I believe there is no better field than hospital medicine to find your career path, and there’s no better organization than SHM to support you as you follow that path. My path is probably similar to most, a little unplanned and a little unexpected, but I am sure each member has their story. Hospital medicine made an early impact on me during an internship where I was exposed to physician role models with terrific leadership skills. They were blazing trails by challenging long-held beliefs about the care of hospitalized patients.

The term “hospitalist” had not yet quite penetrated national consciousness, but Dr. Bob Wachter and Dr. Lee Goldman had already started implementing the model at the University of California, San Francisco, where I was privileged to be an intern during an exciting time. There, I learned directly from some of the individuals who would quickly become pioneers in hospital medicine, influencing a generation of physicians by putting definition and structure around the concept of a hospitalist.

During residency, I saw these hospitalists demonstrate key leadership attributes that distinguished from other physicians. They had an appreciation for the team, a collaborative approach, and an ability to understand the complexity of coordinating acute care. They led from the front, not from behind the lines. So it was no wonder that so many of my colleagues gravitated toward this new field.

After residency, my first job was at a community hospital in Marin, Calif., where a new hospitalist program had started just a year or two earlier. The same collaborative skills that created better patient care with nurses, pharmacists, and the medical staff were positively reinforced and recognized. I got married and had my first child, and my path took a turn east to the Cleveland Clinic. Now back in the academic world and after two more children, that path for me turned in highly unexpected ways—as a department chair, then as medical director for data and analytics, then briefly overseeing population health, and now as head of a hospital in the Cleveland Clinic system.

Stories like mine are not at all extraordinary. At HM16 in San Diego, I heard stories of hospitalists ascendant in their organizations, being given incredible responsibilities and a long rope. The day-to-day work we have done as hospitalists has been our training for all these roles. This daily practice demands a level of growth, development, and exposure that no other specialty requires. There is no better environment to learn about leadership, teaching, and complex systems than perhaps the most complex system of all—the hospital. In this environment, we have innumerable opportunities to find, pick, and create our own paths to improve our healthcare system at every level from the bedside to the top of the Centers for Medicare & Medicaid Services (CMS).

Hospital medicine puts so many components and challenges of healthcare in our daily practice: complex team problem-solving; relationships up, down, and across a hierarchy; IT; education; process improvement; ethics; medical staff politics. The successful hospitalist, by definition, has to be able to learn and attain mastery across a broad set of knowledge and skills. We have become naturals in a world of "matrixes management" because it is how we live our lives every day. This is why when our medical staffs and administration come looking for a project leader, a new department chair, a head of patient experience, a leader, or an educator, they come looking for us.

As SHM’s new president, I commit to SHM being the organization that is dedicated to helping you. It’s impossible to see around every corner, but starting in the coming year, I think SHM and hospitalists have to move forward in four key directions:

 

1. Expand and engage SHM’s membership. Although we just reached our 15,000th member, there are 52,000 hospitalists, plus even more when you include advanced practice colleagues, whom we would like to become SHM members under our “big tent.” We want to draw in those hospitalists, show them how, whether it’s through our educational offerings, learning portal, or active involvement in projects and committees, we can engage them at every stage of their career—and ask them what else we can do to help them find their path and be prepared for it.
2. We must continue pushing our members and projects to be focused on patient- and family-centered care. Every project that takes the extra steps of incorporating the thoughts and feelings of our patients and families will get a better result. I would like to see hospitalists everywhere take a strong position to remember that our patients and their families are our partners in their care; We need to lead on the patient experience and patient-centered care front. Two years ago, we launched the Patient Experience Committee to do just that, and it is an important research topic on the minds of the Journal of Hospital Medicine editors. After all, we are all people needing people.
3. We have to move assertively to understand our role in an era of risk. While in many senses we have been managing risk either directly or indirectly for decades, the payment models of care (episodes, bundles, MIPS, ACOs) are evolving quickly, and we must stake out our place in this new risk-sharing world and identify our partners. Hospitalists need to have a clear message about how what we do mitigates risk and adds value. In the coming year, SHM will start to do that.
4. In the coming years, we will need to clarify our position regarding specialty recognition, including our training programs. We already have many key components that we identify with as a specialty. While this is also something contentious and political, when we look at the divergence between what we have to do to be clinically effective (e.g., palliative medicine, ICU care, QI, leadership, etc.) and what our training programs provide for us, that gap appears to be increasing. SHM has stepped up with curriculum to fill these gaps and will continue to do so. However, we must question how best to train physicians for these roles and if the current model is sustainable and suitable.

I am privileged and honored to serve as your new president, and I ask each of you to look at yourselves and the opportunities that your practice provides you with to grow—personally and professionally—and make our system and specialty better. Look to SHM to help you, support you, and provide resources for you to walk your path. TH

---

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 Lerner College of Medicine in Cleveland.

I believe there is no better field than hospital medicine to find your career path, and there’s no better organization than SHM to support you as you follow that path. My path is probably similar to most, a little unplanned and a little unexpected, but I am sure each member has their story. Hospital medicine made an early impact on me during an internship where I was exposed to physician role models with terrific leadership skills. They were blazing trails by challenging long-held beliefs about the care of hospitalized patients.

The term “hospitalist” had not yet quite penetrated national consciousness, but Dr. Bob Wachter and Dr. Lee Goldman had already started implementing the model at the University of California, San Francisco, where I was privileged to be an intern during an exciting time. There, I learned directly from some of the individuals who would quickly become pioneers in hospital medicine, influencing a generation of physicians by putting definition and structure around the concept of a hospitalist.

During residency, I saw these hospitalists demonstrate key leadership attributes that distinguished from other physicians. They had an appreciation for the team, a collaborative approach, and an ability to understand the complexity of coordinating acute care. They led from the front, not from behind the lines. So it was no wonder that so many of my colleagues gravitated toward this new field.

After residency, my first job was at a community hospital in Marin, Calif., where a new hospitalist program had started just a year or two earlier. The same collaborative skills that created better patient care with nurses, pharmacists, and the medical staff were positively reinforced and recognized. I got married and had my first child, and my path took a turn east to the Cleveland Clinic. Now back in the academic world and after two more children, that path for me turned in highly unexpected ways—as a department chair, then as medical director for data and analytics, then briefly overseeing population health, and now as head of a hospital in the Cleveland Clinic system.

Stories like mine are not at all extraordinary. At HM16 in San Diego, I heard stories of hospitalists ascendant in their organizations, being given incredible responsibilities and a long rope. The day-to-day work we have done as hospitalists has been our training for all these roles. This daily practice demands a level of growth, development, and exposure that no other specialty requires. There is no better environment to learn about leadership, teaching, and complex systems than perhaps the most complex system of all—the hospital. In this environment, we have innumerable opportunities to find, pick, and create our own paths to improve our healthcare system at every level from the bedside to the top of the Centers for Medicare & Medicaid Services (CMS).

Hospital medicine puts so many components and challenges of healthcare in our daily practice: complex team problem-solving; relationships up, down, and across a hierarchy; IT; education; process improvement; ethics; medical staff politics. The successful hospitalist, by definition, has to be able to learn and attain mastery across a broad set of knowledge and skills. We have become naturals in a world of "matrixes management" because it is how we live our lives every day. This is why when our medical staffs and administration come looking for a project leader, a new department chair, a head of patient experience, a leader, or an educator, they come looking for us.

As SHM’s new president, I commit to SHM being the organization that is dedicated to helping you. It’s impossible to see around every corner, but starting in the coming year, I think SHM and hospitalists have to move forward in four key directions:

 

1. Expand and engage SHM’s membership. Although we just reached our 15,000th member, there are 52,000 hospitalists, plus even more when you include advanced practice colleagues, whom we would like to become SHM members under our “big tent.” We want to draw in those hospitalists, show them how, whether it’s through our educational offerings, learning portal, or active involvement in projects and committees, we can engage them at every stage of their career—and ask them what else we can do to help them find their path and be prepared for it.
2. We must continue pushing our members and projects to be focused on patient- and family-centered care. Every project that takes the extra steps of incorporating the thoughts and feelings of our patients and families will get a better result. I would like to see hospitalists everywhere take a strong position to remember that our patients and their families are our partners in their care; We need to lead on the patient experience and patient-centered care front. Two years ago, we launched the Patient Experience Committee to do just that, and it is an important research topic on the minds of the Journal of Hospital Medicine editors. After all, we are all people needing people.
3. We have to move assertively to understand our role in an era of risk. While in many senses we have been managing risk either directly or indirectly for decades, the payment models of care (episodes, bundles, MIPS, ACOs) are evolving quickly, and we must stake out our place in this new risk-sharing world and identify our partners. Hospitalists need to have a clear message about how what we do mitigates risk and adds value. In the coming year, SHM will start to do that.
4. In the coming years, we will need to clarify our position regarding specialty recognition, including our training programs. We already have many key components that we identify with as a specialty. While this is also something contentious and political, when we look at the divergence between what we have to do to be clinically effective (e.g., palliative medicine, ICU care, QI, leadership, etc.) and what our training programs provide for us, that gap appears to be increasing. SHM has stepped up with curriculum to fill these gaps and will continue to do so. However, we must question how best to train physicians for these roles and if the current model is sustainable and suitable.

I am privileged and honored to serve as your new president, and I ask each of you to look at yourselves and the opportunities that your practice provides you with to grow—personally and professionally—and make our system and specialty better. Look to SHM to help you, support you, and provide resources for you to walk your path. TH

---

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 Lerner College of Medicine in Cleveland.

I believe there is no better field than hospital medicine to find your career path, and there’s no better organization than SHM to support you as you follow that path. My path is probably similar to most, a little unplanned and a little unexpected, but I am sure each member has their story. Hospital medicine made an early impact on me during an internship where I was exposed to physician role models with terrific leadership skills. They were blazing trails by challenging long-held beliefs about the care of hospitalized patients.

The term “hospitalist” had not yet quite penetrated national consciousness, but Dr. Bob Wachter and Dr. Lee Goldman had already started implementing the model at the University of California, San Francisco, where I was privileged to be an intern during an exciting time. There, I learned directly from some of the individuals who would quickly become pioneers in hospital medicine, influencing a generation of physicians by putting definition and structure around the concept of a hospitalist.

During residency, I saw these hospitalists demonstrate key leadership attributes that distinguished from other physicians. They had an appreciation for the team, a collaborative approach, and an ability to understand the complexity of coordinating acute care. They led from the front, not from behind the lines. So it was no wonder that so many of my colleagues gravitated toward this new field.

After residency, my first job was at a community hospital in Marin, Calif., where a new hospitalist program had started just a year or two earlier. The same collaborative skills that created better patient care with nurses, pharmacists, and the medical staff were positively reinforced and recognized. I got married and had my first child, and my path took a turn east to the Cleveland Clinic. Now back in the academic world and after two more children, that path for me turned in highly unexpected ways—as a department chair, then as medical director for data and analytics, then briefly overseeing population health, and now as head of a hospital in the Cleveland Clinic system.

Stories like mine are not at all extraordinary. At HM16 in San Diego, I heard stories of hospitalists ascendant in their organizations, being given incredible responsibilities and a long rope. The day-to-day work we have done as hospitalists has been our training for all these roles. This daily practice demands a level of growth, development, and exposure that no other specialty requires. There is no better environment to learn about leadership, teaching, and complex systems than perhaps the most complex system of all—the hospital. In this environment, we have innumerable opportunities to find, pick, and create our own paths to improve our healthcare system at every level from the bedside to the top of the Centers for Medicare & Medicaid Services (CMS).

Hospital medicine puts so many components and challenges of healthcare in our daily practice: complex team problem-solving; relationships up, down, and across a hierarchy; IT; education; process improvement; ethics; medical staff politics. The successful hospitalist, by definition, has to be able to learn and attain mastery across a broad set of knowledge and skills. We have become naturals in a world of "matrixes management" because it is how we live our lives every day. This is why when our medical staffs and administration come looking for a project leader, a new department chair, a head of patient experience, a leader, or an educator, they come looking for us.

As SHM’s new president, I commit to SHM being the organization that is dedicated to helping you. It’s impossible to see around every corner, but starting in the coming year, I think SHM and hospitalists have to move forward in four key directions:

 

1. Expand and engage SHM’s membership. Although we just reached our 15,000th member, there are 52,000 hospitalists, plus even more when you include advanced practice colleagues, whom we would like to become SHM members under our “big tent.” We want to draw in those hospitalists, show them how, whether it’s through our educational offerings, learning portal, or active involvement in projects and committees, we can engage them at every stage of their career—and ask them what else we can do to help them find their path and be prepared for it.
2. We must continue pushing our members and projects to be focused on patient- and family-centered care. Every project that takes the extra steps of incorporating the thoughts and feelings of our patients and families will get a better result. I would like to see hospitalists everywhere take a strong position to remember that our patients and their families are our partners in their care; We need to lead on the patient experience and patient-centered care front. Two years ago, we launched the Patient Experience Committee to do just that, and it is an important research topic on the minds of the Journal of Hospital Medicine editors. After all, we are all people needing people.
3. We have to move assertively to understand our role in an era of risk. While in many senses we have been managing risk either directly or indirectly for decades, the payment models of care (episodes, bundles, MIPS, ACOs) are evolving quickly, and we must stake out our place in this new risk-sharing world and identify our partners. Hospitalists need to have a clear message about how what we do mitigates risk and adds value. In the coming year, SHM will start to do that.
4. In the coming years, we will need to clarify our position regarding specialty recognition, including our training programs. We already have many key components that we identify with as a specialty. While this is also something contentious and political, when we look at the divergence between what we have to do to be clinically effective (e.g., palliative medicine, ICU care, QI, leadership, etc.) and what our training programs provide for us, that gap appears to be increasing. SHM has stepped up with curriculum to fill these gaps and will continue to do so. However, we must question how best to train physicians for these roles and if the current model is sustainable and suitable.

I am privileged and honored to serve as your new president, and I ask each of you to look at yourselves and the opportunities that your practice provides you with to grow—personally and professionally—and make our system and specialty better. Look to SHM to help you, support you, and provide resources for you to walk your path. TH

---

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 Lerner College of Medicine in Cleveland.

The National Institutes of Health (NIH) has suspended production in 2 of its facilities—a National Cancer Institute (NCI) laboratory engaged in the production of cell therapies and a National Institute of Mental Health facility producing positron emission tomography (PET) materials.

Last year, an inspection by the US Food and Drug Administration revealed problems with facilities, equipment, procedures, and training in the NIH Clinical Center Pharmaceutical Development Section (PDS), which is responsible for managing investigational drugs.

So the NIH closed the sterile production unit of the PDS and hired 2 companies specializing in quality assurance for manufacturing and compounding—Working Buildings and Clinical IQ—to evaluate all NIH facilities producing sterile or infused products for administration to research participants.

This review is still underway, and preliminary findings have identified facilities not in compliance with quality and safety standards, and not suitable for the production of sterile or infused products.

As a result, the NIH suspended production in the aforementioned facilities manufacturing cell therapy and PET materials.

The NIH said there is no evidence that any patients have been harmed, but a rigorous clinical review will be conducted. And the NIH will not enroll new patients in affected trials until the issues are resolved.

The NCI facility produces cell therapies in cooperation with Kite Pharma, Inc. The company and the NCI are advancing multiple clinical trials under Cooperative Research and Development Agreements for the treatment of hematologic malignancies and solid tumors.

Patients currently enrolled in ongoing NCI trials of cell therapy will continue to receive treatment, but no new patients will be enrolled until the review is complete.

And Kite Pharma said its 4 trials of the chimeric antigen receptor T-cell therapy KTE-C19 will continue. This includes:

ZUMA-1—KTE-C19 in patients with refractory, aggressive non-Hodgkin lymphoma

ZUMA-2—KTE-C19 in patients with relapsed/refractory mantle cell lymphoma

ZUMA-3—KTE-C19 in adults with relapsed/refractory B-precursor acute lymphoblastic leukemia

ZUMA-4—KTE-C19 in pediatric and adolescent patients with relapsed/refractory B-precursor acute lymphoblastic leukemia.

The company stressed that the review of the NCI’s manufacturing facilities is not related to KTE-C19 or Kite’s manufacturing capabilities.

The National Institutes of Health (NIH) has suspended production in 2 of its facilities—a National Cancer Institute (NCI) laboratory engaged in the production of cell therapies and a National Institute of Mental Health facility producing positron emission tomography (PET) materials.

Last year, an inspection by the US Food and Drug Administration revealed problems with facilities, equipment, procedures, and training in the NIH Clinical Center Pharmaceutical Development Section (PDS), which is responsible for managing investigational drugs.

So the NIH closed the sterile production unit of the PDS and hired 2 companies specializing in quality assurance for manufacturing and compounding—Working Buildings and Clinical IQ—to evaluate all NIH facilities producing sterile or infused products for administration to research participants.

This review is still underway, and preliminary findings have identified facilities not in compliance with quality and safety standards, and not suitable for the production of sterile or infused products.

As a result, the NIH suspended production in the aforementioned facilities manufacturing cell therapy and PET materials.

The NIH said there is no evidence that any patients have been harmed, but a rigorous clinical review will be conducted. And the NIH will not enroll new patients in affected trials until the issues are resolved.

The NCI facility produces cell therapies in cooperation with Kite Pharma, Inc. The company and the NCI are advancing multiple clinical trials under Cooperative Research and Development Agreements for the treatment of hematologic malignancies and solid tumors.

Patients currently enrolled in ongoing NCI trials of cell therapy will continue to receive treatment, but no new patients will be enrolled until the review is complete.

And Kite Pharma said its 4 trials of the chimeric antigen receptor T-cell therapy KTE-C19 will continue. This includes:

ZUMA-1—KTE-C19 in patients with refractory, aggressive non-Hodgkin lymphoma

ZUMA-2—KTE-C19 in patients with relapsed/refractory mantle cell lymphoma

ZUMA-3—KTE-C19 in adults with relapsed/refractory B-precursor acute lymphoblastic leukemia

ZUMA-4—KTE-C19 in pediatric and adolescent patients with relapsed/refractory B-precursor acute lymphoblastic leukemia.

The company stressed that the review of the NCI’s manufacturing facilities is not related to KTE-C19 or Kite’s manufacturing capabilities.

The National Institutes of Health (NIH) has suspended production in 2 of its facilities—a National Cancer Institute (NCI) laboratory engaged in the production of cell therapies and a National Institute of Mental Health facility producing positron emission tomography (PET) materials.

Last year, an inspection by the US Food and Drug Administration revealed problems with facilities, equipment, procedures, and training in the NIH Clinical Center Pharmaceutical Development Section (PDS), which is responsible for managing investigational drugs.

So the NIH closed the sterile production unit of the PDS and hired 2 companies specializing in quality assurance for manufacturing and compounding—Working Buildings and Clinical IQ—to evaluate all NIH facilities producing sterile or infused products for administration to research participants.

This review is still underway, and preliminary findings have identified facilities not in compliance with quality and safety standards, and not suitable for the production of sterile or infused products.

As a result, the NIH suspended production in the aforementioned facilities manufacturing cell therapy and PET materials.

The NIH said there is no evidence that any patients have been harmed, but a rigorous clinical review will be conducted. And the NIH will not enroll new patients in affected trials until the issues are resolved.

The NCI facility produces cell therapies in cooperation with Kite Pharma, Inc. The company and the NCI are advancing multiple clinical trials under Cooperative Research and Development Agreements for the treatment of hematologic malignancies and solid tumors.

Patients currently enrolled in ongoing NCI trials of cell therapy will continue to receive treatment, but no new patients will be enrolled until the review is complete.

And Kite Pharma said its 4 trials of the chimeric antigen receptor T-cell therapy KTE-C19 will continue. This includes:

ZUMA-1—KTE-C19 in patients with refractory, aggressive non-Hodgkin lymphoma

ZUMA-2—KTE-C19 in patients with relapsed/refractory mantle cell lymphoma

ZUMA-3—KTE-C19 in adults with relapsed/refractory B-precursor acute lymphoblastic leukemia

ZUMA-4—KTE-C19 in pediatric and adolescent patients with relapsed/refractory B-precursor acute lymphoblastic leukemia.

The company stressed that the review of the NCI’s manufacturing facilities is not related to KTE-C19 or Kite’s manufacturing capabilities.

BALTIMORE – Hemithyroidectomy for low-risk micropapillary thyroid cancer can have advantages over active surveillance, according to findings from a study that examined outcomes by cost and quality of life data.

Endocrinologists and surgeons need to have in-depth conversations with their patients to determine their level of anxiety about cancer, surgery, and about their quality of life, to determine the best course of treatment, researchers at the University of California, San Francisco (UCSF) reported at the annual meeting of the American Association of Endocrine Surgeons.

“Our study found that hemithyroidectomy is cost effective in the majority of scenarios,” presenter Shriya Venkatesh said. “However, patient perception of micropapillary thyroid cancer as well as [the patient’s] life expectancy can play a major role in deciding which therapeutic option to choose.”

The study involved a cost-effectiveness analysis of the surgery vs. active surveillance, “which is especially relevant in our current times,” Ms. Venkatesh said in an interview. “What we wanted to do is give physicians information for when they approach their patients, not only in assessing the tumor from the medical aspect but also when looking at it from quality-of-life and cost-benefit perspectives.”

Both courses of management were modeled over a 20-year period with Medicare data and literature review to calculate costs and health utilities. The UCSF researchers used Markov statistical models for both approaches in which the reference case was a 40-year-old, otherwise healthy patient with a recent diagnosis of micropapillary thyroid cancer without high-risk factors. Either hemithyroidectomy or surveillance would be reasonable treatment options.

“We found that hemithyroidectomy was about $8,000 more costly than active surveillance, but it also afforded an increase in about 1.09 quality-adjusted life years,” Ms. Venkatesh said. Hemithyroidectomy is most cost effective for patients with a life expectancy of 3 years or more and who perceive that living with low-grade thyroid cancer would have even a modest detriment on their quality of life, she said.

“Unfortunately there is no current published quality-of-life assessment of active surveillance for thyroid cancer,” Ms. Venkatesh said. “We believe that estimating active surveillance to the equivalent of surgery underestimates the anxiety some patients may feel upon receiving their diagnosis.”

The paucity of literature on active surveillance for thyroid cancer prompted the UCSF researchers to turn to the prostate cancer literature, which has more data on active surveillance, to try to determine the disutility of active surveillance for micropapillary thyroid cancer. “Our extrapolation from the literature yields a mean disutility of 0.11,” she said.

However, the utility estimates the researchers came up with were variable, Ms. Venkatesh said. “This really pushes physicians to have that conversation with their patients, not only about the physical aspects of how they’re doing but also the mental aspects,” she said.

But quality of life is difficult to quantify, senior author Dr. Insoo Suh said in an interview. “What we found is that no matter how one measures quality of life, the qualitative degree of quality of life decrease that people associate with ‘living with cancer’ need not be that significant in order for surgery to be a potentially cost-effective treatment for them,” said Dr. Suh, an endocrine surgeon at UCSF and an ACS Fellow.

During the discussion, Dr. Peter Angelos of the University of Chicago and an ACS Fellow, said, “I’m curious how this information should impact the individual decision-making and informed consent for a specific patient, because I’m not sure that an individual patient would care if active surveillance is more cost effective or not.”

“When speaking to your patients, obviously discussing the rates of progression of the disease is important and then [so is] talking to them about different therapeutic options,” Ms. Venkatesh said. “The physician should also make an assessment about the patient’s quality of life to see if there are likely to be any changes due to the diagnosis.”

The limitations of the study include the extrapolation of data from the prostate cancer literature to define a utility scale and also the reference case used in the Markov model. Other utility measures showed variability as well.

Ms. Venkatesh, Dr. Suh and their coauthors had no financial relationships to disclose.

BALTIMORE – Hemithyroidectomy for low-risk micropapillary thyroid cancer can have advantages over active surveillance, according to findings from a study that examined outcomes by cost and quality of life data.

Endocrinologists and surgeons need to have in-depth conversations with their patients to determine their level of anxiety about cancer, surgery, and about their quality of life, to determine the best course of treatment, researchers at the University of California, San Francisco (UCSF) reported at the annual meeting of the American Association of Endocrine Surgeons.

“Our study found that hemithyroidectomy is cost effective in the majority of scenarios,” presenter Shriya Venkatesh said. “However, patient perception of micropapillary thyroid cancer as well as [the patient’s] life expectancy can play a major role in deciding which therapeutic option to choose.”

The study involved a cost-effectiveness analysis of the surgery vs. active surveillance, “which is especially relevant in our current times,” Ms. Venkatesh said in an interview. “What we wanted to do is give physicians information for when they approach their patients, not only in assessing the tumor from the medical aspect but also when looking at it from quality-of-life and cost-benefit perspectives.”

Both courses of management were modeled over a 20-year period with Medicare data and literature review to calculate costs and health utilities. The UCSF researchers used Markov statistical models for both approaches in which the reference case was a 40-year-old, otherwise healthy patient with a recent diagnosis of micropapillary thyroid cancer without high-risk factors. Either hemithyroidectomy or surveillance would be reasonable treatment options.

“We found that hemithyroidectomy was about $8,000 more costly than active surveillance, but it also afforded an increase in about 1.09 quality-adjusted life years,” Ms. Venkatesh said. Hemithyroidectomy is most cost effective for patients with a life expectancy of 3 years or more and who perceive that living with low-grade thyroid cancer would have even a modest detriment on their quality of life, she said.

“Unfortunately there is no current published quality-of-life assessment of active surveillance for thyroid cancer,” Ms. Venkatesh said. “We believe that estimating active surveillance to the equivalent of surgery underestimates the anxiety some patients may feel upon receiving their diagnosis.”

The paucity of literature on active surveillance for thyroid cancer prompted the UCSF researchers to turn to the prostate cancer literature, which has more data on active surveillance, to try to determine the disutility of active surveillance for micropapillary thyroid cancer. “Our extrapolation from the literature yields a mean disutility of 0.11,” she said.

However, the utility estimates the researchers came up with were variable, Ms. Venkatesh said. “This really pushes physicians to have that conversation with their patients, not only about the physical aspects of how they’re doing but also the mental aspects,” she said.

But quality of life is difficult to quantify, senior author Dr. Insoo Suh said in an interview. “What we found is that no matter how one measures quality of life, the qualitative degree of quality of life decrease that people associate with ‘living with cancer’ need not be that significant in order for surgery to be a potentially cost-effective treatment for them,” said Dr. Suh, an endocrine surgeon at UCSF and an ACS Fellow.

During the discussion, Dr. Peter Angelos of the University of Chicago and an ACS Fellow, said, “I’m curious how this information should impact the individual decision-making and informed consent for a specific patient, because I’m not sure that an individual patient would care if active surveillance is more cost effective or not.”

“When speaking to your patients, obviously discussing the rates of progression of the disease is important and then [so is] talking to them about different therapeutic options,” Ms. Venkatesh said. “The physician should also make an assessment about the patient’s quality of life to see if there are likely to be any changes due to the diagnosis.”

The limitations of the study include the extrapolation of data from the prostate cancer literature to define a utility scale and also the reference case used in the Markov model. Other utility measures showed variability as well.

Ms. Venkatesh, Dr. Suh and their coauthors had no financial relationships to disclose.

BALTIMORE – Hemithyroidectomy for low-risk micropapillary thyroid cancer can have advantages over active surveillance, according to findings from a study that examined outcomes by cost and quality of life data.

Endocrinologists and surgeons need to have in-depth conversations with their patients to determine their level of anxiety about cancer, surgery, and about their quality of life, to determine the best course of treatment, researchers at the University of California, San Francisco (UCSF) reported at the annual meeting of the American Association of Endocrine Surgeons.

“Our study found that hemithyroidectomy is cost effective in the majority of scenarios,” presenter Shriya Venkatesh said. “However, patient perception of micropapillary thyroid cancer as well as [the patient’s] life expectancy can play a major role in deciding which therapeutic option to choose.”

The study involved a cost-effectiveness analysis of the surgery vs. active surveillance, “which is especially relevant in our current times,” Ms. Venkatesh said in an interview. “What we wanted to do is give physicians information for when they approach their patients, not only in assessing the tumor from the medical aspect but also when looking at it from quality-of-life and cost-benefit perspectives.”

Both courses of management were modeled over a 20-year period with Medicare data and literature review to calculate costs and health utilities. The UCSF researchers used Markov statistical models for both approaches in which the reference case was a 40-year-old, otherwise healthy patient with a recent diagnosis of micropapillary thyroid cancer without high-risk factors. Either hemithyroidectomy or surveillance would be reasonable treatment options.

“We found that hemithyroidectomy was about $8,000 more costly than active surveillance, but it also afforded an increase in about 1.09 quality-adjusted life years,” Ms. Venkatesh said. Hemithyroidectomy is most cost effective for patients with a life expectancy of 3 years or more and who perceive that living with low-grade thyroid cancer would have even a modest detriment on their quality of life, she said.

“Unfortunately there is no current published quality-of-life assessment of active surveillance for thyroid cancer,” Ms. Venkatesh said. “We believe that estimating active surveillance to the equivalent of surgery underestimates the anxiety some patients may feel upon receiving their diagnosis.”

The paucity of literature on active surveillance for thyroid cancer prompted the UCSF researchers to turn to the prostate cancer literature, which has more data on active surveillance, to try to determine the disutility of active surveillance for micropapillary thyroid cancer. “Our extrapolation from the literature yields a mean disutility of 0.11,” she said.

However, the utility estimates the researchers came up with were variable, Ms. Venkatesh said. “This really pushes physicians to have that conversation with their patients, not only about the physical aspects of how they’re doing but also the mental aspects,” she said.

But quality of life is difficult to quantify, senior author Dr. Insoo Suh said in an interview. “What we found is that no matter how one measures quality of life, the qualitative degree of quality of life decrease that people associate with ‘living with cancer’ need not be that significant in order for surgery to be a potentially cost-effective treatment for them,” said Dr. Suh, an endocrine surgeon at UCSF and an ACS Fellow.

During the discussion, Dr. Peter Angelos of the University of Chicago and an ACS Fellow, said, “I’m curious how this information should impact the individual decision-making and informed consent for a specific patient, because I’m not sure that an individual patient would care if active surveillance is more cost effective or not.”

“When speaking to your patients, obviously discussing the rates of progression of the disease is important and then [so is] talking to them about different therapeutic options,” Ms. Venkatesh said. “The physician should also make an assessment about the patient’s quality of life to see if there are likely to be any changes due to the diagnosis.”

The limitations of the study include the extrapolation of data from the prostate cancer literature to define a utility scale and also the reference case used in the Markov model. Other utility measures showed variability as well.

Ms. Venkatesh, Dr. Suh and their coauthors had no financial relationships to disclose.

BALTIMORE – Patients who have had parathyroidectomy for primary hyperparathyroidism can have disease recurrence 10 years or longer after surgery, raising the possibility that postop follow-up should never end, according to a study presented at the annual meeting of the American Association of Endocrine Surgeons.

Dr. Irene Lou of the University of Wisconsin–Madison reported on results of a retrospective study of 196 patients who had a presumably “curative” parathyroidectomy at the institution between November 2000 and June 2005. The mean age of the study population was 61 years.

“The long-term recurrences of primary hyperparathyroidism after curative parathyroidectomy is likely higher than previously reported, with over a third of recurrences occurring 10 years after their operation,” Dr. Lou said.

The study also identified independent predictors of recurrence, among them younger age, a drop in intraoperative parathyroid hormone less than 70%, and double adenoma, Dr. Lou said. All patients after parathyroidectomy should have at minimum an annual serum calcium test, especially younger patients with longer life expectancies, she said. This recommendation, however, may be altered for older patients or those with additional comorbidities.

The study defined recurrence as serum calcium of 10.2 mg/dL or greater 6 months or longer after the initial operation. The overall 10-year recurrence rate was 14.8% and the median time to recurrence was 6.3 years. “We found that 41.4% of patients who recurred did so by 5 years and 65.5% by 10 years,” Dr. Lou said.

The University of Wisconsin and University of Alabama at Birmingham investigators undertook the study because the recent data on recurrence was limited, with the longest study topping out at 7 years, Dr. Lou said. “We previously looked at this problem in other perspectives and we found that a lot of curves separated at around 8 years,” she said.

With regard to the type of operation the patients had, whether unilateral minimally invasive parathyroidectomy or bilateral open surgery, the study found no significant differences in recurrence rates, Dr. Lou said. “This is an excellent study,” Dr. Samuel K. Snyder of Temple, Tex., said during the discussion. “You’re telling us we need to follow patients much longer than perhaps we did previously, but we all see patients who have normal calcium and still have a residual elevated parathyroid hormone level.” He asked if the study considered parathyroid hormone levels at 6 months or more after surgery or vitamin D levels, but Dr. Lou said this information was not available, therefore could not be evaluated.

Dr. Lou and her coauthors had no financial relationships to disclose.

BALTIMORE – Patients who have had parathyroidectomy for primary hyperparathyroidism can have disease recurrence 10 years or longer after surgery, raising the possibility that postop follow-up should never end, according to a study presented at the annual meeting of the American Association of Endocrine Surgeons.

Dr. Irene Lou of the University of Wisconsin–Madison reported on results of a retrospective study of 196 patients who had a presumably “curative” parathyroidectomy at the institution between November 2000 and June 2005. The mean age of the study population was 61 years.

“The long-term recurrences of primary hyperparathyroidism after curative parathyroidectomy is likely higher than previously reported, with over a third of recurrences occurring 10 years after their operation,” Dr. Lou said.

The study also identified independent predictors of recurrence, among them younger age, a drop in intraoperative parathyroid hormone less than 70%, and double adenoma, Dr. Lou said. All patients after parathyroidectomy should have at minimum an annual serum calcium test, especially younger patients with longer life expectancies, she said. This recommendation, however, may be altered for older patients or those with additional comorbidities.

The study defined recurrence as serum calcium of 10.2 mg/dL or greater 6 months or longer after the initial operation. The overall 10-year recurrence rate was 14.8% and the median time to recurrence was 6.3 years. “We found that 41.4% of patients who recurred did so by 5 years and 65.5% by 10 years,” Dr. Lou said.

The University of Wisconsin and University of Alabama at Birmingham investigators undertook the study because the recent data on recurrence was limited, with the longest study topping out at 7 years, Dr. Lou said. “We previously looked at this problem in other perspectives and we found that a lot of curves separated at around 8 years,” she said.

With regard to the type of operation the patients had, whether unilateral minimally invasive parathyroidectomy or bilateral open surgery, the study found no significant differences in recurrence rates, Dr. Lou said. “This is an excellent study,” Dr. Samuel K. Snyder of Temple, Tex., said during the discussion. “You’re telling us we need to follow patients much longer than perhaps we did previously, but we all see patients who have normal calcium and still have a residual elevated parathyroid hormone level.” He asked if the study considered parathyroid hormone levels at 6 months or more after surgery or vitamin D levels, but Dr. Lou said this information was not available, therefore could not be evaluated.

Dr. Lou and her coauthors had no financial relationships to disclose.

BALTIMORE – Patients who have had parathyroidectomy for primary hyperparathyroidism can have disease recurrence 10 years or longer after surgery, raising the possibility that postop follow-up should never end, according to a study presented at the annual meeting of the American Association of Endocrine Surgeons.

Dr. Irene Lou of the University of Wisconsin–Madison reported on results of a retrospective study of 196 patients who had a presumably “curative” parathyroidectomy at the institution between November 2000 and June 2005. The mean age of the study population was 61 years.

“The long-term recurrences of primary hyperparathyroidism after curative parathyroidectomy is likely higher than previously reported, with over a third of recurrences occurring 10 years after their operation,” Dr. Lou said.

The study also identified independent predictors of recurrence, among them younger age, a drop in intraoperative parathyroid hormone less than 70%, and double adenoma, Dr. Lou said. All patients after parathyroidectomy should have at minimum an annual serum calcium test, especially younger patients with longer life expectancies, she said. This recommendation, however, may be altered for older patients or those with additional comorbidities.

The study defined recurrence as serum calcium of 10.2 mg/dL or greater 6 months or longer after the initial operation. The overall 10-year recurrence rate was 14.8% and the median time to recurrence was 6.3 years. “We found that 41.4% of patients who recurred did so by 5 years and 65.5% by 10 years,” Dr. Lou said.

The University of Wisconsin and University of Alabama at Birmingham investigators undertook the study because the recent data on recurrence was limited, with the longest study topping out at 7 years, Dr. Lou said. “We previously looked at this problem in other perspectives and we found that a lot of curves separated at around 8 years,” she said.

With regard to the type of operation the patients had, whether unilateral minimally invasive parathyroidectomy or bilateral open surgery, the study found no significant differences in recurrence rates, Dr. Lou said. “This is an excellent study,” Dr. Samuel K. Snyder of Temple, Tex., said during the discussion. “You’re telling us we need to follow patients much longer than perhaps we did previously, but we all see patients who have normal calcium and still have a residual elevated parathyroid hormone level.” He asked if the study considered parathyroid hormone levels at 6 months or more after surgery or vitamin D levels, but Dr. Lou said this information was not available, therefore could not be evaluated.

Dr. Lou and her coauthors had no financial relationships to disclose.

Extubated patients who either received noninvasive ventilation (NIV) therapy or high-flow nasal cannula oxygen had a lower risk of reintubation, compared with extubated patients who received some form of standard oxygen therapy, according to the results of two multicenter, randomized clinical trials published online in JAMA.

Participants in one of the studies, which included abdominal surgery patients diagnosed with respiratory failure within 7 days following surgery, either received NIV or standard oxygen therapy for 30 days or until ICU discharge, whichever came first. While NIV has been effectively used to treat nonsurgical patients with acute exacerbations of chronic obstructive pulmonary disease and cardiogenic pulmonary edema, there is no evidence to support the use of NIV in surgical patients with hypoxemic acute respiratory failure after abdominal surgery, according to Dr. Samir Jaber of the Saint Eloi University Hospital and Montpellier School of Medicine, both in Montpellier, France, and his colleagues (JAMA. 2016 Apr 5;315[13]:1345-53).

The second study included adult patients who had received mechanical ventilation for more than 12 hours and who met criteria for being considered at low risk for reintubation. Patients were administered either high-flow oxygen therapy through nasal cannula immediately after extubation or continuous conventional oxygen therapy through nasal cannula or nonrebreather facemask; the patients were observed for 72 hours. High-flow therapy has been shown to improve oxygenation and survival in clinical studies of critically ill patients in the acute phase of respiratory failure. “[A study by S.M. Maggiore and his colleagues (Am J Respir Crit Care Med. 2014;190(3):282-8)] suggested that high-flow therapy after planned extubation decreased the reintubation rate in a general population of critical patients, but the benefits might be mainly attributable to improvements in high-risk patients,” said Dr. Gonzalo Hernandez, of the Hospital Virgen de la Salud, Toledo, Spain, and his colleagues (JAMA. 2016 Apr 5;315[13]:1354-61).

In the first study, 148 patients received NIV and 145 patients received standard oxygen therapy only. NIV was administered through a facemask connected to an ICU- or a NIV-dedicated ventilator, using either a heated humidifier or heat and moisture exchanger to warm and humidify inspired gases. Patients were encouraged to use NIV for 6 hours during the first 24 hours of the study and received standard oxygen therapy at a rate of up to 15 L/minute to maintain an arterial oxygen saturation estimate (SpO₂) of at least 94% in between NIV sessions. NIV was started at an inspiratory positive airway pressure of 5 cm H₂O, increasing to a maximum inspiratory pressure of 15 cm H₂O, aiming to achieve an expiratory tidal volume between 6 and 8 mL/kg of predicted body weight and a respiratory rate lower than 25/min. The patients in this study’s control group only received the standard oxygen therapy.

In the other study, 263 patients received conventional therapy, with the oxygen flow having been adjusted to maintain an arterial oxygen saturation estimate of greater than 92%. This study’s other 264 patients received high-flow oxygen therapy, with the flow having been initially set at 10 L/min and titrated upward in 5-L/min steps until patients experienced discomfort. The high-flow therapy was stopped after 24 hours and was followed by conventional oxygen therapy, when needed.

The primary outcome measure in the study involving NIV was cause for reintubation within 7 days of randomization.

Secondary outcome measures included gas exchange, healthcare-associated infection rate within 30 days, number of ventilator-free days between days 1 and 30, antibiotic use duration, ICU and in-hospital length of stay, and 30- and 90-day mortality.

Reintubation occurred in 49 patients in the NIV group and 66 patients in the standard oxygen therapy group, a significant difference (P = .03). Among the reintubated patients, those who had received NIV spent less time under invasive mechanical ventilation as did the patients given standard oxygen therapy. The interquartile ranges of days of invasive mechanical ventilation were 0-3 for patients in the NIV group and 0-5 for patients in the standard oxygen therapy group (P = .05). At 30 days, NIV was associated with significantly more ventilator-free days than standard oxygen therapy (25.4 vs. 23.2; P = .04). At 90 days, 22 patients in the NIV group and 31 patients in the standard oxygen therapy group had died (P = .15).

“Recent high-impact trials have demonstrated the benefits in nonsurgical hypoxemic respiratory failure or equivalence of high-flow nasal cannula compared with NIV in patients after cardiothoracic surgery with moderate to severe hypoxemia. Future studies comparing use of high-flow oxygen cannula vs standard oxygen therapy and NIV for patients after abdominal surgery as preventive (prophylactic) or curative applications are needed,” according to Dr. Jaber and his colleagues.

 

The primary outcome measure for the study of patients receiving high-flow oxygen therapy was reintubation within 72 hours after extubation; this occurred in fewer patients in the high-flow oxygen group than in the conventional therapy group (13 or 4.9% vs. 32 or 12.2%.) This statistically significant difference was mainly attributable to a lower incidence of respiratory-related reintubation in the high-flow group, compared with the conventional therapy group (1.5% vs. 8.7%), said Dr. Hernandez and his colleagues.

Secondary outcome measures included postextubation respiratory failure, respiratory infection, sepsis, multiorgan failure, ICU and hospital length of stay and mortality, time to reintubation, and adverse effects. Postintubation respiratory failure was less common in the high-flow therapy group than in the conventional therapy group (22 patients or 8.3% vs. 38 or 14.4%). Differences between the two groups in other secondary outcomes were not statistically significant.

“The main finding of this study was that high-flow oxygen significantly reduced the reintubation rate in critically ill patients at low risk for extubation failure ... High-flow therapy improves oxygenation, and the lower rate of reintubation secondary to hypoxia in the high-flow group corroborates this finding. High-flow oxygen also seems to reduce other causes of respiratory failure such as increased work of breathing and respiratory muscle fatigue, which are frequently associated with reintubation secondary to hypoxia. Another way in which high-flow therapy improves extubation outcome is by conditioning the inspired gas,” said Dr. Hernandez and his colleagues.

No adverse events were reported in either study.

Dr. Hernandez and his colleagues reported no conflicts of interest. Dr. Jaber and his colleagues disclosed no potential conflicts of interest with their study’s sponsors, Montpellier (France) University Hospital and the APARD Foundation.

[email protected]

Extubated patients who either received noninvasive ventilation (NIV) therapy or high-flow nasal cannula oxygen had a lower risk of reintubation, compared with extubated patients who received some form of standard oxygen therapy, according to the results of two multicenter, randomized clinical trials published online in JAMA.

Participants in one of the studies, which included abdominal surgery patients diagnosed with respiratory failure within 7 days following surgery, either received NIV or standard oxygen therapy for 30 days or until ICU discharge, whichever came first. While NIV has been effectively used to treat nonsurgical patients with acute exacerbations of chronic obstructive pulmonary disease and cardiogenic pulmonary edema, there is no evidence to support the use of NIV in surgical patients with hypoxemic acute respiratory failure after abdominal surgery, according to Dr. Samir Jaber of the Saint Eloi University Hospital and Montpellier School of Medicine, both in Montpellier, France, and his colleagues (JAMA. 2016 Apr 5;315[13]:1345-53).

The second study included adult patients who had received mechanical ventilation for more than 12 hours and who met criteria for being considered at low risk for reintubation. Patients were administered either high-flow oxygen therapy through nasal cannula immediately after extubation or continuous conventional oxygen therapy through nasal cannula or nonrebreather facemask; the patients were observed for 72 hours. High-flow therapy has been shown to improve oxygenation and survival in clinical studies of critically ill patients in the acute phase of respiratory failure. “[A study by S.M. Maggiore and his colleagues (Am J Respir Crit Care Med. 2014;190(3):282-8)] suggested that high-flow therapy after planned extubation decreased the reintubation rate in a general population of critical patients, but the benefits might be mainly attributable to improvements in high-risk patients,” said Dr. Gonzalo Hernandez, of the Hospital Virgen de la Salud, Toledo, Spain, and his colleagues (JAMA. 2016 Apr 5;315[13]:1354-61).

In the first study, 148 patients received NIV and 145 patients received standard oxygen therapy only. NIV was administered through a facemask connected to an ICU- or a NIV-dedicated ventilator, using either a heated humidifier or heat and moisture exchanger to warm and humidify inspired gases. Patients were encouraged to use NIV for 6 hours during the first 24 hours of the study and received standard oxygen therapy at a rate of up to 15 L/minute to maintain an arterial oxygen saturation estimate (SpO₂) of at least 94% in between NIV sessions. NIV was started at an inspiratory positive airway pressure of 5 cm H₂O, increasing to a maximum inspiratory pressure of 15 cm H₂O, aiming to achieve an expiratory tidal volume between 6 and 8 mL/kg of predicted body weight and a respiratory rate lower than 25/min. The patients in this study’s control group only received the standard oxygen therapy.

In the other study, 263 patients received conventional therapy, with the oxygen flow having been adjusted to maintain an arterial oxygen saturation estimate of greater than 92%. This study’s other 264 patients received high-flow oxygen therapy, with the flow having been initially set at 10 L/min and titrated upward in 5-L/min steps until patients experienced discomfort. The high-flow therapy was stopped after 24 hours and was followed by conventional oxygen therapy, when needed.

The primary outcome measure in the study involving NIV was cause for reintubation within 7 days of randomization.

Secondary outcome measures included gas exchange, healthcare-associated infection rate within 30 days, number of ventilator-free days between days 1 and 30, antibiotic use duration, ICU and in-hospital length of stay, and 30- and 90-day mortality.

Reintubation occurred in 49 patients in the NIV group and 66 patients in the standard oxygen therapy group, a significant difference (P = .03). Among the reintubated patients, those who had received NIV spent less time under invasive mechanical ventilation as did the patients given standard oxygen therapy. The interquartile ranges of days of invasive mechanical ventilation were 0-3 for patients in the NIV group and 0-5 for patients in the standard oxygen therapy group (P = .05). At 30 days, NIV was associated with significantly more ventilator-free days than standard oxygen therapy (25.4 vs. 23.2; P = .04). At 90 days, 22 patients in the NIV group and 31 patients in the standard oxygen therapy group had died (P = .15).

“Recent high-impact trials have demonstrated the benefits in nonsurgical hypoxemic respiratory failure or equivalence of high-flow nasal cannula compared with NIV in patients after cardiothoracic surgery with moderate to severe hypoxemia. Future studies comparing use of high-flow oxygen cannula vs standard oxygen therapy and NIV for patients after abdominal surgery as preventive (prophylactic) or curative applications are needed,” according to Dr. Jaber and his colleagues.

 

The primary outcome measure for the study of patients receiving high-flow oxygen therapy was reintubation within 72 hours after extubation; this occurred in fewer patients in the high-flow oxygen group than in the conventional therapy group (13 or 4.9% vs. 32 or 12.2%.) This statistically significant difference was mainly attributable to a lower incidence of respiratory-related reintubation in the high-flow group, compared with the conventional therapy group (1.5% vs. 8.7%), said Dr. Hernandez and his colleagues.

Secondary outcome measures included postextubation respiratory failure, respiratory infection, sepsis, multiorgan failure, ICU and hospital length of stay and mortality, time to reintubation, and adverse effects. Postintubation respiratory failure was less common in the high-flow therapy group than in the conventional therapy group (22 patients or 8.3% vs. 38 or 14.4%). Differences between the two groups in other secondary outcomes were not statistically significant.

“The main finding of this study was that high-flow oxygen significantly reduced the reintubation rate in critically ill patients at low risk for extubation failure ... High-flow therapy improves oxygenation, and the lower rate of reintubation secondary to hypoxia in the high-flow group corroborates this finding. High-flow oxygen also seems to reduce other causes of respiratory failure such as increased work of breathing and respiratory muscle fatigue, which are frequently associated with reintubation secondary to hypoxia. Another way in which high-flow therapy improves extubation outcome is by conditioning the inspired gas,” said Dr. Hernandez and his colleagues.

No adverse events were reported in either study.

Dr. Hernandez and his colleagues reported no conflicts of interest. Dr. Jaber and his colleagues disclosed no potential conflicts of interest with their study’s sponsors, Montpellier (France) University Hospital and the APARD Foundation.

[email protected]

Extubated patients who either received noninvasive ventilation (NIV) therapy or high-flow nasal cannula oxygen had a lower risk of reintubation, compared with extubated patients who received some form of standard oxygen therapy, according to the results of two multicenter, randomized clinical trials published online in JAMA.

Participants in one of the studies, which included abdominal surgery patients diagnosed with respiratory failure within 7 days following surgery, either received NIV or standard oxygen therapy for 30 days or until ICU discharge, whichever came first. While NIV has been effectively used to treat nonsurgical patients with acute exacerbations of chronic obstructive pulmonary disease and cardiogenic pulmonary edema, there is no evidence to support the use of NIV in surgical patients with hypoxemic acute respiratory failure after abdominal surgery, according to Dr. Samir Jaber of the Saint Eloi University Hospital and Montpellier School of Medicine, both in Montpellier, France, and his colleagues (JAMA. 2016 Apr 5;315[13]:1345-53).

The second study included adult patients who had received mechanical ventilation for more than 12 hours and who met criteria for being considered at low risk for reintubation. Patients were administered either high-flow oxygen therapy through nasal cannula immediately after extubation or continuous conventional oxygen therapy through nasal cannula or nonrebreather facemask; the patients were observed for 72 hours. High-flow therapy has been shown to improve oxygenation and survival in clinical studies of critically ill patients in the acute phase of respiratory failure. “[A study by S.M. Maggiore and his colleagues (Am J Respir Crit Care Med. 2014;190(3):282-8)] suggested that high-flow therapy after planned extubation decreased the reintubation rate in a general population of critical patients, but the benefits might be mainly attributable to improvements in high-risk patients,” said Dr. Gonzalo Hernandez, of the Hospital Virgen de la Salud, Toledo, Spain, and his colleagues (JAMA. 2016 Apr 5;315[13]:1354-61).

In the first study, 148 patients received NIV and 145 patients received standard oxygen therapy only. NIV was administered through a facemask connected to an ICU- or a NIV-dedicated ventilator, using either a heated humidifier or heat and moisture exchanger to warm and humidify inspired gases. Patients were encouraged to use NIV for 6 hours during the first 24 hours of the study and received standard oxygen therapy at a rate of up to 15 L/minute to maintain an arterial oxygen saturation estimate (SpO₂) of at least 94% in between NIV sessions. NIV was started at an inspiratory positive airway pressure of 5 cm H₂O, increasing to a maximum inspiratory pressure of 15 cm H₂O, aiming to achieve an expiratory tidal volume between 6 and 8 mL/kg of predicted body weight and a respiratory rate lower than 25/min. The patients in this study’s control group only received the standard oxygen therapy.

In the other study, 263 patients received conventional therapy, with the oxygen flow having been adjusted to maintain an arterial oxygen saturation estimate of greater than 92%. This study’s other 264 patients received high-flow oxygen therapy, with the flow having been initially set at 10 L/min and titrated upward in 5-L/min steps until patients experienced discomfort. The high-flow therapy was stopped after 24 hours and was followed by conventional oxygen therapy, when needed.

The primary outcome measure in the study involving NIV was cause for reintubation within 7 days of randomization.

Secondary outcome measures included gas exchange, healthcare-associated infection rate within 30 days, number of ventilator-free days between days 1 and 30, antibiotic use duration, ICU and in-hospital length of stay, and 30- and 90-day mortality.

Reintubation occurred in 49 patients in the NIV group and 66 patients in the standard oxygen therapy group, a significant difference (P = .03). Among the reintubated patients, those who had received NIV spent less time under invasive mechanical ventilation as did the patients given standard oxygen therapy. The interquartile ranges of days of invasive mechanical ventilation were 0-3 for patients in the NIV group and 0-5 for patients in the standard oxygen therapy group (P = .05). At 30 days, NIV was associated with significantly more ventilator-free days than standard oxygen therapy (25.4 vs. 23.2; P = .04). At 90 days, 22 patients in the NIV group and 31 patients in the standard oxygen therapy group had died (P = .15).

“Recent high-impact trials have demonstrated the benefits in nonsurgical hypoxemic respiratory failure or equivalence of high-flow nasal cannula compared with NIV in patients after cardiothoracic surgery with moderate to severe hypoxemia. Future studies comparing use of high-flow oxygen cannula vs standard oxygen therapy and NIV for patients after abdominal surgery as preventive (prophylactic) or curative applications are needed,” according to Dr. Jaber and his colleagues.

 

The primary outcome measure for the study of patients receiving high-flow oxygen therapy was reintubation within 72 hours after extubation; this occurred in fewer patients in the high-flow oxygen group than in the conventional therapy group (13 or 4.9% vs. 32 or 12.2%.) This statistically significant difference was mainly attributable to a lower incidence of respiratory-related reintubation in the high-flow group, compared with the conventional therapy group (1.5% vs. 8.7%), said Dr. Hernandez and his colleagues.

Secondary outcome measures included postextubation respiratory failure, respiratory infection, sepsis, multiorgan failure, ICU and hospital length of stay and mortality, time to reintubation, and adverse effects. Postintubation respiratory failure was less common in the high-flow therapy group than in the conventional therapy group (22 patients or 8.3% vs. 38 or 14.4%). Differences between the two groups in other secondary outcomes were not statistically significant.

“The main finding of this study was that high-flow oxygen significantly reduced the reintubation rate in critically ill patients at low risk for extubation failure ... High-flow therapy improves oxygenation, and the lower rate of reintubation secondary to hypoxia in the high-flow group corroborates this finding. High-flow oxygen also seems to reduce other causes of respiratory failure such as increased work of breathing and respiratory muscle fatigue, which are frequently associated with reintubation secondary to hypoxia. Another way in which high-flow therapy improves extubation outcome is by conditioning the inspired gas,” said Dr. Hernandez and his colleagues.

No adverse events were reported in either study.

Dr. Hernandez and his colleagues reported no conflicts of interest. Dr. Jaber and his colleagues disclosed no potential conflicts of interest with their study’s sponsors, Montpellier (France) University Hospital and the APARD Foundation.

[email protected]

LOS ANGELES – A new Cochrane systematic review and meta-analysis has concluded there is no consistent evidence that specific allergen immunotherapy is beneficial in patients with atopic dermatitis, Dr. Herman H. Tam reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“We know that for specific allergen immunotherapy, there have been really good results in allergic rhinitis and venom allergy. For atopic dermatitis, however, dating back almost 40 years, we found there have only been 12 randomized trials using standardized allergen extracts. The quality of evidence was low, and the study findings have been inconsistent,” Dr. Tam, first author of the Cochrane review, said in an interview.

Bruce Jancin/Frontline Medical News

The dozen trials included a total of 733 children and adults in nine countries. Because of insufficient follow-up in most of the studies, coupled with the use of a variety of endpoints, the analysis concluded that “specific allergen immunotherapy cannot be recommended for atopic eczema at present” (Cochrane Database Syst Rev. 2016 Feb 12;2:CD008774).

“We found no consistent evidence that specific allergen immunotherapy provides a treatment benefit for people with allergic eczema, compared with placebo or no treatment. The message of this review is that we need more large randomized trials with better controls, modern high-quality allergen extracts that have proven themselves in other allergic diseases, and patient-centered outcome measures,” according to Dr. Tam, who participated in the Cochrane review while at Imperial College London and is now a pediatric resident at the University of Manitoba, Winnipeg.

He reported having no relevant financial conflicts.

[email protected]

LOS ANGELES – A new Cochrane systematic review and meta-analysis has concluded there is no consistent evidence that specific allergen immunotherapy is beneficial in patients with atopic dermatitis, Dr. Herman H. Tam reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“We know that for specific allergen immunotherapy, there have been really good results in allergic rhinitis and venom allergy. For atopic dermatitis, however, dating back almost 40 years, we found there have only been 12 randomized trials using standardized allergen extracts. The quality of evidence was low, and the study findings have been inconsistent,” Dr. Tam, first author of the Cochrane review, said in an interview.

Bruce Jancin/Frontline Medical News

The dozen trials included a total of 733 children and adults in nine countries. Because of insufficient follow-up in most of the studies, coupled with the use of a variety of endpoints, the analysis concluded that “specific allergen immunotherapy cannot be recommended for atopic eczema at present” (Cochrane Database Syst Rev. 2016 Feb 12;2:CD008774).

“We found no consistent evidence that specific allergen immunotherapy provides a treatment benefit for people with allergic eczema, compared with placebo or no treatment. The message of this review is that we need more large randomized trials with better controls, modern high-quality allergen extracts that have proven themselves in other allergic diseases, and patient-centered outcome measures,” according to Dr. Tam, who participated in the Cochrane review while at Imperial College London and is now a pediatric resident at the University of Manitoba, Winnipeg.

He reported having no relevant financial conflicts.

[email protected]

LOS ANGELES – A new Cochrane systematic review and meta-analysis has concluded there is no consistent evidence that specific allergen immunotherapy is beneficial in patients with atopic dermatitis, Dr. Herman H. Tam reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“We know that for specific allergen immunotherapy, there have been really good results in allergic rhinitis and venom allergy. For atopic dermatitis, however, dating back almost 40 years, we found there have only been 12 randomized trials using standardized allergen extracts. The quality of evidence was low, and the study findings have been inconsistent,” Dr. Tam, first author of the Cochrane review, said in an interview.

Bruce Jancin/Frontline Medical News

The dozen trials included a total of 733 children and adults in nine countries. Because of insufficient follow-up in most of the studies, coupled with the use of a variety of endpoints, the analysis concluded that “specific allergen immunotherapy cannot be recommended for atopic eczema at present” (Cochrane Database Syst Rev. 2016 Feb 12;2:CD008774).

“We found no consistent evidence that specific allergen immunotherapy provides a treatment benefit for people with allergic eczema, compared with placebo or no treatment. The message of this review is that we need more large randomized trials with better controls, modern high-quality allergen extracts that have proven themselves in other allergic diseases, and patient-centered outcome measures,” according to Dr. Tam, who participated in the Cochrane review while at Imperial College London and is now a pediatric resident at the University of Manitoba, Winnipeg.

He reported having no relevant financial conflicts.

[email protected]

BALTIMORE – In the treatment of primary hyperparathyroidism, clinical guidelines recommend using sestamibi scan for localizing adenoma, but increasingly endocrinologists are using sestamibi results to determine whether or not to refer a patient for parathyroidectomy surgery, while surgeons are using the scans as a factor in deciding whether to perform the operation.

That was the conclusion of a paper Dr. Susana Wu presented at the American Association of Endocrine Surgeons annual meeting. Dr. Wu reported on behalf of her colleagues at Kaiser Permanente Los Angeles Medical Center and at Scripps Clinic in San Diego.

“This study suggests that negative sestamibi scan (SS) results influence management of patients with primary hyperparathyroidism,” Dr. Wu said. “Endocrinologists were less likely to refer to surgeons and surgeons were less likely to offer parathyroidectomy to a patient with a negative sestamibi scan.”

The study involved a retrospective chart review of all 539 patients with primary hyperparathyroidism in the Kaiser Permanente Southern California database from December 2011 to December 2013, 452 of whom were seen by 63 endocrinologists at 14 centers. Among these patients, 260 had SS – 120 negative and 140 positive. The study identified statistically significant variations in how both endocrinologists and surgeons managed patients depending on SS results. The researchers used Kaiser Permanente’s electronic referral system to track referrals.

“The most significant negative predictor for endocrinologists referring to surgeons was a negative sestamibi scan, with an odds ratio of 0.36,” Dr. Wu said.

Endocrinologists referred 86% of patients with positive SS to surgeons, but only 68% of those with negative SS. Surgeons exhibited a similar practice pattern. “Surgeons were less likely to recommend parathyroidectomy for patients with a negative sestamibi scan, with an odds ratio of 0.20,” Dr. Wu said. Surgeons operated on 87% of patients with a negative SS scan but 96% with a positive SS.

In an interview, study coauthor Dr. Philip Haigh explained that parathyroidectomy when the SS is negative is a more difficult operation for the surgeon, and that might make some physicians hesitate before going forward with surgery. “It has been previously shown by other studies that it is a more difficult operation when the sestamibi scan is negative because you have to look at four glands instead of removing just one, but if the surgeon is experienced, it should achieve a high success rate,” Dr. Haigh said. He said that parathyroidectomy in sestamibi-negative hyperparathyroidism had a cure rate as high as 98% in the study presented.

He offered two thoughts on how clinicians should use the study results. “To the endocrinologist, if you’re going to order a sestamibi scan, don’t change your referral practice depending on the result,” Dr. Haigh said. “To the surgeon, if you’re not comfortable operating on a patient with a negative sestamibi scan, then find someone who is.”

The study had a few limitations, Dr. Wu said. Along with its retrospective nature, the study also did not account for potential disparity in radiological vs. surgeon interpretation of the scans.

During the discussion, Dr. Samuel Snyder, of Baylor Scott & White Health, Temple, Tex., said he concurred with the results Dr. Wu reported. “It really worries me about what is happening to patients who have negative scans,” he said. “What I’ve seen in patients referred for surgery is a lot of variation in how the sestamibi scan is done.” He asked if the study accounted for the different types of sestamibi scans and how they were performed, but Dr. Wu said it did not.

Dr. Christopher McHenry of MetroHealth Medical Center, Cleveland, also concurred. “I think this is a phenomenon that occurs more often than we think or we’re aware of,” he said. “I continue to be amazed with how clinicians equate a negative sestamibi scan with not having primary hyperparathyroidism. I think it needs to reemphasized that the sestamibi scan is not diagnostic; it’s for localization.”

He asked Dr. Wu, “How do we change behavior to deal with this problem?”

Dr. Wu said her institution is developing a safety-net program that would aim to increase the identification and chart coding of patients with primary hyperparathyroidism, automate essential labs to be ordered in patients with high calcium, and automate referral to endocrinologists. The study and its findings will be disseminated to endocrinologists in the region.

The study authors had no disclosures.

BALTIMORE – In the treatment of primary hyperparathyroidism, clinical guidelines recommend using sestamibi scan for localizing adenoma, but increasingly endocrinologists are using sestamibi results to determine whether or not to refer a patient for parathyroidectomy surgery, while surgeons are using the scans as a factor in deciding whether to perform the operation.

That was the conclusion of a paper Dr. Susana Wu presented at the American Association of Endocrine Surgeons annual meeting. Dr. Wu reported on behalf of her colleagues at Kaiser Permanente Los Angeles Medical Center and at Scripps Clinic in San Diego.

“This study suggests that negative sestamibi scan (SS) results influence management of patients with primary hyperparathyroidism,” Dr. Wu said. “Endocrinologists were less likely to refer to surgeons and surgeons were less likely to offer parathyroidectomy to a patient with a negative sestamibi scan.”

The study involved a retrospective chart review of all 539 patients with primary hyperparathyroidism in the Kaiser Permanente Southern California database from December 2011 to December 2013, 452 of whom were seen by 63 endocrinologists at 14 centers. Among these patients, 260 had SS – 120 negative and 140 positive. The study identified statistically significant variations in how both endocrinologists and surgeons managed patients depending on SS results. The researchers used Kaiser Permanente’s electronic referral system to track referrals.

“The most significant negative predictor for endocrinologists referring to surgeons was a negative sestamibi scan, with an odds ratio of 0.36,” Dr. Wu said.

Endocrinologists referred 86% of patients with positive SS to surgeons, but only 68% of those with negative SS. Surgeons exhibited a similar practice pattern. “Surgeons were less likely to recommend parathyroidectomy for patients with a negative sestamibi scan, with an odds ratio of 0.20,” Dr. Wu said. Surgeons operated on 87% of patients with a negative SS scan but 96% with a positive SS.

In an interview, study coauthor Dr. Philip Haigh explained that parathyroidectomy when the SS is negative is a more difficult operation for the surgeon, and that might make some physicians hesitate before going forward with surgery. “It has been previously shown by other studies that it is a more difficult operation when the sestamibi scan is negative because you have to look at four glands instead of removing just one, but if the surgeon is experienced, it should achieve a high success rate,” Dr. Haigh said. He said that parathyroidectomy in sestamibi-negative hyperparathyroidism had a cure rate as high as 98% in the study presented.

He offered two thoughts on how clinicians should use the study results. “To the endocrinologist, if you’re going to order a sestamibi scan, don’t change your referral practice depending on the result,” Dr. Haigh said. “To the surgeon, if you’re not comfortable operating on a patient with a negative sestamibi scan, then find someone who is.”

The study had a few limitations, Dr. Wu said. Along with its retrospective nature, the study also did not account for potential disparity in radiological vs. surgeon interpretation of the scans.

During the discussion, Dr. Samuel Snyder, of Baylor Scott & White Health, Temple, Tex., said he concurred with the results Dr. Wu reported. “It really worries me about what is happening to patients who have negative scans,” he said. “What I’ve seen in patients referred for surgery is a lot of variation in how the sestamibi scan is done.” He asked if the study accounted for the different types of sestamibi scans and how they were performed, but Dr. Wu said it did not.

Dr. Christopher McHenry of MetroHealth Medical Center, Cleveland, also concurred. “I think this is a phenomenon that occurs more often than we think or we’re aware of,” he said. “I continue to be amazed with how clinicians equate a negative sestamibi scan with not having primary hyperparathyroidism. I think it needs to reemphasized that the sestamibi scan is not diagnostic; it’s for localization.”

He asked Dr. Wu, “How do we change behavior to deal with this problem?”

Dr. Wu said her institution is developing a safety-net program that would aim to increase the identification and chart coding of patients with primary hyperparathyroidism, automate essential labs to be ordered in patients with high calcium, and automate referral to endocrinologists. The study and its findings will be disseminated to endocrinologists in the region.

The study authors had no disclosures.

BALTIMORE – In the treatment of primary hyperparathyroidism, clinical guidelines recommend using sestamibi scan for localizing adenoma, but increasingly endocrinologists are using sestamibi results to determine whether or not to refer a patient for parathyroidectomy surgery, while surgeons are using the scans as a factor in deciding whether to perform the operation.

That was the conclusion of a paper Dr. Susana Wu presented at the American Association of Endocrine Surgeons annual meeting. Dr. Wu reported on behalf of her colleagues at Kaiser Permanente Los Angeles Medical Center and at Scripps Clinic in San Diego.

“This study suggests that negative sestamibi scan (SS) results influence management of patients with primary hyperparathyroidism,” Dr. Wu said. “Endocrinologists were less likely to refer to surgeons and surgeons were less likely to offer parathyroidectomy to a patient with a negative sestamibi scan.”

The study involved a retrospective chart review of all 539 patients with primary hyperparathyroidism in the Kaiser Permanente Southern California database from December 2011 to December 2013, 452 of whom were seen by 63 endocrinologists at 14 centers. Among these patients, 260 had SS – 120 negative and 140 positive. The study identified statistically significant variations in how both endocrinologists and surgeons managed patients depending on SS results. The researchers used Kaiser Permanente’s electronic referral system to track referrals.

“The most significant negative predictor for endocrinologists referring to surgeons was a negative sestamibi scan, with an odds ratio of 0.36,” Dr. Wu said.

Endocrinologists referred 86% of patients with positive SS to surgeons, but only 68% of those with negative SS. Surgeons exhibited a similar practice pattern. “Surgeons were less likely to recommend parathyroidectomy for patients with a negative sestamibi scan, with an odds ratio of 0.20,” Dr. Wu said. Surgeons operated on 87% of patients with a negative SS scan but 96% with a positive SS.

In an interview, study coauthor Dr. Philip Haigh explained that parathyroidectomy when the SS is negative is a more difficult operation for the surgeon, and that might make some physicians hesitate before going forward with surgery. “It has been previously shown by other studies that it is a more difficult operation when the sestamibi scan is negative because you have to look at four glands instead of removing just one, but if the surgeon is experienced, it should achieve a high success rate,” Dr. Haigh said. He said that parathyroidectomy in sestamibi-negative hyperparathyroidism had a cure rate as high as 98% in the study presented.

He offered two thoughts on how clinicians should use the study results. “To the endocrinologist, if you’re going to order a sestamibi scan, don’t change your referral practice depending on the result,” Dr. Haigh said. “To the surgeon, if you’re not comfortable operating on a patient with a negative sestamibi scan, then find someone who is.”

The study had a few limitations, Dr. Wu said. Along with its retrospective nature, the study also did not account for potential disparity in radiological vs. surgeon interpretation of the scans.

During the discussion, Dr. Samuel Snyder, of Baylor Scott & White Health, Temple, Tex., said he concurred with the results Dr. Wu reported. “It really worries me about what is happening to patients who have negative scans,” he said. “What I’ve seen in patients referred for surgery is a lot of variation in how the sestamibi scan is done.” He asked if the study accounted for the different types of sestamibi scans and how they were performed, but Dr. Wu said it did not.

Dr. Christopher McHenry of MetroHealth Medical Center, Cleveland, also concurred. “I think this is a phenomenon that occurs more often than we think or we’re aware of,” he said. “I continue to be amazed with how clinicians equate a negative sestamibi scan with not having primary hyperparathyroidism. I think it needs to reemphasized that the sestamibi scan is not diagnostic; it’s for localization.”

He asked Dr. Wu, “How do we change behavior to deal with this problem?”

Dr. Wu said her institution is developing a safety-net program that would aim to increase the identification and chart coding of patients with primary hyperparathyroidism, automate essential labs to be ordered in patients with high calcium, and automate referral to endocrinologists. The study and its findings will be disseminated to endocrinologists in the region.

The study authors had no disclosures.

The healthcare industry is not yet at zero when it comes to healthcare-associated infections—and that’s a problem. Hand hygiene compliance remains a major cause.

The Joint Commission addresses that problem with the Hand Hygiene Targeted Solutions Tool (TST), an online application that guides the user through collecting and analyzing data, with suggested solutions based on the root causes revealed. “It’s based on robust process improvement, what we refer to as RPI, that brings in Lean, Six Sigma, and change management,” says Erin DuPree, MD, chief medical officer and vice president, The Joint Commission Center for Transforming Healthcare.

The tool was tested in a pilot program summarized in an article in the January 2016 issue of The Joint Commission Journal on Quality and Safety, “Hand Hygiene Tool Linked to Decrease in Health Care-Associated Infections at Memorial Hermann Health System,” by M. Michael Shabot, MD, of Memorial Hermann Health System, Mark R. Chassin, MD, MPP, MPH, of The Joint Commission, and their co-authors. In more than 31,600 observations, the organization’s average hand hygiene compliance improved from 58.1% to 95.6%. Rates of central line–associated bloodstream infections and ventilator-associated pneumonia in adult ICUs decreased by 49% and 45%, respectively.

Dr. DuPree encourages hospitalists to champion hand hygiene at their own organizations. “The more physicians lead and participate, the higher performing the organization is.”

The healthcare industry is not yet at zero when it comes to healthcare-associated infections—and that’s a problem. Hand hygiene compliance remains a major cause.

The Joint Commission addresses that problem with the Hand Hygiene Targeted Solutions Tool (TST), an online application that guides the user through collecting and analyzing data, with suggested solutions based on the root causes revealed. “It’s based on robust process improvement, what we refer to as RPI, that brings in Lean, Six Sigma, and change management,” says Erin DuPree, MD, chief medical officer and vice president, The Joint Commission Center for Transforming Healthcare.

The tool was tested in a pilot program summarized in an article in the January 2016 issue of The Joint Commission Journal on Quality and Safety, “Hand Hygiene Tool Linked to Decrease in Health Care-Associated Infections at Memorial Hermann Health System,” by M. Michael Shabot, MD, of Memorial Hermann Health System, Mark R. Chassin, MD, MPP, MPH, of The Joint Commission, and their co-authors. In more than 31,600 observations, the organization’s average hand hygiene compliance improved from 58.1% to 95.6%. Rates of central line–associated bloodstream infections and ventilator-associated pneumonia in adult ICUs decreased by 49% and 45%, respectively.

Dr. DuPree encourages hospitalists to champion hand hygiene at their own organizations. “The more physicians lead and participate, the higher performing the organization is.”

The healthcare industry is not yet at zero when it comes to healthcare-associated infections—and that’s a problem. Hand hygiene compliance remains a major cause.

The Joint Commission addresses that problem with the Hand Hygiene Targeted Solutions Tool (TST), an online application that guides the user through collecting and analyzing data, with suggested solutions based on the root causes revealed. “It’s based on robust process improvement, what we refer to as RPI, that brings in Lean, Six Sigma, and change management,” says Erin DuPree, MD, chief medical officer and vice president, The Joint Commission Center for Transforming Healthcare.

The tool was tested in a pilot program summarized in an article in the January 2016 issue of The Joint Commission Journal on Quality and Safety, “Hand Hygiene Tool Linked to Decrease in Health Care-Associated Infections at Memorial Hermann Health System,” by M. Michael Shabot, MD, of Memorial Hermann Health System, Mark R. Chassin, MD, MPP, MPH, of The Joint Commission, and their co-authors. In more than 31,600 observations, the organization’s average hand hygiene compliance improved from 58.1% to 95.6%. Rates of central line–associated bloodstream infections and ventilator-associated pneumonia in adult ICUs decreased by 49% and 45%, respectively.

Dr. DuPree encourages hospitalists to champion hand hygiene at their own organizations. “The more physicians lead and participate, the higher performing the organization is.”

Are we overlooking factors that could help bring about necessary changes to the healthcare industry? Elliott S. Fisher, MD, MPH, of the Dartmouth Institute for Health Policy and Clinical Practice, thinks so.

“We are missing an important opportunity to learn from what is going on in health systems every day that could tell us how to make healthcare better and cheaper,” says Dr. Fisher, lead author of a January 2016 JAMA “Viewpoint” called “Implementation Science: A Potential Catalyst for Delivery System Reform.” “That’s the argument for the the field of implementation science.”

Implementation science studies ways to promote the integration of research findings and evidence into the healthcare system. Dr. Fisher says that integration is influenced by multiple factors: the characteristic of the innovation itself, the organizational setting, and the policy or community environment within which that organization is working. Context matters.

“We tend to think about adopting innovations like a new blood pressure medication or a new device,” Dr. Fisher says. “Those decisions rest almost entirely on the shoulders of physicians, so adoption requires thinking about the attributes of biomedical innovations and how physicians think.”

With care delivery innovations—for example, how to provide optimal care for people with heart failure across home, hospital, and nursing home—those are often developed with clinical input but by people who are fundamentally managers.

“It’s a more complex set of actors,” he says, “so you have to think about those decision makers if you’re going to get the best evidence-based practice into their setting.”

A third category of innovation focuses on individual behavior change, where the decision makers are the clinician and the patient and family. “You’ve got to persuade the patient the innovation is worth doing, so different factors may influence the successful adoptions of those interventions,” Dr. Fisher says.

Reference

1. Fisher ES, Shortell SM, Savitz LA. Implementation science: a potential catalyst for delivery system reform. JAMA. 2016;315(4):339-340. doi:10.1001/jama.2015.17949.

Are we overlooking factors that could help bring about necessary changes to the healthcare industry? Elliott S. Fisher, MD, MPH, of the Dartmouth Institute for Health Policy and Clinical Practice, thinks so.

“We are missing an important opportunity to learn from what is going on in health systems every day that could tell us how to make healthcare better and cheaper,” says Dr. Fisher, lead author of a January 2016 JAMA “Viewpoint” called “Implementation Science: A Potential Catalyst for Delivery System Reform.” “That’s the argument for the the field of implementation science.”

Implementation science studies ways to promote the integration of research findings and evidence into the healthcare system. Dr. Fisher says that integration is influenced by multiple factors: the characteristic of the innovation itself, the organizational setting, and the policy or community environment within which that organization is working. Context matters.

“We tend to think about adopting innovations like a new blood pressure medication or a new device,” Dr. Fisher says. “Those decisions rest almost entirely on the shoulders of physicians, so adoption requires thinking about the attributes of biomedical innovations and how physicians think.”

With care delivery innovations—for example, how to provide optimal care for people with heart failure across home, hospital, and nursing home—those are often developed with clinical input but by people who are fundamentally managers.

“It’s a more complex set of actors,” he says, “so you have to think about those decision makers if you’re going to get the best evidence-based practice into their setting.”

A third category of innovation focuses on individual behavior change, where the decision makers are the clinician and the patient and family. “You’ve got to persuade the patient the innovation is worth doing, so different factors may influence the successful adoptions of those interventions,” Dr. Fisher says.

Reference

1. Fisher ES, Shortell SM, Savitz LA. Implementation science: a potential catalyst for delivery system reform. JAMA. 2016;315(4):339-340. doi:10.1001/jama.2015.17949.

Are we overlooking factors that could help bring about necessary changes to the healthcare industry? Elliott S. Fisher, MD, MPH, of the Dartmouth Institute for Health Policy and Clinical Practice, thinks so.

“We are missing an important opportunity to learn from what is going on in health systems every day that could tell us how to make healthcare better and cheaper,” says Dr. Fisher, lead author of a January 2016 JAMA “Viewpoint” called “Implementation Science: A Potential Catalyst for Delivery System Reform.” “That’s the argument for the the field of implementation science.”

Implementation science studies ways to promote the integration of research findings and evidence into the healthcare system. Dr. Fisher says that integration is influenced by multiple factors: the characteristic of the innovation itself, the organizational setting, and the policy or community environment within which that organization is working. Context matters.

“We tend to think about adopting innovations like a new blood pressure medication or a new device,” Dr. Fisher says. “Those decisions rest almost entirely on the shoulders of physicians, so adoption requires thinking about the attributes of biomedical innovations and how physicians think.”

With care delivery innovations—for example, how to provide optimal care for people with heart failure across home, hospital, and nursing home—those are often developed with clinical input but by people who are fundamentally managers.

“It’s a more complex set of actors,” he says, “so you have to think about those decision makers if you’re going to get the best evidence-based practice into their setting.”

A third category of innovation focuses on individual behavior change, where the decision makers are the clinician and the patient and family. “You’ve got to persuade the patient the innovation is worth doing, so different factors may influence the successful adoptions of those interventions,” Dr. Fisher says.

Reference

1. Fisher ES, Shortell SM, Savitz LA. Implementation science: a potential catalyst for delivery system reform. JAMA. 2016;315(4):339-340. doi:10.1001/jama.2015.17949.

The US Department of Health and Human Services (HHS) is providing financial support for a clinical trial of the cobas® Zika test, which is designed to screen blood donations for Zika virus.

The US Food and Drug Administration (FDA) recently authorized the use of this test, under an investigational new drug application protocol, for screening donated blood in areas with active, mosquito-borne transmission of Zika virus.

This means the cobas® Zika test can be used by US blood screening laboratories, but the laboratories will need to be enrolled in and contracted into the clinical trial as specified and agreed with the FDA’s Center for Biologics Evaluation and Research.

Now, the HHS has announced that the Biomedical Advanced Research and Development Authority (BARDA) is supporting the trial, which will evaluate the sensitivity and specificity of the test in its actual use.

The trial is necessary for Roche, the company developing the cobas® Zika test, to apply for FDA approval for commercial marketing.

“BARDA staff has worked closely with our partners at FDA and the Office of the Assistant Secretary of Health to ensure the continuity and safety of the US blood supply,” said Richard Hatchett, BARDA’s acting director.

“Today’s award to Roche is an important step towards securing the safety of the blood supply in Puerto Rico and in the rest of the United States.”

Under the 1-year, $354,500 contract, Roche will study blood samples to confirm whether the test accurately and reliably detects and identifies Zika virus, even when present in very low concentrations in donor blood.

The US Department of Health and Human Services (HHS) is providing financial support for a clinical trial of the cobas® Zika test, which is designed to screen blood donations for Zika virus.

The US Food and Drug Administration (FDA) recently authorized the use of this test, under an investigational new drug application protocol, for screening donated blood in areas with active, mosquito-borne transmission of Zika virus.

This means the cobas® Zika test can be used by US blood screening laboratories, but the laboratories will need to be enrolled in and contracted into the clinical trial as specified and agreed with the FDA’s Center for Biologics Evaluation and Research.

Now, the HHS has announced that the Biomedical Advanced Research and Development Authority (BARDA) is supporting the trial, which will evaluate the sensitivity and specificity of the test in its actual use.

The trial is necessary for Roche, the company developing the cobas® Zika test, to apply for FDA approval for commercial marketing.

“BARDA staff has worked closely with our partners at FDA and the Office of the Assistant Secretary of Health to ensure the continuity and safety of the US blood supply,” said Richard Hatchett, BARDA’s acting director.

“Today’s award to Roche is an important step towards securing the safety of the blood supply in Puerto Rico and in the rest of the United States.”

Under the 1-year, $354,500 contract, Roche will study blood samples to confirm whether the test accurately and reliably detects and identifies Zika virus, even when present in very low concentrations in donor blood.

The US Department of Health and Human Services (HHS) is providing financial support for a clinical trial of the cobas® Zika test, which is designed to screen blood donations for Zika virus.

The US Food and Drug Administration (FDA) recently authorized the use of this test, under an investigational new drug application protocol, for screening donated blood in areas with active, mosquito-borne transmission of Zika virus.

This means the cobas® Zika test can be used by US blood screening laboratories, but the laboratories will need to be enrolled in and contracted into the clinical trial as specified and agreed with the FDA’s Center for Biologics Evaluation and Research.

Now, the HHS has announced that the Biomedical Advanced Research and Development Authority (BARDA) is supporting the trial, which will evaluate the sensitivity and specificity of the test in its actual use.

The trial is necessary for Roche, the company developing the cobas® Zika test, to apply for FDA approval for commercial marketing.

“BARDA staff has worked closely with our partners at FDA and the Office of the Assistant Secretary of Health to ensure the continuity and safety of the US blood supply,” said Richard Hatchett, BARDA’s acting director.

“Today’s award to Roche is an important step towards securing the safety of the blood supply in Puerto Rico and in the rest of the United States.”

Under the 1-year, $354,500 contract, Roche will study blood samples to confirm whether the test accurately and reliably detects and identifies Zika virus, even when present in very low concentrations in donor blood.