Expert Commentary

We work in complex environments and in a flawed and rapidly changing health care system. Caregivers, patients, and communities will be led through this complexity by those who embrace change. Last October, I had the privilege of attending and facilitating the SHM Leadership Academy in Orlando, which allowed me the opportunity to meet a group of people who embrace change, including the benefits and challenges that often accompany it.

SHM board member Jeff Glasheen, MD, SFHM, taught one of the first lessons at Leadership Academy, focusing on the importance of meaningful, difficult change. With comparisons to companies that have embraced change, like Apple, and some that have not, like Sears, Jeff summed up how complacency with “good” and a reluctance to tackle the difficulty of change keeps organizations – and people – from becoming great.

“Good is the enemy of great,” Jeff preached.

He largely focused on hospitalists leading organizational change, but the concepts can apply to personal change, too. He explained that “people generally want things to be different, but they don’t want to change.”

Leaders in training

Ten emerging hospitalist leaders sat at my table, soaking in the message. Several of them, like me 8 years ago, had the responsibilities of leadership unexpectedly thrust upon them. Some carried with them the heavy expectations of their colleagues or hospital administration (or both) that by being elevated into a role such as medical director, they would abruptly be able to make improvements in patient care and hospital operations. They had accepted the challenge to change – to move out of purely clinical roles and take on new ones in leadership despite having little or no experience. Doing so, they gingerly but willingly were following in the footsteps of leaders before them, growing their skills, improving their hospitals, and laying a path for future leaders to follow.

A few weeks prior, I had taken a new leadership position myself. The Cleveland Clinic recently acquired a hospital and health system in Akron, Ohio, about 40 miles away from the city. I assumed the role of president of this acquisition, embracing the complex challenge of leading the process of integrating two health systems. After 3 years overseeing a different hospital in the health system, I finally felt I had developed the people, processes, and culture that I had been striving to build. But like the young leaders at Leadership Academy, I had the opportunity to change, grow, develop, take on new risk, and become a stronger leader in this new role. A significant part of the experience of the Leadership Academy involves table exercises. For the first few exercises, the group was quiet, uncertain, tentative. I was struck both by how early these individuals were in their development and by how so much of what is happening today in hospitals and health care is dependent upon the development and success of individuals like these who are enthusiastic and talented but young and overwhelmed.

I believe that successful hospitalists are, through experience, training, and nature, rapid assimilators into their environments. By the third day, the dynamic at my table had gone from tentative and uncertain to much more confident and assertive. To experience this transformation in person at SHM’s Leadership Academy, we welcome you to Scottsdale, Ariz., later this year. Learn more about the program at www.shmleadershipacademy.org.

At Leadership Academy and beyond, I implore hospitalists to look for opportunities to change during this time of New Year’s resolutions and to take the opposite posture and want to change – change how we think, act, and respond; change our roles to take on new, uncomfortable responsibilities; and change how we view change itself.

We will be better for it both personally and professionally, and we will stand out as role models for our colleagues, coworkers, and hospitalists who follow in our footsteps.

Dr. Harte is a practicing hospitalist, president of the Society of Hospital Medicine, and president of Hillcrest Hospital in Mayfield Heights, Ohio, part of the Cleveland Clinic Health System. He is associate professor of medicine at the Cleveland Clinic, Lerner College of Medicine in Cleveland.

We work in complex environments and in a flawed and rapidly changing health care system. Caregivers, patients, and communities will be led through this complexity by those who embrace change. Last October, I had the privilege of attending and facilitating the SHM Leadership Academy in Orlando, which allowed me the opportunity to meet a group of people who embrace change, including the benefits and challenges that often accompany it.

SHM board member Jeff Glasheen, MD, SFHM, taught one of the first lessons at Leadership Academy, focusing on the importance of meaningful, difficult change. With comparisons to companies that have embraced change, like Apple, and some that have not, like Sears, Jeff summed up how complacency with “good” and a reluctance to tackle the difficulty of change keeps organizations – and people – from becoming great.

“Good is the enemy of great,” Jeff preached.

He largely focused on hospitalists leading organizational change, but the concepts can apply to personal change, too. He explained that “people generally want things to be different, but they don’t want to change.”

Leaders in training

Ten emerging hospitalist leaders sat at my table, soaking in the message. Several of them, like me 8 years ago, had the responsibilities of leadership unexpectedly thrust upon them. Some carried with them the heavy expectations of their colleagues or hospital administration (or both) that by being elevated into a role such as medical director, they would abruptly be able to make improvements in patient care and hospital operations. They had accepted the challenge to change – to move out of purely clinical roles and take on new ones in leadership despite having little or no experience. Doing so, they gingerly but willingly were following in the footsteps of leaders before them, growing their skills, improving their hospitals, and laying a path for future leaders to follow.

A few weeks prior, I had taken a new leadership position myself. The Cleveland Clinic recently acquired a hospital and health system in Akron, Ohio, about 40 miles away from the city. I assumed the role of president of this acquisition, embracing the complex challenge of leading the process of integrating two health systems. After 3 years overseeing a different hospital in the health system, I finally felt I had developed the people, processes, and culture that I had been striving to build. But like the young leaders at Leadership Academy, I had the opportunity to change, grow, develop, take on new risk, and become a stronger leader in this new role. A significant part of the experience of the Leadership Academy involves table exercises. For the first few exercises, the group was quiet, uncertain, tentative. I was struck both by how early these individuals were in their development and by how so much of what is happening today in hospitals and health care is dependent upon the development and success of individuals like these who are enthusiastic and talented but young and overwhelmed.

I believe that successful hospitalists are, through experience, training, and nature, rapid assimilators into their environments. By the third day, the dynamic at my table had gone from tentative and uncertain to much more confident and assertive. To experience this transformation in person at SHM’s Leadership Academy, we welcome you to Scottsdale, Ariz., later this year. Learn more about the program at www.shmleadershipacademy.org.

At Leadership Academy and beyond, I implore hospitalists to look for opportunities to change during this time of New Year’s resolutions and to take the opposite posture and want to change – change how we think, act, and respond; change our roles to take on new, uncomfortable responsibilities; and change how we view change itself.

We will be better for it both personally and professionally, and we will stand out as role models for our colleagues, coworkers, and hospitalists who follow in our footsteps.

Dr. Harte is a practicing hospitalist, president of the Society of Hospital Medicine, and president of Hillcrest Hospital in Mayfield Heights, Ohio, part of the Cleveland Clinic Health System. He is associate professor of medicine at the Cleveland Clinic, Lerner College of Medicine in Cleveland.

We work in complex environments and in a flawed and rapidly changing health care system. Caregivers, patients, and communities will be led through this complexity by those who embrace change. Last October, I had the privilege of attending and facilitating the SHM Leadership Academy in Orlando, which allowed me the opportunity to meet a group of people who embrace change, including the benefits and challenges that often accompany it.

SHM board member Jeff Glasheen, MD, SFHM, taught one of the first lessons at Leadership Academy, focusing on the importance of meaningful, difficult change. With comparisons to companies that have embraced change, like Apple, and some that have not, like Sears, Jeff summed up how complacency with “good” and a reluctance to tackle the difficulty of change keeps organizations – and people – from becoming great.

“Good is the enemy of great,” Jeff preached.

He largely focused on hospitalists leading organizational change, but the concepts can apply to personal change, too. He explained that “people generally want things to be different, but they don’t want to change.”

Leaders in training

Ten emerging hospitalist leaders sat at my table, soaking in the message. Several of them, like me 8 years ago, had the responsibilities of leadership unexpectedly thrust upon them. Some carried with them the heavy expectations of their colleagues or hospital administration (or both) that by being elevated into a role such as medical director, they would abruptly be able to make improvements in patient care and hospital operations. They had accepted the challenge to change – to move out of purely clinical roles and take on new ones in leadership despite having little or no experience. Doing so, they gingerly but willingly were following in the footsteps of leaders before them, growing their skills, improving their hospitals, and laying a path for future leaders to follow.

A few weeks prior, I had taken a new leadership position myself. The Cleveland Clinic recently acquired a hospital and health system in Akron, Ohio, about 40 miles away from the city. I assumed the role of president of this acquisition, embracing the complex challenge of leading the process of integrating two health systems. After 3 years overseeing a different hospital in the health system, I finally felt I had developed the people, processes, and culture that I had been striving to build. But like the young leaders at Leadership Academy, I had the opportunity to change, grow, develop, take on new risk, and become a stronger leader in this new role. A significant part of the experience of the Leadership Academy involves table exercises. For the first few exercises, the group was quiet, uncertain, tentative. I was struck both by how early these individuals were in their development and by how so much of what is happening today in hospitals and health care is dependent upon the development and success of individuals like these who are enthusiastic and talented but young and overwhelmed.

I believe that successful hospitalists are, through experience, training, and nature, rapid assimilators into their environments. By the third day, the dynamic at my table had gone from tentative and uncertain to much more confident and assertive. To experience this transformation in person at SHM’s Leadership Academy, we welcome you to Scottsdale, Ariz., later this year. Learn more about the program at www.shmleadershipacademy.org.

At Leadership Academy and beyond, I implore hospitalists to look for opportunities to change during this time of New Year’s resolutions and to take the opposite posture and want to change – change how we think, act, and respond; change our roles to take on new, uncomfortable responsibilities; and change how we view change itself.

We will be better for it both personally and professionally, and we will stand out as role models for our colleagues, coworkers, and hospitalists who follow in our footsteps.

Dr. Harte is a practicing hospitalist, president of the Society of Hospital Medicine, and president of Hillcrest Hospital in Mayfield Heights, Ohio, part of the Cleveland Clinic Health System. He is associate professor of medicine at the Cleveland Clinic, Lerner College of Medicine in Cleveland.

I’m often asked about effective roles for nurse practitioners (NPs) and physician assistants (PAs), collectively known as advanced practice clinicians (APCs). My first response is always the same: They have much to contribute and can be effective members of hospitalist groups. Most hospital medicine groups (HMGs) should think about having them in their staffing mix if they don’t already.

Yet despite all that NPs/PAs can offer, my experience is that many (even most) hospitalist groups fail to develop roles that optimize their APCs’ skills.

An October 2016 study in the Journal of Clinical Outcomes Management adds additional data to help think about this issue. You may have seen the study mentioned in several news articles and blogs. Most summarized the study along the lines of “using high levels of PA staffing results in lower hospital costs per case.” Framing it this way is awfully misleading, so I’ll go a little deeper here.

Study context

The study, “A Comparison of Conventional and Expanded Physician Assistant Hospitalist Staffing Models at a Community Hospital,” is a retrospective analysis of performance measures from two hospitalist groups at Anne Arundel Medical Center (AAMC) in Annapolis, Md.¹ One HMG is employed by the hospital. The other, called MDICS, is a private company that contracts with AAMC as well as approximately 13 other hospitals and 40 rehabilitation facilities. Tim Capstack, MD, is the AAMC medical director for MDICS and lead author of the study (representing a potential conflict of interest acknowledged in the article). Barry Meisenberg, MD, is a coauthor, a hospitalist in the AAMC-employed group, and chair for quality improvement and health care systems research at AAMC.

Tim told me by phone that both groups have practiced at AAMC for more than 10 years and enjoy a collegial relationship. Both groups employ PAs and pair them with a single physician in a dyad arrangement each day. Tim’s MDICS group, the “expanded PA” group, staffs each day shift with three physicians and three PAs, compared with the nine physicians and two PAs in the hospital-employed “conventional” group. The MDICS PAs are responsible for more patients each day than their conventional-group counterparts and, during the January 2012 to July 2013 study period, averaged 14.2 patients versus 8.3, respectively.

Over the course of the study, PAs in the expanded PA group saw and billed 36% of patient visits independently, compared with 5.9% for the conventional group.
 

Notable study findings

I think the main value of this study is in showing that the expanded PA group had rates of readmission, inpatient mortality, length of stay, and consultant use that weren’t statistically different from the conventional group.

The workloads and years of experience of doctors and PAs in each group were similar. And while there were some differences in the patients each group cared for, they seem unlikely to have a significant influence on outcomes. Clearly, there are many unmeasured variables (e.g., culture, morale, and leadership) in each group that could have influenced the outcomes, so this one study at one hospital doesn’t provide a definitive answer about appropriate APC staffing levels. However, it didn’t uncover big differences in the measured outcomes.

And this study did show that higher levels of PA staffing were associated with lower hospital charges per case. Although the difference was a modest 3%, it was statistically significant (P less than .001). I’m skeptical there is causation here; this more likely is just correlation.

It would be great to see a larger study of this.

Information applications

So does this study support the idea that HMGs can or should increase APC staffing and workload significantly to realize lower hospital cost per case and not harm patient outcomes? Not so fast!

This study only compared two hospitalist groups at one hospital. It’s probably not very generalizable.

And as described in the paper, and stressed by Tim talking with me by phone, the outcomes of their expanded PA model likely have a lot to do with their very careful recruiting and screening of experienced PAs before hiring them, not to mention a lengthy and deliberate on-boarding process (summarized in the article) to support their ability to perform well. Groups that are not as thoughtful and deliberate in how they hire and position APCs to contribute to the practice may not perform as well.
 

Why study only PAs? What about NPs? Tim told me that his group is agnostic regarding the training background of the APCs they hire; he suspects an identical study with NPs rather than PAs in each hospitalist group would probably yield very similar results. I see this the same way. Although there are differences in background and training between NPs and PAs, I think personal traits like years of experience in various health care settings and the ability to work efficiently are more important than training background.
 

A practical approach

Any group who thinks this study is evidence that adding more APCs and having them manage a higher number of patients relatively independently will go well in any setting is mistaken. But it does offer a story of one place where, with careful planning and execution, it went OK.

In my view, the real take-home message is to think carefully to ensure any APCs in your group have professionally satisfying roles that position them to contribute effectively. While common, I think configuring APCs and physicians as rounding dyads often ends up underperforming and not working out well because of inefficiency. When well executed, as is apparently the case in this study, it can be fine. But my experience is that positioning APCs to assume primary responsibility for some clinical activities, such as covering the observation unit or serving as an evening admitter/cross-cover provider (all with appropriate physician collaboration and backup), more reliably turns out well.
 

Reference

Capstack TM, Seguija C, Vollono LM, Moser JD, Meisenberg BR, Michtalik HJ. A comparison of conventional and expanded physician assistant hospitalist staffing models at a community hospital. J Clin Outcomes Manag. 2016;23(10):455-61.
 

Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. Write to him at [email protected].

I’m often asked about effective roles for nurse practitioners (NPs) and physician assistants (PAs), collectively known as advanced practice clinicians (APCs). My first response is always the same: They have much to contribute and can be effective members of hospitalist groups. Most hospital medicine groups (HMGs) should think about having them in their staffing mix if they don’t already.

Yet despite all that NPs/PAs can offer, my experience is that many (even most) hospitalist groups fail to develop roles that optimize their APCs’ skills.

An October 2016 study in the Journal of Clinical Outcomes Management adds additional data to help think about this issue. You may have seen the study mentioned in several news articles and blogs. Most summarized the study along the lines of “using high levels of PA staffing results in lower hospital costs per case.” Framing it this way is awfully misleading, so I’ll go a little deeper here.

Study context

The study, “A Comparison of Conventional and Expanded Physician Assistant Hospitalist Staffing Models at a Community Hospital,” is a retrospective analysis of performance measures from two hospitalist groups at Anne Arundel Medical Center (AAMC) in Annapolis, Md.¹ One HMG is employed by the hospital. The other, called MDICS, is a private company that contracts with AAMC as well as approximately 13 other hospitals and 40 rehabilitation facilities. Tim Capstack, MD, is the AAMC medical director for MDICS and lead author of the study (representing a potential conflict of interest acknowledged in the article). Barry Meisenberg, MD, is a coauthor, a hospitalist in the AAMC-employed group, and chair for quality improvement and health care systems research at AAMC.

Tim told me by phone that both groups have practiced at AAMC for more than 10 years and enjoy a collegial relationship. Both groups employ PAs and pair them with a single physician in a dyad arrangement each day. Tim’s MDICS group, the “expanded PA” group, staffs each day shift with three physicians and three PAs, compared with the nine physicians and two PAs in the hospital-employed “conventional” group. The MDICS PAs are responsible for more patients each day than their conventional-group counterparts and, during the January 2012 to July 2013 study period, averaged 14.2 patients versus 8.3, respectively.

Over the course of the study, PAs in the expanded PA group saw and billed 36% of patient visits independently, compared with 5.9% for the conventional group.
 

Notable study findings

I think the main value of this study is in showing that the expanded PA group had rates of readmission, inpatient mortality, length of stay, and consultant use that weren’t statistically different from the conventional group.

The workloads and years of experience of doctors and PAs in each group were similar. And while there were some differences in the patients each group cared for, they seem unlikely to have a significant influence on outcomes. Clearly, there are many unmeasured variables (e.g., culture, morale, and leadership) in each group that could have influenced the outcomes, so this one study at one hospital doesn’t provide a definitive answer about appropriate APC staffing levels. However, it didn’t uncover big differences in the measured outcomes.

And this study did show that higher levels of PA staffing were associated with lower hospital charges per case. Although the difference was a modest 3%, it was statistically significant (P less than .001). I’m skeptical there is causation here; this more likely is just correlation.

It would be great to see a larger study of this.

Information applications

So does this study support the idea that HMGs can or should increase APC staffing and workload significantly to realize lower hospital cost per case and not harm patient outcomes? Not so fast!

This study only compared two hospitalist groups at one hospital. It’s probably not very generalizable.

And as described in the paper, and stressed by Tim talking with me by phone, the outcomes of their expanded PA model likely have a lot to do with their very careful recruiting and screening of experienced PAs before hiring them, not to mention a lengthy and deliberate on-boarding process (summarized in the article) to support their ability to perform well. Groups that are not as thoughtful and deliberate in how they hire and position APCs to contribute to the practice may not perform as well.
 

Why study only PAs? What about NPs? Tim told me that his group is agnostic regarding the training background of the APCs they hire; he suspects an identical study with NPs rather than PAs in each hospitalist group would probably yield very similar results. I see this the same way. Although there are differences in background and training between NPs and PAs, I think personal traits like years of experience in various health care settings and the ability to work efficiently are more important than training background.
 

A practical approach

Any group who thinks this study is evidence that adding more APCs and having them manage a higher number of patients relatively independently will go well in any setting is mistaken. But it does offer a story of one place where, with careful planning and execution, it went OK.

In my view, the real take-home message is to think carefully to ensure any APCs in your group have professionally satisfying roles that position them to contribute effectively. While common, I think configuring APCs and physicians as rounding dyads often ends up underperforming and not working out well because of inefficiency. When well executed, as is apparently the case in this study, it can be fine. But my experience is that positioning APCs to assume primary responsibility for some clinical activities, such as covering the observation unit or serving as an evening admitter/cross-cover provider (all with appropriate physician collaboration and backup), more reliably turns out well.
 

Reference

Capstack TM, Seguija C, Vollono LM, Moser JD, Meisenberg BR, Michtalik HJ. A comparison of conventional and expanded physician assistant hospitalist staffing models at a community hospital. J Clin Outcomes Manag. 2016;23(10):455-61.
 

Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. Write to him at [email protected].

I’m often asked about effective roles for nurse practitioners (NPs) and physician assistants (PAs), collectively known as advanced practice clinicians (APCs). My first response is always the same: They have much to contribute and can be effective members of hospitalist groups. Most hospital medicine groups (HMGs) should think about having them in their staffing mix if they don’t already.

Yet despite all that NPs/PAs can offer, my experience is that many (even most) hospitalist groups fail to develop roles that optimize their APCs’ skills.

An October 2016 study in the Journal of Clinical Outcomes Management adds additional data to help think about this issue. You may have seen the study mentioned in several news articles and blogs. Most summarized the study along the lines of “using high levels of PA staffing results in lower hospital costs per case.” Framing it this way is awfully misleading, so I’ll go a little deeper here.

Study context

The study, “A Comparison of Conventional and Expanded Physician Assistant Hospitalist Staffing Models at a Community Hospital,” is a retrospective analysis of performance measures from two hospitalist groups at Anne Arundel Medical Center (AAMC) in Annapolis, Md.¹ One HMG is employed by the hospital. The other, called MDICS, is a private company that contracts with AAMC as well as approximately 13 other hospitals and 40 rehabilitation facilities. Tim Capstack, MD, is the AAMC medical director for MDICS and lead author of the study (representing a potential conflict of interest acknowledged in the article). Barry Meisenberg, MD, is a coauthor, a hospitalist in the AAMC-employed group, and chair for quality improvement and health care systems research at AAMC.

Tim told me by phone that both groups have practiced at AAMC for more than 10 years and enjoy a collegial relationship. Both groups employ PAs and pair them with a single physician in a dyad arrangement each day. Tim’s MDICS group, the “expanded PA” group, staffs each day shift with three physicians and three PAs, compared with the nine physicians and two PAs in the hospital-employed “conventional” group. The MDICS PAs are responsible for more patients each day than their conventional-group counterparts and, during the January 2012 to July 2013 study period, averaged 14.2 patients versus 8.3, respectively.

Over the course of the study, PAs in the expanded PA group saw and billed 36% of patient visits independently, compared with 5.9% for the conventional group.
 

Notable study findings

I think the main value of this study is in showing that the expanded PA group had rates of readmission, inpatient mortality, length of stay, and consultant use that weren’t statistically different from the conventional group.

The workloads and years of experience of doctors and PAs in each group were similar. And while there were some differences in the patients each group cared for, they seem unlikely to have a significant influence on outcomes. Clearly, there are many unmeasured variables (e.g., culture, morale, and leadership) in each group that could have influenced the outcomes, so this one study at one hospital doesn’t provide a definitive answer about appropriate APC staffing levels. However, it didn’t uncover big differences in the measured outcomes.

And this study did show that higher levels of PA staffing were associated with lower hospital charges per case. Although the difference was a modest 3%, it was statistically significant (P less than .001). I’m skeptical there is causation here; this more likely is just correlation.

It would be great to see a larger study of this.

Information applications

So does this study support the idea that HMGs can or should increase APC staffing and workload significantly to realize lower hospital cost per case and not harm patient outcomes? Not so fast!

This study only compared two hospitalist groups at one hospital. It’s probably not very generalizable.

And as described in the paper, and stressed by Tim talking with me by phone, the outcomes of their expanded PA model likely have a lot to do with their very careful recruiting and screening of experienced PAs before hiring them, not to mention a lengthy and deliberate on-boarding process (summarized in the article) to support their ability to perform well. Groups that are not as thoughtful and deliberate in how they hire and position APCs to contribute to the practice may not perform as well.
 

Why study only PAs? What about NPs? Tim told me that his group is agnostic regarding the training background of the APCs they hire; he suspects an identical study with NPs rather than PAs in each hospitalist group would probably yield very similar results. I see this the same way. Although there are differences in background and training between NPs and PAs, I think personal traits like years of experience in various health care settings and the ability to work efficiently are more important than training background.
 

A practical approach

Any group who thinks this study is evidence that adding more APCs and having them manage a higher number of patients relatively independently will go well in any setting is mistaken. But it does offer a story of one place where, with careful planning and execution, it went OK.

In my view, the real take-home message is to think carefully to ensure any APCs in your group have professionally satisfying roles that position them to contribute effectively. While common, I think configuring APCs and physicians as rounding dyads often ends up underperforming and not working out well because of inefficiency. When well executed, as is apparently the case in this study, it can be fine. But my experience is that positioning APCs to assume primary responsibility for some clinical activities, such as covering the observation unit or serving as an evening admitter/cross-cover provider (all with appropriate physician collaboration and backup), more reliably turns out well.
 

Reference

Capstack TM, Seguija C, Vollono LM, Moser JD, Meisenberg BR, Michtalik HJ. A comparison of conventional and expanded physician assistant hospitalist staffing models at a community hospital. J Clin Outcomes Manag. 2016;23(10):455-61.
 

Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. Write to him at [email protected].

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While in medical school, I learned about what was then called GRID (gay-related immune deficiency) and we now know as HIV/AIDS. I thought this condition would become so central to practice in nearly any specialty that I decided to try to keep up with all of the literature on it. It wasn’t yet in textbooks, so I thought it would be very important to keep up with all the new research studies and review articles about it.

I kept in my apartment a growing file of articles photocopied and torn out of journals. But I had badly misjudged the enormity of the task, and within a few years, there were far too many articles for me to read or keep up with in any fashion. Before long, HIV medicine became its own specialty, and while it has always been something I, like any hospitalist, need to know something about, I’ve left it to others to be the real HIV experts.

I was naive to have embarked on the quest. What seemed manageable at first became overwhelming very quickly. The same could be said for trying to keep up with new payment models.

New Professional Fee Reimbursement Models

For decades, most physicians could understand the general concept of how their professional activities generated revenue. But it’s gotten a lot more complicated lately.

The growing prevalence of capitation and other managed-care reimbursement models in the ’80s and ’90s might have been when reimbursement complexity began to increase significantly. But while nearly every doctor in the country heard about managed care, for many, it was something happening elsewhere that never made its way to them.

But for hospitalists, I think the arrival of the Physician Quality Reporting System (PQRS, originally Physician Quality Reporting Initiative, or PQRI) marks the swerve in reimbursement complexity. Some years ago I wrote in these pages about the importance of hospitalists understanding PQRS and described key features of the program.

Like HIV/AIDS medicine literature, the breadth and complexity of reimbursement programs from the Centers for Medicare & Medicaid Services (and other payors) seem to have grown logarithmically since PQRS. The still relatively new bundled payment and MACRA-related models are far more complicated than PQRS. And they change often. Calendar milestones come and go with changes in relevant metrics and performance thresholds, etc. Even the terminology changes frequently. Did you know, for example, that under MIPSi “Advancing Care Information” is essentially a new name for EHR Meaningful Use?

Bundled payments and MACRA are only a small portion of new models implemented over the last few years. There are many others, and dedicated effort is required just to keep track of whether each model influences only physicians (and other providers), only hospitals, or both.

Clinicians’ Responsibility for Keeping Up

My thinking about most hospitalists, or doctors in any specialty, keeping up with all of these models has evolved the same way it did with HIV/AIDS. I think it’s pretty clear that it’s folly to expect most clinicians to know more than the broad outlines of these programs.

Payment models are important. Someone needs to know them in detail, but clinicians should reserve brain cells for clinical knowledge base and focus only on the big picture of payment models. Think how well you’ve done learning and keeping up with CPT coding, observation versus inpatient status determinations, and clinical documentation. You probably still aren’t an expert at these things, so is it wise to set about becoming an expert in new payment models?

Instead, most hospitalists should rely on others to keep up with the precise details of these programs. Most commonly that will mean our employer will appoint or hire one or more people, or engage an outside party, to do this.

Don’t Feel Guilty

It’s common to leave a presentation or doctor’s lounge conversation on payment models feeling like you need to study up on the details of this or that payment model since good performance under that model will be important for your paycheck and to remain a viable “player.” And speakers sometimes intentionally or unintentionally enhance your anxiety about this. Maybe they love to show off what they know, and it’s easy for them to think only about their topic and not keep in mind all of the other stuff you need to know.

It’s terrific if someone in your practice is particularly interested in payment models and chooses to stay on top of them. Just make sure that doesn’t come at the expense of keeping up with changes in clinical practice. Most groups won’t have such a person and should rely on others, including SHM, without feeling the smallest bit of guilt.

SHM is advocating on behalf of hospitalists and working diligently to distill the impact MACRA and its various alternative payment frameworks will have on hospital medicine. With webinars, Q&As, and additional online and print resources, SHM will continue to provide digestible updates for hospitalists and their practices.

The End of Small-Group Physician Practice?

While the intent of these programs is to encourage and reward improvements in clinical practice, keeping up with and managing them is a tax that takes resources away from clinical practice. This is an especially difficult burden for small private practices and may prove to be a significant factor in nearly extinguishing them. There are relatively few small private hospitalist groups,ii but all of them should carefully consider how they will keep up with new reimbursement models.

While in medical school, I learned about what was then called GRID (gay-related immune deficiency) and we now know as HIV/AIDS. I thought this condition would become so central to practice in nearly any specialty that I decided to try to keep up with all of the literature on it. It wasn’t yet in textbooks, so I thought it would be very important to keep up with all the new research studies and review articles about it.

I kept in my apartment a growing file of articles photocopied and torn out of journals. But I had badly misjudged the enormity of the task, and within a few years, there were far too many articles for me to read or keep up with in any fashion. Before long, HIV medicine became its own specialty, and while it has always been something I, like any hospitalist, need to know something about, I’ve left it to others to be the real HIV experts.

I was naive to have embarked on the quest. What seemed manageable at first became overwhelming very quickly. The same could be said for trying to keep up with new payment models.

New Professional Fee Reimbursement Models

For decades, most physicians could understand the general concept of how their professional activities generated revenue. But it’s gotten a lot more complicated lately.

The growing prevalence of capitation and other managed-care reimbursement models in the ’80s and ’90s might have been when reimbursement complexity began to increase significantly. But while nearly every doctor in the country heard about managed care, for many, it was something happening elsewhere that never made its way to them.

But for hospitalists, I think the arrival of the Physician Quality Reporting System (PQRS, originally Physician Quality Reporting Initiative, or PQRI) marks the swerve in reimbursement complexity. Some years ago I wrote in these pages about the importance of hospitalists understanding PQRS and described key features of the program.

Like HIV/AIDS medicine literature, the breadth and complexity of reimbursement programs from the Centers for Medicare & Medicaid Services (and other payors) seem to have grown logarithmically since PQRS. The still relatively new bundled payment and MACRA-related models are far more complicated than PQRS. And they change often. Calendar milestones come and go with changes in relevant metrics and performance thresholds, etc. Even the terminology changes frequently. Did you know, for example, that under MIPSi “Advancing Care Information” is essentially a new name for EHR Meaningful Use?

Bundled payments and MACRA are only a small portion of new models implemented over the last few years. There are many others, and dedicated effort is required just to keep track of whether each model influences only physicians (and other providers), only hospitals, or both.

Clinicians’ Responsibility for Keeping Up

My thinking about most hospitalists, or doctors in any specialty, keeping up with all of these models has evolved the same way it did with HIV/AIDS. I think it’s pretty clear that it’s folly to expect most clinicians to know more than the broad outlines of these programs.

Payment models are important. Someone needs to know them in detail, but clinicians should reserve brain cells for clinical knowledge base and focus only on the big picture of payment models. Think how well you’ve done learning and keeping up with CPT coding, observation versus inpatient status determinations, and clinical documentation. You probably still aren’t an expert at these things, so is it wise to set about becoming an expert in new payment models?

Instead, most hospitalists should rely on others to keep up with the precise details of these programs. Most commonly that will mean our employer will appoint or hire one or more people, or engage an outside party, to do this.

Don’t Feel Guilty

It’s common to leave a presentation or doctor’s lounge conversation on payment models feeling like you need to study up on the details of this or that payment model since good performance under that model will be important for your paycheck and to remain a viable “player.” And speakers sometimes intentionally or unintentionally enhance your anxiety about this. Maybe they love to show off what they know, and it’s easy for them to think only about their topic and not keep in mind all of the other stuff you need to know.

It’s terrific if someone in your practice is particularly interested in payment models and chooses to stay on top of them. Just make sure that doesn’t come at the expense of keeping up with changes in clinical practice. Most groups won’t have such a person and should rely on others, including SHM, without feeling the smallest bit of guilt.

SHM is advocating on behalf of hospitalists and working diligently to distill the impact MACRA and its various alternative payment frameworks will have on hospital medicine. With webinars, Q&As, and additional online and print resources, SHM will continue to provide digestible updates for hospitalists and their practices.

The End of Small-Group Physician Practice?

While the intent of these programs is to encourage and reward improvements in clinical practice, keeping up with and managing them is a tax that takes resources away from clinical practice. This is an especially difficult burden for small private practices and may prove to be a significant factor in nearly extinguishing them. There are relatively few small private hospitalist groups,ii but all of them should carefully consider how they will keep up with new reimbursement models.

While in medical school, I learned about what was then called GRID (gay-related immune deficiency) and we now know as HIV/AIDS. I thought this condition would become so central to practice in nearly any specialty that I decided to try to keep up with all of the literature on it. It wasn’t yet in textbooks, so I thought it would be very important to keep up with all the new research studies and review articles about it.

I kept in my apartment a growing file of articles photocopied and torn out of journals. But I had badly misjudged the enormity of the task, and within a few years, there were far too many articles for me to read or keep up with in any fashion. Before long, HIV medicine became its own specialty, and while it has always been something I, like any hospitalist, need to know something about, I’ve left it to others to be the real HIV experts.

I was naive to have embarked on the quest. What seemed manageable at first became overwhelming very quickly. The same could be said for trying to keep up with new payment models.

New Professional Fee Reimbursement Models

For decades, most physicians could understand the general concept of how their professional activities generated revenue. But it’s gotten a lot more complicated lately.

The growing prevalence of capitation and other managed-care reimbursement models in the ’80s and ’90s might have been when reimbursement complexity began to increase significantly. But while nearly every doctor in the country heard about managed care, for many, it was something happening elsewhere that never made its way to them.

But for hospitalists, I think the arrival of the Physician Quality Reporting System (PQRS, originally Physician Quality Reporting Initiative, or PQRI) marks the swerve in reimbursement complexity. Some years ago I wrote in these pages about the importance of hospitalists understanding PQRS and described key features of the program.

Like HIV/AIDS medicine literature, the breadth and complexity of reimbursement programs from the Centers for Medicare & Medicaid Services (and other payors) seem to have grown logarithmically since PQRS. The still relatively new bundled payment and MACRA-related models are far more complicated than PQRS. And they change often. Calendar milestones come and go with changes in relevant metrics and performance thresholds, etc. Even the terminology changes frequently. Did you know, for example, that under MIPSi “Advancing Care Information” is essentially a new name for EHR Meaningful Use?

Bundled payments and MACRA are only a small portion of new models implemented over the last few years. There are many others, and dedicated effort is required just to keep track of whether each model influences only physicians (and other providers), only hospitals, or both.

Clinicians’ Responsibility for Keeping Up

My thinking about most hospitalists, or doctors in any specialty, keeping up with all of these models has evolved the same way it did with HIV/AIDS. I think it’s pretty clear that it’s folly to expect most clinicians to know more than the broad outlines of these programs.

Payment models are important. Someone needs to know them in detail, but clinicians should reserve brain cells for clinical knowledge base and focus only on the big picture of payment models. Think how well you’ve done learning and keeping up with CPT coding, observation versus inpatient status determinations, and clinical documentation. You probably still aren’t an expert at these things, so is it wise to set about becoming an expert in new payment models?

Instead, most hospitalists should rely on others to keep up with the precise details of these programs. Most commonly that will mean our employer will appoint or hire one or more people, or engage an outside party, to do this.

Don’t Feel Guilty

It’s common to leave a presentation or doctor’s lounge conversation on payment models feeling like you need to study up on the details of this or that payment model since good performance under that model will be important for your paycheck and to remain a viable “player.” And speakers sometimes intentionally or unintentionally enhance your anxiety about this. Maybe they love to show off what they know, and it’s easy for them to think only about their topic and not keep in mind all of the other stuff you need to know.

It’s terrific if someone in your practice is particularly interested in payment models and chooses to stay on top of them. Just make sure that doesn’t come at the expense of keeping up with changes in clinical practice. Most groups won’t have such a person and should rely on others, including SHM, without feeling the smallest bit of guilt.

SHM is advocating on behalf of hospitalists and working diligently to distill the impact MACRA and its various alternative payment frameworks will have on hospital medicine. With webinars, Q&As, and additional online and print resources, SHM will continue to provide digestible updates for hospitalists and their practices.

The End of Small-Group Physician Practice?

While the intent of these programs is to encourage and reward improvements in clinical practice, keeping up with and managing them is a tax that takes resources away from clinical practice. This is an especially difficult burden for small private practices and may prove to be a significant factor in nearly extinguishing them. There are relatively few small private hospitalist groups,ii but all of them should carefully consider how they will keep up with new reimbursement models.

Fear of potential pain caused by insertion of an intrauterine device (IUD) prevents some women from using this highly effective and safe contraceptive method. Recently, investigators conducted a randomized, placebo-controlled trial to assess whether vaginal lidocaine gel administered shortly before IUD placement was associated with a decrease from baseline in patient-reported pain scores.¹

In this blinded trial, Rapkinand colleagues randomly assigned nulliparous women presenting for IUD placement (either the copper T380A IUD or the 52-mg levonorgestrel-releasing IUD) at faculty and resident clinics at a US urban academic center to place 4 mL of 2% lidocaine gel or placebo gel vaginally (using an applicator) 5 to 15 minutes prior to IUD placement.¹ A 100-mm visual analog scale (VAS) was used to assess pain at each step of the procedure, including at baseline (before speculum insertion), after speculum placement, tenaculum placement, uterine sound, IUD insertion, and 5 minutes after speculum removal.

Among the 58 evaluable participants, the mean age was 23 years in the lidocaine group and 24 years in the placebo group; more than 80% of the women were white.

The study’s primary outcome was change in pain experience from baseline to IUD insertion. Pain was measured on a VAS from 0 mm (no pain) to 100 mm (worst pain in my life). Secondary outcomes included patient acceptability of gel self-insertion, physician-reported ease of IUD insertion, and need for pain medication for up to 7 days after IUD insertion.

Related article:
Liletta gets a new inserter: Steps for successful placement

What the investigators found

The mean change in pain scores with IUD placement was 61 mm for the lidocaine group and 69 mm for the placebo group (P = .06). Thus, no difference in the primary outcome was found between the 2 groups. However, women who received the lidocaine gel treatment experiencedsignificantly less pain with tenaculum placement than those who received placebo gel (32 mm vs 56 mm; P = .02), and they were substantially less likely to require cervical dilation (3.3% vs 34.5%; P = .002), an often painful procedure.

Related article:
Does the injection of ketorolac prior to IUD placement reduce pain?
 

Patient acceptability and satisfaction. Five minutes after the IUD placement procedure, approximately two-thirds of women in both groups indicated that they experienced an acceptable level of discomfort, and more than three-quarters indicated that they were satisfied with the placement procedure. Fully 67% of the lidocaine group and 68% of the placebo group indicated definitely or probably yes when asked if the level of discomfort they experienced was acceptable, with 27% and 21%, respectively, responding as neutral. When asked if getting the IUD was worth the level of discomfort experienced, 73% of the lidocaine group and 82% of the placebo group responded “yes,” while 23% and 18%, respectively, were unsure.

Pearls for practice

As this study showed, self-administered lidocaine vaginal gel did not alter the primary outcome (pain with IUD placement), but the reduced need for cervical dilation is a promising finding and warrants additional study.

Tip. Interestingly, the placebo-treated women experienced pain intensity with cervical tenaculum placement similar to that associated with IUD placement. This finding illuminates the fact that IUD placement is not the only action that can produce pain. For this reason, I use a finer, single-tooth tenaculum designed for use with sonohysterograms (Goldstein Grasp Cervical Stabilizer).² This instrument appears to cause less pain and bleeding than conventional tenacula.

Related article:
How to identify and localize IUDs on ultrasound
 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Fear of potential pain caused by insertion of an intrauterine device (IUD) prevents some women from using this highly effective and safe contraceptive method. Recently, investigators conducted a randomized, placebo-controlled trial to assess whether vaginal lidocaine gel administered shortly before IUD placement was associated with a decrease from baseline in patient-reported pain scores.¹

In this blinded trial, Rapkinand colleagues randomly assigned nulliparous women presenting for IUD placement (either the copper T380A IUD or the 52-mg levonorgestrel-releasing IUD) at faculty and resident clinics at a US urban academic center to place 4 mL of 2% lidocaine gel or placebo gel vaginally (using an applicator) 5 to 15 minutes prior to IUD placement.¹ A 100-mm visual analog scale (VAS) was used to assess pain at each step of the procedure, including at baseline (before speculum insertion), after speculum placement, tenaculum placement, uterine sound, IUD insertion, and 5 minutes after speculum removal.

Among the 58 evaluable participants, the mean age was 23 years in the lidocaine group and 24 years in the placebo group; more than 80% of the women were white.

The study’s primary outcome was change in pain experience from baseline to IUD insertion. Pain was measured on a VAS from 0 mm (no pain) to 100 mm (worst pain in my life). Secondary outcomes included patient acceptability of gel self-insertion, physician-reported ease of IUD insertion, and need for pain medication for up to 7 days after IUD insertion.

Related article:
Liletta gets a new inserter: Steps for successful placement

What the investigators found

The mean change in pain scores with IUD placement was 61 mm for the lidocaine group and 69 mm for the placebo group (P = .06). Thus, no difference in the primary outcome was found between the 2 groups. However, women who received the lidocaine gel treatment experiencedsignificantly less pain with tenaculum placement than those who received placebo gel (32 mm vs 56 mm; P = .02), and they were substantially less likely to require cervical dilation (3.3% vs 34.5%; P = .002), an often painful procedure.

Related article:
Does the injection of ketorolac prior to IUD placement reduce pain?
 

Patient acceptability and satisfaction. Five minutes after the IUD placement procedure, approximately two-thirds of women in both groups indicated that they experienced an acceptable level of discomfort, and more than three-quarters indicated that they were satisfied with the placement procedure. Fully 67% of the lidocaine group and 68% of the placebo group indicated definitely or probably yes when asked if the level of discomfort they experienced was acceptable, with 27% and 21%, respectively, responding as neutral. When asked if getting the IUD was worth the level of discomfort experienced, 73% of the lidocaine group and 82% of the placebo group responded “yes,” while 23% and 18%, respectively, were unsure.

Pearls for practice

As this study showed, self-administered lidocaine vaginal gel did not alter the primary outcome (pain with IUD placement), but the reduced need for cervical dilation is a promising finding and warrants additional study.

Tip. Interestingly, the placebo-treated women experienced pain intensity with cervical tenaculum placement similar to that associated with IUD placement. This finding illuminates the fact that IUD placement is not the only action that can produce pain. For this reason, I use a finer, single-tooth tenaculum designed for use with sonohysterograms (Goldstein Grasp Cervical Stabilizer).² This instrument appears to cause less pain and bleeding than conventional tenacula.

Related article:
How to identify and localize IUDs on ultrasound
 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Fear of potential pain caused by insertion of an intrauterine device (IUD) prevents some women from using this highly effective and safe contraceptive method. Recently, investigators conducted a randomized, placebo-controlled trial to assess whether vaginal lidocaine gel administered shortly before IUD placement was associated with a decrease from baseline in patient-reported pain scores.¹

In this blinded trial, Rapkinand colleagues randomly assigned nulliparous women presenting for IUD placement (either the copper T380A IUD or the 52-mg levonorgestrel-releasing IUD) at faculty and resident clinics at a US urban academic center to place 4 mL of 2% lidocaine gel or placebo gel vaginally (using an applicator) 5 to 15 minutes prior to IUD placement.¹ A 100-mm visual analog scale (VAS) was used to assess pain at each step of the procedure, including at baseline (before speculum insertion), after speculum placement, tenaculum placement, uterine sound, IUD insertion, and 5 minutes after speculum removal.

Among the 58 evaluable participants, the mean age was 23 years in the lidocaine group and 24 years in the placebo group; more than 80% of the women were white.

The study’s primary outcome was change in pain experience from baseline to IUD insertion. Pain was measured on a VAS from 0 mm (no pain) to 100 mm (worst pain in my life). Secondary outcomes included patient acceptability of gel self-insertion, physician-reported ease of IUD insertion, and need for pain medication for up to 7 days after IUD insertion.

Related article:
Liletta gets a new inserter: Steps for successful placement

What the investigators found

The mean change in pain scores with IUD placement was 61 mm for the lidocaine group and 69 mm for the placebo group (P = .06). Thus, no difference in the primary outcome was found between the 2 groups. However, women who received the lidocaine gel treatment experiencedsignificantly less pain with tenaculum placement than those who received placebo gel (32 mm vs 56 mm; P = .02), and they were substantially less likely to require cervical dilation (3.3% vs 34.5%; P = .002), an often painful procedure.

Related article:
Does the injection of ketorolac prior to IUD placement reduce pain?
 

Patient acceptability and satisfaction. Five minutes after the IUD placement procedure, approximately two-thirds of women in both groups indicated that they experienced an acceptable level of discomfort, and more than three-quarters indicated that they were satisfied with the placement procedure. Fully 67% of the lidocaine group and 68% of the placebo group indicated definitely or probably yes when asked if the level of discomfort they experienced was acceptable, with 27% and 21%, respectively, responding as neutral. When asked if getting the IUD was worth the level of discomfort experienced, 73% of the lidocaine group and 82% of the placebo group responded “yes,” while 23% and 18%, respectively, were unsure.

Pearls for practice

As this study showed, self-administered lidocaine vaginal gel did not alter the primary outcome (pain with IUD placement), but the reduced need for cervical dilation is a promising finding and warrants additional study.

Tip. Interestingly, the placebo-treated women experienced pain intensity with cervical tenaculum placement similar to that associated with IUD placement. This finding illuminates the fact that IUD placement is not the only action that can produce pain. For this reason, I use a finer, single-tooth tenaculum designed for use with sonohysterograms (Goldstein Grasp Cervical Stabilizer).² This instrument appears to cause less pain and bleeding than conventional tenacula.

Related article:
How to identify and localize IUDs on ultrasound
 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

• Visit NAMS

• Visit NAMS

• Visit NAMS

• Visit NAMS

• Visit NAMS

• Visit NAMS

A new single-handed inserter (SHI) for placement of Liletta has been introduced and is currently available (FIGURE 1). Liletta is a levonorgestrel 52-mg intrauterine system (IUS) that is currently approved for 3 years of use as a contraceptive in the United States. The same product in Europe, known as Levosert, is approved for both contraception and the treatment of heavy menstrual bleeding. Liletta, as a branded contraceptive, is being studied through a large Phase 3 clinical trial called ACCESS IUS, which will continue to evaluate the contraceptive efficacy of Liletta for at least 7 years of use.¹ A recent publication from the study showed that the levonorgestrel release rates from Liletta are almost identical to the rates reported for the other levonorgestrel 52-mg IUS on the market (Mirena) through 5 years and supports the continued study of the IUS for at least 7 years.²

Image copyright Medicines360.

Related article:
Benefit of self-administered vaginal lidocaine gel in IUD placement

The initial marketing and distribution of Liletta used a two-handed inserter that allowed for successful placement but required multiple steps. The SHI will make loading and placement of Liletta easier for all clinicians. Features of the new SHI include:

• A double-slider mechanism in which the first slider moves into the second slider during IUS placement, providing a tactile sense for the user during the insertion process
• The ability to reload the inserter if needed before placement
• A firm but bendable tube (that is 2 cm longer than other IUS inserters on the market). This length can be helpful for obese patients or postprocedure placements.
• Depth markings to 12 cm on both sides of the insertion tube.

Related article:
2016 Update on contraception

Liletta is an important and unique product in the US market. For most public sector providers and clinics, Liletta costs only $50, significantly less than other long-acting reversible contraceptives. The price of the IUS is only one aspect of its overall cost, however, as women still need to pay for any office visit or insertion fees. Liletta is unique in its pricing. Sales of Liletta in the private sector support the low price in the public sector. As a health care community, even if we do not directly care for women in public-sector settings, we all can help poor women access affordable, effective contraception. For providers, Liletta is a highly effective and lower-cost alternative to currently available hormonal IUS products.

How to insert Liletta

Insertion can be performed using a no-touch technique. The loading and placement technique outlined below should occur after speculum and tenaculum placement, sounding of the uterus, and vaginal preparation as would be performed for any intrauterine contraceptive insertion. Never force the uterine sound or insertion tube through the cervix; if necessary, stop and dilate the cervical canal. The steps below are the main points for successful Liletta placement; see the full product label for more details.³

Related article:
In which clinical situations can the use of the 52-mg levonorgestrel-releasing IUD (Mirena) and the TCu380A copper-IUD (ParaGard) be extended?

The key steps to remember are firm-gentle-firm

1. Load the device. While pushing forward firmly on the blue slider (with the number 1), load Liletta by pulling down evenly on the threads. The IUS should be laid on a flat surface in the sterile tray to keep the arms parallel to the floor while pulling on the threads. Once loaded, the threads can be pulled up or down to be locked in the cleft. The tip of the IUS will form a hemispheric dome at the top of the insertion tube.
2. Adjust the flange to the measured uterine depth based on sounding using the notch in the tray.
3. Place inserter into the cervix. Apply gentle traction on the tenaculum to align the cervical canal and uterine cavity. While still holding firm forward pressure on the blue slider, place the tube through the cervical canal until the flange is approximately 1.5 to 2 cm from the cervix. (FIGURE 2.) Gently slide the blue slider downward until it is flush with the green slider (with the number 2; FIGURE 3). This step will allow the IUS arms to open in the lower uterine segment; wait 10 to 15 seconds for the arms to fully unfold. By sliding gently, you will feel when to stop moving the slider.
   

   

   Image copyright Medicines360.

   
   

   

   Image copyright Medicines360.

4. Advance the inserter. While holding traction on the tenaculum, advance the inserter to the fundus. You will feel slight resistance when the IUS is at the fundus and the flange should be flush against the cervix.
5. Firmly slide both sliders together downward until a click is heard (FIGURE 4). A green indicator will be visible at the bottom of the handle to show that the threads have been ejected from the cleft.
   

   

   Image copyright Medicines360.

6. Withdraw the inserter from the uterus and cut the threads with blunt tipped scissors approximately 3 cm from the cervical os.

Technique video

Allergan and Medicines360 offer a video demonstrating proper Liletta insertion technique at www.lilettahcp.com. The video includes proper loading of the inserter as well as correct uterine depth measurement and release of Liletta from the inserter. Clinicians are reminded to use aseptic technique during the entire insertion procedure.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

A new single-handed inserter (SHI) for placement of Liletta has been introduced and is currently available (FIGURE 1). Liletta is a levonorgestrel 52-mg intrauterine system (IUS) that is currently approved for 3 years of use as a contraceptive in the United States. The same product in Europe, known as Levosert, is approved for both contraception and the treatment of heavy menstrual bleeding. Liletta, as a branded contraceptive, is being studied through a large Phase 3 clinical trial called ACCESS IUS, which will continue to evaluate the contraceptive efficacy of Liletta for at least 7 years of use.¹ A recent publication from the study showed that the levonorgestrel release rates from Liletta are almost identical to the rates reported for the other levonorgestrel 52-mg IUS on the market (Mirena) through 5 years and supports the continued study of the IUS for at least 7 years.²

Image copyright Medicines360.

Related article:
Benefit of self-administered vaginal lidocaine gel in IUD placement

The initial marketing and distribution of Liletta used a two-handed inserter that allowed for successful placement but required multiple steps. The SHI will make loading and placement of Liletta easier for all clinicians. Features of the new SHI include:

• A double-slider mechanism in which the first slider moves into the second slider during IUS placement, providing a tactile sense for the user during the insertion process
• The ability to reload the inserter if needed before placement
• A firm but bendable tube (that is 2 cm longer than other IUS inserters on the market). This length can be helpful for obese patients or postprocedure placements.
• Depth markings to 12 cm on both sides of the insertion tube.

Related article:
2016 Update on contraception

Liletta is an important and unique product in the US market. For most public sector providers and clinics, Liletta costs only $50, significantly less than other long-acting reversible contraceptives. The price of the IUS is only one aspect of its overall cost, however, as women still need to pay for any office visit or insertion fees. Liletta is unique in its pricing. Sales of Liletta in the private sector support the low price in the public sector. As a health care community, even if we do not directly care for women in public-sector settings, we all can help poor women access affordable, effective contraception. For providers, Liletta is a highly effective and lower-cost alternative to currently available hormonal IUS products.

How to insert Liletta

Insertion can be performed using a no-touch technique. The loading and placement technique outlined below should occur after speculum and tenaculum placement, sounding of the uterus, and vaginal preparation as would be performed for any intrauterine contraceptive insertion. Never force the uterine sound or insertion tube through the cervix; if necessary, stop and dilate the cervical canal. The steps below are the main points for successful Liletta placement; see the full product label for more details.³

Related article:
In which clinical situations can the use of the 52-mg levonorgestrel-releasing IUD (Mirena) and the TCu380A copper-IUD (ParaGard) be extended?

The key steps to remember are firm-gentle-firm

1. Load the device. While pushing forward firmly on the blue slider (with the number 1), load Liletta by pulling down evenly on the threads. The IUS should be laid on a flat surface in the sterile tray to keep the arms parallel to the floor while pulling on the threads. Once loaded, the threads can be pulled up or down to be locked in the cleft. The tip of the IUS will form a hemispheric dome at the top of the insertion tube.
2. Adjust the flange to the measured uterine depth based on sounding using the notch in the tray.
3. Place inserter into the cervix. Apply gentle traction on the tenaculum to align the cervical canal and uterine cavity. While still holding firm forward pressure on the blue slider, place the tube through the cervical canal until the flange is approximately 1.5 to 2 cm from the cervix. (FIGURE 2.) Gently slide the blue slider downward until it is flush with the green slider (with the number 2; FIGURE 3). This step will allow the IUS arms to open in the lower uterine segment; wait 10 to 15 seconds for the arms to fully unfold. By sliding gently, you will feel when to stop moving the slider.
   

   

   Image copyright Medicines360.

   
   

   

   Image copyright Medicines360.

4. Advance the inserter. While holding traction on the tenaculum, advance the inserter to the fundus. You will feel slight resistance when the IUS is at the fundus and the flange should be flush against the cervix.
5. Firmly slide both sliders together downward until a click is heard (FIGURE 4). A green indicator will be visible at the bottom of the handle to show that the threads have been ejected from the cleft.
   

   

   Image copyright Medicines360.

6. Withdraw the inserter from the uterus and cut the threads with blunt tipped scissors approximately 3 cm from the cervical os.

Technique video

Allergan and Medicines360 offer a video demonstrating proper Liletta insertion technique at www.lilettahcp.com. The video includes proper loading of the inserter as well as correct uterine depth measurement and release of Liletta from the inserter. Clinicians are reminded to use aseptic technique during the entire insertion procedure.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

A new single-handed inserter (SHI) for placement of Liletta has been introduced and is currently available (FIGURE 1). Liletta is a levonorgestrel 52-mg intrauterine system (IUS) that is currently approved for 3 years of use as a contraceptive in the United States. The same product in Europe, known as Levosert, is approved for both contraception and the treatment of heavy menstrual bleeding. Liletta, as a branded contraceptive, is being studied through a large Phase 3 clinical trial called ACCESS IUS, which will continue to evaluate the contraceptive efficacy of Liletta for at least 7 years of use.¹ A recent publication from the study showed that the levonorgestrel release rates from Liletta are almost identical to the rates reported for the other levonorgestrel 52-mg IUS on the market (Mirena) through 5 years and supports the continued study of the IUS for at least 7 years.²

Image copyright Medicines360.

Related article:
Benefit of self-administered vaginal lidocaine gel in IUD placement

The initial marketing and distribution of Liletta used a two-handed inserter that allowed for successful placement but required multiple steps. The SHI will make loading and placement of Liletta easier for all clinicians. Features of the new SHI include:

• A double-slider mechanism in which the first slider moves into the second slider during IUS placement, providing a tactile sense for the user during the insertion process
• The ability to reload the inserter if needed before placement
• A firm but bendable tube (that is 2 cm longer than other IUS inserters on the market). This length can be helpful for obese patients or postprocedure placements.
• Depth markings to 12 cm on both sides of the insertion tube.

Related article:
2016 Update on contraception

Liletta is an important and unique product in the US market. For most public sector providers and clinics, Liletta costs only $50, significantly less than other long-acting reversible contraceptives. The price of the IUS is only one aspect of its overall cost, however, as women still need to pay for any office visit or insertion fees. Liletta is unique in its pricing. Sales of Liletta in the private sector support the low price in the public sector. As a health care community, even if we do not directly care for women in public-sector settings, we all can help poor women access affordable, effective contraception. For providers, Liletta is a highly effective and lower-cost alternative to currently available hormonal IUS products.

How to insert Liletta

Insertion can be performed using a no-touch technique. The loading and placement technique outlined below should occur after speculum and tenaculum placement, sounding of the uterus, and vaginal preparation as would be performed for any intrauterine contraceptive insertion. Never force the uterine sound or insertion tube through the cervix; if necessary, stop and dilate the cervical canal. The steps below are the main points for successful Liletta placement; see the full product label for more details.³

Related article:
In which clinical situations can the use of the 52-mg levonorgestrel-releasing IUD (Mirena) and the TCu380A copper-IUD (ParaGard) be extended?

The key steps to remember are firm-gentle-firm

1. Load the device. While pushing forward firmly on the blue slider (with the number 1), load Liletta by pulling down evenly on the threads. The IUS should be laid on a flat surface in the sterile tray to keep the arms parallel to the floor while pulling on the threads. Once loaded, the threads can be pulled up or down to be locked in the cleft. The tip of the IUS will form a hemispheric dome at the top of the insertion tube.
2. Adjust the flange to the measured uterine depth based on sounding using the notch in the tray.
3. Place inserter into the cervix. Apply gentle traction on the tenaculum to align the cervical canal and uterine cavity. While still holding firm forward pressure on the blue slider, place the tube through the cervical canal until the flange is approximately 1.5 to 2 cm from the cervix. (FIGURE 2.) Gently slide the blue slider downward until it is flush with the green slider (with the number 2; FIGURE 3). This step will allow the IUS arms to open in the lower uterine segment; wait 10 to 15 seconds for the arms to fully unfold. By sliding gently, you will feel when to stop moving the slider.
   

   

   Image copyright Medicines360.

   
   

   

   Image copyright Medicines360.

4. Advance the inserter. While holding traction on the tenaculum, advance the inserter to the fundus. You will feel slight resistance when the IUS is at the fundus and the flange should be flush against the cervix.
5. Firmly slide both sliders together downward until a click is heard (FIGURE 4). A green indicator will be visible at the bottom of the handle to show that the threads have been ejected from the cleft.
   

   

   Image copyright Medicines360.

6. Withdraw the inserter from the uterus and cut the threads with blunt tipped scissors approximately 3 cm from the cervical os.

Technique video

Allergan and Medicines360 offer a video demonstrating proper Liletta insertion technique at www.lilettahcp.com. The video includes proper loading of the inserter as well as correct uterine depth measurement and release of Liletta from the inserter. Clinicians are reminded to use aseptic technique during the entire insertion procedure.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

John M. Thorp Jr, MD, McAllister Distinguished Professor, Division Director, General Obstetrics and Gynecology, Vice Chair of Research, Department of Ob-Gyn, University of North Carolina Schools of Medicine and Public Health, Chapel Hill.

Five years ago one of our interns operating with the director of labor and delivery challenged him as to why we were not using evidenced-based surgical techniques for cesarean delivery. Bruised by the formidable (and at times misleading) club of “evidence-based medicine” that is held as sacrosanct by the modern obstetrician, the director responded to the charge by researching a systematic review on abdominal delivery that amalgamated studies of poor quality with precious few trials. He unilaterally decided that we needed an opening in the transparent portion of the drape overlying the incision site so that we might use “evidence” to prevent operative site infection. The end result: No change in the incidence of wound infections, and adhesive drapes that did not adhere well, thereby displacing the effluent of amniotic fluid and blood that are part of a cesarean delivery back into the first assistant’s socks, shoes, and clothing. It was as if the clock had been turned back to my early years as an attending when we had cloth drapes. So much for having an evidence-based protocol. I was thus elated at reading the results of the CORONIS trial.

Details of the study

The CORONIS trial, in which investigators randomly assigned almost 16,000 women from 7 countries (Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan), used a sophisticated factorial design and followed up 13,153 (84%) of the women for 3 years. The investigators tested an array of technical questions about 5 intervention pairs used during abdominal delivery and reported the main outcomes of interest for each intervention, including:

• blunt versus sharp abdominal entry—no evidence of a difference in risk of abdominal hernias (adjusted risk ratio [RR], 0.66; 95% confidence interval [CI], 0.39–1.11)
• exteriorization of the uterus versus intra-abdominal repair—no evidence of a difference in risk of infertility (RR, 0.91; 95% CI, 0.71–1.18) or of ectopic pregnancy (RR, 0.50; CI, 0.15–1.66)
• single- versus double-layer closure of the uterus—no evidence of a difference in maternal death (RR, 0.78; 95% CI, 0.46–1.32) or a composite of pregnancy complications (RR, 1.20; 95% CI, 0.75–1.90)
• closure versus nonclosure of the peritoneum—no evidence of a difference in any outcomes relating to symptoms associated with pelvic adhesions, such as infertility (RR, 0.8; 95% CI, 0.61–1.06)
• chromic catgut versus polyglactin-910 sutures—no evidence of a difference in the main comparisons for adverse pregnancy outcomes in a subsequent pregnancy, such as uterine rupture (RR, 3.05; 95% CI, 0.32–29.29).

Strengths and limitations. The CORONIS trial included a large number of participants and had comprehensive follow-up, a rigorous data collection process, and the participation of many countries. The trial’s participating centers, however, were mostly large referral hospitals with high research interest; adverse outcomes might have been higher in other settings. As well, a lower incidence of subsequent pregnancy among participants limited the study’s power to detect differences in outcomes between the intervention pairs.

Conclusions. None of the alternative techniques produced any real benefits despite syntheses-suggested benefit reported in systematic reviews. Surgeon preference for cesarean delivery techniques likely will continue to guide clinical practice along with economic and institution factors.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

John M. Thorp Jr, MD, McAllister Distinguished Professor, Division Director, General Obstetrics and Gynecology, Vice Chair of Research, Department of Ob-Gyn, University of North Carolina Schools of Medicine and Public Health, Chapel Hill.

Five years ago one of our interns operating with the director of labor and delivery challenged him as to why we were not using evidenced-based surgical techniques for cesarean delivery. Bruised by the formidable (and at times misleading) club of “evidence-based medicine” that is held as sacrosanct by the modern obstetrician, the director responded to the charge by researching a systematic review on abdominal delivery that amalgamated studies of poor quality with precious few trials. He unilaterally decided that we needed an opening in the transparent portion of the drape overlying the incision site so that we might use “evidence” to prevent operative site infection. The end result: No change in the incidence of wound infections, and adhesive drapes that did not adhere well, thereby displacing the effluent of amniotic fluid and blood that are part of a cesarean delivery back into the first assistant’s socks, shoes, and clothing. It was as if the clock had been turned back to my early years as an attending when we had cloth drapes. So much for having an evidence-based protocol. I was thus elated at reading the results of the CORONIS trial.

Details of the study

The CORONIS trial, in which investigators randomly assigned almost 16,000 women from 7 countries (Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan), used a sophisticated factorial design and followed up 13,153 (84%) of the women for 3 years. The investigators tested an array of technical questions about 5 intervention pairs used during abdominal delivery and reported the main outcomes of interest for each intervention, including:

• blunt versus sharp abdominal entry—no evidence of a difference in risk of abdominal hernias (adjusted risk ratio [RR], 0.66; 95% confidence interval [CI], 0.39–1.11)
• exteriorization of the uterus versus intra-abdominal repair—no evidence of a difference in risk of infertility (RR, 0.91; 95% CI, 0.71–1.18) or of ectopic pregnancy (RR, 0.50; CI, 0.15–1.66)
• single- versus double-layer closure of the uterus—no evidence of a difference in maternal death (RR, 0.78; 95% CI, 0.46–1.32) or a composite of pregnancy complications (RR, 1.20; 95% CI, 0.75–1.90)
• closure versus nonclosure of the peritoneum—no evidence of a difference in any outcomes relating to symptoms associated with pelvic adhesions, such as infertility (RR, 0.8; 95% CI, 0.61–1.06)
• chromic catgut versus polyglactin-910 sutures—no evidence of a difference in the main comparisons for adverse pregnancy outcomes in a subsequent pregnancy, such as uterine rupture (RR, 3.05; 95% CI, 0.32–29.29).

Strengths and limitations. The CORONIS trial included a large number of participants and had comprehensive follow-up, a rigorous data collection process, and the participation of many countries. The trial’s participating centers, however, were mostly large referral hospitals with high research interest; adverse outcomes might have been higher in other settings. As well, a lower incidence of subsequent pregnancy among participants limited the study’s power to detect differences in outcomes between the intervention pairs.

Conclusions. None of the alternative techniques produced any real benefits despite syntheses-suggested benefit reported in systematic reviews. Surgeon preference for cesarean delivery techniques likely will continue to guide clinical practice along with economic and institution factors.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

John M. Thorp Jr, MD, McAllister Distinguished Professor, Division Director, General Obstetrics and Gynecology, Vice Chair of Research, Department of Ob-Gyn, University of North Carolina Schools of Medicine and Public Health, Chapel Hill.

Five years ago one of our interns operating with the director of labor and delivery challenged him as to why we were not using evidenced-based surgical techniques for cesarean delivery. Bruised by the formidable (and at times misleading) club of “evidence-based medicine” that is held as sacrosanct by the modern obstetrician, the director responded to the charge by researching a systematic review on abdominal delivery that amalgamated studies of poor quality with precious few trials. He unilaterally decided that we needed an opening in the transparent portion of the drape overlying the incision site so that we might use “evidence” to prevent operative site infection. The end result: No change in the incidence of wound infections, and adhesive drapes that did not adhere well, thereby displacing the effluent of amniotic fluid and blood that are part of a cesarean delivery back into the first assistant’s socks, shoes, and clothing. It was as if the clock had been turned back to my early years as an attending when we had cloth drapes. So much for having an evidence-based protocol. I was thus elated at reading the results of the CORONIS trial.

Details of the study

The CORONIS trial, in which investigators randomly assigned almost 16,000 women from 7 countries (Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan), used a sophisticated factorial design and followed up 13,153 (84%) of the women for 3 years. The investigators tested an array of technical questions about 5 intervention pairs used during abdominal delivery and reported the main outcomes of interest for each intervention, including:

• blunt versus sharp abdominal entry—no evidence of a difference in risk of abdominal hernias (adjusted risk ratio [RR], 0.66; 95% confidence interval [CI], 0.39–1.11)
• exteriorization of the uterus versus intra-abdominal repair—no evidence of a difference in risk of infertility (RR, 0.91; 95% CI, 0.71–1.18) or of ectopic pregnancy (RR, 0.50; CI, 0.15–1.66)
• single- versus double-layer closure of the uterus—no evidence of a difference in maternal death (RR, 0.78; 95% CI, 0.46–1.32) or a composite of pregnancy complications (RR, 1.20; 95% CI, 0.75–1.90)
• closure versus nonclosure of the peritoneum—no evidence of a difference in any outcomes relating to symptoms associated with pelvic adhesions, such as infertility (RR, 0.8; 95% CI, 0.61–1.06)
• chromic catgut versus polyglactin-910 sutures—no evidence of a difference in the main comparisons for adverse pregnancy outcomes in a subsequent pregnancy, such as uterine rupture (RR, 3.05; 95% CI, 0.32–29.29).

Strengths and limitations. The CORONIS trial included a large number of participants and had comprehensive follow-up, a rigorous data collection process, and the participation of many countries. The trial’s participating centers, however, were mostly large referral hospitals with high research interest; adverse outcomes might have been higher in other settings. As well, a lower incidence of subsequent pregnancy among participants limited the study’s power to detect differences in outcomes between the intervention pairs.

Conclusions. None of the alternative techniques produced any real benefits despite syntheses-suggested benefit reported in systematic reviews. Surgeon preference for cesarean delivery techniques likely will continue to guide clinical practice along with economic and institution factors.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.