The Hospitalist

Hospitals and health systems are increasingly looking to physicians to provide leadership at the most senior executive level. While the chief medical officer (CMO) or similar role has given physicians a seat at the executive table at many organizations, physicians are also being sought for the CEO role at the head of that table.

A commonly referenced study from 2011 by Amanda Goodall, MD, in Social Science & Medicine concluded that, among a cohort of highly ranked hospitals, overall quality metrics were approximately 25% higher in hospitals where a physician was CEO, in comparison to hospitals with non-physician CEOs (2011 Aug;73[4]:535-9). In addition, new positions at both the hospital and health system level are coming into existence: Examples include chief (or VP) of population health, chief innovation officer, chief quality officer, chief patient experience officer, and others.

There is every reason to think that these senior executive physician roles can – and in many cases perhaps should – be filled by hospitalists. Hospital medicine is an ideal “proving ground” for future physician executives and leaders. I believe that the best practitioners of hospital medicine are also the best candidates for hospital, health care, and health system physician executive leadership, because many of the characteristics essential for success as an executive are the same characteristics that are essential for success as a hospitalist. Strong candidates should have the following characteristics:

• A patient-centered perspective. Perhaps the most important characteristic of a leader is empathy. To appreciate the complex, and often (if not usual) challenging emotional states of our patients keeps us connected at the most fundamental, human level to the work we do and to our patients and families. Empathy can – and should – extend to fellow caregivers as well, and allows us to practice and lead teams in the most human of professions. No leader – in health care, anyway – can last long without being able to demonstrate empathy, through words and behavior.
• A systems-based practice: A hospitalist must be able to have a foot in each of two canoes – to be able to see each patient and their family individually and develop preference-based plans of care, and also to be able to focus on process, structure, and outcomes for the hospital system as a whole. The former trait is imbued in us during training and is the critical foundation for the patient-physician relationship. The latter, however, is something different entirely and reflects an ability to have perspective on the entire ecosystem of care – and apply principles of process and quality improvement to achieve forward looking results. That’s leadership.
• Team leadership: Another fundamental attribute of leaders is to assemble a talented and diverse team around an objective, and then to delegate both tasks and their ownership, deferring to expertise. Hospitalists – the best ones, anyway – similarly recognize that for the vast majority of a patient’s hospital stay, the most important caregiver in a patient’s care is someone other than themselves. At any given time, it might be the nurse, aide, pharmacist, care manager, transporter, radiology tech, urologist, housekeeper, surgical resident, or anyone involved in that patient’s care. The hospitalist’s greatest value is in developing the plan of care with the patient and their family, and then communicating – and therefore delegating – that plan to individuals with the expertise to execute that plan. I believe the biggest difficulty hospitalists have in assuming leadership roles is getting out of the comfortable weeds of daily clinical operations and instead focusing on goals, strategies, and teams to accomplish them. The best hospitalists are doing this already as part of their daily care.
• The ability to manage relationships: Hospitalists manage and work among a team of diverse talents. They also often have accountability relationships to a myriad of clinical and administrative leaders in the hospital, each of whom may be in a position of authority to place demands on the hospitalists: A partial list might include the CEO, the chief medical officer, chief nurse, chief of staff, other medical staff departments, academic leaders, and of course, patients and their families. Functioning in a “matrixed” organization – in which lines of authority can go in many directions, depending on the situation – is standard fare, even at the executive level, and the key competency is open and frequent communication.
• Experience: Already, hospitalists assume leadership roles in their hospitals – leaders in quality, medical informatics, patient experience, and continuous improvement. In these roles, physicians work with senior executives and other hospital leaders to both set goals and implement strategies, providing visibility and working relationships that can be helpful to aspiring leaders.

Perhaps more so than most other specialties, then, hospitalists demonstrate foundational leadership skills in their day-to-day practice – an ideal start to a leadership path. This is not to say or suggest that a career devoted purely to clinical practice is somehow inferior – far from it. However, as health care organizations turn to the medical community to provider leadership, hospitalists are well positioned to develop and be developed as executive leaders.

How can the Society of Hospital Medicine help? While management degrees become a common pathway for many, some health systems and professional organizations support their membership with a leadership development curriculum which may be a better place to start. In my opinion, SHM provides one of the most thorough and relevant experiences available. The SHM Leadership Academy focuses on developing a broad set of additional leadership competencies across a spectrum of experience. The format varies depending on the course, but all rely heavily upon experienced hospitalist leaders – in fact, many current and former Board members and officers volunteer their time to facilitate and teach at the Academy, including at the entry level. It’s a powerful way to learn from others who have started walking the leadership path.
 

Dr. Harte is a past president of SHM and president of Cleveland Clinic Akron General and Southern Region.

Hospitals and health systems are increasingly looking to physicians to provide leadership at the most senior executive level. While the chief medical officer (CMO) or similar role has given physicians a seat at the executive table at many organizations, physicians are also being sought for the CEO role at the head of that table.

A commonly referenced study from 2011 by Amanda Goodall, MD, in Social Science & Medicine concluded that, among a cohort of highly ranked hospitals, overall quality metrics were approximately 25% higher in hospitals where a physician was CEO, in comparison to hospitals with non-physician CEOs (2011 Aug;73[4]:535-9). In addition, new positions at both the hospital and health system level are coming into existence: Examples include chief (or VP) of population health, chief innovation officer, chief quality officer, chief patient experience officer, and others.

There is every reason to think that these senior executive physician roles can – and in many cases perhaps should – be filled by hospitalists. Hospital medicine is an ideal “proving ground” for future physician executives and leaders. I believe that the best practitioners of hospital medicine are also the best candidates for hospital, health care, and health system physician executive leadership, because many of the characteristics essential for success as an executive are the same characteristics that are essential for success as a hospitalist. Strong candidates should have the following characteristics:

• A patient-centered perspective. Perhaps the most important characteristic of a leader is empathy. To appreciate the complex, and often (if not usual) challenging emotional states of our patients keeps us connected at the most fundamental, human level to the work we do and to our patients and families. Empathy can – and should – extend to fellow caregivers as well, and allows us to practice and lead teams in the most human of professions. No leader – in health care, anyway – can last long without being able to demonstrate empathy, through words and behavior.
• A systems-based practice: A hospitalist must be able to have a foot in each of two canoes – to be able to see each patient and their family individually and develop preference-based plans of care, and also to be able to focus on process, structure, and outcomes for the hospital system as a whole. The former trait is imbued in us during training and is the critical foundation for the patient-physician relationship. The latter, however, is something different entirely and reflects an ability to have perspective on the entire ecosystem of care – and apply principles of process and quality improvement to achieve forward looking results. That’s leadership.
• Team leadership: Another fundamental attribute of leaders is to assemble a talented and diverse team around an objective, and then to delegate both tasks and their ownership, deferring to expertise. Hospitalists – the best ones, anyway – similarly recognize that for the vast majority of a patient’s hospital stay, the most important caregiver in a patient’s care is someone other than themselves. At any given time, it might be the nurse, aide, pharmacist, care manager, transporter, radiology tech, urologist, housekeeper, surgical resident, or anyone involved in that patient’s care. The hospitalist’s greatest value is in developing the plan of care with the patient and their family, and then communicating – and therefore delegating – that plan to individuals with the expertise to execute that plan. I believe the biggest difficulty hospitalists have in assuming leadership roles is getting out of the comfortable weeds of daily clinical operations and instead focusing on goals, strategies, and teams to accomplish them. The best hospitalists are doing this already as part of their daily care.
• The ability to manage relationships: Hospitalists manage and work among a team of diverse talents. They also often have accountability relationships to a myriad of clinical and administrative leaders in the hospital, each of whom may be in a position of authority to place demands on the hospitalists: A partial list might include the CEO, the chief medical officer, chief nurse, chief of staff, other medical staff departments, academic leaders, and of course, patients and their families. Functioning in a “matrixed” organization – in which lines of authority can go in many directions, depending on the situation – is standard fare, even at the executive level, and the key competency is open and frequent communication.
• Experience: Already, hospitalists assume leadership roles in their hospitals – leaders in quality, medical informatics, patient experience, and continuous improvement. In these roles, physicians work with senior executives and other hospital leaders to both set goals and implement strategies, providing visibility and working relationships that can be helpful to aspiring leaders.

Perhaps more so than most other specialties, then, hospitalists demonstrate foundational leadership skills in their day-to-day practice – an ideal start to a leadership path. This is not to say or suggest that a career devoted purely to clinical practice is somehow inferior – far from it. However, as health care organizations turn to the medical community to provider leadership, hospitalists are well positioned to develop and be developed as executive leaders.

How can the Society of Hospital Medicine help? While management degrees become a common pathway for many, some health systems and professional organizations support their membership with a leadership development curriculum which may be a better place to start. In my opinion, SHM provides one of the most thorough and relevant experiences available. The SHM Leadership Academy focuses on developing a broad set of additional leadership competencies across a spectrum of experience. The format varies depending on the course, but all rely heavily upon experienced hospitalist leaders – in fact, many current and former Board members and officers volunteer their time to facilitate and teach at the Academy, including at the entry level. It’s a powerful way to learn from others who have started walking the leadership path.
 

Dr. Harte is a past president of SHM and president of Cleveland Clinic Akron General and Southern Region.

Hospitals and health systems are increasingly looking to physicians to provide leadership at the most senior executive level. While the chief medical officer (CMO) or similar role has given physicians a seat at the executive table at many organizations, physicians are also being sought for the CEO role at the head of that table.

A commonly referenced study from 2011 by Amanda Goodall, MD, in Social Science & Medicine concluded that, among a cohort of highly ranked hospitals, overall quality metrics were approximately 25% higher in hospitals where a physician was CEO, in comparison to hospitals with non-physician CEOs (2011 Aug;73[4]:535-9). In addition, new positions at both the hospital and health system level are coming into existence: Examples include chief (or VP) of population health, chief innovation officer, chief quality officer, chief patient experience officer, and others.

There is every reason to think that these senior executive physician roles can – and in many cases perhaps should – be filled by hospitalists. Hospital medicine is an ideal “proving ground” for future physician executives and leaders. I believe that the best practitioners of hospital medicine are also the best candidates for hospital, health care, and health system physician executive leadership, because many of the characteristics essential for success as an executive are the same characteristics that are essential for success as a hospitalist. Strong candidates should have the following characteristics:

• A patient-centered perspective. Perhaps the most important characteristic of a leader is empathy. To appreciate the complex, and often (if not usual) challenging emotional states of our patients keeps us connected at the most fundamental, human level to the work we do and to our patients and families. Empathy can – and should – extend to fellow caregivers as well, and allows us to practice and lead teams in the most human of professions. No leader – in health care, anyway – can last long without being able to demonstrate empathy, through words and behavior.
• A systems-based practice: A hospitalist must be able to have a foot in each of two canoes – to be able to see each patient and their family individually and develop preference-based plans of care, and also to be able to focus on process, structure, and outcomes for the hospital system as a whole. The former trait is imbued in us during training and is the critical foundation for the patient-physician relationship. The latter, however, is something different entirely and reflects an ability to have perspective on the entire ecosystem of care – and apply principles of process and quality improvement to achieve forward looking results. That’s leadership.
• Team leadership: Another fundamental attribute of leaders is to assemble a talented and diverse team around an objective, and then to delegate both tasks and their ownership, deferring to expertise. Hospitalists – the best ones, anyway – similarly recognize that for the vast majority of a patient’s hospital stay, the most important caregiver in a patient’s care is someone other than themselves. At any given time, it might be the nurse, aide, pharmacist, care manager, transporter, radiology tech, urologist, housekeeper, surgical resident, or anyone involved in that patient’s care. The hospitalist’s greatest value is in developing the plan of care with the patient and their family, and then communicating – and therefore delegating – that plan to individuals with the expertise to execute that plan. I believe the biggest difficulty hospitalists have in assuming leadership roles is getting out of the comfortable weeds of daily clinical operations and instead focusing on goals, strategies, and teams to accomplish them. The best hospitalists are doing this already as part of their daily care.
• The ability to manage relationships: Hospitalists manage and work among a team of diverse talents. They also often have accountability relationships to a myriad of clinical and administrative leaders in the hospital, each of whom may be in a position of authority to place demands on the hospitalists: A partial list might include the CEO, the chief medical officer, chief nurse, chief of staff, other medical staff departments, academic leaders, and of course, patients and their families. Functioning in a “matrixed” organization – in which lines of authority can go in many directions, depending on the situation – is standard fare, even at the executive level, and the key competency is open and frequent communication.
• Experience: Already, hospitalists assume leadership roles in their hospitals – leaders in quality, medical informatics, patient experience, and continuous improvement. In these roles, physicians work with senior executives and other hospital leaders to both set goals and implement strategies, providing visibility and working relationships that can be helpful to aspiring leaders.

Perhaps more so than most other specialties, then, hospitalists demonstrate foundational leadership skills in their day-to-day practice – an ideal start to a leadership path. This is not to say or suggest that a career devoted purely to clinical practice is somehow inferior – far from it. However, as health care organizations turn to the medical community to provider leadership, hospitalists are well positioned to develop and be developed as executive leaders.

How can the Society of Hospital Medicine help? While management degrees become a common pathway for many, some health systems and professional organizations support their membership with a leadership development curriculum which may be a better place to start. In my opinion, SHM provides one of the most thorough and relevant experiences available. The SHM Leadership Academy focuses on developing a broad set of additional leadership competencies across a spectrum of experience. The format varies depending on the course, but all rely heavily upon experienced hospitalist leaders – in fact, many current and former Board members and officers volunteer their time to facilitate and teach at the Academy, including at the entry level. It’s a powerful way to learn from others who have started walking the leadership path.
 

Dr. Harte is a past president of SHM and president of Cleveland Clinic Akron General and Southern Region.

Over the course of a career, it is not uncommon for people to become narrower and more focused in their work purview and interests. Competence in select procedures and practices imparts confidence and reliability in performance and results. One develops a reputation for those skills and capabilities, and others call upon them.

Rewards and incentives encourage advancement and promotion along established career paths, further accelerating specialization and concentration. At the top of your game, you advocate for and ease into your comfort zone. That zone is defined by the knowns of practice and the certainties they provide.

For those who prefer to practice in the confines of a narrow clinical sphere, that strategy could be the pathway to career success.

However, for those promoted to leadership positions, the inward and insulated focus today is counterproductive and even dangerous. Many times, physicians advance to a senior position because it is the next step in a preset career ladder, the reward for acumen in clinical skills, or simply out of boredom, with hope for a new landscape and a higher wage. But just because one has a high rank or impressive title does not mean that one is fulfilling the mandates of leadership. It takes more than that. You must be attuned to what is known and unknown in building stability and progress for those you lead.

A brief historic angle: For years, medicine occupied a sweet spot within the health care system. The profession protected its perks and privileges deriving from its untouchable status. With it came superiority, dominance, and protectionism. It was an inward, parochial focus of thinking, status, and reward. The problem was: This insulated mindset prompted a blind spot. The profession missed changes and transformation that were occurring just beyond the comfort zone. Those changes were unknowns in planning and perspective.

In the 1990s, medicine as a whole woke up to calls for change and a new order. The rise of the hospitalist was in part an outgrowth of that wake-up call. It reshaped power structures, status, and lucrative business arrangements within the profession. For many, the sweet spot soured.

The problem with collapsing into a sweet spot today is that so much is changing: all that is known and much that is unknown. Finances, technology, and demand are all in flux. The health care system finds itself in a quantity/quality/cost paradox. Volume accelerates, but at what cost to quality and morale? If someone or something can accomplish similar outcomes at less cost, why not go with the cheaper option? These questions can best be addressed by seeing them in the context of larger changes happening in the health system.

A new view for leaders

The “meta” in metaleadership hopes to provide a broader, disciplined slant on this phenomenon. That prefix – used to modify many concepts and terms – refers to a wider, more expansive view or a more comprehensive and transcendent perch on a topic. A “meta-” prefix invites a critical analysis of the original topic with the addition of new perspectives and insights, as with a meta-analysis.

Why then the need now for a “meta” view among health care leaders? It is easy in the course of career progression to lose track of the bigger picture of what you are doing and how it fits into changes occurring in society and for the profession. Even if your focus is on a particular clinical procedure, how does what you are doing fit into larger metatrends and changes? How might you tangibly contribute to the evolution of those trends? If you are in a leadership position, how do you fit your practice or department into the bigger picture? How might this enterprise perspective speak to your career trajectory?

To inform these questions, build your platform for knowns and unknowns. There are four combinations in the “known-unknown” equation. They are each important and provocative for leaders. Your awareness of them prompts curiosity about “meta” problems and problem solving.

• There are the “known-knowns”: what you know and you know you know it. The problem here is that you may assume that you know something that you don’t.
• There are the “known-unknowns”: Clear and curious about what you need to learn, you develop pathways to find out.
• There are the “unknown-knowns”: what others know and you don’t; a point of vulnerability if you are not careful to discover and figure this out.
• And finally, the “unknown-unknowns”: the mysteries of what could lie ahead that no one yet fully comprehends.

The task for the “metaleader”? Be clear on what you know, and seek always to learn and discover those unknowns. The better you factor them into your assessments, the better you are able to shape trends and the less likely you are to be overrun by them.

Just as you become more specialized with time, as a leader, you can leverage your experience to widen your lens and see more, understand it better, and – with that knowledge – chart a pathway that corresponds with where the health system is going. With this wider mindset, you fashion a fresh and innovative perspective on what is happening with health care and the options for constructively addressing new constraints and opportunities. You think big, reach far, and with this broader understanding, foment a lively set of perspectives and options that would otherwise not be available for those you lead. And when seen as a puzzle to learn and solve, the “meta” perch provides an engaging angle on the game of health care change. You too can be a player.

Dr. Marcus is coauthor of “Renegotiating Health Care: Resolving Conflict to Build Collaboration,” 2nd ed. (San Francisco: Jossey-Bass Publishers, 2011) and is director of the program for health care negotiation and conflict resolution at Harvard T.H. Chan School of Public Health, Boston. Dr. Marcus teaches regularly in the SHM Leadership Academy. He can be reached at [email protected].

Over the course of a career, it is not uncommon for people to become narrower and more focused in their work purview and interests. Competence in select procedures and practices imparts confidence and reliability in performance and results. One develops a reputation for those skills and capabilities, and others call upon them.

Rewards and incentives encourage advancement and promotion along established career paths, further accelerating specialization and concentration. At the top of your game, you advocate for and ease into your comfort zone. That zone is defined by the knowns of practice and the certainties they provide.

For those who prefer to practice in the confines of a narrow clinical sphere, that strategy could be the pathway to career success.

However, for those promoted to leadership positions, the inward and insulated focus today is counterproductive and even dangerous. Many times, physicians advance to a senior position because it is the next step in a preset career ladder, the reward for acumen in clinical skills, or simply out of boredom, with hope for a new landscape and a higher wage. But just because one has a high rank or impressive title does not mean that one is fulfilling the mandates of leadership. It takes more than that. You must be attuned to what is known and unknown in building stability and progress for those you lead.

A brief historic angle: For years, medicine occupied a sweet spot within the health care system. The profession protected its perks and privileges deriving from its untouchable status. With it came superiority, dominance, and protectionism. It was an inward, parochial focus of thinking, status, and reward. The problem was: This insulated mindset prompted a blind spot. The profession missed changes and transformation that were occurring just beyond the comfort zone. Those changes were unknowns in planning and perspective.

In the 1990s, medicine as a whole woke up to calls for change and a new order. The rise of the hospitalist was in part an outgrowth of that wake-up call. It reshaped power structures, status, and lucrative business arrangements within the profession. For many, the sweet spot soured.

The problem with collapsing into a sweet spot today is that so much is changing: all that is known and much that is unknown. Finances, technology, and demand are all in flux. The health care system finds itself in a quantity/quality/cost paradox. Volume accelerates, but at what cost to quality and morale? If someone or something can accomplish similar outcomes at less cost, why not go with the cheaper option? These questions can best be addressed by seeing them in the context of larger changes happening in the health system.

A new view for leaders

The “meta” in metaleadership hopes to provide a broader, disciplined slant on this phenomenon. That prefix – used to modify many concepts and terms – refers to a wider, more expansive view or a more comprehensive and transcendent perch on a topic. A “meta-” prefix invites a critical analysis of the original topic with the addition of new perspectives and insights, as with a meta-analysis.

Why then the need now for a “meta” view among health care leaders? It is easy in the course of career progression to lose track of the bigger picture of what you are doing and how it fits into changes occurring in society and for the profession. Even if your focus is on a particular clinical procedure, how does what you are doing fit into larger metatrends and changes? How might you tangibly contribute to the evolution of those trends? If you are in a leadership position, how do you fit your practice or department into the bigger picture? How might this enterprise perspective speak to your career trajectory?

To inform these questions, build your platform for knowns and unknowns. There are four combinations in the “known-unknown” equation. They are each important and provocative for leaders. Your awareness of them prompts curiosity about “meta” problems and problem solving.

• There are the “known-knowns”: what you know and you know you know it. The problem here is that you may assume that you know something that you don’t.
• There are the “known-unknowns”: Clear and curious about what you need to learn, you develop pathways to find out.
• There are the “unknown-knowns”: what others know and you don’t; a point of vulnerability if you are not careful to discover and figure this out.
• And finally, the “unknown-unknowns”: the mysteries of what could lie ahead that no one yet fully comprehends.

The task for the “metaleader”? Be clear on what you know, and seek always to learn and discover those unknowns. The better you factor them into your assessments, the better you are able to shape trends and the less likely you are to be overrun by them.

Just as you become more specialized with time, as a leader, you can leverage your experience to widen your lens and see more, understand it better, and – with that knowledge – chart a pathway that corresponds with where the health system is going. With this wider mindset, you fashion a fresh and innovative perspective on what is happening with health care and the options for constructively addressing new constraints and opportunities. You think big, reach far, and with this broader understanding, foment a lively set of perspectives and options that would otherwise not be available for those you lead. And when seen as a puzzle to learn and solve, the “meta” perch provides an engaging angle on the game of health care change. You too can be a player.

Dr. Marcus is coauthor of “Renegotiating Health Care: Resolving Conflict to Build Collaboration,” 2nd ed. (San Francisco: Jossey-Bass Publishers, 2011) and is director of the program for health care negotiation and conflict resolution at Harvard T.H. Chan School of Public Health, Boston. Dr. Marcus teaches regularly in the SHM Leadership Academy. He can be reached at [email protected].

Over the course of a career, it is not uncommon for people to become narrower and more focused in their work purview and interests. Competence in select procedures and practices imparts confidence and reliability in performance and results. One develops a reputation for those skills and capabilities, and others call upon them.

Rewards and incentives encourage advancement and promotion along established career paths, further accelerating specialization and concentration. At the top of your game, you advocate for and ease into your comfort zone. That zone is defined by the knowns of practice and the certainties they provide.

For those who prefer to practice in the confines of a narrow clinical sphere, that strategy could be the pathway to career success.

However, for those promoted to leadership positions, the inward and insulated focus today is counterproductive and even dangerous. Many times, physicians advance to a senior position because it is the next step in a preset career ladder, the reward for acumen in clinical skills, or simply out of boredom, with hope for a new landscape and a higher wage. But just because one has a high rank or impressive title does not mean that one is fulfilling the mandates of leadership. It takes more than that. You must be attuned to what is known and unknown in building stability and progress for those you lead.

A brief historic angle: For years, medicine occupied a sweet spot within the health care system. The profession protected its perks and privileges deriving from its untouchable status. With it came superiority, dominance, and protectionism. It was an inward, parochial focus of thinking, status, and reward. The problem was: This insulated mindset prompted a blind spot. The profession missed changes and transformation that were occurring just beyond the comfort zone. Those changes were unknowns in planning and perspective.

In the 1990s, medicine as a whole woke up to calls for change and a new order. The rise of the hospitalist was in part an outgrowth of that wake-up call. It reshaped power structures, status, and lucrative business arrangements within the profession. For many, the sweet spot soured.

The problem with collapsing into a sweet spot today is that so much is changing: all that is known and much that is unknown. Finances, technology, and demand are all in flux. The health care system finds itself in a quantity/quality/cost paradox. Volume accelerates, but at what cost to quality and morale? If someone or something can accomplish similar outcomes at less cost, why not go with the cheaper option? These questions can best be addressed by seeing them in the context of larger changes happening in the health system.

A new view for leaders

The “meta” in metaleadership hopes to provide a broader, disciplined slant on this phenomenon. That prefix – used to modify many concepts and terms – refers to a wider, more expansive view or a more comprehensive and transcendent perch on a topic. A “meta-” prefix invites a critical analysis of the original topic with the addition of new perspectives and insights, as with a meta-analysis.

Why then the need now for a “meta” view among health care leaders? It is easy in the course of career progression to lose track of the bigger picture of what you are doing and how it fits into changes occurring in society and for the profession. Even if your focus is on a particular clinical procedure, how does what you are doing fit into larger metatrends and changes? How might you tangibly contribute to the evolution of those trends? If you are in a leadership position, how do you fit your practice or department into the bigger picture? How might this enterprise perspective speak to your career trajectory?

To inform these questions, build your platform for knowns and unknowns. There are four combinations in the “known-unknown” equation. They are each important and provocative for leaders. Your awareness of them prompts curiosity about “meta” problems and problem solving.

• There are the “known-knowns”: what you know and you know you know it. The problem here is that you may assume that you know something that you don’t.
• There are the “known-unknowns”: Clear and curious about what you need to learn, you develop pathways to find out.
• There are the “unknown-knowns”: what others know and you don’t; a point of vulnerability if you are not careful to discover and figure this out.
• And finally, the “unknown-unknowns”: the mysteries of what could lie ahead that no one yet fully comprehends.

The task for the “metaleader”? Be clear on what you know, and seek always to learn and discover those unknowns. The better you factor them into your assessments, the better you are able to shape trends and the less likely you are to be overrun by them.

Just as you become more specialized with time, as a leader, you can leverage your experience to widen your lens and see more, understand it better, and – with that knowledge – chart a pathway that corresponds with where the health system is going. With this wider mindset, you fashion a fresh and innovative perspective on what is happening with health care and the options for constructively addressing new constraints and opportunities. You think big, reach far, and with this broader understanding, foment a lively set of perspectives and options that would otherwise not be available for those you lead. And when seen as a puzzle to learn and solve, the “meta” perch provides an engaging angle on the game of health care change. You too can be a player.

Dr. Marcus is coauthor of “Renegotiating Health Care: Resolving Conflict to Build Collaboration,” 2nd ed. (San Francisco: Jossey-Bass Publishers, 2011) and is director of the program for health care negotiation and conflict resolution at Harvard T.H. Chan School of Public Health, Boston. Dr. Marcus teaches regularly in the SHM Leadership Academy. He can be reached at [email protected].

The American Society of Hematology has released a new set of guidelines for the prevention, diagnosis, and management of venous thromboembolism.

The new guidelines, released on Nov. 27, contain more than 150 individual recommendations, including sections devoted to managing venous thromboembolism (VTE) during pregnancy and in pediatric patients. Guideline highlights cited by some of the writing-panel participants included a high reliance on low-molecular-weight heparin (LMWH) agents as the preferred treatment for many patients, reliance on the D-dimer test to rule out VTE in patients with a low pretest probability of disease, and reliance on the 4Ts score to identify patients with heparin-induced thrombocytopenia.

The guidelines took more than 3 years to develop, an effort that began in 2015.

An updated set of VTE guidelines were needed because clinicians now have a “greater understanding of risk factors” for VTE as well as having “more options available for treating VTE, including new medications,” Adam C. Cuker, MD, cochair of the guideline-writing group and a hematologist and thrombosis specialist at the University of Pennsylvania, Philadelphia, said during a webcast to unveil the new guidelines.

Prevention

For preventing VTE in hospitalized medical patients the guidelines recommended initial assessment of the patient’s risk for both VTE and bleeding. Patients with a high bleeding risk who need VTE prevention should preferentially receive mechanical prophylaxis, either compression stockings or pneumatic sleeves. But in patients with a high VTE risk and an “acceptable” bleeding risk, prophylaxis with an anticoagulant is preferred over mechanical measures, said Mary Cushman, MD, professor and medical director of the thrombosis and hemostasis program at the University of Vermont, Burlington.

For prevention of VTE in medical inpatients, LMWH is preferred over unfractionated heparin because of its once-daily dosing and fewer complications, said Dr. Cushman, a member of the writing group. The panel also endorsed LMWH over a direct-acting oral anticoagulant, both during hospitalization and following discharge. The guidelines for prevention in medical patients explicitly “recommended against” using a direct-acting oral anticoagulant “over other treatments” both for hospitalized medical patients and after discharge, and the guidelines further recommend against extended prophylaxis after discharge with any other anticoagulant.

Another important takeaway from the prevention section was a statement that combining both mechanical and medical prophylaxis was not needed for medical inpatients. And once patients are discharged, if they take a long air trip they have no need for compression stockings or aspirin if their risk for thrombosis is not elevated. People with a “substantially increased” thrombosis risk “may benefit” from compression stockings or treatment with LMWH, Dr. Cushman said.

Diagnosis

For diagnosis, Wendy Lim, MD, highlighted the need for first categorizing patients as having a low or high probability for VTE, a judgment that can aid the accuracy of the diagnosis and helps avoid unnecessary testing.

For patients with low pretest probability, the guidelines recommended the D-dimer test as the best first step. Further testing isn’t needed when the D-dimer is negative, noted Dr. Lim, a hematologist and professor at McMaster University, Hamilton, Ont.

The guidelines also recommended using ventilation-perfusion scintigraphy (V/Q scan) for imaging a pulmonary embolism over a CT scan, which uses more radiation. But V/Q scans are not ideal for assessing older patients or patients with lung disease, Dr. Lim cautioned.

Management

Management of VTE should occur, when feasible, through a specialized anticoagulation management service center, which can provide care that is best suited to the complexities of anticoagulation therapy. But it’s a level of care that many U.S. patients don’t currently receive and hence is an area ripe for growth, said Daniel M. Witt, PharmD, professor and vice-chair of pharmacotherapy at the University of Utah, Salt Lake City.

CDC/Janice Carr

The guidelines recommended against bridging therapy with LMWH for most patients who need to stop warfarin when undergoing an invasive procedure. The guidelines also called for “thoughtful” use of anticoagulant reversal agents and advised that patients who survive a major bleed while on anticoagulation should often resume the anticoagulant once they are stabilized.

For patients who develop heparin-induced thrombocytopenia, the 4Ts score is the best way to make a more accurate diagnosis and boost the prospects for recovery, said Dr. Cuker (Blood. 2012 Nov 15;120[20]:4160-7). The guidelines cite several agents now available to treat this common complication, which affects about 1% of the 12 million Americans treated with heparin annually: argatroban, bivalirudin, danaparoid, fondaparinux, apixaban, dabigatran, edoxaban, and rivaroxaban.

ASH has a VTE website with links to detailed information for each of the guideline subcategories: prophylaxis in medical patients, diagnosis, therapy, heparin-induced thrombocytopenia, VTE in pregnancy, and VTE in children. The website indicates that additional guidelines will soon be released on managing VTE in patients with cancer, in patients with thrombophilia, and for prophylaxis in surgical patients, as well as further information on treatment. A spokesperson for ASH said that these additional documents will post sometime in 2019.

At the time of the release, the guidelines panel published six articles in the journal Blood Advances that detailed the guidelines and their documentation.

The articles include prophylaxis of medical patients (Blood Advances. 2018 Nov 27;2[22]:3198-225), diagnosis (Blood Advances. 2018 Nov 27;2[22]:3226-56), anticoagulation therapy (Blood Advances. 2018 Nov 27;2[22]:3257-91), pediatrics (Blood Advances. 2018 Nov 27;2[22]:3292-316), pregnancy (Blood Advances. 2018 Nov 27;2[22]:3317-59), and heparin-induced thrombocytopenia (Blood Advances. 2018 Nov 27;2[22]:3360-92).

Dr. Cushman, Dr. Lim, and Dr. Witt reported having no relevant disclosures. Dr. Cuker reported receiving research support from T2 Biosystems.

[email protected]

The American Society of Hematology has released a new set of guidelines for the prevention, diagnosis, and management of venous thromboembolism.

The new guidelines, released on Nov. 27, contain more than 150 individual recommendations, including sections devoted to managing venous thromboembolism (VTE) during pregnancy and in pediatric patients. Guideline highlights cited by some of the writing-panel participants included a high reliance on low-molecular-weight heparin (LMWH) agents as the preferred treatment for many patients, reliance on the D-dimer test to rule out VTE in patients with a low pretest probability of disease, and reliance on the 4Ts score to identify patients with heparin-induced thrombocytopenia.

The guidelines took more than 3 years to develop, an effort that began in 2015.

An updated set of VTE guidelines were needed because clinicians now have a “greater understanding of risk factors” for VTE as well as having “more options available for treating VTE, including new medications,” Adam C. Cuker, MD, cochair of the guideline-writing group and a hematologist and thrombosis specialist at the University of Pennsylvania, Philadelphia, said during a webcast to unveil the new guidelines.

Prevention

For preventing VTE in hospitalized medical patients the guidelines recommended initial assessment of the patient’s risk for both VTE and bleeding. Patients with a high bleeding risk who need VTE prevention should preferentially receive mechanical prophylaxis, either compression stockings or pneumatic sleeves. But in patients with a high VTE risk and an “acceptable” bleeding risk, prophylaxis with an anticoagulant is preferred over mechanical measures, said Mary Cushman, MD, professor and medical director of the thrombosis and hemostasis program at the University of Vermont, Burlington.

For prevention of VTE in medical inpatients, LMWH is preferred over unfractionated heparin because of its once-daily dosing and fewer complications, said Dr. Cushman, a member of the writing group. The panel also endorsed LMWH over a direct-acting oral anticoagulant, both during hospitalization and following discharge. The guidelines for prevention in medical patients explicitly “recommended against” using a direct-acting oral anticoagulant “over other treatments” both for hospitalized medical patients and after discharge, and the guidelines further recommend against extended prophylaxis after discharge with any other anticoagulant.

Another important takeaway from the prevention section was a statement that combining both mechanical and medical prophylaxis was not needed for medical inpatients. And once patients are discharged, if they take a long air trip they have no need for compression stockings or aspirin if their risk for thrombosis is not elevated. People with a “substantially increased” thrombosis risk “may benefit” from compression stockings or treatment with LMWH, Dr. Cushman said.

Diagnosis

For diagnosis, Wendy Lim, MD, highlighted the need for first categorizing patients as having a low or high probability for VTE, a judgment that can aid the accuracy of the diagnosis and helps avoid unnecessary testing.

For patients with low pretest probability, the guidelines recommended the D-dimer test as the best first step. Further testing isn’t needed when the D-dimer is negative, noted Dr. Lim, a hematologist and professor at McMaster University, Hamilton, Ont.

The guidelines also recommended using ventilation-perfusion scintigraphy (V/Q scan) for imaging a pulmonary embolism over a CT scan, which uses more radiation. But V/Q scans are not ideal for assessing older patients or patients with lung disease, Dr. Lim cautioned.

Management

Management of VTE should occur, when feasible, through a specialized anticoagulation management service center, which can provide care that is best suited to the complexities of anticoagulation therapy. But it’s a level of care that many U.S. patients don’t currently receive and hence is an area ripe for growth, said Daniel M. Witt, PharmD, professor and vice-chair of pharmacotherapy at the University of Utah, Salt Lake City.

CDC/Janice Carr

The guidelines recommended against bridging therapy with LMWH for most patients who need to stop warfarin when undergoing an invasive procedure. The guidelines also called for “thoughtful” use of anticoagulant reversal agents and advised that patients who survive a major bleed while on anticoagulation should often resume the anticoagulant once they are stabilized.

For patients who develop heparin-induced thrombocytopenia, the 4Ts score is the best way to make a more accurate diagnosis and boost the prospects for recovery, said Dr. Cuker (Blood. 2012 Nov 15;120[20]:4160-7). The guidelines cite several agents now available to treat this common complication, which affects about 1% of the 12 million Americans treated with heparin annually: argatroban, bivalirudin, danaparoid, fondaparinux, apixaban, dabigatran, edoxaban, and rivaroxaban.

ASH has a VTE website with links to detailed information for each of the guideline subcategories: prophylaxis in medical patients, diagnosis, therapy, heparin-induced thrombocytopenia, VTE in pregnancy, and VTE in children. The website indicates that additional guidelines will soon be released on managing VTE in patients with cancer, in patients with thrombophilia, and for prophylaxis in surgical patients, as well as further information on treatment. A spokesperson for ASH said that these additional documents will post sometime in 2019.

At the time of the release, the guidelines panel published six articles in the journal Blood Advances that detailed the guidelines and their documentation.

The articles include prophylaxis of medical patients (Blood Advances. 2018 Nov 27;2[22]:3198-225), diagnosis (Blood Advances. 2018 Nov 27;2[22]:3226-56), anticoagulation therapy (Blood Advances. 2018 Nov 27;2[22]:3257-91), pediatrics (Blood Advances. 2018 Nov 27;2[22]:3292-316), pregnancy (Blood Advances. 2018 Nov 27;2[22]:3317-59), and heparin-induced thrombocytopenia (Blood Advances. 2018 Nov 27;2[22]:3360-92).

Dr. Cushman, Dr. Lim, and Dr. Witt reported having no relevant disclosures. Dr. Cuker reported receiving research support from T2 Biosystems.

[email protected]

The American Society of Hematology has released a new set of guidelines for the prevention, diagnosis, and management of venous thromboembolism.

The new guidelines, released on Nov. 27, contain more than 150 individual recommendations, including sections devoted to managing venous thromboembolism (VTE) during pregnancy and in pediatric patients. Guideline highlights cited by some of the writing-panel participants included a high reliance on low-molecular-weight heparin (LMWH) agents as the preferred treatment for many patients, reliance on the D-dimer test to rule out VTE in patients with a low pretest probability of disease, and reliance on the 4Ts score to identify patients with heparin-induced thrombocytopenia.

The guidelines took more than 3 years to develop, an effort that began in 2015.

An updated set of VTE guidelines were needed because clinicians now have a “greater understanding of risk factors” for VTE as well as having “more options available for treating VTE, including new medications,” Adam C. Cuker, MD, cochair of the guideline-writing group and a hematologist and thrombosis specialist at the University of Pennsylvania, Philadelphia, said during a webcast to unveil the new guidelines.

Prevention

For preventing VTE in hospitalized medical patients the guidelines recommended initial assessment of the patient’s risk for both VTE and bleeding. Patients with a high bleeding risk who need VTE prevention should preferentially receive mechanical prophylaxis, either compression stockings or pneumatic sleeves. But in patients with a high VTE risk and an “acceptable” bleeding risk, prophylaxis with an anticoagulant is preferred over mechanical measures, said Mary Cushman, MD, professor and medical director of the thrombosis and hemostasis program at the University of Vermont, Burlington.

For prevention of VTE in medical inpatients, LMWH is preferred over unfractionated heparin because of its once-daily dosing and fewer complications, said Dr. Cushman, a member of the writing group. The panel also endorsed LMWH over a direct-acting oral anticoagulant, both during hospitalization and following discharge. The guidelines for prevention in medical patients explicitly “recommended against” using a direct-acting oral anticoagulant “over other treatments” both for hospitalized medical patients and after discharge, and the guidelines further recommend against extended prophylaxis after discharge with any other anticoagulant.

Another important takeaway from the prevention section was a statement that combining both mechanical and medical prophylaxis was not needed for medical inpatients. And once patients are discharged, if they take a long air trip they have no need for compression stockings or aspirin if their risk for thrombosis is not elevated. People with a “substantially increased” thrombosis risk “may benefit” from compression stockings or treatment with LMWH, Dr. Cushman said.

Diagnosis

For diagnosis, Wendy Lim, MD, highlighted the need for first categorizing patients as having a low or high probability for VTE, a judgment that can aid the accuracy of the diagnosis and helps avoid unnecessary testing.

For patients with low pretest probability, the guidelines recommended the D-dimer test as the best first step. Further testing isn’t needed when the D-dimer is negative, noted Dr. Lim, a hematologist and professor at McMaster University, Hamilton, Ont.

The guidelines also recommended using ventilation-perfusion scintigraphy (V/Q scan) for imaging a pulmonary embolism over a CT scan, which uses more radiation. But V/Q scans are not ideal for assessing older patients or patients with lung disease, Dr. Lim cautioned.

Management

Management of VTE should occur, when feasible, through a specialized anticoagulation management service center, which can provide care that is best suited to the complexities of anticoagulation therapy. But it’s a level of care that many U.S. patients don’t currently receive and hence is an area ripe for growth, said Daniel M. Witt, PharmD, professor and vice-chair of pharmacotherapy at the University of Utah, Salt Lake City.

CDC/Janice Carr

The guidelines recommended against bridging therapy with LMWH for most patients who need to stop warfarin when undergoing an invasive procedure. The guidelines also called for “thoughtful” use of anticoagulant reversal agents and advised that patients who survive a major bleed while on anticoagulation should often resume the anticoagulant once they are stabilized.

For patients who develop heparin-induced thrombocytopenia, the 4Ts score is the best way to make a more accurate diagnosis and boost the prospects for recovery, said Dr. Cuker (Blood. 2012 Nov 15;120[20]:4160-7). The guidelines cite several agents now available to treat this common complication, which affects about 1% of the 12 million Americans treated with heparin annually: argatroban, bivalirudin, danaparoid, fondaparinux, apixaban, dabigatran, edoxaban, and rivaroxaban.

ASH has a VTE website with links to detailed information for each of the guideline subcategories: prophylaxis in medical patients, diagnosis, therapy, heparin-induced thrombocytopenia, VTE in pregnancy, and VTE in children. The website indicates that additional guidelines will soon be released on managing VTE in patients with cancer, in patients with thrombophilia, and for prophylaxis in surgical patients, as well as further information on treatment. A spokesperson for ASH said that these additional documents will post sometime in 2019.

At the time of the release, the guidelines panel published six articles in the journal Blood Advances that detailed the guidelines and their documentation.

The articles include prophylaxis of medical patients (Blood Advances. 2018 Nov 27;2[22]:3198-225), diagnosis (Blood Advances. 2018 Nov 27;2[22]:3226-56), anticoagulation therapy (Blood Advances. 2018 Nov 27;2[22]:3257-91), pediatrics (Blood Advances. 2018 Nov 27;2[22]:3292-316), pregnancy (Blood Advances. 2018 Nov 27;2[22]:3317-59), and heparin-induced thrombocytopenia (Blood Advances. 2018 Nov 27;2[22]:3360-92).

Dr. Cushman, Dr. Lim, and Dr. Witt reported having no relevant disclosures. Dr. Cuker reported receiving research support from T2 Biosystems.

[email protected]

Mel C. Anderson, MD, FACP, section chief of hospital medicine for the Veterans Administration of Eastern Colorado, and his hospitalist colleagues share a mission to care for the men and women who served their country in the armed forces and are now being served by the VA.

“That mission binds us together in a deep and impactful way,” he said. “One of the greatest joys of my life has been to dedicate, with the teams I lead, our hearts and minds to serving this population of veterans.”

Approximately 400 hospitalists work nationwide in the VA, the country’s largest integrated health system, typically in groups of about a dozen. Not every VA medical center employs hospitalists; this depends on local tradition and size of the facility. Dr. Anderson was for several years the lone hospitalist at the VA Medical Center in Denver, starting in 2005, and now he heads a group of 17. The Denver facility employs five inpatient teams plus nocturnists, supported by residents, interns, and medical students in training from the University of Colorado at Denver, Aurora, to deliver all of its inpatient medical care.

“We also have an open ICU here. Hospitalists are able to follow their patients across the hospital, and we can make the decision to move them to the ICU,” Dr. Anderson said. The Denver group also established a hospitalist-staffed postdischarge clinic, where patients can reconnect with their hospital team. “It’s not to supplant primary care but to help promote safe transit as the patient moves back to the community,” he said. “We’ve also developed a surgery consult service for orthopedics and other surgical subspecialties.”

The VA’s integrated electronic medical record facilitates communication between hospitalists and primary care physicians, with instant messaging for updating the PCPs on the patient’s hospital stay.

The Denver VA hospitalists value their collegial culture, Dr. Anderson said. “We are invested in our group and in one another and in life-long learning. I often ask my group for their feedback. It’s one of the singular joys of my career to lead such a wonderful group, which has been built up person by person. I hired every single member. As much as their clinical skills and the achievements on their curriculum vitae were important, I also paid attention to their interpersonal communication skills.”

Members of the Denver hospitalist group also share an academic focus and commitment to scholarship and research. Dr. Anderson’s academic emphasis is on how to promote teaching and faculty development through organized bedside rounding and how to orient students to teaching as a potential career path. He is associate program director for medicine residencies at the University of Colorado and leads its Clinician/Educator Pathway.

The VA hospital’s interdisciplinary bedside rounding initiative involves the medicine team – students, residents, attending – and pharmacist, plus the patient’s bedside nurse and nurse care coordinator. “We have worked on fostering an interdisciplinary culture, and we’re very proud of the rounding model we developed here. We all round together at the bedside, and typically that might include 7 or 8 people,” Dr. Anderson explained.

“In planning this program, we used a Rapid Performance Improvement Project team with a nurse, pharmacist, and physical therapist helping us envision how to redesign rounds to overcome the time constraints,” he said. “We altered nurses’ work flow to permit them to join the rounding for their patients, and we moved morning medication administration to 7 a.m., so it wouldn’t get in the way of the rounding. We now audit rates of physician-to-nurse communication on rounds and how often we successfully achieve the nurse’s participation.”¹ This approach has also cut rates of phone pages from nurses to house staff, and substantially increased job satisfaction.
 

What’s different in the VA?

The work of hospitalists in the VA is mostly similar to other hospital settings, but perhaps with more intensity, Dr. Anderson said. There are comorbidities such as higher rates of PTSD, alcohol use disorder, substance abuse, and mental health issues – all of which have an effect over time on patients. But veterans also have different attitudes about, for example, pain.

“When patients are asked to rate their pain on a scale of 0 to 10, for a veteran of a foreign war, 2 out of 10 is not the same as someone else’s 2 out of 10. How do we compensate for that difference?” he said. “And while awareness of PTSD and efforts to mitigate its impact have made incredible gains over the past 15 years, we still see a lot of these issues and their manifestations in social challenges such as homelessness. We are fortunate to have VA outpatient services and homeless veteran programs to help with these issues.”

There is a different paradigm for care at the VA, Dr. Anderson said. “We are a not-for-profit institution with the welfare of veterans as our primary aim. Beyond their health and wellness, that means supporting them in other ways and reaching out into the community. As doctors and nurses we feel a kinship around that mission, although we also have to be stewards of taxpayer dollars. We recognize that the VA is a large and complicated, somewhat inertia-laden organization in which making changes can be very challenging. But there are also opportunities as a national organization to effect changes on a national scale.”

Dr. Anderson chairs the VA’s Hospitalist Field Advisory Committee (HFAC), a group of about eight hospitalists empaneled to advise the system’s Office of Specialty Care Services on clinical policy and program development. They serve 3-year terms and meet monthly by phone and annually in Washington. The HFAC’s last annual meeting occurred in mid-September 2018 in Washington with a focus on developing a hospital medicine annual survey and needs assessment, revisiting strategic goals, and convening multilateral meetings with the chiefs of medicine and emergency medicine FACs.

“Our biggest emphasis is clinical – this includes clinical pathways, best practices for managing PTSD or acute coronary syndrome, and the like. We also share management issues, such as how to configure medical records or arrange night coverage. This is a national conversation to share what some sites have already experienced and learned,” Dr. Anderson said.

“We also have a VA Academic Hospitalist Subcommittee, working together on multisite research studies and on resident education protocols. Because we’re a large system, we’re able to connect with one another and leverage what we’ve learned. I get emails almost every day about research topics from colleagues across the country,” he said. A collaborative website and email distribution list allows doctors to post questions to their peers nationwide.
 

A calling for hospital medicine

Before moving to Denver, Dr. Anderson served as a major in the Air Force Medical Corps and was based at the David Grant US Air Force Medical Center on Travis Air Force Base in California – which is where he did his residency. In the course of a “traditionalist” internal medical training, including 4-month stints on hospital wards in addition to outpatient services, he realized he had a calling for hospital medicine.

In a job at the Providence (R.I.) VA Medical Center, he exclusively practiced outpatient care, but he found that he missed key aspects of inpatient work, such as the intensity of the clinical issues and teaching encounters. “I cold-called the hospital’s chief of medicine and volunteered to start mentoring inpatient residents,” Dr. Anderson said. “That was 17 years ago.”

Another abiding interest derived from Dr. Anderson’s military service is travel medicine. While a physician in the Air Force, he was deployed to Haiti in 1995 and to Nicaragua in 2000, where he treated thousands of patients – both U.S. service personnel and local populations.

“In Haiti, our primary mission was for U.S. troops who were still based there following the 1994 Operation Uphold Democracy intervention, but there were a lot fewer of them, so we mostly kept busy providing care to Haitian nationals,” he said. “That work was eye opening, to say the least,” and led to a professional interest in tropical illnesses. “Since then, I’ve been a visiting professor for the University of Colorado posted to the University of Zimbabwe in Harare in 2012 and 2016.”

What gives Dr. Anderson such joy and enthusiasm for his VA work? “I am a curious lifelong learner. Every day, there are 10 new things I need to learn, whether clinically or operationally in a big hospital system or just the day-to-day realities of leading a group of physicians. I never feel like I’m treading water,” he said. He is also energized by teaching – seeing “the light bulb go on” for the students he is instructing – and by serving as a role model for doctors in training.

“As I contemplate all the simultaneous balls I have in the air, including our recent move into a new hospital building, sometimes I think it is kind of crazy to be doing as much as I do,” he said. “But I also take time away, balancing work versus nonwork.” He spends quality time with his wife of 21 years, 17-year-old daughter, other relatives, and friends, as well as on physical activity, reading books about philosophy, and his hobby of rebuilding motorcycles, which he says offers a kind of meditative calm.

“I also feel a deep sense of service – to patients, colleagues, students, and to the mission of the VA,” Dr. Anderson said. “There is truly something special about caring for the veteran. It’s hard to articulate, but it really keeps us coming back for more. I’ve had vets sing to me, tell jokes, do magic tricks, share their war stories. I’ve had patients open up to me in ways that were both profound and humbling.”
 

References

1. Young E et al. Impact of altered medication administration time on interdisciplinary bedside rounds on academic medical ward. J Nurs Care Qual. 2017 Jul/Sep;32(3):218-225.

Mel C. Anderson, MD, FACP, section chief of hospital medicine for the Veterans Administration of Eastern Colorado, and his hospitalist colleagues share a mission to care for the men and women who served their country in the armed forces and are now being served by the VA.

“That mission binds us together in a deep and impactful way,” he said. “One of the greatest joys of my life has been to dedicate, with the teams I lead, our hearts and minds to serving this population of veterans.”

Approximately 400 hospitalists work nationwide in the VA, the country’s largest integrated health system, typically in groups of about a dozen. Not every VA medical center employs hospitalists; this depends on local tradition and size of the facility. Dr. Anderson was for several years the lone hospitalist at the VA Medical Center in Denver, starting in 2005, and now he heads a group of 17. The Denver facility employs five inpatient teams plus nocturnists, supported by residents, interns, and medical students in training from the University of Colorado at Denver, Aurora, to deliver all of its inpatient medical care.

“We also have an open ICU here. Hospitalists are able to follow their patients across the hospital, and we can make the decision to move them to the ICU,” Dr. Anderson said. The Denver group also established a hospitalist-staffed postdischarge clinic, where patients can reconnect with their hospital team. “It’s not to supplant primary care but to help promote safe transit as the patient moves back to the community,” he said. “We’ve also developed a surgery consult service for orthopedics and other surgical subspecialties.”

The VA’s integrated electronic medical record facilitates communication between hospitalists and primary care physicians, with instant messaging for updating the PCPs on the patient’s hospital stay.

The Denver VA hospitalists value their collegial culture, Dr. Anderson said. “We are invested in our group and in one another and in life-long learning. I often ask my group for their feedback. It’s one of the singular joys of my career to lead such a wonderful group, which has been built up person by person. I hired every single member. As much as their clinical skills and the achievements on their curriculum vitae were important, I also paid attention to their interpersonal communication skills.”

Members of the Denver hospitalist group also share an academic focus and commitment to scholarship and research. Dr. Anderson’s academic emphasis is on how to promote teaching and faculty development through organized bedside rounding and how to orient students to teaching as a potential career path. He is associate program director for medicine residencies at the University of Colorado and leads its Clinician/Educator Pathway.

The VA hospital’s interdisciplinary bedside rounding initiative involves the medicine team – students, residents, attending – and pharmacist, plus the patient’s bedside nurse and nurse care coordinator. “We have worked on fostering an interdisciplinary culture, and we’re very proud of the rounding model we developed here. We all round together at the bedside, and typically that might include 7 or 8 people,” Dr. Anderson explained.

“In planning this program, we used a Rapid Performance Improvement Project team with a nurse, pharmacist, and physical therapist helping us envision how to redesign rounds to overcome the time constraints,” he said. “We altered nurses’ work flow to permit them to join the rounding for their patients, and we moved morning medication administration to 7 a.m., so it wouldn’t get in the way of the rounding. We now audit rates of physician-to-nurse communication on rounds and how often we successfully achieve the nurse’s participation.”¹ This approach has also cut rates of phone pages from nurses to house staff, and substantially increased job satisfaction.
 

What’s different in the VA?

The work of hospitalists in the VA is mostly similar to other hospital settings, but perhaps with more intensity, Dr. Anderson said. There are comorbidities such as higher rates of PTSD, alcohol use disorder, substance abuse, and mental health issues – all of which have an effect over time on patients. But veterans also have different attitudes about, for example, pain.

“When patients are asked to rate their pain on a scale of 0 to 10, for a veteran of a foreign war, 2 out of 10 is not the same as someone else’s 2 out of 10. How do we compensate for that difference?” he said. “And while awareness of PTSD and efforts to mitigate its impact have made incredible gains over the past 15 years, we still see a lot of these issues and their manifestations in social challenges such as homelessness. We are fortunate to have VA outpatient services and homeless veteran programs to help with these issues.”

There is a different paradigm for care at the VA, Dr. Anderson said. “We are a not-for-profit institution with the welfare of veterans as our primary aim. Beyond their health and wellness, that means supporting them in other ways and reaching out into the community. As doctors and nurses we feel a kinship around that mission, although we also have to be stewards of taxpayer dollars. We recognize that the VA is a large and complicated, somewhat inertia-laden organization in which making changes can be very challenging. But there are also opportunities as a national organization to effect changes on a national scale.”

Dr. Anderson chairs the VA’s Hospitalist Field Advisory Committee (HFAC), a group of about eight hospitalists empaneled to advise the system’s Office of Specialty Care Services on clinical policy and program development. They serve 3-year terms and meet monthly by phone and annually in Washington. The HFAC’s last annual meeting occurred in mid-September 2018 in Washington with a focus on developing a hospital medicine annual survey and needs assessment, revisiting strategic goals, and convening multilateral meetings with the chiefs of medicine and emergency medicine FACs.

“Our biggest emphasis is clinical – this includes clinical pathways, best practices for managing PTSD or acute coronary syndrome, and the like. We also share management issues, such as how to configure medical records or arrange night coverage. This is a national conversation to share what some sites have already experienced and learned,” Dr. Anderson said.

“We also have a VA Academic Hospitalist Subcommittee, working together on multisite research studies and on resident education protocols. Because we’re a large system, we’re able to connect with one another and leverage what we’ve learned. I get emails almost every day about research topics from colleagues across the country,” he said. A collaborative website and email distribution list allows doctors to post questions to their peers nationwide.
 

A calling for hospital medicine

Before moving to Denver, Dr. Anderson served as a major in the Air Force Medical Corps and was based at the David Grant US Air Force Medical Center on Travis Air Force Base in California – which is where he did his residency. In the course of a “traditionalist” internal medical training, including 4-month stints on hospital wards in addition to outpatient services, he realized he had a calling for hospital medicine.

In a job at the Providence (R.I.) VA Medical Center, he exclusively practiced outpatient care, but he found that he missed key aspects of inpatient work, such as the intensity of the clinical issues and teaching encounters. “I cold-called the hospital’s chief of medicine and volunteered to start mentoring inpatient residents,” Dr. Anderson said. “That was 17 years ago.”

Another abiding interest derived from Dr. Anderson’s military service is travel medicine. While a physician in the Air Force, he was deployed to Haiti in 1995 and to Nicaragua in 2000, where he treated thousands of patients – both U.S. service personnel and local populations.

“In Haiti, our primary mission was for U.S. troops who were still based there following the 1994 Operation Uphold Democracy intervention, but there were a lot fewer of them, so we mostly kept busy providing care to Haitian nationals,” he said. “That work was eye opening, to say the least,” and led to a professional interest in tropical illnesses. “Since then, I’ve been a visiting professor for the University of Colorado posted to the University of Zimbabwe in Harare in 2012 and 2016.”

What gives Dr. Anderson such joy and enthusiasm for his VA work? “I am a curious lifelong learner. Every day, there are 10 new things I need to learn, whether clinically or operationally in a big hospital system or just the day-to-day realities of leading a group of physicians. I never feel like I’m treading water,” he said. He is also energized by teaching – seeing “the light bulb go on” for the students he is instructing – and by serving as a role model for doctors in training.

“As I contemplate all the simultaneous balls I have in the air, including our recent move into a new hospital building, sometimes I think it is kind of crazy to be doing as much as I do,” he said. “But I also take time away, balancing work versus nonwork.” He spends quality time with his wife of 21 years, 17-year-old daughter, other relatives, and friends, as well as on physical activity, reading books about philosophy, and his hobby of rebuilding motorcycles, which he says offers a kind of meditative calm.

“I also feel a deep sense of service – to patients, colleagues, students, and to the mission of the VA,” Dr. Anderson said. “There is truly something special about caring for the veteran. It’s hard to articulate, but it really keeps us coming back for more. I’ve had vets sing to me, tell jokes, do magic tricks, share their war stories. I’ve had patients open up to me in ways that were both profound and humbling.”
 

References

1. Young E et al. Impact of altered medication administration time on interdisciplinary bedside rounds on academic medical ward. J Nurs Care Qual. 2017 Jul/Sep;32(3):218-225.

Mel C. Anderson, MD, FACP, section chief of hospital medicine for the Veterans Administration of Eastern Colorado, and his hospitalist colleagues share a mission to care for the men and women who served their country in the armed forces and are now being served by the VA.

“That mission binds us together in a deep and impactful way,” he said. “One of the greatest joys of my life has been to dedicate, with the teams I lead, our hearts and minds to serving this population of veterans.”

Approximately 400 hospitalists work nationwide in the VA, the country’s largest integrated health system, typically in groups of about a dozen. Not every VA medical center employs hospitalists; this depends on local tradition and size of the facility. Dr. Anderson was for several years the lone hospitalist at the VA Medical Center in Denver, starting in 2005, and now he heads a group of 17. The Denver facility employs five inpatient teams plus nocturnists, supported by residents, interns, and medical students in training from the University of Colorado at Denver, Aurora, to deliver all of its inpatient medical care.

“We also have an open ICU here. Hospitalists are able to follow their patients across the hospital, and we can make the decision to move them to the ICU,” Dr. Anderson said. The Denver group also established a hospitalist-staffed postdischarge clinic, where patients can reconnect with their hospital team. “It’s not to supplant primary care but to help promote safe transit as the patient moves back to the community,” he said. “We’ve also developed a surgery consult service for orthopedics and other surgical subspecialties.”

The VA’s integrated electronic medical record facilitates communication between hospitalists and primary care physicians, with instant messaging for updating the PCPs on the patient’s hospital stay.

The Denver VA hospitalists value their collegial culture, Dr. Anderson said. “We are invested in our group and in one another and in life-long learning. I often ask my group for their feedback. It’s one of the singular joys of my career to lead such a wonderful group, which has been built up person by person. I hired every single member. As much as their clinical skills and the achievements on their curriculum vitae were important, I also paid attention to their interpersonal communication skills.”

Members of the Denver hospitalist group also share an academic focus and commitment to scholarship and research. Dr. Anderson’s academic emphasis is on how to promote teaching and faculty development through organized bedside rounding and how to orient students to teaching as a potential career path. He is associate program director for medicine residencies at the University of Colorado and leads its Clinician/Educator Pathway.

The VA hospital’s interdisciplinary bedside rounding initiative involves the medicine team – students, residents, attending – and pharmacist, plus the patient’s bedside nurse and nurse care coordinator. “We have worked on fostering an interdisciplinary culture, and we’re very proud of the rounding model we developed here. We all round together at the bedside, and typically that might include 7 or 8 people,” Dr. Anderson explained.

“In planning this program, we used a Rapid Performance Improvement Project team with a nurse, pharmacist, and physical therapist helping us envision how to redesign rounds to overcome the time constraints,” he said. “We altered nurses’ work flow to permit them to join the rounding for their patients, and we moved morning medication administration to 7 a.m., so it wouldn’t get in the way of the rounding. We now audit rates of physician-to-nurse communication on rounds and how often we successfully achieve the nurse’s participation.”¹ This approach has also cut rates of phone pages from nurses to house staff, and substantially increased job satisfaction.
 

What’s different in the VA?

The work of hospitalists in the VA is mostly similar to other hospital settings, but perhaps with more intensity, Dr. Anderson said. There are comorbidities such as higher rates of PTSD, alcohol use disorder, substance abuse, and mental health issues – all of which have an effect over time on patients. But veterans also have different attitudes about, for example, pain.

“When patients are asked to rate their pain on a scale of 0 to 10, for a veteran of a foreign war, 2 out of 10 is not the same as someone else’s 2 out of 10. How do we compensate for that difference?” he said. “And while awareness of PTSD and efforts to mitigate its impact have made incredible gains over the past 15 years, we still see a lot of these issues and their manifestations in social challenges such as homelessness. We are fortunate to have VA outpatient services and homeless veteran programs to help with these issues.”

There is a different paradigm for care at the VA, Dr. Anderson said. “We are a not-for-profit institution with the welfare of veterans as our primary aim. Beyond their health and wellness, that means supporting them in other ways and reaching out into the community. As doctors and nurses we feel a kinship around that mission, although we also have to be stewards of taxpayer dollars. We recognize that the VA is a large and complicated, somewhat inertia-laden organization in which making changes can be very challenging. But there are also opportunities as a national organization to effect changes on a national scale.”

Dr. Anderson chairs the VA’s Hospitalist Field Advisory Committee (HFAC), a group of about eight hospitalists empaneled to advise the system’s Office of Specialty Care Services on clinical policy and program development. They serve 3-year terms and meet monthly by phone and annually in Washington. The HFAC’s last annual meeting occurred in mid-September 2018 in Washington with a focus on developing a hospital medicine annual survey and needs assessment, revisiting strategic goals, and convening multilateral meetings with the chiefs of medicine and emergency medicine FACs.

“Our biggest emphasis is clinical – this includes clinical pathways, best practices for managing PTSD or acute coronary syndrome, and the like. We also share management issues, such as how to configure medical records or arrange night coverage. This is a national conversation to share what some sites have already experienced and learned,” Dr. Anderson said.

“We also have a VA Academic Hospitalist Subcommittee, working together on multisite research studies and on resident education protocols. Because we’re a large system, we’re able to connect with one another and leverage what we’ve learned. I get emails almost every day about research topics from colleagues across the country,” he said. A collaborative website and email distribution list allows doctors to post questions to their peers nationwide.
 

A calling for hospital medicine

Before moving to Denver, Dr. Anderson served as a major in the Air Force Medical Corps and was based at the David Grant US Air Force Medical Center on Travis Air Force Base in California – which is where he did his residency. In the course of a “traditionalist” internal medical training, including 4-month stints on hospital wards in addition to outpatient services, he realized he had a calling for hospital medicine.

In a job at the Providence (R.I.) VA Medical Center, he exclusively practiced outpatient care, but he found that he missed key aspects of inpatient work, such as the intensity of the clinical issues and teaching encounters. “I cold-called the hospital’s chief of medicine and volunteered to start mentoring inpatient residents,” Dr. Anderson said. “That was 17 years ago.”

Another abiding interest derived from Dr. Anderson’s military service is travel medicine. While a physician in the Air Force, he was deployed to Haiti in 1995 and to Nicaragua in 2000, where he treated thousands of patients – both U.S. service personnel and local populations.

“In Haiti, our primary mission was for U.S. troops who were still based there following the 1994 Operation Uphold Democracy intervention, but there were a lot fewer of them, so we mostly kept busy providing care to Haitian nationals,” he said. “That work was eye opening, to say the least,” and led to a professional interest in tropical illnesses. “Since then, I’ve been a visiting professor for the University of Colorado posted to the University of Zimbabwe in Harare in 2012 and 2016.”

What gives Dr. Anderson such joy and enthusiasm for his VA work? “I am a curious lifelong learner. Every day, there are 10 new things I need to learn, whether clinically or operationally in a big hospital system or just the day-to-day realities of leading a group of physicians. I never feel like I’m treading water,” he said. He is also energized by teaching – seeing “the light bulb go on” for the students he is instructing – and by serving as a role model for doctors in training.

“As I contemplate all the simultaneous balls I have in the air, including our recent move into a new hospital building, sometimes I think it is kind of crazy to be doing as much as I do,” he said. “But I also take time away, balancing work versus nonwork.” He spends quality time with his wife of 21 years, 17-year-old daughter, other relatives, and friends, as well as on physical activity, reading books about philosophy, and his hobby of rebuilding motorcycles, which he says offers a kind of meditative calm.

“I also feel a deep sense of service – to patients, colleagues, students, and to the mission of the VA,” Dr. Anderson said. “There is truly something special about caring for the veteran. It’s hard to articulate, but it really keeps us coming back for more. I’ve had vets sing to me, tell jokes, do magic tricks, share their war stories. I’ve had patients open up to me in ways that were both profound and humbling.”
 

References

1. Young E et al. Impact of altered medication administration time on interdisciplinary bedside rounds on academic medical ward. J Nurs Care Qual. 2017 Jul/Sep;32(3):218-225.

Opioids are still often overprescribed after surgery and the quantity of the prescription is associated with higher patient-reported consumption, according to a population-based study of surgery patients.

sdominick/iStock/Getty Images

Ryan Howard, MD, FACS, of the department of surgery at the University of Michigan, Ann Arbor, and his coauthors analyzed data from the Michigan Surgical Quality Collaborative and sampled 2,392 patients who underwent 1 of 12 common surgical procedures in Michigan between Jan. 1 and Sept. 30, 2017, and were prescribed opioids for pain. For all patients, the quantity of opioid prescribed – converted to oral morphine equivalents (OMEs) to adjust for varying potency – was considerably greater than the quantity actually consumed by the patient, wrote Dr. Howard and his colleagues in JAMA Surgery.

The study findings have troubling implications, the authors suggested. “Overprescribing was universally observed in this cohort, affecting each of the 12 procedures analyzed. This phenomenon was not limited to single, outlier institutions, but was widespread across many hospitals. This resulted in increased opioid consumption among patients who received larger prescriptions, as well as tens of thousands of leftover pills in 9 months that entered communities across the state of Michigan.”

The median amount prescribed was 150 OMEs, the equivalent of 30 pills of hydrocodone/acetaminophen, 5/325 mg. The median consumed, as reported by patients, was 45 OMEs, or 9 pills, meaning only 27% of the prescribed amount was used. Prescription size was also strongly associated with higher consumption; patients used an additional 0.53 OMEs (95% confidence interval, 0.40-0.65; P less than .001), or 5.3 more pills, for every 10 extra pills prescribed. The larger the initial prescription, the more patients used, an association that persisted when the data were adjusted for procedure and patient-specific factors such as postoperative pain.

The study’s acknowledged limitations included an inability to estimate how many patients were contacted for patient-reported outcome collection, which obscures how representative this sample may be of the patient population in general. There was also no data gathered regarding preoperative opioid use, a near certainty in this cohort given a 3%-4% prevalence of chronic opioid use.

That said, the investigators noted that “intentionally keeping future recommendations liberal in quantity may ultimately aid with widespread adoption, especially for clinicians concerned that prescribing reductions may lead to increased pain and calls for refills after surgery.” They commended local efforts already underway to combat this issue– including their own work at the University of Michigan, where evidence-based prescribing recommendations resulted in a 63% reduction in opioid prescription size without an increase in refills or pain – but reiterated that more needs to be done at a state level.

The authors offered a possible reason for the link between prescription size and patient consumption. “A plausible explanation for the association between prescription size and medication use is the anchoring and adjustment heuristic. This is a psychologic heuristic wherein a piece of information serves as an anchor on which adjustments are made to reach an estimation or decision. For example, obesity literature has shown that food intake increases with portion size. In this case, a larger amount of opioids may serve as a mental anchor by which patients estimate their analgesic needs.”

Michael Englesbe, MD, Jennifer Waljee,MD, and Chad Brummett, MD, reported receiving funding from the Michigan Department of Health and Human Services and the National Institute on Drug Abuse. Joceline Vu, MD, reported receiving funding from the National Institutes of Health Ruth L. Kirschstein National Research Service Award; Jay Lee, MD, reported receiving funding from the National Cancer Institute.

SOURCE: Howard R et al. JAMA Surg. 2018 Nov 7. doi: 10.1001/jamasurg.2018.4234.

Opioids are still often overprescribed after surgery and the quantity of the prescription is associated with higher patient-reported consumption, according to a population-based study of surgery patients.

sdominick/iStock/Getty Images

Ryan Howard, MD, FACS, of the department of surgery at the University of Michigan, Ann Arbor, and his coauthors analyzed data from the Michigan Surgical Quality Collaborative and sampled 2,392 patients who underwent 1 of 12 common surgical procedures in Michigan between Jan. 1 and Sept. 30, 2017, and were prescribed opioids for pain. For all patients, the quantity of opioid prescribed – converted to oral morphine equivalents (OMEs) to adjust for varying potency – was considerably greater than the quantity actually consumed by the patient, wrote Dr. Howard and his colleagues in JAMA Surgery.

The study findings have troubling implications, the authors suggested. “Overprescribing was universally observed in this cohort, affecting each of the 12 procedures analyzed. This phenomenon was not limited to single, outlier institutions, but was widespread across many hospitals. This resulted in increased opioid consumption among patients who received larger prescriptions, as well as tens of thousands of leftover pills in 9 months that entered communities across the state of Michigan.”

The median amount prescribed was 150 OMEs, the equivalent of 30 pills of hydrocodone/acetaminophen, 5/325 mg. The median consumed, as reported by patients, was 45 OMEs, or 9 pills, meaning only 27% of the prescribed amount was used. Prescription size was also strongly associated with higher consumption; patients used an additional 0.53 OMEs (95% confidence interval, 0.40-0.65; P less than .001), or 5.3 more pills, for every 10 extra pills prescribed. The larger the initial prescription, the more patients used, an association that persisted when the data were adjusted for procedure and patient-specific factors such as postoperative pain.

The study’s acknowledged limitations included an inability to estimate how many patients were contacted for patient-reported outcome collection, which obscures how representative this sample may be of the patient population in general. There was also no data gathered regarding preoperative opioid use, a near certainty in this cohort given a 3%-4% prevalence of chronic opioid use.

That said, the investigators noted that “intentionally keeping future recommendations liberal in quantity may ultimately aid with widespread adoption, especially for clinicians concerned that prescribing reductions may lead to increased pain and calls for refills after surgery.” They commended local efforts already underway to combat this issue– including their own work at the University of Michigan, where evidence-based prescribing recommendations resulted in a 63% reduction in opioid prescription size without an increase in refills or pain – but reiterated that more needs to be done at a state level.

The authors offered a possible reason for the link between prescription size and patient consumption. “A plausible explanation for the association between prescription size and medication use is the anchoring and adjustment heuristic. This is a psychologic heuristic wherein a piece of information serves as an anchor on which adjustments are made to reach an estimation or decision. For example, obesity literature has shown that food intake increases with portion size. In this case, a larger amount of opioids may serve as a mental anchor by which patients estimate their analgesic needs.”

Michael Englesbe, MD, Jennifer Waljee,MD, and Chad Brummett, MD, reported receiving funding from the Michigan Department of Health and Human Services and the National Institute on Drug Abuse. Joceline Vu, MD, reported receiving funding from the National Institutes of Health Ruth L. Kirschstein National Research Service Award; Jay Lee, MD, reported receiving funding from the National Cancer Institute.

SOURCE: Howard R et al. JAMA Surg. 2018 Nov 7. doi: 10.1001/jamasurg.2018.4234.

Opioids are still often overprescribed after surgery and the quantity of the prescription is associated with higher patient-reported consumption, according to a population-based study of surgery patients.

sdominick/iStock/Getty Images

Ryan Howard, MD, FACS, of the department of surgery at the University of Michigan, Ann Arbor, and his coauthors analyzed data from the Michigan Surgical Quality Collaborative and sampled 2,392 patients who underwent 1 of 12 common surgical procedures in Michigan between Jan. 1 and Sept. 30, 2017, and were prescribed opioids for pain. For all patients, the quantity of opioid prescribed – converted to oral morphine equivalents (OMEs) to adjust for varying potency – was considerably greater than the quantity actually consumed by the patient, wrote Dr. Howard and his colleagues in JAMA Surgery.

The study findings have troubling implications, the authors suggested. “Overprescribing was universally observed in this cohort, affecting each of the 12 procedures analyzed. This phenomenon was not limited to single, outlier institutions, but was widespread across many hospitals. This resulted in increased opioid consumption among patients who received larger prescriptions, as well as tens of thousands of leftover pills in 9 months that entered communities across the state of Michigan.”

The median amount prescribed was 150 OMEs, the equivalent of 30 pills of hydrocodone/acetaminophen, 5/325 mg. The median consumed, as reported by patients, was 45 OMEs, or 9 pills, meaning only 27% of the prescribed amount was used. Prescription size was also strongly associated with higher consumption; patients used an additional 0.53 OMEs (95% confidence interval, 0.40-0.65; P less than .001), or 5.3 more pills, for every 10 extra pills prescribed. The larger the initial prescription, the more patients used, an association that persisted when the data were adjusted for procedure and patient-specific factors such as postoperative pain.

The study’s acknowledged limitations included an inability to estimate how many patients were contacted for patient-reported outcome collection, which obscures how representative this sample may be of the patient population in general. There was also no data gathered regarding preoperative opioid use, a near certainty in this cohort given a 3%-4% prevalence of chronic opioid use.

That said, the investigators noted that “intentionally keeping future recommendations liberal in quantity may ultimately aid with widespread adoption, especially for clinicians concerned that prescribing reductions may lead to increased pain and calls for refills after surgery.” They commended local efforts already underway to combat this issue– including their own work at the University of Michigan, where evidence-based prescribing recommendations resulted in a 63% reduction in opioid prescription size without an increase in refills or pain – but reiterated that more needs to be done at a state level.

The authors offered a possible reason for the link between prescription size and patient consumption. “A plausible explanation for the association between prescription size and medication use is the anchoring and adjustment heuristic. This is a psychologic heuristic wherein a piece of information serves as an anchor on which adjustments are made to reach an estimation or decision. For example, obesity literature has shown that food intake increases with portion size. In this case, a larger amount of opioids may serve as a mental anchor by which patients estimate their analgesic needs.”

Michael Englesbe, MD, Jennifer Waljee,MD, and Chad Brummett, MD, reported receiving funding from the Michigan Department of Health and Human Services and the National Institute on Drug Abuse. Joceline Vu, MD, reported receiving funding from the National Institutes of Health Ruth L. Kirschstein National Research Service Award; Jay Lee, MD, reported receiving funding from the National Cancer Institute.

SOURCE: Howard R et al. JAMA Surg. 2018 Nov 7. doi: 10.1001/jamasurg.2018.4234.

Clinical question

In pediatric postoperative spinal fusion/adolescent idiopathic scoliosis patients, do alternatives to traditional opioid-based analgesic pain regimens lead to improved clinical outcomes?

Background

Traditional care for pediatric postoperative spinal fusion (PSF) patients has included late mobilization most often because of significant pain that requires significant opioid administration. This has led to side effects of heavy opioid use, primarily nausea/vomiting and sleepiness.

In the United States, prescribers have become more aware of the pitfalls of opioid use given that more people now die of opioid misuse than breast cancer. An approach of multimodal analgesia with early mobilization has been shown to have decreased length of stay (LOS) and improve patient satisfaction, but data on clinical outcomes have been lacking.

Study design

Single-center quality improvement (QI) project.

Setting

Urban, 527-bed, quaternary care, free-standing children’s hospital.

Synopsis

Based on the recognition that multiple “standards” of care were utilized in the postoperative management of PSF patients, a QI project was undertaken. The primary outcome measured was functional recovery, as measured by average LOS and pain scores at the first 6:00 am after surgery then on postoperative days 1, 2, and 3.

Process measures were: use of multimodal agents (gabapentin and ketorolac) and discontinuation of patient-controlled analgesia (PCA) before postoperative day 3. Balancing measures were 30-day readmissions or ED revisit. Patients were divided into three groups by analyzing outcomes in three consecutive time periods: conventional management (n = 134), transition period (n = 104), and rapid recovery pathway (n = 84). In the conventional management time period, patients received intraoperative methadone and postoperative morphine/hydromorphone PCA. During the transition period, plan-do-study-act (PDSA) cycles with ketorolac and gabapentin pilots were instituted and assessed. Finally, a rapid recovery pathway (RRP) was designed and published as a web-based algorithm. Standardized entry order sets were developed to maintain compliance and consistency among health care professionals, and a transition period was allowed to reach the highest possible percentage of patients adhering to multimodal analgesia regimen.

Adherence to the multimodal regimen led to 90% of patients receiving ketorolac on postoperative day 1, 100% receiving gabapentin on night of surgery, 86% off of IV PCA by postoperative day 3, and 100% order set adherence after full implementation of the RRP. LOS decreased from 5.7 to 4 days after RRP implementation. Pain scores also showed significant improvement on postoperative day 0 (average pain score, 3.8 vs. 4.9) and postoperative day 1 (3.8 vs. 5). Balancing measures of 30-day readmissions or ED visits after discharge was 2.9% and rose to 3.6% after full implementation.

Bottom line

Multimodal analgesia – including preoperative gabapentin and acetaminophen, intraoperative methadone and acetaminophen, and postoperative PCA diazepam, gabapentin, acetaminophen, and ketorolac – results in decreased length of stay and improved self-reported daily pain scores.

Citation

Muhly WT et al. Rapid recovery pathway after spinal fusion for idiopathic scoliosis. Pediatrics. 2016 Apr;137(4):e20151568.

Dr. Giordano is a pediatric neurosurgery hospitalist and assistant professor in pediatrics at Columbia University Irving Medical Center in New York.

Clinical question

In pediatric postoperative spinal fusion/adolescent idiopathic scoliosis patients, do alternatives to traditional opioid-based analgesic pain regimens lead to improved clinical outcomes?

Background

Traditional care for pediatric postoperative spinal fusion (PSF) patients has included late mobilization most often because of significant pain that requires significant opioid administration. This has led to side effects of heavy opioid use, primarily nausea/vomiting and sleepiness.

In the United States, prescribers have become more aware of the pitfalls of opioid use given that more people now die of opioid misuse than breast cancer. An approach of multimodal analgesia with early mobilization has been shown to have decreased length of stay (LOS) and improve patient satisfaction, but data on clinical outcomes have been lacking.

Study design

Single-center quality improvement (QI) project.

Setting

Urban, 527-bed, quaternary care, free-standing children’s hospital.

Synopsis

Based on the recognition that multiple “standards” of care were utilized in the postoperative management of PSF patients, a QI project was undertaken. The primary outcome measured was functional recovery, as measured by average LOS and pain scores at the first 6:00 am after surgery then on postoperative days 1, 2, and 3.

Process measures were: use of multimodal agents (gabapentin and ketorolac) and discontinuation of patient-controlled analgesia (PCA) before postoperative day 3. Balancing measures were 30-day readmissions or ED revisit. Patients were divided into three groups by analyzing outcomes in three consecutive time periods: conventional management (n = 134), transition period (n = 104), and rapid recovery pathway (n = 84). In the conventional management time period, patients received intraoperative methadone and postoperative morphine/hydromorphone PCA. During the transition period, plan-do-study-act (PDSA) cycles with ketorolac and gabapentin pilots were instituted and assessed. Finally, a rapid recovery pathway (RRP) was designed and published as a web-based algorithm. Standardized entry order sets were developed to maintain compliance and consistency among health care professionals, and a transition period was allowed to reach the highest possible percentage of patients adhering to multimodal analgesia regimen.

Adherence to the multimodal regimen led to 90% of patients receiving ketorolac on postoperative day 1, 100% receiving gabapentin on night of surgery, 86% off of IV PCA by postoperative day 3, and 100% order set adherence after full implementation of the RRP. LOS decreased from 5.7 to 4 days after RRP implementation. Pain scores also showed significant improvement on postoperative day 0 (average pain score, 3.8 vs. 4.9) and postoperative day 1 (3.8 vs. 5). Balancing measures of 30-day readmissions or ED visits after discharge was 2.9% and rose to 3.6% after full implementation.

Bottom line

Multimodal analgesia – including preoperative gabapentin and acetaminophen, intraoperative methadone and acetaminophen, and postoperative PCA diazepam, gabapentin, acetaminophen, and ketorolac – results in decreased length of stay and improved self-reported daily pain scores.

Citation

Muhly WT et al. Rapid recovery pathway after spinal fusion for idiopathic scoliosis. Pediatrics. 2016 Apr;137(4):e20151568.

Dr. Giordano is a pediatric neurosurgery hospitalist and assistant professor in pediatrics at Columbia University Irving Medical Center in New York.

Clinical question

In pediatric postoperative spinal fusion/adolescent idiopathic scoliosis patients, do alternatives to traditional opioid-based analgesic pain regimens lead to improved clinical outcomes?

Background

Traditional care for pediatric postoperative spinal fusion (PSF) patients has included late mobilization most often because of significant pain that requires significant opioid administration. This has led to side effects of heavy opioid use, primarily nausea/vomiting and sleepiness.

In the United States, prescribers have become more aware of the pitfalls of opioid use given that more people now die of opioid misuse than breast cancer. An approach of multimodal analgesia with early mobilization has been shown to have decreased length of stay (LOS) and improve patient satisfaction, but data on clinical outcomes have been lacking.

Study design

Single-center quality improvement (QI) project.

Setting

Urban, 527-bed, quaternary care, free-standing children’s hospital.

Synopsis

Based on the recognition that multiple “standards” of care were utilized in the postoperative management of PSF patients, a QI project was undertaken. The primary outcome measured was functional recovery, as measured by average LOS and pain scores at the first 6:00 am after surgery then on postoperative days 1, 2, and 3.

Process measures were: use of multimodal agents (gabapentin and ketorolac) and discontinuation of patient-controlled analgesia (PCA) before postoperative day 3. Balancing measures were 30-day readmissions or ED revisit. Patients were divided into three groups by analyzing outcomes in three consecutive time periods: conventional management (n = 134), transition period (n = 104), and rapid recovery pathway (n = 84). In the conventional management time period, patients received intraoperative methadone and postoperative morphine/hydromorphone PCA. During the transition period, plan-do-study-act (PDSA) cycles with ketorolac and gabapentin pilots were instituted and assessed. Finally, a rapid recovery pathway (RRP) was designed and published as a web-based algorithm. Standardized entry order sets were developed to maintain compliance and consistency among health care professionals, and a transition period was allowed to reach the highest possible percentage of patients adhering to multimodal analgesia regimen.

Adherence to the multimodal regimen led to 90% of patients receiving ketorolac on postoperative day 1, 100% receiving gabapentin on night of surgery, 86% off of IV PCA by postoperative day 3, and 100% order set adherence after full implementation of the RRP. LOS decreased from 5.7 to 4 days after RRP implementation. Pain scores also showed significant improvement on postoperative day 0 (average pain score, 3.8 vs. 4.9) and postoperative day 1 (3.8 vs. 5). Balancing measures of 30-day readmissions or ED visits after discharge was 2.9% and rose to 3.6% after full implementation.

Bottom line

Multimodal analgesia – including preoperative gabapentin and acetaminophen, intraoperative methadone and acetaminophen, and postoperative PCA diazepam, gabapentin, acetaminophen, and ketorolac – results in decreased length of stay and improved self-reported daily pain scores.

Citation

Muhly WT et al. Rapid recovery pathway after spinal fusion for idiopathic scoliosis. Pediatrics. 2016 Apr;137(4):e20151568.

Dr. Giordano is a pediatric neurosurgery hospitalist and assistant professor in pediatrics at Columbia University Irving Medical Center in New York.

Clinical question: Is the combination of aspirin and clopidogrel effective in reducing stroke recurrence?

Background: The risk of recurrent stroke varies from 3% to 15% in the 3 months after a minor ischemic stroke (NIH Stroke Scale score of 3 or less) or high-risk transient ischemic attack (ABCD2 score of 4 or less). Dual-antiplatelet therapy with aspirin and clopidogrel reduces recurrent coronary syndrome; therefore, this strategy can prevent recurrent stroke.

Study design: Prospective, randomized, double-blind, multicenter, placebo-controlled trial.

Setting: 269 sites in 10 countries, mostly in the United States, from May 28, 2010, to Dec. 19, 2017.

Synopsis: The POINT (­Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke) trial enrolled 4,881 patients older than 18 years of age randomized to a loading dose of 600 mg of clopidogrel followed by 75 mg per day or placebo, and aspirin 162 mg daily for 5 days followed by 81 mg daily. The primary outcome was the risk of major ischemic events, including ischemic stroke, myocardial infarction, or death from ischemic vascular causes. Major ischemic events were observed in 5.0% receiving dual therapy and in 6.5% of those receiving aspirin alone (hazard ratio, 0.75; 95% confidence interval, 0.59-0.95; P = .02) with most occurring within a week after the initial stroke. Major hemorrhage occurred in only 23 patients (0.9%), most of which were extracranial and nonfatal. One of the main limitations is the difficulty in objectively diagnosing TIAs, accounting for 43% of the patients in the study.

Bottom line: Dual-antiplatelet therapy with aspirin and clopidogrel is beneficial, mainly in the first week after a minor stroke or high-risk TIA with low risk of major bleeding.

Citation: Johnston SC et al. Clopidogrel and aspirin in acute ischemic stroke and high-risk TIA. N Engl J Med. 2018;379:215-25.

Dr. Vela-Duarte is assistant professor of neurology at the University of Colorado, Denver.

Clinical question: Is the combination of aspirin and clopidogrel effective in reducing stroke recurrence?

Background: The risk of recurrent stroke varies from 3% to 15% in the 3 months after a minor ischemic stroke (NIH Stroke Scale score of 3 or less) or high-risk transient ischemic attack (ABCD2 score of 4 or less). Dual-antiplatelet therapy with aspirin and clopidogrel reduces recurrent coronary syndrome; therefore, this strategy can prevent recurrent stroke.

Study design: Prospective, randomized, double-blind, multicenter, placebo-controlled trial.

Setting: 269 sites in 10 countries, mostly in the United States, from May 28, 2010, to Dec. 19, 2017.

Synopsis: The POINT (­Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke) trial enrolled 4,881 patients older than 18 years of age randomized to a loading dose of 600 mg of clopidogrel followed by 75 mg per day or placebo, and aspirin 162 mg daily for 5 days followed by 81 mg daily. The primary outcome was the risk of major ischemic events, including ischemic stroke, myocardial infarction, or death from ischemic vascular causes. Major ischemic events were observed in 5.0% receiving dual therapy and in 6.5% of those receiving aspirin alone (hazard ratio, 0.75; 95% confidence interval, 0.59-0.95; P = .02) with most occurring within a week after the initial stroke. Major hemorrhage occurred in only 23 patients (0.9%), most of which were extracranial and nonfatal. One of the main limitations is the difficulty in objectively diagnosing TIAs, accounting for 43% of the patients in the study.

Bottom line: Dual-antiplatelet therapy with aspirin and clopidogrel is beneficial, mainly in the first week after a minor stroke or high-risk TIA with low risk of major bleeding.

Citation: Johnston SC et al. Clopidogrel and aspirin in acute ischemic stroke and high-risk TIA. N Engl J Med. 2018;379:215-25.

Dr. Vela-Duarte is assistant professor of neurology at the University of Colorado, Denver.

Clinical question: Is the combination of aspirin and clopidogrel effective in reducing stroke recurrence?

Background: The risk of recurrent stroke varies from 3% to 15% in the 3 months after a minor ischemic stroke (NIH Stroke Scale score of 3 or less) or high-risk transient ischemic attack (ABCD2 score of 4 or less). Dual-antiplatelet therapy with aspirin and clopidogrel reduces recurrent coronary syndrome; therefore, this strategy can prevent recurrent stroke.

Study design: Prospective, randomized, double-blind, multicenter, placebo-controlled trial.

Setting: 269 sites in 10 countries, mostly in the United States, from May 28, 2010, to Dec. 19, 2017.

Synopsis: The POINT (­Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke) trial enrolled 4,881 patients older than 18 years of age randomized to a loading dose of 600 mg of clopidogrel followed by 75 mg per day or placebo, and aspirin 162 mg daily for 5 days followed by 81 mg daily. The primary outcome was the risk of major ischemic events, including ischemic stroke, myocardial infarction, or death from ischemic vascular causes. Major ischemic events were observed in 5.0% receiving dual therapy and in 6.5% of those receiving aspirin alone (hazard ratio, 0.75; 95% confidence interval, 0.59-0.95; P = .02) with most occurring within a week after the initial stroke. Major hemorrhage occurred in only 23 patients (0.9%), most of which were extracranial and nonfatal. One of the main limitations is the difficulty in objectively diagnosing TIAs, accounting for 43% of the patients in the study.

Bottom line: Dual-antiplatelet therapy with aspirin and clopidogrel is beneficial, mainly in the first week after a minor stroke or high-risk TIA with low risk of major bleeding.

Citation: Johnston SC et al. Clopidogrel and aspirin in acute ischemic stroke and high-risk TIA. N Engl J Med. 2018;379:215-25.

Dr. Vela-Duarte is assistant professor of neurology at the University of Colorado, Denver.

Clinical question: Does rivaroxaban prevent recurrent ischemic stroke in patients with embolic stroke from undetermined source?

Background: Embolic stroke of undetermined source (ESUS) represents approximately 20% of ischemic strokes. Rivaroxaban inhibits factor Xa and is shown to be effective for secondary stroke prevention in patients with nonvalvular atrial fibrillation. Strategies to prevent cryptogenic stroke caused by mechanisms other than cardioembolic sources are lacking.

Study design: International, double-blind, event-­driven, randomized, phase III trial.

Recurrent stroke was observed in 158 in the rivaroxaban group and 156 in the aspirin group, mostly ischemic. The trial was terminated early because of a higher incidence of intracranial hemorrhage and major bleeding among patients assigned to rivaroxaban at an annual rate of 1.8%, compared with 0.7% (hazard ratio, 2.72; 95% confidence interval, 1.68-4.39; P less than .001). Although the study utilized strict criteria to define ESUS, it is feasible that the lack of benefit may be due to heterogeneous arterial, cardiogenic, and paradoxical emboli with diverse composition and poor response to rivaroxaban.

Bottom line: Rivaroxaban does not confer protection from recurrent stroke in patients with embolic stroke of unknown origin and increases risk for intracranial hemorrhage and major bleeding.

Citation: Hart RG et al. Rivaroxaban for stroke prevention after embolic stroke of undetermined source. N Engl J Med. 2018;378(23):2191-201.

Dr. Vela-Duarte is assistant professor of neurology at the University of Colorado, Denver

Clinical question: Does rivaroxaban prevent recurrent ischemic stroke in patients with embolic stroke from undetermined source?

Background: Embolic stroke of undetermined source (ESUS) represents approximately 20% of ischemic strokes. Rivaroxaban inhibits factor Xa and is shown to be effective for secondary stroke prevention in patients with nonvalvular atrial fibrillation. Strategies to prevent cryptogenic stroke caused by mechanisms other than cardioembolic sources are lacking.

Study design: International, double-blind, event-­driven, randomized, phase III trial.

Recurrent stroke was observed in 158 in the rivaroxaban group and 156 in the aspirin group, mostly ischemic. The trial was terminated early because of a higher incidence of intracranial hemorrhage and major bleeding among patients assigned to rivaroxaban at an annual rate of 1.8%, compared with 0.7% (hazard ratio, 2.72; 95% confidence interval, 1.68-4.39; P less than .001). Although the study utilized strict criteria to define ESUS, it is feasible that the lack of benefit may be due to heterogeneous arterial, cardiogenic, and paradoxical emboli with diverse composition and poor response to rivaroxaban.

Bottom line: Rivaroxaban does not confer protection from recurrent stroke in patients with embolic stroke of unknown origin and increases risk for intracranial hemorrhage and major bleeding.

Citation: Hart RG et al. Rivaroxaban for stroke prevention after embolic stroke of undetermined source. N Engl J Med. 2018;378(23):2191-201.

Dr. Vela-Duarte is assistant professor of neurology at the University of Colorado, Denver

Clinical question: Does rivaroxaban prevent recurrent ischemic stroke in patients with embolic stroke from undetermined source?

Background: Embolic stroke of undetermined source (ESUS) represents approximately 20% of ischemic strokes. Rivaroxaban inhibits factor Xa and is shown to be effective for secondary stroke prevention in patients with nonvalvular atrial fibrillation. Strategies to prevent cryptogenic stroke caused by mechanisms other than cardioembolic sources are lacking.

Study design: International, double-blind, event-­driven, randomized, phase III trial.

Recurrent stroke was observed in 158 in the rivaroxaban group and 156 in the aspirin group, mostly ischemic. The trial was terminated early because of a higher incidence of intracranial hemorrhage and major bleeding among patients assigned to rivaroxaban at an annual rate of 1.8%, compared with 0.7% (hazard ratio, 2.72; 95% confidence interval, 1.68-4.39; P less than .001). Although the study utilized strict criteria to define ESUS, it is feasible that the lack of benefit may be due to heterogeneous arterial, cardiogenic, and paradoxical emboli with diverse composition and poor response to rivaroxaban.

Bottom line: Rivaroxaban does not confer protection from recurrent stroke in patients with embolic stroke of unknown origin and increases risk for intracranial hemorrhage and major bleeding.

Citation: Hart RG et al. Rivaroxaban for stroke prevention after embolic stroke of undetermined source. N Engl J Med. 2018;378(23):2191-201.

Dr. Vela-Duarte is assistant professor of neurology at the University of Colorado, Denver

BERLIN – A dry-powder nasal formulation of glucagon was as good as intramuscular delivery for the reversal of severe hypoglycemia in patients with type 1 diabetes mellitus (T1DM) in a randomized controlled trial.

Sara Freeman/MDedge News

A 100% treatment success rate (n = 66) was seen for both nasal glucagon and intramuscular glucagon, defined as an increase in plasma glucose to 70 mg/dL (3.9 mmol/L or greater) or more or an increase of 20 mg/L (1.1 mmol/L) or more from the glucose nadir within 30 minutes of administration.

Furthermore, slightly more than 97% of patients achieved treatment success within 15 minutes in both treatment groups, with mean times of 11.4 minutes for the nasal formulation and 9.8 minutes for intramuscular administration.

Similar glucose responses were observed within 40 minutes of glucagon administration, study investigator Leona Plum-Mörschel, MD, PhD, reported at the annual meeting of the European Association for the Study of Diabetes. Dr. Plum-Mörschel is the CEO of the clinical research organization Profil Mainz (Germany), which helped Eli Lilly conduct the trial.

“We are all aware and fully agree that severe hypoglycemia is a serious and potentially life-threatening complication of diabetes treatment with insulin and the sulfonylureas,” said Dr. Plum-Mörschel. At least one in three patients with diabetes reports one hypoglycemic episode per year, she added. While this is quite prevalent in patients with T1DM, it’s not uncommon for those with type 2 diabetes mellitus (T2DM) to experience hypoglycemic episodes.

“Outside of a hospital or emergency room setting, injectable glucagon is currently the only option to treat severe hypoglycemia,” Dr. Plum-Mörschel reminded delegates. “Thankfully, the available injectable glucagon emergency kits are highly effective for the treatment of hypoglycemic events,” she added.

However, for untrained caregivers they can be “really challenging to use,” according to Dr. Plum-Mörschel. This is because the available kits involve multiple steps, including reconstitution, before being ready to inject. A severe hypoglycemic event is stressful enough without them worrying about getting things right, she suggested.

This is where a nasal formulation would be advantageous, and it is something that’s been touted to be on the horizon for a few years. Studies have previously shown that nasal glucagon is comparable to intramuscular glucagon in both adult and pediatric populations. Turning the formulation used in those studies into a commercial product however, has meant more clinical testing before being licensed by the regulatory authorities.

The nasal formulation consists of a dry power containing 3 mg glucagon that is provided in a single-use, compact, and thus, portable, device. It’s been designed to be stored at room temperature and is ready to use immediately. Pressing the plunger on the device releases the fine powder that does not require inhalation to work, which means it can be given easily to an unconscious patient with severe hypoglycemia.

“The aim of the present study was to compare the efficacy and safety of commercially manufactured nasal glucagon with intramuscular glucagon for the treatment of insulin-induced hypoglycemia in adults with type 1 diabetes,” Dr. Plum-Mörschel said.

It was a randomized, single-dose, crossover study involving 70 adult patients with T1DM with hypoglycemia artificially induced by an intravenous insulin infusion during the two dosing visits. Five minutes after stopping insulin, nasal glucagon (3 mg) or intramuscular (1 mg) was given, with multiple plasma glucose measurements taken for up to 90 minutes.

The mean age of participants was 41.7 years old, 61% were male, the mean duration of diabetes was 19.8 years, with a baseline glycated hemoglobin (HbA_1c) of 7.3%.

As for safety, Dr. Plum-Mörschel noted that nasal glucagon had a safety profile that was acceptable for emergency treatment. There was no difference between the nasal or intramuscular glucagon treatment groups in the percentages of patients experiencing treatment-emergent adverse events (at least 5% frequency): nausea was seen in 22% and 29%, vomiting in 10% and 12%, and headache in 12% and 7%, respectively.

Asking patients who had been treated with nasal glucagon about specific symptoms related to nasal administration showed around 63% had watery eyes, 49% nasal itching, 39% nasal congestion, 37% a runny nose, 24% sneezing, 20% itchy eyes, and 12.9% itchy throat. “All of these events were transient, generally mild or moderate in nature, and none were serious. Indeed, there were no deaths in the study and no other serious AEs [adverse events] occurred.”

Dr. Plum-Mörschel concluded: “These results support nasal glucagon as a viable alternative to intramuscular glucagon for the treatment of severe hypoglycemia.

“I personally would expect that, due to its simplicity of use, nasal glucagon will create a greater community who can render quick aid in a rescue situation.”

The study was funded by Eli Lilly. Dr. Plum-Mörschel is an employee of Profil Mainz and has received travel grants and speaker honoraria from Eli Lilly and Novo Nordisk.
 

SOURCE: Suico J et al. EASD 2018, Abstract 150.

BERLIN – A dry-powder nasal formulation of glucagon was as good as intramuscular delivery for the reversal of severe hypoglycemia in patients with type 1 diabetes mellitus (T1DM) in a randomized controlled trial.

Sara Freeman/MDedge News

A 100% treatment success rate (n = 66) was seen for both nasal glucagon and intramuscular glucagon, defined as an increase in plasma glucose to 70 mg/dL (3.9 mmol/L or greater) or more or an increase of 20 mg/L (1.1 mmol/L) or more from the glucose nadir within 30 minutes of administration.

Furthermore, slightly more than 97% of patients achieved treatment success within 15 minutes in both treatment groups, with mean times of 11.4 minutes for the nasal formulation and 9.8 minutes for intramuscular administration.

Similar glucose responses were observed within 40 minutes of glucagon administration, study investigator Leona Plum-Mörschel, MD, PhD, reported at the annual meeting of the European Association for the Study of Diabetes. Dr. Plum-Mörschel is the CEO of the clinical research organization Profil Mainz (Germany), which helped Eli Lilly conduct the trial.

“We are all aware and fully agree that severe hypoglycemia is a serious and potentially life-threatening complication of diabetes treatment with insulin and the sulfonylureas,” said Dr. Plum-Mörschel. At least one in three patients with diabetes reports one hypoglycemic episode per year, she added. While this is quite prevalent in patients with T1DM, it’s not uncommon for those with type 2 diabetes mellitus (T2DM) to experience hypoglycemic episodes.

“Outside of a hospital or emergency room setting, injectable glucagon is currently the only option to treat severe hypoglycemia,” Dr. Plum-Mörschel reminded delegates. “Thankfully, the available injectable glucagon emergency kits are highly effective for the treatment of hypoglycemic events,” she added.

However, for untrained caregivers they can be “really challenging to use,” according to Dr. Plum-Mörschel. This is because the available kits involve multiple steps, including reconstitution, before being ready to inject. A severe hypoglycemic event is stressful enough without them worrying about getting things right, she suggested.

This is where a nasal formulation would be advantageous, and it is something that’s been touted to be on the horizon for a few years. Studies have previously shown that nasal glucagon is comparable to intramuscular glucagon in both adult and pediatric populations. Turning the formulation used in those studies into a commercial product however, has meant more clinical testing before being licensed by the regulatory authorities.

The nasal formulation consists of a dry power containing 3 mg glucagon that is provided in a single-use, compact, and thus, portable, device. It’s been designed to be stored at room temperature and is ready to use immediately. Pressing the plunger on the device releases the fine powder that does not require inhalation to work, which means it can be given easily to an unconscious patient with severe hypoglycemia.

“The aim of the present study was to compare the efficacy and safety of commercially manufactured nasal glucagon with intramuscular glucagon for the treatment of insulin-induced hypoglycemia in adults with type 1 diabetes,” Dr. Plum-Mörschel said.

It was a randomized, single-dose, crossover study involving 70 adult patients with T1DM with hypoglycemia artificially induced by an intravenous insulin infusion during the two dosing visits. Five minutes after stopping insulin, nasal glucagon (3 mg) or intramuscular (1 mg) was given, with multiple plasma glucose measurements taken for up to 90 minutes.

The mean age of participants was 41.7 years old, 61% were male, the mean duration of diabetes was 19.8 years, with a baseline glycated hemoglobin (HbA_1c) of 7.3%.

As for safety, Dr. Plum-Mörschel noted that nasal glucagon had a safety profile that was acceptable for emergency treatment. There was no difference between the nasal or intramuscular glucagon treatment groups in the percentages of patients experiencing treatment-emergent adverse events (at least 5% frequency): nausea was seen in 22% and 29%, vomiting in 10% and 12%, and headache in 12% and 7%, respectively.

Asking patients who had been treated with nasal glucagon about specific symptoms related to nasal administration showed around 63% had watery eyes, 49% nasal itching, 39% nasal congestion, 37% a runny nose, 24% sneezing, 20% itchy eyes, and 12.9% itchy throat. “All of these events were transient, generally mild or moderate in nature, and none were serious. Indeed, there were no deaths in the study and no other serious AEs [adverse events] occurred.”

Dr. Plum-Mörschel concluded: “These results support nasal glucagon as a viable alternative to intramuscular glucagon for the treatment of severe hypoglycemia.

“I personally would expect that, due to its simplicity of use, nasal glucagon will create a greater community who can render quick aid in a rescue situation.”

The study was funded by Eli Lilly. Dr. Plum-Mörschel is an employee of Profil Mainz and has received travel grants and speaker honoraria from Eli Lilly and Novo Nordisk.
 

SOURCE: Suico J et al. EASD 2018, Abstract 150.

BERLIN – A dry-powder nasal formulation of glucagon was as good as intramuscular delivery for the reversal of severe hypoglycemia in patients with type 1 diabetes mellitus (T1DM) in a randomized controlled trial.

Sara Freeman/MDedge News

A 100% treatment success rate (n = 66) was seen for both nasal glucagon and intramuscular glucagon, defined as an increase in plasma glucose to 70 mg/dL (3.9 mmol/L or greater) or more or an increase of 20 mg/L (1.1 mmol/L) or more from the glucose nadir within 30 minutes of administration.

Furthermore, slightly more than 97% of patients achieved treatment success within 15 minutes in both treatment groups, with mean times of 11.4 minutes for the nasal formulation and 9.8 minutes for intramuscular administration.

Similar glucose responses were observed within 40 minutes of glucagon administration, study investigator Leona Plum-Mörschel, MD, PhD, reported at the annual meeting of the European Association for the Study of Diabetes. Dr. Plum-Mörschel is the CEO of the clinical research organization Profil Mainz (Germany), which helped Eli Lilly conduct the trial.

“We are all aware and fully agree that severe hypoglycemia is a serious and potentially life-threatening complication of diabetes treatment with insulin and the sulfonylureas,” said Dr. Plum-Mörschel. At least one in three patients with diabetes reports one hypoglycemic episode per year, she added. While this is quite prevalent in patients with T1DM, it’s not uncommon for those with type 2 diabetes mellitus (T2DM) to experience hypoglycemic episodes.

“Outside of a hospital or emergency room setting, injectable glucagon is currently the only option to treat severe hypoglycemia,” Dr. Plum-Mörschel reminded delegates. “Thankfully, the available injectable glucagon emergency kits are highly effective for the treatment of hypoglycemic events,” she added.

However, for untrained caregivers they can be “really challenging to use,” according to Dr. Plum-Mörschel. This is because the available kits involve multiple steps, including reconstitution, before being ready to inject. A severe hypoglycemic event is stressful enough without them worrying about getting things right, she suggested.

This is where a nasal formulation would be advantageous, and it is something that’s been touted to be on the horizon for a few years. Studies have previously shown that nasal glucagon is comparable to intramuscular glucagon in both adult and pediatric populations. Turning the formulation used in those studies into a commercial product however, has meant more clinical testing before being licensed by the regulatory authorities.

The nasal formulation consists of a dry power containing 3 mg glucagon that is provided in a single-use, compact, and thus, portable, device. It’s been designed to be stored at room temperature and is ready to use immediately. Pressing the plunger on the device releases the fine powder that does not require inhalation to work, which means it can be given easily to an unconscious patient with severe hypoglycemia.

“The aim of the present study was to compare the efficacy and safety of commercially manufactured nasal glucagon with intramuscular glucagon for the treatment of insulin-induced hypoglycemia in adults with type 1 diabetes,” Dr. Plum-Mörschel said.

It was a randomized, single-dose, crossover study involving 70 adult patients with T1DM with hypoglycemia artificially induced by an intravenous insulin infusion during the two dosing visits. Five minutes after stopping insulin, nasal glucagon (3 mg) or intramuscular (1 mg) was given, with multiple plasma glucose measurements taken for up to 90 minutes.

The mean age of participants was 41.7 years old, 61% were male, the mean duration of diabetes was 19.8 years, with a baseline glycated hemoglobin (HbA_1c) of 7.3%.

As for safety, Dr. Plum-Mörschel noted that nasal glucagon had a safety profile that was acceptable for emergency treatment. There was no difference between the nasal or intramuscular glucagon treatment groups in the percentages of patients experiencing treatment-emergent adverse events (at least 5% frequency): nausea was seen in 22% and 29%, vomiting in 10% and 12%, and headache in 12% and 7%, respectively.

Asking patients who had been treated with nasal glucagon about specific symptoms related to nasal administration showed around 63% had watery eyes, 49% nasal itching, 39% nasal congestion, 37% a runny nose, 24% sneezing, 20% itchy eyes, and 12.9% itchy throat. “All of these events were transient, generally mild or moderate in nature, and none were serious. Indeed, there were no deaths in the study and no other serious AEs [adverse events] occurred.”

Dr. Plum-Mörschel concluded: “These results support nasal glucagon as a viable alternative to intramuscular glucagon for the treatment of severe hypoglycemia.

“I personally would expect that, due to its simplicity of use, nasal glucagon will create a greater community who can render quick aid in a rescue situation.”

The study was funded by Eli Lilly. Dr. Plum-Mörschel is an employee of Profil Mainz and has received travel grants and speaker honoraria from Eli Lilly and Novo Nordisk.
 

SOURCE: Suico J et al. EASD 2018, Abstract 150.

Recurrence risk is significant among all patients with venous thromboembolism (VTE), though recurrence is most frequent in patients with cancer-related VTE, according to a nationwide Danish study.

Ida Ehlers Albertsen, MD, of Aalborg (Denmark) University Hospital and her coauthors followed 73,993 patients who were diagnosed with incident VTE during January 2000–December 2015. The patients’ VTEs were classified as either cancer-related, unprovoked (occurring in patients without any provoking factors), or provoked (occurring in patients with one or more provoking factors, such as recent major surgery, recent fracture/trauma, obesity, or hormone replacement therapy).

The researchers found similar risks of recurrence among patients with unprovoked and provoked VTE at 6-month follow-up, with rates per 100 person-years of 6.80 and 6.92, respectively. By comparison, the recurrence rate for cancer-related VTE at 6 months was 9.06. The findings were reported in the American Journal of Medicine.

However, at 10-year follow-up the rates were 3.70 for cancer-related VTE, 2.84 for unprovoked VTE, and 2.22 for provoked VTE, which reinforces the belief that “unprovoked venous thromboembolism is associated with long-term higher risk of recurrence than provoked venous thromboembolism.”

Additionally, at 10-year follow-up, the absolute recurrence risk of cancer-related VTE and unprovoked VTE were both at approximately 20%, with recurrence risk of provoked VTE at just above 15%. Compared with the recurrence risk of provoked VTE at 10-year follow-up, the hazard ratios of cancer-related VTE and unprovoked VTE recurrence risk were 1.23 (95% confidence interval, 1.13-1.33) and 1.18 (95% CI, 1.13-1.24), respectively.

The coauthors observed several challenges in comparing their study to previous analyses on recurrent risk, noting that the definition of provoked VTE “varies throughout the literature” and that the majority of VTE studies “provide cumulative incidence proportions and not the actual rates.” They also stated that indefinite or extended therapy for all VTE patients comes with its own potential complications, even with the improved safety of non–vitamin K antagonist oral anticoagulants, writing that “treatment should be given to patients where the benefits outweigh the risks.”

Despite the differences in recurrence rates at 6-month and 10-year follow-up, the coauthors suggested that enough risk was present in all types to warrant additional studies and reconsider how VTE patients are categorized.

“A high recurrence risk in all types of venous thromboembolism indicates that further research is needed to optimize risk stratification for venous thromboembolism patients,” they wrote.

The study was partially funded by a grant from the Obel Family Foundation. Some authors reported financial disclosures related to Janssen, Bayer, Roche, and others.

SOURCE: Albertsen IE et al. Am J Med. 2018 Sep;131(9):1067-74.e4.

Recurrence risk is significant among all patients with venous thromboembolism (VTE), though recurrence is most frequent in patients with cancer-related VTE, according to a nationwide Danish study.

Ida Ehlers Albertsen, MD, of Aalborg (Denmark) University Hospital and her coauthors followed 73,993 patients who were diagnosed with incident VTE during January 2000–December 2015. The patients’ VTEs were classified as either cancer-related, unprovoked (occurring in patients without any provoking factors), or provoked (occurring in patients with one or more provoking factors, such as recent major surgery, recent fracture/trauma, obesity, or hormone replacement therapy).

The researchers found similar risks of recurrence among patients with unprovoked and provoked VTE at 6-month follow-up, with rates per 100 person-years of 6.80 and 6.92, respectively. By comparison, the recurrence rate for cancer-related VTE at 6 months was 9.06. The findings were reported in the American Journal of Medicine.

However, at 10-year follow-up the rates were 3.70 for cancer-related VTE, 2.84 for unprovoked VTE, and 2.22 for provoked VTE, which reinforces the belief that “unprovoked venous thromboembolism is associated with long-term higher risk of recurrence than provoked venous thromboembolism.”

Additionally, at 10-year follow-up, the absolute recurrence risk of cancer-related VTE and unprovoked VTE were both at approximately 20%, with recurrence risk of provoked VTE at just above 15%. Compared with the recurrence risk of provoked VTE at 10-year follow-up, the hazard ratios of cancer-related VTE and unprovoked VTE recurrence risk were 1.23 (95% confidence interval, 1.13-1.33) and 1.18 (95% CI, 1.13-1.24), respectively.

The coauthors observed several challenges in comparing their study to previous analyses on recurrent risk, noting that the definition of provoked VTE “varies throughout the literature” and that the majority of VTE studies “provide cumulative incidence proportions and not the actual rates.” They also stated that indefinite or extended therapy for all VTE patients comes with its own potential complications, even with the improved safety of non–vitamin K antagonist oral anticoagulants, writing that “treatment should be given to patients where the benefits outweigh the risks.”

Despite the differences in recurrence rates at 6-month and 10-year follow-up, the coauthors suggested that enough risk was present in all types to warrant additional studies and reconsider how VTE patients are categorized.

“A high recurrence risk in all types of venous thromboembolism indicates that further research is needed to optimize risk stratification for venous thromboembolism patients,” they wrote.

The study was partially funded by a grant from the Obel Family Foundation. Some authors reported financial disclosures related to Janssen, Bayer, Roche, and others.

SOURCE: Albertsen IE et al. Am J Med. 2018 Sep;131(9):1067-74.e4.

Recurrence risk is significant among all patients with venous thromboembolism (VTE), though recurrence is most frequent in patients with cancer-related VTE, according to a nationwide Danish study.

Ida Ehlers Albertsen, MD, of Aalborg (Denmark) University Hospital and her coauthors followed 73,993 patients who were diagnosed with incident VTE during January 2000–December 2015. The patients’ VTEs were classified as either cancer-related, unprovoked (occurring in patients without any provoking factors), or provoked (occurring in patients with one or more provoking factors, such as recent major surgery, recent fracture/trauma, obesity, or hormone replacement therapy).

The researchers found similar risks of recurrence among patients with unprovoked and provoked VTE at 6-month follow-up, with rates per 100 person-years of 6.80 and 6.92, respectively. By comparison, the recurrence rate for cancer-related VTE at 6 months was 9.06. The findings were reported in the American Journal of Medicine.

However, at 10-year follow-up the rates were 3.70 for cancer-related VTE, 2.84 for unprovoked VTE, and 2.22 for provoked VTE, which reinforces the belief that “unprovoked venous thromboembolism is associated with long-term higher risk of recurrence than provoked venous thromboembolism.”

Additionally, at 10-year follow-up, the absolute recurrence risk of cancer-related VTE and unprovoked VTE were both at approximately 20%, with recurrence risk of provoked VTE at just above 15%. Compared with the recurrence risk of provoked VTE at 10-year follow-up, the hazard ratios of cancer-related VTE and unprovoked VTE recurrence risk were 1.23 (95% confidence interval, 1.13-1.33) and 1.18 (95% CI, 1.13-1.24), respectively.

The coauthors observed several challenges in comparing their study to previous analyses on recurrent risk, noting that the definition of provoked VTE “varies throughout the literature” and that the majority of VTE studies “provide cumulative incidence proportions and not the actual rates.” They also stated that indefinite or extended therapy for all VTE patients comes with its own potential complications, even with the improved safety of non–vitamin K antagonist oral anticoagulants, writing that “treatment should be given to patients where the benefits outweigh the risks.”

Despite the differences in recurrence rates at 6-month and 10-year follow-up, the coauthors suggested that enough risk was present in all types to warrant additional studies and reconsider how VTE patients are categorized.

“A high recurrence risk in all types of venous thromboembolism indicates that further research is needed to optimize risk stratification for venous thromboembolism patients,” they wrote.

The study was partially funded by a grant from the Obel Family Foundation. Some authors reported financial disclosures related to Janssen, Bayer, Roche, and others.

SOURCE: Albertsen IE et al. Am J Med. 2018 Sep;131(9):1067-74.e4.