchia and colleagues gave an estimate of unadjusted incident rates for patients treated with statin monotherapy vs fish oil and statin combination therapy in patients having a recent MI.⁴ Based on this information, a power analysis determined that a 2% difference in incidence rate of adverse cardiovascular events could be detected between the 2 cohorts with 1,000 veterans in the statin cohort, and 500 veterans in the fish oil and statin cohort assuming a time to event interval of about 7.5 years. An α level of 0.05 was set to determine statistical significance.

Results

A total of 3,940 veterans with prescriptions for fish oil or statin therapy were randomly reviewed and sorted based on inclusion and exclusion criteria. This inclusion criteria resulted in 2,575 fish oil and statin combination patients and 1,365 statin monotherapy patients. Exclusion criteria produced a final total of 437 fish oil and statin combination patients and 559 statin monotherapy patients. Patient demographics are presented in Table 3. 

All baseline laboratory data were collected within 90 days of therapy initiation (Table 4). Statin monotherapy patients had lower triglyceride levels compared with those of the fish oil and statin combination patients. However, both high-density lipoprotein (HDL) and low-density lipoprotein (LDL) levels were higher in the statin monotherapy patients. As seen in Table 5, diagnosis of heart failure, hypertension, hypothyroidism, and dyslipidemia were higher in the statin monotherapy cohort, while tobacco use and pancreatitis were more prevalent in the fish oil and statin combination cohort. 

Kaplan Meier curves of the primary outcome, time to aggregate adverse cardiovascular event, and the secondary outcome, time to all-cause mortality are shown in Figure 1 and Figure 2, respectively.  This shows adverse cardiovascular events and all-cause mortality for approximately 4,500 days for the fish oil and statin cohort and approximately 6,000 days for the statin monotherapy cohort.

Discussion

Analysis of this study failed to detect a statistically significant difference for time to aggregate adverse cardiovascular events or all-cause mortality. This may be due to fewer adverse cardiovascular events and mortality in the 2 cohorts than was anticipated.

There are no studies examining fish oil and statin therapy in the veteran population and only limited studies comparing statin and fish oil combination therapy vs statin monotherapy for adverse cardiovascular outcomes and all-cause mortality. One of the few comparison studies was by Macchia and colleagues and consisted of 7,924 post MI patients in Italy. Over a 4-year period, researchers found a slight improvement in the adjusted paired-matched population for all-cause mortality in the fish oil and statin therapy cohort vs statin monotherapy (8.6% vs 13.6% P < .001).³ A benefit also was seen in the fish oil and statin cohort vs statin monotherapy in the adjusted paired-matched population for death or stroke (16.7% vs 11.5% P < .001).³

In contrast, this study did not address postmyocardial infarction patients exclusively. Rather, patients in this study had lower morbidity, which resulted in fewer adverse cardiovascular outcomes and a greater difficulty to detect a difference in this healthier population. These healthier patients may derive less benefit from primary or secondary prevention with statin and fish oil combination therapy.

In this study, there were extensive inclusion and exclusion criteria to assess the relationship between the cohorts for adverse cardiovascular events caused by atherosclerotic disease. Veterans were required to take fish oil and statin therapy or statin monotherapy for at least 1 year. Other literature has only examined clinical impact on adverse cardiovascular event outcomes if therapy was a year or longer.⁷ Therefore, to prevent confounders from other medications, veterans who used any hyperlipidemia agent other than fish oil and statin therapy for longer than 1 year were excluded. Extensive exclusion criteria eliminated many veterans. However, the robust exclusion of clotting disorders, arrhythmias, chronic anticoagulation other than aspirin, hormonal medication use, or illegal substance abuse prevented the potential confounder of nonatherosclerotic adverse cardiovascular events, for example, a stroke due to poorly controlled atrial fibrillation.

Comparison of demographic data showed both cohorts were of similar age, sex, and race. Of note the Fargo veteran population was primarily white (> 80% in both cohorts). This is slightly higher than the percentage of whites for all US veterans. The slight difference most likely had a minimal clinical impact. Laboratory values recorded within 90 days of initiation of therapy were largely clinically similar except for triglycerides being significantly higher in the fish oil and statin combination cohort (Table 4). This may reflect selection bias, where providers may be more likely to add fish oil therapy for the potential to further control triglycerides.

Diagnoses of hypertension, heart failure, and dyslipidemia were higher in the statin monotherapy cohort. However, body mass index, tobacco use, and pancreatitis were statistically higher in fish oil and statin combination cohort. Even though there was a statistically significant difference in disease diagnoses, this likely created a minor clinical difference between the groups. This is further illustrated by the similarity of the Charlson Comorbidity Index of 1.6 for fish oil and statin cohort and 1.4 in statin monotherapy cohort.

Strengths

A strength of this study was its adherence rates. Adherence rates were high in both cohorts (Table 6). Fish oil and statin cohort did have slightly lower adherence compared with that of statin monotherapy. This may demonstrate extra pill burden influencing adherence. Overall demographics, laboratory values, disease, and adherence rates were clinically similar in both cohorts, thus reducing the potential for confounders.

Limitations

Limitations of this study include its retrospective chart review design. This design is susceptible to incorrect recording of events. The primary outcome, aggregate adverse cardiovascular events, may have been incorrectly recorded in the medical record as other diseases, such as coronary artery disease or heart disease, and therefore not captured by ICD 9 code retrieval. Also, important information, such as laboratory data, disease, and medication adherence, may not have been documented for all patients. Of note 1 patient in the fish oil and statin combination cohort did not have any recorded laboratory data, disease, or adherence data.

Another limitation is lack of access to medical notes from non-VA providers, which can result in missed data collection. To reduce this limitation, the study excluded veterans that received non-VA fish oil, statins, or other hyperlipidemia medications for > 1 year. Veterans were included only if they used VA-provided fish oil or statins. This inclusion and exclusion criteria reduced the chance of missing data from other facilities because it favored inclusion of only subjects that received care exclusively through the VA.

Last, on study initiation it was not realized that fish oil was not provided by the health care system until about the year 2004. This resulted in less risk days for the fish oil and statin cohort. However, Kaplan Meier analysis lessens this issue from being a confounder. Time to event rates for both the primary and secondary outcomes were similar and most likely would have continued to trend together with the same therapy duration.

Conclusion

Fish oil and statin combination therapy when compared with statin monotherapy failed to show that a statistically significant difference exists in the rates of MI, stroke, transient ischemic attack, coronary artery bypass graft, and percutaneous intervention. The clinical difference of fish oil and statin combination therapy vs statin monotherapy is most likely small or nonexistent. From our literature search, this is the only study concerning the use of fish oil and statin combination therapy in the veteran population. It is most likely that fish oil and statin combination therapy and statin monotherapy are similar for the reduction of time to aggregate adverse cardiovascular events and all-cause mortality in the veteran population.

Acknowledgments
This material is the result of work supported with resources and the use of facilities at the Fargo VA Healthcare System.

The Centers for Disease Control and Prevention lists cardiovascular-related diseases as a leading cause of mortality.¹ The medication class of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, more commonly known as statins, is first-line therapy to prevent negative cardiovascular outcomes and reduce premature death.² Additional hyperlipidemia medications, such as fish oil, can be added for potential cardiovascular benefit.

Yokoyama and colleagues demonstrated that fish oil is a promising treatment for the prevention of major coronary events in patients with hypercholesterolemia.³ Furthermore, Macchia and colleagues found reductions in cardiovascular outcomes and all-cause mortality in postmyocardial infarction patients treated with fish oil and statin combination therapy.⁴ In contrast, the Outcomes Reduction with an Initial Glargine Intervention (ORIGIN) trial found glucose intolerant and patients with diabetes mellitus did not have improved cardiovascular outcomes with fish oil therapy.⁵ Likewise The Risk and Prevention Study Collaborative Group found fish oil supplementation provided no benefit for primary prevention in patients with multiple cardiovascular risk factors.⁶ These studies demonstrate fish oil therapy can cause diverse cardiovascular outcomes in different patient populations.

Currently, there are no studies examining the impact of fish oil and statin combination therapy on the US veteran population. The research of Yokoyama, Macchia, and The Risk and Prevention Study Collaborative Group took place in Japanese and Italian populations, which impacts their external validity.^3,4,6 Furthermore, these studies had higher rates of female subjects when compared with the US veteran population. For example, 68% of female subjects in the Yokoyama study received fish oil therapy.³ Also, the ORIGIN trial subjects were restricted to patients with diabetes mellitus or who were glucose intolerant, which is not reflective of the entire veteran population.⁵ These differences can make it difficult to define the role of fish oil and statin combination therapy in treating cardiovascular disease and reducing mortality in the veteran population.

This study aims to help the US Department of Veterans Affairs (VA) primary care providers and clinical pharmacists address the role of fish oil and statin combination therapy in the prevention of cardiovascular disease and all-cause mortality in the veteran population. The addition of fish oil to statin therapy was compared with an established standard of care, statin monotherapy, in veterans at the Fargo Veterans Affairs Health Care System (FVAHCS).

Methods

A retrospective chart review was conducted using the FVAHCS Computerized Patient Record System (CPRS). The institution’s review board and VA medical center approved the study. Eligible veterans with prescriptions for fish oil or statin therapy between January 1, 2000 and September 30, 2015 were randomly selected, reviewed, and sorted based on inclusion and exclusion criteria. 

The primary outcome was time to aggregate cardiovascular events, specifically myocardial infarction (MI), stroke, transient ischemic attack, coronary artery bypass graft, and percutaneous intervention. Adverse cardiovascular event data were obtained from the veterans’ International Classification of Disease (ICD) 9 codes. Furthermore, the secondary outcome—time to all-cause mortality—was gathered by death records in CPRS. Time to these events was compared in veterans on fish oil and statin combination therapy or statin monotherapy. The date of the cardiovascular event or death was recorded for each outcome and was obtained by reviewing provider notes that documented the incidence. If a specific day or month of incidence was not documented, July 1 was selected as the default date for the adverse cardiovascular event.

Demographics, medication adherence, diagnoses, lab values within 90 days of initiation of therapy, and primary and secondary outcomes were collected. Demographics that included age, race, and sex all were obtained via chart review. Diagnoses were gathered using ICD 9 codes. Refill history was retrieved to assess adherence. Adherence was calculated by the total days of medication therapy divided by the total days within the study. Total days in the study was calculated by the duration of therapy days between therapy initiation date and a terminating factor. Terminating factors included an adverse cardiovascular event, death, or the study termination date.

Statistics

Demographic and other cohort characterization variables were compared either by a t test, rank sum test, or Fisher exact test given the character of the variable. Kaplan Meier analysis was used to evaluate time to aggregate cardiovascular events and all-cause mortality. VA Informatics and Computing Infrastructure (VINCI) R 3.4.3 was used for data analysis. One of the few combination studies by Macchia and colleagues gave an estimate of unadjusted incident rates for patients treated with statin monotherapy vs fish oil and statin combination therapy in patients having a recent MI.⁴ Based on this information, a power analysis determined that a 2% difference in incidence rate of adverse cardiovascular events could be detected between the 2 cohorts with 1,000 veterans in the statin cohort, and 500 veterans in the fish oil and statin cohort assuming a time to event interval of about 7.5 years. An α level of 0.05 was set to determine statistical significance.

Results

A total of 3,940 veterans with prescriptions for fish oil or statin therapy were randomly reviewed and sorted based on inclusion and exclusion criteria. This inclusion criteria resulted in 2,575 fish oil and statin combination patients and 1,365 statin monotherapy patients. Exclusion criteria produced a final total of 437 fish oil and statin combination patients and 559 statin monotherapy patients. Patient demographics are presented in Table 3. 

All baseline laboratory data were collected within 90 days of therapy initiation (Table 4). Statin monotherapy patients had lower triglyceride levels compared with those of the fish oil and statin combination patients. However, both high-density lipoprotein (HDL) and low-density lipoprotein (LDL) levels were higher in the statin monotherapy patients. As seen in Table 5, diagnosis of heart failure, hypertension, hypothyroidism, and dyslipidemia were higher in the statin monotherapy cohort, while tobacco use and pancreatitis were more prevalent in the fish oil and statin combination cohort. 

Kaplan Meier curves of the primary outcome, time to aggregate adverse cardiovascular event, and the secondary outcome, time to all-cause mortality are shown in Figure 1 and Figure 2, respectively.  This shows adverse cardiovascular events and all-cause mortality for approximately 4,500 days for the fish oil and statin cohort and approximately 6,000 days for the statin monotherapy cohort.

Discussion

Analysis of this study failed to detect a statistically significant difference for time to aggregate adverse cardiovascular events or all-cause mortality. This may be due to fewer adverse cardiovascular events and mortality in the 2 cohorts than was anticipated.

There are no studies examining fish oil and statin therapy in the veteran population and only limited studies comparing statin and fish oil combination therapy vs statin monotherapy for adverse cardiovascular outcomes and all-cause mortality. One of the few comparison studies was by Macchia and colleagues and consisted of 7,924 post MI patients in Italy. Over a 4-year period, researchers found a slight improvement in the adjusted paired-matched population for all-cause mortality in the fish oil and statin therapy cohort vs statin monotherapy (8.6% vs 13.6% P < .001).³ A benefit also was seen in the fish oil and statin cohort vs statin monotherapy in the adjusted paired-matched population for death or stroke (16.7% vs 11.5% P < .001).³

In contrast, this study did not address postmyocardial infarction patients exclusively. Rather, patients in this study had lower morbidity, which resulted in fewer adverse cardiovascular outcomes and a greater difficulty to detect a difference in this healthier population. These healthier patients may derive less benefit from primary or secondary prevention with statin and fish oil combination therapy.

In this study, there were extensive inclusion and exclusion criteria to assess the relationship between the cohorts for adverse cardiovascular events caused by atherosclerotic disease. Veterans were required to take fish oil and statin therapy or statin monotherapy for at least 1 year. Other literature has only examined clinical impact on adverse cardiovascular event outcomes if therapy was a year or longer.⁷ Therefore, to prevent confounders from other medications, veterans who used any hyperlipidemia agent other than fish oil and statin therapy for longer than 1 year were excluded. Extensive exclusion criteria eliminated many veterans. However, the robust exclusion of clotting disorders, arrhythmias, chronic anticoagulation other than aspirin, hormonal medication use, or illegal substance abuse prevented the potential confounder of nonatherosclerotic adverse cardiovascular events, for example, a stroke due to poorly controlled atrial fibrillation.

Comparison of demographic data showed both cohorts were of similar age, sex, and race. Of note the Fargo veteran population was primarily white (> 80% in both cohorts). This is slightly higher than the percentage of whites for all US veterans. The slight difference most likely had a minimal clinical impact. Laboratory values recorded within 90 days of initiation of therapy were largely clinically similar except for triglycerides being significantly higher in the fish oil and statin combination cohort (Table 4). This may reflect selection bias, where providers may be more likely to add fish oil therapy for the potential to further control triglycerides.

Diagnoses of hypertension, heart failure, and dyslipidemia were higher in the statin monotherapy cohort. However, body mass index, tobacco use, and pancreatitis were statistically higher in fish oil and statin combination cohort. Even though there was a statistically significant difference in disease diagnoses, this likely created a minor clinical difference between the groups. This is further illustrated by the similarity of the Charlson Comorbidity Index of 1.6 for fish oil and statin cohort and 1.4 in statin monotherapy cohort.

Strengths

A strength of this study was its adherence rates. Adherence rates were high in both cohorts (Table 6). Fish oil and statin cohort did have slightly lower adherence compared with that of statin monotherapy. This may demonstrate extra pill burden influencing adherence. Overall demographics, laboratory values, disease, and adherence rates were clinically similar in both cohorts, thus reducing the potential for confounders.

Limitations

Limitations of this study include its retrospective chart review design. This design is susceptible to incorrect recording of events. The primary outcome, aggregate adverse cardiovascular events, may have been incorrectly recorded in the medical record as other diseases, such as coronary artery disease or heart disease, and therefore not captured by ICD 9 code retrieval. Also, important information, such as laboratory data, disease, and medication adherence, may not have been documented for all patients. Of note 1 patient in the fish oil and statin combination cohort did not have any recorded laboratory data, disease, or adherence data.

Another limitation is lack of access to medical notes from non-VA providers, which can result in missed data collection. To reduce this limitation, the study excluded veterans that received non-VA fish oil, statins, or other hyperlipidemia medications for > 1 year. Veterans were included only if they used VA-provided fish oil or statins. This inclusion and exclusion criteria reduced the chance of missing data from other facilities because it favored inclusion of only subjects that received care exclusively through the VA.

Last, on study initiation it was not realized that fish oil was not provided by the health care system until about the year 2004. This resulted in less risk days for the fish oil and statin cohort. However, Kaplan Meier analysis lessens this issue from being a confounder. Time to event rates for both the primary and secondary outcomes were similar and most likely would have continued to trend together with the same therapy duration.

Conclusion

Fish oil and statin combination therapy when compared with statin monotherapy failed to show that a statistically significant difference exists in the rates of MI, stroke, transient ischemic attack, coronary artery bypass graft, and percutaneous intervention. The clinical difference of fish oil and statin combination therapy vs statin monotherapy is most likely small or nonexistent. From our literature search, this is the only study concerning the use of fish oil and statin combination therapy in the veteran population. It is most likely that fish oil and statin combination therapy and statin monotherapy are similar for the reduction of time to aggregate adverse cardiovascular events and all-cause mortality in the veteran population.

Acknowledgments
This material is the result of work supported with resources and the use of facilities at the Fargo VA Healthcare System.

The Centers for Disease Control and Prevention lists cardiovascular-related diseases as a leading cause of mortality.¹ The medication class of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, more commonly known as statins, is first-line therapy to prevent negative cardiovascular outcomes and reduce premature death.² Additional hyperlipidemia medications, such as fish oil, can be added for potential cardiovascular benefit.

Yokoyama and colleagues demonstrated that fish oil is a promising treatment for the prevention of major coronary events in patients with hypercholesterolemia.³ Furthermore, Macchia and colleagues found reductions in cardiovascular outcomes and all-cause mortality in postmyocardial infarction patients treated with fish oil and statin combination therapy.⁴ In contrast, the Outcomes Reduction with an Initial Glargine Intervention (ORIGIN) trial found glucose intolerant and patients with diabetes mellitus did not have improved cardiovascular outcomes with fish oil therapy.⁵ Likewise The Risk and Prevention Study Collaborative Group found fish oil supplementation provided no benefit for primary prevention in patients with multiple cardiovascular risk factors.⁶ These studies demonstrate fish oil therapy can cause diverse cardiovascular outcomes in different patient populations.

Currently, there are no studies examining the impact of fish oil and statin combination therapy on the US veteran population. The research of Yokoyama, Macchia, and The Risk and Prevention Study Collaborative Group took place in Japanese and Italian populations, which impacts their external validity.^3,4,6 Furthermore, these studies had higher rates of female subjects when compared with the US veteran population. For example, 68% of female subjects in the Yokoyama study received fish oil therapy.³ Also, the ORIGIN trial subjects were restricted to patients with diabetes mellitus or who were glucose intolerant, which is not reflective of the entire veteran population.⁵ These differences can make it difficult to define the role of fish oil and statin combination therapy in treating cardiovascular disease and reducing mortality in the veteran population.

This study aims to help the US Department of Veterans Affairs (VA) primary care providers and clinical pharmacists address the role of fish oil and statin combination therapy in the prevention of cardiovascular disease and all-cause mortality in the veteran population. The addition of fish oil to statin therapy was compared with an established standard of care, statin monotherapy, in veterans at the Fargo Veterans Affairs Health Care System (FVAHCS).

Methods

A retrospective chart review was conducted using the FVAHCS Computerized Patient Record System (CPRS). The institution’s review board and VA medical center approved the study. Eligible veterans with prescriptions for fish oil or statin therapy between January 1, 2000 and September 30, 2015 were randomly selected, reviewed, and sorted based on inclusion and exclusion criteria. 

The primary outcome was time to aggregate cardiovascular events, specifically myocardial infarction (MI), stroke, transient ischemic attack, coronary artery bypass graft, and percutaneous intervention. Adverse cardiovascular event data were obtained from the veterans’ International Classification of Disease (ICD) 9 codes. Furthermore, the secondary outcome—time to all-cause mortality—was gathered by death records in CPRS. Time to these events was compared in veterans on fish oil and statin combination therapy or statin monotherapy. The date of the cardiovascular event or death was recorded for each outcome and was obtained by reviewing provider notes that documented the incidence. If a specific day or month of incidence was not documented, July 1 was selected as the default date for the adverse cardiovascular event.

Demographics, medication adherence, diagnoses, lab values within 90 days of initiation of therapy, and primary and secondary outcomes were collected. Demographics that included age, race, and sex all were obtained via chart review. Diagnoses were gathered using ICD 9 codes. Refill history was retrieved to assess adherence. Adherence was calculated by the total days of medication therapy divided by the total days within the study. Total days in the study was calculated by the duration of therapy days between therapy initiation date and a terminating factor. Terminating factors included an adverse cardiovascular event, death, or the study termination date.

Statistics

Demographic and other cohort characterization variables were compared either by a t test, rank sum test, or Fisher exact test given the character of the variable. Kaplan Meier analysis was used to evaluate time to aggregate cardiovascular events and all-cause mortality. VA Informatics and Computing Infrastructure (VINCI) R 3.4.3 was used for data analysis. One of the few combination studies by Macchia and colleagues gave an estimate of unadjusted incident rates for patients treated with statin monotherapy vs fish oil and statin combination therapy in patients having a recent MI.⁴ Based on this information, a power analysis determined that a 2% difference in incidence rate of adverse cardiovascular events could be detected between the 2 cohorts with 1,000 veterans in the statin cohort, and 500 veterans in the fish oil and statin cohort assuming a time to event interval of about 7.5 years. An α level of 0.05 was set to determine statistical significance.

Results

A total of 3,940 veterans with prescriptions for fish oil or statin therapy were randomly reviewed and sorted based on inclusion and exclusion criteria. This inclusion criteria resulted in 2,575 fish oil and statin combination patients and 1,365 statin monotherapy patients. Exclusion criteria produced a final total of 437 fish oil and statin combination patients and 559 statin monotherapy patients. Patient demographics are presented in Table 3. 

All baseline laboratory data were collected within 90 days of therapy initiation (Table 4). Statin monotherapy patients had lower triglyceride levels compared with those of the fish oil and statin combination patients. However, both high-density lipoprotein (HDL) and low-density lipoprotein (LDL) levels were higher in the statin monotherapy patients. As seen in Table 5, diagnosis of heart failure, hypertension, hypothyroidism, and dyslipidemia were higher in the statin monotherapy cohort, while tobacco use and pancreatitis were more prevalent in the fish oil and statin combination cohort. 

Kaplan Meier curves of the primary outcome, time to aggregate adverse cardiovascular event, and the secondary outcome, time to all-cause mortality are shown in Figure 1 and Figure 2, respectively.  This shows adverse cardiovascular events and all-cause mortality for approximately 4,500 days for the fish oil and statin cohort and approximately 6,000 days for the statin monotherapy cohort.

Discussion

Analysis of this study failed to detect a statistically significant difference for time to aggregate adverse cardiovascular events or all-cause mortality. This may be due to fewer adverse cardiovascular events and mortality in the 2 cohorts than was anticipated.

There are no studies examining fish oil and statin therapy in the veteran population and only limited studies comparing statin and fish oil combination therapy vs statin monotherapy for adverse cardiovascular outcomes and all-cause mortality. One of the few comparison studies was by Macchia and colleagues and consisted of 7,924 post MI patients in Italy. Over a 4-year period, researchers found a slight improvement in the adjusted paired-matched population for all-cause mortality in the fish oil and statin therapy cohort vs statin monotherapy (8.6% vs 13.6% P < .001).³ A benefit also was seen in the fish oil and statin cohort vs statin monotherapy in the adjusted paired-matched population for death or stroke (16.7% vs 11.5% P < .001).³

In contrast, this study did not address postmyocardial infarction patients exclusively. Rather, patients in this study had lower morbidity, which resulted in fewer adverse cardiovascular outcomes and a greater difficulty to detect a difference in this healthier population. These healthier patients may derive less benefit from primary or secondary prevention with statin and fish oil combination therapy.

In this study, there were extensive inclusion and exclusion criteria to assess the relationship between the cohorts for adverse cardiovascular events caused by atherosclerotic disease. Veterans were required to take fish oil and statin therapy or statin monotherapy for at least 1 year. Other literature has only examined clinical impact on adverse cardiovascular event outcomes if therapy was a year or longer.⁷ Therefore, to prevent confounders from other medications, veterans who used any hyperlipidemia agent other than fish oil and statin therapy for longer than 1 year were excluded. Extensive exclusion criteria eliminated many veterans. However, the robust exclusion of clotting disorders, arrhythmias, chronic anticoagulation other than aspirin, hormonal medication use, or illegal substance abuse prevented the potential confounder of nonatherosclerotic adverse cardiovascular events, for example, a stroke due to poorly controlled atrial fibrillation.

Comparison of demographic data showed both cohorts were of similar age, sex, and race. Of note the Fargo veteran population was primarily white (> 80% in both cohorts). This is slightly higher than the percentage of whites for all US veterans. The slight difference most likely had a minimal clinical impact. Laboratory values recorded within 90 days of initiation of therapy were largely clinically similar except for triglycerides being significantly higher in the fish oil and statin combination cohort (Table 4). This may reflect selection bias, where providers may be more likely to add fish oil therapy for the potential to further control triglycerides.

Diagnoses of hypertension, heart failure, and dyslipidemia were higher in the statin monotherapy cohort. However, body mass index, tobacco use, and pancreatitis were statistically higher in fish oil and statin combination cohort. Even though there was a statistically significant difference in disease diagnoses, this likely created a minor clinical difference between the groups. This is further illustrated by the similarity of the Charlson Comorbidity Index of 1.6 for fish oil and statin cohort and 1.4 in statin monotherapy cohort.

Strengths

A strength of this study was its adherence rates. Adherence rates were high in both cohorts (Table 6). Fish oil and statin cohort did have slightly lower adherence compared with that of statin monotherapy. This may demonstrate extra pill burden influencing adherence. Overall demographics, laboratory values, disease, and adherence rates were clinically similar in both cohorts, thus reducing the potential for confounders.

Limitations

Limitations of this study include its retrospective chart review design. This design is susceptible to incorrect recording of events. The primary outcome, aggregate adverse cardiovascular events, may have been incorrectly recorded in the medical record as other diseases, such as coronary artery disease or heart disease, and therefore not captured by ICD 9 code retrieval. Also, important information, such as laboratory data, disease, and medication adherence, may not have been documented for all patients. Of note 1 patient in the fish oil and statin combination cohort did not have any recorded laboratory data, disease, or adherence data.

Another limitation is lack of access to medical notes from non-VA providers, which can result in missed data collection. To reduce this limitation, the study excluded veterans that received non-VA fish oil, statins, or other hyperlipidemia medications for > 1 year. Veterans were included only if they used VA-provided fish oil or statins. This inclusion and exclusion criteria reduced the chance of missing data from other facilities because it favored inclusion of only subjects that received care exclusively through the VA.

Last, on study initiation it was not realized that fish oil was not provided by the health care system until about the year 2004. This resulted in less risk days for the fish oil and statin cohort. However, Kaplan Meier analysis lessens this issue from being a confounder. Time to event rates for both the primary and secondary outcomes were similar and most likely would have continued to trend together with the same therapy duration.

Conclusion

Fish oil and statin combination therapy when compared with statin monotherapy failed to show that a statistically significant difference exists in the rates of MI, stroke, transient ischemic attack, coronary artery bypass graft, and percutaneous intervention. The clinical difference of fish oil and statin combination therapy vs statin monotherapy is most likely small or nonexistent. From our literature search, this is the only study concerning the use of fish oil and statin combination therapy in the veteran population. It is most likely that fish oil and statin combination therapy and statin monotherapy are similar for the reduction of time to aggregate adverse cardiovascular events and all-cause mortality in the veteran population.

Acknowledgments
This material is the result of work supported with resources and the use of facilities at the Fargo VA Healthcare System.

Targeting inflammation in people with schizophrenia could lead to improvements in daily functioning, a study by Sophia Kogan, MD, PhD, and her associates at the Icahn School of Medicine at Mount Sinai, New York, has suggested.

“Our findings invite speculation about the underlying link between inflammation and neurocognitive dysfunction in schizophrenia,” Dr. Kogan and her associates wrote in Brain, Behavior, and Immunity. “Our results suggest that these associations also extend to poor daily functioning in this population.”

The researchers used data collected from a clinical trial that examined the effect of aerobic exercise training on neurocognition in schizophrenia (NCT01897064) to analyze neurocognition, functions of daily living, and inflammatory markers in 41 adults aged 18-55 years with schizophrenia, schizoaffective disorder, or psychosis. Among the individuals in the trial, 36% were female, the average age was 37 years, and the average body mass index was 31 kg/m². In addition, all of the individuals were either taking antipsychotics or were on doses of injectable depot antipsychotics. People with active substance use and mild depressive symptoms were excluded.

Dr. Kogan and her associates found that poorer neurocognition was tied to increased levels of peripheral tumor necrosis factor–alpha (TNF-a) and interleukin-12 (IL-12p70).

“For TNF-a, these findings were driven primarily by significant associations with poorer neurocognitive performance in the domains of speed of processing (P = .02), visual learning (P = .02), and reasoning and problem solving (P = .03),” wrote Dr. Kogan and her associates. “Similarly, the association between neurocognition and IL-12p70 was driven primarily by decreased speed of processing (P less than .01) and visual learning (P = .05).”

The small sample size was cited as a limitation, as was the exclusion of people with substance use and mild depressive symptoms.

The National Institute of Mental Health funded the study. Dr. Kogan reported no conflicts of interest. Coauthor David Kimhy, PhD, is a consultant to NeuroCog Trials relating to another project.

SOURCE: Kogan S et al. Brain Behav Immun. 2018 Sep 12. doi: 10.1016/j.bbi.2018.09.016.

Targeting inflammation in people with schizophrenia could lead to improvements in daily functioning, a study by Sophia Kogan, MD, PhD, and her associates at the Icahn School of Medicine at Mount Sinai, New York, has suggested.

“Our findings invite speculation about the underlying link between inflammation and neurocognitive dysfunction in schizophrenia,” Dr. Kogan and her associates wrote in Brain, Behavior, and Immunity. “Our results suggest that these associations also extend to poor daily functioning in this population.”

The researchers used data collected from a clinical trial that examined the effect of aerobic exercise training on neurocognition in schizophrenia (NCT01897064) to analyze neurocognition, functions of daily living, and inflammatory markers in 41 adults aged 18-55 years with schizophrenia, schizoaffective disorder, or psychosis. Among the individuals in the trial, 36% were female, the average age was 37 years, and the average body mass index was 31 kg/m². In addition, all of the individuals were either taking antipsychotics or were on doses of injectable depot antipsychotics. People with active substance use and mild depressive symptoms were excluded.

Dr. Kogan and her associates found that poorer neurocognition was tied to increased levels of peripheral tumor necrosis factor–alpha (TNF-a) and interleukin-12 (IL-12p70).

“For TNF-a, these findings were driven primarily by significant associations with poorer neurocognitive performance in the domains of speed of processing (P = .02), visual learning (P = .02), and reasoning and problem solving (P = .03),” wrote Dr. Kogan and her associates. “Similarly, the association between neurocognition and IL-12p70 was driven primarily by decreased speed of processing (P less than .01) and visual learning (P = .05).”

The small sample size was cited as a limitation, as was the exclusion of people with substance use and mild depressive symptoms.

The National Institute of Mental Health funded the study. Dr. Kogan reported no conflicts of interest. Coauthor David Kimhy, PhD, is a consultant to NeuroCog Trials relating to another project.

SOURCE: Kogan S et al. Brain Behav Immun. 2018 Sep 12. doi: 10.1016/j.bbi.2018.09.016.

Targeting inflammation in people with schizophrenia could lead to improvements in daily functioning, a study by Sophia Kogan, MD, PhD, and her associates at the Icahn School of Medicine at Mount Sinai, New York, has suggested.

“Our findings invite speculation about the underlying link between inflammation and neurocognitive dysfunction in schizophrenia,” Dr. Kogan and her associates wrote in Brain, Behavior, and Immunity. “Our results suggest that these associations also extend to poor daily functioning in this population.”

The researchers used data collected from a clinical trial that examined the effect of aerobic exercise training on neurocognition in schizophrenia (NCT01897064) to analyze neurocognition, functions of daily living, and inflammatory markers in 41 adults aged 18-55 years with schizophrenia, schizoaffective disorder, or psychosis. Among the individuals in the trial, 36% were female, the average age was 37 years, and the average body mass index was 31 kg/m². In addition, all of the individuals were either taking antipsychotics or were on doses of injectable depot antipsychotics. People with active substance use and mild depressive symptoms were excluded.

Dr. Kogan and her associates found that poorer neurocognition was tied to increased levels of peripheral tumor necrosis factor–alpha (TNF-a) and interleukin-12 (IL-12p70).

“For TNF-a, these findings were driven primarily by significant associations with poorer neurocognitive performance in the domains of speed of processing (P = .02), visual learning (P = .02), and reasoning and problem solving (P = .03),” wrote Dr. Kogan and her associates. “Similarly, the association between neurocognition and IL-12p70 was driven primarily by decreased speed of processing (P less than .01) and visual learning (P = .05).”

The small sample size was cited as a limitation, as was the exclusion of people with substance use and mild depressive symptoms.

The National Institute of Mental Health funded the study. Dr. Kogan reported no conflicts of interest. Coauthor David Kimhy, PhD, is a consultant to NeuroCog Trials relating to another project.

SOURCE: Kogan S et al. Brain Behav Immun. 2018 Sep 12. doi: 10.1016/j.bbi.2018.09.016.

SAN DIEGO – A simplified version of the SYNTAX score for coronary artery disease complexity strongly correlated with the unmodified SYNTAX score and could make it easier for cardiologists to employ it in everyday practice. The modified version can be easily memorized and has simplified values that a clinician can calculate and use to determine an appropriate treatment without breaking their work flow to consult a computerized system.

Jim Kling/MDedge News

“It’s primarily simplifying the values for the location of the lesions that has allowed it to be more memorizable. That does make it a slightly blunter tool, but only slightly,” said Sonya Burgess, MBCHB, during a presentation at the Transcatheter Cardiovascular Therapeutics annual meeting. Dr. Burgess is an interventional cardiologist at the University of New South Wales, Sydney.

In common practice, SYNTAX scores often go uncalculated because of their complexity, despite guidelines that recommend it. “My guess might be that 1 in every 10 [cardiologists] do it, and that’s not right for our patients,” said Dr. Burgess.

Others at the session agreed that SYNTAX is underutilized, but not all agreed with Dr. Burgess’ solution. Notable among the attendees was Patrick Serruys, MD, of Erasmus University, Rotterdam, the Netherlands, who originally published the SYNTAX system. He doesn’t like the idea of simplifying SYNTAX, based in part on previous experience. “About 10 years ago, Boston Scientific found the score too difficult and they wanted to simplify it, but the score completely lost its prognostic value. I was very emotional about that and I said, ‘no, we have to keep all of the components until we understand [the risk factors] much better,’ ” said Dr. Serruys.

But Dr. Burgess argued that the simplified system, which she and her coinvestigators created, makes concessions to the realities of an interventional cardiology suite. To obtain a standard SYNTAX score, “they have to stop doing something or rebook something, or there’s a lesion there that they just want to treat. [With the simplified score], at least before they go on to treat that lesion, they don’t have to take their gowns and gloves off. You can even have a card hanging on the bar [to refer to].” Dr. Burgess did not provide details of the system.

Courtesy Cardiovascular Research Foundation

Dr. Serruys agreed with the source of the problem. “Dr. Burgess is right, it is somewhat demanding,” he allowed, but he also called on clinicians to consider the needs of the patient, even going so far as picturing the patient as a family member. “People complain that doing the SYNTAX is on average 7 minutes, with a standard deviation of 7, so you could work 15 minutes just looking at film. But when you think that the future of your father or brother is depending on the surgeon and the cardiologist looking carefully, I find the argument absolutely obnoxious,” said Dr. Serruys at the meeting sponsored by the Cardiovascular Research Foundation.

Rather than simplification, he stresses teamwork. With at least three people looking at the angiogram, the results are consistent and useful. “You look at the film with the trainees, and that’s how they learn. Never do a SYNTAX score alone,” said Dr. Serruys.

To assess the simplified SYNTAX score, the researchers conducted a retrospective assessment of both the SYNTAX score and the simplified SYNTAX score in 617 patients who had multivessel disease. They performed both assessments in subgroups of patients with 169 patients with ST-segment elevation MI, 78 patients with chronic total occlusion, and 113 patients with left main coronary artery (LMCA) stenosis. They used a 100-patient derivation cohort to determine cutoffs for patients who would not be suitable for percutaneous coronary intervention. They also looked at the accuracy of the simplified version compared with standard SYNTAX in 517 patients from five tertiary centers.

The Spearman’s rho value was 0.93 overall and at least 0.91 for all subgroups (P less than .001 for all). In patients with LMCA stenosis, the simplified version had a sensitivity of 100%, specificity of 85%, negative predictive of 100%, and an area under the curve of 1.0 (P less than .001). For patients with multivessel disease and no LMCA stenosis, the values were 98%, 82%, 99%, and 0.971, respectively (P less than .001).

Dr. Burgess and Dr. Serruys reported no financial conflicts of interest.

SAN DIEGO – A simplified version of the SYNTAX score for coronary artery disease complexity strongly correlated with the unmodified SYNTAX score and could make it easier for cardiologists to employ it in everyday practice. The modified version can be easily memorized and has simplified values that a clinician can calculate and use to determine an appropriate treatment without breaking their work flow to consult a computerized system.

Jim Kling/MDedge News

“It’s primarily simplifying the values for the location of the lesions that has allowed it to be more memorizable. That does make it a slightly blunter tool, but only slightly,” said Sonya Burgess, MBCHB, during a presentation at the Transcatheter Cardiovascular Therapeutics annual meeting. Dr. Burgess is an interventional cardiologist at the University of New South Wales, Sydney.

In common practice, SYNTAX scores often go uncalculated because of their complexity, despite guidelines that recommend it. “My guess might be that 1 in every 10 [cardiologists] do it, and that’s not right for our patients,” said Dr. Burgess.

Others at the session agreed that SYNTAX is underutilized, but not all agreed with Dr. Burgess’ solution. Notable among the attendees was Patrick Serruys, MD, of Erasmus University, Rotterdam, the Netherlands, who originally published the SYNTAX system. He doesn’t like the idea of simplifying SYNTAX, based in part on previous experience. “About 10 years ago, Boston Scientific found the score too difficult and they wanted to simplify it, but the score completely lost its prognostic value. I was very emotional about that and I said, ‘no, we have to keep all of the components until we understand [the risk factors] much better,’ ” said Dr. Serruys.

But Dr. Burgess argued that the simplified system, which she and her coinvestigators created, makes concessions to the realities of an interventional cardiology suite. To obtain a standard SYNTAX score, “they have to stop doing something or rebook something, or there’s a lesion there that they just want to treat. [With the simplified score], at least before they go on to treat that lesion, they don’t have to take their gowns and gloves off. You can even have a card hanging on the bar [to refer to].” Dr. Burgess did not provide details of the system.

Courtesy Cardiovascular Research Foundation

Dr. Serruys agreed with the source of the problem. “Dr. Burgess is right, it is somewhat demanding,” he allowed, but he also called on clinicians to consider the needs of the patient, even going so far as picturing the patient as a family member. “People complain that doing the SYNTAX is on average 7 minutes, with a standard deviation of 7, so you could work 15 minutes just looking at film. But when you think that the future of your father or brother is depending on the surgeon and the cardiologist looking carefully, I find the argument absolutely obnoxious,” said Dr. Serruys at the meeting sponsored by the Cardiovascular Research Foundation.

Rather than simplification, he stresses teamwork. With at least three people looking at the angiogram, the results are consistent and useful. “You look at the film with the trainees, and that’s how they learn. Never do a SYNTAX score alone,” said Dr. Serruys.

To assess the simplified SYNTAX score, the researchers conducted a retrospective assessment of both the SYNTAX score and the simplified SYNTAX score in 617 patients who had multivessel disease. They performed both assessments in subgroups of patients with 169 patients with ST-segment elevation MI, 78 patients with chronic total occlusion, and 113 patients with left main coronary artery (LMCA) stenosis. They used a 100-patient derivation cohort to determine cutoffs for patients who would not be suitable for percutaneous coronary intervention. They also looked at the accuracy of the simplified version compared with standard SYNTAX in 517 patients from five tertiary centers.

The Spearman’s rho value was 0.93 overall and at least 0.91 for all subgroups (P less than .001 for all). In patients with LMCA stenosis, the simplified version had a sensitivity of 100%, specificity of 85%, negative predictive of 100%, and an area under the curve of 1.0 (P less than .001). For patients with multivessel disease and no LMCA stenosis, the values were 98%, 82%, 99%, and 0.971, respectively (P less than .001).

Dr. Burgess and Dr. Serruys reported no financial conflicts of interest.

SAN DIEGO – A simplified version of the SYNTAX score for coronary artery disease complexity strongly correlated with the unmodified SYNTAX score and could make it easier for cardiologists to employ it in everyday practice. The modified version can be easily memorized and has simplified values that a clinician can calculate and use to determine an appropriate treatment without breaking their work flow to consult a computerized system.

Jim Kling/MDedge News

“It’s primarily simplifying the values for the location of the lesions that has allowed it to be more memorizable. That does make it a slightly blunter tool, but only slightly,” said Sonya Burgess, MBCHB, during a presentation at the Transcatheter Cardiovascular Therapeutics annual meeting. Dr. Burgess is an interventional cardiologist at the University of New South Wales, Sydney.

In common practice, SYNTAX scores often go uncalculated because of their complexity, despite guidelines that recommend it. “My guess might be that 1 in every 10 [cardiologists] do it, and that’s not right for our patients,” said Dr. Burgess.

Others at the session agreed that SYNTAX is underutilized, but not all agreed with Dr. Burgess’ solution. Notable among the attendees was Patrick Serruys, MD, of Erasmus University, Rotterdam, the Netherlands, who originally published the SYNTAX system. He doesn’t like the idea of simplifying SYNTAX, based in part on previous experience. “About 10 years ago, Boston Scientific found the score too difficult and they wanted to simplify it, but the score completely lost its prognostic value. I was very emotional about that and I said, ‘no, we have to keep all of the components until we understand [the risk factors] much better,’ ” said Dr. Serruys.

But Dr. Burgess argued that the simplified system, which she and her coinvestigators created, makes concessions to the realities of an interventional cardiology suite. To obtain a standard SYNTAX score, “they have to stop doing something or rebook something, or there’s a lesion there that they just want to treat. [With the simplified score], at least before they go on to treat that lesion, they don’t have to take their gowns and gloves off. You can even have a card hanging on the bar [to refer to].” Dr. Burgess did not provide details of the system.

Courtesy Cardiovascular Research Foundation

Dr. Serruys agreed with the source of the problem. “Dr. Burgess is right, it is somewhat demanding,” he allowed, but he also called on clinicians to consider the needs of the patient, even going so far as picturing the patient as a family member. “People complain that doing the SYNTAX is on average 7 minutes, with a standard deviation of 7, so you could work 15 minutes just looking at film. But when you think that the future of your father or brother is depending on the surgeon and the cardiologist looking carefully, I find the argument absolutely obnoxious,” said Dr. Serruys at the meeting sponsored by the Cardiovascular Research Foundation.

Rather than simplification, he stresses teamwork. With at least three people looking at the angiogram, the results are consistent and useful. “You look at the film with the trainees, and that’s how they learn. Never do a SYNTAX score alone,” said Dr. Serruys.

To assess the simplified SYNTAX score, the researchers conducted a retrospective assessment of both the SYNTAX score and the simplified SYNTAX score in 617 patients who had multivessel disease. They performed both assessments in subgroups of patients with 169 patients with ST-segment elevation MI, 78 patients with chronic total occlusion, and 113 patients with left main coronary artery (LMCA) stenosis. They used a 100-patient derivation cohort to determine cutoffs for patients who would not be suitable for percutaneous coronary intervention. They also looked at the accuracy of the simplified version compared with standard SYNTAX in 517 patients from five tertiary centers.

The Spearman’s rho value was 0.93 overall and at least 0.91 for all subgroups (P less than .001 for all). In patients with LMCA stenosis, the simplified version had a sensitivity of 100%, specificity of 85%, negative predictive of 100%, and an area under the curve of 1.0 (P less than .001). For patients with multivessel disease and no LMCA stenosis, the values were 98%, 82%, 99%, and 0.971, respectively (P less than .001).

Dr. Burgess and Dr. Serruys reported no financial conflicts of interest.

Click here to read the supplement.

What can be done to address the burden of asthma beyond pharmacotherapy? A panel of experts discuss steps for addressing sensitization to allergens that trigger increased asthma burden.

Topics Include:

• Identifying Patients with Allergic Components of Asthma
• Identifying and Addressing Allergen Exposure in Daily Practice
• The Opportunity for Payers and Health Systems for Supporting Trigger Avoidance Education

Click here to read the supplement.

Click here to read the supplement.

What can be done to address the burden of asthma beyond pharmacotherapy? A panel of experts discuss steps for addressing sensitization to allergens that trigger increased asthma burden.

Topics Include:

• Identifying Patients with Allergic Components of Asthma
• Identifying and Addressing Allergen Exposure in Daily Practice
• The Opportunity for Payers and Health Systems for Supporting Trigger Avoidance Education

Click here to read the supplement.

Click here to read the supplement.

What can be done to address the burden of asthma beyond pharmacotherapy? A panel of experts discuss steps for addressing sensitization to allergens that trigger increased asthma burden.

Topics Include:

• Identifying Patients with Allergic Components of Asthma
• Identifying and Addressing Allergen Exposure in Daily Practice
• The Opportunity for Payers and Health Systems for Supporting Trigger Avoidance Education

Click here to read the supplement.

The link between obesity and renal cell carcinoma (RCC) appears to be complex and may provide insight into differing etiologies for various histologic subtypes of this cancer, according to a nested case-control study and subsequent meta-analysis.

Investigators led by Catherine L. Callahan, PhD, a postdoctoral fellow with the Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Md., first analyzed data from the Kaiser Permanente Northern California health care network. They matched 685 patients with RCC (421 clear cell, 65 papillary, 24 chromophobe, 35 other, and 140 not otherwise specified) with 4,266 unaffected control patients on age, sex, race/ethnicity, duration of network membership, and medical center of diagnosis.

Compared with normal-weight counterparts (body mass index less than 25 kg/m²), obese patients (body mass index of at least 30 kg/m²), had a significantly elevated risk of clear cell RCC (odds ratio, 1.5) and a nonsignificantly elevated risk of chromophobe RCC (2.5), but a similar risk of papillary RCC (1.0), according to results reported in Cancer Epidemiology. Associations weakened when cases were restricted to stage II or higher RCC, suggesting potential bias from incidental diagnoses related to abdominal imaging. Patients who were overweight (body mass index of 25 to 29.9 kg/m²) did not have significantly elevated risks of any subtype of RCC.

The investigators next conducted a meta-analysis, including this new study and three others. Results showed a significant link between obesity and clear cell RCC (summary relative risk, 1.8) and chromophobe RCC (2.2), but not papillary RCC (1.2). Here, however, patients who were overweight also had elevated risks of clear cell RCC (1.3) and chromophobe RCC (1.9).

“Our results provide support for the hypothesis that histologic subtypes of RCC represent distinct etiologic pathways, and that obesity is more strongly associated with risk of clear cell RCC. Additional research to elucidate the underlying biology of specific subtypes of RCC is warranted,” wrote Dr. Callahan and her coinvestigators. “More generally, our findings underscore the importance of accounting for histologic subtype in investigations of RCC etiology.”

The investigators disclosed that they had no conflicts of interest. The research was supported by the Intramural Research Program of the NIH and the National Cancer Institute.

SOURCE: Callahan CL et al. Cancer Epidemiol. 2018 Jul 18, doi: 10.1016/j.canep.2018.07.002.

The link between obesity and renal cell carcinoma (RCC) appears to be complex and may provide insight into differing etiologies for various histologic subtypes of this cancer, according to a nested case-control study and subsequent meta-analysis.

Investigators led by Catherine L. Callahan, PhD, a postdoctoral fellow with the Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Md., first analyzed data from the Kaiser Permanente Northern California health care network. They matched 685 patients with RCC (421 clear cell, 65 papillary, 24 chromophobe, 35 other, and 140 not otherwise specified) with 4,266 unaffected control patients on age, sex, race/ethnicity, duration of network membership, and medical center of diagnosis.

Compared with normal-weight counterparts (body mass index less than 25 kg/m²), obese patients (body mass index of at least 30 kg/m²), had a significantly elevated risk of clear cell RCC (odds ratio, 1.5) and a nonsignificantly elevated risk of chromophobe RCC (2.5), but a similar risk of papillary RCC (1.0), according to results reported in Cancer Epidemiology. Associations weakened when cases were restricted to stage II or higher RCC, suggesting potential bias from incidental diagnoses related to abdominal imaging. Patients who were overweight (body mass index of 25 to 29.9 kg/m²) did not have significantly elevated risks of any subtype of RCC.

The investigators next conducted a meta-analysis, including this new study and three others. Results showed a significant link between obesity and clear cell RCC (summary relative risk, 1.8) and chromophobe RCC (2.2), but not papillary RCC (1.2). Here, however, patients who were overweight also had elevated risks of clear cell RCC (1.3) and chromophobe RCC (1.9).

“Our results provide support for the hypothesis that histologic subtypes of RCC represent distinct etiologic pathways, and that obesity is more strongly associated with risk of clear cell RCC. Additional research to elucidate the underlying biology of specific subtypes of RCC is warranted,” wrote Dr. Callahan and her coinvestigators. “More generally, our findings underscore the importance of accounting for histologic subtype in investigations of RCC etiology.”

The investigators disclosed that they had no conflicts of interest. The research was supported by the Intramural Research Program of the NIH and the National Cancer Institute.

SOURCE: Callahan CL et al. Cancer Epidemiol. 2018 Jul 18, doi: 10.1016/j.canep.2018.07.002.

The link between obesity and renal cell carcinoma (RCC) appears to be complex and may provide insight into differing etiologies for various histologic subtypes of this cancer, according to a nested case-control study and subsequent meta-analysis.

Investigators led by Catherine L. Callahan, PhD, a postdoctoral fellow with the Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Md., first analyzed data from the Kaiser Permanente Northern California health care network. They matched 685 patients with RCC (421 clear cell, 65 papillary, 24 chromophobe, 35 other, and 140 not otherwise specified) with 4,266 unaffected control patients on age, sex, race/ethnicity, duration of network membership, and medical center of diagnosis.

Compared with normal-weight counterparts (body mass index less than 25 kg/m²), obese patients (body mass index of at least 30 kg/m²), had a significantly elevated risk of clear cell RCC (odds ratio, 1.5) and a nonsignificantly elevated risk of chromophobe RCC (2.5), but a similar risk of papillary RCC (1.0), according to results reported in Cancer Epidemiology. Associations weakened when cases were restricted to stage II or higher RCC, suggesting potential bias from incidental diagnoses related to abdominal imaging. Patients who were overweight (body mass index of 25 to 29.9 kg/m²) did not have significantly elevated risks of any subtype of RCC.

The investigators next conducted a meta-analysis, including this new study and three others. Results showed a significant link between obesity and clear cell RCC (summary relative risk, 1.8) and chromophobe RCC (2.2), but not papillary RCC (1.2). Here, however, patients who were overweight also had elevated risks of clear cell RCC (1.3) and chromophobe RCC (1.9).

“Our results provide support for the hypothesis that histologic subtypes of RCC represent distinct etiologic pathways, and that obesity is more strongly associated with risk of clear cell RCC. Additional research to elucidate the underlying biology of specific subtypes of RCC is warranted,” wrote Dr. Callahan and her coinvestigators. “More generally, our findings underscore the importance of accounting for histologic subtype in investigations of RCC etiology.”

The investigators disclosed that they had no conflicts of interest. The research was supported by the Intramural Research Program of the NIH and the National Cancer Institute.

SOURCE: Callahan CL et al. Cancer Epidemiol. 2018 Jul 18, doi: 10.1016/j.canep.2018.07.002.

Clinical question: Can one predict whether nonoperative management of spinal epidural abscesses will fail?

Background: Even though spinal epidural abscesses have a low incidence and nonspecific presentation, a delay in treatment can lead to significant morbidity. Previously, operative management was the preferred treatment; however, improvements in imaging and timing of diagnosis have led to an increased interest in nonoperative management. Few studies have identified possible predictors of failure for nonoperative management, and no algorithm exists for weighing the different possible predictors with the outcome of nonoperative management failure.

Study design: Retrospective cohort study.

Setting: A Massachusetts hospital system with two tertiary academic medical centers and three regional community hospitals.

Synopsis: The study evaluated 1,053 patients admitted with a spinal epidural abscess during 1993-2016. Of these, 432 patients were managed nonoperatively, and 367 were included in the analysis. Failure of nonoperative management occurred in 99 patients (27%). These patients were compared with 266 patients with successful nonoperative management with more than 60 days of follow-up. Six independent factors were associated with failure of nonoperative management including motor deficit at presentation (odds ratio, 7.85), pathological or compression fractures (OR, 6.12), active malignancy (OR, 3.32), diabetes (OR, 2.92), sensory changes at presentation (3.48), and location of the abscess dorsal to the thecal sac (OR, 0.29). Subsequently, a clinical algorithm was created to predict the likelihood of failure of nonoperative management.

Because of its retrospective design, the study was unable to assess the efficacy of surgery versus nonoperative management.
 

Bottom line: Specific measures of general health, neurologic status at presentation, and anatomical data of a patient with a spinal epidural abscess have led to the development of a clinical algorithm to determine the risk of failure in nonoperative management of spinal epidural abscesses.

Citation: Shah AA et al. Nonoperative management of spinal epidural abscess: Development of a predictive algorithm for failure. J Bone Joint Surg Am. 2018;100(7):546-55.

Dr. Tsien is a hospitalist in the division of hospital medicine in the department of medicine at Loyola University Chicago, Maywood, Ill.

Clinical question: Can one predict whether nonoperative management of spinal epidural abscesses will fail?

Background: Even though spinal epidural abscesses have a low incidence and nonspecific presentation, a delay in treatment can lead to significant morbidity. Previously, operative management was the preferred treatment; however, improvements in imaging and timing of diagnosis have led to an increased interest in nonoperative management. Few studies have identified possible predictors of failure for nonoperative management, and no algorithm exists for weighing the different possible predictors with the outcome of nonoperative management failure.

Study design: Retrospective cohort study.

Setting: A Massachusetts hospital system with two tertiary academic medical centers and three regional community hospitals.

Synopsis: The study evaluated 1,053 patients admitted with a spinal epidural abscess during 1993-2016. Of these, 432 patients were managed nonoperatively, and 367 were included in the analysis. Failure of nonoperative management occurred in 99 patients (27%). These patients were compared with 266 patients with successful nonoperative management with more than 60 days of follow-up. Six independent factors were associated with failure of nonoperative management including motor deficit at presentation (odds ratio, 7.85), pathological or compression fractures (OR, 6.12), active malignancy (OR, 3.32), diabetes (OR, 2.92), sensory changes at presentation (3.48), and location of the abscess dorsal to the thecal sac (OR, 0.29). Subsequently, a clinical algorithm was created to predict the likelihood of failure of nonoperative management.

Because of its retrospective design, the study was unable to assess the efficacy of surgery versus nonoperative management.
 

Bottom line: Specific measures of general health, neurologic status at presentation, and anatomical data of a patient with a spinal epidural abscess have led to the development of a clinical algorithm to determine the risk of failure in nonoperative management of spinal epidural abscesses.

Citation: Shah AA et al. Nonoperative management of spinal epidural abscess: Development of a predictive algorithm for failure. J Bone Joint Surg Am. 2018;100(7):546-55.

Dr. Tsien is a hospitalist in the division of hospital medicine in the department of medicine at Loyola University Chicago, Maywood, Ill.

Clinical question: Can one predict whether nonoperative management of spinal epidural abscesses will fail?

Background: Even though spinal epidural abscesses have a low incidence and nonspecific presentation, a delay in treatment can lead to significant morbidity. Previously, operative management was the preferred treatment; however, improvements in imaging and timing of diagnosis have led to an increased interest in nonoperative management. Few studies have identified possible predictors of failure for nonoperative management, and no algorithm exists for weighing the different possible predictors with the outcome of nonoperative management failure.

Study design: Retrospective cohort study.

Setting: A Massachusetts hospital system with two tertiary academic medical centers and three regional community hospitals.

Synopsis: The study evaluated 1,053 patients admitted with a spinal epidural abscess during 1993-2016. Of these, 432 patients were managed nonoperatively, and 367 were included in the analysis. Failure of nonoperative management occurred in 99 patients (27%). These patients were compared with 266 patients with successful nonoperative management with more than 60 days of follow-up. Six independent factors were associated with failure of nonoperative management including motor deficit at presentation (odds ratio, 7.85), pathological or compression fractures (OR, 6.12), active malignancy (OR, 3.32), diabetes (OR, 2.92), sensory changes at presentation (3.48), and location of the abscess dorsal to the thecal sac (OR, 0.29). Subsequently, a clinical algorithm was created to predict the likelihood of failure of nonoperative management.

Because of its retrospective design, the study was unable to assess the efficacy of surgery versus nonoperative management.
 

Bottom line: Specific measures of general health, neurologic status at presentation, and anatomical data of a patient with a spinal epidural abscess have led to the development of a clinical algorithm to determine the risk of failure in nonoperative management of spinal epidural abscesses.

Citation: Shah AA et al. Nonoperative management of spinal epidural abscess: Development of a predictive algorithm for failure. J Bone Joint Surg Am. 2018;100(7):546-55.

Dr. Tsien is a hospitalist in the division of hospital medicine in the department of medicine at Loyola University Chicago, Maywood, Ill.

Key leadership in research and oncology addressed attendees of the recent AVAHO annual meeting in Chicago. Carolyn Clancy, MD, deputy undersecretary for health discovery, education and affiliated networks, discussed the important role of cancer in the VA’s research and clinical mission. Neil Spector, MD, director of the National Precision Oncology Program (NPOP) outlined the significant growth in the use of tumor sequencing by NPOP, while Michael Kelley, MD, director of operations for National Oncology discussed the significant strides in opening up access to clinical trials at the VA.

Dr. Clancy addressed AVAHO for the first time and remarked upon the impressive array of research conducted by AVAHO members. “I love the idea of telehealth for genomics,” she remarked about the Genomic Medicine Service Uses Group Telehealth Appointments poster abstract, “it’s brilliant and it’s only the beginning.” The VA’s unique blend of clinical care and research puts it in a unique position to provide cutting edge care to its patients.

Clancy also addressed the larger shift in the VA as it moves from a closed integrated health care system to a high performing network. “We are closer than most systems in this country—public or private—to having a research enterprise that is integral to our mission of providing veterans with great care,” she said. “The magic of bringing [research and clinical] groups together is to enhance the visibility. But frankly it’s also to enhance our capability to take advantage of these assets strategically.” That means providing veterans with “cutting-edge care, and what could be better than that? When we do great things in how we deliver health care that helps your work,” she told attendees.

This shift, as outlined by the VA’s new leadership under Secretary Robert Wilkie and Richard A. Stone, MD, executive in charge of the Veterans Health Administration (VHA), is designed to restore veterans’ trust and confidence in the system, foster an environment of continuous learning to improve quality, and transform the VHA into a “high-reliability organization,” to reduce medical errors. The goal, according to Dr. Clancy, is to develop a culture—like the National Aeronautics and Space Administration or air traffic control systems—where all members of the organization search for and eliminate potential problems. Improving safety, she insisted, has to be a top priority for everyone.

Dr. Clancy also reported that 700,000 veterans enrolled in the VA’s Million Veteran Program (MVP) “We not only have the largest repository of genomic information on people but we also have their clinical data” Later, she told AVAHO members “I am hugely optimistic about the work that is being done in oncology research.” In July, the VA made an arrangement with the National Cancer Institute to allows veterans access to clinical trials. “We need to do more of that, she said, “this is only the beginning of the exciting work we will be doing in cancer research.”

Dr. Spector reported on the progress made by NPOP over the previous year. Currently, NPOP is sequencing solid tumors with a recent biopsy (liquid biopsies are acceptable), but hopes to begin examination of sarcomas and hematologic malignancies. NPOP has grown from about 100 samples analyzed monthly in January 2017 to nearly 350 in June 2018 with a goal of reaching 600 monthly samples across the VA. “You should be sending tumor tissues to be sequenced,” he explained. “It’s free, sequencing tumor tissue is the standard of care, and we need to be sequencing our patients to provide them with an opportunity to get patients onto clinical trials.”

Although the initial analysis can take up to 21 days, the program offers a 72-hour turn-around time for e-consultations. Depending on the quality of trial data, patients may be eligible for treatment even if there is no FDA-approved treatment. According to Spector, the goal of the program is to get patients on the right treatment and avoid costly treatment that will not work for a patient’s cancer type. “We do not want to be giving an expensive drug to someone who will not respond,” he explained.

Multiple efforts are underway to streamline and increase access to oncology care in the VA, according to Dr. Kelley. The development of a national cancer strategy is “long overdue” he admitted, but multiple efforts are underway to including the Fast Track to VA Cancer Care, a single national point of entry for VA cancer care, mechanisms to streamline enrolling patients in non-VA clinical trials, virtual tumor boards, and oncology-specific dashboards. “We have to be transparent and show not only to ourselves, but the whole worlds that we are doing a great job,” he told attendees.

One of the biggest challenges the VA faces will be the roll out of a new electronic health record system. While the new Cerner system has an oncology package, it does not have a cancer registry. According to Kelley, the VA is searching for a commercial system that can interface with Cerner to provide a cancer registry.

Kelley also focused on Annie, a new VA texting platform that allow patients to report on symptoms and get advice The Annie system is automated and allows patients to provide self-care. Already, cancer care providers are experimenting with Annie and Kelley expects the program to develop further.

Key leadership in research and oncology addressed attendees of the recent AVAHO annual meeting in Chicago. Carolyn Clancy, MD, deputy undersecretary for health discovery, education and affiliated networks, discussed the important role of cancer in the VA’s research and clinical mission. Neil Spector, MD, director of the National Precision Oncology Program (NPOP) outlined the significant growth in the use of tumor sequencing by NPOP, while Michael Kelley, MD, director of operations for National Oncology discussed the significant strides in opening up access to clinical trials at the VA.

Dr. Clancy addressed AVAHO for the first time and remarked upon the impressive array of research conducted by AVAHO members. “I love the idea of telehealth for genomics,” she remarked about the Genomic Medicine Service Uses Group Telehealth Appointments poster abstract, “it’s brilliant and it’s only the beginning.” The VA’s unique blend of clinical care and research puts it in a unique position to provide cutting edge care to its patients.

Clancy also addressed the larger shift in the VA as it moves from a closed integrated health care system to a high performing network. “We are closer than most systems in this country—public or private—to having a research enterprise that is integral to our mission of providing veterans with great care,” she said. “The magic of bringing [research and clinical] groups together is to enhance the visibility. But frankly it’s also to enhance our capability to take advantage of these assets strategically.” That means providing veterans with “cutting-edge care, and what could be better than that? When we do great things in how we deliver health care that helps your work,” she told attendees.

This shift, as outlined by the VA’s new leadership under Secretary Robert Wilkie and Richard A. Stone, MD, executive in charge of the Veterans Health Administration (VHA), is designed to restore veterans’ trust and confidence in the system, foster an environment of continuous learning to improve quality, and transform the VHA into a “high-reliability organization,” to reduce medical errors. The goal, according to Dr. Clancy, is to develop a culture—like the National Aeronautics and Space Administration or air traffic control systems—where all members of the organization search for and eliminate potential problems. Improving safety, she insisted, has to be a top priority for everyone.

Dr. Clancy also reported that 700,000 veterans enrolled in the VA’s Million Veteran Program (MVP) “We not only have the largest repository of genomic information on people but we also have their clinical data” Later, she told AVAHO members “I am hugely optimistic about the work that is being done in oncology research.” In July, the VA made an arrangement with the National Cancer Institute to allows veterans access to clinical trials. “We need to do more of that, she said, “this is only the beginning of the exciting work we will be doing in cancer research.”

Dr. Spector reported on the progress made by NPOP over the previous year. Currently, NPOP is sequencing solid tumors with a recent biopsy (liquid biopsies are acceptable), but hopes to begin examination of sarcomas and hematologic malignancies. NPOP has grown from about 100 samples analyzed monthly in January 2017 to nearly 350 in June 2018 with a goal of reaching 600 monthly samples across the VA. “You should be sending tumor tissues to be sequenced,” he explained. “It’s free, sequencing tumor tissue is the standard of care, and we need to be sequencing our patients to provide them with an opportunity to get patients onto clinical trials.”

Although the initial analysis can take up to 21 days, the program offers a 72-hour turn-around time for e-consultations. Depending on the quality of trial data, patients may be eligible for treatment even if there is no FDA-approved treatment. According to Spector, the goal of the program is to get patients on the right treatment and avoid costly treatment that will not work for a patient’s cancer type. “We do not want to be giving an expensive drug to someone who will not respond,” he explained.

Multiple efforts are underway to streamline and increase access to oncology care in the VA, according to Dr. Kelley. The development of a national cancer strategy is “long overdue” he admitted, but multiple efforts are underway to including the Fast Track to VA Cancer Care, a single national point of entry for VA cancer care, mechanisms to streamline enrolling patients in non-VA clinical trials, virtual tumor boards, and oncology-specific dashboards. “We have to be transparent and show not only to ourselves, but the whole worlds that we are doing a great job,” he told attendees.

One of the biggest challenges the VA faces will be the roll out of a new electronic health record system. While the new Cerner system has an oncology package, it does not have a cancer registry. According to Kelley, the VA is searching for a commercial system that can interface with Cerner to provide a cancer registry.

Kelley also focused on Annie, a new VA texting platform that allow patients to report on symptoms and get advice The Annie system is automated and allows patients to provide self-care. Already, cancer care providers are experimenting with Annie and Kelley expects the program to develop further.

Key leadership in research and oncology addressed attendees of the recent AVAHO annual meeting in Chicago. Carolyn Clancy, MD, deputy undersecretary for health discovery, education and affiliated networks, discussed the important role of cancer in the VA’s research and clinical mission. Neil Spector, MD, director of the National Precision Oncology Program (NPOP) outlined the significant growth in the use of tumor sequencing by NPOP, while Michael Kelley, MD, director of operations for National Oncology discussed the significant strides in opening up access to clinical trials at the VA.

Dr. Clancy addressed AVAHO for the first time and remarked upon the impressive array of research conducted by AVAHO members. “I love the idea of telehealth for genomics,” she remarked about the Genomic Medicine Service Uses Group Telehealth Appointments poster abstract, “it’s brilliant and it’s only the beginning.” The VA’s unique blend of clinical care and research puts it in a unique position to provide cutting edge care to its patients.

Clancy also addressed the larger shift in the VA as it moves from a closed integrated health care system to a high performing network. “We are closer than most systems in this country—public or private—to having a research enterprise that is integral to our mission of providing veterans with great care,” she said. “The magic of bringing [research and clinical] groups together is to enhance the visibility. But frankly it’s also to enhance our capability to take advantage of these assets strategically.” That means providing veterans with “cutting-edge care, and what could be better than that? When we do great things in how we deliver health care that helps your work,” she told attendees.

This shift, as outlined by the VA’s new leadership under Secretary Robert Wilkie and Richard A. Stone, MD, executive in charge of the Veterans Health Administration (VHA), is designed to restore veterans’ trust and confidence in the system, foster an environment of continuous learning to improve quality, and transform the VHA into a “high-reliability organization,” to reduce medical errors. The goal, according to Dr. Clancy, is to develop a culture—like the National Aeronautics and Space Administration or air traffic control systems—where all members of the organization search for and eliminate potential problems. Improving safety, she insisted, has to be a top priority for everyone.

Dr. Clancy also reported that 700,000 veterans enrolled in the VA’s Million Veteran Program (MVP) “We not only have the largest repository of genomic information on people but we also have their clinical data” Later, she told AVAHO members “I am hugely optimistic about the work that is being done in oncology research.” In July, the VA made an arrangement with the National Cancer Institute to allows veterans access to clinical trials. “We need to do more of that, she said, “this is only the beginning of the exciting work we will be doing in cancer research.”

Dr. Spector reported on the progress made by NPOP over the previous year. Currently, NPOP is sequencing solid tumors with a recent biopsy (liquid biopsies are acceptable), but hopes to begin examination of sarcomas and hematologic malignancies. NPOP has grown from about 100 samples analyzed monthly in January 2017 to nearly 350 in June 2018 with a goal of reaching 600 monthly samples across the VA. “You should be sending tumor tissues to be sequenced,” he explained. “It’s free, sequencing tumor tissue is the standard of care, and we need to be sequencing our patients to provide them with an opportunity to get patients onto clinical trials.”

Although the initial analysis can take up to 21 days, the program offers a 72-hour turn-around time for e-consultations. Depending on the quality of trial data, patients may be eligible for treatment even if there is no FDA-approved treatment. According to Spector, the goal of the program is to get patients on the right treatment and avoid costly treatment that will not work for a patient’s cancer type. “We do not want to be giving an expensive drug to someone who will not respond,” he explained.

Multiple efforts are underway to streamline and increase access to oncology care in the VA, according to Dr. Kelley. The development of a national cancer strategy is “long overdue” he admitted, but multiple efforts are underway to including the Fast Track to VA Cancer Care, a single national point of entry for VA cancer care, mechanisms to streamline enrolling patients in non-VA clinical trials, virtual tumor boards, and oncology-specific dashboards. “We have to be transparent and show not only to ourselves, but the whole worlds that we are doing a great job,” he told attendees.

One of the biggest challenges the VA faces will be the roll out of a new electronic health record system. While the new Cerner system has an oncology package, it does not have a cancer registry. According to Kelley, the VA is searching for a commercial system that can interface with Cerner to provide a cancer registry.

Kelley also focused on Annie, a new VA texting platform that allow patients to report on symptoms and get advice The Annie system is automated and allows patients to provide self-care. Already, cancer care providers are experimenting with Annie and Kelley expects the program to develop further.

The Food and Drug Administration has approved an amikacin liposome inhalation suspension (Arikayce) for the treatment of lung disease that has been caused by members of the Mycobacterium avium complex and is refractory to other treatments.

In a randomized, controlled trial, patients with refractory M. avium complex infections were assigned to receive either Arikayce plus a multidrug antibacterial regimen or just the antibacterial regimen. By 6 months, sputum cultures for 29% of those treated with the combination had shown no mycobacterial growth for 3 consecutive months, whereas this was only true for the cultures for 9% of patients on the multidrug antibacterial regimen alone.

The Arikayce prescribing information includes a boxed warning regarding the increased risk of respiratory conditions, including hypersensitivity pneumonitis, bronchospasm, exacerbation of underlying lung disease, and hemoptysis, some of which have proven serious enough to lead to hospitalization. Other side effects include dysphonia, cough, musculoskeletal pain, nausea, and fatigue.

According to the press announcement from the FDA, this is the first approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs, which was set up by Congress “to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need.” It does so by allowing a more streamlined clinical development program that may involve smaller, shorter, or fewer clinical trials.

More information can be found in the full press announcement.

[email protected]

The Food and Drug Administration has approved an amikacin liposome inhalation suspension (Arikayce) for the treatment of lung disease that has been caused by members of the Mycobacterium avium complex and is refractory to other treatments.

In a randomized, controlled trial, patients with refractory M. avium complex infections were assigned to receive either Arikayce plus a multidrug antibacterial regimen or just the antibacterial regimen. By 6 months, sputum cultures for 29% of those treated with the combination had shown no mycobacterial growth for 3 consecutive months, whereas this was only true for the cultures for 9% of patients on the multidrug antibacterial regimen alone.

The Arikayce prescribing information includes a boxed warning regarding the increased risk of respiratory conditions, including hypersensitivity pneumonitis, bronchospasm, exacerbation of underlying lung disease, and hemoptysis, some of which have proven serious enough to lead to hospitalization. Other side effects include dysphonia, cough, musculoskeletal pain, nausea, and fatigue.

According to the press announcement from the FDA, this is the first approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs, which was set up by Congress “to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need.” It does so by allowing a more streamlined clinical development program that may involve smaller, shorter, or fewer clinical trials.

More information can be found in the full press announcement.

[email protected]

The Food and Drug Administration has approved an amikacin liposome inhalation suspension (Arikayce) for the treatment of lung disease that has been caused by members of the Mycobacterium avium complex and is refractory to other treatments.

In a randomized, controlled trial, patients with refractory M. avium complex infections were assigned to receive either Arikayce plus a multidrug antibacterial regimen or just the antibacterial regimen. By 6 months, sputum cultures for 29% of those treated with the combination had shown no mycobacterial growth for 3 consecutive months, whereas this was only true for the cultures for 9% of patients on the multidrug antibacterial regimen alone.

The Arikayce prescribing information includes a boxed warning regarding the increased risk of respiratory conditions, including hypersensitivity pneumonitis, bronchospasm, exacerbation of underlying lung disease, and hemoptysis, some of which have proven serious enough to lead to hospitalization. Other side effects include dysphonia, cough, musculoskeletal pain, nausea, and fatigue.

According to the press announcement from the FDA, this is the first approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs, which was set up by Congress “to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need.” It does so by allowing a more streamlined clinical development program that may involve smaller, shorter, or fewer clinical trials.

More information can be found in the full press announcement.

[email protected]