As I reflect upon the past year, 2018 has certainly made a mark for addressing burnout among medical professionals, enforcing wellness, and targeting implicit and explicit gender bias in medicine and surgery.

Looking back, I entered surgery with a dream to change the culture of surgery. I knew I didn’t fit the traditional mold of an aggressive or arrogant surgeon. But I thought that my empathetic, open, and compassionate ways may spark a change in paradigm for that traditional surgical ideology. However, what I encountered as I made my way on this long, ever-winding journey was a system, culture, and tradition that beats you down, and what I thought were my strengths were quickly turned into weaknesses. As I grew and matured, this loss of identity in a culture of depersonalization surrounded by gender bias, for me, was a perfect recipe leading straight to burnout. However, this was an impetus for change, to be that voice and spark for a cultural transformation of surgery and for the women who work in the specialty.

More women are entering medical and surgical specialties. However, despite the advances made there are still clear gender-based disparities influencing overall wellness and work satisfaction. For instance, a study by Meyerson et al. demonstrated that female residents receive less operating room autonomy than male ones. I see it daily within my own curriculum and in observing other female residents in other surgical specialties. Furthermore, female residents are less often introduced by their physician titles, compared with their male counterparts, are often confused as nonphysicians, and are perceived as being less competent. This influences, to no small extent, overall confidence. It’s discouraging and disheartening to have worked so hard and yet still be treated in a sexist paradigm. And to top it all off, female physicians face a motherhood penalty.

In a recent study by Magudia et al., out of 12 top medical institutions that provided maternity leave, only 8 did so for residents with a grant total of 6.6 weeks on average. Furthermore, women with children or women who plan to have children have constrained career opportunities and are less likely to get full professorship or leadership positions. Anecdotally, a surgeon in passing semijokingly told me that if I were to take a specific academic vascular position, I may have to sign an agreement not to get pregnant ... probably not the job for me.

It’s appalling that, in this day and age, these explicit beliefs still exist, but what scares me more are all the implicit unconscious biases that affect all women not only in surgery but in medicine as well.

Looking back, 2018 is a year of beginning difficult conversations about physician and surgeon wellness, burnout, and gender bias. What’s obvious is that there is a hell of a lot of work to do. But change is slowly starting. We are now recognizing what the issues are, and the next step is to take action. It’s difficult to steer big ships, but there is an active community investing in strategies to improve the cultural scope of surgery and supporting and valuing women and what they have to offer.

References

Magudia K et al. JAMA. 2018;320(22):2372-4.

Meyerson SL et al. J Surg Educ. 2017;74(6):e111-18.

Dr. Drudi is a vascular surgery resident at McGill University, Montreal, and the resident medical editor of Vascular Specialist.

As I reflect upon the past year, 2018 has certainly made a mark for addressing burnout among medical professionals, enforcing wellness, and targeting implicit and explicit gender bias in medicine and surgery.

Looking back, I entered surgery with a dream to change the culture of surgery. I knew I didn’t fit the traditional mold of an aggressive or arrogant surgeon. But I thought that my empathetic, open, and compassionate ways may spark a change in paradigm for that traditional surgical ideology. However, what I encountered as I made my way on this long, ever-winding journey was a system, culture, and tradition that beats you down, and what I thought were my strengths were quickly turned into weaknesses. As I grew and matured, this loss of identity in a culture of depersonalization surrounded by gender bias, for me, was a perfect recipe leading straight to burnout. However, this was an impetus for change, to be that voice and spark for a cultural transformation of surgery and for the women who work in the specialty.

More women are entering medical and surgical specialties. However, despite the advances made there are still clear gender-based disparities influencing overall wellness and work satisfaction. For instance, a study by Meyerson et al. demonstrated that female residents receive less operating room autonomy than male ones. I see it daily within my own curriculum and in observing other female residents in other surgical specialties. Furthermore, female residents are less often introduced by their physician titles, compared with their male counterparts, are often confused as nonphysicians, and are perceived as being less competent. This influences, to no small extent, overall confidence. It’s discouraging and disheartening to have worked so hard and yet still be treated in a sexist paradigm. And to top it all off, female physicians face a motherhood penalty.

In a recent study by Magudia et al., out of 12 top medical institutions that provided maternity leave, only 8 did so for residents with a grant total of 6.6 weeks on average. Furthermore, women with children or women who plan to have children have constrained career opportunities and are less likely to get full professorship or leadership positions. Anecdotally, a surgeon in passing semijokingly told me that if I were to take a specific academic vascular position, I may have to sign an agreement not to get pregnant ... probably not the job for me.

It’s appalling that, in this day and age, these explicit beliefs still exist, but what scares me more are all the implicit unconscious biases that affect all women not only in surgery but in medicine as well.

Looking back, 2018 is a year of beginning difficult conversations about physician and surgeon wellness, burnout, and gender bias. What’s obvious is that there is a hell of a lot of work to do. But change is slowly starting. We are now recognizing what the issues are, and the next step is to take action. It’s difficult to steer big ships, but there is an active community investing in strategies to improve the cultural scope of surgery and supporting and valuing women and what they have to offer.

References

Magudia K et al. JAMA. 2018;320(22):2372-4.

Meyerson SL et al. J Surg Educ. 2017;74(6):e111-18.

Dr. Drudi is a vascular surgery resident at McGill University, Montreal, and the resident medical editor of Vascular Specialist.

As I reflect upon the past year, 2018 has certainly made a mark for addressing burnout among medical professionals, enforcing wellness, and targeting implicit and explicit gender bias in medicine and surgery.

Looking back, I entered surgery with a dream to change the culture of surgery. I knew I didn’t fit the traditional mold of an aggressive or arrogant surgeon. But I thought that my empathetic, open, and compassionate ways may spark a change in paradigm for that traditional surgical ideology. However, what I encountered as I made my way on this long, ever-winding journey was a system, culture, and tradition that beats you down, and what I thought were my strengths were quickly turned into weaknesses. As I grew and matured, this loss of identity in a culture of depersonalization surrounded by gender bias, for me, was a perfect recipe leading straight to burnout. However, this was an impetus for change, to be that voice and spark for a cultural transformation of surgery and for the women who work in the specialty.

More women are entering medical and surgical specialties. However, despite the advances made there are still clear gender-based disparities influencing overall wellness and work satisfaction. For instance, a study by Meyerson et al. demonstrated that female residents receive less operating room autonomy than male ones. I see it daily within my own curriculum and in observing other female residents in other surgical specialties. Furthermore, female residents are less often introduced by their physician titles, compared with their male counterparts, are often confused as nonphysicians, and are perceived as being less competent. This influences, to no small extent, overall confidence. It’s discouraging and disheartening to have worked so hard and yet still be treated in a sexist paradigm. And to top it all off, female physicians face a motherhood penalty.

In a recent study by Magudia et al., out of 12 top medical institutions that provided maternity leave, only 8 did so for residents with a grant total of 6.6 weeks on average. Furthermore, women with children or women who plan to have children have constrained career opportunities and are less likely to get full professorship or leadership positions. Anecdotally, a surgeon in passing semijokingly told me that if I were to take a specific academic vascular position, I may have to sign an agreement not to get pregnant ... probably not the job for me.

It’s appalling that, in this day and age, these explicit beliefs still exist, but what scares me more are all the implicit unconscious biases that affect all women not only in surgery but in medicine as well.

Looking back, 2018 is a year of beginning difficult conversations about physician and surgeon wellness, burnout, and gender bias. What’s obvious is that there is a hell of a lot of work to do. But change is slowly starting. We are now recognizing what the issues are, and the next step is to take action. It’s difficult to steer big ships, but there is an active community investing in strategies to improve the cultural scope of surgery and supporting and valuing women and what they have to offer.

References

Magudia K et al. JAMA. 2018;320(22):2372-4.

Meyerson SL et al. J Surg Educ. 2017;74(6):e111-18.

Dr. Drudi is a vascular surgery resident at McGill University, Montreal, and the resident medical editor of Vascular Specialist.

A recent survey of rheumatologists revealed they are finding little value in the maintenance of certification program.

Among the 515 rheumatologists responding to the survey, 74.8% “did not think there is significant additional value in MOC, beyond what is already achieved from Continuing Medical Education,” Amr Sawalha, MD, and Patrick Coit, both of the University of Michigan, Ann Arbor, wrote in Arthritis Care & Research. The survey was sent to 3,107 rheumatologists in the United States.

The survey also found that 63.5% of respondents “did not believe board recertification and MOC are valuable in terms of improving patients’ care,” although 65.6% did perceive that staying current with new knowledge was a positive effect of participating in the MOC process, Dr. Sawalha and Mr. Coit wrote.

On the flip side, requiring MOC was perceived to be a contributor to physician burnout by 77.7% of respondents and to early retirements by 67.4% of respondents.

“If participation in MOC indeed does not have a significant value on improving patient care in rheumatology, as indicated by the perception of practicing rheumatologists, and if it remains a requirement to practice for at least over a third of rheumatologists in the United States, then an argument can be made that elimination of MOC might be a way to sustain and improve the rheumatology workforce without compromising quality,” Dr. Sawalha and Mr. Coit wrote. “To our knowledge, there have not been any studies to show that rheumatologists participating in MOC activities provide better care.”

Another aspect that the survey revealed is the rheumatologists’ perception of certifying organizations.

“A striking finding from our study is the indication that there seems to be a lack of trust in [the] board-certifying organization and their motives among practicing rheumatologists in the United States,” the authors wrote. “When asked to rank in order what is thought to be the reason for creating MOC programs, financial well-being of board-certifying organizations was the highest ranked answer. Improving patient care, which is the motive claimed by board-certifying organizations, was the least likely ranked answer.”

Indeed, about 60% of respondents believe alternative organizations, such as the American College of Rheumatology, should be administering or overseeing the board certification process for rheumatologists.

“Regardless of what the motive might be, these results suggest that practicing physicians, and in this case rheumatologists, do not trust board-certifying organizations,” Dr. Sawalha and Mr. Coit wrote. “Therefore, we suggest that these organizations revisit their relationship with practicing physicians and facilitate true collaboration with physicians to determine the best way to assess and ensure physician competence and knowledge.”

The authors declared that they have no financial conflicts of interest.

[email protected]

SOURCE: Sawalha A and Coit P. Arthritis Care Res. 2018 Dec 20. doi: 10.1002/acr.23823

A recent survey of rheumatologists revealed they are finding little value in the maintenance of certification program.

Among the 515 rheumatologists responding to the survey, 74.8% “did not think there is significant additional value in MOC, beyond what is already achieved from Continuing Medical Education,” Amr Sawalha, MD, and Patrick Coit, both of the University of Michigan, Ann Arbor, wrote in Arthritis Care & Research. The survey was sent to 3,107 rheumatologists in the United States.

The survey also found that 63.5% of respondents “did not believe board recertification and MOC are valuable in terms of improving patients’ care,” although 65.6% did perceive that staying current with new knowledge was a positive effect of participating in the MOC process, Dr. Sawalha and Mr. Coit wrote.

On the flip side, requiring MOC was perceived to be a contributor to physician burnout by 77.7% of respondents and to early retirements by 67.4% of respondents.

“If participation in MOC indeed does not have a significant value on improving patient care in rheumatology, as indicated by the perception of practicing rheumatologists, and if it remains a requirement to practice for at least over a third of rheumatologists in the United States, then an argument can be made that elimination of MOC might be a way to sustain and improve the rheumatology workforce without compromising quality,” Dr. Sawalha and Mr. Coit wrote. “To our knowledge, there have not been any studies to show that rheumatologists participating in MOC activities provide better care.”

Another aspect that the survey revealed is the rheumatologists’ perception of certifying organizations.

“A striking finding from our study is the indication that there seems to be a lack of trust in [the] board-certifying organization and their motives among practicing rheumatologists in the United States,” the authors wrote. “When asked to rank in order what is thought to be the reason for creating MOC programs, financial well-being of board-certifying organizations was the highest ranked answer. Improving patient care, which is the motive claimed by board-certifying organizations, was the least likely ranked answer.”

Indeed, about 60% of respondents believe alternative organizations, such as the American College of Rheumatology, should be administering or overseeing the board certification process for rheumatologists.

“Regardless of what the motive might be, these results suggest that practicing physicians, and in this case rheumatologists, do not trust board-certifying organizations,” Dr. Sawalha and Mr. Coit wrote. “Therefore, we suggest that these organizations revisit their relationship with practicing physicians and facilitate true collaboration with physicians to determine the best way to assess and ensure physician competence and knowledge.”

The authors declared that they have no financial conflicts of interest.

[email protected]

SOURCE: Sawalha A and Coit P. Arthritis Care Res. 2018 Dec 20. doi: 10.1002/acr.23823

A recent survey of rheumatologists revealed they are finding little value in the maintenance of certification program.

Among the 515 rheumatologists responding to the survey, 74.8% “did not think there is significant additional value in MOC, beyond what is already achieved from Continuing Medical Education,” Amr Sawalha, MD, and Patrick Coit, both of the University of Michigan, Ann Arbor, wrote in Arthritis Care & Research. The survey was sent to 3,107 rheumatologists in the United States.

The survey also found that 63.5% of respondents “did not believe board recertification and MOC are valuable in terms of improving patients’ care,” although 65.6% did perceive that staying current with new knowledge was a positive effect of participating in the MOC process, Dr. Sawalha and Mr. Coit wrote.

On the flip side, requiring MOC was perceived to be a contributor to physician burnout by 77.7% of respondents and to early retirements by 67.4% of respondents.

“If participation in MOC indeed does not have a significant value on improving patient care in rheumatology, as indicated by the perception of practicing rheumatologists, and if it remains a requirement to practice for at least over a third of rheumatologists in the United States, then an argument can be made that elimination of MOC might be a way to sustain and improve the rheumatology workforce without compromising quality,” Dr. Sawalha and Mr. Coit wrote. “To our knowledge, there have not been any studies to show that rheumatologists participating in MOC activities provide better care.”

Another aspect that the survey revealed is the rheumatologists’ perception of certifying organizations.

“A striking finding from our study is the indication that there seems to be a lack of trust in [the] board-certifying organization and their motives among practicing rheumatologists in the United States,” the authors wrote. “When asked to rank in order what is thought to be the reason for creating MOC programs, financial well-being of board-certifying organizations was the highest ranked answer. Improving patient care, which is the motive claimed by board-certifying organizations, was the least likely ranked answer.”

Indeed, about 60% of respondents believe alternative organizations, such as the American College of Rheumatology, should be administering or overseeing the board certification process for rheumatologists.

“Regardless of what the motive might be, these results suggest that practicing physicians, and in this case rheumatologists, do not trust board-certifying organizations,” Dr. Sawalha and Mr. Coit wrote. “Therefore, we suggest that these organizations revisit their relationship with practicing physicians and facilitate true collaboration with physicians to determine the best way to assess and ensure physician competence and knowledge.”

The authors declared that they have no financial conflicts of interest.

[email protected]

SOURCE: Sawalha A and Coit P. Arthritis Care Res. 2018 Dec 20. doi: 10.1002/acr.23823

Life is short, art long, opportunity fleeting. – Hippocrates

The new year provides an opportunity to reflect on old things: to decide what to keep and what to toss out, to contemplate the habits to which we choose to rededicate ourselves, and those we choose to let wane. Over the last few years, while some older physicians have expressed a yearning for the comfort of paper charts, most of us have come to embrace the benefits of the electronic health record. That is a good thing. The EHR offers many advantages over paper, and, like it or not, it’s here to stay.

Many younger physicians have not ever seen a paper chart. The other day I was working with a resident, admitting a patient to a nursing home. I handed her the inch-thick stack of papers that came from the hospital, and she immediately asked what we were supposed to do with it. When I explained that it was the hospital chart, she wondered aloud how she was supposed to navigate to the different sections in order to review the information. I was stupefied but understood the reason behind her question. The way we document has changed so dramatically over just the past decade. Unfortunately, without intention, the way that we chart has affected the way we relate to patients.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other person for all their complexity, in their full humanness. We acknowledge and approach the person as a unique individual who has dreams, goals, fears, and wishes that may be different than ours but to which we can still relate.

While the importance and benefits of the electronic record are clear, we must constantly remind ourselves that the EHR is a tool of care and not the goal of care. While the people we see have health needs that must be diagnosed, treated, and recorded, and their illnesses are an important part of their being, they do not define their being. Nor should they define our relationship with them. Patients agree; when surveyed about the attributes of a good physician, they regularly respond that they want their physicians to have a sense of them as people, not just patients.

Recently, I was reminded of the challenge of keeping this simple task in the forefront of care while on hospital service. I had occasion to sit and talk with one of my patients without a computer in the room. This was unusual for me, as I typically fill out the EHR as I am seeing the patient. As I listened to the individual in his gown, lying on his hospital bed and describing the symptoms that brought him to the hospital, I was reminded of the subtle pauses and nuances that occur during focused conversations, during deep listening.

We have written in previous columns about exciting applications of technology that are in the pipeline. Artificial intelligence with “deep learning” is predicted to change the way we diagnose and treat disease. Deep learning is a term that has been used to describe a type of machine analysis where data are interpreted and analyzed in layers, allowing the computer to detect patterns. In the first layer of learning, the computer may identify the way pixels of the same color form a line or a curve. In the next layer it might detect the way that curve resembles a face. Peeling away layer after layer, the computer might eventually recognize whose face is being represented. This is the type of programing that has allowed computers to interpret mammograms and retina scans, detecting patterns that represent cancer or small retinal hemorrhages. While deep learning will be the subject of much excitement over the next few years, at the start of this new year we think it is equally important be reminded of an essential quality of the excellent physician – deep listening.

Deep listening requires a lifetime of practice. We have all experienced it, both as listeners and as those being listened to. When we are in the presence of someone who is truly interested in what we are saying – in our story and in our life – we feel reaffirmed and refreshed. Regardless of the topic of our discussion, we feel a sense of trust, for we believe that the person with whom we are speaking understands us, and, in that understanding, cares about us. We have a sense that we could trust the listener with our lives.

A lifetime of practice – that is the promise of our jobs as physicians. Every time we enter the exam room we have the opportunity to carry out the sacred skill of hearing others, while trying in some way to improve their lives. With each visit we have the opportunity to perfect our craft. Chaucer, the medieval English poet, observed, “the life so short, the craft so long to learn.” It seems he borrowed that idea from a physician, Hippocrates.

Hippocrates opened his medical text with the words, “Vita brevis, ars longa, occasio praeceps,” which means, “Life is short, the art long, opportunity fleeting.” Hippocrates recognized the challenge involved in learning all that is necessary to take care of our fellow man. This challenge has only become more difficult as the quantity of information required to practice competent medicine has increased. In addition, we now need to record data into the EHR to be used for record keeping, billing, and the further advancement of knowledge. Hippocrates’ medical text continued, “The physician must not only be prepared to do what is right himself, but also to make the patient, the attendants, and externals cooperate.”

On the occasion of this New Year, it is a perfect time to reflect and rededicate ourselves to listening to our patients, to being interested in them and their stories. We just may find that in deep listening, and in the trust that comes from that singular focus, lie solutions to many of the largest problems we face in medicine today: burnout, poor adherence, and regaining the moral authority that comes with truly caring for those in need.

Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Notte is a family physician and associate chief medical information officer for Abington Jefferson Health. Follow him on twitter (@doctornotte).

Life is short, art long, opportunity fleeting. – Hippocrates

The new year provides an opportunity to reflect on old things: to decide what to keep and what to toss out, to contemplate the habits to which we choose to rededicate ourselves, and those we choose to let wane. Over the last few years, while some older physicians have expressed a yearning for the comfort of paper charts, most of us have come to embrace the benefits of the electronic health record. That is a good thing. The EHR offers many advantages over paper, and, like it or not, it’s here to stay.

Many younger physicians have not ever seen a paper chart. The other day I was working with a resident, admitting a patient to a nursing home. I handed her the inch-thick stack of papers that came from the hospital, and she immediately asked what we were supposed to do with it. When I explained that it was the hospital chart, she wondered aloud how she was supposed to navigate to the different sections in order to review the information. I was stupefied but understood the reason behind her question. The way we document has changed so dramatically over just the past decade. Unfortunately, without intention, the way that we chart has affected the way we relate to patients.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other person for all their complexity, in their full humanness. We acknowledge and approach the person as a unique individual who has dreams, goals, fears, and wishes that may be different than ours but to which we can still relate.

While the importance and benefits of the electronic record are clear, we must constantly remind ourselves that the EHR is a tool of care and not the goal of care. While the people we see have health needs that must be diagnosed, treated, and recorded, and their illnesses are an important part of their being, they do not define their being. Nor should they define our relationship with them. Patients agree; when surveyed about the attributes of a good physician, they regularly respond that they want their physicians to have a sense of them as people, not just patients.

Recently, I was reminded of the challenge of keeping this simple task in the forefront of care while on hospital service. I had occasion to sit and talk with one of my patients without a computer in the room. This was unusual for me, as I typically fill out the EHR as I am seeing the patient. As I listened to the individual in his gown, lying on his hospital bed and describing the symptoms that brought him to the hospital, I was reminded of the subtle pauses and nuances that occur during focused conversations, during deep listening.

We have written in previous columns about exciting applications of technology that are in the pipeline. Artificial intelligence with “deep learning” is predicted to change the way we diagnose and treat disease. Deep learning is a term that has been used to describe a type of machine analysis where data are interpreted and analyzed in layers, allowing the computer to detect patterns. In the first layer of learning, the computer may identify the way pixels of the same color form a line or a curve. In the next layer it might detect the way that curve resembles a face. Peeling away layer after layer, the computer might eventually recognize whose face is being represented. This is the type of programing that has allowed computers to interpret mammograms and retina scans, detecting patterns that represent cancer or small retinal hemorrhages. While deep learning will be the subject of much excitement over the next few years, at the start of this new year we think it is equally important be reminded of an essential quality of the excellent physician – deep listening.

Deep listening requires a lifetime of practice. We have all experienced it, both as listeners and as those being listened to. When we are in the presence of someone who is truly interested in what we are saying – in our story and in our life – we feel reaffirmed and refreshed. Regardless of the topic of our discussion, we feel a sense of trust, for we believe that the person with whom we are speaking understands us, and, in that understanding, cares about us. We have a sense that we could trust the listener with our lives.

A lifetime of practice – that is the promise of our jobs as physicians. Every time we enter the exam room we have the opportunity to carry out the sacred skill of hearing others, while trying in some way to improve their lives. With each visit we have the opportunity to perfect our craft. Chaucer, the medieval English poet, observed, “the life so short, the craft so long to learn.” It seems he borrowed that idea from a physician, Hippocrates.

Hippocrates opened his medical text with the words, “Vita brevis, ars longa, occasio praeceps,” which means, “Life is short, the art long, opportunity fleeting.” Hippocrates recognized the challenge involved in learning all that is necessary to take care of our fellow man. This challenge has only become more difficult as the quantity of information required to practice competent medicine has increased. In addition, we now need to record data into the EHR to be used for record keeping, billing, and the further advancement of knowledge. Hippocrates’ medical text continued, “The physician must not only be prepared to do what is right himself, but also to make the patient, the attendants, and externals cooperate.”

On the occasion of this New Year, it is a perfect time to reflect and rededicate ourselves to listening to our patients, to being interested in them and their stories. We just may find that in deep listening, and in the trust that comes from that singular focus, lie solutions to many of the largest problems we face in medicine today: burnout, poor adherence, and regaining the moral authority that comes with truly caring for those in need.

Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Notte is a family physician and associate chief medical information officer for Abington Jefferson Health. Follow him on twitter (@doctornotte).

Life is short, art long, opportunity fleeting. – Hippocrates

The new year provides an opportunity to reflect on old things: to decide what to keep and what to toss out, to contemplate the habits to which we choose to rededicate ourselves, and those we choose to let wane. Over the last few years, while some older physicians have expressed a yearning for the comfort of paper charts, most of us have come to embrace the benefits of the electronic health record. That is a good thing. The EHR offers many advantages over paper, and, like it or not, it’s here to stay.

Many younger physicians have not ever seen a paper chart. The other day I was working with a resident, admitting a patient to a nursing home. I handed her the inch-thick stack of papers that came from the hospital, and she immediately asked what we were supposed to do with it. When I explained that it was the hospital chart, she wondered aloud how she was supposed to navigate to the different sections in order to review the information. I was stupefied but understood the reason behind her question. The way we document has changed so dramatically over just the past decade. Unfortunately, without intention, the way that we chart has affected the way we relate to patients.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other person for all their complexity, in their full humanness. We acknowledge and approach the person as a unique individual who has dreams, goals, fears, and wishes that may be different than ours but to which we can still relate.

While the importance and benefits of the electronic record are clear, we must constantly remind ourselves that the EHR is a tool of care and not the goal of care. While the people we see have health needs that must be diagnosed, treated, and recorded, and their illnesses are an important part of their being, they do not define their being. Nor should they define our relationship with them. Patients agree; when surveyed about the attributes of a good physician, they regularly respond that they want their physicians to have a sense of them as people, not just patients.

Recently, I was reminded of the challenge of keeping this simple task in the forefront of care while on hospital service. I had occasion to sit and talk with one of my patients without a computer in the room. This was unusual for me, as I typically fill out the EHR as I am seeing the patient. As I listened to the individual in his gown, lying on his hospital bed and describing the symptoms that brought him to the hospital, I was reminded of the subtle pauses and nuances that occur during focused conversations, during deep listening.

We have written in previous columns about exciting applications of technology that are in the pipeline. Artificial intelligence with “deep learning” is predicted to change the way we diagnose and treat disease. Deep learning is a term that has been used to describe a type of machine analysis where data are interpreted and analyzed in layers, allowing the computer to detect patterns. In the first layer of learning, the computer may identify the way pixels of the same color form a line or a curve. In the next layer it might detect the way that curve resembles a face. Peeling away layer after layer, the computer might eventually recognize whose face is being represented. This is the type of programing that has allowed computers to interpret mammograms and retina scans, detecting patterns that represent cancer or small retinal hemorrhages. While deep learning will be the subject of much excitement over the next few years, at the start of this new year we think it is equally important be reminded of an essential quality of the excellent physician – deep listening.

Deep listening requires a lifetime of practice. We have all experienced it, both as listeners and as those being listened to. When we are in the presence of someone who is truly interested in what we are saying – in our story and in our life – we feel reaffirmed and refreshed. Regardless of the topic of our discussion, we feel a sense of trust, for we believe that the person with whom we are speaking understands us, and, in that understanding, cares about us. We have a sense that we could trust the listener with our lives.

A lifetime of practice – that is the promise of our jobs as physicians. Every time we enter the exam room we have the opportunity to carry out the sacred skill of hearing others, while trying in some way to improve their lives. With each visit we have the opportunity to perfect our craft. Chaucer, the medieval English poet, observed, “the life so short, the craft so long to learn.” It seems he borrowed that idea from a physician, Hippocrates.

Hippocrates opened his medical text with the words, “Vita brevis, ars longa, occasio praeceps,” which means, “Life is short, the art long, opportunity fleeting.” Hippocrates recognized the challenge involved in learning all that is necessary to take care of our fellow man. This challenge has only become more difficult as the quantity of information required to practice competent medicine has increased. In addition, we now need to record data into the EHR to be used for record keeping, billing, and the further advancement of knowledge. Hippocrates’ medical text continued, “The physician must not only be prepared to do what is right himself, but also to make the patient, the attendants, and externals cooperate.”

On the occasion of this New Year, it is a perfect time to reflect and rededicate ourselves to listening to our patients, to being interested in them and their stories. We just may find that in deep listening, and in the trust that comes from that singular focus, lie solutions to many of the largest problems we face in medicine today: burnout, poor adherence, and regaining the moral authority that comes with truly caring for those in need.

Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Notte is a family physician and associate chief medical information officer for Abington Jefferson Health. Follow him on twitter (@doctornotte).

This story republished by permission of ProPublica.

Hundreds of doctors packed an auditorium at Memorial Sloan Kettering Cancer Center on Oct. 1, deeply angered by revelations that the hospital’s top medical officer and other leaders had cultivated lucrative relationships with for-profit companies.

One by one, they stood up to challenge the stewardship of their beloved institution, often to emotional applause. Some speakers accused their leaders of letting the quest to make more money undermine the hospital’s mission. Others bemoaned a rigid, hierarchical management that had left them feeling they had no real voice in the hospital’s direction.

“Slowly, I’ve seen more and more of the higher-up meetings happening with people who are dressed up in suits as opposed to white coats,” said Viviane Tabar, MD, chairwoman of the neurosurgery department.

“The corporatization of this institution is clear to many of us who have been here a long time,” said Carol L. Brown, MD, a gynecologic cancer surgeon, according to an audio recording of the meeting.

The meeting ended after several doctors advocated an immediate no-confidence vote in the hospital’s senior leadership. The turmoil followed reports by The New York Times and ProPublica that the hospital’s chief medical officer, José Baselga, MD, had been paid millions by drug and health care companies and failed to disclose those ties more than 100 times in medical journals, and that hospital insiders had made lucrative side deals that stood to earn them handsome profits, sometimes for work they had done on the job.

The day after the meeting, the hospital’s chief executive, Craig B. Thompson, MD, promised greater openness with rank-and-file doctors about decisionmaking. He also committed to doing the “root-cause analysis” requested by the doctors of how “egregious conflicts of interest,” as one physician put it, had been allowed to happen.

Other hospitals around the country are confronting similar dilemmas. But at Memorial Sloan Kettering, one of the nation’s leading cancer research and treatment centers, they are especially acute. Internal emails, audio recordings of meetings and interviews with doctors show how this major New York institution has struggled to contain a crisis of confidence in its leadership.

Closer ties between nonprofit research centers like Memorial Sloan Kettering and corporations are being fueled by a rush of potentially breakthrough cancer treatments. Venture capital firms and drug companies have looked to cash in on the scientific discoveries, said Brad Loncar, the founder of an investment fund that focuses on cancer. “Money follows success,” he said, and Memorial Sloan Kettering has been a focus “because they conduct terrific science there.”

In recent years, the hospital, like its competitors, has struck increasingly sophisticated deals to commercialize its discoveries, in some cases receiving equity stakes in startups rather than simply collecting royalties.

The predicament of Memorial Sloan Kettering also reflects a shift in its own culture. Its prior chief executive, Harold E. Varmus, MD, a Nobel Prize-winning scientist, personally kept companies at arm’s length, while Dr. Thompson, also a respected cancer researcher, has more fully embraced such relationships. The new approach has been applauded by some for expanding access to the cancer center’s discoveries, even as others have worried that the hospital may be losing sight of its mission.

Its leaders and top researchers also hold influential positions in the corporate world. When news of Dr. Baselga’s disclosure lapses broke in September, 12 doctors and researchers at the hospital served on the boards of publicly traded companies, more than at any other major cancer center, according to a review by the Times and ProPublica. Dr. Baselga has since resigned from the hospital and the two boards he served on. And a day after the physicians’ meeting on Oct. 1, Dr. Thompson resigned from the boards of the pharmaceutical giant Merck and Charles River Laboratories, a health care company, that together had paid him $585,050 in compensation in 2017.

The concern of ethicists and health experts is that a bias in favor of industry can unduly influence scientific research and medical treatments and remove a valuable check on soaring drug prices.

“We do have to sort of decide which side of this we’re on, or at least notice that we are feeding at the very trough that is causing worse access here than in any other Western country,” Peter B. Bach, MD, director of the hospital’s Center for Health Policy and Outcomes, said at the Oct. 1 meeting.

The problems at Memorial Sloan Kettering have shaken other cancer centers. At Dana-Farber Cancer Institute, officials have said they are considering whether Laurie H. Glimcher, MD, their chief executive, and others should continue to serve on the boards of publicly traded companies, including the drugmaker GlaxoSmithKline, on whose board Dr. Glimcher sits.

At the Fred Hutchinson Cancer Research Center in Seattle, a task force is reviewing the conflict-of-interest policies that govern employees’ financial relationships with drug companies. And medical centers around the country have instructed researchers to review their financial disclosures to medical journals, leading to a series of corrections to scientific articles.

Even as Memorial Sloan Kettering leaders have promised greater transparency, they have engaged a public affairs firm, SKDKnickerbocker, to manage their message and have aggressively pushed back against the idea that the hospital’s leaders are too close to industry.

“I can see how someone might think that business relationships are problematic,” said Lisa DeAngelis, MD, who has stepped into Dr. Baselga’s former position at Memorial Sloan Kettering on an acting basis. “But I’m telling you, as someone who works with patients, and I’ve worked with patients throughout my entire career here, that working with industry has helped me save lives.”

The Times and ProPublica asked to speak to Dr. Tabar and Dr. Brown about the critical remarks they made about the hospital’s direction at the Oct. 1 meeting. Mike Morey, managing director of the communications firm engaged by the hospital, arranged for them to speak to reporters on the phone while he listened. The doctors said they were not specifically referring to Memorial Sloan Kettering during the meeting that was recorded by one of those in attendance, but to broader changes in the medical world.

Defining an Institution’s Role

Founded in 1884 as the New York Cancer Hospital, Memorial Sloan Kettering was the first hospital in the country devoted exclusively to treating cancer. Its benefactors have included some of the wealthiest families in America, from the Astors and Rockefellers in its early years to the Kochs today.

It now operates more than 120 research laboratories, employs more than 1,000 doctors, admits some 23,500 patients a year, operates one of the world’s largest clinical trial programs and had revenues of nearly $4.5 billion in 2017. It recently completed a $3.5 billion fundraising drive, and its charity ball remains a fixture on New York’s social calendar.

As a leading force in cancer research, the hospital has long grappled with striking a balance in its collaborations with drug companies. While it did business with industry during the tenure of Dr. Varmus, a former director of the National Institutes of Health, he and a top deputy, Robert E. Wittes, MD, did not consult for companies, own their stock or serve on their boards, according to several people who worked for Dr. Varmus while he was at the hospital from 2000 to 2010. Dr. Varmus and Dr. Wittes declined to comment.

But some on the hospital’s board wanted its chief executive to do more to encourage company-financed clinical trials and to bring discoveries to market. In an interview, John R. Gunn, the cancer center’s chief operating officer from 1987 to 2015, said board members felt gems of research were “lying fallow and nobody was kind of pushing it, to commercialize it.”

By the time Dr. Varmus left to direct the National Cancer Institute in 2010, Memorial Sloan Kettering’s board was looking for a leader who was as comfortable in a corporate boardroom as in the lab, according to several longtime current and former cancer center employees.

Dr. Thompson met that criteria. He headed the Abramson Cancer Center at the University of Pennsylvania, was the co-founder of a biotech startup, Agios, and served on the board of Merck.

His early tenure was marred by controversy. In 2011 and 2012, he was sued by his former employers, the Abramson center and the University of Pennsylvania, which accused him of walking off with valuable research and using it to start Agios. At the time, Dr. Thompson denied wrongdoing and the suits were later settled for an undisclosed sum.

In 2012, Dr. Thompson hired Dr. Baselga to be the top physician at Memorial Sloan Kettering. Dr. Baselga, who had made his name as a key investigator of the breast cancer drug Herceptin, was also seen as having bridged the worlds of research and industry. Dr. DeAngelis, the hospital’s acting physician-in-chief, said that under Dr. Baselga, clinical trials were approved more quickly, helping speed treatments to patients.

But several doctors who worked under Dr. Baselga said in interviews that he had an abrasive style and created a culture where ties to industry were not kept in check. Dr. Baselga has not responded to requests for comment.

In his years at Memorial Sloan Kettering, Dr. Baselga’s personal financial conflicts were handled differently from those of other doctors, according to Clifford A. Hudis, MD, who was chairman of the hospital’s conflict-of-interest advisory committee through early 2016, when he left to become chief executive of the American Society of Clinical Oncology.

Dr. Baselga’s conflicts were not overseen by Dr. Hudis’ committee, but by the audit committee of the hospital’s board of directors. “I was told this was pretty standard for the highest level executives,” Dr. Hudis said. “I didn’t understand why any clinician would have separate rules from any other.”

Mr. Morey said that the hospital is evaluating its process for reviewing conflicts of interest, but that executives like Dr. Baselga had their financial relationships overseen by the board “to protect faculty from being put in a position of having to review their supervisor’s potential conflicts.”

Dr. Baselga is not the only leading researcher to have maintained extensive ties to the drug and health care companies — as some also did under Dr. Varmus. Jedd Wolchok, MD, a noted pioneer in immunotherapy, has financial relationships with more than 30 companies, according to recent disclosures. Charles L. Sawyers, MD, another of the hospital’s biggest names, has founded several cancer startups, one of which Memorial Sloan Kettering has invested in, and serves on the board of the Swiss pharmaceutical giant Novartis.

Ethicists and health experts say having leaders and researchers at nonprofit hospitals sit on corporate boards is especially problematic. When they serve on the board of a publicly traded company, they have a legal duty to the corporation and its shareholders, which can clash with their duty to their patients and primary employers. Those who sit on boards are often paid hundreds of thousands of dollars a year.

“I don’t think you can serve two masters,” said Bernard Lo, MD, who led an influential Institute of Medicine panel in 2009 that investigated financial conflicts in medicine. “The whole reason for being in the cancer care business is that you’re trying to help people in need, and that’s not at all the company’s main purpose. It’s to generate profits on their products.”

A report in November in BioPharma Dive found that 12 of the 19 largest pharmaceutical and biotech companies had at least one board member who also worked at a nonprofit health care institution. A 2014 study in JAMA found that about 40 percent of the largest publicly traded drug companies had a leader of an academic medical center on their boards.

Robert Benezra, PhD, who heads a lab at Memorial Sloan Kettering that focuses on how tumors grow, is the president, chief executive officer and a board member of AngioGenex, a tiny, publicly traded biotech company that is developing drugs to treat cancer based on the discoveries made in his lab.

Though he takes no salary from AngioGenex, Benezra owns nearly 9 percent of the company he helped found through stock or options, setting him up for a lucrative payday if the company is acquired or its drugs come to market.

In 2017, Dr. Benezra wrote to AngioGenex shareholders that a recent policy and leadership change at the hospital “afforded me the freedom to assume a more active role in the company” and to recruit other Memorial Sloan Kettering scientists to work with the company.

Dr. Benezra said in a statement issued through the hospital, “While I do not work directly with patients, I hope that this important science can one day make an impact in the lives of cancer sufferers.”

Mr. Morey said Dr. Benezra spends just 30 hours a year on business related to the publicly traded company. “We’re talking about 45 minutes a week, which is less than what most people spend on Netflix in a night,” Mr. Morey said.

Dr. DeAngelis, the acting physician-in-chief, said the high number of Memorial Sloan Kettering leaders who serve on corporate boards is reflective of their stature. “Maybe we should turn this around and say, we have more people on corporate boards because people value the opinions from our faculty,” she said in an interview.
 

A Staff in Turmoil

Tensions among doctors at the hospital over conflicts of interests mounted through September. On Sept. 28, Colin Begg, PhD, the chairman of its department of epidemiology and biostatistics, wrote to other department heads. “The key substantive issue is that the problems we face were not caused by failures to disclose conflicts. The problems were due to the conflicts themselves,” he wrote in the email, a copy of which was obtained by the Times and ProPublica.

Referring to Dr. Thompson and Douglas A. Warner III, the outgoing chairman of the hospital’s board of managers and overseers, who is known as Sandy, he said: “As far as I can tell neither Sandy nor Craig understand this very basic point. And if you don’t recognize that a problem exists there is no chance you will solve it.”

He also said: “Making billions is not our mission. MSK is a nonprofit with a fundamentally social mission.”

Dr. Begg declined to comment.

Shortly before the doctors met on Oct. 1, Dr. Thompson sounded a conciliatory note. “I want to start by apologizing to the medical staff on behalf of myself and the rest of senior management,” he said, according to a draft transcript of the staff meeting. “The events of the last few weeks have not been handled as well as I would have liked.”

Mr. Warner also addressed the doctors, informing them that the board was assessing whether Dr. Thompson should remain on Merck’s board.

“Should Craig continue to sit on the Merck board? We have no policy on that,” Mr. Warner said, according to the transcript, noting that Dr. Thompson’s role on the board was initially seen as a “good thing” when he joined the hospital. “We need to step back from that now and ask ourselves whether that continues to be appropriate, whether it’s appropriate in the future.”

The next day, Oct. 2, Dr. Thompson announced that he was resigning from both the boards on which he served.

Requests to interview Dr. Thompson and Mr. Warner were declined. Instead, the hospital arranged for reporters to speak to Dr. DeAngelis, who said she saw nothing wrong with the corporate ties that Dr. Thompson had earlier said were under review.

She downplayed the concerns voiced by Dr. Begg about the culture of the hospital. ”He is a biostatistician. He does not work with patients. He works with data,” she said, adding that he does not have “as full an understanding” about policies to prevent doctors with corporate ties from having an undue influence on clinical trials.

Dr. Thompson and two deputies, including Dr. DeAngelis, sent a note to hospital doctors on Dec. 20, warning them about this article. While it mentioned the ongoing review, it offered a full-throated defense of those serving on corporate boards.

“We expect the piece to question the ethics of some of our most accomplished researchers and clinicians. We want you to know that we reject these insinuations and we stand behind our faculty 100 percent.”
 

Katie Thomas covers the pharmaceutical industry for The New York Times.

This story republished by permission of ProPublica.

Hundreds of doctors packed an auditorium at Memorial Sloan Kettering Cancer Center on Oct. 1, deeply angered by revelations that the hospital’s top medical officer and other leaders had cultivated lucrative relationships with for-profit companies.

One by one, they stood up to challenge the stewardship of their beloved institution, often to emotional applause. Some speakers accused their leaders of letting the quest to make more money undermine the hospital’s mission. Others bemoaned a rigid, hierarchical management that had left them feeling they had no real voice in the hospital’s direction.

“Slowly, I’ve seen more and more of the higher-up meetings happening with people who are dressed up in suits as opposed to white coats,” said Viviane Tabar, MD, chairwoman of the neurosurgery department.

“The corporatization of this institution is clear to many of us who have been here a long time,” said Carol L. Brown, MD, a gynecologic cancer surgeon, according to an audio recording of the meeting.

The meeting ended after several doctors advocated an immediate no-confidence vote in the hospital’s senior leadership. The turmoil followed reports by The New York Times and ProPublica that the hospital’s chief medical officer, José Baselga, MD, had been paid millions by drug and health care companies and failed to disclose those ties more than 100 times in medical journals, and that hospital insiders had made lucrative side deals that stood to earn them handsome profits, sometimes for work they had done on the job.

The day after the meeting, the hospital’s chief executive, Craig B. Thompson, MD, promised greater openness with rank-and-file doctors about decisionmaking. He also committed to doing the “root-cause analysis” requested by the doctors of how “egregious conflicts of interest,” as one physician put it, had been allowed to happen.

Other hospitals around the country are confronting similar dilemmas. But at Memorial Sloan Kettering, one of the nation’s leading cancer research and treatment centers, they are especially acute. Internal emails, audio recordings of meetings and interviews with doctors show how this major New York institution has struggled to contain a crisis of confidence in its leadership.

Closer ties between nonprofit research centers like Memorial Sloan Kettering and corporations are being fueled by a rush of potentially breakthrough cancer treatments. Venture capital firms and drug companies have looked to cash in on the scientific discoveries, said Brad Loncar, the founder of an investment fund that focuses on cancer. “Money follows success,” he said, and Memorial Sloan Kettering has been a focus “because they conduct terrific science there.”

In recent years, the hospital, like its competitors, has struck increasingly sophisticated deals to commercialize its discoveries, in some cases receiving equity stakes in startups rather than simply collecting royalties.

The predicament of Memorial Sloan Kettering also reflects a shift in its own culture. Its prior chief executive, Harold E. Varmus, MD, a Nobel Prize-winning scientist, personally kept companies at arm’s length, while Dr. Thompson, also a respected cancer researcher, has more fully embraced such relationships. The new approach has been applauded by some for expanding access to the cancer center’s discoveries, even as others have worried that the hospital may be losing sight of its mission.

Its leaders and top researchers also hold influential positions in the corporate world. When news of Dr. Baselga’s disclosure lapses broke in September, 12 doctors and researchers at the hospital served on the boards of publicly traded companies, more than at any other major cancer center, according to a review by the Times and ProPublica. Dr. Baselga has since resigned from the hospital and the two boards he served on. And a day after the physicians’ meeting on Oct. 1, Dr. Thompson resigned from the boards of the pharmaceutical giant Merck and Charles River Laboratories, a health care company, that together had paid him $585,050 in compensation in 2017.

The concern of ethicists and health experts is that a bias in favor of industry can unduly influence scientific research and medical treatments and remove a valuable check on soaring drug prices.

“We do have to sort of decide which side of this we’re on, or at least notice that we are feeding at the very trough that is causing worse access here than in any other Western country,” Peter B. Bach, MD, director of the hospital’s Center for Health Policy and Outcomes, said at the Oct. 1 meeting.

The problems at Memorial Sloan Kettering have shaken other cancer centers. At Dana-Farber Cancer Institute, officials have said they are considering whether Laurie H. Glimcher, MD, their chief executive, and others should continue to serve on the boards of publicly traded companies, including the drugmaker GlaxoSmithKline, on whose board Dr. Glimcher sits.

At the Fred Hutchinson Cancer Research Center in Seattle, a task force is reviewing the conflict-of-interest policies that govern employees’ financial relationships with drug companies. And medical centers around the country have instructed researchers to review their financial disclosures to medical journals, leading to a series of corrections to scientific articles.

Even as Memorial Sloan Kettering leaders have promised greater transparency, they have engaged a public affairs firm, SKDKnickerbocker, to manage their message and have aggressively pushed back against the idea that the hospital’s leaders are too close to industry.

“I can see how someone might think that business relationships are problematic,” said Lisa DeAngelis, MD, who has stepped into Dr. Baselga’s former position at Memorial Sloan Kettering on an acting basis. “But I’m telling you, as someone who works with patients, and I’ve worked with patients throughout my entire career here, that working with industry has helped me save lives.”

The Times and ProPublica asked to speak to Dr. Tabar and Dr. Brown about the critical remarks they made about the hospital’s direction at the Oct. 1 meeting. Mike Morey, managing director of the communications firm engaged by the hospital, arranged for them to speak to reporters on the phone while he listened. The doctors said they were not specifically referring to Memorial Sloan Kettering during the meeting that was recorded by one of those in attendance, but to broader changes in the medical world.

Defining an Institution’s Role

Founded in 1884 as the New York Cancer Hospital, Memorial Sloan Kettering was the first hospital in the country devoted exclusively to treating cancer. Its benefactors have included some of the wealthiest families in America, from the Astors and Rockefellers in its early years to the Kochs today.

It now operates more than 120 research laboratories, employs more than 1,000 doctors, admits some 23,500 patients a year, operates one of the world’s largest clinical trial programs and had revenues of nearly $4.5 billion in 2017. It recently completed a $3.5 billion fundraising drive, and its charity ball remains a fixture on New York’s social calendar.

As a leading force in cancer research, the hospital has long grappled with striking a balance in its collaborations with drug companies. While it did business with industry during the tenure of Dr. Varmus, a former director of the National Institutes of Health, he and a top deputy, Robert E. Wittes, MD, did not consult for companies, own their stock or serve on their boards, according to several people who worked for Dr. Varmus while he was at the hospital from 2000 to 2010. Dr. Varmus and Dr. Wittes declined to comment.

But some on the hospital’s board wanted its chief executive to do more to encourage company-financed clinical trials and to bring discoveries to market. In an interview, John R. Gunn, the cancer center’s chief operating officer from 1987 to 2015, said board members felt gems of research were “lying fallow and nobody was kind of pushing it, to commercialize it.”

By the time Dr. Varmus left to direct the National Cancer Institute in 2010, Memorial Sloan Kettering’s board was looking for a leader who was as comfortable in a corporate boardroom as in the lab, according to several longtime current and former cancer center employees.

Dr. Thompson met that criteria. He headed the Abramson Cancer Center at the University of Pennsylvania, was the co-founder of a biotech startup, Agios, and served on the board of Merck.

His early tenure was marred by controversy. In 2011 and 2012, he was sued by his former employers, the Abramson center and the University of Pennsylvania, which accused him of walking off with valuable research and using it to start Agios. At the time, Dr. Thompson denied wrongdoing and the suits were later settled for an undisclosed sum.

In 2012, Dr. Thompson hired Dr. Baselga to be the top physician at Memorial Sloan Kettering. Dr. Baselga, who had made his name as a key investigator of the breast cancer drug Herceptin, was also seen as having bridged the worlds of research and industry. Dr. DeAngelis, the hospital’s acting physician-in-chief, said that under Dr. Baselga, clinical trials were approved more quickly, helping speed treatments to patients.

But several doctors who worked under Dr. Baselga said in interviews that he had an abrasive style and created a culture where ties to industry were not kept in check. Dr. Baselga has not responded to requests for comment.

In his years at Memorial Sloan Kettering, Dr. Baselga’s personal financial conflicts were handled differently from those of other doctors, according to Clifford A. Hudis, MD, who was chairman of the hospital’s conflict-of-interest advisory committee through early 2016, when he left to become chief executive of the American Society of Clinical Oncology.

Dr. Baselga’s conflicts were not overseen by Dr. Hudis’ committee, but by the audit committee of the hospital’s board of directors. “I was told this was pretty standard for the highest level executives,” Dr. Hudis said. “I didn’t understand why any clinician would have separate rules from any other.”

Mr. Morey said that the hospital is evaluating its process for reviewing conflicts of interest, but that executives like Dr. Baselga had their financial relationships overseen by the board “to protect faculty from being put in a position of having to review their supervisor’s potential conflicts.”

Dr. Baselga is not the only leading researcher to have maintained extensive ties to the drug and health care companies — as some also did under Dr. Varmus. Jedd Wolchok, MD, a noted pioneer in immunotherapy, has financial relationships with more than 30 companies, according to recent disclosures. Charles L. Sawyers, MD, another of the hospital’s biggest names, has founded several cancer startups, one of which Memorial Sloan Kettering has invested in, and serves on the board of the Swiss pharmaceutical giant Novartis.

Ethicists and health experts say having leaders and researchers at nonprofit hospitals sit on corporate boards is especially problematic. When they serve on the board of a publicly traded company, they have a legal duty to the corporation and its shareholders, which can clash with their duty to their patients and primary employers. Those who sit on boards are often paid hundreds of thousands of dollars a year.

“I don’t think you can serve two masters,” said Bernard Lo, MD, who led an influential Institute of Medicine panel in 2009 that investigated financial conflicts in medicine. “The whole reason for being in the cancer care business is that you’re trying to help people in need, and that’s not at all the company’s main purpose. It’s to generate profits on their products.”

A report in November in BioPharma Dive found that 12 of the 19 largest pharmaceutical and biotech companies had at least one board member who also worked at a nonprofit health care institution. A 2014 study in JAMA found that about 40 percent of the largest publicly traded drug companies had a leader of an academic medical center on their boards.

Robert Benezra, PhD, who heads a lab at Memorial Sloan Kettering that focuses on how tumors grow, is the president, chief executive officer and a board member of AngioGenex, a tiny, publicly traded biotech company that is developing drugs to treat cancer based on the discoveries made in his lab.

Though he takes no salary from AngioGenex, Benezra owns nearly 9 percent of the company he helped found through stock or options, setting him up for a lucrative payday if the company is acquired or its drugs come to market.

In 2017, Dr. Benezra wrote to AngioGenex shareholders that a recent policy and leadership change at the hospital “afforded me the freedom to assume a more active role in the company” and to recruit other Memorial Sloan Kettering scientists to work with the company.

Dr. Benezra said in a statement issued through the hospital, “While I do not work directly with patients, I hope that this important science can one day make an impact in the lives of cancer sufferers.”

Mr. Morey said Dr. Benezra spends just 30 hours a year on business related to the publicly traded company. “We’re talking about 45 minutes a week, which is less than what most people spend on Netflix in a night,” Mr. Morey said.

Dr. DeAngelis, the acting physician-in-chief, said the high number of Memorial Sloan Kettering leaders who serve on corporate boards is reflective of their stature. “Maybe we should turn this around and say, we have more people on corporate boards because people value the opinions from our faculty,” she said in an interview.
 

A Staff in Turmoil

Tensions among doctors at the hospital over conflicts of interests mounted through September. On Sept. 28, Colin Begg, PhD, the chairman of its department of epidemiology and biostatistics, wrote to other department heads. “The key substantive issue is that the problems we face were not caused by failures to disclose conflicts. The problems were due to the conflicts themselves,” he wrote in the email, a copy of which was obtained by the Times and ProPublica.

Referring to Dr. Thompson and Douglas A. Warner III, the outgoing chairman of the hospital’s board of managers and overseers, who is known as Sandy, he said: “As far as I can tell neither Sandy nor Craig understand this very basic point. And if you don’t recognize that a problem exists there is no chance you will solve it.”

He also said: “Making billions is not our mission. MSK is a nonprofit with a fundamentally social mission.”

Dr. Begg declined to comment.

Shortly before the doctors met on Oct. 1, Dr. Thompson sounded a conciliatory note. “I want to start by apologizing to the medical staff on behalf of myself and the rest of senior management,” he said, according to a draft transcript of the staff meeting. “The events of the last few weeks have not been handled as well as I would have liked.”

Mr. Warner also addressed the doctors, informing them that the board was assessing whether Dr. Thompson should remain on Merck’s board.

“Should Craig continue to sit on the Merck board? We have no policy on that,” Mr. Warner said, according to the transcript, noting that Dr. Thompson’s role on the board was initially seen as a “good thing” when he joined the hospital. “We need to step back from that now and ask ourselves whether that continues to be appropriate, whether it’s appropriate in the future.”

The next day, Oct. 2, Dr. Thompson announced that he was resigning from both the boards on which he served.

Requests to interview Dr. Thompson and Mr. Warner were declined. Instead, the hospital arranged for reporters to speak to Dr. DeAngelis, who said she saw nothing wrong with the corporate ties that Dr. Thompson had earlier said were under review.

She downplayed the concerns voiced by Dr. Begg about the culture of the hospital. ”He is a biostatistician. He does not work with patients. He works with data,” she said, adding that he does not have “as full an understanding” about policies to prevent doctors with corporate ties from having an undue influence on clinical trials.

Dr. Thompson and two deputies, including Dr. DeAngelis, sent a note to hospital doctors on Dec. 20, warning them about this article. While it mentioned the ongoing review, it offered a full-throated defense of those serving on corporate boards.

“We expect the piece to question the ethics of some of our most accomplished researchers and clinicians. We want you to know that we reject these insinuations and we stand behind our faculty 100 percent.”
 

Katie Thomas covers the pharmaceutical industry for The New York Times.

This story republished by permission of ProPublica.

Hundreds of doctors packed an auditorium at Memorial Sloan Kettering Cancer Center on Oct. 1, deeply angered by revelations that the hospital’s top medical officer and other leaders had cultivated lucrative relationships with for-profit companies.

One by one, they stood up to challenge the stewardship of their beloved institution, often to emotional applause. Some speakers accused their leaders of letting the quest to make more money undermine the hospital’s mission. Others bemoaned a rigid, hierarchical management that had left them feeling they had no real voice in the hospital’s direction.

“Slowly, I’ve seen more and more of the higher-up meetings happening with people who are dressed up in suits as opposed to white coats,” said Viviane Tabar, MD, chairwoman of the neurosurgery department.

“The corporatization of this institution is clear to many of us who have been here a long time,” said Carol L. Brown, MD, a gynecologic cancer surgeon, according to an audio recording of the meeting.

The meeting ended after several doctors advocated an immediate no-confidence vote in the hospital’s senior leadership. The turmoil followed reports by The New York Times and ProPublica that the hospital’s chief medical officer, José Baselga, MD, had been paid millions by drug and health care companies and failed to disclose those ties more than 100 times in medical journals, and that hospital insiders had made lucrative side deals that stood to earn them handsome profits, sometimes for work they had done on the job.

The day after the meeting, the hospital’s chief executive, Craig B. Thompson, MD, promised greater openness with rank-and-file doctors about decisionmaking. He also committed to doing the “root-cause analysis” requested by the doctors of how “egregious conflicts of interest,” as one physician put it, had been allowed to happen.

Other hospitals around the country are confronting similar dilemmas. But at Memorial Sloan Kettering, one of the nation’s leading cancer research and treatment centers, they are especially acute. Internal emails, audio recordings of meetings and interviews with doctors show how this major New York institution has struggled to contain a crisis of confidence in its leadership.

Closer ties between nonprofit research centers like Memorial Sloan Kettering and corporations are being fueled by a rush of potentially breakthrough cancer treatments. Venture capital firms and drug companies have looked to cash in on the scientific discoveries, said Brad Loncar, the founder of an investment fund that focuses on cancer. “Money follows success,” he said, and Memorial Sloan Kettering has been a focus “because they conduct terrific science there.”

In recent years, the hospital, like its competitors, has struck increasingly sophisticated deals to commercialize its discoveries, in some cases receiving equity stakes in startups rather than simply collecting royalties.

The predicament of Memorial Sloan Kettering also reflects a shift in its own culture. Its prior chief executive, Harold E. Varmus, MD, a Nobel Prize-winning scientist, personally kept companies at arm’s length, while Dr. Thompson, also a respected cancer researcher, has more fully embraced such relationships. The new approach has been applauded by some for expanding access to the cancer center’s discoveries, even as others have worried that the hospital may be losing sight of its mission.

Its leaders and top researchers also hold influential positions in the corporate world. When news of Dr. Baselga’s disclosure lapses broke in September, 12 doctors and researchers at the hospital served on the boards of publicly traded companies, more than at any other major cancer center, according to a review by the Times and ProPublica. Dr. Baselga has since resigned from the hospital and the two boards he served on. And a day after the physicians’ meeting on Oct. 1, Dr. Thompson resigned from the boards of the pharmaceutical giant Merck and Charles River Laboratories, a health care company, that together had paid him $585,050 in compensation in 2017.

The concern of ethicists and health experts is that a bias in favor of industry can unduly influence scientific research and medical treatments and remove a valuable check on soaring drug prices.

“We do have to sort of decide which side of this we’re on, or at least notice that we are feeding at the very trough that is causing worse access here than in any other Western country,” Peter B. Bach, MD, director of the hospital’s Center for Health Policy and Outcomes, said at the Oct. 1 meeting.

The problems at Memorial Sloan Kettering have shaken other cancer centers. At Dana-Farber Cancer Institute, officials have said they are considering whether Laurie H. Glimcher, MD, their chief executive, and others should continue to serve on the boards of publicly traded companies, including the drugmaker GlaxoSmithKline, on whose board Dr. Glimcher sits.

At the Fred Hutchinson Cancer Research Center in Seattle, a task force is reviewing the conflict-of-interest policies that govern employees’ financial relationships with drug companies. And medical centers around the country have instructed researchers to review their financial disclosures to medical journals, leading to a series of corrections to scientific articles.

Even as Memorial Sloan Kettering leaders have promised greater transparency, they have engaged a public affairs firm, SKDKnickerbocker, to manage their message and have aggressively pushed back against the idea that the hospital’s leaders are too close to industry.

“I can see how someone might think that business relationships are problematic,” said Lisa DeAngelis, MD, who has stepped into Dr. Baselga’s former position at Memorial Sloan Kettering on an acting basis. “But I’m telling you, as someone who works with patients, and I’ve worked with patients throughout my entire career here, that working with industry has helped me save lives.”

The Times and ProPublica asked to speak to Dr. Tabar and Dr. Brown about the critical remarks they made about the hospital’s direction at the Oct. 1 meeting. Mike Morey, managing director of the communications firm engaged by the hospital, arranged for them to speak to reporters on the phone while he listened. The doctors said they were not specifically referring to Memorial Sloan Kettering during the meeting that was recorded by one of those in attendance, but to broader changes in the medical world.

Defining an Institution’s Role

Founded in 1884 as the New York Cancer Hospital, Memorial Sloan Kettering was the first hospital in the country devoted exclusively to treating cancer. Its benefactors have included some of the wealthiest families in America, from the Astors and Rockefellers in its early years to the Kochs today.

It now operates more than 120 research laboratories, employs more than 1,000 doctors, admits some 23,500 patients a year, operates one of the world’s largest clinical trial programs and had revenues of nearly $4.5 billion in 2017. It recently completed a $3.5 billion fundraising drive, and its charity ball remains a fixture on New York’s social calendar.

As a leading force in cancer research, the hospital has long grappled with striking a balance in its collaborations with drug companies. While it did business with industry during the tenure of Dr. Varmus, a former director of the National Institutes of Health, he and a top deputy, Robert E. Wittes, MD, did not consult for companies, own their stock or serve on their boards, according to several people who worked for Dr. Varmus while he was at the hospital from 2000 to 2010. Dr. Varmus and Dr. Wittes declined to comment.

But some on the hospital’s board wanted its chief executive to do more to encourage company-financed clinical trials and to bring discoveries to market. In an interview, John R. Gunn, the cancer center’s chief operating officer from 1987 to 2015, said board members felt gems of research were “lying fallow and nobody was kind of pushing it, to commercialize it.”

By the time Dr. Varmus left to direct the National Cancer Institute in 2010, Memorial Sloan Kettering’s board was looking for a leader who was as comfortable in a corporate boardroom as in the lab, according to several longtime current and former cancer center employees.

Dr. Thompson met that criteria. He headed the Abramson Cancer Center at the University of Pennsylvania, was the co-founder of a biotech startup, Agios, and served on the board of Merck.

His early tenure was marred by controversy. In 2011 and 2012, he was sued by his former employers, the Abramson center and the University of Pennsylvania, which accused him of walking off with valuable research and using it to start Agios. At the time, Dr. Thompson denied wrongdoing and the suits were later settled for an undisclosed sum.

In 2012, Dr. Thompson hired Dr. Baselga to be the top physician at Memorial Sloan Kettering. Dr. Baselga, who had made his name as a key investigator of the breast cancer drug Herceptin, was also seen as having bridged the worlds of research and industry. Dr. DeAngelis, the hospital’s acting physician-in-chief, said that under Dr. Baselga, clinical trials were approved more quickly, helping speed treatments to patients.

But several doctors who worked under Dr. Baselga said in interviews that he had an abrasive style and created a culture where ties to industry were not kept in check. Dr. Baselga has not responded to requests for comment.

In his years at Memorial Sloan Kettering, Dr. Baselga’s personal financial conflicts were handled differently from those of other doctors, according to Clifford A. Hudis, MD, who was chairman of the hospital’s conflict-of-interest advisory committee through early 2016, when he left to become chief executive of the American Society of Clinical Oncology.

Dr. Baselga’s conflicts were not overseen by Dr. Hudis’ committee, but by the audit committee of the hospital’s board of directors. “I was told this was pretty standard for the highest level executives,” Dr. Hudis said. “I didn’t understand why any clinician would have separate rules from any other.”

Mr. Morey said that the hospital is evaluating its process for reviewing conflicts of interest, but that executives like Dr. Baselga had their financial relationships overseen by the board “to protect faculty from being put in a position of having to review their supervisor’s potential conflicts.”

Dr. Baselga is not the only leading researcher to have maintained extensive ties to the drug and health care companies — as some also did under Dr. Varmus. Jedd Wolchok, MD, a noted pioneer in immunotherapy, has financial relationships with more than 30 companies, according to recent disclosures. Charles L. Sawyers, MD, another of the hospital’s biggest names, has founded several cancer startups, one of which Memorial Sloan Kettering has invested in, and serves on the board of the Swiss pharmaceutical giant Novartis.

Ethicists and health experts say having leaders and researchers at nonprofit hospitals sit on corporate boards is especially problematic. When they serve on the board of a publicly traded company, they have a legal duty to the corporation and its shareholders, which can clash with their duty to their patients and primary employers. Those who sit on boards are often paid hundreds of thousands of dollars a year.

“I don’t think you can serve two masters,” said Bernard Lo, MD, who led an influential Institute of Medicine panel in 2009 that investigated financial conflicts in medicine. “The whole reason for being in the cancer care business is that you’re trying to help people in need, and that’s not at all the company’s main purpose. It’s to generate profits on their products.”

A report in November in BioPharma Dive found that 12 of the 19 largest pharmaceutical and biotech companies had at least one board member who also worked at a nonprofit health care institution. A 2014 study in JAMA found that about 40 percent of the largest publicly traded drug companies had a leader of an academic medical center on their boards.

Robert Benezra, PhD, who heads a lab at Memorial Sloan Kettering that focuses on how tumors grow, is the president, chief executive officer and a board member of AngioGenex, a tiny, publicly traded biotech company that is developing drugs to treat cancer based on the discoveries made in his lab.

Though he takes no salary from AngioGenex, Benezra owns nearly 9 percent of the company he helped found through stock or options, setting him up for a lucrative payday if the company is acquired or its drugs come to market.

In 2017, Dr. Benezra wrote to AngioGenex shareholders that a recent policy and leadership change at the hospital “afforded me the freedom to assume a more active role in the company” and to recruit other Memorial Sloan Kettering scientists to work with the company.

Dr. Benezra said in a statement issued through the hospital, “While I do not work directly with patients, I hope that this important science can one day make an impact in the lives of cancer sufferers.”

Mr. Morey said Dr. Benezra spends just 30 hours a year on business related to the publicly traded company. “We’re talking about 45 minutes a week, which is less than what most people spend on Netflix in a night,” Mr. Morey said.

Dr. DeAngelis, the acting physician-in-chief, said the high number of Memorial Sloan Kettering leaders who serve on corporate boards is reflective of their stature. “Maybe we should turn this around and say, we have more people on corporate boards because people value the opinions from our faculty,” she said in an interview.
 

A Staff in Turmoil

Tensions among doctors at the hospital over conflicts of interests mounted through September. On Sept. 28, Colin Begg, PhD, the chairman of its department of epidemiology and biostatistics, wrote to other department heads. “The key substantive issue is that the problems we face were not caused by failures to disclose conflicts. The problems were due to the conflicts themselves,” he wrote in the email, a copy of which was obtained by the Times and ProPublica.

Referring to Dr. Thompson and Douglas A. Warner III, the outgoing chairman of the hospital’s board of managers and overseers, who is known as Sandy, he said: “As far as I can tell neither Sandy nor Craig understand this very basic point. And if you don’t recognize that a problem exists there is no chance you will solve it.”

He also said: “Making billions is not our mission. MSK is a nonprofit with a fundamentally social mission.”

Dr. Begg declined to comment.

Shortly before the doctors met on Oct. 1, Dr. Thompson sounded a conciliatory note. “I want to start by apologizing to the medical staff on behalf of myself and the rest of senior management,” he said, according to a draft transcript of the staff meeting. “The events of the last few weeks have not been handled as well as I would have liked.”

Mr. Warner also addressed the doctors, informing them that the board was assessing whether Dr. Thompson should remain on Merck’s board.

“Should Craig continue to sit on the Merck board? We have no policy on that,” Mr. Warner said, according to the transcript, noting that Dr. Thompson’s role on the board was initially seen as a “good thing” when he joined the hospital. “We need to step back from that now and ask ourselves whether that continues to be appropriate, whether it’s appropriate in the future.”

The next day, Oct. 2, Dr. Thompson announced that he was resigning from both the boards on which he served.

Requests to interview Dr. Thompson and Mr. Warner were declined. Instead, the hospital arranged for reporters to speak to Dr. DeAngelis, who said she saw nothing wrong with the corporate ties that Dr. Thompson had earlier said were under review.

She downplayed the concerns voiced by Dr. Begg about the culture of the hospital. ”He is a biostatistician. He does not work with patients. He works with data,” she said, adding that he does not have “as full an understanding” about policies to prevent doctors with corporate ties from having an undue influence on clinical trials.

Dr. Thompson and two deputies, including Dr. DeAngelis, sent a note to hospital doctors on Dec. 20, warning them about this article. While it mentioned the ongoing review, it offered a full-throated defense of those serving on corporate boards.

“We expect the piece to question the ethics of some of our most accomplished researchers and clinicians. We want you to know that we reject these insinuations and we stand behind our faculty 100 percent.”
 

Katie Thomas covers the pharmaceutical industry for The New York Times.

Single-agent therapy with quizartinib slightly but significantly prolonged survival – compared with salvage chemotherapy – for patients with relapsed/refractory acute myeloid leukemia (AML) bearing the FLT3-ITD mutation, results of the phase 3 randomized QuANTUM-R trial showed.

Neil Osterweil/MDedge News

Median overall survival (OS), the trial’s primary endpoint, was 6.2 months for 245 patients randomized to quizartinib, compared with 4.7 months for 122 patients assigned to salvage chemotherapy, a difference that translated into a hazard ratio (HR) for death of 0.76 (P = .0177), reported Jorge E. Cortes, MD, of the University of Texas MD Anderson Cancer Center in Houston.

“This study is the first study that demonstrates in a randomized fashion an overall survival benefit in the salvage setting for patients with FLT-3 mutated refractory or relapsed AML,” he said at the annual meeting of the American Society of Hematology. “I will also add that these results you saw here are very consistent with all the trials previously with quizartinib with more than 1,000 patients treated.”

Quizartinib, a tyrosine kinase inhibitor (TKI), has previously been shown to be associated with higher response rates among patients with AML bearing the FLT3-ITD mutation than in patients with AML without the deleterious mutation.

Investigators in the QuANTUM-R trial enrolled 367 adults with FTL3-ITD mutated AML that was refractory to the most recent line of therapy or had relapsed within 6 months of first remission, with or without hematopoietic stem cell transplant (HSCT).

The patients had all received at least one cycle of standard-dose induction therapy containing an anthracycline or mitoxantrone, and had a 3% or greater FLT3-ITD allelic ratio in their AML cells.

The patients were randomly assigned on a 2:1 basis to receive either quizartinib or salvage chemotherapy. Quizartinib was dosed 30 mg per day for 15 days, which could be titrated upward to 60 mg daily if the corrected QT interval by Fredericia (QTcF) was 450 ms or less on day 16.

Chemotherapy was the investigator’s choice of one of three specified regimens: either low-dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte-colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA). Up to two cycles of MEC or FLAG-IDA were permitted; quizartinib and LoDAC were given until lack of benefit, unacceptable toxicity, or until the patient went on to HSCT.

The analysis was by intention-to-treat. In the quizartinib arm, 241 of the 245 randomized patients (98.4%) received treatment. In the chemotherapy arm, 94 of 122 randomized patients (77%) received chemotherapy. Of this group, 22 received LoDAC, 25 received MEC, and 47 received FLAG-IDA.

The median treatment duration was 97 days in the quizartinib arm versus 28 days (one cycle) in the chemotherapy arm.

The 1-year overall survival rate was 27% for patients assigned to quizartinib, compared with 20% for patients assigned to chemotherapy.

An analysis of OS by subgroup indicated a trend or significant benefit for quizartinib in all categories, including age over or under 65 years, sex, low or high-intensity chemotherapy, response to prior therapy, FLT3 variant allele frequency, prior allogenic HSCT, and AML risk score.

For the secondary endpoint of event-free survival in the ITT population, there was no significant difference between the study arms. In a per-protocol analysis, however, median event-free survival was better with quizartinib, at 1.4 months versus 0.0 months (P = .006).

In all, 32% of patients assigned to quizartinib went on to HSCT, compared with 12% of patients randomized to chemotherapy.

Rates of treatment-emergent adverse events (TEAEs) were similar between the study arms, despite higher total drug exposure in patients randomized to quizartinib. The most frequent grade 3 or greater TEAEs in each arm were infections and cytopenia-related events.

Two patients discontinued quizartinib due to QTcF prolongation. Grade 3 QTcF (greater than 500 ms) occurred in 3% of patients treated with quizartinib, but no grade 4 cases were seen.

The adverse event profile for patients who resumed quizartinib following HSCT was similar to that of patients who received the drug pretransplant.

The combination of standard chemotherapy, with or without quizartinib, is currently being explored in the phase 3 QuANTUM-First trial, Dr. Cortes said.

Daiichi Sankyo sponsored the trial. Dr. Cortes reported financial relationships with Daiichi Sankyo, Pfizer, Arog, Astellas Pharma, and Novartis.

SOURCE: Cortes JE et al. ASH 2018, Abstract 563.

Single-agent therapy with quizartinib slightly but significantly prolonged survival – compared with salvage chemotherapy – for patients with relapsed/refractory acute myeloid leukemia (AML) bearing the FLT3-ITD mutation, results of the phase 3 randomized QuANTUM-R trial showed.

Neil Osterweil/MDedge News

Median overall survival (OS), the trial’s primary endpoint, was 6.2 months for 245 patients randomized to quizartinib, compared with 4.7 months for 122 patients assigned to salvage chemotherapy, a difference that translated into a hazard ratio (HR) for death of 0.76 (P = .0177), reported Jorge E. Cortes, MD, of the University of Texas MD Anderson Cancer Center in Houston.

“This study is the first study that demonstrates in a randomized fashion an overall survival benefit in the salvage setting for patients with FLT-3 mutated refractory or relapsed AML,” he said at the annual meeting of the American Society of Hematology. “I will also add that these results you saw here are very consistent with all the trials previously with quizartinib with more than 1,000 patients treated.”

Quizartinib, a tyrosine kinase inhibitor (TKI), has previously been shown to be associated with higher response rates among patients with AML bearing the FLT3-ITD mutation than in patients with AML without the deleterious mutation.

Investigators in the QuANTUM-R trial enrolled 367 adults with FTL3-ITD mutated AML that was refractory to the most recent line of therapy or had relapsed within 6 months of first remission, with or without hematopoietic stem cell transplant (HSCT).

The patients had all received at least one cycle of standard-dose induction therapy containing an anthracycline or mitoxantrone, and had a 3% or greater FLT3-ITD allelic ratio in their AML cells.

The patients were randomly assigned on a 2:1 basis to receive either quizartinib or salvage chemotherapy. Quizartinib was dosed 30 mg per day for 15 days, which could be titrated upward to 60 mg daily if the corrected QT interval by Fredericia (QTcF) was 450 ms or less on day 16.

Chemotherapy was the investigator’s choice of one of three specified regimens: either low-dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte-colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA). Up to two cycles of MEC or FLAG-IDA were permitted; quizartinib and LoDAC were given until lack of benefit, unacceptable toxicity, or until the patient went on to HSCT.

The analysis was by intention-to-treat. In the quizartinib arm, 241 of the 245 randomized patients (98.4%) received treatment. In the chemotherapy arm, 94 of 122 randomized patients (77%) received chemotherapy. Of this group, 22 received LoDAC, 25 received MEC, and 47 received FLAG-IDA.

The median treatment duration was 97 days in the quizartinib arm versus 28 days (one cycle) in the chemotherapy arm.

The 1-year overall survival rate was 27% for patients assigned to quizartinib, compared with 20% for patients assigned to chemotherapy.

An analysis of OS by subgroup indicated a trend or significant benefit for quizartinib in all categories, including age over or under 65 years, sex, low or high-intensity chemotherapy, response to prior therapy, FLT3 variant allele frequency, prior allogenic HSCT, and AML risk score.

For the secondary endpoint of event-free survival in the ITT population, there was no significant difference between the study arms. In a per-protocol analysis, however, median event-free survival was better with quizartinib, at 1.4 months versus 0.0 months (P = .006).

In all, 32% of patients assigned to quizartinib went on to HSCT, compared with 12% of patients randomized to chemotherapy.

Rates of treatment-emergent adverse events (TEAEs) were similar between the study arms, despite higher total drug exposure in patients randomized to quizartinib. The most frequent grade 3 or greater TEAEs in each arm were infections and cytopenia-related events.

Two patients discontinued quizartinib due to QTcF prolongation. Grade 3 QTcF (greater than 500 ms) occurred in 3% of patients treated with quizartinib, but no grade 4 cases were seen.

The adverse event profile for patients who resumed quizartinib following HSCT was similar to that of patients who received the drug pretransplant.

The combination of standard chemotherapy, with or without quizartinib, is currently being explored in the phase 3 QuANTUM-First trial, Dr. Cortes said.

Daiichi Sankyo sponsored the trial. Dr. Cortes reported financial relationships with Daiichi Sankyo, Pfizer, Arog, Astellas Pharma, and Novartis.

SOURCE: Cortes JE et al. ASH 2018, Abstract 563.

Single-agent therapy with quizartinib slightly but significantly prolonged survival – compared with salvage chemotherapy – for patients with relapsed/refractory acute myeloid leukemia (AML) bearing the FLT3-ITD mutation, results of the phase 3 randomized QuANTUM-R trial showed.

Neil Osterweil/MDedge News

Median overall survival (OS), the trial’s primary endpoint, was 6.2 months for 245 patients randomized to quizartinib, compared with 4.7 months for 122 patients assigned to salvage chemotherapy, a difference that translated into a hazard ratio (HR) for death of 0.76 (P = .0177), reported Jorge E. Cortes, MD, of the University of Texas MD Anderson Cancer Center in Houston.

“This study is the first study that demonstrates in a randomized fashion an overall survival benefit in the salvage setting for patients with FLT-3 mutated refractory or relapsed AML,” he said at the annual meeting of the American Society of Hematology. “I will also add that these results you saw here are very consistent with all the trials previously with quizartinib with more than 1,000 patients treated.”

Quizartinib, a tyrosine kinase inhibitor (TKI), has previously been shown to be associated with higher response rates among patients with AML bearing the FLT3-ITD mutation than in patients with AML without the deleterious mutation.

Investigators in the QuANTUM-R trial enrolled 367 adults with FTL3-ITD mutated AML that was refractory to the most recent line of therapy or had relapsed within 6 months of first remission, with or without hematopoietic stem cell transplant (HSCT).

The patients had all received at least one cycle of standard-dose induction therapy containing an anthracycline or mitoxantrone, and had a 3% or greater FLT3-ITD allelic ratio in their AML cells.

The patients were randomly assigned on a 2:1 basis to receive either quizartinib or salvage chemotherapy. Quizartinib was dosed 30 mg per day for 15 days, which could be titrated upward to 60 mg daily if the corrected QT interval by Fredericia (QTcF) was 450 ms or less on day 16.

Chemotherapy was the investigator’s choice of one of three specified regimens: either low-dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte-colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA). Up to two cycles of MEC or FLAG-IDA were permitted; quizartinib and LoDAC were given until lack of benefit, unacceptable toxicity, or until the patient went on to HSCT.

The analysis was by intention-to-treat. In the quizartinib arm, 241 of the 245 randomized patients (98.4%) received treatment. In the chemotherapy arm, 94 of 122 randomized patients (77%) received chemotherapy. Of this group, 22 received LoDAC, 25 received MEC, and 47 received FLAG-IDA.

The median treatment duration was 97 days in the quizartinib arm versus 28 days (one cycle) in the chemotherapy arm.

The 1-year overall survival rate was 27% for patients assigned to quizartinib, compared with 20% for patients assigned to chemotherapy.

An analysis of OS by subgroup indicated a trend or significant benefit for quizartinib in all categories, including age over or under 65 years, sex, low or high-intensity chemotherapy, response to prior therapy, FLT3 variant allele frequency, prior allogenic HSCT, and AML risk score.

For the secondary endpoint of event-free survival in the ITT population, there was no significant difference between the study arms. In a per-protocol analysis, however, median event-free survival was better with quizartinib, at 1.4 months versus 0.0 months (P = .006).

In all, 32% of patients assigned to quizartinib went on to HSCT, compared with 12% of patients randomized to chemotherapy.

Rates of treatment-emergent adverse events (TEAEs) were similar between the study arms, despite higher total drug exposure in patients randomized to quizartinib. The most frequent grade 3 or greater TEAEs in each arm were infections and cytopenia-related events.

Two patients discontinued quizartinib due to QTcF prolongation. Grade 3 QTcF (greater than 500 ms) occurred in 3% of patients treated with quizartinib, but no grade 4 cases were seen.

The adverse event profile for patients who resumed quizartinib following HSCT was similar to that of patients who received the drug pretransplant.

The combination of standard chemotherapy, with or without quizartinib, is currently being explored in the phase 3 QuANTUM-First trial, Dr. Cortes said.

Daiichi Sankyo sponsored the trial. Dr. Cortes reported financial relationships with Daiichi Sankyo, Pfizer, Arog, Astellas Pharma, and Novartis.

SOURCE: Cortes JE et al. ASH 2018, Abstract 563.

Do food delivery programs reduce the use of costly health services and decrease medical spending in a population of patients dually eligible for Medicare and Medicaid?

Researchers in Massachusetts wanted to determine whether home meal delivery of either medically tailored food or nontailored food reduces the use of selected health care services and medical spending in a sample of adult “dual eligibles.”

“Compared with matched nonparticipants, participants had fewer emergency department visits in both the medically tailored meal program and the nontailored food program,” the investigators found. “Participants in the medically tailored meal program also had fewer inpatient admissions and lower medical spending. Participation in the nontailored food program was not associated with fewer inpatient admissions but was associated with lower medical spending.”
 

Reference

Berkowitz SA et al. Meal delivery programs reduce the use of costly health care in dually eligible Medicare and Medicaid beneficiaries. Health Aff (Millwood). 2018 Apr;37(4):535-42.

Do food delivery programs reduce the use of costly health services and decrease medical spending in a population of patients dually eligible for Medicare and Medicaid?

Researchers in Massachusetts wanted to determine whether home meal delivery of either medically tailored food or nontailored food reduces the use of selected health care services and medical spending in a sample of adult “dual eligibles.”

“Compared with matched nonparticipants, participants had fewer emergency department visits in both the medically tailored meal program and the nontailored food program,” the investigators found. “Participants in the medically tailored meal program also had fewer inpatient admissions and lower medical spending. Participation in the nontailored food program was not associated with fewer inpatient admissions but was associated with lower medical spending.”
 

Reference

Berkowitz SA et al. Meal delivery programs reduce the use of costly health care in dually eligible Medicare and Medicaid beneficiaries. Health Aff (Millwood). 2018 Apr;37(4):535-42.

Do food delivery programs reduce the use of costly health services and decrease medical spending in a population of patients dually eligible for Medicare and Medicaid?

Researchers in Massachusetts wanted to determine whether home meal delivery of either medically tailored food or nontailored food reduces the use of selected health care services and medical spending in a sample of adult “dual eligibles.”

“Compared with matched nonparticipants, participants had fewer emergency department visits in both the medically tailored meal program and the nontailored food program,” the investigators found. “Participants in the medically tailored meal program also had fewer inpatient admissions and lower medical spending. Participation in the nontailored food program was not associated with fewer inpatient admissions but was associated with lower medical spending.”
 

Reference

Berkowitz SA et al. Meal delivery programs reduce the use of costly health care in dually eligible Medicare and Medicaid beneficiaries. Health Aff (Millwood). 2018 Apr;37(4):535-42.

Resources

US Department of Health and Human Services. Physical Activity Guidelines for Americans. 2nd ed. Office of Disease Prevention and Health Promotion Web site. Published 2018. https://health.gov/paguidelines/second-edition/. Accessed January 7, 2019.

Piercy KL, Troiano RP, Ballard RM, et al. The Physical Activity Guidelines for Americans. JAMA. 2018;320:2020-2028.

Resources

US Department of Health and Human Services. Physical Activity Guidelines for Americans. 2nd ed. Office of Disease Prevention and Health Promotion Web site. Published 2018. https://health.gov/paguidelines/second-edition/. Accessed January 7, 2019.

Piercy KL, Troiano RP, Ballard RM, et al. The Physical Activity Guidelines for Americans. JAMA. 2018;320:2020-2028.

Resources

US Department of Health and Human Services. Physical Activity Guidelines for Americans. 2nd ed. Office of Disease Prevention and Health Promotion Web site. Published 2018. https://health.gov/paguidelines/second-edition/. Accessed January 7, 2019.

Piercy KL, Troiano RP, Ballard RM, et al. The Physical Activity Guidelines for Americans. JAMA. 2018;320:2020-2028.

This month’s issue is packed with important science – nice to get back to medicine and not focus on politics. On page one, we highlight important new clinical guidance on the use of thiopurines in inflammatory bowel disease. This clinical practice update has some very specific and clear recommendations about thiopurines, especially in combination with biologic agents. As any clinician knowns, treatment of IBD has become complex from both a biologic standpoint and because we now recognize the importance of social determinants of health in our management of chronic diseases. We have seen an enormous outpouring of work that helps gastroenterologists develop multidisciplinary “homes” for IBD patients. These programs are now becoming best practice standards. Such approaches are practical for both academic and community GI practices. Best practice for our IBD patients now involves following clinical guidelines, understanding the impact of IBD on patients’ social and behavioral health and the incorporation of support services (or referral), and outcomes measurement. This clinical practice update will help us enhance our medical therapy for patients with both Crohn’s disease and ulcerative colitis.

Other stories include a review of the new AGA clinical practice update on endoscopic submucosal dissection for early stage cancers with important information about technique, indications, and management of complications. Questions about our approach to prevention of GI bleeding for patients in the ICU are raised by a new multicentered trial of PPI use in over 3,500 patients. Essentially, PPI prophylaxis should be reserved for seriously ill patients at high risk for bleeding – prophylaxis may not be needed in other ICU patients. Finally, another study does not support use of probiotics (at least in the current formulation) in children with gastroenteritis.

I hope you enjoy the issue and that you had a wonderful year’s end. We look forward to more excitement in 2019.

John I. Allen, MD, MBA, AGAF
Editor in Chief

This month’s issue is packed with important science – nice to get back to medicine and not focus on politics. On page one, we highlight important new clinical guidance on the use of thiopurines in inflammatory bowel disease. This clinical practice update has some very specific and clear recommendations about thiopurines, especially in combination with biologic agents. As any clinician knowns, treatment of IBD has become complex from both a biologic standpoint and because we now recognize the importance of social determinants of health in our management of chronic diseases. We have seen an enormous outpouring of work that helps gastroenterologists develop multidisciplinary “homes” for IBD patients. These programs are now becoming best practice standards. Such approaches are practical for both academic and community GI practices. Best practice for our IBD patients now involves following clinical guidelines, understanding the impact of IBD on patients’ social and behavioral health and the incorporation of support services (or referral), and outcomes measurement. This clinical practice update will help us enhance our medical therapy for patients with both Crohn’s disease and ulcerative colitis.

Other stories include a review of the new AGA clinical practice update on endoscopic submucosal dissection for early stage cancers with important information about technique, indications, and management of complications. Questions about our approach to prevention of GI bleeding for patients in the ICU are raised by a new multicentered trial of PPI use in over 3,500 patients. Essentially, PPI prophylaxis should be reserved for seriously ill patients at high risk for bleeding – prophylaxis may not be needed in other ICU patients. Finally, another study does not support use of probiotics (at least in the current formulation) in children with gastroenteritis.

I hope you enjoy the issue and that you had a wonderful year’s end. We look forward to more excitement in 2019.

John I. Allen, MD, MBA, AGAF
Editor in Chief

This month’s issue is packed with important science – nice to get back to medicine and not focus on politics. On page one, we highlight important new clinical guidance on the use of thiopurines in inflammatory bowel disease. This clinical practice update has some very specific and clear recommendations about thiopurines, especially in combination with biologic agents. As any clinician knowns, treatment of IBD has become complex from both a biologic standpoint and because we now recognize the importance of social determinants of health in our management of chronic diseases. We have seen an enormous outpouring of work that helps gastroenterologists develop multidisciplinary “homes” for IBD patients. These programs are now becoming best practice standards. Such approaches are practical for both academic and community GI practices. Best practice for our IBD patients now involves following clinical guidelines, understanding the impact of IBD on patients’ social and behavioral health and the incorporation of support services (or referral), and outcomes measurement. This clinical practice update will help us enhance our medical therapy for patients with both Crohn’s disease and ulcerative colitis.

Other stories include a review of the new AGA clinical practice update on endoscopic submucosal dissection for early stage cancers with important information about technique, indications, and management of complications. Questions about our approach to prevention of GI bleeding for patients in the ICU are raised by a new multicentered trial of PPI use in over 3,500 patients. Essentially, PPI prophylaxis should be reserved for seriously ill patients at high risk for bleeding – prophylaxis may not be needed in other ICU patients. Finally, another study does not support use of probiotics (at least in the current formulation) in children with gastroenteritis.

I hope you enjoy the issue and that you had a wonderful year’s end. We look forward to more excitement in 2019.

John I. Allen, MD, MBA, AGAF
Editor in Chief

Elevated eosinophil levels and interleukin-4 (IL-4) levels were significantly associated with an increased risk of overlapping asthma and chronic obstructive pulmonary disease (COPD) in firefighters exposed to toxins at the World Trade Center on Sept. 11, 2001.

Courtesy Andrea Booher/FEMA News Photo

Patients with asthma/COPD overlap experience decreased quality of life and increased mortality, compared with patients who have either isolated COPD or isolated asthma, and longitudinal data on risk factors for the overlapping condition are lacking, wrote Ankura Singh, MPH, of Albert Einstein College of Medicine, New York, and colleagues.

In a study published in CHEST, the researchers reviewed data from 2,137 firefighters exposed to toxins at the World Trade Center on 9/11. The study participants underwent a bronchodilator pulmonary function test between Sept. 9, 2001, and Sept. 10, 2017, and at least three routine monitoring pulmonary function tests between these two dates.

In a multivariate analysis, eosinophil concentration of at least 300 cells/mcL was a significant predictor of asthma/COPD overlap. Serum IL-4 levels also were significant predictors of asthma/COPD overlap (hazard ratio, 1.51).

In addition, a greater concentration of IL-21 was associated with both isolated asthma and isolated COPD, but not with the overlap.

The study results were strengthened by the availability of pre-exposure medical data for the firefighters and the close follow-up, although limitations included the mostly white male population and a limited definition of asthma, the researchers noted.

However, the findings suggest that “high eosinophil concentrations, uniquely associated with asthma/COPD overlap in this population, may reflect biological pathways that predispose one to exaggerated inflammation and/or poor counterregulatory responses to inflammation, leading to reversible and fixed airflow obstruction,” they wrote. Consequently, early interventions targeting specific inflammatory pathways may improve lung function outcomes.

The study was supported in part by the National Institute of Occupational Safety and Health and the National Institutes of Health.

SOURCE: Singh A et al. CHEST. 2018 Dec;154;1301-10.

Elevated eosinophil levels and interleukin-4 (IL-4) levels were significantly associated with an increased risk of overlapping asthma and chronic obstructive pulmonary disease (COPD) in firefighters exposed to toxins at the World Trade Center on Sept. 11, 2001.

Courtesy Andrea Booher/FEMA News Photo

Patients with asthma/COPD overlap experience decreased quality of life and increased mortality, compared with patients who have either isolated COPD or isolated asthma, and longitudinal data on risk factors for the overlapping condition are lacking, wrote Ankura Singh, MPH, of Albert Einstein College of Medicine, New York, and colleagues.

In a study published in CHEST, the researchers reviewed data from 2,137 firefighters exposed to toxins at the World Trade Center on 9/11. The study participants underwent a bronchodilator pulmonary function test between Sept. 9, 2001, and Sept. 10, 2017, and at least three routine monitoring pulmonary function tests between these two dates.

In a multivariate analysis, eosinophil concentration of at least 300 cells/mcL was a significant predictor of asthma/COPD overlap. Serum IL-4 levels also were significant predictors of asthma/COPD overlap (hazard ratio, 1.51).

In addition, a greater concentration of IL-21 was associated with both isolated asthma and isolated COPD, but not with the overlap.

The study results were strengthened by the availability of pre-exposure medical data for the firefighters and the close follow-up, although limitations included the mostly white male population and a limited definition of asthma, the researchers noted.

However, the findings suggest that “high eosinophil concentrations, uniquely associated with asthma/COPD overlap in this population, may reflect biological pathways that predispose one to exaggerated inflammation and/or poor counterregulatory responses to inflammation, leading to reversible and fixed airflow obstruction,” they wrote. Consequently, early interventions targeting specific inflammatory pathways may improve lung function outcomes.

The study was supported in part by the National Institute of Occupational Safety and Health and the National Institutes of Health.

SOURCE: Singh A et al. CHEST. 2018 Dec;154;1301-10.

Elevated eosinophil levels and interleukin-4 (IL-4) levels were significantly associated with an increased risk of overlapping asthma and chronic obstructive pulmonary disease (COPD) in firefighters exposed to toxins at the World Trade Center on Sept. 11, 2001.

Courtesy Andrea Booher/FEMA News Photo

Patients with asthma/COPD overlap experience decreased quality of life and increased mortality, compared with patients who have either isolated COPD or isolated asthma, and longitudinal data on risk factors for the overlapping condition are lacking, wrote Ankura Singh, MPH, of Albert Einstein College of Medicine, New York, and colleagues.

In a study published in CHEST, the researchers reviewed data from 2,137 firefighters exposed to toxins at the World Trade Center on 9/11. The study participants underwent a bronchodilator pulmonary function test between Sept. 9, 2001, and Sept. 10, 2017, and at least three routine monitoring pulmonary function tests between these two dates.

In a multivariate analysis, eosinophil concentration of at least 300 cells/mcL was a significant predictor of asthma/COPD overlap. Serum IL-4 levels also were significant predictors of asthma/COPD overlap (hazard ratio, 1.51).

In addition, a greater concentration of IL-21 was associated with both isolated asthma and isolated COPD, but not with the overlap.

The study results were strengthened by the availability of pre-exposure medical data for the firefighters and the close follow-up, although limitations included the mostly white male population and a limited definition of asthma, the researchers noted.

However, the findings suggest that “high eosinophil concentrations, uniquely associated with asthma/COPD overlap in this population, may reflect biological pathways that predispose one to exaggerated inflammation and/or poor counterregulatory responses to inflammation, leading to reversible and fixed airflow obstruction,” they wrote. Consequently, early interventions targeting specific inflammatory pathways may improve lung function outcomes.

The study was supported in part by the National Institute of Occupational Safety and Health and the National Institutes of Health.

SOURCE: Singh A et al. CHEST. 2018 Dec;154;1301-10.

The currently recommended method for hospital antimicrobial stewardship programs (ASPs) to measure antibiotic use is Days of Therapy/1,000 patient-days, but there are a few disadvantages of using the DOT, said Maryrose Laguio-Vila, MD, coauthor of a recent study on stewardship.

luchschen/Thinkstock

“For accurate measurement, it requires information technology (IT) support to assist an ASP in generating reports of antibiotic prescriptions and administrations to patients, often from an electronic medical record (EMR). In hospitals where there is no EMR, DOT is probably not easily done and would have to be manually extracted (a herculean task),” she said. “Second, DOT tends to be an aggregate measurement of antibiotics used at an institution or hospital location; if an ASP does a specific intervention targeting a group of antibiotics or infectious indication, changes in the hospital-wide DOT or drug-class DOT may not accurately reflect the exact impact of an ASP’s intervention.”

The paper offers an alternative/supplemental method for ASPs to quantify their impact on antibiotic use without using an EMR or needing IT support: Days of Therapy Avoided. “DOTA can be tracked prospectively (or retrospectively) with each intervention an ASP makes, and calculates an exact amount of antibiotic use avoided,” Dr. Laguio-Vila said. “If the ASP also tracks the types of antibiotic recommendations made according to infectious indication, comparison of DOTA between indications – such as pneumonia versus UTI [urinary tract infection] – can lead to ideas of which type of indication needs clinical guidelines development, or order set revision, or which type of infection the ASP should target to reduce high-risk antibiotics.”

Also, she added, because most ASPs have several types of interventions at once (such as education on pneumonia guidelines, as well as penicillin-allergy assessment), aggregate assessments of institutional antibiotic use like the DOT cannot quantify how much impact a specific intervention has accomplished. DOTA may offer a fairer assessment of the direct changes in antibiotic use resulting from specific ASP activities, because tracking DOTA is extracted from each specific patient intervention.

“Now that the Joint Commission has a requirement that all hospitals seeking JC accreditation have some form of an ASP in place and measure antibiotic use in some way at their institution, there may be numerous hospitals facing the same challenges with calculating a DOT. DOTA would meet these requirements, but in a ‘low tech’ way,” Dr. Laguio-Vila said. “For hospitalists with interests in being the antibiotic steward or champion for their institution, DOTA is an option for measuring antibiotic use.”
 

Reference

Datta S et al. Days of therapy avoided: A novel method for measuring the impact of an antimicrobial stewardship program to stop antibiotics. J Hosp Med. 2018 Feb 8. doi: 10.12788/jhm.2927.






 

The currently recommended method for hospital antimicrobial stewardship programs (ASPs) to measure antibiotic use is Days of Therapy/1,000 patient-days, but there are a few disadvantages of using the DOT, said Maryrose Laguio-Vila, MD, coauthor of a recent study on stewardship.

luchschen/Thinkstock

“For accurate measurement, it requires information technology (IT) support to assist an ASP in generating reports of antibiotic prescriptions and administrations to patients, often from an electronic medical record (EMR). In hospitals where there is no EMR, DOT is probably not easily done and would have to be manually extracted (a herculean task),” she said. “Second, DOT tends to be an aggregate measurement of antibiotics used at an institution or hospital location; if an ASP does a specific intervention targeting a group of antibiotics or infectious indication, changes in the hospital-wide DOT or drug-class DOT may not accurately reflect the exact impact of an ASP’s intervention.”

The paper offers an alternative/supplemental method for ASPs to quantify their impact on antibiotic use without using an EMR or needing IT support: Days of Therapy Avoided. “DOTA can be tracked prospectively (or retrospectively) with each intervention an ASP makes, and calculates an exact amount of antibiotic use avoided,” Dr. Laguio-Vila said. “If the ASP also tracks the types of antibiotic recommendations made according to infectious indication, comparison of DOTA between indications – such as pneumonia versus UTI [urinary tract infection] – can lead to ideas of which type of indication needs clinical guidelines development, or order set revision, or which type of infection the ASP should target to reduce high-risk antibiotics.”

Also, she added, because most ASPs have several types of interventions at once (such as education on pneumonia guidelines, as well as penicillin-allergy assessment), aggregate assessments of institutional antibiotic use like the DOT cannot quantify how much impact a specific intervention has accomplished. DOTA may offer a fairer assessment of the direct changes in antibiotic use resulting from specific ASP activities, because tracking DOTA is extracted from each specific patient intervention.

“Now that the Joint Commission has a requirement that all hospitals seeking JC accreditation have some form of an ASP in place and measure antibiotic use in some way at their institution, there may be numerous hospitals facing the same challenges with calculating a DOT. DOTA would meet these requirements, but in a ‘low tech’ way,” Dr. Laguio-Vila said. “For hospitalists with interests in being the antibiotic steward or champion for their institution, DOTA is an option for measuring antibiotic use.”
 

Reference

Datta S et al. Days of therapy avoided: A novel method for measuring the impact of an antimicrobial stewardship program to stop antibiotics. J Hosp Med. 2018 Feb 8. doi: 10.12788/jhm.2927.






 

The currently recommended method for hospital antimicrobial stewardship programs (ASPs) to measure antibiotic use is Days of Therapy/1,000 patient-days, but there are a few disadvantages of using the DOT, said Maryrose Laguio-Vila, MD, coauthor of a recent study on stewardship.

luchschen/Thinkstock

“For accurate measurement, it requires information technology (IT) support to assist an ASP in generating reports of antibiotic prescriptions and administrations to patients, often from an electronic medical record (EMR). In hospitals where there is no EMR, DOT is probably not easily done and would have to be manually extracted (a herculean task),” she said. “Second, DOT tends to be an aggregate measurement of antibiotics used at an institution or hospital location; if an ASP does a specific intervention targeting a group of antibiotics or infectious indication, changes in the hospital-wide DOT or drug-class DOT may not accurately reflect the exact impact of an ASP’s intervention.”

The paper offers an alternative/supplemental method for ASPs to quantify their impact on antibiotic use without using an EMR or needing IT support: Days of Therapy Avoided. “DOTA can be tracked prospectively (or retrospectively) with each intervention an ASP makes, and calculates an exact amount of antibiotic use avoided,” Dr. Laguio-Vila said. “If the ASP also tracks the types of antibiotic recommendations made according to infectious indication, comparison of DOTA between indications – such as pneumonia versus UTI [urinary tract infection] – can lead to ideas of which type of indication needs clinical guidelines development, or order set revision, or which type of infection the ASP should target to reduce high-risk antibiotics.”

Also, she added, because most ASPs have several types of interventions at once (such as education on pneumonia guidelines, as well as penicillin-allergy assessment), aggregate assessments of institutional antibiotic use like the DOT cannot quantify how much impact a specific intervention has accomplished. DOTA may offer a fairer assessment of the direct changes in antibiotic use resulting from specific ASP activities, because tracking DOTA is extracted from each specific patient intervention.

“Now that the Joint Commission has a requirement that all hospitals seeking JC accreditation have some form of an ASP in place and measure antibiotic use in some way at their institution, there may be numerous hospitals facing the same challenges with calculating a DOT. DOTA would meet these requirements, but in a ‘low tech’ way,” Dr. Laguio-Vila said. “For hospitalists with interests in being the antibiotic steward or champion for their institution, DOTA is an option for measuring antibiotic use.”
 

Reference

Datta S et al. Days of therapy avoided: A novel method for measuring the impact of an antimicrobial stewardship program to stop antibiotics. J Hosp Med. 2018 Feb 8. doi: 10.12788/jhm.2927.